Resolving the Critical Challenges Now Facing the Global Programme to Eliminate Lymphatic Filariasis - An overview of the Gates Foundation grant to the Global Alliance - Background Recognizing the need for additional operational research to support the Global Programme to Eliminate Lymphatic Filariasis (GPELF), the Bill and Melinda Gates Foundation in May, 2006 agreed to consider a proposal from the Global Alliance (GAELF) addressing these needs. The proposal, entitled Resolving the critical challenges now facing the GPELF, focuses on specific researchable targets identified as essential to the Programme by the GPELF and agreed to by the Foundation. With input from many in the LF community the proposal was developed and submitted by the GAELF in late July, 2006 and was accepted by the Foundation in October. The total award is for $11.7 million over 4 years (October, 2006 October, 2010). It will be managed on behalf of the GAELF by the LF Support Center at the Task Force for Child Survival and Development in Atlanta (as described more fully below). Goals and Objectives. The goal of the grant is to ensure the ultimate success of the GPELF by finding solutions to the challenges and potential barriers facing it today. These challenges identified and articulated by scientists, public health leaders and program managers through a series of international meetings and publications have translated as the specific goals of the project; namely, 1) To facilitate programmatic decision-making by identifying epidemiological and operational criteria that distinguish programs able to succeed in LF elimination using Mass Drug Administration (MDA) alone from those requiring MDAs + other supplemental measures; 2) To identify supplemental interventions that would be most effective and cost-effective in facilitating interruption of LF transmission where current MDA strategies might not be sufficient or rapid enough 3) To develop innovative financing strategies for countries (particularly in Africa) to build financially sustainable programs to achieve LF elimination. To achieve these 3 goals the grant targets 8 specific Objectives (4 relating to the 1 st goal, 2 relating to the 2 nd goal, and 2 relating to the 3 rd goal). Since the 1 st goal requires precise technical definitions and means to assess program success, the objectives of this goal focus principally on tools standardizing those now available, comparing their effectiveness in demonstrating the absence of LF transmission, and selecting the most effective approaches for defining program end-points, conducting surveillance and assessing the impact of population compliance. The 2 nd goal addresses the challenge of identifying effective and cost-effective supplementary measures (specifically, vector control or modified drug treatment regimens) for programs requiring more than the current MDA approaches. Since vector control strategies for malaria (targeting 1
Anopheles) and for source reduction of Culex are already well established, studies will define just how effective these are against LF and in what situations they could be utilized cost-effectively; results could have a major impact on how LF programs are implemented, especially where LF and malaria co-exist. Because ivermectin and albendazole are used for the 2-drug MDA regimens at dosages below those optimal for each drug used alone, regimens employing twice the current dosages of these drugs and/or double the frequency of administration (i.e., twice-yearly) will be evaluated in clinical trials for possible use where interventions beyond MDA may be required to interrupt transmission. The 3 rd goal recognizes the significant financial challenges faced by the GPELF and seeks to develop innovative strategies to achieve long-term, sustainable funding. Its first objective is to create a financial situation analysis that includes a thorough review of the current national allocations for LF (and other NTDs [Neglected Tropical Diseases]) in selected countries and identification of factors important for gaining decision-makers support for LF programs. The second objective builds on this information and utilizes the World Bank to establish linkages among national LF programs, ministries of health and finance, and international development organizations and agencies both to promote recognition by these organizations of the value that programs targeting LF and other NTDs have for development and to increase access of LF programs to available international funding. Organization and Management To carry out the specific research required to meet the grant s 8 objectives will require the collaboration of at least 25 different investigators in more than 20 different countries. The idea is to define the specific research elements of each objective, identify the best places and investigators to address the questions efficiently and economically, and then to solicit the cooperation of these groups to participate in multi-center studies. A Technical Group has been established to oversee and advise on each of these 8 Objectives of the grant. Members of the Group are individuals selected not only because of their LF and technical expertise but also because of their independence from receiving any research funds from the grant itself. Though each member of the Technical Group will generally coordinate activities for one Objective, they will all share in advising on all aspects of the grant activities. The members of the Technical Group and their principal responsibilities are: o Objective No.1 Diagnostic tool refinement / operationalization Mark Bradley o Objective No.2 Epidemiological practice / outcome determinants Rafe Henderson* o Objective No.3 Post-MDA surveillance strategies Boakye Boatin o Objective No.4 Impact of population compliance Gautam Biswas** o Objective No.5 Supplementary vector control Graham White o Objective No.6 Alternative chemotherapy schedules John Horton o Objective No.7 Financial situation analysis - selected countries *** o Objective No.8 Bridging gaps between need and funds available *** * with Gautam Biswas; ** with Rafe Henderson; *** Bernhard Liese to liaise with Ousman Bangoura and the World Bank The Secretariat located at the Task Force for Child Survival and Development in Atlanta supports this Technical Group and is ultimately responsible to the GAELF s Executive Group for all of the grant s activities and initiatives. This Secretariat is comprised of: 2
o Principal Investigator / Program Director Eric Ottesen o Project Director Dominique Kyelem o Financial Analyst Waithera Kagira-Watson o Administrative Assistant DiAnn Watson In addition, Professor Steven Williams is volunteering his sabbatical year (2/07 2/08) to work in Atlanta with the Secretariat principally on all the tool-development activities of Goal No.1. Study Sites and Participating Investigators Selection of study sites and investigators is determined on the basis not only of interest and willingness of the investigators to participate but principally on the likelihood of their being able to answer the research questions successfully and cost-effectively. The requirements if the grant dictate that the study sites represent all of the major vector-parasite situations that country programmes will face as they try to determine when to stop the MDA components of their national programmes. Future Updates on Progress of Grant Updates on progress within each specific Objective will be posted monthly on the GAELF website www.filariasis.org beginning 1 May 2007. Also posted on that website are o This summary overview of the grant s goals and objectves o The timeline of activities originally proposed in the grant request to the Gates Foundation and against which the progress must be measured o A schematic of the grant s Goals/Objectives and how they relate to the Global Programme s needs o A schematic of the organization of the oversight of grant activities 3
Grant Goals/Objectives Schematic Global Programme to Eliminate LF Gates/GAELF Grant (10/06-10/10): Resolving the Critical Challenges Program Managers Guidelines Conduct mapping Mf > 1%? Mass drug administration < 1% mf < 0.1% ICT LQAS 3000 children Stop MDA? No Further MDA rounds Stop MDA? Gates Grant Baseline Mid term Evaluation of sentinel sites Defining programme successfulness Objective #1 Prospective Analysis Have we really interrupted transmission? - Select, refine, operationalize best tools - assess impact of MDA s after 5 rounds Pre & Post 5 th MDA ICT DNA Antibodies Success? Passive surveillance Objective #3 Surveillance Strategies -Prospective surveillance - Passive surveillance Objective #2 Retrospective Analysis Analysis of programmes to identify determinants of successful and not yet successful programmes - Baseline infection - Mf, ICT, Vectors - MDA Coverage and compliance No Goal #2 Supplemental Interventions - Objective # 5 Vector control - Objective #6 Alternative chemotherapy Objective #4 Compliance - Impact of systematic non-compliance - Prevention of systematic non-compliance Goal #3 Innovative Financing Strategies - Objective #7 Financial situational analysis - Objective #8 Bridging the gap 4
Grant Organization/Oversight Schematic Resolving the Critical Challenges Now Facing the Global Programme to Eliminate Lymphatic Filariasis Global Alliance: EG and RCG Secretariat 1. Assessment tools / Impact 2. Determinants for success 3. Surveillance 4. Compliance impact Technical Oversight Group 1 2 3 4 5 6 7 8 5. Vector control 6. Alternative drug dosages 7. Financial situation analysis 8. LF program links to IDF 5