Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health Acronyms ABC—Abstinence, Be Faithful, or use Condoms ACMS—Cameroonian Association for Social Marketing AIDS—Acquired Immunodeficiency Syndrome AIDSTAR—AIDS Support & Technical Assistance Resources ART—Antiretroviral Therapy CCP—Comprehensive Condom Programming CDD—Catholics for the Right to Decide CE—European Conformity Marking CHANGE—Center for Health and Gender Equity COP—Country Operational Plan DFID—United Kingdom Department for International Development DHS—Demographic Health Survey FC1—First-generation Female Condom (Female Health Company) FC2—Second-generation Female Condom (Female Health Company) FHC—Female Health Company FY—Fiscal Year GFATM—Global Fund to Fight AIDS, Tuberculosis, and Malaria GHI—United States Global Health Initiative HIV—Human Immunodeficiency Virus HPM—Hunger Project Malawi JCRC—Joint Clinical Research Center (Uganda) JSI—John Snow, Inc. MOH—Ministry of Health MOHCW—Ministry of Health and Child Welfare (Zimbabwe) NGI—Next Generation Indicators NGO—Nongovernmental Organization OGAC—Office of the Global AIDS Coordinator PEPFAR—President’s Emergency Plan for AIDS Relief PrEP—Pre-Exposure Prophylaxis PSI—Population Services International RHU—Reproductive Health Unit (Malawi Ministry of Health) RFA—Request for Applications RFP—Request for Proposals STI—Sexually Transmitted Infection TB—Tuberculosis TSG—Technical Support Group UAFC—Universal Access to Female Condoms Joint Programme UNAIDS—Joint United Nations Programme on HIV/AIDS UNFPA—United Nations Population Fund USAID—United States Agency for International Development USFDA—United States Food and Drug Administration WASN—Women and AIDS Support Network WHO—World Health Organization TABLE OF CONTENTS ABOUT THE REPORT 5 EXECUTIVE SUMMARY 7 INTRODUCTION: THE GLOBAL FAILURE ON FEMALE CONDOMS 13 PART ONE: THE CASE FOR FEMALE CONDOMS 15 I. Female Condom Products 15 II. Female Condom Qualities: Acceptable, Effective, and Much More 15 Female Condoms are Acceptable Female Condoms are Effective Female Condoms Have Numerous Benefits and Advantages PART TWO: CHALLENGES TO FEMALE CONDOMS 19 I. Problems Stem Predominantly from Lack of Commitment 20 Commodity Challenges Stockouts Programming Challenges Female Condom Training and Health Provider Bias Cost PART THREE: THE REALITY AND POSSIBILITY OF U.S. POLICY ON FEMALE CONDOMS 25 I. U.S. Global HIV Prevention and Female Condoms: PEPFAR, USAID, and GHI 25 II. The U.S. and Female Condom Procurement 26 III. The U.S. and Female Condom Logistics 28 IV. The U.S. and Female Condom Programming 28 V. Limitations on U.S. Procurement and Programming of Female Condoms 30 PEPFAR and the Condom Gap Negative Attitudes or Lack of Awareness among U.S. Government Officials PEPFAR Funding Restrictions PEPFAR Data Collection and Reporting Efforts 1 2 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health PART FOUR: IMPACT AND CHALLENGES IN THE FIELD: COUNTRY CASE STUDIES 35 I. Zimbabwe35 History and Female Condom Introduction Revitalizing Female Condoms Current Program Structure and Support Successes Challenges II. Malawi39 History and Female Condom Introduction Revitalizing Female Condoms Recent Developments in Program Structure and Support Successes Challenges III. Cameroon41 History Current Program Successes and Challenges IV. Bolivia43 Background History Current Program Successes and Challenges V. Strengths and Weaknesses of U.S. Government Field Support for Female Condom Programs 45 U.S. Strengths Commodity Financing, Coordination, and Logistics Collaboration and Alignment with other Donors, Governments, and Stakeholders Support for Social Marketing U.S. Weaknesses Insufficient Funding for Programming Lack of Female Condom Oversight or Program Tracking Limited USAID Mission Outreach to Civil Society VI. Ingredients of an Effective Female Condom Program 48 Table of Contents PART FIVE: FINDINGS AND RECOMMENDATIONS 51 NOTES 55 BIBLIOGRAPHY 63 ANNEXES 67 Annex A: Female Condom Products 67 Annex B: U.S. Female Condom Procurement for International Programs 71 Annex C: UNFPA and UNAIDS Inter-Agency 10-Step Strategic Approach to Scale Up Comprehensive Condom Programming at the National Level 73 3 4 ABOUT THE REPORT T oday, we have a dual protection tool to prevent HIV/STIs and unintended pregnancy that is designed for women to initiate. It is available now. It is effective. And it is acceptable. Yet, globally, female condoms continue to be underfunded and underused due to cost, stigma, and a lack of political will. Among donors, the U.S. government is a leader in supporting female condoms. Despite this leadership, female condoms represented just 3.2 percent of total U.S. condom shipments in 2009. Since the release of its 2008 report on U.S. foreign assistance and female condoms, Saving Lives Now: Female Condoms and the Role of U.S. Foreign Aid, CHANGE has seen improvements in U.S. support for female condoms: In 2008, the U.S. Congress reauthorized the President’s Emergency Plan for AIDS Relief (PEPFAR), which for the first time explicitly mentioned both female and male condoms and the need to increase the availability of and access to these commodities. Female condoms are explicitly mentioned in PEPFAR’s most recent guidance to the field, PEPFAR’s FY 2011 Country Operational Plan Guidance. Guidance appendices, which are used in the field to guide program planning, state: “…given the priority placed upon a women and girls-centered approach in the PEPFAR 5 Year Strategy and GHI, prevention programming should include interventions that empower women and address gender inequities in accordance with the epidemiology in each context. Tools like the female condom, which give women more options for practicing safer sex, are important options.” The U.S. has dramatically increased its procurement of female condoms, with international shipments growing from 1,109,000 in 2003 to a record high of 14,676,000 in 2009. While we recognize and applaud the increased attention from the U.S. government to female condom procurement and programming, more efforts are needed to make female condoms truly available, accessible, and affordable for individuals who would benefit greatly from their use. The purpose of this report is to inform policy makers, 5 6 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health donors, and advocates about female condoms and recent U.S. support for procurement, distribution, and programming of female condoms. The report includes countryspecific case studies to demonstrate what is needed to ensure successful female condom programming. We hope this information will propagate successful practices and spark new ideas and strategies to increase support for procurement, distribution, and programming of female condoms. This report is based on a review of published literature, in addition to extensive interviews with experts from organizations and the U.S. government to gather information that is not available in literature or policy documents. Based on these interviews and review of existing evidence on female condoms, CHANGE concludes the report with findings and recommendations to remove barriers that have denied women, men, and youth access to female condoms, and to ensure stronger U.S. support for female condoms in the future. Female condoms are not the magic bullet to stop HIV/AIDS, but they are an important tool for a combination and rights-based approach to HIV prevention. With increased and steady support from donors like the U.S., and a commitment to improve and expand programming and training, female condoms will gradually become available to all, improving health and saving lives. Serra Sippel President Center for Health and Gender Equity (CHANGE) EXECUTIVE SUMMARY I t would be quite reasonable to assume that the world is already investing enthusiastically and overwhelmingly in female condoms. On the face of it, pouring time and treasure into purchasing and promoting a product that can give women the ability to initiate their own protection from unwanted pregnancy, HIV transmission, and other sexually transmitted infections (STIs)—all extremely urgent health concerns for women of reproductive age—seems like an obvious solution. Yet, remarkably, investment in female condom procurement and programming has been negligible in comparison to other prevention approaches. While donors and governments have made some increases in recent years thanks in large part to civil society efforts, they have remained largely resistant to making the sizable investment in female condoms warranted by the product’s potential. This resistance flies in the face of evidence. A number of female condom products are currently available on public and private markets, with additional products in development—a testament in itself to consumer demand. Research shows female condoms to be acceptable by diverse users across a variety of settings, and to be efficacious in preventing HIV/STIs and pregnancy when used correctly and consistently. Female condoms also offer an array of unique benefits and advantages to women, men, and young people who use them. Evidence suggests that when promoted and programmed alongside male condoms, female condoms increase the total number of protected sex acts because they are sometimes used in instances that would not otherwise be protected by male condoms. Qualitative studies have also shown that women view the female condom as a means for enhancing their ability to negotiate conditions for safer sex within the relationship. In spite of good acceptability, high rates of efficacy, and unique benefits, widespread female condom availability and use has been hampered by a range of factors, most significant of which is the lack of robust investment due to anemic commitment from most donors, program implementers, and governments. In 2009, donor support for female condom commodities represented only 0.38 percent of the total donor expenditure on global HIV/AIDS, despite the substantial unmet need for condoms. A problem associated with lack of sufficient investment in female condom procurement is stockouts, which have plagued many countries that have introduced the product. And while a steady supply is crucial, the full potential of female condoms can only be realized with effective and comprehensive programming, which is essential for creating demand and enabling sustained use. Yet funding for programming is 7 8 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health even scarcer than the funding for female condoms themselves, which can result in poor access and low levels of use. In addition, negative attitudes of health providers toward female condoms are widely acknowledged by researchers, government officials, and advocates as a serious obstruction to increased access and use, as the quality and comprehensiveness of training can be severely compromised. Finally, cost is regularly cited as a barrier because some donors and program managers are initially hesitant to invest in female condoms given their cost relative to male condoms. However, the argument over cost-effectiveness of female versus male condoms is only ethical if one assumes that female condoms offer no unique advantages to women, and that the absence of female condoms would result in no reduction of protected sex acts, neither of which is borne out by research. As the world’s largest donor to HIV/AIDS and reproductive health programs, the U.S. government has a critical opportunity to show exemplary leadership in advancing access to female condoms. This opportunity is heightened given the Obama administration’s emphasis on integration and gender equality as articulated in the Global Health Initiative (GHI). Yet commitment to female condoms among U.S. decision makers is not pervasive throughout the foreign assistance structure, and has only advanced slowly and sporadically. The U.S. government is the largest procurer of female condoms, accounting for nearly 40 percent of female condom donor shipments to developing countries in 2009. When the President’s Emergency Plan for AIDS Relief (PEPFAR)—the U.S. government’s global initiative on HIV/AIDS—was renewed by Congress in 2008, the law recognized for the first time that access to both female and male condoms is a priority for U.S. global HIV prevention efforts. Since PEPFAR reauthorization, the Office of the Global AIDS Coordinator (OGAC)—the agency that oversees and coordinates PEPFAR—has included female condoms in important guidance documents to the field. Advocates have witnessed a significant number of PEPFARfunded countries include female condoms in their country operational plans or their partnership framework agreements. Furthermore, the U.S. Agency for International Development (USAID) is an instrumental partner in ensuring effective, country-level female condom logistics management and distribution, and is a source of financial and technical support for female condom programming. However, there are several challenges to scaling up U.S. investment in female condom procurement and programming that ultimately originate from Washingtonbased policies, procedures, or funding restrictions. OGAC officials recently drew attention to a burgeoning “condom gap”—an acute shortage of female and male condoms in many countries in Africa with high HIV prevalence. Evidence suggests that the female condom gap is due to inadequate funding from OGAC for female condom commodities and programming. In addition, lack of awareness and/or negative attitudes of headquarters officials and Mission field staff pose barriers to female condom support. OGAC and USAID still have no specific policy guidance for the field to promote female condoms or provide incentives to procure and program them, which would help combat these negative attitudes. Moreover, PEPFAR reauthorization contains provisions that favor abstinence and fidelity activities, sometimes to the Executive Summary exclusion of comprehensive approaches that contain female and male condoms. Finally, even though officials routinely ask to see more evidence of female condom uptake and utilization as a precursor to any scale up, OGAC has no mechanism to collect data on female condom distribution or use. Case studies of countries where female condoms have been introduced, programmed, or sustained with support from the U.S. government provide valuable insight. Zimbabwe is regularly cited as a female condom success story and has among the highest distribution and sales of female condoms in the world; it also enjoys strong backing from the U.S. government in terms of procurement and program assistance. Malawi has a growing female condom program that has recently benefitted from the U.S. government’s support—confined mostly to commodities. Cameroon is currently scaling up its female condom program in spite of little support from the U.S. government. While Bolivia’s HIV/AIDS prevalence among the general population is low, and the national government has only a limited response to HIV/AIDS, the U.S. government has sustained modest support for female condoms for nearly a decade— without many of the systems in place that allow female condoms to thrive in countries like Zimbabwe and Malawi. In general, these case studies reveal that the U.S. government is excelling when it comes to female condom commodity financing, coordination, and logistics; collaboration and alignment with other donors, governments, and stakeholders; and support for social marketing. U.S. weaknesses include insufficient funding for programming, lack of female condom oversight or program tracking, and limited USAID Mission outreach to civil society. Based on an extensive review of current literature on female condoms, in addition to interviews with key experts, the findings and recommendations of this report are as follows: Finding: OGAC has identified a serious “condom gap” affecting several high HIV prevalence countries in Africa. Yet, OGAC is not allocating enough funding to support female condom procurement and programming, especially for former focus countries, which cannot access female and male condoms through the Commodity Fund. Recommendation: OGAC should centrally finance female and male condom procurement to help close the condom gap. OGAC should allocate funds directly to the Commodity Fund so that all countries can be eligible to access this account to procure female condoms. In addition, OGAC should also allocate robust resources to support female and male condom programming, especially for former focus countries. Finding: Communication and coordination between OGAC and USAID officials on female condoms is limited, contributing to female condoms being overlooked in decision making on funding priorities. In addition, there is no clear mechanism or oversight at OGAC or USAID regarding financial and technical support for female condom programming. 9 10 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health Recommendation: OGAC and USAID should form an interagency task team to engage in strategic thinking and resource allocation planning on female condoms and the broader condom gap. OGAC and USAID should also conduct an evaluation of PEPFAR support for female condom programming, and develop a system to track financial and technical support for female condom programs. Finding: Whether the U.S. procures female condoms in a given country is highly dependent on the personal biases of USAID Mission staff. Some Washington- and field-based U.S. officials lack awareness of the female condom or hold negative attitudes about it, in part because there is currently no guidance explaining the importance and relevance of female condoms in HIV prevention and family planning programs. Recommendation: OGAC and USAID should expedite the issuance of guidance to U.S. global health personnel in the field highlighting the evidence on female condoms. The U.S. should also include the female condom in GHI guidance as an important example of integrated, woman-centered programming. OGAC and USAID should fund training for PEPFAR- and USAID-funded doctors, nurses, and counselors about the female condom. Finding: The U.S. government continues to release funding instruments that focus on failed stand-alone abstinence and fidelity programs for HIV prevention. This contradicts PEPFAR’s new Five-Year Strategy that espouses comprehensive and evidence-based prevention. Recommendation: The U.S. government should only fund integrated, comprehensive, and evidence-based HIV prevention programming that includes female and male condom programming. Funding announcements should explicitly mention female and male condoms, as opposed to “condoms,” to provide further incentive for programs to include female condoms. Finding: OGAC does not disaggregate female and male condom service outlets in PEPFAR data collection efforts and does not require countries to report on the number of male condom distribution outlets. The USAID-funded MEASURE DHS (Demographic Health Survey) does not collect data on female condom use. Recommendation: OGAC should revise the Next Generation Indicators (NGI) Reference Guide to disaggregate female and male condoms and require countries to report on female and male condom distribution outlets. USAID should disaggregate female and male condom use in the MEASURE DHS HIV/AIDS Survey Indicators on condom use. Executive Summary Finding: The 2008 reauthorization of PEPFAR includes a preference for abstinence and fidelity programming. In addition, female and male condom distribution is still restricted to individuals 15 years of age and older. Recommendation: Congress should remove all funding directives for abstinence and fidelity prevention programs and fund comprehensive, integrated, and evidence-based HIV prevention programs that include female condoms. OGAC should issue new guidance on prevention that ensures that all women, men, and young people have access to female and male condom education and distribution in PEPFAR-supported programs. Finding: At the country level, the U.S. government has no mechanism to involve civil society in female condom procurement, distribution, and programming decision making. Recommendation: The U.S. should actively include civil society, especially women’s health and rights groups, in stakeholder meetings and encourage financing mechanisms that increase government-civil society collaboration in female condom programming. Finding: The U.S. excels at assisting countries in female condom procurement and logistics. Recommendation: The U.S. should expand technical assistance for female condom logistics and procurement to additional countries to increase HIV prevention efforts. 11 12 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health Female condom advocates from Mexico, Guatemala, Honduras, El Salvador, Costa Rica, and Dominican Republic pose as new members of CHANGE’s Prevention Now! Campaign. INTRODUCTION The Global Failure on Female Condoms I t would be quite reasonable to assume that the world is already investing enthusiastically and overwhelmingly in female condoms. On the face of it, pouring time and treasure into purchasing and promoting a product that can give women the ability to initiate their own protection from unwanted pregnancy, HIV transmission, and other sexually transmitted infections (STIs)—all extremely urgent health concerns for women of reproductive age—seems like an obvious solution. A simple glance at the statistics should be compelling enough. According to the World Health Organization (WHO), HIV/AIDS is a leading cause of death and disease in women of reproductive age.1 Women comprise slightly more than half of all adults living with HIV and 60 percent in sub-Saharan Africa.2,3 In developing countries, 215 million women who wish to delay or space their pregnancies do not have access to modern contraceptives.4 An estimated 358,000 women die each year from complications associated with pregnancy and childbirth, with unsafe abortion accounting for a significant number of maternal deaths.5 Expanded HIV/STI and pregnancy prevention efforts that include all available methods and services—especially those that women can initiate and control—are clearly needed now more than ever. Against this backdrop, scientists continue to research, develop, and test new behavioral and biomedical prevention options such as microbicides, pre-exposure prophylaxis (PrEP), and vaccines, with varying success. New and groundbreaking findings from the CAPRISA 004 vaginal microbicides trial and the iPrex trial with men on oral PrEP suggest that these interventions are at least partially effective in preventing sexual transmission of HIV. 6,7 In addition, a recent AIDS vaccine trial based in Thailand found modest evidence of protection against HIV—the first vaccine efficacy trial to do so, though the significance of its findings has been debated by experts.8 While these trials demonstrate exciting advancements in prevention research, they also underscore that these first generation technologies will not be 100 percent effective. Even male circumcision, which is receiving amplified attention from donors and governments, has been shown by studies to reduce risk of HIV acquisition by only 50 to 60 percent in men.9 Scientists, policy makers, and advocates acknowledge that there is no single magic bullet for HIV prevention. “Combination prevention”—the concept that successful HIV prevention combines evidence-based medical, behavioral, and structural interventions—is increasingly gaining prominence. As the only effective HIV/STI and pregnancy “dual” protection methods available today, female and male condoms are 13 14 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health particularly critical components of a comprehensive, rights-based prevention package. But when it comes to HIV/STI and pregnancy dual protection technologies that are designed to be initiated by women and available today, the female condom stands alone. Yet, remarkably, investment in female condom procurement and programming has been negligible in comparison to other prevention approaches. Moreover, aside from a few notable champions among donors and program implementers, the push for access to female condoms has come almost exclusively from civil society. While donors and governments have made some increases in recent years thanks in large part to civil society efforts, they have remained largely resistant to making the sizable investment in female condoms warranted by the product’s potential. This resistance flies in the face of evidence. As Part One of this report elaborates, the two most important questions about female condoms as a prevention intervention— acceptability and efficacy—have been conclusively established. Part Two examines the challenges the product faces due to low investment, and Part Three analyzes existing U.S. foreign policy on female condoms and possibilities for change. Finally, Part Four explores four country case studies, highlighting best practices, essential elements, and lessons learned for successful procurement and programming of female condoms, while Part Five offers recommendations for the U.S. government to strengthen support for female condoms. PART ONE The Case for Female Condoms T he importance of female condoms as a prevention method has been widely recognized by researchers and advocates alike. Years of empirical research confirm that female condoms have good acceptability among diverse populations, high rates of efficacy, and numerous advantages for women, men, and young people.10 CHANGE’s 2008 report on female condoms, Saving Lives Now: Female Condoms and the Role of U.S. Foreign Aid, gives a thorough documentation of female condom characteristics and benefits. Female Condom Products A number of female condom products are currently available to consumers while others are still in development. These products vary in appearance, design, material, and regulatory status.i The FC1 and FC2 female condoms, manufactured by the Female Health Company (FHC), are the most widely distributed female condoms in the world. They are also the only female condoms approved by the U.S. Food and Drug Administration (USFDA) at this time. Female condoms that are currently available or have been previously distributed in some countries include the VA w.o.w., Cupid, Phoenurse, and the Natural Sensation Panty Condom. Other female condoms, such as the Woman’s Condom, are just beginning to enter the market. For more information about female condom products, please see Annex A on page 67. Female Condom Qualities: Acceptable, Effective, and Much More ii Female Condoms are Acceptable Research shows female condoms to be acceptable by diverse users across a variety of settings. Studies conducted in more than 40 countries suggest that female condom acceptability among women and men of various ages, socio-economic statuses, sexual i For a summary of female condom products and regulatory issues, please consult a recent article by Mags Beksinska et al., “Female Condom Technology: New Products and Regulatory Issues,” Contraception, 83, no. 4 (2011): 316-321. Published electronically September 15, 2010. ii The vast majority of scholarly research on the female condom uses the FC1 and sometimes the FC2 as the condom under study. For the purposes of our report, the term “female condom” refers to the FC1 or FC2 unless otherwise specified. 15 16 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health orientations, and geographic locations ranges from 37 percent to 96 percent.11,12 A new study examining acceptability among female sex workers in the Dominican Republic reported that “women found the female condom very acceptable, and they also believed it was the method preferred by their clients and regular partners.”13 This finding is noteworthy because both men and women approved of consistent female condom use. Although research on long-term acceptability and use of the female condom is limited, new findings from Brazil indicate that with proper counseling and adequate supply, many women will regularly use the female condom for at least one year. Kalckmann et al. (2009) followed women who received female condom product, counseling, and education at three separate sites in Brazil and their use of the female condom for 12 months. Service delivery sites included HIV/STI clinics, primary care units, and community-based organizations. Researchers found that after one year, almost 15 percent of the full study sample of 2,469 women—about one in seven women—reported regular use of the female condom.14 The effect was strongest for women who received product and education from peers at the community-based sites, suggesting that female condom peer education may have a larger impact on longer-term use than efforts through more traditional health outlets. Female and male condoms, when used consistently and correctly, are comparable in effectiveness in preventing HIV/STIs and pregnancy. Female Condoms are Effective Female and male condoms, when used consistently and correctly, are comparable in effectiveness in preventing HIV/STIs and pregnancy. Correct use of the female condom has been estimated by Trussell et al. (1994) to reduce the per-act probability of HIV transmission by up to 97 percent.15 In other words, the study’s modeling exercise estimates that perfect use of the female condom by a woman having sexual intercourse twice a week with an HIV-infected partner could reduce her risk of acquiring HIV by more than 90 percent.16 Furthermore, laboratory studies have found the female condom to be impermeable to various STI organisms, including HIV.17 Female condoms also prevent pregnancy. When female condoms are used correctly with each act of sexual intercourse during one year, only five unintended pregnancies will occur per 100 women.18 With typical female condom use, there will be 21 unintended pregnancies per 100 women in the span of one year.19 Many users value the female condom precisely for its efficacy and dual protection properties. A study in Zimbabwe assessing acceptability and uptake of female condoms documented high interest from women in using the female condom for dual protection.20 In many countries where the female condom has been socially marketed, including Zimbabwe, the product was positioned as contraception to avoid stigma associated with HIV and disease. However, it is important for program planners and health educators to recognize that some women appreciate and use the female condom for both HIV/STI and pregnancy prevention, and to tailor their messages and programs accordingly. Female Condoms Have Numerous Benefits and Advantages Female condoms offer an array of unique benefits and advantages to women, men, and young people who use them. Female condoms made of polyurethane or nitrile, such Part One: The Case for Female Condoms as the FC1, FC2, and the Woman’s Condom, can be used with water- and oil-based lubricants. This is critical because in some parts of the world water-based lubricants are difficult to find. Some female condoms can be inserted a few hours in advance, thus avoiding interruption of sexual activity to initiate protection. As one female study participant in El Salvador attested, “We [women] can put it on ahead of time. If… we already know that he doesn’t like to use a condom, we can go to the bathroom a half-hour ahead of time and put it on.”21 Some users report increased pleasure and stimulation from the FC2 female condom, with the inner ring “tickling men” and the outer ring “tickling women.”22 Female condoms are particularly valuable for women living with HIV, as they provide a female-initiated option to pursue safe sex and prevent HIV transmission, reinfection, or superinfection. And although no female condom has received USFDA approval for anal intercourse, some men and women report use of the female condom for protection during anal intercourse—the sexual behavior with the highest probability of HIV transmission. Consequently, in some countries including the United States, health departments urge providers to promote “off-label” use of the female condom for anal intercourse, rationalizing that some protection is better than none. Female condoms are a value-added complement to male condoms. Studies from Madagascar, Kenya, India, Brazil, and the United States found that female condom promotion and use increases the total number of protected sex acts, which helps reduce rates of STIs and the risk of HIV infection.23,24 Rather than replacing use of male condoms, female condoms are sometimes used during acts of sexual intercourse that would not otherwise be protected by male condoms, thus boosting the overall number of sex acts where protection is used. For example, some studies show that women, when provided with the additional option of female condoms, tend to alternate use of female and male condoms depending on the sexual partner and circumstances.25 Formative research on female condoms in Central America, funded by the U.S. Agency for International Development (USAID), found that some men who refuse to use a male condom are willing to have their partner use a female condom, demonstrating that the female condom offers unique protection.26 While studies have documented individuals replacing some use of male condoms with female condoms, the net level of protection achieved by offering two methods is typically greater than through male condom distribution alone. Qualitative studies have shown that women view the female condom as a means for enhancing their ability to negotiate conditions for safe sex within the relationship, particularly when women obtain female condoms within the context of an intervention focused on women’s sexuality and empowerment.27 Female or male condom use typically requires negotiation between partners. However, because the female condom is designed for women to initiate and wear, it offers women an important negotiation tactic if their partners refuse male condom use. According to a female participant in a study in Kenya, “When [my husband] comes to the house and doesn’t want to use a male condom I tell him that we too have ours here, and if using the male condom is a problem then let’s use the female condom. At first he didn’t want to use the female condom but now we have used it and we don’t have any problem.”28 A female sex worker Because the female condom is designed for women to initiate and wear, it offers women an important negotiation tactic if their partners refuse male condom use. 17 18 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health in El Salvador had a similar experience negotiating female condom use. “For me, a client passed by who told me that he wanted to do it without anything. I told him that I had a female condom. I used it and he liked it.”29 The strategy of using female condoms as a negotiation tool has also been promoted by organizations that address domestic violence. In Uganda, where the female condom was recently reintroduced by the government, organizations such as the Center for Domestic Violence Prevention receive requests from women for female condoms in situations of marital rape. According to the organization, when these women are sometimes able to negotiate condom use, men come up with excuses or resist using male condoms. The women say that if they had female condoms with them, they could put them on before they have sex, giving them an additional tool for negotiation and protection.30 Women rally in support of expanding global access to female condoms at the 2008 International AIDS Conference in Mexico City. PART TWO Challenges to Female Condoms I n spite of good acceptability, high rates of efficacy, and unique benefits, widespread female condom availability and use has been hampered by a range of factors, the most significant of which is the lack of robust investment due to anemic commitment from most donors, program implementers, and governments. Acceptability and efficacy are generally the most important criteria for rolling out a prevention intervention. For some interventions, in fact, demonstrated efficacy is sufficient to trigger an outpouring of donor investment. For example, soon after studies confirmed that male circumcision decreases the risk of HIV acquisition for men, donors launched major initiatives to fund and program male circumcision as HIV prevention. While questions have been raised about male acceptance of circumcision and the impact of circumcision on male condom use, these questions have not dampened donor enthusiasm for this intervention. By contrast, the threshold for justification of female condom investment seems strikingly high. Acceptability and efficacy studies by themselves have clearly not been enough to spark massive donor interest. For example, during the mid 1990s, dozens of female condom acceptability studies were carried out with overwhelmingly positive results, as documented by WHO.iii Some countries that participated in these studies had leftover stocks of female condoms, but these countries were not given additional donor support for procurement or programming.31 Countries were expected to continue female condom programs without donor support, and donors have since set their sights on new prevention interventions, such as male circumcision, as referenced above. In the absence of sufficient donor support for female condoms, civil society groups have sought to pressure donors and governments through advocacy campaigns. Still, these advocates have found that, unlike with other prevention technologies and interventions, they are often challenged by donors and government ministries to prove that women and couples will use them—even before any significant effort has been invested in their promotion and use.32 iii For WHO’s seminal review of female condom acceptability studies, please consult the following: UNDP/UNFPA/WHO/World Bank Special Programme of Research on Human Reproduction, The Female Condom: A Review (Geneva: WHO, 1997). 19 20 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health Figure 1. 2009 Donor Expenditure on Global HIV/AIDS Spending on Female Condom Commodities: US$29.2 Million (0.38%) Total Spending on Global HIV/AIDS, US$7.6 Billion Problems Stem Predominantly from Lack of Commitment The timid approach to female condoms by donors and governments has undermined incipient female condom programs. Commodity Challenges Donor investment in female condom commodities in 2009 was approximately 0.38 percent of the total donor expenditure on global HIV/AIDS. Funding dispersed by donors in 2009 for the global HIV/AIDS response was about US$7.6 billion.33 Within this figure, donor support for female condoms represents the tiniest sliver. According to the United Nations Population Fund (UNFPA), in 2009, donorsiv spent about $29.2 million on female condom commodities for developing countries.34 In other words, donor investment in female condom commodities in 2009 was approximately 0.38 percent of the total donor expenditure on global HIV/AIDS. Advocates find the situation to be even more frustrating given that donor financing of female and male condoms falls far short of projected need. In 2009, approximately 2.8 billion female and male condoms were supplied to developing countries by donors.35 The Reproductive Health Supplies Coalition estimates that donors must finance at least 4.4 billion condoms by 2015 to address the family planning and HIV prevention needs of developing countries that are not able to procure their own condoms.36 iv UNFPA’s donor expenditure estimates exclude the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM) and the World Bank. Including these donors would not dramatically alter the 0.38 percent figure. Part Two: Challenges to Female Condoms Figure 2. Female Condoms and the WHO Essential Medicines List While donor financing of female condom commodities is vital for many developing countries, national government investment—however modest—is just as important, especially for programs sustained over the long run. National governments often look to WHO to help inform their health resource allocation decisions. Many governments consult WHO’s Model List of Essential Medicines for guidance on which medicines and medical devices are essential to satisfy priority health needs of populations. They then create their country-specific essential medicine lists and align their budgets accordingly. Female condoms are not listed on WHO’s current essential medicines list, only “condoms.”37 As it follows, female condoms are rarely prioritized in country-level lists and budgets. Donor contributions for female condoms are often left without complementary allocations from national governments, which hinders female condom availability and program longevity. Stockouts A problem associated with lack of sufficient investment in female condom procurement is stockouts. An obvious component to successful delivery and programming of any prevention method is to ensure that enough high-quality product is available to keep pace with consumer demand. When demand exceeds the amount of product supplied, stockouts occur. Unfortunately, female condom stockouts are common in countries that have introduced the method. One reason for this is donor preference for pilot projects. Pilot programs fund product introduction and related activities in targeted areas for a short duration; they do not support long-term programs. As such, female condom pilot programs can initially generate high interest and curiosity in the product. However, projects come to a close just as demand starts taking off. Female condoms disappear from shelves and communities, leaving women and men empty-handed. This was the case in Cameroon, where initial donor investment helped launch the product in 2002, yet donors—including the U.S. government—withdrew support shortly thereafter, contributing to a major stockout in 2006.38 Understandably, stockouts lead consumers to reduce reliance on a product they would otherwise use regularly. Programming Challenges While a steady supply is extremely important, the full potential of female condoms can only be realized with effective and comprehensive programming, which is essential for creating demand and enabling sustained use. Yet funding for programming is even scarcer than funding for female condoms themselves. While programming is often viewed in the traditional sense of health promotion activities, it can also be regarded as a broader set of structural factors that ensure a health intervention’s success. Using the latter definition of programming, truly comprehensive female condom programs consist of a strategic mix of human, financial, and technical resources employed over the long run. UNFPA and the Joint United Nations Programme on HIV/AIDS (UNAIDS) Inter-Agency Task Team developed a 10-Step Framework for Comprehensive Condom Programming (CCP) that serves as a blueprint for building an effective female and male condom program (See Annex C for The full potential of female condoms can only be realized with effective and comprehensive programming, which is essential for creating demand and enabling sustained use. 21 22 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health a full description). The CCP Framework underscores that programs are multifaceted and require committed resources, time, and strategic thinking from stakeholders in order to succeed. This point cannot be emphasized enough for the female condom. Systems and activities such as those highlighted in the CCP framework must be put in place to create an environment where female condoms can flourish, as has been the case in countries like Zimbabwe and Malawi. Despite the importance of quality programs, donors have rarely provided sufficient funding for them. This can result in poor access and low levels of use. According to Bidia Deperthes, HIV/AIDS technical advisor for comprehensive condom programming at UNFPA, “while the majority of donors willingly contribute essential commodities, including male and female condoms, little money is allocated to laying the groundwork needed to create awareness and demand, and to train women to use condoms correctly and consistently.”39 This view is echoed by Lucie van Mens, coordinator of Universal Access to Female Condoms (UAFC) Joint Programme, who says that it is a struggle to “make donors understand that investment in programming, and not only procurement, is vital for success.”40 As a result, female condoms—the product—often get blamed for failure when in fact inadequate programming and the lack of sustained resources are larger culprits. Figure 3. UNFPA and UNAIDS Inter-Agency Task Team 10-Step Strategic Approach to Scale Up CCP at the National Level41 Step 1. Establish a National Condom Support Team Step 2. Undertake a Situation Analysis Step 3. Develop a Comprehensive and Integrated National Strategy for Male and Female Condoms Step 4. Develop a Multi-Year Operational Plan and Budget Step 5. Link the Multi-Year Operational Plan with the National Commodity Security Plan Step 6. Mobilize Financial Resources Step 7. Strengthen Human Resources and Institutional Capacity Step 8. Create and Sustain Demand for Condoms Step 9. Strengthen Advocacy and Engage the Media Step 10. Monitor Program Implementation Routinely, Conduct Research, and Evaluate Outcomes Part Two: Challenges to Female Condoms Female Condom Training and Health Provider Bias An important component of female condom programming is the education and training that women, men, and young people receive. Components of an effective female condom education program are well-documented in the literature. Among many things, these include: grounding in health behavior theory, accurate and comprehensive education about benefits and drawbacks, opportunity to practice insertion, discussion around realistic expectations with use, lessons in condom negotiation with sexual partners, and information on female genital anatomy.42 Effective training helps overcome initial concerns about the female condom, such as size, noise, or difficulty with insertion, in addition to dispelling misperceptions, myths, and negative attitudes. Good training programs also educate and involve men in female condom use. While many men are supportive partners, some men are skeptical or unreceptive toward female condoms. Social marketing programs in Zimbabwe and Malawi have trained male barbers to sensitize their male clients to female condoms, and UNFPA has led focus groups in Guyana and Trinidad and Tobago to better understand men’s perceptions and needs when it comes to understanding and using female condoms.43 Training and education on the female condom, however, can only be as effective as the trainers, medical professionals, and counselors charged with carrying them out. Negative attitudes of health providers toward female condoms are widely acknowledged by researchers, government officials, and advocates as a serious obstruction to increased access and use. According to Weeks et al. (2010), “one of the greatest continuing barriers to female condom uptake results from negative provider reactions to it and their own lack of familiarity or comfort with explaining its proper use. The initial responses of many health and service providers, including primary care physicians, pharmacists, clinicians, and even HIV counselors, tend to be dismissive and denigrating of female condoms.”44 As a result, the quality and comprehensiveness of female condom training can be severely compromised, leaving individuals without the full range of information and skills needed to use female condoms confidently and correctly. More efforts must be made by governments and donors to invest resources in equipping health providers with the knowledge and skills to talk confidently and comfortably about female condoms with consumers. Good training programs also educate and involve men in female condom use. Cost Some donors and program managers are initially hesitant to make substantial investments in female condoms because of their cost relative to the male condom. Purchased in bulk by USAID in 2009, the FC2 female condom cost US$0.55 each, while male condoms cost only US$0.03724.45 This FC2 price is significantly less than the 2008 unit price of the FC1, which cost USAID US$0.80 or US$0.86, depending on the contract.46 The cost differential between female and male condoms exists because the FC2 is more costly to manufacture and far fewer female condoms are purchased. However, the FC2 pricing schedule is based on volume. This means that as demand increases, FHC’s scale-up of production will shift the basic FC2 cost structure 23 24 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health downward.47 In other words, as donors increase their investments in the female condom, cost becomes less of an issue. Female condom programming costs can also decline over time. When Population Services International (PSI) first started female condom promotion in Zimbabwe, the cost per unit was US$4.50. However, as the program expanded and began increasing sales, the product plus programming cost dropped to less than US$1 per unit.48 In 2008, net unit costsv for female condoms in countries where PSI sold more than 30,000 units ranged from US$0.99 in the Central African Republic to US$6.26 in Lesotho.49 The Zimbabwe case demonstrates potential cost-effectiveness for other female condom programs, if they are adequately managed and sustained over time. While female condoms are more expensive than male condoms, female condom use that averts HIV acquisition or transmission is highly cost-effective as compared with the costs of antiretroviral therapy (ART) for life.50 Female condoms can also be cost-effective when compared with other HIV prevention options, such as voluntary counseling and testing, which PSI reports as costing US$24.43 per unit delivered in 2008.51 Some researchers have found that there are few circumstances where the female condom could be cost-effective when compared with the male condom—the female condom’s most logical alternative.52 However, the argument over cost-effectiveness of female versus male condoms is only ethical if one assumes that female condoms offer no unique advantages to women, and that the absence of female condoms would result in no reduction of protected sex acts, neither of which is borne out by research. v These costs include the commodity, procurement fees, packaging, and programming. PART THREE The Reality and Possibility of U.S. Policy on Female Condoms I n a single product, effectively-programmed female condoms integrate attention to family planning, HIV prevention, and gender equality. Within this context, the procurement and programming of female condoms should be a central component of U.S. global health policy, especially given the Obama administration’s emphasis on integration and gender equality as articulated in the Global Health Initiative (GHI). As the world’s largest donor to HIV/AIDS and reproductive health programs, the U.S. government has a critical opportunity to show exemplary leadership in advancing access to female condoms. Yet commitment to female condoms among U.S. decision makers is not pervasive throughout the foreign assistance structure, and has only advanced slowly and sporadically. U.S. Global HIV Prevention and Female Condoms: PEPFAR, USAID, and GHI The President’s Emergency Plan for AIDS Relief (PEPFAR), authorized in 2003 and renewed in 2008, is the U.S. government’s response to global HIV and AIDS. Among PEPFAR’s targets for fiscal years 2010-2014 are to support the prevention of more than 12 million new HIV infections, provide direct support for more than four million people on treatment, and provide care for more than 12 million people, including five million orphans and vulnerable children. The original Global AIDS Act created the Office of the Global AIDS Coordinator (OGAC) within the Department of State to oversee PEPFAR. OGAC continues to be responsible for the oversight and coordination of all financial resources and international activities of the U.S. government to address the HIV/AIDS pandemic. By law, all U.S. funding that is spent on global HIV/AIDS is considered PEPFAR funding.53 Prior to PEPFAR, USAID was the government agency primarily responsible for coordinating U.S. efforts to combat global HIV/AIDS. In addition to supporting programming, USAID allocated its global health funding to procure female and male condoms for HIV prevention and family planning. Although OGAC is now responsible for overseeing U.S. international HIV/AIDS assistance, female and male condom procurement under PEPFAR is coordinated through USAID.vi USAID also provides technical assistance for female and male condom programming and collaborates with OGAC on program guidance. vi At this time, USAID only procures female and male condoms that have regulatory approval from USFDA. 25 26 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health Launched in May 2009 by President Obama, the GHI is a six-year (2009-2014), US$63 billion initiative that focuses on HIV/AIDS, malaria, tuberculosis (TB), child health, nutrition, family planning, maternal health, and neglected tropical diseases.54 Several key principles guide the initiative, including a focus on women, girls, and gender equality; strategic coordination and integration; country ownership; collaboration with multilateral organizations; health system strengthening; improved metrics; and promotion of research and innovation. Administration officials refer to PEPFAR as the cornerstone of the GHI. The U.S. and Female Condom Procurement Whereas the Global AIDS Act of 2003 did not mention female condoms, only “condoms,” the 2008 PEPFAR reauthorization legislation recognizes that access to and availability of both female and male condoms is a priority for U.S. global HIV prevention efforts. The U.S. government plays an important role in shaping global trends in reproductive and sexual health supplies. U.S. funding for international family planning and HIV prevention commodities represented more than one-third of global donor support in 2009.55 This leadership has also extended to the female condom, where in 2009, the U.S. government accounted for nearly 40 percent of female condom shipments to developing countries.56 The U.S. government has been a strong supporter of female condom research and development. USAID was instrumental in bringing the FC1 female condom to market by supporting effectiveness and early acceptability studies, which are required for USFDA approval of female condoms.57,58 USAID also supported PATH in its development of the Woman’s Condom; the National Institute of Child Health and Human Development is now conducting the contraceptive efficacy trial. In addition, recent changes in U.S. international law and policy have created new opportunities for U.S. support for female condom procurement and programming. Whereas the Global AIDS Act of 2003 did not mention female condoms, only “condoms,” the 2008 PEPFAR reauthorization legislation recognizes that access to and availability of both female and male condoms is a priority for U.S. global HIV prevention efforts. Building on the PEPFAR reauthorization law, OGAC released a Five-Year Strategy for PEPFAR in 2009 that reflects the core GHI principles and creates new and strategic opportunities for increased female condom support. The strategy underscores that prevention “remains the paramount challenge of the HIV epidemic…and truly halting and reversing this epidemic will require a comprehensive, multisectoral prevention, treatment, and care response.”59 In PEPFAR’s Five-Year Strategy Annex on the GHI, OGAC states that it will adopt a woman- and girl-centered approach to health. It recognizes that “women are the gateway to healthy families and key to achieving long-term development goals,” and that a woman-centered approach “takes into account the realities of women’s and girls’ lives as shaped by gender norms, service availability, and larger structural factors.”60 OGAC further acknowledges that PEPFAR is “working to expand the linkages between reproductive health and HIV care and treatment services.”61 While the PEPFAR Five-Year Strategy does not explicitly mention female condoms, some OGAC officials interviewed affirmed that the female condom epitomizes a woman-centered approach and integrates HIV prevention and family planning in one product, and thus is critical to GHI’s goals. Part Three: The Reality and Possibility of U.S. Policy on Female Condoms Other recent documents go further, in a sign that female condoms are increasingly visible among U.S. decision makers. To assist U.S. officials overseas in developing their operational plans, OGAC sends guidance to help explain technical requirements, best practices, and what programs should consider to align with U.S. congressional and administrative requirements and policies. PEPFAR’s 2010 Fiscal Year Country Operational Plan (COP) Guidance asked country programs in their technical assistance narratives on sexual prevention to “describe the availability of male and female condoms in your country and the USG contribution to that supply” and to “discuss any problems or stock-outs with procurement and distribution of condoms.”62 Female condoms are also explicitly mentioned in OGAC’s most recent guidance to the field, PEPFAR’s Fiscal Year 2011 Country Operational Plan Guidance. Guidance appendices, which are used in the field to guide program planning, state: “…given the priority placed upon a women and girls-centered approach in the PEPFAR 5 Year Strategy and GHI, prevention programming should include interventions that empower women and address gender inequities in accordance with the epidemiology in each context. Tools like the female condom, which give women more options for practicing safer sex, are important options.”63 OGAC officials report that most country operational plans now mention female condoms, which has not been the case in the past. It remains to be seen whether the increase in the number of countries including female condoms in their COP translates to a commensurate growth in female condom procurement and programming in these countries. Such increases in U.S. government support for female condoms at the country level would continue a recent trend. The U.S. has supplied female condoms to 36 countries since 2000 and to 22 countries from 2009 to 2010.64 It has dramatically increased its distribution of female condoms in recent years, with shipments growing from 1,109,000 in 2003 to a record high of 14,676,000 in 2009.65 However, even considering these numbers, female condoms represented just 3.2 percent of total U.S. condom shipments in 2009. By this measure, and in comparison to the articulated demand, U.S. government investment in female condom procurement falls short. Figure 4. FC2 Registration and The Case of Mexico FC2 female condom registration is required in all countries before it can be imported for private or public sector distribution.67 Product registration is an important measure for quality assurance. USAID will only procure FC2 female condoms for a given country if the country’s registration and importation requirements have been met. Registering the FC2, however, can be a very labor- and time-intensive endeavor, as has been the case in Mexico. Mexico has a relatively long history with female condoms; nongovernmental organizations (NGOs) and commercial outlets have distributed and sold the FC1 female condom for almost a decade. FC2 registration was initiated in June 2008 and was not awarded until June 2010 because of issues with quality assurance paperwork.68 Officials at the Mexican Ministry of Health (MOH), as well as members of the Mexican Congress, resorted to petitioning the regulatory agency to expedite FC2 registration.69 Currently, a quality testing monograph is being finalized by the regulatory agency. Until this process concludes, no FC2 female condoms can be imported into the country, leaving women and men without access to this life-saving tool. Female condoms represented just 3.2 percent of total U.S. condom shipments in 2009. 27 28 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health Figure 5. The Commodity Fund In 2002, USAID established the Commodity Fund to help overseas Missions address the global need for HIV prevention. The Commodity Fund is a central procurement account that provides USAID Missions with female and male condoms for HIV prevention programs free of charge, so that they do not have to spend money on condoms that would otherwise go to other HIV interventions. Condoms from the Commodity Fund are solely for HIV prevention or dual protection. Missions that want to procure female condoms for family planning programs without an HIV component are not eligible to receive free female condoms through the Commodity Fund and must pay for the method out of their Mission budgets. Beginning in 2006, the U.S. government decided that because HIV/AIDS funding levels for the 15 PEPFAR focus countries were significantly higher than those for nonfocus countries, the focus countries must pay for female and male condoms from their own budgets. Even though PEPFAR reauthorization in 2008 eliminated focus country designation in the law, this policy still applies to the former focus countries. The Commodity Fund’s budget for FY2009 was about US$20.3 million, and the budget request for FY2010 was US$27 million.70 The U.S. and Female Condom Logistics Commodity security, including effective logistics management and distribution systems, is essential for the success of the female condom. Through a USAID-funded contract implemented by John Snow, Inc. (JSI) and subcontractors, the USAID | DELIVER Project works to ensure that supplies of contraceptive and HIV commodities, including the female condom, align with the quantity, quality, and distribution needs of each country covered by the project. JSI assists host governments and USAID Missions in forecasting future need for a variety of products and helps determine demand for an array of public health pharmaceuticals, contraceptives, and female and male condoms. The project also provides partners with software to help to calculate need, and in some countries, the project assists in the management and distribution of commodities.71 USAID is reported as being a strong and reliable procurement partner. USAID | DELIVER operates only in countries where USAID Missions have requested and can pay for such support; currently it has offices in 38 countries. If any of these 38 countries receive donor-financed female condom shipments, irrespective of the donor, USAID | DELIVER is involved with coordinating that supply, as requested by the USAID Mission.72 However, the project is not involved in female condom logistics management in countries that lack a USAID | DELIVER office, even if the country receives U.S. government-procured female condoms. The U.S. and Female Condom Programming Neither OGAC nor USAID directly programs female condoms. Using PEPFAR money, USAID issues contracts to, or enters into cooperative agreements with, international or local organizations to carry out female condom education programming or social marketing in countries that receive U.S. global HIV/AIDS assistance. For example, in 2009, USAID funded PSI’s female condom programs in 19 countries.73 In addition to Part Three: The Reality and Possibility of U.S. Policy on Female Condoms providing financial support for programming, OGAC and USAID have the option of issuing technical assistance or guidance to the field on female condom programming. According to USAID, if Missions ask headquarters for technical assistance for female condom programming, USAID will provide it.74 OGAC and USAID also collaborate on various guidance documents for the field; currently they are in the process of finalizing female condom guidance. From 1997 to 2007, USAID funded female condom social marketing and programming through AIDSMark, a cooperative agreement with PSI and six other partners.75 This agreement ended in December 2007 and was replaced with AIDSTAR (AIDS Support & Technical Assistance Resources). The AIDSTAR mechanism is an indefinite quantity contract managed out of the Office of HIV/AIDS in USAID’s Bureau for Global Health that provides access to technical expertise and support for program implementation across a range of HIV/AIDS-related technical areas.76 It is available to U.S. government country teams, USAID/Washington operating units, Missions, and other U.S. government agencies. For example, USAID Missions can submit task orders under AIDSTAR for HIV/AIDS programming support that will then be awarded to an AIDSTAR prime contractor, such as PSI.vii It is difficult to determine the amount of AIDSTAR support for female condom programming because this analysis requires each of the prime contractors to do a budget breakdown of all their task orders. USAID Missions are charged with initiating, designing, and managing their own task orders, meaning that there is no outside force encouraging or requiring USAID Missions to include female condom programming in their task orders. AIDSTAR task orders are supporting female condom programming only in Zambia (PSI) and Guyana (Management Sciences for Health).77,78 When asked why the USAID Mission in Zambia chose to include female condoms in its AIDSTAR task order, USAID/Zambia responded that it was a matter of market share for female condoms and equity of access to health services by men and women, the latter of which is required by the host government, the Mission, and PEPFAR.79 PEPFAR Partnership Framework agreements, which were newly mandated under PEPFAR reauthorization in 2008, present another opportunity to advance female condom programming. Partnership Frameworks provide an overarching joint fiveyear strategy for cooperation on HIV/AIDS between the U.S. government and the partner government or regional authority. Each framework establishes plans and sets measurable objectives and targets for provision of technical assistance and support for service delivery, policy development, and coordinated financial commitments in the country or region.80 Partnership Frameworks are developed under the authority of OGAC and the in-country ambassador and support staff, with participation by the country government and civil society partners. They then serve as the blueprint for country- or region-specific implementation plans, which go into greater detail about vii AIDSTAR consists of 13 prime contractors that are divided into two sectors: AIDSTAR I and AIDSTAR II. The seven contractors under AIDSTAR Sector I specialize in technical assistance for program implementation and HIV/AIDS technical areas, whereas the six contractors under AIDSTAR Sector II focus mostly on management systems, capacity building, and technical leadership. When USAID Missions submit task orders for female condom programming funds through the AIDSTAR mechanism, they likely go to the AIDSTAR Sector I contractors for bidding. These contractors include: PSI, Family Health International, JHPIEGO, JSI, Management Science for Health, PATH, and RTI International. 29 30 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health activities. According to the U.S. government, Partnership Frameworks espouse the GHI principles of strengthened country capacity, ownership, and leadership. To date, 21 country- and region-specific Partnership Frameworks have been signed and made available to the public. Even though Partnership Frameworks are high-level documents—meaning that they do not get into great detail—seven of the 21 agreements specifically mention advancing female condoms through U.S. or national government procurement and distribution or through policy change.viii These are Angola, Botswana, Central America, Kenya, Namibia, Rwanda, and Tanzania. Because they are guided by what is written in the Partnership Frameworks, program implementation plans for these countries and regions should include activities related to female condoms. The absence of female condoms in the Partnership Framework, however, does not necessarily preclude the incorporation of female condoms in implementation plans. For example, Malawi signed a Partnership Framework agreement without specific mention of female condoms, but the country still includes female condom activities in its implementation plan.81 Country-level decision makers primarily determine whether “female condoms” make it into Partnership Frameworks or the implementation plans. OGAC, saying that it must remain non-prescriptive and that countries need to set their own priorities, has not promoted female condom inclusion in the Partnership Frameworks. It is also unclear how the U.S. government ensures robust participation of civil society partners in the development of the Partnership Frameworks, especially that of marginalized groups. There is no way to discern in the framework documents which civil society groups were consulted and how civil society recommendations were incorporated. Given that civil society advocacy has been one of the strongest forces putting female condoms on the political agenda, the U.S. may be missing opportunities to include female condoms in the frameworks without meaningful participation of all interested civil society stakeholders. Limitations on U.S. Procurement and Programming of Female Condoms There are several challenges to scaling up U.S. investment in female condom procurement and programming that ultimately originate from Washington-based policies, procedures, or funding restrictions. PEPFAR and the Condom Gap In the case of female condoms, evidence suggests that the condom gap—especially among the former PEPFAR focus countries— is due to inadequate funding from OGAC for female condom commodities. In a January 2011 meeting of the PEPFAR Scientific Advisory Board, OGAC officials called attention to a burgeoning “condom gap,” highlighting findings from a forthcoming report on the acute lack of availability of female and male condoms in many countries in Africa with high HIV prevalence.82 OGAC officials identified barriers that it and other donors should address, such as insufficient support for condom provision and demand creation, ineffective funding mechanisms, and confusion over the U.S. government position on condoms.83 In the case of female viii CHANGE performed content analysis for female condoms in each PEPFAR Partnership Framework. All publicly available Partnership Frameworks can be found at http://www.pepfar. gov/frameworks/index.htm Part Three: The Reality and Possibility of U.S. Policy on Female Condoms condoms, evidence suggests that the condom gap—especially among the former PEPFAR focus countries—is due to inadequate funding from OGAC for female condom commodities, which is related more broadly to issues of strategic planning and resource allocation. As noted above, USAID coordinates female and male condom procurement for PEPFAR activities through the Commodity Fund, which was established in 2002 to provide U.S. Missions with female and male condoms at no cost to the Mission to address the need for HIV prevention. It is important to note that the Commodity Fund is a USAID account that the agency supports with its own budget for global HIV/AIDS. OGAC does not financially support the Commodity Fund, even though OGAC has a significantly larger budget for global HIV/AIDS than USAID. While the Commodity Fund is “PEPFAR” funding because, as previously stated, all U.S. funding spent on global HIV/AIDS is considered PEPFAR funding, it is incorrect to assume that OGAC substantially invests in female condom procurement and programming. Public documents do not reveal how much OGAC spends on female and male condoms, as OGAC includes these expenditures within a broader category of spending on “other prevention” activities aimed at reducing sexual transmission of HIV. But it is apparent that OGAC spending on female and male condoms represents only a small portion of total OGAC spending. In fiscal year 2009, the Other Sexual Prevention category, funded at $268.3 million, made up only 5.2 percent of total approved OGAC funding.84 Therefore, former PEPFAR focus countries—which cannot access the Commodity Fund—have little incentive to procure female condoms. As a result, female condom procurement in these countries has lagged. As indicated in Figure 5, PEPFAR focus countries were no longer eligible to access the Commodity Fund as of 2006, even though the “focus country” designation was eliminated in the 2008 PEPFAR reauthorization law. This policy change was made in part because PEPFAR focus countries have much larger HIV/AIDS budgets than non-focus countries and should accordingly have enough resources to budget for female and male condoms, if prioritized by the U.S. Mission. Even so, these focus countries must work within finite prevention budgets and even smaller condom budgets, which put female condoms at a disadvantage given their cost per unit (US$0.55) compared with that of male condoms (US$.04). Barring any incentive or policy from OGAC encouraging procurement of female condoms, country coordinators have little reason to request the higher-priced product. OGAC’s limited support for female condom procurement and programming may be symptomatic of broader issues with strategic planning and resource allocation. CHANGE’s interviews with officials at OGAC and USAID revealed that communication between the two agencies on female condoms is limited. Consequently, female condoms tend to be overlooked in decision making on funding priorities. OGAC, moreover, is the ultimate decision maker when it comes to PEPFAR funding and resource allocation at the central level. If condoms are a priority to OGAC, this would be reflected by actions such as the provision of ample central funding to increase female and male condom availability at the country level. 31 32 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health Negative Attitudes or Lack of Awareness among U.S. Government Officials Officials at OGAC and USAID consistently mention the barriers posed by lack of awareness and/or negative attitudes of headquarters officials and Mission field staff. Currently, OGAC and USAID have no specific policy guidance for the field to promote female condoms or provide incentives to procure and program them, though female condom guidance is under development. This information and communication vacuum has contributed to a scenario at the country level where female condom promotion depends on the personal beliefs of the USAID Health, Nutrition, and Population officer, the USAID Mission director, or the U.S. ambassador, which has in some cases presented significant hindrances. Some Missions seem to have tried female condom programming, but have given up when faced with obstacles common to launching a new program on women’s reproductive health. For example, in 2009, as chair of the UNFPA Civil Society Advocacy Working Group, CHANGE facilitated a joint meeting in Swaziland with civil society female and male condom advocates and a PEPFAR field official. The advocates highlighted the importance of female condoms and asked for U.S. support for their programming. In response, the PEPFAR official said that female condoms are not very accepted in Swaziland because of gender roles, and that until gender roles change, they are not worth the investment. Another example comes from Uganda, where the Ministry of Health (MOH) decided to reintroduce female condoms in 2009 largely because women vocally demanded access to them. When advocates met with a USAID official in Uganda to ask for their support, the official said they needed evidence that civil society wanted them—in spite of the advocates giving them just that. Despite demonstrated support from diverse sectors of Ugandan society, the U.S. government has no concrete plans to support female condoms in the country.ix Rather, in August 2009, Mike Strong, coordinator of PEPFAR in Uganda, was quoted by TIME.com as saying about female condoms, “Why should we divert attention from pills, IUDs and male condoms to what’s really a niche market?”85 PEPFAR Funding Restrictions Within the Global AIDS Act of 2003, the U.S. Congress mandated that 33 percent of PEPFAR prevention funds be allocated for abstinence-until-marriage programs starting in 2006. Consequently, OGAC adopted the “ABC approach”—“Abstinence, Be Faithful, or use Condoms”—and defined abstinence-until-marriage programs as those that exclusively teach abstinence and/or being faithful. Implementation guidance further restricted condom distribution to individuals 15 years and older. When the U.S. Congress reauthorized PEPFAR in 2008, it removed the 33 percent “abstinence-until-marriage earmark.” However, it was replaced with a requirement that the Global AIDS Coordinator issue justification to Congress if PEPFAR programs ix For the first time ever, USAID is slated to ship female condoms to Uganda. According to officials at USAID, 6,000 FC2 female condoms will be shipped and donated to the Joint Clinical Research Center (JCRC) in 2011. JCRC is a nongovernmental institution that provides ART services and care to approximately 10,000 Ugandans at its Kampala-based clinic. The FC2 female condoms are for distribution among JCRC’s clients, though it is unclear what this distribution will look like in terms of training and education. Part Three: The Reality and Possibility of U.S. Policy on Female Condoms in countries with generalized epidemics spend less than 50 percent of PEPFAR HIV prevention funds on programs that promote abstinence, delay of sexual debut, monogamy, fidelity, and partner reduction—henceforth referred to as “abstinence and fidelity” activities. While PEPFAR programs are not mandated to spend 50 percent of their HIV prevention budgets on abstinence and fidelity activities, this reporting requirement continues to emphasize abstinence and fidelity sometimes to the exclusion of comprehensive approaches, such as those that include education about female and male condoms. PEPFAR’s new Five-Year Strategy issued under the Obama administration does not include any language about abstinence and states that PEPFAR’s prevention programs will focus on scaling up high-impact, evidence-based, comprehensive prevention programs. OGAC officials have said that there is no guidance to field staff favoring implementation of abstinence and fidelity programming. Nevertheless, PEPFAR is still funding these programs. For example, a U.S. Department of Health and Human Services Request for Applications for Nigeria, dated March 2010, states that prevention programs should include “coordination of the ‘Abstinence and Be Faithful’ initiative through education on abstinence targeted among in- and out-of-school youths, and fidelity among married couples and those in monogamous relationships.”86 Condom use was mentioned briefly at the end of the request, but the inclusion of condom education or distribution is not required of applicants. The disconnect between OGAC’s stated position on comprehensive prevention and program funding instruments that favor abstinence and fidelity activities results in lost opportunities to fund comprehensive prevention programs that include female and male condoms. Additionally, new guidance on condom promotion has not been issued and, per existing guidance, female and male condom distribution is restricted to individuals 15 years of age and older, despite evidence that many young people need comprehensive prevention messages before age 15. Prevention advocates are awaiting OGAC’s promised new PEPFAR guidance on comprehensive prevention that will supplant existing guidance on the ABC approach. Another funding restriction under PEPFAR that precludes access to female and male condom information and services is the so-called “conscience clause.” The original PEPFAR law contained a provision that enabled organizations receiving U.S. funding to elect which prevention and treatment services they wish to provide. This clause allowed organizations receiving public funding to carry out prevention programs based on their own philosophy, even if it is in conflict with human rights and evidence-based interventions. For example, millions of dollars go to organizations for HIV prevention services, even if they refuse to discuss safer sex options like female and male condoms in preventing the spread of HIV. The disconnect between OGAC’s stated position on comprehensive prevention and program funding instruments that favor abstinence and fidelity activities results in lost opportunities to fund comprehensive prevention programs that include female and male condoms. PEPFAR Data Collection and Reporting Efforts In August 2009, OGAC released its Next Generation Indicators (NGI) Reference Guide, which offers guidance to PEPFAR country teams and programs on indicators to use for data collection and reporting. The indicators were developed by PEPFAR technical working groups that included the participation of multilateral partners like WHO, 33 34 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health PEPFAR-funded implementers, and civil society. OGAC acknowledges that its list of indicators is not exhaustive, but taken together, the indicators “promote responsible program monitoring across and within PEPFAR funded technical areas.”87 While some indicators are “essential” and must be reported to headquarters, others are simply “recommended.” None of the NGI indicators mention female condoms, only “condoms.” Furthermore, there is only one indicator specific to PEPFAR output on Program managers and OGAC officials condoms: the “number of targeted condom service outlets.”88 This condom indicator routinely ask to see more evidence of female is only recommended, meaning that PEPFAR country programs are not required condom uptake and utilization—yet very few to use this data collection indicator, let alone report findings back to OGAC. By are collecting this data on a national scale. not requiring countries to report on condom distribution—and specifically female condom distribution—the U.S. government has no mechanism to monitor and evaluate PEPFAR’s condom efforts. PEPFAR is not alone in its lack of data collection on female condoms. MEASURE DHS (Demographic Health Survey), which is funded by USAID, is the premier data collection and analysis vehicle for nationally representative statistics on health issues such as HIV/AIDS, family planning, and maternal health. MEASURE DHS does not disaggregate female and male condom use in its HIV/AIDS Survey Indicators pertaining to condom use; its indicators refer only to “condoms.”89 This has contributed to the dearth of country-level data on female condom distribution and use and is particularly detrimental to scaling up female condom activities. Program managers and OGAC officials routinely ask to see more evidence of female condom uptake and utilization—yet very few are collecting this data on a national scale. Women from El Salvador and Honduras practice inserting the FC2 female condom into a pelvic model at a February 2011 workshop on female condom advocacy, organized by CHANGE. PART FOUR Impact & Challenges in the Field: Country Case Studies W hile the female condom may be available in more than 120 countries, only a handful of countries have been able to develop and sustain the right mix of political commitment, donor investment, public and private sector infrastructure, and civil society involvement to support a strong female condom program. In many of these countries, the U.S. has played a prominent role, in spite of some of the U.S. foreign policy and funding barriers previously mentioned. This section will describe female condom efforts in four countries where the U.S. has provided some degree of financial or technical support for the product and will compare and contrast program successes, challenges, and lessons learned. ZIMBABWE “A strength of Zimbabwe’s program is investment in the female condom as a program and not a project.” —Kumbirai Chatora, PSI/Zimbabwe History and Female Condom Introduction Zimbabwe is regularly cited as a female condom success story and has among the highest distribution and sales of female condoms in the world.90 Women’s rights and reproductive health organizations played a significant role in bringing female condoms to Zimbabwe by identifying a need for the product and advocating for their government’s support in procurement. Women and AIDS Support Network (WASN) organized a successful, nationwide petition drive in support of female condoms that coincided with the government’s efforts. The government of Zimbabwe launched the FC1 female condom in 1997, making it available without branding in the public sector through 30 pilot districts.91 In addition, PSI/Zimbabwe introduced the ‘Care Contraceptive Sheath’—the first branded female condom in Africa.92 PSI/Zimbabwe used mass media to position Care female condoms as contraception so that use was not associated strictly with HIV prevention, a potentially stigmatizing position. PSI/Zimbabwe employed innovative social marketing strategies to promote the female condom, using hair salons in low-income, urban areas as training, distribution, and retail outlets. With funding from USAID and the United Kingdom Department for International Development (DFID), PSI/Zimbabwe trained female Zimbabwe is regularly cited as a female condom success story and has among the highest distribution and sales of female condoms in the world. 35 36 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health hairstylists from 500 salons in low-income neighborhoods to demonstrate correct use, discuss common misperceptions, and answer questions on female condoms.93 The public sector program, however, faced setbacks, including a lack of programming strategy. Despite this, between 2002 and 2004, the percentage of Zimbabwean women who reported ever using the female condom increased from 15 percent to 28 percent.94 Revitalizing Female Condoms In recent years, many factors have reenergized and strengthened female condom procurement, distribution, and programming. In 2005, UNFPA launched the Global Female Condom Initiative aimed at scaling up access to and use of female condoms through financial and technical support to country programs. Zimbabwe was enrolled in this initiative, which is now part of UNFPA’s broader CCP efforts. Recognizing the need for a more strategic urban/rural and public/social marketing approach in Zimbabwe, UNFPA worked with the government to form a Technical Support Group (TSG) on female and male condom programming.95 The TSG, consisting of representatives from the Ministry of Health and Child Welfare (MOHCW), the Zimbabwe National Family Planning Council, PSI/Zimbabwe, Business Council on AIDS, civil society organizations, and donors, assisted the government in undertaking a female condom research review as well as a situation analysis to provide evidence for the development of a national female condom strategy. These efforts fed into a National Stakeholder Meeting in 2006 aimed at creating a roadmap to scale up Zimbabwe’s female condom program. In addition to representation from government ministries, diverse civil society organizations participated in the meeting, including the Interfaith Network, Men’s Forum on Gender, Women’s Action Group, WASN, Business Council on AIDS, and the Network of People Living with HIV.96 This meeting culminated in the development of the Zimbabwe Five Year National Female Condom Strategy (2006-2010), which harmonized with the national AIDS response and reproductive health program.97 Since then, the stakeholders have been involved in rolling out the female condom strategy. Current Program Structure and Support Today, the MOHCW oversees and demonstrates a strong commitment to the female condom program. Yet, Zimbabwe still relies on donor support for both its female and male condom programs; its major funders are UNFPA, USAID, and DFID. UNFPA has largely financed Zimbabwe’s female condom program implementation and public sector capacity-building.98 For example, UNFPA supports a National Condom Coordinator who is housed in the MOHCW. UNFPA also funds service provider trainings and has procured female pelvic models for training and distribution among health personnel. USAID pays for the vast majority of Zimbabwe’s condoms, both female and male. Using the Commodity Fund, USAID purchased and shipped approximately 5.5 million FC1 female condoms in 2008 and nearly 10 million FC1 and FC2 female condoms in 2009—the largest ever U.S. female condom shipment during a calendar year.99 The main recipients of U.S.-funded female condoms are the public sector (MOHCW and the Zimbabwe National Family Planning Council) and social marketers (PSI/Zimbabwe).100 Part Four: Impacts and Challenges in the Field: Country Case Studies USAID and DFID support female condom logistics in Zimbabwe. USAID gives annual funding to the USAID | DELIVER Project that provides condom forecasting, logistics, distribution and reporting for female and male condoms. USAID | DELIVER distributes female and male condoms directly to service delivery points in the public sector and selected NGOs on behalf of the Zimbabwe National Family Planning Council.101 Female condoms are distributed for free through government institutions such as clinics and government offices, as well as through community-based distributors. According to OGAC, the National Family Planning Council’s distribution system “routinely achieves nearly 95% coverage of public sector health care facilities and maintains stockout rates below 5 percent for male condoms.”102 The stockout rate is the same for female condoms.103 Social marketing and sales of female condoms are implemented by PSI/Zimbabwe with support from USAID and DFID. Today, PSI/Zimbabwe has trained more than 2,000 hairdressers operating in more than 1,700 hair salons in low-income neighborhoods.104 A two-pack of Care female condoms sells for about US$0.20.105 In addition to the hair salon initiative, program implementers have pursued alternative channels of distribution and programming, such as barber shops targeting men, commercial sex worker networks, and support groups for people living with HIV and AIDS. For instance, women living with HIV and AIDS have been trained to conduct interpersonal communication trainings on positive prevention and have sold Care female condoms to support groups.106 Successes “Women say they feel safe, because they can buy [Care] and put it on themselves, so they are sure the condom is there to protect them.” —Patience Kunaka, Communications Manager, PSI/Zimbabwe A total of 4.7 million female condoms were distributed through public sector and social marketing channels in Zimbabwe in 2009.107 Public sector distribution has climbed since 2004, reaching a high of 2.6 million units distributed in 2009.108 The public sector program now accounts for the majority of female condoms accessed by users in the country. Growth of the public sector program stems largely from local-level promotion and demand generation performed by community-based distributors and behavior change facilitators. Likewise, sales of Care female condoms have flourished. Between 1997 and 2009, annual sales of Care increased from 120,720 to 2.1 million.109 The hair salon initiative is responsible for a significant proportion of female condom sales in Zimbabwe and has strongly influenced knowledge of and demand for female condoms. According to Peter Halpert, health director of USAID/Zimbabwe, “the result has been a 135 percent increase in [Care] sales between 2005 and 2009.”110 37 38 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health Figure 6. Zimbabwe Public Sector and Social Marketing Female Condom Distribution and Sales, 2000-2010 Female Condom Units Distributed or Sold Source: MOHCW data 6,000,000 Social Marketing 5,000,000 Public Sector Total 4,000,000 Linear Trend (Total) 3,000,000 Exponential Trend (Public Sector) 2,000,000 1,000,000 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Zimbabwe Public Sector and Social Marketing Public sector distribution and social marketing sales figures shown in Figure 6 Female Condom Distribution and Sales 2000-2010 underscore the strength of Zimbabwe’s total market approach to female (and male) condoms. Total market approach can be understood as when public, private, NGO, and/or donor-financed social marketing sectors are integrated into “one market” that can be segmented into target populations. As illustrated in Figure 6, female condoms hit peak distribution at more than five million units in 2008, with social marketing sales accounting for the majority distributed—mainly because of low prices resulting from hyperinflation. Even though social marketing sales declined in 2009 and 2010, overall distribution these years remained steady because of the increases in public sector distribution. Zimbabwe’s female condom distribution has been very successful in light of economic and political challenges thanks in large part to the flexibility and responsiveness of its complementary public and private sector approaches. Challenges In spite of numerous successes, Zimbabwe’s female condom program has faced obstacles. In 2008, violence around elections and the temporary suspension of NGO activity made it difficult to deliver female condom services and training. Today, water shortages and power outages affect PSI/Zimbabwe’s hair salon operations, and many salons have reduced their hours or closed.112 Hyperinflation and the collapse of Zimbabwean currency also hinder female condom sales and distribution. The U.S. dollar is now being used for many transactions, yet Zimbabweans do not have access to U.S. coins, making it difficult to purchase the Care two-pack at US$0.20 each.113 A related challenge is the price of female condoms relative to male condoms. For the cost of a two-pack of Care female condoms, consumers can purchase six male condoms.114 Even seemingly affordable prices have become more burdensome in light of Zimbabwe’s economic situation. Part Four: Impacts and Challenges in the Field: Country Case Studies Finally, negative health worker attitudes continue to be one of the greatest barriers to female condom uptake at public health sites.115 Since the 2006 launch of the female condom strategy, UNFPA has prioritized health worker trainings at service delivery sites to help mitigate this problem and to ensure women build skills needed to negotiate female and male condom use. MALAWI “The female condom is actually empowering women to become more assertive and to stand up for their own health issues.” —Sandra Mapemba, Condom Programme Coordinator, UNFPA/Malawi History and Female Condom Introduction The FC1 female condom was first piloted in Malawi in 2000 with funding from UNFPA, but registered little success. Initially the product was sent to clinics for distribution without first training providers, which led to misinformation and low uptake.116 In 2004, the FC1 female condom was then re-piloted in 22 areas across the country, and subsequent studies found greater acceptability.117 From 2006 onward, programs have been scaled up with the goal of making female condoms available across Malawi by 2010.118 Similar to Zimbabwe, Malawian civil society and grassroots advocates played an active role in helping to raise the urgency of female condoms with donors and the government. Hunger Project Malawi (HPM), a nongovernmental organization (NGO) that strives to end hunger and poverty, began working with female condoms among rural populations in 2003 with support from UNFPA. HPM was one of several organizations that convened a landmark NGO female condom meeting in 2006 to urge the government to increase availability and access to the method. The meeting ended with the creation of an advocacy document endorsed by more than 10 NGOs.119 In addition to NGO advocacy, UNFPA was instrumental in raising the visibility of female condoms with the Malawian MOH and other important stakeholders. UNFPA and the MOH organized a joint meeting in 2006 for regional participants with the objective of addressing the gaps in coordination, supply, distribution, and access to female condoms. Officials from the MOH signaled strong support for female and male condoms as dual protection methods and committed to support meeting outcomes to increase their availability. Similar to Zimbabwe, Malawian civil society and grassroots advocates played an active role in helping to raise the urgency of female condoms with donors and the government. Revitalizing Female Condoms Commitment to female condoms and coordination among the MOH–Reproductive Health Unit (RHU), PSI/Malawi, donors such as UNFPA and its CCP initiative, and civil society organizations allowed for strategic public-private sector reintroduction of the FC2 female condom in 2008, after the product was registered. That year, the government began distributing unbranded FC2 female condoms for free through the public health system. At the same time, PSI/Malawi, with support from the MOH 39 40 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health and UNFPA, launched a social marketing campaign featuring a branded Care female condom, drawing inspiration and best practices from Zimbabwe. Recent Developments in Program Structure and Support In 2009 and 2010, new donors including USAID and the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM) began financing commodities, and female condoms were added to the mainstream national supply chain. USAID began supporting female condom procurement upon request from the MOH. In 2009, 1.5 million FC2 female condoms were shipped to stock Malawi’s public sector and were paid for using the Commodity Fund.120 USAID has committed to shipping 5.2 million FC2 female condoms between 2010 and 2011, with 3.5 million units obligated in 2010.121 GFATM has committed to procuring 200,000 units apiece in 2010 and 2011, and an additional 500,000 units in 2012.122 These new donors supplement existing funding from donors such as UNFPA, which has provided assistance for female condom commodities, social marketing, and public sector capacity building, including financial support for a CCP focal person within the RHU.123 In terms of female condom logistics, UNFPA and the RHU controlled female condom supply and distribution prior to 2009. This changed in July 2009 when the USAID | DELIVER Project transitioned female condoms to the national supply chain, in response to advocacy from UNFPA and commitment from the MOH.124 Supply and distribution are now centrally managed by the Health Technical Services and Support division of the MOH and Central Medical Stores—the mechanism that provides pharmaceuticals and medical supplies to Malawian government health facilities. USAID | DELIVER now provides supply management and forecasting support. Key donors receive monthly condom stock reports through USAID | DELIVER to help ensure commodity needs are being met. Because female condoms have entered the main supply chain, district health authorities now have the option to include female condoms in their budgets.125 Today, the MOH–RHU, with financial support from UNFPA and USAID, continues to coordinate Malawi’s female condom efforts, which reach clients through the public sector, social marketing, workplace programs, and NGOs.126 PSI/Malawi, with UNFPA and USAID support, works with salon owners to conduct trainings with staff on educating and promoting female condoms through information-sharing and demonstrations. Care female condoms are sold mainly in beauty salons, as well as pharmacies and private clinics. A two-pack of Care female condoms sells for about US$0.25—a price that is subsidized by UNFPA.127 Recently, barber shops have been included as education and distribution sites as a way to engage men. PSI/Malawi is also looking to expand its reach with partners in rural areas such as the Farming and Milk Producers’ Associations and with marginalized populations such as sex workers. Successes “In the past men…would direct things and at the expense of women’s health. I am glad that women have a choice to protect themselves against STIs and unwanted pregnancies using this new condom.” —Martha Banda, Beautician, Malawi Part Four: Impacts and Challenges in the Field: Country Case Studies Malawi’s female condom program is starting to show real results. Some 2,400 Malawian hairdressers now sell FC2 female condoms and serve as advocates. In 2009, 28 district hospitals, 100 health centers, and 58 NGOs were distributing female condoms.128 According to UNFPA, over the course of three years, female condom distribution through the public sector alone increased from 124,000 in 2005 to nearly one million in 2008.129 Care female condom sales have more than doubled since the product launch, from almost 40,000 units in 2008 to 90,000 units in 2009.130 Challenges In spite of these successes, many challenges still confront Malawi’s growing female condom program. Stockouts are an issue cited by many stakeholders, especially those located in rural areas. According to a provider at the STI Clinic in Balaka District Hospital, “When women come for female condoms we can only give five at a time, whereas we give 20 male condoms. They have to keep coming back and sometimes we have no [female] condoms to give them…. We’ve only had male condoms, but they are no use to the women whose husbands or boyfriends refuse to use them. We need a better supply of female condoms so that we can provide adequately for everyone.”131 Another obstacle concerns provider training and health workforce strengthening. Female condoms require service providers to have the right skills and knowledge to promote the product to clients in a nonjudgmental, supportive way. Negative attitudes and lack of proper training among service providers is still a problem in Malawi. Moreover, health care worker turnover is high, which makes it difficult for trainings to keep pace with personnel.132 Lastly, resources for programming continue to be a challenge in Malawi especially as demand increases. For example, there has been no money to procure pelvic models for female condom demonstrations, which are valuable for showing women and men how female condom insertion works.133 At this point, UNFPA has largely shouldered the costs of Malawi’s female condom programming. With USAID recently coming to the table with female condom commodities, there is a ripe opportunity for the U.S. government to ensure these female condoms have the maximum impact by supporting programming. CAMEROON “As a woman, I have the right to negotiate for safer sex with the use of the female condom in order to protect myself from any STIs.” — Joy, volunteer with Society for Women and AIDS Cameroon History Cameroon is a country that is currently scaling up its female condom program in spite of limited support from the U.S. government. Cameroon initiated its female condom efforts in 2002. The Cameroonian Association for Social Marketing (ACMS), a PSI affiliate, worked with the Cameroonian government, UNFPA, and USAID to develop 41 42 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health the brand “Protectiv” for the FC1 female condom.134 ACMS/PSI’s activities included education through women’s groups and a poster campaign. Social marketing was complemented by a commercial sales network. USAID shipped more than 300,000 FC1 to ACMS/PSI between 2002 and 2006, and UNFPA began its commodity support by furnishing 300,000 FC1 units in 2006.135 However, minimal funding for programming and irregular product supply at the time made it difficult to expand the program, and stockouts were widespread.136 For instance, USAID’s commodity support for Cameroon nosedived dramatically to fewer than 10,000 units shipped between 2007 and 2009. Current Program Female condom efforts in Cameroon have been recently reinvigorated through a new initiative—the Universal Access to Female Condoms (UAFC) Joint Programme. UAFC is a partnership among Oxfam Novib, World Population Foundation, i+solutions, and the Netherlands’ Ministry of Foreign Affairs. UAFC is funding a female condom pilot program in Cameroon (January 2009 to December 2011) whose goal is to distribute 3.4 million female condoms.138 Similar to Zimbabwe and Malawi, UAFC coordinates with a variety of stakeholders including the MOH and the National AIDS Control Committee; the Ministry of Mines, Industry, and Technological Development; multilateral organizations like UNFPA and UNAIDS; LANCOME—the Cameroonian laboratory for quality testing; retail shops; community- and faith-based organizations; and women’s groups such as the Society for Women Against AIDS in Africa.139 On the supply side, i+solutions works with ACMS to develop procurement tables, though ACMS is ultimately responsible for supply chain management within Cameroon.140 Both FC2 and VA w.o.w. female condoms are registered in Cameroon and procured and distributed by UAFC in re-packaged and re-branded form. They are then distributed by trained hairdressers, peer educators, health workers, and taxi drivers, who offer interpersonal communication and education about the product. Female condoms are also sold in small retail stores, pharmacies, and health centers. While UAFC is focusing on the private sector, UNFPA/Cameroon has increased its female condom activity primarily through public sector capacity-building. UNFPA/Cameroon provides technical assistance to the MOH in developing plans for procurement and distribution of female and male condoms.141 It also purchases female condoms that are then distributed for free through the public sector and to a smaller degree through ACMS’ social marketing efforts. Finally, UNFPA/ Cameroon implements a joint sexual and reproductive health project with the African Development Bank that supplies female and male condoms to health districts and trains service providers on condom promotion and use.142 UNFPA procured some 500,000 FC2 female condoms from 2008 to 2010 for its programs, complementing the social marketing efforts supported by UAFC.143,144 UAFC is funded by the Netherlands Ministry of Foreign Affairs, Danish International Development Agency, Swedish International Development Cooperation Agency, the Norwegian Agency for Development Cooperation (2008 only), the William and Flora Hewlett Foundation, and Oxfam Novib; funding will expire in December 2011. USAID is not currently providing financial support to UAFC; however, the U.S. Part Four: Impacts and Challenges in the Field: Country Case Studies government did support ACMS/PSI and its female condom activities in 2009.145 The U.S. government does not have a USAID Mission in Cameroon, and USAID only offers limited support to Cameroon’s HIV/AIDS programs at present. For instance, in 2009, Cameroon received a modest US$500,000 in bilateral aid from PEPFAR.146 Successes and Challenges The UAFC female condom program has already produced notable successes. The program secured support for female condoms from key political figures, such as the Prime Minister, the Minister of Health, and the Minister of Women’s and Family’s Affairs.147 In addition, UAFC has cultivated a female condom “champion” in the Cameroonian musician Manu Dibango, who performed at the launch of UAFC’s program in November 2009. In 2009, ACMS/PSI trained 483 peer educators and involved 32 health facilities and 31 pharmacies in the distribution and sales of female condoms.148 Around 700,000 female condoms were sold in Cameroon in 2009,149 compared with less than 350,000 distributed in 2008.150 When it comes to challenges, ACMS/PSI reports that monitoring and evaluation of interventions in the field is an ongoing difficulty. There could also be increased coordination and collaboration between UAFC and UNFPA. However, one of the largest challenges is finding donor support for female condom activities after UAFC’s funding expires in 2011.151 BOLIVIA “The female condom is little known for cultural reasons among poor and indigenous women. It is necessary to create a comprehensive strategy that takes into account the diversity in perceptions and practices of the Bolivian population.” —Teresa Lanza, Catholics for the Right to Decide (CDD)/Bolivia Background Bolivia’s context in terms of HIV/AIDS and national health spending is much different from Zimbabwe, Malawi, and Cameroon, and its female condom programming history reflects this. Bolivia’s HIV/AIDS prevalence in the general population is low, with concentrated levels among men who have sex with men and to a lesser extent among commercial sex workers. The Bolivian government’s response to HIV/AIDS has been limited and dependent almost completely on foreign aid, which makes the country an interesting case study on whether and how a female condom program can succeed in light of these circumstances. History The FC1 female condom was launched as a pilot project in Santa Cruz, Bolivia in 1996.152 At the time, the Bolivia Social Marketing Project—a PSI affiliate—provided technical assistance to Bolivian NGO PROSALUD to develop and implement social marketing programs for various prevention methods, including female condoms.153 43 44 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health PROSALUD was founded in 1985 with technical and financial assistance from USAID and now supports a network of primary and secondary care facilities that serves more than half a million low- and middle-income Bolivians in peri-urban areas. In the early phases of its social marketing program, PROSALUD reported modest female condom sales, approximately 208,885 FC1 from 1996 to 2004.155 Its target populations were youth, rural communities, and women of reproductive age.156 While PROSALUD offers subsidized services throughout Bolivia, none of its services are provided for free, except for those offered in partnership with the MOH.157 PROSALUD continued its female condom social marketing program in spite of losing technical assistance from PSI/Bolivia when the affiliate closed its office in the early 2000s.158 USAID began shipping female condoms to PROSALUD in 2004, using the Commodity Fund to purchase the condoms. From 2004 to 2009, USAID shipped 173,000 FC1 female condoms to PROSALUD.159 Bolivia also received modest numbers of female condoms from GFATM and UNFPA from 2006 to 2007.160 Current Program Today, PROSALUD is one of just a few entities distributing female condoms in Bolivia. USAID continues to provide commodities for PROSALUD and shipped nearly 100,000 FC1 female condoms from 2008 to 2009.161 PROSALUD’s health commodity distribution network reaches municipal and commercial pharmacies, NGOs, and public services, and female condoms have been distributed through these and other channels including brothels and motels. According to CDD/Bolivia, some pharmacies used to sell the female condom at the relatively high price of US$1.20 per unit, but they no longer sell them.162 PROSALUD also works with the project, Socios para el Desarrollo (Partners for Development), to promote and distribute female condoms to a single target population: commercial sex workers.163 Although PROSALUD’s financial and technical support from USAID is set to expire soon, USAID will likely continue to support its social marketing program.164 PROSALUD plans to distribute the FC2 female condom once registration is secured. Currently, there is no free public sector distribution of female condoms. The MOH does not view female condoms as a priority.165 Only a handful of NGOs are involved with female condom distribution, and there are not many organizations that currently possess PROSALUD’s capacity or infrastructure that could take it on.166 Meanwhile, UNFPA/Bolivia is just beginning to map out a strategy for female condoms. It plans to convene a stakeholder meeting to develop a strategic plan for female and male condoms, as part of a broader initiative on contraceptives.167 UNFPA/Bolivia intends to reach out to the MOH, USAID, NGOs, and civil society—including commercial sex workers and women living with HIV. Finally, FC2 product registration in Bolivia is underway. As referenced earlier, countries require the FC2 female condom to be registered before it can be imported for public or private sector distribution. A local company must be identified to act as registration holder for the country, meaning that the company compiles and submits a dossier of registration information to the appropriate regulatory body.168 In August 2009, USAID/Bolivia contacted FHC for the necessary registration documents Part Four: Impacts and Challenges in the Field: Country Case Studies because PROSALUD wanted to register the product. FHC notified UNFPA/Bolivia of PROSALUD’s plans, and after consultation with PROSALUD, UNFPA assumed the lead and submitted the registration request to the appropriate regulatory agency.169 Successes and Challenges Bolivia is unique in that female condoms have been available in the country for the past 15 years, and programming efforts have been led almost exclusively by NGOs, which are typically well-positioned to reach marginalized populations in need of services. And although PROSALUD’s sales are not high compared with other countries, the organization has been able to create and maintain a demand for female condoms.170 On the other hand, even though the female condom has been available in Bolivia for 15 years, it is not very accessible. Poor and indigenous women—a key population for female condom use—know very little about the female condom.171 One reason may be that social marketing efforts have focused heavily on sex workers, sometimes to the exclusion of other at-risk populations. Bolivia also differs markedly from other countries with female condom programs in that there is a lack of strategy guiding efforts, limited coordination among stakeholders, and little interest from national authorities to take the lead. For example, UNFPA/ Bolivia reports that it has not yet spoken with the USAID Mission in the country about female condoms.172 However, in 2010, the MOH, USAID, and FHC met for the first time to discuss registration of the FC2 and strategies for female condom reintroduction.173 Communication and advocacy between Bolivian NGOs and the USAID Mission have also been tenuous. For example, CDD/Bolivia has never advocated with the USAID Mission because of concern about backlash from not signing the Global Gag Rule (Mexico City Policy), even though it was repealed by President Obama in 2009.174 Furthermore, delicate diplomatic relationships between the Bolivian and U.S. governments make it difficult for Bolivian NGOs to approach the U.S. government with any requests. As a result, civil society and NGOs are not able to effectively weigh in with the USAID Mission on female condoms—a critical missed opportunity given that USAID Missions make the procurement decisions.175 Poor and indigenous women—a key population for female condom use— know very little about the female condom. Strengths and Weaknesses of U.S. Government Field Support for Female Condom Programs Zimbabwe and Malawi—two promising examples of female condom programs in developing countries—benefit significantly from U.S. government support. However, as Bolivia illustrates, U.S. investment in female condoms alone does not automatically translate into an effective program in the absence of buy-in from and coordination with other major stakeholders. In fact, strong U.S. government support is not a prerequisite for an effective female condom program, as evidenced by Cameroon. Nevertheless, these four countries offer important lessons about where and how the U.S. is excelling in its field-level support for international female condom programs and where improvements can be made. 45 46 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health U.S. Strengths Commodity Financing, Coordination, and Logistics Perhaps the U.S. government’s greatest contribution to country programs has been its ability to ensure a robust, steady, and well-coordinated supply of female condoms. Perhaps the U.S. government’s greatest contribution to country programs has been its ability to ensure a robust, steady, and well-coordinated supply of female condoms. This is crucial because female condom shortages and stockouts are repeatedly cited as chief reasons for low demand and program failure. The impact of U.S. commodity support is further strengthened when U.S. dollars are leveraged alongside assistance from other donors such as DFID or UNFPA, who tend to put more funds into female condom distribution and programming. Hence, different donors pay for complementary pieces of a female condom program, as illustrated by Zimbabwe and Malawi. USAID’s Commodity Fund has been an invaluable resource for PEPFAR non-focus countries to procure female (and male) condoms from the U.S. government. All four countries featured in this report have been able to access the Commodity Fund. USAID | DELIVER has played an integral role in Zimbabwe and Malawi’s program by offering technical support with female condom forecasting and supply management. USAID | DELIVER has been an active player in Zimbabwe and Malawi’s technical working groups and has ensured that stakeholders receive timely and accurate condom stock reports. In fact, USAID/Zimbabwe cites “a good logistics system” as one of the key factors that has enabled the country to be a female condom success story. Collaboration and Alignment with other Donors, Governments, and Stakeholders USAID field staff in Zimbabwe and Malawi are involved in numerous technical working groups that address female condoms. These working groups are composed of country government officials, donors, civil society, NGOs, and the private sector. For example, USAID/Malawi actively participates in the reproductive health technical working group, donor coordination meetings, drugs and medical supplies working group, and the condom coordination group. According to one USAID official in Malawi, USAID has recently taken “an active role in ensuring that condom programming will be integrated into priorities of the HIV prevention and broader HIV technical working groups.”177 This collaboration opens the door for USAID to offer technical assistance for procurement and programming when needed by partners, such as PSI.178 Support for Social Marketing The U.S. government has played a leading role in supporting female condom social marketing and programming efforts through financial support to international NGOs such as PSI and local NGOs like PROSALUD in Bolivia. Indeed, PSI/Zimbabwe points to ample support from USAID and DFID for female condom programming as crucial for smooth and sustained operations.179 U.S. Weaknesses Insufficient Funding for Programming Many stakeholders rightly recognize and applaud the U.S. government for being a vital partner in making female condoms available and affordable in developing countries, Part Four: Impacts and Challenges in the Field: Country Case Studies yet some believe there is more the U.S. can do, especially regarding programming. According to Lucie van Mens of UAFC, who coordinates the initiative’s efforts in Cameroon, “We would like to see the U.S. government integrate female condom programming into its financing of activities on HIV prevention… and to invest not only in procurement but also in programming.”180 UAFC operates female condom programs in Cameroon and Nigeria and is hoping to expand efforts to Mozambique, and has done this largely without U.S. support. However, these are pilot programs that are in need of a longer-term funding source. The U.S. government could play an important role here. Similarly, Sandra Mapemba of UNFPA/Malawi echoed the need for more U.S. investment in programming, stating that “funding [from USAID] committed to one portion of the female condom program would assist widely.”181 Yet this message has not been fully communicated with the USAID Mission in Malawi. According to an official USAID/Malawi, “UNFPA has been taking the lead in female condom programming for the country and has not requested additional support since demand has not been there in the past.”182 Now that demand is indeed growing in Malawi, additional U.S. support for programming can be crucial to meet the need and bolster demand among consumers. Lack of Female Condom Oversight or Program Tracking An underlying issue regarding financial support for programming in the field is that there is no clear tracking mechanism or oversight at OGAC or USAID headquarters for female condom programming. OGAC’s database does not have the sophistication or level of detail to determine in which countries it supports female condoms and how financial support is allocated across commodities and programs.183 It is also difficult and cumbersome for implementing organizations like PSI to establish how much or what percentage of U.S. government funding goes to procurement or programming.184 PSI explains that because its female condom programs are usually part of larger condom social marketing programs funded by multiple donors, it would have to review multiple budgets for each of its countries with female condom programs to break down USAID’s financial support for procurement and programming. The result is that U.S. government officials do not have a clear picture of U.S. support for female condom programming. This absence of information complicates OGAC’s and USAID’s resource allocation planning and evaluation efforts, and makes it more difficult for recipient governments, other donors, and NGOs in the field to advocate for increased investment in programming. U.S. government officials do not have a clear picture of U.S. support for female condom programming. Limited USAID Mission Outreach to Civil Society Another challenge that surfaced in each country is the limited outreach from the USAID Missions to civil society and NGOs on female condoms. When asked if it reaches out to civil society organizations for input on U.S. support for female condoms, the USAID Mission in Zimbabwe says it does through “various meetings and forums.”185 In spite of this, organizations like Women’s Action Group Zimbabwe—a longstanding women’s rights organization engaged in advocacy and programming on female condoms—have never met or spoken with the Mission about female condoms.186 47 48 As Bolivia illustrates, U.S. foreign policies like the Global Gag Rule can have a lasting negative impact on civil society engagement with the U.S. government. Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health USAID/Malawi concedes that it does not directly reach out to civil society organizations but that it does work with them through funded partner organizations such as PSI.187 Cameroon is at a particular disadvantage for civil society engagement because the country no longer has a USAID office; USAID coordinates its activity in Cameroon through the West Africa office based in Ghana.188 And Bolivia has its own set of unique challenges including the lack of a robust female condom program in the first place and delicate relationships between the U.S. and Bolivian governments. As Bolivia illustrates, U.S. foreign policies like the Global Gag Rule can have a lasting negative impact on civil society engagement with the U.S. government. Civil society communication and advocacy with USAID Missions on female condoms are important for several reasons. First, procurement decisions ultimately rest with USAID Missions. While it should not be up to civil society to prove demand for female condoms, if Missions do not hear or witness demand for female condoms, they will be less likely to procure them. Another issue is that U.S. foreign assistance is shifting toward a model of country ownership under the GHI, meaning that countries themselves will determine priority areas and lead the response. However, advocates worry that the priorities of civil society, especially women at the margins—women living with HIV and AIDS, incarcerated women, refugee or migrant women, sex workers, young women, or drug users—will not be heard or reflected in critical policy or program discussions. It therefore behooves the U.S. government to find ways to meaningfully involve civil society in decision making about how U.S. foreign assistance will be spent, with female condoms included in this discussion. Ingredients of an Effective Female Condom Program Best practices and lessons learned from female condom programs in developing countries offer insight into the building blocks for an effective program. As these country case studies show, effective female condom programs are complex. Commodities, while straightforward, are just one piece of a program. Successful models of female condom programs contain most or all of the following elements: Support of the national government. Commitment and support from the national government is critical; it lays the foundation for all other aspects of a female condom program. When government ministries coordinate, oversee, and fund female condom efforts, it helps institutionalize and legitimize the program. Sustained resources from donors. Robust and sustained funding from bilateral and multilateral donors is essential. Many existing programs are funded by multiple donors because it can be difficult for one donor to pay for all the necessary programmatic components. While it makes sense for donors to put money into their own areas of specialty (i.e. USAID funding commodities or UNFPA funding programming), more money overall and more overlapping and flexible funding is needed. Part Four: Impacts and Challenges in the Field: Country Case Studies Multisectoral female condom strategy. Effective female condom programs have a well-thought out female (and male) condom strategy guiding efforts. These strategies are often borne out of landscape analyses or market research that informs stakeholders of the female condom gaps and strengths. Female condom strategies should take into account public and private sector approaches, and they should harmonize with existing HIV/AIDS or contraceptive plans. Well-functioning supply chain and distribution. Programs not only need sufficient quantities of female condoms, they also need strong supply chains and smooth logistics. This is a major strength of U.S. government involvement through its USAID | DELIVER Project. Countries with USAID | DELIVER offices that are looking to program female condoms should strongly consider reaching out to USAID | DELIVER for its involvement and expertise. Distribution plans should take into account public, private, and interpersonal channels. These channels could include government health clinics, schools and universities, pharmacies, hotels, bars, NGOs, and peer-to-peer mechanisms. Attention to provider bias. Health provider bias against female condoms presents a significant challenge to distribution and programming and is a fairly ubiquitous issue. HIV prevention and family planning program designers should incorporate regular training for doctors, nurses, and counselors about the female condom and how to discuss and distribute the product with accurate information and a nonjudgmental demeanor. Comprehensive and rights-based education. In order to facilitate increased female condom use and uptake, women, men, and young people need comprehensive education on female condoms. At minimum, trainings should provide accurate information about female condoms properties, use, benefits, and drawbacks; opportunities to practice insertion on oneself or using pelvic models; discussion around realistic expectations with use; lessons in condom negotiation with sexual partners; and information on female genital anatomy. Trainings should also consider lessons on female condoms and anal intercourse, gender roles and self esteem, and intimate partner violence. Innovative social marketing. Creative social marketing of female condoms is an important complement to “traditional” service provision. Hair salon and barber initiatives, in particular, have proven to be effective ways to reach women and men with education about the female condom and product provision in some African countries. Mass media is also an important component of social marketing that helps raise awareness and generate demand. Male involvement. A comprehensive female condom program takes into consideration the perspectives and needs of men. While female condoms are designed for women to initiate and wear, men also initiate and use female 49 50 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health condoms for vaginal and/or anal sex. Men should be involved in female condom program design and message testing, and they should also be targeted for female condom education and distribution. Coordination among stakeholders. Effective female condom programs benefit from coordination and collaboration among a variety of stakeholders through regular meetings or technical working groups. Stakeholders include government officials, donors, civil society, NGOs, and representatives from the private sector. Information-sharing and transparency allows stakeholders to continually improve upon the program, identify potential gaps or weaknesses, and stay abreast of developments. Civil society participation. Civil society must be involved in all levels of a female condom program, from strategy development to program implementation. NGOs and civil society have important perspectives on the issues and circumstances confronting women and men at the community level and are well-positioned to reach marginalized populations. The voices of women—especially women living with HIV and AIDS—must be included in these processes. Monitoring and evaluation. It is very important to monitor and evaluate the female condom program. Program planners and implementers need evidence of what works and does not work to further refine and tailor programs. Information on “typical” users, reasons for using female condoms, and actual utilization rates are important to capture if possible—especially to report back to donors and governments. Comprehensive condom programming civil society champions from Swaziland, Zimbabwe, Malawi, and Zambia attend a December 2009 female and male condom advocacy workshop led by CHANGE and the Centre for Population and Development Activities for the UNFPA Civil Society Advocacy Working Group. PART FIVE Findings & Recommendations Finding: OGAC has identified a serious “condom gap” affecting several high HIV prevalence countries in Africa. Yet, OGAC is not allocating enough funding to support female condom procurement and programming, especially for former focus countries, which cannot access female and male condoms through the Commodity Fund. These countries must pay for female and male condoms out of their prevention budgets, which negatively impacts procurement of female condoms, as male condoms are cheaper and Missions tend to purchase the cheaper product. Recommendation: OGAC should centrally finance female and male condom procurement to help close the condom gap. OGAC should allocate funds directly to the Commodity Fund so that all countries can be eligible to access this account to procure female condoms. In addition, OGAC should also allocate robust resources to support female and male condom programming, especially for former focus countries. Finding: Communication and coordination between OGAC and USAID officials on female condoms is limited, contributing to female condoms being overlooked in decision making on funding priorities. In addition, there is no clear mechanism or oversight at OGAC or USAID regarding financial and technical support for female condom programming. Recommendation: OGAC and USAID should form an interagency task team to engage in strategic thinking and resource allocation planning on female condoms and the broader condom gap. OGAC and USAID should also conduct an evaluation of PEPFAR support for female condom programming, and develop a system to track financial and technical support for female condom programs. Finding: Whether the U.S. procures female condoms in a given country is highly dependent on the personal biases of USAID Mission staff. Some Washington- and field-based U.S. officials lack awareness of the female condom or hold negative attitudes about it, in part because there is currently no guidance explaining the importance and relevance of female condoms in HIV prevention and family planning programs. Recommendation: OGAC and USAID should expedite the issuance of guidance to U.S. global health personnel in the field highlighting the evidence on female condom efficacy, acceptability, availability, and cost-effectiveness. The U.S. should also include 51 52 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health the female condom in GHI guidance as an important example of integrated, womancentered programming. OGAC and USAID should fund training for PEPFAR- and USAID-funded doctors, nurses, and counselors about the female condom and how to discuss and distribute the product with accurate information, in a nonjudgmental way. Finding: The U.S. government continues to release requests for applications (RFAs) and requests for proposals (RFPs)—such as the March 2010 U.S. Department of Health and Human Services Request for Applications for Nigeria—that focus on failed stand-alone abstinence and fidelity programs for HIV prevention. This contradicts PEPFAR’s new Five Year Strategy that espouses comprehensive and evidence-based prevention, and hampers comprehensive programming including female and male condoms. Recommendation: U.S. government RFAs and RFPs should call for integrated, comprehensive, and evidence-based HIV prevention programming, including female and male condom programming. Funding announcements should explicitly mention female and male condoms, as opposed to “condoms,” to provide further incentive for programs to include female condoms. Finding: OGAC’s Next Generation Indicators (NGI) Reference Guide does not disaggregate female and male condom service outlets in PEPFAR data collection efforts and does not even require countries to report on the number of male condom distribution outlets. The USAID-funded MEASURE DHS does not collect data on female condom use, contributing to the dearth of national level data on female condom use. Recommendation: OGAC should revise the NGI Guide to disaggregate female and male condoms and require countries to report on female and male condom distribution outlets. USAID should disaggregate female and male condom use in the MEASURE DHS HIV/AIDS Survey Indicators on condom use. Finding: The 2008 reauthorization of PEPFAR included a requirement that the Global AIDS Coordinator issue justification to Congress if PEPFAR programs in countries with generalized epidemics spend less than 50 percent of PEPFAR HIV prevention funds on programs that promote abstinence, delay of sexual debut, monogamy, fidelity, and partner reduction. In addition, OGAC has not issued new guidance on prevention and condoms, and female and male condom distribution is still restricted to individuals 15 years of age and older. Recommendation: Congress should remove all funding directives for abstinence and fidelity prevention programs and fund comprehensive, integrated, and evidence-based HIV prevention programs that include female condoms. OGAC should issue new guidance on prevention that ensures that all women, men, and young people have access to female and male condom education and distribution in PEPFAR-supported programs. In such guidance, OGAC and USAID should consider female condoms’ contributions to the GHI’s principles of a comprehensive, integrated, and womancentered approach. Part Five: Findings and Recommendations Finding: At the country level, the U.S. government has no mechanism to involve civil society in female condom procurement, distribution, and programming decision making. Recommendation: The U.S. should actively include civil society, especially women’s health and rights groups, in stakeholder meetings and encourage financing mechanisms that increase government-civil society collaboration in female condom programming. Finding: The U.S. excels at assisting countries in female condom procurement and logistics. Recommendation: The U.S. should expand technical assistance for female condom logistics and procurement to additional countries to increase HIV prevention efforts. 53 54 NOTES WHO, Women and Health: Today’s Evidence, Tomorrow’s Agenda (Geneva: WHO, 2009). 2 UNAIDS and WHO, AIDS Epidemic Update: 2009 (Geneva: UNAIDS and WHO, 2009). 3 UNAIDS, UNAIDS Report on the Global AIDS Epidemic: 2010 (Geneva: UNAIDS, 2010). 4 Susheela Singh et al., Adding It Up: The Costs and Benefits of Investing in Family Planning and Maternal and Newborn Health (New York: Guttmacher Institute and UNFPA, 2009). 5 WHO, Trends in Maternal Mortality: 1990 to 2008: Estimates developed by WHO, UNICEF, UNFPA and the World Bank (Geneva: WHO, 2010). 6 “Caprisa 004,” AVAC—Global Advocacy for HIV Prevention, accessed August 20, 2010, http://www.avac.org/ht/d/sp/i/28226/pid/28226. 7 AVAC—Global Advocacy for HIV Prevention, What PrEP Is and What PrEP is Not (New York, AVAC, 2010). 8 AVAC—Global Advocacy for HIV Prevention, The Thai Way Forward (New York: AVAC, 2010). 9 Global Campaign for Microbicides, Male Circumcision: What Does it Mean for Women? (Washington, DC: Global Campaign for Microbicides, 2009). 10 Gowri Vijayakumar et al., “A Review of Female Condom Effectiveness: Patterns of Use and Impact on Protected Sex Acts and STI Incidence,” International Journal of STD & AIDS, no. 17 (2006): 652-659. 11 UNDP/UNFPA/WHO/World Bank Special Programme of Research on Human Reproduction, The Female Condom: A Review (Geneva: WHO, 1997). 12 Heather Cecil et al., “The Female Condom: What We Have Learned Thus Far,” AIDS and Behavior 2, no. 3 (1998): 241. 13 Diana K. Lara et al., “Acceptability and Use of the Female Condom and Diaphragm among Sex Workers in Dominican Republic: Results from a Prospective Study,” AIDS Education and Prevention 21, no. 6 (2009): 548. 14 Susan Kalckmann et al., “Evaluation of Continuity of Use of Female Condoms among Users of the Brazilian National Health System (SUS): Longitudinal Analysis in Units in the Metropolitan Region of São Paulo, Brazil,” Rev Bras Epidemiol 12, no. 2 (2009): 1. 15 James Trussell et al., “Comparative Contraceptive Efficacy of the Female Condom and Other Barrier Methods,” Family Planning Perspectives 26, no. 2 (1994): 66. 16 Ibid. 17 PATH and UNFPA, Female Condom: A Powerful Tool for Protection, Second Edition (Seattle: PATH, UNFPA, and UNAIDS, forthcoming). 18 Johns Hopkins Bloomberg School of Public Health, USAID, and WHO, Family Planning: A Global Handbook for Providers (Baltimore: INFO Project, 2007). 19 Ibid. 20 Sue Napierala et al., “Female Condom Uptake and Acceptability in Zimbabwe,” AIDS Education and Prevention 20, no. 2 (2008): 121. 21 Mack et al., “Introducing Female Condoms to Sex Workers in Central America,” International Perspectives on Sexual and Reproductive Health, 36, no. 3 (2010): 152. 22 Edinah Masiyiwa (Executive Director of Women’s Action Group Zimbabwe), personal communication with author, March 9, 2010. 23 Center for Health and Gender Equity (CHANGE), Saving Lives Now: Female Condoms and the Role of U.S. Foreign Aid (Washington, DC: CHANGE, 2008). 1 55 56 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health 24 Kyung-Hee Choi et al., “The Efficacy of a Female Condom Skills Training in HIV Risk Reduction among Women: A Randomized Controlled Trial,” American Journal of Public Health 98, no. 10 (2008): 1841. 25 CHANGE, Saving Lives Now, 2008. 26 Natasha Mack et al., Formative Research on Female Condom Promotion in Central America (Washington, DC: USAID, 2008). 27 CHANGE, Saving Lives Now, 2008, 16. 28 Population Council and Liverpool VCT, Care & Treatment, Female Initiated Prevention: Integrating Female Condoms into HIV Risk Reduction Activities in Kenya (Nairobi: Population Council, 2009), 18. 29 Mack et al., “Central American Sex Workers’ Introduction of the Female Condom to Different Types of Sexual Partners,” AIDS Education and Prevention, 22, no. 5 (2010): 466. 30 Serra Sippel, “Uganda to Reintroduce Female Condoms,” RH Reality Check, June 29, 2009, http://www.rhrealitycheck.org/node/10572 31 Mags Beksinska (Investigator, Maternal, Adolescent and Child Health (MatCH), Department of Obstetrics and Gynaecology, University of Witwatersrand), personal communication with author, February 13, 2011. 32 CHANGE has witnessed this firsthand at meetings between civil society advocates and donor/government officials, for example, in Uganda in June 2009. CHANGE has also uncovered this dynamic in countries ranging from Guatemala to Botswana through secondary research and personal communication with stakeholders. 33 UNAIDS, Global AIDS Epidemic, 2010. 34 UNFPA, Donor Support for Contraceptives and Condoms for STI/HIV Prevention 2009 (New York: UNFPA, 2010). 35 Reproductive Health Supplies Coalition, Contraceptive Projections and the Donor Gap: Meeting the Challenge (Brussels: Reproductive Health Supplies Coalition, 2009). 36 Ibid. 37 WHO, WHO Model List of Essential Medicines, 16th List (Geneva: WHO, 2009). 38 Peters et al., “The Female Condom: The International Denial of a Strong Potential,” Reproductive Health Matters 18, no. 25 (2010): 119-128. 39 UNFPA, “Empowering Women to Protect Themselves: Promoting the Female Condom in Zimbabwe,” UNFPA, July 1, 2010, http://www.unfpa.org/public/News/pid/3913 40 Lucie van Mens (Coordinator of UAFC Joint Programme), personal communication with author, August 17, 2010. 41 UNFPA, Towards a Unified Approach: UNAIDS Inter-Agency Task Team on Comprehensive Condom Programming (New York: UNFPA, 2010). 42 Choi et al., “Female Condom Skills Training,” 2008. 43 UNFPA, “Partnering with Men to Promote the Female Condom,” Condom Programming in the Caribbean 1, no. 2 (2009): 1. 44 Weeks et al., “Multilevel Social Influences on Female Condom Use and Adoption among Women in the Urban United States,” AIDS Patient Care and STDs 24, no. 5 (2010): 307. 45 Doris Anderson (Program Analyst, Contraceptive Commodity Procurement Team, Office of Population and Reproductive Health, USAID), personal communication with author, June 23, 2010. 46 Ibid. 47 Mary Ann Leeper, Overview of the FC2 Female Condom (Chicago: Female Health Company, 2009). This is an unpublished document. 48 Yasmin Madan (PSI Vietnam Country Director), as cited in CHANGE, Saving Lives Now, 2008. Notes 49 Population Services International (PSI), Annual Cost Effectiveness Report 2008 (Washington, DC: PSI, 2009). 50 David W. Dowdy et al., “Country-Wide Distribution of the Nitrile Female Condom (FC2) in Brazil and South Africa: A Cost-Effectiveness Analysis,” AIDS 20, no. 16 (2006): 2091. 51 PSI, Cost Effectiveness Report, 2009. 52 FSG Social Impact Advisors and Elliot Marseille and James G. Kahn, Smarter Programming of the Female Condom: Increasing Its Impact on HIV Prevention in the Developing World (Seattle: FSG, 2008). 53 Doris Anderson, personal communication, 2010. 54 USAID, Fact Sheet: The U.S. Government’s Global Health Initiative (Washington, DC: USAID, 2010). 55 UNFPA, Donor Support for Contraceptives, 2010. 56 Ibid. 57 Gatson Farr et al., “Contraceptive Efficacy and Acceptability of the Female Condom,” American Journal of Public Health, no. 84 (1994): 1960-1964. 58 CHANGE, Saving Lives Now, 2008. 59 PEPFAR, The U.S. President’s Emergency Plan for AIDS Relief Five-Year Strategy (Washington, DC: OGAC, 2009), 15. 60 PEPFAR, The U.S. President’s Emergency Plan for AIDS Relief Five-Year Strategy Annex: PEPFAR’s Contributions to the Global Health Initiative (Washington, DC: OGAC, 2009), 6. 61 Ibid, 6-7. 62 PEPFAR, FY 2010 Country Operational Plan (COP) Guidance: Programmatic Considerations (Washington, DC: OGAC, 2009), 151. 63 PEPFAR, FY 2011: Country Operational Plan Guidance Appendices (Washington, DC: OGAC, 2010), 13. 64 RHInterchange, http://rhi.rhsupplies.org/rhi/index.do?locale=en_US, accessed July 1, 2010. 65 Ibid. 66 Ibid. 67 Bidia Deperthes (HIV/AIDS Technical Advisor for Comprehensive Condom Programming, UNFPA), personal communication with author, February 22, 2011. 68 Simone Martins (former Program Advisor for Latin America and Caribbean, SUPPORT Worldwide), personal communication with author, January 21, 2011. 69 Ibid. 70 Anderson, personal communication, 2010. 71 David Sarley (Activity Director for USAID | DELIVER, JSI), as cited in CHANGE, Saving Lives Now, 2008. 72 Lois Todhunter (Director of Supply Operations for USAID | DELIVER, JSI) personal communication with author, June 18, 2010. 73 Krishna Jafa (Director, HIV, TB, and Reproductive Health, PSI), interview with author, April 23, 2010. 74 Jeff Spieler (Senior Technical Advisor for Science and Technology, Office of Population and Reproductive Health, USAID), interview with author, March 23, 2010. 75 CHANGE, Saving Lives Now, 2008. 76 “About AIDSTAR,” USAID, accessed August 31, 2010, http://ghiqc.usaid.gov/aidstar/ about/index.html 77 Jafa, interview, 2010. 78 Silvia Gurrola Bonilla (GHARP II Chief of Party, Management Sciences for Health), personal communication with author, September 1, 2010. 57 58 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health 79 George Sinyangwe (Senior Health Advisor, USAID/Malawi), personal communication with author, September 7, 2010. 80 PEPFAR, The U.S. President’s Emergency Plan for AIDS Relief Five-Year Strategy Annex: PEPFAR and the Global Context of HIV (Washington, DC: OGAC, 2009), 5. 81 Beth Deutsch (Senior HIV Prevention Advisor, USAID/Malawi), interview with author, April 8, 2010. 82 Caroline Ryan, “Overview of PEPFAR Prevention,” (power point presented at the PEPFAR Scientific Advisory Board Meeting, Washington, DC, January 7, 2011). 83 Ibid. 84 PEPFAR, Fiscal Year 2009: PEPFAR Operational Plan (Washington, DC: OGAC, 2010). 85 Nick Wadhams, “The Battle in Uganda over Condoms,” TIME.com, August 30, 2009, http://www.time.com/time/world/article/0,8599,1919311,00.html 86 U.S. Department of Health and Human Services (DHHS), Providing Quality Comprehensive HIV/AIDS Prevention, Care, and Treatment Services in the Federal Republic of Nigeria, Under the President’s Emergency Plan for AIDS Relief (PEPFAR) (Washington, DC: DHHS, 2010), 10. 87 PEPFAR, Next Generation Indicators (NGI) Reference Guide (Washington, DC: OGAC, 2009), 3. 88 Ibid, 27. 89 “MEASURE DHS HIV/AIDS Survey Indicators Database,” MEASURE DHS, accessed February 23, 2011, http://www.measuredhs.com/hivdata/ind_tbl.cfm. 90 UNFPA, UNFPA Female Condom Global Initiative: 2006-2007 Progress Report (New York: UNFPA, 2007). 91 Daisy Nyamukapa (condom programming specialist formerly with UNFPA/ Zimbabwe), e-mail message to Implementing Best Practices e-Forum on Female Condoms, May 1, 2008. 92 Kumbirai Chatora (Deputy Country Director, PSI/Zimbabwe), interview with author, April 28, 2010. 93 CHANGE, Saving Lives Now, 2008. 94 Ibid. 95 UNFPA, Female Condom Global Initiative, 2007. 96 Nyamukapa, e-mail message to Best Practices, 2008. 97 Ibid. 98 UNFPA, UNFPA Global Condom Initiative—Scaling Up Male and Female Condom Programming: Zimbabwe January-December 2009 (Harare: UNFPA, 2009). 99 RHInterchange, 2010. 100 Peter Halpert (Health and Education Team Leader, USAID/Zimbabwe), interview with author, April 23, 2010. 101 Nyamukapa, personal communication with author, February 22, 2011. 102 PEPFAR, 2009 Country Operational Plan: Zimbabwe (Washington, DC: OGAC, 2009), 20. 103 Nyamukapa, personal communication, 2011. 104 Halpert, interview, 2010. 105 UNFPA, Global Condom Initiative Zimbabwe, 2009. 106 Global Health Technical Assistance Project, Zimbabwe HIV/AIDS Partnership Project & Behaviour Change Programme: A Joint USAID/DFID Assessment (Washington, DC: Global Health Technical Assistance Project, 2008). 107 UNFPA, Global Condom Initiative Zimbabwe, 2009. 108 Ibid. 109 Halpert, interview, 2010. 110 Ibid. Notes 111 Kathryn Bice, “Female Condom Popular in Zimbabwe,” Kubatana. net, August 6, 2010, http://www.kubatanablogs.net/kubatana/?p=3518&utm_ source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+kubatana+(Kubat ana.net+speaks+out+from+Zimbabwe 112 Ibid. 113 Ibid. 114 UNFPA, Global Condom Initiative Zimbabwe, 2009. 115 Ibid. 116 PlusNews, “Malawi: High Hopes for Female Condom,” PlusNews, July 29, 2008, http:// www.irinnews.org/report.aspx?ReportID=79506. 117 Countdown 2015 Europe, Female Condoms Now! How European Governments Can Help to Increase Access to Female Condoms for Women in the Developing Countries (Brussels: Countdown 2015 Europe, 2009). 118 Ibid. 119 Hunger Project Malawi, Position Paper on the Availability and Access to Female Condoms in the Prevention of HIV Infections and Other Reproductive Health Services (Blantyre: Hunger Project Malawi, 2006). 120 Deutsch, interview, 2010. 121 Sandra Mapemba (Condom Programme Coordinator, UNFPA/Malawi), interview with author, April 6, 2010. 122 Ibid. 123 Ibid. 124 Deutsch, interview, 2010. 125 Countdown 2015 Europe, Female Condoms Now!, 2009. 126 Sandra Mapemba, “Breaking Down the Barriers to Achieve Gender Equity—The Female Condom Programme in Malawi” (power point presented at USAID, Washington, DC, November 19, 2009). 127 Countdown 2015 Europe, Female Condoms Now!, 2009. 128 UNFPA, UNFPA Global Condom Initiative—Scaling Up Male and Female Condom Programming: Malawi Jan-Dec 2009 (Lilongwe: UNFPA, 2009). 129 UNFPA, “Empowering Women,” 2010. 130 Mapemba, “Breaking Down the Barriers,” 2009. 131 Countdown 2015 Europe, Female Condoms Now!, 2009. 132 Ibid. 133 UNFPA, Global Condom Initiative Malawi, 2009. 134 Nestor Ankiba (Executive Director, ACMS), interview with author, April 26, 2010. 135 RHInterchange, 2010. 136 Ankiba, interview, 2010. 137 RHInterchange, 2010. 138 Ankiba, interview, 2010. 139 van Mens, interview, 2010. 140 Ibid. 141 Gislaine Ada Ngaska (Programme Advisor for Central and South Africa, SUPPORT Worldwide), personal communication with author, August 23, 2010. 142 Ibid. 143 RHInterchange, 2010. 144 Ada Ngaska, personal communication, 2010. 145 Jafa, interview, 2010. 146 Ibid. 147 Ankiba, interview, 2010. 148 ACMS, Le Préservatif Féminin s’Insère au Cameroun (Yaoundé: ACMS, 2010). 59 60 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health 149 van Mens, interview, 2010. ACMS, Préservatif Féminin, 2010. 151 van Mens, interview, 2010. 152 UNAIDS, Global Directory of Condom Social Marketing Projects and Organizations (Geneva: UNAIDS, 1999). 153 Ibid. 154 Health Systems 20/20, “Bolivia: Strengthening PROSALUD,” Abt Associates Inc., accessed August 20, 2010, http://www.healthsystems2020.org/section/where_we_work/ bolivia. 155 PROSALUD, “Mercadeo Social de Productos,” PROSALUD, accessed August 20, 2010, http://www.prosalud.org/mercadeosocial.html 156 USAID, Country Profile: HIV/AIDS Bolivia (Washington, DC: The Synergy Project, 2004). 157 Diddie Schaaf (HIV/AIDS Officer, UNFPA/Bolivia), interview with author, June 15, 2010. 158 Ibid. 159 RHInterchange, 2010. 160 Ibid. 161 Ibid. 162 Teresa Lanza (Executive Director, CDD/Bolivia), interview with author, May 25, 2010. 163 Ibid. 164 Stanley Blanco (Health Development Specialist, USAID/Bolivia), interview with author, May 20, 2010. 165 Schaaf, interview, 2010. 166 Blanco, interview, 2010. 167 Schaaf, interview, 2010. 168 Martins, personal communication, 2011. 169 Martins, personal communication, 2010. 170 Ibid. 171 Lanza, interview, 2010. 172 Schaaf, interview, 2010. 173 Schaaf, personal communication, 2011. 174 Lanza, interview, 2010. 175 Ibid. 176 Halpert, interview, 2010. 177 Deutsch, interview, 2010. 178 Chatora, interview, 2010. 179 Ibid. 180 van Mens, interview, 2010. 181 Mapemba, interview, 2010. 182 Deutsch, interview, 2010. 183 Nina Hasen (Technical Advisor, HIV/AIDS Prevention, OGAC), interview with author, August 10, 2010. 184 Jafa, interview, 2010. 185 Halpert, interview, 2010. 186 Masiyiwa, personal communication, 2010. 187 Deutsch, interview, 2010. 188 Ada Ngaska, personal communication, 2010. 189 Female Health Company, Vision + Partnership, Working Together to Improve Women’s Health Worldwide: The Female Health Company 2009 Annual Report (Chicago: The Female Health Company, 2010). 150 Notes 190 Ibid. Leeper, FC2 Female Condom, 2009. 192 Maya Gokul, “FC2 Female Condom” (power point presented at the XVIII International AIDS Conference, Vienna, Austria, July 19, 2010). 193 Reproductive Health Supplies Coalition, Female Condom (Seattle: PATH, 2009). 194 Carol Joanis (consultant to UAFC and i+Solutions), personal communication with author, January 4, 2011. 195 Phil Harvey (Founder and President of DKT International), personal communication with author, January 5, 2011. 196 Ibid. 197 Patricia Coffey (Senior Program Officer and Woman’s Condom Team Leader, PATH), personal communication with author, February 16, 2011. 198 Beksinska et al., “Female Condom Technology: New Products and Regulatory Issues,” Contraception, 83, no. 4 (2011): 316-321. Published electronically September 15, 2010. 199 Ibid. 200 Ibid. 201 Sonia Correa (Associate Researcher, Development Alternatives with Women for a New Era and Brazilian Interdisciplinary AIDS Association), personal communication with author, January 4, 2011. 202 Reproductive Health Supplies Coalition, Female Condom, 2009. 203 Patricia Karlin (CEO, Silk Parasol Female Panty Condom), interview with author, January 4, 2011. 204 PATH and UNFPA, Powerful Tool for Protection, forthcoming. 191 61 62 BIBLIOGRAPHY AVAC—Global Advocacy for HIV Prevention. The Thai Way Forward. New York: AVAC, 2010. ------. What PrEP Is and What PrEP is Not. New York: AVAC, 2010. Beksinska, Mags, Jenni Smit, Carol Joanis, Margaret Usher-Patel, and William Potter. “Female Condom Technology: New Products and Regulatory Issues.” Contraception, 83, no. 4 (2011): 316-321. Published electronically September 15, 2010. Cameroonian Association for Social Marketing (ACMS). Le Préservatif Féminin s’Insère au Cameroun. Yaoundé: ACMS, 2010. Cecil, Heather, Melissa J. Perry, David W. Seal, and Steven D. Pinkerton. “The Female Condom: What We Have Learned Thus Far.” AIDS and Behavior 2, no. 3 (1998): 241-56. Center for Health and Gender Equity (CHANGE). Saving Lives Now: Female Condoms and the Role of U.S Foreign Aid. Washington, DC: CHANGE, 2008. Choi, Kyung-Hee, Colleen Hoff, Steven E. Gregorich, Olga Grinstead, Cynthia Gomez, and Wendy Hussey. “The Efficacy of a Female Condom Skills Training in HIV Risk Reduction among Women: A Randomized Controlled Trial.” American Journal of Public Health 98, no. 10 (2008): 1841-48. Countdown 2015 Europe. Female Condoms Now! How European Governments Can Help to Increase Access to Female Condoms for Women in the Developing Countries. Brussels: Countdown 2015 Europe, 2009. Dowdy, David W., Michael D. Sweat, and David R. Holtgrave. “Country-Wide Distribution of the Nitrile Female Condom (FC2) in Brazil and South Africa: A Cost-Effectiveness Analysis.” AIDS 20, no. 16 (2006): 2091-98. Farr, Gatson, Henry Gabelnick, Kim Sturgen, and Laneta Dorfiinger. “Contraceptive Efficacy and Acceptability of the Female Condom,” American Journal of Public Health, no. 84 (1994): 1960-1964. Female Health Company. Vision + Partnership, Working Together to Improve Women’s Health Worldwide: The Female Health Company 2009 Annual Report. Chicago: The Female Health Company, 2010. FSG Social Impact Advisors and Elliot Marseille and James G. Kahn. Smarter Programming of the Female Condom: Increasing Its Impact on HIV Prevention in the Developing World. Seattle: FSG, 2008. Global Campaign for Microbicides. Male Circumcision: What Does it Mean for Women? Washington, DC: Global Campaign for Microbicides, 2009. Global Health Technical Assistance Project. Zimbabwe HIV/AIDS Partnership Project & Behaviour Change Programme: A Joint USAID/DFID Assessment. Washington, DC: Global Health Technical Assistance Project, 2008. Hunger Project Malawi. Position Paper on the Availability and Access to Female Condoms in the Prevention of HIV Infections and Other Reproductive Health Services. Blantyre: Hunger Project Malawi, 2006. Johns Hopkins Bloomberg School of Public Health, USAID, and WHO. Family Planning: A Global Handbook for Providers. Baltimore: INFO Project, 2007. Kalckmann, Susan, Norma Farias, and José da Rocha Carvalheiro. “Evaluation of Continuity of Use of Female Condoms among Users of the Brazilian National Health System (SUS): Longitudinal Analysis in Units in the Metropolitan Region of São Paulo, Brazil.” Rev Bras Epidemiol 12, no. 2 (2009): 1-12. 63 64 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health Lara, Diana K., Daniel A. Grossman, Jhoanne E. Muñoz, Santo R. Rosario, Bayardo J. Gómez, and Sandra G. García. “Acceptability and Use of the Female Condom and Diaphragm among Sex Workers in Dominican Republic: Results from a Prospective Study.” AIDS Education and Prevention 21, no. 6 (2009): 538-51. Leeper, Mary Ann. Overview of the FC2 Female Condom. Chicago: Female Health Company, 2009. This is an unpublished document. Mack, Natasha, Claudia Interiano Matta, Alexis Amsterdam, Nancy Williamson, and Mercaplan. Formative Research on Female Condom Promotion in Central America. Research Triangle Park: Family Health International, 2008. Mack, Natasha, Thomas G. Grey, Alexis Amsterdam, Nancy Williamson, and Claudia Interiano Matta. “Central American Sex Workers’ Introduction of the Female Condom to Different Types of Sexual Partners.” AIDS Education and Prevention 22, no. 5 (2010): 466-481. ------. “Introducing Female Condoms to Female Sex Workers in Central America.” International Perspectives on Sexual and Reproductive Health 36, no. 3 (2010): 149-156. Napierala, Sue, Mi-Suk Kang, Tsungai Chipato, Nancy Padian, and Ariane van der Straten. “Female Condom Uptake and Acceptability in Zimbabwe.” AIDS Education and Prevention 20, no. 2 (2008): 121-34. PATH. The Woman’s Condom: A New Style in Protection. Seattle: PATH, 2009. PATH and UNFPA. Female Condom: A Powerful Tool for Protection, Second Edition. Seattle: PATH, UNFPA, and UNAIDS, forthcoming. PEPFAR. 2009 Country Operational Plan: Zimbabwe. Washington, DC: OGAC, 2009. ------. FY 2010 Country Operational Plan (COP) Guidance: Programmatic Considerations. Washington, DC: OGAC, 2009. ------. Next Generation Indicators (NGI) Reference Guide. Washington, DC: OGAC, 2009. ------. The U.S. President’s Emergency Plan for AIDS Relief Five-Year Strategy. Washington, DC: OGAC, 2009. ------. The U.S. President’s Emergency Plan for AIDS Relief Five-Year Strategy Annex: PEPFAR’s Contributions to the Global Health Initiative. Washington, DC: OGAC, 2009. ------. The U.S. President’s Emergency Plan for AIDS Relief Five-Year Strategy Annex: PEPFAR and the Global Context of HIV. Washington, DC: OGAC, 2009. ------. Fiscal Year 2009: PEPFAR Operational Plan. Washington, DC: OGAC, 2010. ------. FY 2011: Country Operational Plan Guidance Appendices. Washington, DC: OGAC, 2010. Peters, Anny, Willy Jansen, and Francien van Driel. “The Female Condom: The International Denial of a Strong Potential.” Reproductive Health Matters 18, no. 25 (2010): 119-128. Population Council and Liverpool VCT, Care & Treatment. Female-initiated Prevention: Integrating Female Condoms into HIV Risk-Reduction Activities in Kenya. Nairobi: Population Council, 2009. Population Services International (PSI). Annual Cost Effectiveness Report 2008. Washington, DC: PSI, 2009. Reproductive Health Supplies Coalition. Contraceptive Projections and the Donor Gap: Meeting the Challenge. Brussels: Reproductive Health Supplies Coalition, 2009. ------. Female Condom. Seattle: PATH, 2009. RHInterchange. Brussels: Reproductive Health Supplies Coalition, 2010-2011. http://rhi. rhsupplies.org/rhi/index.do?locale=en_US. Bibliography Singh, Susheela, Jacqueline E. Darroch, Lori S. Ashford, and Michael Vlassoff. Adding It Up: The Costs and Benefits of Investing in Family Planning and Maternal and Newborn Health. New York: Guttmacher Institute and UNFPA, 2009. Trussell, James, Kim Sturgen, Jennifer Stickler, and Rosalie Dominik. “Comparative Contraceptive Efficacy of the Female Condom and Other Barrier Methods.” Family Planning Perspectives 26, no. 2 (1994): 66-72. UNAIDS. Global Directory of Condom Social Marketing Projects and Organizations. Geneva: UNAIDS, 1999. ------. UNAIDS Report on the Global AIDS Epidemic: 2010. Geneva: UNAIDS, 2010. UNAIDS and WHO. AIDS Epidemic Update: 2009. Geneva: UNAIDS and WHO, 2009. UNDP/UNFPA/WHO/World Bank Special Programme of Research on Human Reproduction. The Female Condom: A Review. Geneva: WHO, 1997. UNFPA. UNFPA Female Condom Global Initiative: 2006-2007 Progress Report. New York: UNFPA, 2007. ------. “Partnering with Men to Promote the Female Condom.” Condom Programming in the Caribbean 1, no. 2 (2009): 1-4. ------. UNFPA Global Condom Initiative—Scaling Up Male and Female Condom Programming: Malawi January-December 2009. Lilongwe: UNFPA, 2009. ------. UNFPA Global Condom Initiative—Scaling Up Male and Female Condom Programming: Zimbabwe January-December 2009. Harare: UNFPA, 2009. ------. Donor Support for Contraceptives and Condoms for STI/HIV Prevention 2009. New York: UNFPA, 2010. ------. Towards a Unified Approach: UNAIDS Inter-Agency Task Team on Comprehensive Condom Programming. New York: UNFPA, 2010. USAID. Country Profile: HIV/AIDS Bolivia. Washington, DC: The Synergy Project, 2004. ------. Fact Sheet: The U.S. Government’s Global Health Initiative. Washington, DC: USAID, 2010. U.S. Department of Health and Human Services (DHHS). Providing Quality Comprehensive HIV/AIDS Prevention, Care, and Treatment Services in the Federal Republic of Nigeria, Under the President’s Emergency Plan for AIDS Relief (PEPFAR). Washington, DC: DHHS, 2010. Vijayakumar, Gowri, Zonke Mabude, Jenni Smit, Mags Beksinska, and Mark Lurie. “A Review of Female Condom Effectiveness: Patterns of Use and Impact on Protected Sex Acts and STI Incidence,” International Journal of STD & AIDS, no. 17 (2006): 652-659. Weeks, Margaret R., Jianghong Li, Emil Coman, Maryann Abbott, Laurie Sylla, Michelle Corbett, and Julia Dickson-Gomez. “Multilevel Social Influences on Female Condom Use and Adoption among Women in the Urban United States.” AIDS Patient Care and STDs 24, no. 5 (2010): 297-309. WHO. WHO Model List of Essential Medicines, 16th List. Geneva: WHO, 2009. ------. Women and Health: Today’s Evidence, Tomorrow’s Agenda. Geneva: WHO, 2009. ------. Trends in Maternal Mortality: 1990 to 2008: Estimates developed by WHO, UNICEF, UNFPA, and the World Bank. Geneva: WHO, 2010. 65 66 ANNEX A Female Condom Products Currently Available or Previously Distributed on Public or Private Markets FC1 and FC2 FC1 and FC2 female condoms are manufactured by FHC. The FC1 is a silicone lubricated, polyurethane sheath with flexible rings located at each end to aid insertion into the vagina and to hold the condom in place. The FC1 first came on the market in 1992. However, its production ceased in 2009 shortly after FHC’s second generation “FC2” female condom received regulatory approval from USFDA. The FC2 is identical to the FC1 in design and appearance but is composed of nitrile, a synthetic latex, which decreases manufacturing costs. The FC2 is currently being manufactured in Malaysia. FHC began to develop the FC2 in 2003, and product development finished two years later.189 In 2006, a WHO technical review committee examined FC2 clinical data and deemed it acceptable for bulk purchase by public sector agencies such as United Nations agencies. Shortly thereafter, UNFPA began procuring FC2 for its reproductive health programs worldwide. Since WHO clearance of FC2, approximately 40 million FC2 units have been distributed in 105 countries.190 To date, the FC1 and FC2 are the only female condoms that have received regulatory approval from USFDA. Before female condom products can become available on U.S. markets, they must undergo rigorous USFDA review to meet safety and efficacy standards. USFDA approval also has significant implications for U.S. HIV/AIDS and family planning programs overseas. As mentioned earlier, USAID has only procured female and male condoms that have USFDA approval to date. USFDA approval of the FC2 was heralded because the FC2 costs approximately 30 percent less than the FC1.191 The lower unit cost is one important factor that can help increase access to the FC2 both in the United States and internationally. The FC2 received USFDA approval in March 2009. This paved the way for USAID to exhaust FC1 shipments and begin procuring and shipping the less expensive FC2 to its programs worldwide. In the fall of 2009, the FC2 became available to U.S. public sector programs. It is now available in some retail outlets, such as CVS drugstores in Washington, D.C., and Walgreens pharmacies nationwide. FC2 is currently available in more than 120 countries worldwide.192 FC2 Female Condom 67 68 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health VA w.o.w. Feminine Condom or “Reddy” Female Condom The VA w.o.w. (“worn-of-women”) female condom, also known under brands like “Reddy” or “L’amour,” was developed by Medtech Products Ltd of India. This product is made of latex, comes lubricated with silicone, and uses a sponge to secure the condom in a woman’s vagina. The VA w.o.w. does not have USFDA approval or WHO clearance for bulk procurement by public sector agencies. However, it carries the CE mark for sale in Europe. The VA w.o.w. has been distributed in many countries including India, Brazil, Portugal, South Africa, and the United Kingdom, and approximately 5 million pieces were sold commercially between 2003 and 2007.193 They are also currently being distributed by UAFC’s program in Cameroon. VA w.o.w. Female Condom Although VA w.o.w. female condoms are still available in some countries, manufacturing has ceased due to closure of the Medtech factory.194, 195 The cause of the closure is unclear. The Indonesia office of DKT International, a social marketing organization that has procured VA w.o.w. female condoms in the past, reports that Medtech failed to fill outstanding purchase orders in 2010.196 Closure of the Medtech Products Ltd factory does not mean that the VA w.o.w. is a failed product. On the contrary, this female condom is just as efficacious as other female condom models and has been shown to be acceptable by diverse users. Discussions among Medtech stakeholders are currently underway to allow the product to continue to be manufactured. Woman’s Condom Woman’s Condom The Woman’s Condom, developed by PATH and manufactured by the Dahua Medical Apparatus Company in China, received the CE mark at the end of 2010 and is newly on the market in some places. The novel design of the Woman’s Condom was created in consultation with women and couples from around the world to identify features that promoted comfort and ease of use. The Woman’s Condom is a polyurethane pouch that is partially enclosed in a capsule to aid insertion. The capsule dissolves in the vagina which releases the pouch, and foam pads secure the condom within the vagina. This product is not pre-lubricated; couples must apply lubricant to the inside of the condom pouch before use. The Woman’s Condom does not have USFDA approval or WHO clearance for bulk procurement by public sector agencies. The National Institute of Child Health and Human Development is now conducting a contraceptive efficacy trial that will lead to a USFDA application for market approval.197 Cupid Female Condom The Cupid female condom, though it has similarities with the VA w.o.w., is a new design that is manufactured in India and available there and in some European countries. It is made of latex, comes lubricated with silicone, has an octagonal frame, is available in natural and pink colors, and uses a sponge to secure the condom in the vagina.198 Cupid does not have USFDA approval or WHO clearance for bulk procurement by public sector agencies. Cupid holds the CE mark and is registered by the India Drug Authority Control.199 Cupid Female Condom ANNEX A Phoenurse Female Condom The Phoenurse female condom is produced and distributed in China. It is made of polyurethane and comes with an insertion tool, a water-based lubricant, sanitary towel, and disposable bag. The Phoenurse does not have USFDA or WHO clearance for bulk procurement by public sector agencies, though it has approval from the Chinese State Food and Drug Administration for distribution at the provincial level.200 Natural Sensation Panty Condom The Natural Sensation Panty Condom is in limited supply globally, and evidence suggests that it is no longer being produced. It was previously manufactured by Phoenurse Female Condom Natural Sensation Condoms in Bogota, Colombia, but the company does not list the product for sale on its website. Profamilia, an International Planned Parenthood Federation affiliate in Colombia, reports that the product left the market several years ago.201 Panty female condoms have a distinct design from other female condoms. The panty contains a condom sheath secured at its base, while the panty itself performs the same function as the outer ring or frame in other female condoms. The condom sheath unfurls and encapsulates the penis when penetration occurs. Condom sheaths must be removed and replaced with new ones after each use. The Natural Sensation Panty Condom does not have USFDA approval or WHO clearance for bulk procurement by public sector agencies, though it carries the CE mark.202 Products Still in Development Silk Parasol Female Panty Condom and Origami Female Condom Other female condoms in development are the Silk Parasol Female Panty Condom (U.S.), which is seeking funding to begin phase I clinical trials, and the Origami Female Condom (U.S.), which is undergoing feasibility and acceptability studies in the United States.203, 204 69 70 ANNEX B U.S. Female Condom Procurement for International Programs Units Shipped Source: RHInterchange. Brussels: Reproductive Health Supplies Coalition, 2011. 15,000,000 12,000,000 9,000,000 6,000,000 3,000,000 0 2003 2004 2005 2006 2007 2008 2009 2010 2011 U.S. Female Condom Shipments, 2003-2011 Data on U.S. international female condom shipments should be analyzed in terms of overall trends. Shipment quantities vary from year to year because of multi-year procurement cycles. The data above indicates a clear upward trend for U.S. international female condom shipments. 71 72 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health U.S. Female Condom Shipments by Country, 2003-2011 Country Angola Benin Bolivia Burkina Faso Cameroon China Cote d’Ivoire* Democratic Republic of Congo El Salvador Ghana Guatemala Haiti* Indonesia Kyrgyzstan Laos Lesotho Liberia Madagascar Malawi Mali Myanmar Papua New Guinea Senegal South Africa* Swaziland Tanzania* Thailand Togo Trinidad & Tobago Ukraine Vietnam* Zambia* Zimbabwe Total 2003 2004 2005 2006 2007 2008 2009 2010 2011 Total 0 41,000 0 0 0 0 0 0 0 41,000 0 0 0 5,000 2,000 11,000 14,000 0 0 32,000 0 60,000 0 45,000 68,000 76,000 23,000 0 0 272,000 70,000 0 0 0 0 0 0 0 0 70,000 60,000 138,000 60,000 46,000 1,000 7,000 0 0 0 312,000 0 0 0 0 0 40,000 26,000 5,000 0 71,000 20,000 0 0 0 0 0 0 0 0 20,000 455,000 300,000 400,000 24,000 104,000 570,000 0 1,817,000 2,000,000 5,670,000 0 0 0 0 0 0 50,000 0 0 50,000 0 0 0 0 0 0 0 40,000 0 40,000 25,000 50,000 0 50,000 50,000 0 0 0 0 175,000 45,000 0 35,000 85,000 235,000 0 338,000 0 0 738,000 0 0 0 0 0 500,000 0 0 0 500,000 0 0 0 0 0 85,000 0 0 0 85,000 0 0 0 0 40,000 10,000 624,000 0 0 674,000 55,000 0 0 0 999,000 0 0 0 0 1,054,000 0 0 0 0 0 35,000 40,000 0 0 75,000 0 0 0 0 88,000 44,000 44,000 49,000 44,000 269,000 0 0 0 0 0 0 1,500,000 1,500,000 2,000,000 5,000,000 0 75,000 50,000 0 0 0 0 60,000 0 185,000 0 0 0 0 0 200,000 0 200,000 250,000 650,000 0 0 0 0 0 15,000 0 0 100,000 115,000 240,000 57,000 183,000 0 232,000 126,000 70,000 0 0 908,000 10,000 0 0 300,000 0 0 600,000 250,000 446,000 1,606,000 5,000 0 0 0 28,000 0 0 0 0 33,000 100,000 190,000 180,000 1,056,000 549,000 1,074,000 1,032,000 0 0 4,181,000 0 0 0 0 15,000 0 248,000 100,000 345,000 708,000 24,000 30,000 71,000 62,000 0 0 0 0 0 187,000 0 0 0 0 0 2,000 90,000 40,000 0 132,000 0 0 0 0 0 0 0 250,000 0 250,000 0 0 5,000 20,000 20,000 0 40,000 0 0 85,000 0 0 0 495,000 275,000 0 0 1,100,000 0 1,870,000 0 1,000,000 300,000 2,475,000 6,125,000 5,503,000 9,937,000 0 4,813,000 30,153,000 1,109,000 1,941,000 1,284,000 4,663,000 8,831,000 8,298,000 14,676,000 5,411,000 9,998,000 56,211,000 *Former PEPFAR Focus Country Source: RHInterchange. Brussels: Reproductive Health Supplies Coalition, 2011. ANNEX C UNFPA and UNAIDS Inter-Agency Task Team 10-Step Strategic Approach to Scale Up Comprehensive Condom Programming at the National Level Development Phase STEP 1: ESTABLISH A NATIONAL CONDOM SUPPORT TEAM Assemble a team from an existing reproductive health commodity security working group and/or HIV prevention committee. The team should include representatives from: Line ministries (such as health, finance, gender, education, and tourism) Institutions working in family planning and sexual and reproductive health National AIDS council Local condom ‘champions’ Regulatory authorities responsible for local standards and quality assurance Donor community Civil society (including people living with HIV, young people, faith-based, and nongovernmental organizations) Social marketing organizations Private sector and business coalitions The purpose of the team is to provide guidance and support to government in developing and monitoring the national CCP strategy and operational plan. The team should have clearly designated roles and responsibilities. STEP 2: UNDERTAKE A SITUATION ANALYSIS Undertake a desk review of documents, reports, and research pertaining to HIV and sexual and reproductive health to gain background information on the various components of the CCP framework (leadership and coordination; demand, access, and utilization; supply and commodity security; and support). Where information from the desk review is insufficient, collect data from the field (see the CCP Rapid Needs Assessment and Strategic Planning Tool). Convene a stakeholders meeting to share findings from the situation analysis, build consensus and support, and agree on a concrete roadmap for scaling up condom programming efforts. 73 74 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health STEP 3: DEVELOP A COMPREHENSIVE AND INTEGRATED NATIONAL STRATEGY FOR MALE AND FEMALE CONDOMS Identify responsible agencies and/or stakeholders to implement and oversee coordinated activities in each of the following areas and, if possible, link them programmatically. The national strategy should reflect the components of the CCP framework: Leadership and coordination Coordination of partnerships Advocacy Policies and regulations Resource mobilization Demand, access, and utilization Market research Total market approach Targeted distribution IEC and behaviour change communication strategies Social mobilization Supply and commodity security Forecasting Procurement Quality assurance Warehousing and storage Distribution to supply chains Logistics management information system Support Advocacy Social, behavioural, and operations research Capacity and institutional strengthening Monitoring and evaluation Documentation and dissemination ANNEX C STEP 4: DEVELOP A MULTI-YEAR OPERATIONAL PLAN AND BUDGET For each component of the national condom strategy, including integration with other programmes and the steps outlined below, ensure that the operational plan specifies: Activities Division of labour for each partner Time frame Cost Process indicators Most importantly, ensure the buy-in of key stakeholders, including ‘gate-keepers’, by including them in important programme decisions. Implementation Phase STEP 5: LINK THE MULTI-YEAR OPERATIONAL PLAN WITH THE NATIONAL COMMODITY SECURITY PLAN Link the operational plan, where possible, to the existing logistics system for essential drugs and reproductive health and HIV-related commodities, including systems for forecasting, procurement, distribution, and warehousing. If there is no reproductive health commodity security committee, the national condom support team should advocate for the establishment of one. STEP 6: MOBILIZE FINANCIAL RESOURCES Based on the operational plan: Identify available, committed, and potential resources at the local, national, regional, and global levels in the areas of HIV prevention, treatment, care and support, and sexual and reproductive health, to scale up CCP. Determine funding gaps in the operational plan. Advocate and secure funds for implementation of the operational plan. Develop a reporting system to provide routine feedback about programme implementation to donors. STEP 7: STRENGTHEN HUMAN RESOURCES AND INSTITUTIONAL CAPACITY Identify human resource capacity strengths and gaps and determine how these can be utilized or filled. Identify institutional capacity strengths and gaps and determine how these can be utilized or filled. Develop, obtain, or adapt existing training materials (such as manuals, guidelines, and demonstration models). 75 76 Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health Train trainers, drawing from the public and private sectors, civil society, and social marketers. Ensure standards are met and support is maintained. Cascade training to service providers at different levels (for example, at the provincial, district, and community level) and ensure quality of training. STEP 8: CREATE AND SUSTAIN DEMAND FOR CONDOMS Conduct formative research, including market research, on preferences, target audience segmentation, and values and perceptions that influence the use of male and female condoms. Develop a communication strategy that includes key messages, target audiences, and channels for stimulating and sustaining demand. Employ creative and nontraditional outlets for promoting and distributing condoms (such as condom dispensers, hair salons, and youth centres). Stimulate social mobilization of communities to ensure a supportive environment for male and female condoms. STEP 9: STRENGTHEN ADVOCACY AND ENGAGE THE MEDIA Initiate policy and regulatory analysis and dialogue. From the situation analysis, identify policy issues that require advocacy for change. Hold a stakeholders meeting to review policy issues and start the dialogue process. Identify and strengthen condom ‘champions’. Champions may be found in government, civil society, and among those providing reproductive health/family planning or HIV services or implementing related programmes. Strengthen technical and advocacy skills of condom champions through training. Build coalitions and partnerships (through networking and engagement with civil society and other segments of society). Identify a wide range of stakeholders interested in working to improve the policy environment. Establish a common goal, mission statement, roles and responsibilities, and communication process. Develop and implement the advocacy plan. Coordinate media outreach and capacity-building. Develop a communication strategy to engage the media. Provide sensitization and skills-building for journalists and members of the mass media. ANNEX C STEP 10: MONITOR PROGRAMME IMPLEMENTATION ROUTINELY, CONDUCT RESEARCH, AND EVALUATE OUTCOMES Incorporate the CCP monitoring & evaluation framework into the national M & E framework. Review and update operational plan indicators. Identify research areas and conduct research to support programme implementation. Establish baselines. Identify milestones and intended targets. Update baseline data indicators and undertake a baseline study, as necessary. Monitor programme implementation. Collect and analyse routine data on programme delivery among target populations (risk groups) and the various public-health interventions in which condom programming has been integrated. Hold regular review and planning meetings with the national condom support team. Share feedback from the review with implementing partners. Ensure that feedback is used by implementing partners to adapt, readjust, and improve programme implementation. Evaluation Conduct annual, mid-term, and end-of-term evaluations. Provide feedback from evaluations to implementing partners. Evaluate overall impact of the national strategy. Source: UNFPA. Towards a Unified Approach: UNAIDS Inter-Agency Task Team on Comprehensive Condom Programming. New York: UNFPA, 2010. 77 78 79 80 Acknowledgments The Center for Health and Gender Equity (CHANGE) would like to express gratitude to all those who worked on this report and the many people who were interviewed and provided critical information. This report was written by CHANGE staff. Kimberly Whipkey conducted research and wrote the report; Mary Beth Hastings provided editing support. We thank staff at the U.S. Agency for International Development (USAID) and Office of the Global AIDS Coordinator (OGAC) who were very generous with their time and shared information. CHANGE is grateful to the following individuals for their review of this document: Bidia Deperthes, Sandra Mapemba, Clemens Benedikt, Bruce Campbell, Daisy Nyamukapa, Diddie Schaaf, Patricia Coffey, Theresa Hoke, Mags Beksinska, Mark Rilling, and Erin Balch. About the Center For Health and Gender Equity The Center for Health and Gender Equity (CHANGE) is a U.S.-based nongovernmental organization whose mission is to ensure that U.S. international policies and programs promote sexual and reproductive health within a human rights framework for women and girls worldwide. CHANGE advocates for effective, evidence-based policies, and increased funding for critical programs. CHANGE believes that every individual has the right to basic information, technologies, and services needed to enjoy a healthy and safe sexual and reproductive life free from coercion and preventable illness. About the Prevention Now! Campaign Prevention Now! is a global campaign to increase access to existing prevention methods, especially female and male condoms, in order to stem the spread of HIV/STIs, reduce unintended pregnancy, and improve the sexual and reproductive health of women, men, and young people worldwide. Through education and advocacy, the Prevention Now! Campaign seeks to ensure that governments and donor agencies provide the funds and policy needed to dramatically increase access to female condoms. Prevention Now! achieves its goals through network and capacity building, engagement of key decision makers and policy makers, and media outreach in the U.S. and internationally. To join the campaign, please visit www.preventionnow.net Center for Health and Gender Equity (CHANGE) 1317 F Street NW, Suite 400 Washington, DC 20004 USA tel +1 (202) 393-5930 fax +1 (202) 393-5937 Email: [email protected] www.genderhealth.org This report was developed and published by the Center for Health and Gender Equity (CHANGE). Please cite as: Center for Health and Gender Equity. Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health. Washington, DC: Center for Health and Gender Equity, 2011. © 2011 by Center for Health and Gender Equity. All rights reserved.
© Copyright 2024