Global Health Sector Strategy on Sexually Transmitted Infections
Draft for Consultation Global Health Sector Strategy on Sexually Transmitted Infections 2016–2021 Introduction and context This draft global health sector strategy on STIs for 2016–2021 has been developed for discussion during a series of multi-stakeholder consultations from March to December 2015. The strategy builds on the Global strategy for the prevention and control of sexually transmitted infections 2006– 2015, and will be closely aligned with the post-2015 health and development agenda and targets, and the drive towards universal health coverage. The updated strategy also builds on the evaluation of the 2006–2015 global strategy, which recommended: Strengthening financing mechanisms for STI services and strengthening human resource capacity; Scaling up STI interventions, in particular for vulnerable and key populations; Increasing access to services by integrating the prevention and management of STIs into the broader agendas of HIV, reproductive health and other key platforms; Strengthening surveillance and improving knowledge of prevalence, etiology and antimicrobial resistance; Accelerating access to innovations through the development of point-of-care diagnostic tests and new preventive interventions such as vaccines, microbicides and health promotion methods. The strategy outlines a vision, goals and actions for the global health sector. It defines the essential quality-assured STI services to meet people’s needs, and proposes actions to address the underlying determinants of STI epidemics, including the inequities that put people at greater risk for infection and block access to effective prevention and treatment services. It describes how to ensure equitable coverage of services and maximum impact with a particular focus on key populations, recommends strategies to minimize the risk of financial hardship for those requiring the services, and embraces innovation to drive rapid progress. Many of the priority actions highlighted draw on 1 the strong body of evidence generated by the implementation of the 2006–2015 STI strategy and responses around the world. The strategy also sets targets for expanding, enhancing and accelerating the STI response. These are aligned with related global health strategies and plans, including those for sexual and reproductive health, maternal and newborn health, adolescent health, HIV, noncommunicable diseases, viral hepatitis, blood safety, and tuberculosis. A shortened version of this draft strategy has been made available in various language versions to support the online consultation. This document does not represent a comprehensive or near-final version of the strategic approach required to drive an effective health sector response to STIs through 2016–2021. It provides a basis for discussion. Why a stronger STI response should be a global priority Infections with sexually transmitted pathogens impose an enormous burden of morbidity and mortality worldwide (see box) by compromising the quality of life, sexual and reproductive and child health, and indirectly by facilitating the sexual transmission of HIV and causing cellular changes that precede some types of cancers. STIs rank among the top five disease categories for which adults seek health care in middle- and low-income countries and are a substantial strain on the budgets of both national health systems and households. 2 The hidden toll of STIs It is estimated that almost 400 million people aged 15-49 years acquire one of four STIs each year: Chlamydia trachomatis (146 million), Neisseria gonorrhoeae (51 million), syphilis (5 million), or Trichomonas vaginalis (239 million).* The prevalence of some viral STIs is similarly high, with an estimated 417 million people infected with herpes simplex type 2, and approximately 291 million women harbouring the human papillomavirus (HPV). The prevalence of these STIs varies by region and gender. These epidemics have a profound impact on the health and lives of children and adults worldwide: fetal and neonatal deaths — syphilis in pregnancy leads to over 300 000 fetal and neonatal deaths each year, and places an additional 215 000 infants at increased risk of early death; cervical cancer — the human papillomavirus (HPV) infection is responsible for an estimated 530 000 cases of cervical cancer and 275 000 cervical cancer deaths each year; infertility — STIs such as gonorrhoea and chlamydia are important causes of infertility, especially in subSaharan Africa; HIV risk — the presence of an STI, such as syphilis or herpes simplex virus infection, greatly increases the risk of acquiring or transmitting HIV infection (by up to 50% in some populations); the physical, psychological and social consequences of STIs severely compromise people’s quality of life. Adequate control and/or elimination of STIs will contribute to reducing disease and human suffering. * Most recent estimates are for 2012. Complications due to STIs have a profound impact on sexual and reproductive health and disproportionately affect women, especially in resource-poor settings. In addition to causing acute infection, some STIs greatly increase the risk of HIV acquisition. Syphilis infection during pregnancy results in hundreds of thousands of fetal and neonatal deaths each year, as well as multi-organ malformations in affected newborns (congenital syphilis syndrome). Gonorrhoea and chlamydia infections are major causes of pelvic inflammatory disease, adverse pregnancy outcomes and female infertility, as well as stillbirths, neonatal deaths and congenital malformations. Other sexually transmitted pathogens such as the human papillomavirus (HPV) and the hepatitis B virus are responsible for large numbers of cervical and other genital cancers, and hepatic cancers, respectively. 3 Figure 1: : Figure 2: 4 There are great opportunities for progress Since the Global strategy for the prevention and control of sexually transmitted infections 2006– 2015 was endorsed at the 2006 World Health Assembly, the vast majority of countries have updated their STI policies and guidelines. A large proportion of countries have adopted the recommended syndromic approach for STI management. All regions have endorsed and adopted the 2007 WHO Strategy on the global elimination of congenital syphilis, which increasingly is being implemented alongside programmes to eliminate mother-to-child transmission of HIV. There has been an appreciable decline in the incidence of Haemophilus ducreyi (chancroid), in syphilis and gonococcal rates, and in their sequelae such as neonatal conjunctivitis, an increase in pregnant women screened for syphilis and increased access to HPV vaccination (the latter mainly in high-income countries, however). An escalated response would sustain and build on these achievements. However, there is a risk that weak political will and widespread stigma associated with sexual health issues is leading to increased neglect of STI services in some countries. Sufficient allocations of funding and human resources have been slow to materialize. And many of the social and institutional determinants of STI vulnerability and risk are not being addressed adequately. Those determinants include gender inequalities, the criminalization of certain behaviours and activities, including sex work, gender-based violence and violence related to sexual orientation, and stigma and discrimination, including in health care settings. Huge opportunities exist to strengthen and expand services for the prevention and control of STIs, and to create enabling environments that facilitate a greater impact for STI responses. New methods and tools are available for strengthening and refining STI strategic information systems. Effective, proven and affordable technologies and interventions are at hand for preventing, diagnosing and managing STIs. Access to services can be expanded and made more equitable by integrating the prevention and management of STIs into existing primary health care, reproductive health and HIV services. Countries can seize the potential of new technologies and approaches by using them more extensively and strategically. And they can boost those advances by pursuing further innovations, such as new vaccines, microbicides and point-of-care diagnostic tests, with greater resolve. A strategy fit for the era of Sustainable Development Goals Most of the tools for reaching the 2030 targets are in-hand, and potentially vital innovations are on the horizon. Using them to full effect, however, will require quickly increasing investments in the STI response, focusing resources on the most effective programmes and on the populations and geographical locations where need is greatest, and linking STI interventions to mutual benefit with other health services. 5 With limited resources available, countries need to plan carefully and develop compelling investment cases to justify the allocation of additional domestic and external resources for reaching the targets. Investment cases need to define and cost the package of interventions and services required based on the country context, decide on the most strategic use of resources, argue for the most cost-effective interventions, outline the most appropriate allocation of resources across the different levels of the health system, and identify potential and reliable sources of funding. Required over the next six years are refocused strategies, innovations that can boost impact, and a renewed commitment to under-write these efforts with adequate investments. The WHO global health sector strategy on STIs 2016–2021 strategy builds a case for such investments, identifies four strategic directions to focus country programmes and WHO’s actions, and outlines the range of priority interventions and strategies that can achieve the greatest impact — in and beyond the public health realm. Crucially, the strategy is designed to contribute to attaining universal health coverage and to the achievement of key Sustainable Development Goals. A response that succeeds in ending the STIs epidemic would make very significant contributions to improving maternal, newborn health, women’s and men’s sexual and overall health, HIV outcomes and, by extension, the achievement of key Sustainable Developmental Goals. Ensuring financial security and health equity are key concerns in the Sustainable Development Goals, and universal health coverage provides a framework for addressing them. This STI strategy defines the essential services and interventions that people should receive, and identifies ways to assure and improve the quality of services and programmes. It recommends priority actions to expand coverage of services and to ensure equity and maximum impact, and proposes strategies to achieve financial sustainability and minimize the risk of financial hardship for people requiring the services. The strategy makes a strong case for expanding the provision of good quality STI care more widely into primary health care, sexual and reproductive health and HIV services. It emphasizes opportunities to increase coverage by working collaboratively with other government sectors, and with community-based organizations and private providers. In sum, the strategy promotes a long-term, sustainable response that will be bolstered by strengthened health and community systems, by tackling the social determinants of health that drive the epidemic and hinder responses, and by protecting and promoting human rights and gender equity as guiding principles and essential elements of the health sector response. The potential benefits transcend the specific disease challenge and extend across and beyond the health sector. 6 The strategy’s structure The 2016–2021 global health sector strategy on STIs builds on the achievements and lessons of past efforts, including the Global strategy for prevention and control of sexually transmitted infections 2006–2015 and the Reproductive health strategy to accelerate progress towards the attainment of international development goals and targets. It is aligned with other global and regional health strategies and plans, including those for HIV, sexual and reproductive health, maternal and child health and noncommunicable diseases. The strategy describes the priority actions that countries need to take and the support that WHO will provide in order to scale up a global response that capitalizes on the enormous opportunities for ending the STI epidemics as major public health concerns. The four strategic directions are: SD1. Essential, quality services and interventions SD2. Achieving equity and impact: Populations and locations SD3. Innovation for acceleration SD4. Financing for sustainability A crosscutting section focuses on the creation of enabling environment for delivery and impact, and discusses strategic information for advocacy and investment, and the strengthening of systems, partnerships and linkages. Strategy implementation is addressed in the final section. The vision, goal, targets and guiding principles The strategy outlines a vision, goals and actions for the global health sector, including: defining essential STI services to meet people’s needs; describing how to ensure effective and equitable coverage of services and maximum impact with a particular focus on key populations; proposing strategies to minimize the risk of financial hardship for those requiring the services; and embracing innovation to drive rapid progress. These efforts should benefit everyone at risk for STIs: children, adolescents and adults; rich and poor; women and men; and all key populations. The vision Zero new STI infections, zero STI-related deaths and zero discrimination in a world where people living with STIs are able to live long and healthy lives. The goal End the STI epidemics as major public health concerns, and ensure healthy lives and promote wellbeing for all people at all ages. 7 The global targets for 2030 A concerted effort to rapidly scale up effective interventions and services can achieve the goal of ending the STI epidemics by reaching this ambitious set of targets: 90% reduction of T. pallidum incidence (2015 baseline). 90% reduction in N. gonorrhoea incidence (2015 baseline). ≤50 cases of congenital syphilis per 100 000 live births in 100% of countries. 80% (?) human papillomavirus (HPV) vaccine coverage. Milestones for 2020 In order to spur and measure progress towards the 2030 targets, the following milestones for 2020 are proposed: 80% of countries with 95% of pregnant women screened for syphilis and 90% screened for HIV with free, prior and informed consent, and 95% of pregnant, infected women receiving effective treatment. 85% of key populations have access to a full range of STI & HIV services, including condoms. 100% of countries provide STI services or referrals to such services in all primary, HIV, reproductive health, family planning and ante- and post-natal care services. 80% of countries deliver HPV vaccines as part of the NIP. 80% of countries report on antimicrobial resistance in N. gonorrhoea. The broader impact By saving millions of lives directly and indirectly, and by improving the health and wellbeing of even greater numbers of people, an expanded and more effective STI response will contribute significantly to reaching universal health coverage, achieving several Sustainable Development Goals and targets, and realizing people’s overall right to health. The impact will be bigger if those improvements are underpinned by strong health and community systems, are accompanied by strengthened responses in other health areas, and address the social and regulatory factors that increase STI risk and impede access to STI services. By ending or reversing the STI epidemics, the strategy will contribute to the achievement of other health-related targets by 2030, including: reducing the global maternal mortality ratio to less than 70 per 100,000 live births; ending preventable deaths of newborns and children under 5 years of age; eliminating hepatitis B; 8 reducing by one third premature mortality from noncommunicable diseases through prevention and treatment, and promote mental health and wellbeing; ensuring universal access to services for sexual and reproductive health care, family planning, information and education, and the integration of reproductive health into national strategies and programmes; and achieving universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all. The guiding principles The following principles guide the strategy: 1. Universal health coverage. 2. Government stewardship and accountability. 3. Evidence-based interventions, services and policies. 4. Protection and promotion of human rights, gender equality and health equity. 5. Partnership, integration and linkage with relevant sectors, programmes and strategies. 6. Meaningful involvement of people living with STIs, key populations and affected communities. 9 STRATEGIC DIRECTION 1: Essential, quality services and interventions Define a set of core interventions Each country needs to define a set of essential STI interventions and services that should be made available to those in need. Priority should be given to identifying and selecting high-impact interventions that cover the full continuum of prevention, diagnosis, treatment and care. As resources and capacity increase the scope of interventions and services can be expanded progressively, with the aim of further improving STI and broader health outcomes. Countries need to make choices on which interventions to prioritize, how best they can be combined, and the sequence in which they might be introduced or scaled up. The evidence shows clearly that combination packages achieve greater impact than discrete, individual interventions. Although the core set of interventions and services will vary by country, based on epidemic dynamics and country context, each of the following intervention areas should be covered: o reduction of STI vulnerability and risk; o reduction of STI transmission; o STI diagnosis; o management of STIs and related sequelae; o monitoring of microbial resistance strains; and o monitoring and evaluating interventions. The core package needs to be regularly reviewed to ensure that, as new evidence emerges and new technologies and approaches are developed, innovations are rapidly integrated and opportunities are seized. Reduce vulnerability and risk, especially among key populations Reaching the STI targets by 2030 will require major reductions in risk behaviour, new approaches for delivering more effective and combined prevention, testing and treatment interventions to those who need them. Much of that progress hinges on reducing people’s vulnerability and risk for STIs, especially for women and the key populations that are most at risk for infection. A successful STI response has to deal with the underlying determinants of STI epidemics, including the inequities that put people at greater risk for infection and undermine the potential impact of prevention and treatment services. Those determinants include gender inequality and gender-based violence, rights 10 violations (including the criminalization of certain behaviours), and stigma and discrimination (including in health care settings). Effective interventions for reducing STI vulnerability and risk hinge on awareness building and targeted risk reduction communication, and on increased access to and use of sexual and reproductive health services. Progress in those respects requires effective actions to reduce stigma and discrimination in health care settings and the community; initiatives to prevent and manage gender-based violence and violence related to sexual orientation or identity; and interventions that empower women and stigmatized populations. Priority actions for countries Tailor and focus risk reduction interventions to the needs of populations that are most affected. Address the key factors that place people at greater risk for STI infections and that impede access to effective STI services. Increase awareness and coverage of prevention services among adolescents and link those activities with services for prevention of unintended pregnancy and of HIV infection. Priority actions for WHO Update guidance for key populations on STI vulnerability and risk reduction interventions. Produce updated guidance on prevention and management of gender-based and sexual violence, with a focus on adolescents, young women and children. Provide guidance for increasing the involvement of boys and men in reducing STI vulnerability and risk. Work with partners to promote new initiatives on reducing risk and increasing resiliency among adolescent girls and young women. Prevent STI transmission and acquisition Combination prevention is the most effective approach for prevention of STIs. It requires ensuring access to vital information, commodities (such as condoms) and services (such as medical male circumcision, testing, treatment and care) within a human rights framework. Alongside that, behaviour change interventions are critically important for STI/HIV prevention and include the promotion of consistent use of male and female condoms, reduction in the number of sexual partners, increased uptake of HIV/STI testing, delayed sexual debut, as well as the promotion of sexual wellbeing. Many of these interventions have the dual advantage of also preventing unintended pregnancies. Focusing the interventions appropriately for key populations, adolescents and pregnant women is a priority. In addition, when community knowledge about STIs is 11 strengthened and stigma and discrimination are reduced, use of services related to STI tends to improve. Priority actions for countries Prioritize implementation of high impact prevention interventions most relevant to the country’s epidemics, particularly where implementation and/or uptake are lagging . Promote the use of condoms for dual protection against STIs and unintended pregnancy, including for adolescents. Utilize maternal and child health and family planning clinics as additional outlets for provision of care and distribution of condoms to women who could be at risk of STIs. Make greater use of social marketing programmes to increase demand and supply of qualityassured, affordable STI services and condoms in traditional and non-traditional outlets. Supplement condom distribution with community-based distribution and outreach services for most-at-risk populations. Priority actions for WHO Update STI prevention guidance, including rapidly integrating new evidence-based health sector interventions into STI prevention packages for different epidemic contexts, giving particular attention to key populations, adolescents, and women. Promote effective male and female condom programmes, including setting global standards and facilitating procurement. Advocate for increased commitment, resources and actions to eliminate STI infections in newborns. Achieve early diagnosis of STIs and linkage to treatment Early diagnosis of STIs, including those without symptoms, is the best opportunity for effective medical treatment and support, and for preventing further transmission. Screening for STIs, however, remains rare in resource-constrained settings. Each country will need to select the most appropriate combination of diagnostic approaches based on the nature and dynamics of its STI epidemics, the affected populations and its health system. Special efforts are required for the detection and management of asymptomatic infections in key populations, adolescents and young adults, and pregnant women, such as case finding or screening, with enhanced interventions for reaching sexual partners. Specific attention must go towards ensuring the quality of diagnostic tools and services to minimize the risk of misdiagnosis. New pointof-care diagnostic technologies and new diagnostic approaches would offer major opportunities for rapidly expanding STI diagnosis and linking people to treatment and care. 12 Throughout, patient confidentiality must be respected and counselling must be available, along with effective commodities and medicines for managing STIs. The potential impact is far-reaching. Prompt diagnosis and effective management of STIs breaks the chain of transmission and prevents the development of complications and long-term sequelae of STIs. Priority actions for countries Procure, introduce and expand use of WHO prequalified diagnostics. Implement quality assurance and quality improvement measures to lower the risk of misdiagnosis, and reduce delays between collecting specimens, laboratory testing, sharing the results, and access to treatment. Implement strategies for detecting and managing asymptomatic infections in key populations, pregnant women and adolescents, such as case finding or screening, with enhanced interventions for reaching sexual partners. Priority actions for WHO Regularly update consolidated guidance on STIs and HIV testing approaches, strategies and diagnostics, incorporating the latest innovations, with particular focus on early diagnosis. Strengthen the WHO prequalification programme to ensure rapid access to quality STI diagnostics. Support operational research to identify effective, efficient, safe and acceptable STI diagnostic approaches. Manage symptomatic patients Each primary point-of-care for persons with STIs should follow an up-to-date management protocol for people with symptomatic STIs and for their sexual partners, based on global guidelines. Primary point-of-care outlets are varied and include primary health care clinics, sexual and reproductive health services, and services that provide care and management of persons living with HIV. Coverage of treatment services can be increased by working collaboratively with other health programmes, government sectors (education, occupational health, migration, etc), as well as with communitybased organizations and private health care providers. 13 Priority actions for countries Update implementation plans for guiding effective and sustainable scale up of STI management, based on latest evidence. Adapt national STI management guidelines to address major co-infections and comorbidities, notably HIV. Ensure that effective STI management commodities and medicines are available when people seek care for STIs. Ensure procurement of quality-assured drugs. Priority actions for WHO Regularly update consolidated STI management guidelines that include clinical, operational and programmatic guidance that will guide rapid and sustainable treatment scale up. Reach sex partners and offer them treatment Partner notification is integral to effective STI prevention and care. Approaches for informing sex partners and offering them counselling and treatment vary according to circumstances and include patient referral (whereby patients are encouraged to contact their sex partners themselves), provider referral (the health care provider notifies the partner and arranges treatment), contractual patient-provider referral (a two-step approach that links patient and provider referral methods), and expedited partner therapy (the diagnosed patient takes the prescriptions or medication to his/her partner without prior examination of the partner). The selected strategy has to be rights-based and sensitive to gender inequalities, while ensuring and expediting partners’ access to treatment. Reducing waiting times and waiving user fees are additional methods for encouraging sex partners (especially when asymptomatic) to proceed with treatment. In general, partners should be treated with the same medicines as the index patient unless they are pregnant, lactating or allergic to specific medicines. Priority actions for countries Safeguard patient confidentiality; ensure linkage to counselling and treatment. Priority actions for WHO Provide and update evidence-based guidelines for partner notification, diagnosis and treatment. 14 Package interventions for maximum impact The overall public health impact of these core interventions can be boosted by combining them with other initiatives, specifically: the global campaign to eliminate mother-to-child transmission of HIV and syphilis; wider introduction of the vaccine against the human papillomavirus; and strategies to confront the emergence of gonococcal antimicrobial resistance. Eliminate mother-to-child transmission of syphilis and HIV A number of countries have committed to eliminate mother-to-child transmission of syphilis (‘congenital syphilis’). Pilot projects and country experiences confirm that the elimination of ‘congenital syphilis’ is feasible with concerted, timely efforts that achieve serological diagnosis of syphilis and effective single- or multi-dose treatment of all seropositive pregnant women. In many countries the elimination of mother-to-child transmission of syphilis is linked to a dual elimination campaign (elimination of mother-to-child transmission of HIV and syphilis) and a few countries have begun implementing a triple elimination campaign (elimination of mother-to-child transmission of HIV, syphilis and hepatitis B). Priority actions for countries Screen all pregnant women for syphilis, and ensure that those who are seropositive receive either single- or multi-dose treatment, as appropriate. Link this intervention strategically to the drive to eliminate the mother-to-child transmission of HIV. Strengthen monitoring of these interventiosn to validate elimination. Priority actions for WHO Provide guidance on monitoring and evaluation for validating elimination of mother-to-child transmission. Update guidance on the use of rapid tests for syphilis or dual tests for syphilis and HIV. Utilize the human papillomavirus and hepatitis B vaccines A vaccination programme using new vaccines against the HPV could dramatically reduce cervical cancers caused by that virus, while the hepatitis B vaccine has been proven to be safe and effective in preventing hepatitis B infection (see the Global health sector strategy on viral hepatitis, 2016– 2021). Countries should urgently consider introducing or expanding such vaccination programmes. 15 HPV vaccines targeting the adolescent population present a great opportunity for strengthening adolescent health programmes. Priority actions for countries Urgently consider introducing a vaccination programme against HPV as part of a comprehensive approach to cervical cancer prevention. Countries that have not yet introduced hepatitis B vaccination into their national infant immunization programmes should do so urgently, and ensure timely delivery of the birth dose of hepatitis B vaccine to prevent perinatal transmission of hepatitis B infection. Priority actions for WHO Assess schedules and dosages for immunization policies, and advise on the most effective methods for protecting high-risk groups, as well as boys. Support operational research in countries for the introduction of HPV vaccine and for linking it to adolescent health programmes. Control the spread and impact of gonococcal antimicrobial resistance Gonorrhoea is one of the most common STIs worldwide and it has a significant effect on morbidity and mortality. Over the past decades, N. gonorrhoeae has developed resistance to almost all medicines used to treat the infection. The emergence of similar resistance to the current thirdgeneration cephalosporins is highly likely, which raises the prospect of untreatable gonococcal infections. WHO has strengthened the Gonococcal Antimicrobial Surveillance Programme (GASP) by establishing a network of laboratories to coordinate gonococcal antimicrobial resistance monitoring and provide data to inform treatment guidelines. WHO has also developed an action plan to control the spread and mitigate the impact of antimicrobial resistance on N. gonorrhoeae. Other STI pathogens with potential antimicrobial resistance include Treponema pallidum, herpes simplex virus and Haemophilus ducreyi. These are linked to the overall global antimicrobial resistance action plan. Priority actions for countries Implement strategies and interventions to monitor antimicrobial resistance trends, including strengthening national laboratory network capacities. Adapt national treatment guidelines to resistance patterns and implement interventions to limit the spread of antimicrobial resistance. 16 Priority actions for WHO Increase support for the Antimicrobial Surveillance Programme and other efforts to monitor antimicrobial resistance and contain the spread of untreatable gonorrhoea. Support efforts to update treatment guidelines for gonorrhoea. Monitor possible emergence of antimicrobial resistance to treatments for Treponema pallidum, herpes simplex virus and Haemophilus ducreyi. Ensuring quality of interventions and services The quality of interventions and health services should be ensured, so that investments achieve greatest impact and significant risks are averted. Achieving this is closely related to the broader objective of health systems strengthening (discussed in the enabling environment section) and to patients’ experiences of STI services. At an individual level, the quality of care can be assessed based on the ability of the healthcare delivery system to provide safe, effective and patient-centred care in an efficient, timely and equitable manner. Rapid expansion of programmes to improve coverage should neither compromise the quality of services, nor contribute to inequities in access to services and health outcomes. Strengthen the continuum of prevention, diagnosis, treatment and care STI strategies are most effective when people are able to access and benefit from a full continuum of quality-assured services, especially people who are at high risk for infection yet hard to reach with interventions (see Figure 3). Countries should monitor the integrity of their prevention, diagnosis and care cascade to determine where barriers exist, outcomes are suboptimal and people are lost to follow-up, so that remedial actions can be implemented. Services should be organized to minimize ‘leakages’, to maximize retention along the cascade and adherence to prevention and care interventions. Major challenges include: acceptability and uptake of effective prevention interventions, targeting diagnosis to maximum effect and minimizing incorrect diagnoses, linking people to appropriate prevention and treatment services as early as possible, and ensuring treatment adherence. There is a need also to reduce the prescription of antimicrobials by laypersons or by people themselves, a practice that conceals symptoms without halting the infection, delays timely access to health services, and causes microbial resistance to antibiotics. The most effective services are those delivered in ways that are patient-friendly, that respect people’s rights and that address their varying needs without judgment or prejudice. The involvement 17 of community groups and networks has also been shown to be effective, especially for reaching and serving key populations. Strengthened laboratory capacity also helps to ensure accurate diagnoses and supports enhanced surveillance of STIs and monitoring of microbial resistance. A strong continuum of services also requires a supportive institutional and social environment, as well as coordination between different sectors (including the private sector and community-based providers) and across various levels of health service delivery. Figure 3. Priority actions for countries Integrate key indicators for the various steps of prevention and control into national STI monitoring and evaluation systems. Analyse the prevention and control cascade to determine the quality of services, identify major weaknesses and decide on remedial actions. 18 Priority actions for WHO Facilitate the collection of national data on the cascade and report on major findings. Through the analysis of national data, identify common weaknesses in the cascade, review evidence on possible interventions to address the weaknesses and integrate effective interventions and approaches into WHO guidance, with an emphasis on strengthening operational and programmatic guidance. Promote the WHO cascade monitoring and evaluation framework as a key component of national STI monitoring and evaluation systems. Link and integrate services and programmes Greater integration and linking of STI services and programmes with those for other relevant health areas (including for HIV, family planning, maternal and neonatal care, sexual health, immunization, and noncommunicable diseases, and other sectors such as school health education programmes targeting adolescents and occupational health) have the potential to reduce costs, improve efficiency and lead to better outcomes. Appropriate models of integration and linkage will depend on the country context and health system, and should be informed by operational research. These may include working with pharmacies to rationalize the advised use and selling of over-the-counter antibiotics to treat STIs. Priority actions for countries Identify opportunities and appropriate models for integration and linkage between STI and related health areas, based on country context and operational research. Expand the integration of STI services into existing primary health care, reproductive health and HIV care programmes. Strengthen links and collaboration between prevention and control measures for STIs with those for other mother-to-child transmitted diseases, and for cancer and noncommunicable disease programmes. Priority actions for WHO Provide operational and programmatic guidance on possible models of linkage and integration and propose indicators and methods for measuring effective linkage. 19 Implement quality assurance and improvement programmes Quality of care can be enhanced by ensuring that quality-assurked commodities are procured, and that services adhere to national and international norms and standards, are continuously monitored and improved, and are made more accessible and acceptable to patients’ needs and preferences. Indicators and mechanisms for monitoring the quality of commodities and for the organization and delivery of services should address such issues as waiting lists, facility waiting times, frequency of visits, and competencies and supervision of health care workers. Priority actions for countries Establish and implement national norms and standards, based on international guidelines and other standards, monitor their implementation and apply quality improvement measures where deficiencies are identified. Ensure the procurement of quality-assured medicines, vaccines, diagnostics and condoms, including through the use of the WHO prequalification systems. Establish mechanisms to continuously monitor service utilization and acceptability and the preferences and needs of patients, communities and health care workers. Priority actions for WHO Emphasize quality assurance and quality improvement principles, approaches and indicators in WHO guidance. Support capacity building of national regulatory authorities, quality control laboratories, and manufacturers or other private companies, to ensure the quality of medicines including generics. Strengthen the WHO prequalification programme to encourage manufacturers to apply for prequalification of medicines, diagnostics and devices, and to facilitate the rapid assessment of new applications. Regularly report on quality improvement along the STI prevention, care and treatment cascade. 20 STRATEGIC DIRECTION 2: Achieving equity and impact: Populations and locations Access to effective STI services should be equitable and free of discrimination or neglect. Yet this can be challenging. As with HIV, large proportions of people at high risk for STIs do not use prevention methods and services effectively, remain undiagnosed, or do not use or adhere to treatment therapies. This is partly because STIs occur with high frequency among marginalized populations (such as sex workers, men who have sex with men and prison inmates) and among adolescents, all of who commonly experience difficulties in accessing or remaining linked to health services and to STI services in particular. Reaching the STI targets will only be possible by focusing suitable, high-impact interventions and services for populations who are most at risk for STIs and in places where most STI transmission is occurring. Recent innovations in technology and delivery methods make it easier for countries to identify key populations and service gaps, and to achieve equitable provision of high-impact services and interventions. It also requires addressing the underlying factors — such as discrimination and criminalization, poverty, drug dependence and poor mental health — that help generate such health inequities. This is best achieved by involving people most affected by STIs actively in developing strategies and programmes. The respect of human rights is a critical aspect of all these approaches and methods. This section focuses on understanding countries’ epidemics, identifying priority populations, and designing and targeting services accordingly Focus on geographic locations with highest disease burden and transmission Countries need to focus their efforts on locations with the highest disease burden and transmission. Achieving the milestones and targets for STI services requires that countries “know their epidemics” – by achieving reliable estimates of the sizes and distribution of populations most at risk for infection, understanding where they are, their behavioural patterns and other factors that put them at risk, and reaching them with quality-assured prevention and control services. Geographical mapping can help countries design and implement the most efficient and effective responses. Strategic information systems should provide sub-national and disaggregated data to monitor epidemic trends and to map the locations and core groups among which most transmission of STIs is occurring. This will enable resources and services to be allocated accordingly where the greatest impact can be achieved. 21 Priority actions for countries Use innovative survey methods, modelling and mapping tools, involving local communities and key populations, to develop accurate estimates of key population sizes and detailed understandings of sub-national epidemics. Use those data to improve the focus and impact of STI programmes and interventions. Ensure that data collection methods yield high-quality information, meet ethical standards and do not pose risks for communities and health care workers involved. Priority actions for WHO Provide guidance on methods for estimating the sizes of key populations and on setting programme targets for services for key populations. Support countries to develop their strategic information systems and map their STI epidemics and responses. Reach key populations with appropriate services Reaching key populations with the most appropriate interventions will be critical for ending STI epidemics in countries. Actions are needed to overcome or remove barriers that prevent key populations from accessing the STI and broader health services they need, such as age of consent laws, criminalization of behaviours such as sex work and sex between men, and institutionalized stigma and discrimination. The STI response also needs to reflect the fact that different populations may require different sets of interventions and different types of services. WHO and partners have developed guidelines and implementation tools that define essential packages of interventions and service delivery models for different key populations, including sex workers, people who inject drugs, men who have sex with men, transgender people and prisoners. 22 Priority actions for countries Identify key populations, vulnerable to and most affected by STIs, and prioritize implementation of tailored service packages to meet their needs, including links to a broader package of appropriate health services. Monitor access to, and uptake and quality of HIV and STI health services for key populations. Include multisectoral actions to reduce stigmatization and discrimination in national STI strategies, policies and programmes. Involve community-based organizations and peer networks in the planning and delivery of services to improve the reach, quality and effectiveness of STI services. Integrate evidence-based gender-equality interventions into national STI action plans or strategies. Provide services that are appropriate for adolescents and review laws and policies on consent to improve access. Include comprehensive sexual health education in school curricula for adolescents. Priority actions for WHO Build on existing guidance to better define essential packages and service delivery models for specific populations and specific settings, including for adolescents and key populations Update guidance on the implementation of programmes to address gender-based violence, violence against women and the management of adult, adolescent and child survivors of rape. Collaborate with UNESCO, UNICEF and UNFPA to design a package for preventing and managing STIs that meets the needs and realities of young people. Target special settings There are specific settings where vulnerability and risk are high and where access to basic STI services might be severely compromised, such as in prisons and detention centres, refugee camps and settings of humanitarian concern. Countries should ensure that services provided to individuals in these settings are equivalent to those available to the broader community. Priority actions for countries Implement the comprehensive package of STI interventions for prisoners and prison settings as developed by the United Nations Office on Drugs and Crime and WHO. Incorporate contingency plans for essential STI services into national STI plans to ensure continuity of STI services in settings of humanitarian concern. 23 Priority actions for WHO Work with UNHCR to ensure that guidance on the delivery of STI services in settings of humanitarian concern is regularly updated to be consistent with global guidelines. Work with the United Nations Office on Drugs and Crime to regularly update guidance on STI services for prisoners and prison settings. 24 STRATEGIC DIRECTION 3: Innovation for acceleration Achieving the strategy’s targets will require going beyond existing technologies and service delivery approaches. The current package of STI interventions and services needs to be augmented steadily with new, evidence-based technologies and approaches for prevention, diagnosis, treatment and service delivery. However, the existence of effective technologies and interventions does not automatically lead to their widespread use. Along with affordability factors, misgivings and incomplete understandings may discourage wide adoption. Such hurdles can be overcome with robust operational research, by communicating the evidence base, and by providing technical and other support for rapid implementation, and monitoring and evaluating performance and use. Optimize STI prevention The main technologies for preventing STIs have changed little in recent times. Although male and female condoms have been proven to be effective against unintended pregnancies and STIs, low acceptance and incorrect or inconsistent use mean that their potential benefits are not being realized. Innovations that could boost the STI response include: Male and female condoms that employ new designs and materials to increase acceptability and reduce costs (particularly of female condoms), and new marketing methods to boost their demand and use. Multipurpose technologies for preventing STIs and unintended pregnancies – especially female-controlled technologies – and that are more effective and less user-dependent, that do not interfere with sexual pleasure, and that provide additional health benefits. Effective messaging for adolescents, in particular adolescents boys, on dual protection (prevention of pregnancy and of STIs and/or HIV). A bigger range of STI vaccines should be developed and available for preventing the acquisition of STIs, especially herpes simplex virus infection, Chlamydia trachomatis and N. gonorrhoeae. A major scale-up of human papillomavirus and hepatitis B vaccination programmes. Strengthened operational research for the introduction of vaccines. 25 Optimize STI diagnostics New and improved diagnostics technologies, strategies and approaches would lead to earlier and more accurate diagnosis, and strengthened patient monitoring. A major barrier to advancing STI control and prevention is the lack of reliable, low-cost, point-of-care tests. Opportunities for innovation include: Point-of-care diagnostic tests and/or self-testing technologies that are more rapid, reliable and simpler to use will enable more extensive early diagnosis of infections, including the detection of asymptomatic infections, and allow patients to receive diagnosis and treatment in a single visit. Development of a multidiagnostic platform, which would enable simultaneous diagnosis of several STIs at the same time, in particular C. trachomatis, N. gonorrhoeae, syphilis, HIV and antimicrobial resistance Diagnosis for pelvic inflammatory disease. Operational research to guide the most effective methods for introducing rapid tests in countries, and to identify major challenges and opportunities related to them. Optimize medicines and treatment regimens Despite major advances in the safety, potency and acceptability of medicines and regimens, there remain areas where improvements are required and possible. More robust regimens to reduce the risk of drug resistance. New, more effective drugs for treating syphilis, N. gonorrhoeae and herpes simplex virus. Reducing the number of treatment doses to reduce toxicities and costs. Research on communication and use of new technologies, and systematic community-based support to improve treatment adherence. Support operational research to identify effective, efficient, safe and acceptable STI diagnostic and treatment approaches. Optimize service delivery Overall impact is boosted when service delivery approaches fit the realities and needs of potential beneficiaries (especially hard-to-reach priority populations), minimize inefficiencies, use simplified and standard protocols, and fully engage communities. There are opportunities for further innovation in all those respects, including through: 26 Periodic presumptive treatment, a short-term strategy that focused on controlling certain STIs in specific key populations. Decentralization and task-shifting, including for earlier, accurate diagnosis and effective linkage to treatment and care. Community-based service delivery, including effective and more acceptable models for reaching key populations, with comprehensive services. Research for strengthening understandings of health-seeking behaviour. User-friendly services for adolescents that are better-suited and more acceptable to adolescents. Service linkages and integration, including clearly identifying which services would draw mutual benefit from strategic linking or integration, and innovative mechanisms and procedures for linkage or integration. 27 STRATEGIC DIRECTION 4: Financing for sustainability Countries face the challenge of investing in an expanded programme to achieve the targets for 2030 and beyond while ensuring long-term sustainability of funding — all in a context where development priorities are shifting and external financial support might decline. The trend of increasing domestic funding of STI programmes needs to continue even though some low-income countries, especially those with a heavy burden, will need substantial external support to ensure rapid scale-up. Financing for a sustainable STI response requires action in three areas: raising sufficient funds to pay for STI programmes, including through public and private domestic funding and external sources; establishing equitable mechanisms to pool funds for financial risk protection; and optimizing the use of resources by reducing costs and improving efficiencies. Health system financing has a major impact on programme coverage, equity and health outcomes. Develop innovative financing and funding approaches Existing international and domestic funding commitments are not enough to achieve the 2030 targets outlined in this strategy. Additional sources of funding will be required to fund sustainable scale-up of programmes and fill funding gaps resulting from shifting donor priorities. Countries will need to develop and implement financial transition plans as they move from externally to domestically funded programmes. Priority actions for countries Develop financial transition plans with special focus on the transition needs of programmes and services most reliant on external funding (for example programmes for key populations), and negotiate bridging arrangements with donors if necessary. Develop new funding channels, such as a health promotion fund, with a negotiated portion of the revenue earmarked for STI programmes and related services. Advocate for (greater) STI resource allocations within sector-wide funding mechanisms. Priority actions for WHO Advocate for a fully funded STI response that marshals both domestic and external financial support. Support countries to develop investment cases and funding proposals to mobilize funding, and support the development of national health financing plans that incorporate STI programmes. Support operational research on innovative, sustainable health-financing mechanisms. 28 Provide financial risk protection Preventing and controlling STIs is, in principle, relatively easy and affordable in most settings. Many STI services are provided free of charge, and countries increasingly also use supportive arrangements (such as decentralizing services) to minimize the indirect costs for people using services. However, in many places user fees continue to be imposed. As with other out-of-pocket expenses (formal and informal), such fees undermine service use, result in inequities in service access, weaken linkages to treatment, and increase risks of treatment failure. Moreover, they constitute unnecessary financial burdens on households. Financial risk protection for people with STIs will depend on a broader robust and fair national health financing system. WHO supports countries to review their systems based on their health needs and country context. The WHO Health Accounts Country Platform provides countries with a harmonized, integrated platform for annual and timely collection of health expenditure data, with the aim of protecting the population from catastrophic health expenditure and reducing inequities in health. Priority actions for countries Phase out out-of-pocket payments (including ‘informal’ user charges) and reduce other financial barriers to accessing STI and other health services. Provide universal protection against health-related financial risk. Public compulsory health financing systems, including general taxation and compulsory health insurance, are the most equitable and efficient systems for reducing health-related financial risk. Achieve greater health equity by consolidating existing pooled funds into larger pools, thereby avoiding fragmented health insurance systems. Ensure that people’s contributions to health insurance systems reflect their abilities to pay, with subsidies (financed from government tax revenue) available for poor and vulnerable people. Ensure that financial risk protection schemes are universal, covering all populations, including those who are criminalized and marginalized. 29 Priority actions for WHO Provide guidance and technical support to establish robust and fair health financing systems, including the design and implementation of national compulsory health insurance. Promote the WHO Health Accounts Country Platform and support adoption by countries. Support operational research to identify major financial barriers to accessing and utilizing STI services. Reduce prices and costs and improve efficiencies Fiscal pressures require that countries select the most effective STI interventions and approaches, target those activities to the populations and places where they will have greatest impact, reduce the prices of medicines and other health commodities, and increase the efficiency of services. Priority actions for countries Develop and pursue comprehensive strategies to reduce prices of STI vaccines, diagnostics and treatment drugs, including by making full use of flexibilities of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and various WHO mechanisms. Safeguard and expand the availability of generic products, and reduce barriers in product markets. Increase savings through improved planning and more efficient procurement and distribution systems. Achieve greater efficiency and avoid waste, e.g. through integrating or linking relevant health services to share resources and avoid duplication; procuring and using medicines and diagnostics that meet international standards of quality, safety and efficacy; and improving management and coordination mechanisms across all relevant stakeholders (including external donors and partners). Priority actions for WHO Provide strategic information on prices and manufacturers of STI medicines, diagnostics and other commodities including through the WHO Global Price reporting Mechanism and the Regulatory Status database. Provide support to countries to strengthen their capacity to negotiate price reductions with manufacturers and to use the flexibilities of the TRIPS Agreement. Strengthen WHO’s prequalification programme to safeguard and expand availability of generic products. 30 31 An enabling environment for delivery and impact A comprehensive and expanded response that reaches diverse populations in many different settings requires a set of solid building blocks: accurate data and analysis; transparent accountability mechanisms; strong, well-supported health and community systems; the systematic promotion of health equity, gender equality and human rights; and effective collaboration between partners. Improve strategic information for advocacy, planning and impact A robust strategic information system is a prerequisite for advocating, funding, strategic planning and implementing more effective interventions, and for monitoring and improving those interventions and providing evidence of impact. It is essential for countries to “know their epidemics” so that the most current strategic information on the nature of the STI epidemic and the country context guides national responses. Knowing the epidemic thus includes understanding where, how and among whom new infections are occurring. It also requires identifying the factors that facilitate the risk of STI transmission or limit access to and use of STI services. Such a system needs to collect routine, disaggregated data (including for key populations), which requires linking or integrating and then synthesizing data from different data collection systems. Currently, most national STI surveillance systems are based mainly on universal case reporting. There is a great need to strengthen national, regional, and global STI surveillance and monitoring systems in order to arrive at more accurate estimates of STI burdens overall and within particular populations, including adolescents. Setting national targets and identifying indicators for monitoring and evaluating the national programme will enable countries to clearly assess and regularly report on the status of the response, and to use those assessments for further programme improvements. Regular programme reviews help ensure that national strategies, plans and resource allocation reflect actual country needs as they evolve. It is vitally important to use the augmented strategic information to inform policy makers and key opinion leaders about the burden and consequences of STIs. More effective strategies are need to advocate for specific, evidence-based intervention options and cost-effective approaches, and to articulate the policy and legal reforms that would enhance STI prevention and control efforts. Assure global and country accountability Given the range of partners and stakeholders that join forces in an effective response, and the extent of their activities, well-functioning and transparent accountability mechanisms are vital. Those mechanisms need to feature strong civil society participation. The accountability process 32 benefits from strong leadership and governance that features genuine engagement with relevant stakeholders; clear national targets that reflect the Sustainable Development Goals and other pertinent global commitments; appropriate indicators on the availability, coverage, quality and impact of interventions to track progress; and transparent and inclusive assessment and reporting procedures. Strengthen health systems The keystone of an effective STI response is a strong health system that is capable of providing reliable, effective and equitable people-centred care in both the public and private sectors. The hallmarks of such a system are: efficient service delivery models that meet patients’ variable needs; a sufficient and well-trained workforce; a robust health-information system; reliable and affordable access to essential medical products and technologies; adequate health financing; and strong leadership and governance. Currently, very few health systems command all those features. Vital and feasible improvements include: o equipping health workers with the skills and commodities to rapidly expand prevention, testing and treatment of STIs; o health financing systems, financial protection schemes and other mechanisms (such as voucher systems) that enable people to access essential, quality-assured services without suffering financial hardship; and o service delivery methods and approaches (including marshalling private sector providers and pharmacies into the STI response) that provide equitable and effective services for all, particularly for key or neglected populations. Support community systems The involvement of community and other civil society structures and networks is a hallmark of successful health responses, especially in places and populations affected by stigmatization and discrimination. While the importance of these stakeholders is increasingly acknowledged, actual support still lags. At a minimum, legal and regulatory frameworks should facilitate stronger collaboration and partnerships between community groups and the public and private sectors. Other improvements include greater support for capacity development (e.g. to strengthen participation in programme planning, service delivery, and monitoring and evaluation) and increased investment in community-based peer support and outreach programmes. Promote healthy policies and laws When properly enforced, laws and policies that protect and promote human rights can reduce people’s vulnerability to and risk of STI infection, expand access to health services and enhance their reach, quality and effectiveness — including for women and other populations that are at high risk 33 of infection yet encounter difficulties accessing services (such as adolescents, men who have sex with men, transgender people, prisoners and sex workers). Laws and policies that empower and promote equality for women and girls provide an important platform for efforts to protect them from STIs, while legal reforms that empower key populations can also lead to more effective and sustainable STI interventions. Yet an array of legal, institutional and other barriers continues to prevent such key populations from accessing effective health services. The health sector has a unique role in fostering institutional and community environments in which all people can safely access health services. The sector can do so by helping ensure that policies, laws and regulations across various sectors support national health responses, particularly by countering gender inequity and protecting and promoting the human rights of key populations. Priority actions include the removal of legal, regulatory and policy barriers that stigmatize or that hinder equitable access to STI and supportive services – including the decriminalization of sex work – and using public health evidence to shape pro-health laws and actions. Engage and link partners A broad-based approach that engages multiple partners will help strengthen policy coherence, programme coordination and implementation, and address the various factors that affect the outcomes of STI responses. It is also important for mobilizing resources, achieving accountability and strengthening human rights protections that benefit all, including key populations. Opportunities for such partnerships and collaborations exist across the health sector and other relevant government sectors. Strong engagement with civil society, including the faith-based sector, and especially at community level is vital for ensuring that essential services are accessible to all populations. Strategies for linking the provision of STI services across the private and public health care sectors could increase the availability and quality of those services. A wide range of mutual benefits flows from closer integration and/or linking of STI services with other relevant health interventions, especially those for other infectious diseases (including HIV), noncommunicable diseases and mental health. Partnerships with other government services (e.g. substance dependence, mental health, law enforcement and correctional services, etc.) would make it easier to engage and reach priority populations. Structured linkages with private sector and civil society service providers would also help extend coverage while improving quality assurance. 34 Strategy implementation: Accountability, monitoring and evaluation Effective implementation of the strategy depends on concerted action from all stakeholders in the health sector response to STIs, including strong partnerships to ensure policy and programme coherence. Linkages across various disease-specific programmes need to be established and strengthened, and monitoring and evaluation efforts should reflect those linkages and partnerships. Collaboration with other partners WHO has an important convening role in bringing together different constituencies, sectors and organizations in support of a coordinated and coherent health sector response to STIs. In addition to its Member States, the WHO Secretariat works closely with other key partners, including bilateral donor and development agencies and initiatives, funds and foundations, civil society, technical institutions and networks, the commercial private sector and partnership networks. Monitoring, evaluating and reporting Implementation of the strategy will be monitored at three levels, using existing mechanisms: Monitoring and evaluating of progress towards global goals and targets; Monitoring and evaluating the response at country level; and WHO’s framework for results-based management. Monitoring and reporting of progress towards global goals and targets At the global level, regular reviews are planned to assess progress on the various commitments and targets. These reviews will build on the data that countries report through various monitoring and evaluation mechanisms. Progress at global and regional levels towards the targets set out in this strategy will be regularly assessed. Benchmarking — or comparisons between and within countries — will also be used to assess performance in reaching targets. The strategy is designed to be sufficiently flexible to incorporate additional priorities or fill newly identified gaps in the health sector response to STI. To that end, WHO will continue to work with its partners to provide support to countries for the harmonized and standardized collection of core indicators, and in the preparation of global and regional reports. Regular reporting of the data is proposed. WHO will develop a suitable monitoring and accountability framework for the strategy in consultation with key stakeholders. It will also monitor and share data on the uptake of its STI 35 guidelines, as well as on progress in implementation of the strategy, in order to highlight barriers and promote best practices. Monitoring and evaluating the response at country level Progress in implementing the health-sector response to STIs is to be assessed with indicators on availability, coverage outcome and impact, while taking into consideration other relevant recommendations for monitoring implementation. Progress towards the health-related Sustainable Development Goals will be tracked and reported. Indicators for monitoring the strengthening of health systems derive from a common platform for monitoring and evaluating national health strategies, known as the Country Health Systems Surveillance platform, coordinated by WHO. Instruments are also available for measuring progress in implementing policy, legal and structural measures for enhancing the HIV and STI responses. WHO’s framework for results-based management Workplan implementation is monitored through a mid-term review at the end of the first year of each biennium. Progress towards the achievement of the organization-wide expected results is reported at the end of each biennium. 36
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