1. health and fitness

Call for Letters of Interest
Research on innovative approaches for safety monitoring in
Seasonal Malaria Chemoprevention
Deadline for submission: 23 December 2014
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Research teams from African institutions are invited to submit Letters of Interest (LoI) for research on
piloting innovative approaches for safety monitoring in the context of seasonal malaria
chemoprevention.
Under this call, one or two research teams are expected to be selected for funding for a maximum
amount of US$ 75 000 each.
Background and rationale
WHO recommends for malaria prevention that children aged 3-59 months living in areas of highly
seasonal malaria transmission in the Sahel sub-region receive seasonal malaria chemoprevention (SMC)
with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) administered monthly for up to four
months of the year during the period when the children are at greatest risk. Since the WHO
recommendation for SMC was issued in March 2012, countries have included SMC in their strategic
plans for malaria control, and several have started to implement it on the field.
As with all such programmes, adequate safety monitoring should be ensured where SMC is introduced.
However, in many countries where SMC will be implemented, there is currently no robust system for
collecting in an efficient and reliable manner information on safety in such mass treatment
interventions. Implementation research is therefore needed to determine effective and sustainable
methods for monitoring the safety of SMC, as part of a broader system of pharmacovigilance in health
programmes.
This call fits within TDR’s focus to help low- and middle-income countries develop innovative tools and
strategies targeting neglected tropical disease.
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Objectives
The overall objective of the call is to support one or two African research teams to pilot innovative
approaches for safety monitoring in the context of seasonal malaria chemoprevention.
The specific objectives are, primarily, to test new methodologies or practices aiming at strengthening
safety monitoring, and secondarily, to generate data on the safety of SP+AQ used in the context of
SMC.
The expected outcome is data that would aid evidence-based decisions for recommendations on
methodologies to be implemented for safety monitoring in SMC, and potentially in other preventive
mass drug administration programmes.
Methodologies
The research proposal should focus on new and innovative approaches to improve the quality and
effectiveness of safety monitoring systems in the context of SMC. The project is to be embedded in
the normal SMC activities implemented by the national malaria control programme, and should ideally
be carried out in collaboration with the national pharmacovigilance centre.
Examples of interventions and research questions within the scope of this call:
(This list is for guidance on the scope of projects we expect to see. It is not exhaustive. Proposals
addressing questions relevant to the call specifications but not stated below are welcome.)
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Developing innovative approaches for safety monitoring;
Setting up active methodology for safety monitoring of adverse events;
Empowering community health workers to report safety information collected at
community level;
Demonstrating activities or elements that will strengthen effectiveness of current
pharmacovigilance systems;
Demonstrating how can mobile technology (such as mobile phone) contribute to improved
pharmacovigilance in the context of SMC;
Demonstrating how regional networking can support safety monitoring of SMC.
Funding scope
Funds may be requested to support direct costs attributable to the study, including research staff time
(excluding the principal investigator), direct costs due to specific follow-up, consumables and
equipment.
The funding is available for research only. TDR will not fund treatment and routine delivery of health
services needed for the organization and delivery of the SMC or the treatments of adverse events.
Applicants should build the safety monitoring project within the implementation of SMC at country
level and identify at the application stage the health facilities and referral structures which will provide
any health service delivery relevant to the project, including medical management of adverse events
and adverse drug reactions.
The successful project will be awarded funding for implementation during the 2015 SMC season.
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Selection process
The candidates will be selected following an open competitive call for applications. The applications
will be evaluated based on scientific merit, relevance to the call and feasibility.
For those project(s) selected for funding, TDR will work with investigators to develop a protocol for
implementation.
Final protocols will need to be approved by the WHO Ethics Review Committee and relevant local
research ethics committees before funds can be made available and projects can start implementation.
Eligibility criteria
• Resources secured to ensure a functional seasonal malaria chemoprevention programme
during 2015 and willingness of the partners involved in SMC delivery to participate in the
implementation of the research on safety monitoring;
• Referral system in place for management of adverse events and adverse drug reactions;
• Principal Investigators must be based in the country where the project will take place;
• Proposed project is planned to be implemented in 2015.
Evaluation criteria
Upon verification of eligibility by TDR staff, applications will be reviewed and evaluated by an external
scientific working group in consideration of the following criteria:
Relevance to the call
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How much the proposed research falls within the scope of the call
Innovation potential
Potential impact
Linkage with the national pharmacovigilance centre
Feasibility
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Coherence and effectiveness of the work plan
Potential to be implemented smoothly with the identified resources
Quality/suitability of the institution(s)/team (composition, expertise) for the proposed tasks
Feasible implementation timelines
Budget and funding
Risks identified and mitigation measures
Scientific merit
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Investigator and team knowledge, expertise and experience
Application
Applications should be submitted online. A 7-10 page letter of interest should provide a brief outline
of the technical and operational feasibility for the proposed project (see below). A one-page summary
CV of the principal investigator and a supporting letter from the institution’s director should also be
attached.
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The following content should be included in the letter of interest to provide evidence on the feasibility
of the project at your site:
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Brief description of institution’s mandate, structure, staff, current activities, research
experience (maximum 1 page).
Brief description (maximum 1 page) of the SMC implementation plans for SMC season 2015
including areas and number of children to be targeted, number of rounds and months
targeted, strategy for SMC delivery, actors to be involved in the SMC implementation and
foreseen contribution of each actor (please include also actors or partners responsible of SMC
implementation on the field, drug provision). Confirmation of the funding and drug supply
secured for the implementation in 2015 should be included.
Brief description of the current safety reporting system and tools in the country (maximum 1
page).
Description of the proposed research project (minimum 3 pages – maximum 6 pages),
including the methodology proposed, target area for the project implementation, partners to
be involved if any, number of children to be targeted by the safety monitoring intervention
proposed.
Staffing proposed for the study including number of field workers / community health workers.
Proposed budget breakdown.
Proposed timelines (please include foreseen timing for ethical submission if applicable).
Foreseeable risks to the successful achievement of project objectives, along with proposed
measures to mitigate those risks.
Applications can be submitted in English or French.
All applications must be completed and submitted online using the WHO DataCol portal form found on
this link: https://extranet.who.int/datacol/survey.asp?survey_id=3152
The log-in credentials are: User name: callPVSMC - Password: iir-tdr
Only applications submitted through this online portal will be considered for review.
Deadline for submission of letters of interest: 23 December 2014, 16.00 GMT.
Additional application information:
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An active email address is required to use this portal. A confirmation email will be sent to this
address to acknowledge successful submission. Only one application may be submitted by
each team or individual. Multiple submissions will not be processed. Information and
documents to be uploaded are stated in the online application form. Applicants are advised to
prepare the supporting documentation prior to starting the submission process.
Applicants are encouraged to familiarize themselves with the DataCol application form, in
particular the requested information and documents, paying particular attention to the
mandatory fields marked with an asterisk (*).
Applicants are advised to avoid last minute submissions as this could overload the system or
fail due to internet connectivity problems. Applications received after the deadline will not be
considered.
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Please contact TDR ([email protected]) if you encounter technical difficulties during the
completion and submission of the application form. Please mention “Call PV SMC” in the
subject of your message.
For further information on the call, please contact:
Dr Christine Halleux
Special Programme for Research and Training in Tropical Diseases (TDR)
World Health Organization
1211 Geneva 27, Switzerland
Telephone: +41 22 791 2559
E-mail: [email protected]
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