Programme document for phase II (2002-2007) and the phasing-out period (2008-2010)

WORLD HEALTH ORGANIZATION AFRICAN PROGRAMME FOR ONCHOCERCIASIS CONTROL (APOC) PROGRAMME DOCUMENT FOR PHASE II (2002-2007) AND THE PHASING-OUT PERIOD (2008-2010) 28.10.01 WORLD HEALTH ORGANIZATION AFRICAN PROGRAMME FOR ONCHOCERCIASIS CONTROL (APOC) The Programme Director has the honour to submit to the Joint Action Forum for its consideration and eventual approval the proposal for the Programme Document to cover operations of APOC during its Phase II and Phasing-out Period (document JAF7. 8). In preparing the proposal, the Programme Director invited contributions from individuals closely connected with the Programme and took into account comments and suggestions made by the various APOC partners, including but not limited to National Onchocerciasis Task Forces (NOTFs), the Technical Consultative Committee (TCC), the Committee of Sponsoring Agencies (CSA), Merck & Co. Inc., the Mectizan Donation Programme (MDP) and Non-governmental Development Organizations (NGDOs) in partnership with APOC. The attention of the reader is drawn to document JAF7/INF/DOC.2 which provides a thematic overview of the evolution of the control of Onchocerciasis in Africa. Map of Onchocerciasis Control Programmes in Africa (APOC and OCP) Sudan Chad Nigeria C am er oo n CAR RD. Congo Ug a nd a Kenya Ethiopia Tanzania Rwanda Burundi M al aw i Mozambique Angola C o ng o Gabon Eq Guinea Liberia APOC OCP WORLD HEALTH ORGANIZATION AFRICAN PROGRAMME FOR ONCHOCERCIASIS CONTROL PROGRAMME DOCUMENT FOR PHASE II (2002-2007) AND THE PHASING-OUT PERIOD (2008-2010) CONTENT EXECUTIVE SUMMARY .................................................................................................................1 1. INTRODUCTION………………………………………………………………………7 2. OVERALL PROGRAMME ACHIEVEMENTS ............................................................ 8 3. PROGRAMME OBJECTIVE AND EXPECTED BENEFITS..................................... 11 3.1. Objective ...................................................................................................... 11 3.2 Expected Benefits ........................................................................................ 11 3.2.1 Health Benefits................................................................................. 11 3.2.2 Social Benefits ................................................................................. 12 3.2.3 Economic Benefits ........................................................................... 12 4. PROGRAMME STRATEGY........................................................................................ 12 4.1 Ivermectin Distribution ................................................................................ 13 4.1.1 CDTI in high risk areas.................................................................... 13 4.1.2 Treatment in hypo-endemic zones ................................................... 14 4.1.3 IEC and advocacy ............................................................................ 14 4.2 Focal vector eradication activities................................................................ 15 5. SUSTAINABILIY OF CDTI......................................................................................... 15 5.1 The importance of sustainable CDTI ........................................................... 15 5.2 CDTI projects and sustanability................................................................... 15 5.3 APOC financial support to CDTI projects ................................................... 15 5.4 Generating and sustaining commitment to CDTI at all levels ..................... 16 5.4.1 National level ................................................................................... 16 5.4.2 District level ..................................................................................... 16 5.4.3 Community level ............................................................................. 16 5.5 Additional considerations for sustainability ................................................ 17 5.5.1 CDTI as entry point for other community-based health programs .. 17 5.5.2 Role of women in CDTI activities ................................................... 17 5.5.3 Cost recovery and cost sharing ........................................................ 17 JAF7.8 Page ii 6. ORGANIZATIONAL AND MANAGERIAL FRAMEWORK DURING PHASE II AND THE PHASING-OUT PERIOD ...................................................................18 6.1 Governance............................................................................................................18 6.1.1 Joint Action Forum (JAF) .........................................................................18 6.1.2 Commettee of Sponsoring Agencies (CSA)..............................................19 6.1.3 Fiscal agent ................................................................................................19 6.2 Programme Management.......................................................................................19 6.3 Technical Consultative Committee (TCC)............................................................20 6.4 NGDO Coordination Group ..................................................................................20 6.4.1 Role............................................................................................................20 6.4.2 Guiding principles regarding NGDO involvement in APOC....................20 6.4.3 Coordination of the Group=s activities.......................................................21 6.5 Responsibilities of the Governments of APOC countries and the National Onchocerciasis Task Forces (NOTFs)...................................................................21 6.6 Communities..........................................................................................................22 6.7 Mectizan Donation Program (MDP) .....................................................................22 6.8 Disbursement of funds: guiding principles............................................................22 6.9 Purchase of Equipment..........................................................................................23 6.10 External evaluation of APOC................................................................................23 7. PLAN OF OPERATIONS FOR THE SECOND PHASE (2002-2007) AND FORECASTS FOR THE PHASING-OUT PERIOD (2008-2010)................................24 7.1 Introduction ...........................................................................................................24 7.2 Programme targets.................................................................................................24 7.3 Disease distribution: Rapid Epidemiological Mapping of Onchocerciasis (REMO) ...................................................................................26 7.4 Community Directed Ivermectin Treatment projects............................................26 7.4.1 Duration of the Projects.............................................................................26 7.4.2 Estimated number of projects and their implementation during Phase II and the Phasing-out Period and the number of people to be treated ...............................................................................27 7.4.3 Severe adverse events (SAE) related to Loa Loa ......................................28 7.5 Treatment in hypo-endemic zones.........................................................................28 7.6 Vector Eradication Projects ...................................................................................28 7.6.1 Duration of the Projects.............................................................................28 7.6.2 Estimated number of Projects to be implemented during Phase II...........................................................................................29 7.7 Training/Capacity building....................................................................................29 7.8 Advocacy and Information, Education and Communication (IEC) ......................30 JAF7.8 Page iii 7.9 Biostatistics and Information Systems............................................................ 30 7.10 Research .......................................................................................................... 30 7.10.1 Operational research ........................................................................... 30 7.10.2 Research on macrofilaricides and diagnostics .................................... 31 7.11 Programme involvement in other health care and development activities...............................................................................31 7.12 Monitoring and evaluation ...............................................................................32 7.13 Impact assessment of APOC operations ..........................................................32 7.14 Management, administration and support services ..........................................32 7.14.1 Programme Headquarters.....................................................................32 7.14.2 Support from WHO/HQs, WHO/AFRO and the NGDO Coordinator=s Office ..........................................................33 7.15 Consultants= services ........................................................................................33 7.16 Operation Travel ..............................................................................................33 7.17 Statutory meetings............................................................................................33 7.18 External Evaluation..........................................................................................33 8. BUDGETARY FORECASTS FOR PHASE II (2002-2007) AND THE PHASING-OUT PERIOD (2008-2010) FOR DONORS= CONTRIBUTIONS......................................34 8.1 Budget breakdown and justification ................................................................34 8.1.1 National Onchocerciasis Projects.........................................................34 8.1.2 Operational Research ...........................................................................35 8.1.3 Monitoring, Impact Assessment, REMO and REA .............................35 8.1.4 Training/IEC/Advocacy .......................................................................35 8.1.5 Personnel Services ...............................................................................35 8.1.6 Administrative Support-Operating cost-Equipment-Supplies .............35 8.1.7 Consultancy..........................................................................................36 8.1.8 Operational Travel ...............................................................................36 8.1.9 Statutory meetings................................................................................36 8.1.10 Macrofil Project ...................................................................................36 8.2 Summary annual budgets per category of expenditures ..................................36 8.3 Evolution of APOC Budgets estimates from 1996 to 2010 and of Personnel services costs in Phase II and the Phasing-out Period .....................................39 9. RISKS AND SAFEGUARDS ...........................................................................................40 9.1 Decline in commitment to CDTI .....................................................................40 9.2 Civil unrest .......................................................................................................40 9.3 Resistance to ivermectin ..................................................................................40 9.4 Shortage of financial resources ........................................................................40 10. POST-APOC INTER-COUNTRY COLLABORATION .................................................40 ANNEXE 1 ..............................................................................................................................42

JAF7.8 Page 1 INTRODUCTION 1. The present “Programme Document” of the African Programme for Onchocerciasis Control (APOC), submitted to the Joint Action Forum (JAF) for its consideration and eventual approval, contains proposals for the organizational, operational and administrative components of the Programme and includes a detailed plan of action accompanied by the corresponding budgetary forecasts. 2. One of the findings of the Mid-term External Evaluation conducted in 2000 was that there needs to be flexibility in determining the duration for APOC support to the CDTI Projects and that additional funding beyond the regular five years may be required in specific situations to ensure sustainability of CDTI. A provision has therefore been made in the current Programme Document for the extension of APOC support, if required, to a maximum of 8 years. This additional support would focus on full integration of CDTI into the health services and on related national capacity building. 3. Operations in Phase II (2002-2007) will therefore be followed by a Phasing-out Period of three years duration (2008-2010) to allow for the above mentioned extension of APOC support to a certain number of projects in order to enable them achieve satisfactory indices for sustainability. OVERALL PROGRAMME ACHIEVEMENTS 4. As highlighted by the External Mid-term evaluation, APOC has successfully fulfilled its mandate during Phase I: areas and communities to be included in the treatment programme were defined; APOC has made community involvement a cornerstone in its operations; capacity has been built, and resources provided; health service staff is intimately involved in the planning and the execution of the Programme; CDTI has demonstrated the potential for the community-directed treatment (ComDT) approach as a powerful one in the implementation of other health development activities; APOC has launched focal vector eradication projects in three countries; initiated and carried out CDTI project monitoring and impact assessment studies; in 2000, more than 20 million persons were treated with ivermectin; over 77 thousand people were trained or retrained of whom 82% are Community Directed Distributors (CDDs), 17% are health care personnel and others for specific activities or management. In all, the Programme has re-inforced the partnership and succeeded in generating enthusiasm and commitment on a wide scale, influencing positively the health services of Participating Countries in a variety of ways. PROGRAMME OBJECTIVE 5. To establish, within a period of 12 to 15 years, effective and self-sustainable, community-directed ivermectin treatment throughout the endemic areas within the geographic scope of the Programme, and, if possible, in selected and isolated foci, to eradicate the vector by using environmentally safe methods. The attainment of this objective is expected to contribute towards the elimination of onchocerciasis as a disease of public health and socio-economic importance throughout Africa and so improve the welfare of its people. PROGRAMME STRATEGY 6. Experience during Phase I of APOC indicates that ivermectin treatment is popular among endemic populations, and that communities can take responsibility for their own ivermectin treatment. CDTI will therefore remain the principal strategy during Phase II and the Phasing-out Period. EXECUTIVE SUMMARY JAF7.8 Page 2 7. However, the main elements of the strategy will be fine-tuned and optimized for the Programme to reach its objective. Renewed emphasis will be placed on ensuring sustainability by the further development, through collaborative partnership, of community directed ivermectin delivery systems which can be sustained at optimal coverage by the endemic communities and countries themselves through their health systems. 8. In other words, during Phase II and the Phasing-out Period, APOC will have to provide the evidence that CDTI is sustainable after the cessation of its support. An important new task will be to evaluate the experiences of projects where APOC support comes to an end and to apply the lessons learned in the preparation of other CDTI projects towards effective integration into the health system and sustainable implementation of CDTI in the absence of major external support. THE ORGANIZATIONAL AND MANAGERIAL FRAMEWORK DURING PHASE II AND THE PHASING-OUT PERIOD 9. The Programme will continue to be based on a partnership between governments, the multilateral and bilateral agencies, Foundations, NGDOs, the affected communities, the scientific community and the private sector. During Phase II and the Phasing-out Period of the Programme, responsibilities of the various partners will develop in the light of the eventual assumption of responsibility by national authorities for post-APOC CDTI activities. 10. The Programme will continue to be governed by the Joint Action Forum (JAF) whose membership will be augmented to include donor(s) of ivermectin used by the Programme and whose main functions will still be to decide on the overall policy and strategy of the Programme and approve plans of action and budgets. 11. The Committee of Sponsoring Agencies (CSA) will continue to be a separate overseeing body for APOC which will take interim decisions on behalf of JAF when required. Its membership will continue to comprise representatives of UNDP, FAO, the World Bank and WHO. In addition, a representative of the NGDO Coordination Group and a representative of donor(s) of ivermectin used by the Programme will be invited to join the sessions of the CSA. At present, Merck & Co. Inc. is the sole donor of ivermectin to the Programme. If there should be additional donors in the future, all such donors would be asked to select one from among them to represent the group on the CSA. 12. The fiscal agent of the Programme remains the World Bank; the World Health Organization will continue as the Executive Agency. 13. The Technical Consultative Committee (TCC) will realign its focus to technical, implementation and operational research considerations and leave Programme Management to focus on detailed financial, budgetary and managerial issues. TCC will be expanded to a maximum of 12 members as follows: 11 shall be scientists/experts appointed by WHO Director General, three of whom shall be proposed by the NGDO Coordination Group; and one representative of the Mectizan Donation Programme directly appointed by Merck & Co. Inc. 14. The NGDO Coordination Group will maintain its financial support of the Programme, as well as serving as a conduit for operational issues by collaborating with Ministries of Health in endemic countries to establish CDTI projects in all affected communities. 15. Ministries of Health will have the ultimate responsibility for implementing national plans for Onchocerciasis control and particularly sustainable CDTI; they will create a favourable environment for all partners; set up National Onchocerciasis Task Forces (NOTFs) which should include all key partners, especially representation from the NGDOs. The NOTFs are chaired by the MOH and will be responsible for developing the National Onchocerciasis control plans and specific project proposals which will be submitted to APOC for funding. The NOTFs will oversee the implementation of the CDTI projects and ensure the availability and timely delivery of ivermectin to the affected communities. JAF7.8 Page 3 16. The affected communities will remain the most important partners of APOC and will be responsible for the execution of the ivermectin treatment and the sustainability of CDTI will largely depend on them. APOC will therefore optimize its effort to strengthen its current strategy to empower communities to take responsibility and decisions for ivermectin distribution. 17. Merck & Co. Inc. has committed to donate Mectizan® (Ivermectin) for the treatment of Onchocerciasis to all who need it for as long as necessary. It has created the Mectizan Expert Committee (MEC) and the Mectizan Donation Program (MDP) to facilitate the approval, donation and delivery of Mectizan. 18. With regards to the funding mechanism of APOC projects, WHO/APOC will continue to request funding from the Trust Fund held in the World Bank and subsequently will administer and disburse those funds to the NOTFs of Participating countries or their NGDO partners. 19. Funding can be requested for the first five years of a project (including projects started during Phase I). After five years, the project should normally be self-sustaining. However, after assessing the projects against strict sustainability criteria, additional funds (for a maximum of three years) may be made available if required to ensure the full integration of CDTI into the health services and to support related national capacity building. PLAN OF OPERATIONS FOR THE SECOND PHASE (2002-2007) AND FORECASTS FOR THE PHASING OUT PERIOD (2008-2010) 20. New Programme targets have been defined for Phase II and the Phasing-out Period based on the achievements and experience of APOC during Phase I. These new targets are summarized as follows: i) 2003: 85 CDTI projects will have been launched in the endemic countries; ii) 2005: 60% treatment of the total population residing in the high risk zones will have been established; substantial progress will be made toward integration of CDTI into the primary health care activities; larviciding operations for vector eradication will have ceased. iii) 2007: about 45 million persons (65% of the total population), will be receiving annual treatment through CDTI, while for 53 CDTI projects financial support from APOC will have ceased; the post-APOC Plan of Operations for ivermectin delivery will have been completed; iv) 2010: the Programme will have established full geographical coverage and each of the 85 CDTI projects will have reached at least 65% treatment coverage of the total population in high risk communities; all APOC support will have ceased and all community-directed systems will have satisfactory levels of sustainability indicators in place. 21. To reach these targets, activities during Phase II and the Phasing-out Period will focus on the following areas: Disease distribution; Community-directed treatment with Ivermectin; Vector eradication; Training and capacity building; Advocacy; Information, Education and Communication (IEC); Biostatistics and Information Systems; Research; Programme involvement in other health care and development activities; Monitoring and evaluation; Impact assessment of APOC operations; Management, administration and support services; Consultants’ services; Operational travel; Statutory meetings and External Evaluations. 22. 95 national projects (85 CDTI projects; 6 National Secretariat Support projects and 4 vector eradication projects) will be implemented and managed in Phase II and the Phasing-out Period. 23. Substantial Operational research is needed to strengthen the scientific basis of APOC and to adequately address the challenges raised during the implementation of the CDTI projects. JAF7.8 Page 4 24. APOC will continue to support the monitoring of 10 to 14 CDTI projects per year. Two additional rounds of impact assessment studies will be also conducted during Phase II and the Phasing-out Period of APOC. 25. Furthermore, plans have been made for the completion of the REMO and the REA exercises in the countries, and for the integration of the data into the Geographical Information System (GIS). 26. Training, IEC and Advocacy will be intensified to ensure that each country has a reservoir of the technical expertise that Onchocerciasis control needs at senior management level; more appropriate IEC messages will be prepared and disseminated at all levels in the countries. 27. The number of staff members foreseen for 2001 will be maintained in 2002 but should be increased to 46 from 2003 after the closure of OCP. However, the Personnel costs shall significantly decrease during the Phasing-out Period. 28. Provisions are made in the plan of operations, for the support to the Programme from the liaison office, the WHO Headquarters Technical and Administration units as well as the NGDOs coordination office in Geneva; for the administrative and technical support provided by the WHO offices in APOC countries; the maintenance of office buildings and Programme vehicles; for the purchase of office supplies, data processing equipment and vehicles, all at the APOC Headquarters. 29. As in the past, APOC will continue counting on the expertise provided by the Consultants to assist the Programme at the Headquarters level as well as in the field. 30. For advocacy, training of trainers, management of the funds and evaluations, APOC personnel as well as the NGDO Coordinator will have to make several visits to the countries where the projects are being implemented. 31. Provisions are also made for the organization each year of the two regular sessions of the TCC while it is anticipated to reduce CSA sessions to two to three per year. The JAF will continue to meet annually unless it decides to reduce the frequency of its meetings. 32. The development of a macrofilaricide will be pursued during Phase II. It is planned to maintain support until 2007. Particular focus will be on the development of moxidectin. Research will also be undertaken on improved diagnostic tools for O. volvulus and to develop new diagnostic tools for early detection of resistance to Ivermectin. 33. During Phase I, field observations have shown that CDTI involvement in various other community health programmes, using Community-directed Distributors (CDDs) concerned with Ivermectin treatment, was welcomed by these health programmes. It is intended to seize such opportunities to use the community- directed treatment (ComDT) approach as a vehicle for expanding health development. 34. There will be external evaluations, one by the year 2004, another in 2007 and the last at the end of the Programme in 2010. JAF7.8 Page 5 BUDGET FORECASTS FOR PHASE II (2002-2007) AND THE PHASING- OUT PERIOD (20082010) FOR DONORS’ CONTRIBUTION 35. The donor contributions needed to implement the above Plan of Operations are estimated at US$ 68 million for Phase II (2002-2007) operations and US$ 11 million for APOC-funded activities during the Phasing-out Period (2008-2010). 36. The following table specifies the proposed allocation of donor contributions by category of expenditures for Phase II and the Phasing-out Period. Line items Phase 2 US$(000) Phasing out US$(000) Grand total US$(000) National Onchocerciasis Projects 39,647 3,654 43,301 Operational research 2,045 800 2,845 Monitg + Impact assesst, + REMO & REA 1,675 900 2,575 Training + IEC + Advocacy 2,200 500 2,700 Personnel Services 9,220 3,035 12,255 Operating costs, Adminis. Support and Equipment 3,330 980 4,310 Consultants 3,450 950 4,400 Operational travel 1,000 300 1,300 Statutory meetings 950 450 1,400 Macrofil project 4,070 0 4,070 TOTAL 67,587 11,569 79,156 As illustrated by the table above, the total amount under the budget line item “National Onchocerciasis Projects”, represents 55% of the total donor funding needs (US$ 79,156,000), estimated for the Phase II and the Phasing-out period. RISKS AND SAFEGUARDS 37. Given the extended duration of treatment, a relaxation in the commitment to CDTI cannot be excluded. Early integration of CDTI in national health systems will, by itself, counteract possible deterioration in the continuity of treatment. 38. Experience of Phase I operations has demonstrated that special arrangements manage to overcome periodic disruption of ivermectin distribution and delays in establishing CDTI projects due to civil unrest. 39. Although no resistance of Onchocerca volvulus to ivermectin has been demonstrated to date, APOC will continue to support the search for an ivermectin resistance detection tool as well as the search for a field- applicable macrofilaricide and alternative microfilaricide(s). 40. Should situations of insufficient financial resources occur, APOC partners will take the necessary action to provide the additional resources needed. JAF7.8 Page 6 41. Inter-country collaboration in the field of onchocerciasis control after the Programme comes to an end could be arranged by representatives of the “former” APOC countries (including Sudan) meeting during the WHO AFRO Regional Committee sessions to exchange CDTI experience and discuss the organization of any other activity that may require inter-country collaboration. Also, meetings of representatives of NOTFs and “former” APOC partners would facilitate sharing of operational experience, the identification of problems in CDTI implementation and the search for their solutions. JAF7.8 Page 7 1. INTRODUCTION The present “Programme Document” of the African Programme for Onchocerciasis Control (APOC), contains proposals for the organizational, operational and administrative components of the Programme and includes a detailed plan of action accompanied by the corresponding budgetary forecasts. The document is submitted to the Joint Action Forum (JAF) for its consideration and eventual approval together with a Memorandum, which sets out the institutional, financial and legal arrangements. In the APOC Programme Document for Phase I (1996 - 2001), a detailed description was provided of the geographical distribution, the seriousness and the impact of onchocerciasis in the nineteen countries to be covered by the Programme. Readers interested in the background for the creation of APOC are referred to the APOC Programme Document approved by JAF in December 1995. The attention of the reader is also drawn to document JAF7/INF/DOC.2 which provides an overview of the evolution of the control of Onchocerciasis in Africa. During Phase I, the Programme has clearly demonstrated its viability and capability to undertake the planned operations for onchocerciasis control. The Mid-term (Phase I) External Evaluation Team in its report, dated September 2000, emphasized as overall achievements of the Programme the launching of Community-directed Treatment with Ivermectin (CDTI) as "a timely and innovative strategy for fighting a widespread scourge"; the generation of enthusiasm and commitment on a wide scale; the importance of APOC field operations having "positively influenced the health services of the participating countries"; and the Programme's institution of a highly effective and unique partnership between Ministries of Health of affected countries, donor countries and organizations, UN organizations, Non-governmental Development Organizations (NGDOs), a pharmaceutical company, Merck & Co. Inc., and not least the communities concerned. On the operational side, the Evaluation Team further stressed and underlined the effective managerial set-up at APOC headquarters, but which now works under enormous pressure; and the productive screening and monitoring of projects by the Technical Consultative Committee (TCC), which however needs to be restructured and its role redefined “to align it with its technical mandate”. Another finding of the External Evaluation Team was that there needs to be flexibility in determining the duration for APOC support to the CDTI Projects and that additional funding beyond the regular five years may be required in specific situations to ensure sustainability of CDTI. A provision has been made, therefore, for extension of APOC support, if required, to a maximum of 8 years. This additional support would focus on full integration of CDTI into the health services and on related national capacity building. Operations in phase II (2002-2007) will therefore be followed by a Phasing-out Period of three years duration (2008-2010) to allow for the above mentioned extension of APOC support to a certain number of projects in order to enable them to achieve satisfactory indices for sustainability. As APOC is now at the mid-point of its existence, conclusions can be drawn from the experiences of the first six years of operations to help in the preparation of the Programme Document and Memorandum for Phase II and the Phasing-out Period in respect to organizational, operational and managerial matters. The forecasts for Phase II and the Phasing-out Period in the present document are therefore to a large extent based on the experience of operations during Phase I (1996 – 2001). The two main characteristics of APOC operations have been, and will continue to be, an expanded partnership and the reliance on the CDTI mode of control calling for community ownership and full responsibility for planning and implementing ivermectin treatment. During Phase II (2002-2007) and the Phasing-out Period (2008-2010), APOC will pay particular attention to strengthening the conditions for improved geographical and therapeutic coverage with ivermectin and sustainability of treatment for as long as needed after cessation of APOC support. It will also continue its managerial and financial support to CDTI projects, aiming at the highest possible degree of decentralized JAF7.8 Page 8 activities. This will include implementing activities in areas not yet under treatment, (some being highly endemic), enhancing effective ownership at all levels of CDTI operations (communities, districts and Ministries of Health etc.), promoting full integration of the activities within the national health care systems, strengthening national capacity to support CDTI, and evaluating the effectiveness of CDTI after cessation of APOC funding. In preparing the proposal for the present Programme Document, intensive consultations took place with all APOC partners and the document can therefore be considered as a consensus of ideas and opinions of all those collaborating to make the Programme a success. Once approved, the document will constitute the guide for the continuation of APOC activities and a successful handover to the participating governments and affected communities The following sections of the Programme Document deal with the overall achievements of APOC during Phase I; the Programme objective and the expected benefits; the Programme strategy; the organizational and managerial framework; the plan of operations and the budgetary forecasts; risks and safeguards and post-APOC inter-country collaboration. 2. OVERALL PROGRAMME ACHIEVEMENTS APOC, as highlighted by the External Mid-term Evaluation in 2000, has successfully fulfilled its mandate during Phase I. It has defined areas and communities to be included in the treatment programme. It has made community involvement a cornerstone in its operations, so that operations in the field are truly directed by the villagers through the process of Community-directed Treatment with ivermectin (CDTI). This has, by itself, engendered ownership by the communities of activities designed to improve their own health. And through this approach and process it has been possible to reach communities “at the end of the road” which are often underserved by the national health care services due to lack of resources. The Programme has succeeded in generating enthusiasm and commitment on a wide scale. Through its efforts, APOC has positively influenced the health services of Participating Countries in a variety of ways: capacity has been built; and resources provided; health service staff is intimately involved in its planning and execution. These observations of the APOC External Mid-term Evaluation summarise the achievements of APOC. More specifically, the Programme has fostered the organization and infrastructure required for carrying out, and managing its activities and managing at the community, district, national levels. The Programme has further developed a unique and successful partnership as the foundation for its operations including the communities involved in CDTI projects; the Participating Countries; the Donors; NGDOs; UN Agencies; the scientific community; and private industry. APOC has also helped the MOHs to build administrative and technical capacity in health delivery in 14 countries and vector elimination activities in 3 countries. This technical assistance has, to a large extent, been provided through the use of specially trained national staff. In 2000, over 77 thousand people were trained or retrained of whom 82% are Community Directed Distributors, 17% are health care personnel, and others for specific activities or management. These training activities resulted in numerous benefits and contributions to the health care service. For example, the Programme investments in training at all levels of health personnel resulted in greater technical and managerial ability; the emphasis on accountability has introduced a new disciplined approach to resource management. On the operational side, the Programme has undertaken and supported Rapid Epidemiological Mapping of Onchocerciasis (REMO) exercises in the countries before instituting the CDTI process (see Annex 1); launched focal vector eradication projects in three countries; initiated and carried out CDTI project monitoring and impact assessment studies; and established community participation and ownership as the cornerstone of ivermectin treatment. In addition, the CDTI approach has demonstrated the potential for community-directed treatment as a powerful approach in the implementation of other health JAF7.8 Page 9 development activities than onchocerciasis control. In all, 63 projects in 14 countries dealing with CDTI, vector eradication and strengthening of National Onchocerciasis Task Force (NOTF) secretariats had been approved for implementation as at December 2000 as shown in Figure 1. Figure 2 illustrates the evolution of these 63 projects between 1996 and 2000. Figure 1: Geographical distribution of the 63 projects approved between 1996 and 2000 Sudan CDTI: 2 HQ: 1 Ethiopia CDTI: 1 HQ: 1 Uganda CDTI: 4 Vector: 2 Tanzania CDTI: 4 Vector: 1 HQ: 1 Malawi CDTI: 1D.R. Congo CDTI: 1 HQ: 1 Congo CDTI: 1 Gabon CDTI: 1 Eq. Guinea CDTI: 1 Vector: 1 Cameroon CDTI: 8 HQ: 1 Liberia CDTI: 1 Nigeria CDTI: 26 HQ: 1 CAR CDTI: 1 Chad CDTI: 1 JAF7.8 Page 10 Figure 2: Evolution of approved projects from 1996 to 2000 Ivermectin treatment has dramatically increased from 4.9 million persons treated in 1995 to more than 20 million in 2000 (see figure 3). Figure 3: Number of persons treated from 1995 to 2000 4, 91 9, 99 5 7, 91 4, 74 9 11 ,4 57 ,7 42 14 ,0 79 ,6 54 1 8, 01 2, 25 9 20 ,2 98 ,1 39 0 5,000,000 10,000,000 15,000,000 20,000,000 25,000,000 Pe rs o n s tr e a te d 19 95 19 96 19 97 19 99 20 00 19 98 Pre-APOC APOC cumulative 4 25 6 12 16 63 57 45 29 0 10 20 30 40 50 60 70 1996 1997 1998 1999 2000 Projects approved Cumulative JAF7.8 Page 11 In summarizing the main achievements of APOC during Phase I, the External Evaluation Team also identified the challenges with which the Programme is faced and of which the most important are referred to in the following: i The Team emphasized the importance of full integration of CDTI activities within the National health care systems for which the entire commitment of the Ministries of Health would be of essence. The need for intensified advocacy was therefore to be given priority. Also, to ensure continued satisfactory implementation and sustainability of country programmes, special efforts would need to go into strengthening training at the various levels concerned with CDTI activities. ii “APOC’s target is for each project to achieve and sustain a coverage rate of 65% in each population that should be under treatment”. This would imply realistic appraisals of the prospect of projects continuing satisfactory operations after the end of APOC funding. Such appraisal should be carried out during the last years of activities funded by the Programme, and apply standard criteria, with a view to take corrective action whenever required. Also, collaboration with other health development programmes in activities using common approaches may contribute to sustainability of CDTI operations. iii The Team called for REMO exercises to be concluded in all APOC countries. In addition, owing to the possibility of ivermectin-induced Loa encephalopathy, mapping and field surveys on the prevalence of loiasis should be carried out in all areas of suspected co-infection with onchocerciasis. iv Other challenges are the institutionalisation of monitoring (including self monitoring)and the conduct of evaluation exercises. 3. PROGRAMME OBJECTIVE AND EXPECTED BENEFITS 3.1 Objective To establish, within a period of 12 to 15 years, effective and self-sustainable, community-directed ivermectin treatment throughout the endemic areas in the geographic scope of the Programme, and, if possible, in selected and isolated foci to eradicate the vector by using environmentally safe methods. The attainment of this objective is expected to contribute towards the elimination of onchocerciasis as a disease of public health and socio-economic importance throughout Africa and so contribute to improving the welfare of its people. It is worth stressing that the duration of APOC operations is limited in time and that the Participating Countries will assume, without major external support and well beyond the end of APOC, full responsibility for the continuation of community-directed treatment with ivermectin, set in course by the Programme. 3.2 Expected Benefits 3.2.1 Health Benefits Due to APOC activities, by 2000, over 20 million people were receiving annual treatment with ivermectin, severely infected individuals were relieved of intolerable itching, and an estimated 20,000 cases of blindness per year were being prevented. Through Phase II and the Phasing-out Period of APOC, delivery systems will be put in place to provide treatment for 59 million people annually with ivermectin beyond 2010, resulting in cumulative reductions in blindness and itching. The direct involvement in, and assumption of responsibility for, conducting CDTI activities by the communities will result in enhanced health awareness in the field with potential “openings” for instituting similar community-directed approaches for the control of other health problems. JAF7.8 Page 12 CDTI reaches communities at “the end of the road” that have been ignored and have had no, or limited, access to health services. The involvement of peripheral and district health services in supporting the implementation of the Programme will result in a strengthening of health service structures. Also, the direct participation of the national health authorities in the work of the NOTFs has been important in terms of strengthening the collaboration at that level among national and international partners for support to health development beyond onchocerciasis control. Training contributes to capacity building at all levels from the community to the national level. 3.2.2 Social benefits The prevention of new cases of onchocerciasis and the control of existing disease convey many social benefits to individuals and communities. The principal manifestations of the disease are impaired vision, blindness, and skin disease including debilitating itching, all with serious social implications. Onchocercal blindness leads to loss of productivity in affected people, in their most productive years, making them dependent upon their families and the community and reduces life expectancy by more than 12 years. The intolerable itching leads to dermal lesions that often result in social ostracism, especially for women who may find themselves consequently ineligible for marriage. Children in onchocerciasis communities are also at risk. They often drop out of school to care for those who are blind; they themselves may be infected and suffering from the incessant itching. This can lead to social ostracism and school dropout, compromising their futures. 3.2.3 Economic benefits In an overview of several studies on the economic benefits of APOC operations, the World Bank concluded that the economic rate of return (ERR) on the investment to the Programme would be in the order of 17 %, a rate comparing highly favourably with ERR's of other investments in development projects regardless of sector. The cost-benefit analyses, however, underestimated the net benefits of APOC, since it only considered the reduction in blindness as the principal benefit accruing from control operations. They did not take into consideration the benefits from such effects of onchocerciasis control as enhanced productivity, increased household welfare and reduced health expenditures resulting from the reduction in skin-related symptoms associated with the disease. 4. PROGRAMME STRATEGY The main elements of the APOC strategy during Phase II and the Phasing-out Period, although remaining essentially unchanged, will be fine-tuned and optimized for the Programme to reach its objective. However, renewed emphasis will be placed on ensuring sustainability by the further development, through collaborative partnership, of community directed ivermectin delivery systems which can be sustained at optimal coverage by the endemic communities and countries themselves through their health systems. Experience during Phase I of APOC indicates that ivermectin treatment is popular among endemic populations, and that communities can take responsibility for their own ivermectin treatment. Phase II will have to provide the evidence that CDTI is sustainable after cessation of APOC support. An important new task will be to evaluate the experiences of projects where APOC support comes to an end and to apply the lessons learned in the preparation of other CDTI projects towards effective integration into the health system and sustainable implementation of CDTI in the absence of major external support. JAF7.8 Page 13 4.1 Ivermectin Distribution 4.1.1 CDTI in high risk areas (a) Definition In order to control onchocerciasis as a public health and socio-economic problem, CDTI will be the distribution method in “high-risk” areas (areas where onchocerciasis is hyper-endemic or meso-endemic). Hyper-endemic areas are those with onchocercal nodule prevalence rates in adults over 20 years of age of over 39% while meso- endemic areas are those with prevalence rates between 20 - 39%. Other indicators than nodule prevalence may be used to measure endemicity in appropriate circumstances. (b) Strategy in high risk areas In the Phase II and the Phasing-out Period, APOC will optimise its effort to: i expand ivermectin distribution rapidly to cover all high risk communities in the remaining endemic areas (i.e. complete geographic coverage); ii reach satisfactory treatment coverage in endemic communities (therapeutic coverage) of greater than 65% of the total population; iii identify and monitor a list of key indicators of sustainability, cost-effectiveness and satisfactory treatment coverage of CDTI. Each NOTF will produce action plans describing activities promoting sustainability, and schedule monitoring activities and evaluations to assess progress; iv Evaluate the effectiveness and sustainability of CDTI in areas where APOC support has ceased and to determine, on the basis of these evaluations, how conditions for sustainability can be further improved and how to optimize the preparation of CDTI projects towards effective integration into the health system and sustainable implementation of CDTI. v explore additional mechanisms to strengthen the community directed treatment approach in each country towards sustaining the optimum treatment coverage rate; vi strengthen inter-country collaboration on effective and sustained implementation of the CDTI strategy. APOC will assist countries at risk of cross-border re-infection to establish mechanisms that facilitate the exchange of information and to collaborate strategically in maintaining optimal coverage rates; vii advocate effectively to gain more political support for CDTI from policy-makers, decision-makers and other key players in the health care system. (c) Treatment in conflict areas During Phase I it has been shown that CDTI can continue to function in conflict areas at moments of calm. Whenever feasible and without risk to those planning and conducting ivermectin treatment, implementation of projects will continue in Phase II and the Phasing out period in areas of civil conflict, and efforts will be given to organize distribution for populations in refugee camps located either inside or outside of the country/area in question. Given that a conflict area may only be intermittently accessible, the approval for ivermectin delivery will be adaptable and the CDTI application will be flexible to allow for treatments in such areas. The mode of distribution will be determined by the situation and a monitoring mechanism for follow-up action will be defined. Lessons learned from Phase I in implementing CDTI in conflict areas, will provide practical guidance to all projects working in areas of conflict. JAF7.8 Page 14 (d) CDTI in areas of co-existence of onchocerciasis and loiasis Certain areas where CDTI is being implemented are also endemic for another filarial parasite Loa loa (loiasis) that is also affected by ivermectin. In rare instances, persons with exceptionally heavy infection with Loa loa when treated with ivermectin can suffer Severe Adverse Events (SAEs). Support will be given to projects in areas of co-infection of onchocerciasis and loiasis to guarantee that the Mectizan Expert Committee (MEC)/TCC guidelines will be applied, (e.g. to improve mapping of areas at risk, to perform preliminary Rapid Epidemiological Assessment (REA) surveys and put infrastructure in place for management of SAEs. APOC will provide projects with assistance in capacity-building and planning as needed to ensure that trained health personnel and sufficient logistical support (particularly transportation) are available for regular supervision during mass treatment, and financial support is available for effective surveillance, transport and management of any cases of SAEs. APOC will support research to investigate problems associated with SAEs. Special IEC strategies will be developed in areas of co-existence of onchocerciasis and loiasis. In many areas, the fear of side effects from ivermectin treatment is among the major causes of refusals and absenteeism during drug distribution. In areas co-endemic for onchocerciasis and loiasis, the fear of side effects is compounded by the possibility of SAEs. Family members are usually the first to recognize the warning signs of a SAE, and they will alert the CDDs, and will be involved in the care of the patient. Recent research in Cameroon has indicated that family members can be taught to recognize early warning signs of SAEs. Special emphasis will therefore be placed on developing information, education and communication strategies and materials to empower families and communities with the knowledge and skills they need to quickly and appropriately respond to side effects and SAEs. Projects in all co-endemic areas will enlist the collaboration of religious leaders, school teachers and other community members who already provide guidance, support and educational services to families and communities. 4.1.2 Treatment in hypo-endemic zones Hypo-endemic zones are areas where the level of onchocerciasis endemicity is too low (nodule prevalence less than 20%) to consider the disease a sufficiently important public health problem to warrant large-scale treatment with ivermectin. However, whenever possible, ivermectin will be available for treatment by the national health services of those affected by the disease. Treatment in hypo-endemic areas of co-infection with onchocerciasis and loiasis will be carried out according to MEC/TCC guidelines. 4.1.3 IEC and advocacy IEC and advocacy will be important components in Phase II and the Phasing-out Period. Their purpose will be to support CDTI and the sustainability of all programme activities by helping to: i increase awareness about onchocerciasis ii increase and sustain adherence to ivermectin treatment iii promote a sense of ownership of CDTI among community members (i.e., men, women and youth); iv promote dialogue between the different stakeholders in CDTI (including communities, government health services, NGDOs, and other partners); and v garner support from policy-makers, decision-makers and other authorities in the government, civil society and the private sector. JAF7.8 Page 15 4.2 Focal vector eradication activities No new vector eradication activities will be undertaken during Phase II and the Phasing-out Period. Existing activities will be critically reviewed early in Phase II, to determine the cost benefit of each project, and whether the project should be completed. Ground larviciding using the already known environmentally safe insecticides will remain the vector control method of choice. 5. SUSTANABILITY OF CDTI 5.1 The importance of sustainable CDTI Onchocerciasis can be eliminated as a public health problem through annual mass treatment with ivermectin, provided that high treatment coverage can be maintained for a long period of time. It is not yet known how long mass treatment needs to be continued before it can be safely interrupted, but it is expected that at least 15-20 years of treatment will be required. The effectiveness and sustainability of the treatment programme are therefore essential for the success of onchocerciasis control. Experience to date has shown that CDTI is an effective drug delivery mechanism that achieves treatment coverage rates of more than 70% of the total population (over 85% of eligibles), a level that is considered adequate for the elimination of the disease as a public health problem. Operational research has shown that CDTI has important characteristics, such as community ownership of the drug delivery process, that greatly enhance its potential for sustainability. In view of the above, the objective of APOC is “to establish effective and self-sustainable, community-directed ivermectin treatment throughout the endemic areas in the geographic scope of the Programme” (see section 3.1). During phase I, significant progress has been made in establishing effective CDTI in endemic areas. The main emphasis in phase II will be on assessing and strengthening the sustainability of CDTI. As concluded by the Mid Term External Evaluation Team, “sustainability is the key issue for Phase 2 of APOC, and the major challenge for the future of onchocerciasis control”. 5.2 CDTI projects and sustainability The establishment of CDTI is done through projects. Each CDTI project covers a limited geographic area in an endemic country, such as a number of adjacent health districts. This project approach allows for a phased introduction of CDTI in a country, focusing support to the early phases of CDTI development with the view of applying the lessons learned to the rest of the country. The aim of each project is to establish effective and self-sustainable CDTI within a period of about 5 years, and to prepare the conditions that will ensure sustained commitment and support to CDTI after the cessation of APOC support. An important element of this preparatory work is the integration of CDTI into the health system and to strengthen the capacity of the health system to provide the necessary support in the long term. It is recognised that the status and viability of the health system vary significantly from country to country and from district to district within the same country. Therefore the pace and effectiveness of integration would differ from place to place. 5.3 APOC financial support to CDTI projects APOC will monitor progress towards the establishment of sustainable CDTI and determine, on the basis of criteria to be defined by TCC, if and when a project has been successful. The success criteria would cover issues of treatment coverage, community directorship and ownership, health system support and integration of CDTI into the existing health care structures. It is appreciated that, in spite of best efforts, satisfactory conditions for sustainability cannot always be created within 5 years and that additional support may be needed in certain situations to ensure success. If required, such additional support would be made available on condition that serious efforts have been made in trying to establish sustainable CDTI within a period of 5 years, and that this is likely to succeed within the near future. JAF7.8 Page 16 Additional support may be provided for a maximum of three years, and would focus on full integration of CDTI into the health services and on related national capacity building. Where efforts towards establishing sustainability are not considered adequate, APOC may discontinue its financial support to the concerned project while seeking an alternative solution. 5.4 Generating and sustaining commitment to CDTI at all levels 5.4.1 National level Continued commitment towards CDTI at the national level is essential for the success of onchocerciasis control. Indicators of such national commitment include: i adequacy of budgetary provision and timely unencumbered release of funds for the administrative and field operations of CDTI including meetings of NOTFs; ii the facilitation of procurement including tax free importation and community access to ivermectin in accordance with the terms of the Programme Memorandum related to the importation and clearance of Mectizan at the national port of entry of the drug; iii the provision of suitable, secure and adequate storage and transport facilities for the distribution of the drug to the District/State level. APOC supported advocacy towards ensuring continued commitment towards CDTI will be directed at decision and policy makers with the use of appropriate Programme-generated data and effective mode of communication. 5.4.2 District level Operational research undertaken during the first phase of APOC has indicated that an indispensable key to the ultimate sustainability of CDTI is the performance at the District level. District Health Management Teams have the crucial role of ensuring that their staff who manage the frontline health facilities are adequately oriented towards CDTI, appropriately motivated and provided with the means of discharging their diverse responsibilities. These responsibilities include: i ensuring that target endemic communities have timely and adequate access to ivermectin; ii carrying out the training and supervision of Community-Directed Distributors (CDDs); iii monitoring and providing for the management of severe adverse events; iv generally ensuring that CDTI operations run smoothly at the peripheral level. The capacity to execute these responsibilities will not always be available and APOC may need to assist with capacity building through the relevant CDTI projects. Indicators for successful integration of CDTI into the health system include evidence that CDTI activities feature as part and parcel of the process of planning, execution and evaluation of the health service at all level. 5.4.3 Community level Most of the communities have shown in several ways strong commitment to CDTI and willingness to assuming its ownership. The benefits of this commitment are reflected in enhanced community participation in the process and an overall increase in treatment coverage. There remain, however, a few areas of concern for sustainability at the community level that would be vigorously tackled during Phase II. Notable among these are the inter- related problems of CDD attrition over time and the need for providing appropriate community-level incentives JAF7.8 Page 17 by way of inducement, compensation or reward, or a combination of these. NOTFs would be encouraged to seek and provide appropriate local (community-specific) answers, through properly devised and executed operational research projects and through the holding, as regularly as possible, of stakeholders’ meetings which appear to have the potential of enhancing the prospects of sustainability of CDTI at the periphery. 5.5 Additional considerations for sustainability 5.5.1 CDTI as entry point for other community-based health programs One of the cardinal features of CDTI is its potential value as an entry point for other community-based health programmes. Inadequacy of human, material and financial resources has often been given as reason for failure to implement or extend a number of health programmes to many end-of-the-road communities such as those where onchocerciasis is endemic. The window of opportunity provided by CDTI for introducing other health programmes in these and similarly deprived communities is increasingly recognised. For example, an inter- agency meeting held in May 2001 in Uganda recommended “the application of community directed interventions for the prevention and control of other diseases of public health signficance e.g. lymphatic filariasis, schistosomiasis etc.” The feasibility of using CDTI as an entry point for a variety of other health programmes needs to be further investigated. This could be done from many perspectives including assessing, with the concurrence of the communities concerned, the ability of CDDs to assume responsibility for other health related activities in the community. The extension of the CDTI concept could considerably broaden the scope of community-based health programmes introduced in the wake of CDTI during the second phase of APOC, and improve the sustainability of onchocerciasis control. 5.5.2 Role of women in CDTI activities Reports on the first phase of APOC have indicated that increased participation of women in the decision making process of CDTI is associated with better performance. Parameters of effectiveness, such as treatment coverage, and an assortment of indicators of sustainability, such as public awareness and community participation are frequently better when women voluntarily and actively participate in the decision-making processes and arrangements for the distribution of ivermectin. It would be valuable to identify how the traditional roles of women in the various facets of the life of endemic communities could be successfully adapted to include their more active involvement in CDTI. It is intended therefore in the second phase of APOC to encourage NOTFs to enhance the role of women in CDTI, in a manner compatible with societal norms, and acceptable to all sections of the community. 5.5.3 Cost recovery and cost sharing A few APOC countries have adopted the policy of cost recovery as a national primary health care policy. The policy of cost recovery is consonant with the APOC principle of sustainability of CDTI, but several caveats must be noted. First, since ivermectin is donated free of charge by Merck & Co, Inc., cost recovery must not include the cost of the drug. Second, cost recovery should operate in a manner that does not compromise the APOC Programme goal of treatment coverage and sustainability of CDTI. No person should be denied treatment with ivermectin in the CDTI strategy because of inability to pay. Third, communities should be involved in the management of funds collected through the cost recovery mechanism. Such funds may well be used in paying for community expenses incurred in the CDTI strategy, e.g. transport for collection of drugs. While cost recovery holds promise as a tool for sustainability, it may impact negatively on treatment coverage. The issue is one that warrants further attention in the APOC operations research agenda in order to understand the effect of both positive and negative incentives for individuals, communities, CDDs and health workers. JAF7.8 Page 18 6. ORGANIZATIONAL AND MANAGERIAL FRAMEWORK DURING PHASE II AND THE PHASING-OUT PERIOD Figure 4: Organizational chart of the African Programme for Onchocerciasis Control (APOC) Joint Action Forum (JAF) Committee of Sponsoring Agencies (CSA) Technical Consultative Committee (TCC) National Onchocerciasis Task Force (NOTF) (Ministries of Health) Affected Communities APOC Management Non-Governmental DevelopmentOrganization (NGDO) Coordination Group Organizational chart of the African Programme for Onchocerciasis Control (APOC) 6.1 Governance The Programme will be based on a partnership between governments, the multilateral and bilateral agencies, Foundations, NGDOs, the affected communities, the scientific community and the private sector. The organizational framework is designed to reflect this partnership (Figure 4). During Phase II and the Phasing-out Period of the Programme, the responsibilities of the various partners will develop in the light of the eventual assumption of responsibility by national authorities for post-APOC CDTI activities. This will include a critical review of current and planned operations of APOC and, to the extent possible, their gradual transfer to the national level. 6.1.1 Joint Action Forum (JAF) The Programme will continue to be governed by the Joint Action Forum (JAF) consisting of Representatives of the Donors including the Donor(s) of ivermectin used by the Programme; of the Participating Countries; of the members of the Committee of Sponsoring Agencies (CSA); and of the Non-governmental Development JAF7.8 Page 19 Organizations (NGDOs) in partnership with the Programme. Sessions of the Forum are attended by representatives of the Technical Consultative Committee (TCC). The main functions of JAF are to decide on the overall policy and strategy of the Programme; to consider and comment on the progress reports submitted to it by WHO, the Participating Countries and by the NGDO Coordination Group; to review and approve the annual Plan of Action and Budget of the Programme; to assess the global financing requirements of the Programme; and to consider such other matters referred to it by any of its members or by the Programme Management. The JAF meets annually, usually hosted alternatively by a Participating Country and a Donor country. 6.1.2 Committee of Sponsoring Agencies (CSA) In Phase I, the membership of the Committee of Sponsoring Agencies (CSA) comprised representatives of UNDP, FAO, the World Bank and WHO who will continue as Co-sponsoring Members. The Director, APOC, will continue to attend ex-officio all sessions of the CSA. In addition, a representative of the NGDO Coordination Group and a representative of Donor(s) of ivermectin used by the Programme, will be invited to join the sessions of the CSA. At present, Merck & Co. Inc. is the sole donor of ivermectin to the Programme. If there should be additional donors in the future, all such donors would be asked to select one from among them to represent the group on the CSA. The Committee, which is a separate overseeing body for APOC and OCP respectively, but which for practical reasons holds meetings for both Programmes jointly, organizes medium- and long-term planning for the two Programmes (until the closure of OCP); makes arrangements for evaluation exercises; takes interim decisions on behalf of JAF when required; follows closely the financial situation of OCP and APOC; and scrutinizes documentation for the two governing bodies – the Joint Programme Committee (JPC) of OCP and the JAF – whose sessions are organized by CSA and the Management of the two Programmes. 6.1.3 Fiscal agent The fiscal agent of the Programme remains the World Bank, which has established an APOC Trust Fund into which contributions from the Donors are paid and from which the funds necessary for operations of the Programme are drawn. The World Bank is responsible for mobilizing contributions into the Trust Fund and reports annually on the financial situation of APOC before inviting, during each JAF session, Donors to pledge their contributions for the coming year(s). The Trust Fund will be governed by the guidelines of the World Bank. The World Bank has historically waived any fee for administering the Trust Fund. 6.2 Programme Management The World Health Organization will continue as the Executive Agency for the Programme. The Programme’s Headquarters will be located in Africa. The direct supervision of APOC management is carried out by the WHO Regional Office for Africa (AFRO) while WHO HQs provides administrative and technical support as well as operational research support, as and when required. WHO has historically waived its administrative fee for executing APOC. The Programme management will develop standard procedures and guidelines for the design, execution and monitoring of community directed ivermectin distribution projects; support NOTFs; approve new project proposals upon recommendation of the TCC; review and approve NOTFs’ applications for second, third, fourth, fifth etc. years funding and review all annual financial reports; disburse funds to approved projects; ensure monitoring and evaluation of ivermectin distribution projects in relation to the Programme objective and ensure that applied and operational research is carried out in support of control, and that approaches to control are modified when required. The Management will also maintain a geographical information system on African onchocerciasis and its control, ensure training of national staff involved in ivermectin-based control, and provide technical advice, assistance and funds for already-operating small-scale vector eradication projects. Finally the Programme Management will liaise with the NGDO Coordination Group and the Mectizan Expert Committee and will JAF7.8 Page 20 support the Programme’s statutory bodies, particularly the JAF, CSA and TCC, and will develop a close working relationship with research institutions and TDR. 6.3 Technical Consultative Committee (TCC) TCC in Phase II and the Phasing-out Period of APOC will realign its focus to that of technical, implementation and operational research considerations and leave Programme management to focus on detailed financial, budgetary and programme managerial issues (see section 6.2 above). TCC will review new National Plans and Project proposals as well as the annual technical reports of projects. TCC will contribute to establishing the APOC supported research agenda. TCC recommendations will be addressed to the Programme Director or, if required, to the CSA through the Programme Director. The TCC will meet at least once a year. During Phase II and the Phasing-out Period, TCC will be expanded to a maximum of 12 members as follows: eleven (11) shall be scientists/experts appointed by the WHO Director-General upon the recommendation of the CSA three of whom shall be proposed by the NGDO Coordination Group; and one (1) representative of the Mectizan Donation Programme directly appointed by Merck & Co. Inc.. The members appointed by the Executing Agency shall have a membership of three years, renewable for a maximum of three years, on a staggered basis. 6.4 NGDO Coordination Group Since its beginning in 1992, the NGDO Coordination Group has developed rapidly and has been strengthened by the APOC partnership. It is a group which was formed in order to better coordinate activities by those NGDOs involved in ivermectin distribution. The NGDO Coordination Group promotes worldwide interest and support for the use of ivermectin against onchocerciasis in endemic countries, in consultation with the World Health Organisation (WHO) and the Mectizan Donation Program, with the aim of eliminating onchocerciasis as a public health problem. The NGDO community is an important potential resource for the APOC Programme in regard to funding, personnel, community infrastructure, and programme experience. The involvement of NGDOs in APOC offers an opportunity to develop a model of how NGDOs can work in partnership with national Ministries of Health and multilateral agencies in other areas of health development. 6.4.1 Role NGDOs play a major supporting role within APOC that is not fulfilled by either the public and private sectors, international agencies, or bilateral donors. The terms of reference of the NGDO Coordination Group have been defined at the international level and they include: mobilize resources; serve as a conduit for operational issues; facilitate documentation and dissemination of best practices; and participate as appropriate in operational research. The principal tasks of NGDOs in-country is to collaborate with Ministries of Health in endemic countries to establish CDTI projects in all affected communities. 6.4.2 Guiding principles regarding NGDO involvement in APOC NGDOs tend to be independent and varied in their objectives and mode of operations. With this in mind, it is important that the structure of APOC ensure that the NGDOs involved in the programme: i work in partnership and with the agreement of the national ministries of health of the participating APOC countries; ii are members of the NGDO Coordination Group or NGDO Coalitions in-country; JAF7.8 Page 21 iii have a proven track record in delivering effective community services; and iv fulfil the criteria for local and international NGDOs involvement in onchocerciasis control programmes within a given country. Limits on administrative overheads paid by the APOC Programme to participating NGDOs will be fixed by APOC—through the TCC, Programme Management and the CSA—and be kept to a minimum if NGDOs are to be eligible to participate in the Programme. Expatriate personnel employed by NGDOs for involvement in APOC must be experienced and kept to a minimum. The NGDOs should—wherever possible—employ or finance national personnel and, where expatriates are required, national counterparts should be involved from the initiation of operations in order to strengthen national capacity and ensure long-term sustainability for the Programme. The NGDOs will be full partners in the operations of APOC. 6.4.3 Coordination of the Group's activities The NGDO Coordination Group will maintain its links with the Programme for the Prevention of Blindness and Deafness in WHO, Geneva, for liaison and coordination in close contact with APOC. Members of the NGDO Coordination Group will continue to provide support to the post of NGDO Coordinator in the Programme for the Prevention of Blindness and Deafness. The incumbent will continue to be involved in, and contribute to, sessions of APOC statutory bodies. 6.5 Responsibilities of the Governments of APOC countries and the National Onchocerciasis Task Forces (NOTFs) Ministries of Health have the ultimate responsibility for implementing national plans for onchocerciasis control and particularly sustainable CDTI projects. The MOH will create a favourable environment for all partners; provide funds for program activities; ensure the free entry of ivermectin without imposing duty, tax or other costs; and set up and chair the National Onchocerciasis Task Force. Ministries of Health of APOC countries that are implementing CDTI projects have set up National Onchocerciasis Task Forces. The NOTF is created and chaired by the MOH with representation from the NGDOs and other partners. The National Onchocerciasis Coordinator and his/her team act as the Secretariat for the NOTF. The composition of the NOTF should include all key partners/stakeholders of the Programme in order to strengthen the partnership to create a strong body that has a role of overseeing CDTI projects at the end of APOC. With the assistance of APOC, the NOTFs will develop data management systems that will allow for rapid provision of information on program accomplishments, program plans, ivermectin inventories, etc. The NOTF will be responsible for developing the national onchocerciasis control plans and proposals for sustainable CDTI projects which will be submitted to APOC for funding. In addition the NOTFs will: i Oversee the implementation of the CDTI projects and ensure the availability and timely delivery of ivermectin to the affected communities. ii Promote the link between CDTI and the peripheral health systems. The latter will ensure the first level supervision of CDTI activities. iii Review project proposals prior to submitting them to the TCC and the Management of APOC. iv Review financial and technical reports and other activities devolved by the TCC and the Management of APOC. JAF7.8 Page 22 v Coordinate with any other programmes that offer opportunities for mutual benefit (e.g. Lymphatic Filariasis Elimination Programme, Vision 2020, etc.). vi Coordinate operational research. vii Develop strategic plans for the future of partnership when APOC ends. viii Encourage other international and national NGDOs to become involved in onchocerciasis control 6.6 Communities The most important partners of APOC will remain the affected communities themselves. These communities will continue to be responsible for the execution of the ivermectin treatment and the sustainability of treatment will largely depend on them. In Phase II and the Phasing-out Period, APOC will optimize its effort to strengthen its current strategy to empower communities to take responsibility and decisions for ivermectin distribution, including providing support for community distributors. As a consequence, the community will be more involved in aspects of community health care. To promote the participation of community members, special attention will be given to develop strategies that specifically empower women and young people to become more actively involved in decision-making, and, where possible and appropriate, to become ivermectin distributors. Phase II and the Phasing-out Period will also place stronger emphasis on involving community based organizations, including women’s associations, religious groups, schools, and other civil society groups in planning, implementing and overseeing CDTI- related activities. 6.7 Mectizan Donation Program (MDP) In 1987, Merck committed to donate Mectizan (Ivermectin, MSD) for the treatment of onchocerciasis to all who need it for as long as necessary. In 1998 the donation was expanded to the treatment of lymphatic filariasis in the African countries where onchocerciasis and lymphatic filariasis are co-endemic. In order to facilitate the approval, donation and delivery of Mectizan, The Mectizan Expert Committee (MEC) and Mectizan Donation Program (MDP) were founded by Merck & Co. Inc. with the objective of managing the technical and administrative aspects of program implementation of the donation of Mectizan. The MDP and MEC are independent bodies of experts; the MDP oversees the donation program and the MEC is its advisory body. Applications for Mectizan are sent directly to the MDP-Atlanta and are reviewed by the MEC/MDP. On approval of applications, Merck & Co. Inc., arrange shipment of the drug provided there is assurance from the recipient country of exemption of all customs and duties. Merck & Co. Inc., ship through their appointed agent on a Duty Delivery Paid (DDP) basis, i.e. the shipper (Merck) covers all the costs of shipping and handling to the point of delivery of the Consignee. 6.8 Disbursement of funds : guiding principles As in Phase I, the following principles will guide the funding mechanism of APOC projects during Phase II and the Phasing-out Period: i WHO/APOC requests funding from the Trust Fund held in the World Bank and subsequently administers and disburses those funds to the NOTFs of participating countries or their NGDO partners ; JAF7.8 Page 23 ii Funds from the World Bank APOC Trust Fund will be channelled through WHO to the designated project bank account ; iii NOTFs will be expected to develop National Plans for onchocerciasis control and corresponding specific CDTI, and Headquarters support projects proposals for funding ; iv The executing parties of CDTI projects will be able to apply for up to 75% funding from the Programme. The NGDOs and the host governments (working together as the NOTF) will be responsible for 25% of CDTI project costs (in cash or kind) that will not be available from APOC. It is expected that the percentage of APOC funding will decrease over time as projects mature. Contributions from NGDOs toward 25% project cost contributions shall not include overhead costs of these organizations outside the country whose CDTI they are assisting; v For ongoing focal vector eradication projects, the executing parties will be able to apply for 100% funding; vi New proposals for CDTI projects will be reviewed by the TCC which will make recommendations for funding to the Management of APOC ; vii Funding can be requested for the first five years of a project (including projects started during Phase I). After five years, the project should be self-sustaining. After assessing the projects against strict sustainability criteria, additional funds (for a maximum of three years) may be made available if required to ensure the full integration of CDTI into the health services and to support related national capacity building. viii The funding of projects will be on an annual basis to a bank account exclusively earmarked to support the onchocerciasis control projects ; ix Continuation of funding will depend on the provision of satisfactory financial reports as well as detailed technical reports ; x The nature of the work to be performed, and details on the financial arrangements and obligations will be consigned in special contract called Letter of Agreement to be signed between WHO/APOC and the NOTF prior to any disbursement of funds. 6.9 Purchase of Equipment In line with the regulations of WHO, APOC will continue to retain a proportion of funds approved in the budgets submitted by the NOTFs for the purchase of Capital Equipment (e.g. vehicles, etc.). These funds will be utilized through WHO central purchasing system to buy the equipment. The NOTF will be responsible for swift clearance of the equipment as part of the contribution of the Government to the cost of the projects. Funds may be released to the WHO offices in the countries to purchase locally for the NOTFs some other equipment (computers, motorcycles, photocopiers, etc.). 6.10 External evaluations of APOC The External Mid-term Evaluation of Phase I (1996-2001) was completed in 2000. Further external evaluations of APOC will be undertaken in 2004, 2007 and 2010, at the end of the Programme. The evaluations will be supported financially by the donor community. Provided the JAF so agrees, the evaluations will be organized by the CSA. JAF7.8 Page 24 7. PLAN OF OPERATIONS FOR THE SECOND PHASE (2002-2007) AND FORECASTS FOR THE PHASING-OUT PERIOD (2008-2010) 7.1 Introduction The achievements and experience of APOC during Phase I, the findings and recommendations of the APOC Partners’ meeting and the Mid-term (Phase I) External Evaluation in 2000, the deliberations of the NOTFs, TCC and JAF, provide the basis for defining new Programme targets. The guiding principle in preparing the Plan of Operations has been to bring CDTI projects at the end of their APOC funding period to a state where they will continue their activities undiminished for as long as needed to achieve elimination of onchocerciasis as a problem of public health and socioeconomic importance It is anticipated that the implementation and fine-tuning of CDTI and its full integration into existing health systems will take five to eight years. TCC will examine each project and make recommendations on the required duration of funding according to strict sustainability criteria (maximum funding for a project will be eight years). Following the end of funding, there will be a period of some two years, during which the community- directed system will operate on its own without financial support from APOC for ivermectin distribution while, at the same time, it will be monitored closely. An intensified search will continue for a macrofilaricide which, if and when available, may alter the operational targets. 7.2 Programme targets Programme targets for Phase II and the Phasing-out Period have been defined as follows: i by the year 2003, 85 CDTI projects will have been launched in the endemic countries; ii by the year 2005, the programme will have established 60% treatment of the total population residing in the high-risk (hyper- and mesoendemic) zones. APOC financial support will have been withdrawn from at least 25 CDTI projects; larviciding operations for vector eradication will have ceased in the four foci concerned; substantial progress will be made toward integration of APOC projects into the primary health care activities, including the use of national drug procurement and delivery “Essential Drug” programmes; iii by the year 2007 (end of Phase II), about 45 million persons, representing approximately 65% of the estimated total population (70 million) in the project areas, will be receiving annual treatment through CDTI, while for 53 CDTI projects financial support from APOC will have ceased; APOC financial support will also have been withdrawn from all vector eradication projects; the post-APOC Plan of Operations for ivermectin delivery will have been completed; iv by the year 2010 (the end of the Phasing-out period), the Programme will have established full geographical coverage (i.e. CDTI established in all high risk communities); each of the 85 CDTI projects will have reached at least 65% treatment coverage of the total population in high risk communities; all APOC support will have ceased, and all residual support activities will have been integrated in the national health systems; it is the goal of the Programme that all community-directed systems will have satisfactory levels of sustainability indicators in place according to criteria to be defined by the Technical Consultative Committee. Table 1 indicates the estimated number of projects and population to be treated in Phase II and the Phasing-out Period and the progression of treatment implementation during the same periods is shown in Figure 5. JAF7.8 Page 25 Table 1 : Estimated number of Projects and population to be treated in Phase II and the Phasing- out Period Population to be treated Country Number of projects Total Population Eligible population 2007 target 2010 target 1 Angola 2 229,412 195,000 126,750 139,425 2 Burundi 2 329,412 280,000 182,000 200,200 3 Cameroon 14 4,317,647 3,670,000 2,936,000 3,376,400 4 Central African Republic 1 1,235,294 1,050,000 840,000 966,000 5 Chad 1 1,494,118 1,270,000 1,016,000 1,168,400 6 Congo Republic 1 705,882 600,000 480,000 552,000 7 D.R. Congo 9 21,082,353 17,920,000 12,364,800 13,440,000 8 Equatorial Guinea 2 282,353 240,000 192,000 220,800 9 Ethiopia 5 3,647,059 3,100,000 2,480,000 2,852,000 10 Gabon 1 10,582 8,995 6,878 7,937 11 Kenya 1 594 505 386 475 12 Liberia 3 2,776,471 2,360,000 1,888,000 2,171,200 13 Malawi 1 1,647,059 1,400,000 1,120,000 1,288,000 14 Mozambique 1 141,176 120,000 78,000 85,800 15 Nigeria 29 26,188,235 22,260,000 17,808,000 20,479,200 16 Rwanda 1 6,471 5,500 3,236 3,663 17 Uganda 7 1,800,000 1,530,000 1,224,000 1,407,600 18 U. R. Tanzania 10 1,541,176 1,310,000 1,048,000 1,205,200 19 Sudan 4 1,988,235 1,690,000 1,267,500 1,457,625 TOTAL 95 69,423,529 59,010,000 45,061,550 51,021,925 JAF7.8 Page 26 Figure 5: Progression of Annual Ivermectin treatments 7.3 Disease distribution : Rapid Epidemiological Mapping of onchocerciasis (REMO) Programme operations will conclude REMO activities in all participating countries by 2005 and develop capacity in spatial data analysis by use of the geographical information systems for monitoring and evaluation of projects. 7.4 Community Directed Ivermectin Treatment projects 7.4.1 Duration of the Projects As stated earlier, it is anticipated that the implementation and fine-tuning of CDTI and its full integration into existing health systems will take five to eight years. Funding can be requested for the first five years of a project with the aim of making the project self-sustaining after 5 years. Additional funds (for the maximum of three years) may be made available if required to ensure the full integration of CDTI into the health services and to support related national capacity building. After cessation of APOC support (eight years maximum) countries, communities and governments will continue the distribution without support from the APOC Trust Fund, to ensure the elimination of onchocerciasis as a disease of public health importance. Extensions of APOC financial support for projects beyond five years will be based on criteria established by TCC and case-by-case project considerations. 0 10,000,000 20,000,000 30,000,000 40,000,000 50,000,000 60,000,000 Pe rs o n s tr e a te d 19 95 19 96 19 97 19 98 19 99 20 00 20 01 20 02 20 03 20 10 20 04 20 05 20 06 20 07 20 08 20 09 65% of the total populationP re - A PO C Phasing outPhase IIPhase I JAF7.8 Page 27 7.4.2 Estimated number of projects and their implementation during Phase II and the Phasing-out Period and the number of people to be treated During Phase II and the Phasing-out Period, APOC will support 22 new CDTI projects, and continue support for 63 projects initiated in Phase I. A total of 85 CDTI projects will be successfully under the direction of the communities by the end of Phase II (2007). However, as mentioned above, a certain number of projects may still need financial support from APOC during the Phasing-out Period (2008-2010) to achieve satisfactory indices for sustainability. Figure 6 shows the number of CDTI projects supported by APOC by year during the course of Phase I, Phase II and the Phasing-out Period. Programme financial support to each CDTI project will decrease gradually to ensure that governments have developed the capacity in key programme activities like data management, monitoring, community-self-monitoring, integration of CDTI into the PHC and strengthening of peripheral health services to provide the necessary support to communities. Actual field work in ivermectin delivery will continue to be carried out by National Onchocerciasis Task Forces (NOTFs). These will include, planning drug procurement and timely delivery to collection points, mobilization and sensitisation of communities, training community directed distributors (CDDs), supervising the treatment, monitoring and evaluation of operations, reporting and treatment of SAEs, adherence to the timelines on sustainability, and establishment and maintenance of optimal coverage. To increase and strengthen community participation and ownership, programs will involve, whenever possible, community based organizations (CBOs) and national NGOs as partners. Experience from APOC Phase I Period has shown that to establish sustainable ivermectin treatment it is crucial to enhance political commitment, in particular, the long term support of health authorities in participating countries. There will be strong emphasis on securing long-lasting commitment of participating governments to the community directed strategy. To that effect, project self-sufficiency after five years will be determined at the beginning of Phase II for ten projects which will be completing their fifth year of APOC support by the end of 2002: Nigeria (4), Uganda – Phase I projects in four districts, Malawi (1) and Tanzania (1). These projects will be carefully evaluated as they will provide the first evidence on self-sufficiency after 5 years of APOC support, feasibility of integration into the health system and the likely sustainability of CDTI. In supporting ivermectin distribution, the spirit of partnership will prevail. NGDOs and local NGOs will provide technical, administrative support and continue to follow the guidelines of the Programme. Figure 6: Number of CDTI projects supported by APOC by year 0 10 20 30 40 50 60 70 80 90 20 07 20 08 20 09 20 02 20 03 20 04 20 05 20 06 19 97 19 98 19 99 20 00 20 01 19 96 20 10 Phase 1 Phase 2 85 73 80 60 46 37 24 10 5 6863 57 45 29 4 A PO C Su pp o rt ed Pr o jec ts Phasing out JAF7.8 Page 28 7.4.3 Severe adverse events (SAE) related to Loa loa Technical guidelines for CDTI in areas co-endemic for onchocerciasis and Loa-loa have been developed by TCC/MEC, and consist of rapid mapping of loasis, extended REA surveys to verify onchocerciasis endemicity, training, referral and treatment networks to assure the safest possible practices in ivermectin distribution and optimal management of SAEs. a) Mapping of loiasis Field activities to map Loa-loa distribution in the Participating Countries will be completed by 2004 with APOC support. APOC Management will liase with TDR/WHO and other experts to develop rapid mapping methodology and complete the mapping. b) Rapid Epidemiological Assessment (REA) in areas of co-endemicity of onchocerciasis and loiasis Rapid Epidemiological Assessment (REA) will be executed to provide additional data on the endemicity level of onchocerciasis where loiasis is coendemic. The aim for conducting REA studies is to assure that CDTI is only delivered to high risk communities (for onchocerciasis). c) Safest possible practices in ivermectin distribution in coendemic areas for loiasis, and optimal management of SAEs Where CDTI is established, an early warning system should be put in place for caring of potential encephalopathic cases. As mentioned above, the Technical Consultative Committee (TCC) and the Mectizan Expert Committee (MEC) have developed comprehensive technical guidelines for the planning and the implementation of the ivermectin treatment in areas where onchocerciasis and Loa-loa are co-endemic. The guidelines emphasize the importance of providing additional training for all health personnel and community- distributors on the timely recognition, management and follow-up of SAEs and other side effects, and of assuring that designated health facilities are ready and equipped to handle any cases. To empower communities with the information they need to feel more confident about recognizing and responding to potential side effects, APOC is also strengthening its Information, Education and Communication (IEC) component by developing improved IEC strategies and materials. 7.5 Treatment in hypo-endemic zones In hypo-endemic areas, persons diagnosed as having onchocerciasis will be treated in health centres. Treatment will remain the responsibility of the countries with technical guidance from APOC, when necessary. The role of the NOTF will be to facilitate the entry of ivermectin into the country and make it available to curative services, where and when necessary. Treatment records will be kept by health personnel and reported to the NOTF. 7.6 Vector Eradication Projects 7.6.1 Duration of the Projects The Programme objective includes, as a minor activity, focal vector eradication activities in selected and isolated areas where it is believed that two to three years of larviciding will accomplish long lasting impact. Such activities require monitoring for two to three years after the larviciding operations have been completed in order to evaluate entomological status. JAF7.8 Page 29 7.6.2 Estimated number of Projects to be implemented during Phase II Only those projects approved in Phase 1 will continue in Phase II of APOC. A meeting of entomologists and independent consultant experts is needed early in Phase II for the purpose of reviewing the progress toward the vector eradication objective of Phase 1 and deciding which projects should receive continued funding. The vector eradication schedule is shown in table 2. Table 2: Vector eradication projects and their implementation time line during Phase II (2002-2007) Uganda Equatorial Guinea Tanzania Itwara Focus Mpamba-Nkusi Bioko Vector Tukuyu 2002-2003 Support to entomological surveillance Ground larviciding Ground larviciding by national team; entomo- gical surveillance support to entomogical surveillance 2003-2004 Support to entomological surveillance and confirmation of eradication Ground larviciding Support to entomological surveillance support to entomological surveillance 2004-2005 Support to entomological surveillance support to entomological surveillance and confirmation of eradication support to entomolo- gical surveillance and confirmation of eradication 2005-2006 Support to entomolo- gical surveillance 2006-2007 Support to entomolo- gical surveillance and confirmation of eradication 7.7 Training/Capacity building In Phase II and the Phasing-out Period, APOC will focus on improving the quality and the impact of training at all levels. Training activities will focus on three main groups: i Community-Directed Distributors (CDDs); ii Trainers and supervisors of CDDs (health care personnel, CBOs, and NGDO staff members) iii NOTF members. CDDs will continue to receive training that enables them to treat all eligible individuals with ivermectin using appropriate dosages and exclusion criteria, record keeping and reporting, and management and referral of adverse reactions. In addition, CDDs will receive training to improve their skills in informing, educating and communicating about CDTI with other community members. To establish a reservoir of technical expertise in onchocerciasis control in each country, between 2002 and 2008 fellowships will be awarded to nationals of participating countries in management, organization and JAF7.8 Page 30 implementation of large-scale public health activities. The duration of each fellowship may not exceed 12 months and will usually be around 6 to 8 weeks. From 2002 to 2010, APOC will also support in-service technical training programme for nationals to build up a corps of expertise in management of integrated health services, monitoring and evaluation, health education, impact assessment, epidemiology and disciplines to improve their efficiency in distribution control strategy. 7.8 Advocacy and Information, Education and Communication (IEC) In Phase 2 and the Phasing-out Period of APOC, technical assistance will be provided to projects to develop better IEC and advocacy strategies, messages and materials through a participatory process. Special attention will be given to developing innovative materials that utilize traditional media and other communication channels that are appropriate to rural African societies (e.g. songs, theater, testimonials and interviews broadcast on radio, child-to-child activities, community entertainment- education festivals, etc.). Communication channels will utilize local languages. A special effort will be made to target women and youth, who often have less access to information and fewer opportunities to exchange ideas than men. IEC and Advocacy strategies will be evaluated through regular monitoring of a limited number of indicators to assess changes in knowledge, attitudes and behaviours related to treatment adherence, participation, and ownership of CDTI. 7.9 Biostatistics and Information Systems In Phase 2 and the Phasing-out Period, APOC will continue to improve collection of data (routine system and surveys) necessary for monitoring and evaluation of CDTI and Vector Eradication Projects). In this connection, the Programme will develop, as much as possible within national Management Information Systems of the Ministries of Health, a centralized (Programme Headquarters level) and decentralized level (Country National Secretariat level) system for storage, compilation and description of data. The Programme will continue to strengthen or develop capacity at country level for analysis and interpretation of information related to the Programme activities. Special attention will be given to feed back, sharing of information between the Partners, participating countries, donor community, Non-governmental organization for Development (NGDOs) and MDP/MEC. The Programme will set up Website with the existing WHO system for storing data on project implementation and performance. The Programme will support the National Onchocerciasis Task Forces to train and to develop capacity at district level in data analysis and to use that knowledge for operational planning. Feed back to communities on activities of the project will be done on a regular basis by district onchocerciasis teams. Data management activities in Phase II and the Phasing-out Period will assist the NOTFs to develop data management systems that can address issues related to sustainability of ivermectin delivery and use. Information systems will be developed that provide a basis for ordering and reporting tablets needed, treatment projections, security and logistics within national systems, wastage, expiration, destruction of expired tablets, etc. Districts, NOTFs and national pharmaceutical supply lines will be assisted by APOC to manage and report on ivermectin in a sustainable manner. 7.10 Research 7.10.1 Operational research Operational research will be a key activity area in Phase II and the Phasing-out Period of APOC, aimed fundamentally at identifying solutions to issues such as sustainability, maintaining high treatment coverage, JAF7.8 Page 31 identifying important characteristics of successful community distributors, integration of CDTI into health systems, and best ways to avoid or manage severe adverse neurological reactions in areas co-endemic for onchocerciasis and Loa loa. The following research agenda and other issues identified in the course of Phase 2 and the Phasing out period, will be executed in collaboration with WHO/TDR and others with close involvement of TCC. The research agenda will move in Phase 2 toward decentralization to support NOTF decision-making and local projects and researchers’ priorities. For Phase II and the Phasing-out Period of the Programme, operational research priorities will include research on: i Indicators of sustainability of CDTI and effective integration into national health care systems; ii Advocacy strategies and culturally appropriate IEC materials to prepare countries and health systems to support CDTI after APOC; iii Research on factors that influence treatment coverage and sustainability, including community incentives, cost-recovery/cost-sharing, CDD attrition, gender of CDDs, refusals and absenteeism; iv Integrated, multi-disease applications of CDTI; v Treatment strategies for areas in conflict; vi Loa loa: diagnostic tools and rapid assessment methods to identify highly endemic areas; risk factors for severe adverse reactions and strategies for their prevention and management; vii evaluation of the impact of CDTI on the parasite reservoir and prediction of the required duration of mass treatment; viii association of epilepsy and onchocerciasis and impact of ivermectin treatment. 7.10.2 Research on macrofilaricides and diagnostics The development of a macrofilaricide will be pursued during Phase II. It is planned to maintain support until 2007. Particular focus will be on the development of moxidectin. Multicenter phase II and III clinical studies for registration purposes will be conducted in collaboration with investigators in APOC and OCP countries. Research will also be undertaken on improved diagnostic tools for O. volvulus infection and to develop new diagnostic tools for early detection of resistance to Ivermectin. 7.11 Programme involvement in other health care and development activities During Phase I, it was clear that APOC’s CDTI was a major force in strengthening the primary health care system in underserved areas. Furthermore, field observations have shown that CDTI involvement in various other community health programmes, using Community-directed Distributors (CDDs) concerned with ivermectin treatment, was welcomed by these health programmes. It is intended to seize such opportunities to use the community-directed treatment (ComDT) approach as a vehicle for expanding health development efforts by adding to CDTI projects other large-scale control activities in areas with overlapping endemicity e.g. lymphatic filariasis elimination programmes. Other additions could be vitamin A distribution, schistosomiasis and malaria control. This integrated approach could be part of the methods of building a sustainable ivermectin distribution system. The feasibility, organization and modalities of this collaboration, which should not impair the effectiveness of onchocerciasis control, will be a subject for operational research. JAF7.8 Page 32 7.12 Monitoring and evaluation In Phase II and the Phasing-out Period, the Programme will continue to routinely assess project performance and to identify areas needing strengthening or improvement in either the quality or the impact of implementation. Practical and effective monitoring, evaluation, and decision making in management of CDTI at all levels, in a participatory environment, will be carried out through community self monitoring, NOTF monitoring, and external monitoring by independent scientists and managers. Phase I monitoring tools will be refined to enable routine monitoring of the Programme. The APOC HQs Data Collection Initiative will strive to meet the needs of all partners to routinely monitor and update their data bases related to monitoring and evaluation. 7.13 Impact assessment of APOC operations The long-term impact assessment studies of the Programme operations will be conducted through three cross- sectional studies. The initial studies, baseline data collection, were initiated in 1998 and completed in 2000. The second round of the studies has been scheduled in 2004 and the third in 2009. Thirteen evaluation sites will be covered in eight countries: Cameroon (2); Gabon (1); Nigeria (3); Uganda (1); Tanzania (1); Sudan (1); Central African Republic (2); Democratic Republic of Congo (2). 7.14 Management, administration and support services 7.14.1 Programme Headquarters a) Personnel The Plan of Action and Budget for 2001 has made provision for the APOC Programme Headquarters to operate with 23 staff members : i 10 Professionals ii 13 General staff members including those under Special Service Agreement (SSA). In Phase II of APOC , after the closure of OCP on the 31st December 2002, APOC will increase its staff taking into consideration the administrative tasks which are now provided mainly by OCP staff. These tasks are crucial for a smooth running of the Programme. 23 additional staff members will be needed to strengthen the administrative support to APOC. The breakdown of the 46 APOC staff members is as follows : iii 11 Professionals iv 35 General staff members including those under Special Service Agreement (SSA). It is planned to maintain this level of staffing up till the end of Phase II (2007). During the Phasing-out Period, with the significant reduction in the number of APOC funded projects in the countries, the number of staff operating at the HQs level will drop from 100% in 2007 (46 staff members) to about 13%, 11% and 9% in 2008, 2009 and 2010 respectively. b) Administrative support services, logistics and infrastructure Allocation will be made for the maintenance of the buildings at the APOC Headquarters as well as the general running costs of the offices. Additional office equipment (including computers) will be purchased. For the need of transportation to be provided for its own services and for the participants to the meetings organized at the Headquarters level, a limited number of vehicles will be made available to the Programme. One JAF7.8 Page 33 or two vehicles may be purchased during the Phase II in addition to those that may be allocated to the Programme by OCP after its closure. 7.14.2 Support from WHO/HQs, WHO/AFRO and the NGDO coordinator’s Office a) Support from WHO/HQs at Geneva The Management of APOC will continue to benefit from the current OCP liaison office located in WHO/HQs – Geneva. From 2003 after the closure of OCP, APOC will maintain the office and will cover its costs. The mission of the liaison office is to ensure the collaboration between the APOC Management and WHO/Geneva [operational, administrative and finance services as well as the department of Control, Prevention and Eradication (CPE)], and to ensure the link and coordination between the Programme and the Office of the Coordinator of the NGDO group for ivermectin distribution. b) Support from WHO/AFRO As in Phase 1, APOC will maintain close collaboration and administrative links with the WHO Representative offices in the participating countries. In Phase II and the Phasing-out Period, the WHO Representative offices will continue to assist the NOTFs in the implementation and the monitoring of the projects in the countries and provide any assistance needed for good management of funds transferred to the NOTFs for the projects. c) Support from the NGDO Coordinator’s office The NGDO Coordinator’s office will continue to be the link between the Programme and the NGDO group which has been a major partner in the APOC program from the beginning. As in the past six year period, the NGDO group will continue to support the APOC Programme technically and financially. 7.15 Consultants’ services Budgetary allowance will be made for the employment of consultants whenever necessary. The consultants will be recruited to provide support to the Headquarters office as well as to countries in the development, monitoring, financial management and administrative management of CDTI and vector elimination projects. About 70 man/month of consultancy will be needed for the period 2002-2010. 7.16 Operational Travel APOC staff and the NGDO coordinator will regularly visit the participating countries to provide technical support and advocacy during Phase II and the Phasing-out Period. 7.17 Statutory meetings The statutory meetings will be composed of regular twice yearly sessions of the TCC (two sessions) while it is anticipated to reduce the CSA sessions to two to three per year. The Joint Action Forum will continue to meet annually unless it decides to reduce the frequency of its meetings. 7.18 External Evaluation There will be three external evaluations, one by the Year 2004, another in 2007 and the last at the end of the Programme in 2010. Table 3 shows the time line of the main activities of APOC during Phase II and the Phasing-out Period. JAF7.8 Page 34 Table3: Timeline of APOC main activities in Phase II and the Phasing-out Period 8. BUDGETARY FORECASTS FOR PHASE II (2002-2007) AND THE PHASING-OUT PERIOD (2008-2010) FOR DONORS’ CONTRIBUTIONS 8.1 Budget breakdown and justification The Plan of Operations as presented above, constitutes the basis for the budgetary forecasts for Phase II and the Phasing-out Period with regard to donors’ contributions. The amount needed from the Donors for Phase II (2002-2007) is estimated to about US$ 68 million. To achieve satisfactory indices for sustainability for a certain number of CDTI projects, an amount of US$ 11 million will be required for a three year Phasing-out Period (2008-2010). The total amount needed in donor contributions for Phase II and the Phasing-out Period is therefore estimated at approximately US$ 79 million. The following budget breakdown concerns this total amount of US$ 79 million, covering both Phase II and the Phasing-out Period. 8.1.1 National Onchocerciasis Projects: Subtotal: US$ 43,301,429 As already detailed in the Plan of Operations (Table 1), 95 national projects will be funded throughout the period. The breakdown as well as the costs are as follow: - 85 National CDTI Projects each budgeted for 8 years for a total cost of US$ 38,131,429 - 4 National Vector Eradication projects for a total cost of US$ 2,750,000 - 6 National Secretariat Support projects for a total cost of US$ 2,420,000 The total amount budgeted under this line item represents 55% of the total budget (US$ 79 million) for the phase II and the Phasing-out Period of APOC. Activity 2002 2002 2003 2004 2005 2006 2007 2008 2009 2010 CDTI preparation , implementation, monitoring & Integration Larviciding for vector eradication Entomological surveillance Research REMO/REA & GIS Loasis Mapping Impact Assessment External Evaluation JAF7.8 Page 35 8.1.2 Operational Research: Subtotal: US$ 2,845,000 As recommended by the External Reviewers and stated in the Plan of Operations, substantial operational research is needed to strengthen the scientific basis of the APOC and to adequately address the Challenges raised during the implementation of the CDTI projects. Most of the operational research will be conducted by the countries in collaboration with TDR and various research Institutions in the countries. An amount of US$ 2.85 million representing 4% of the total costs for Phase II and the Phasing- out Period is budgeted for these important research activities. To this amount, it should be added an average of US$ 200,000 per year, budgeted under the national CDTI projects cost which will be used by the NOTFs themselves to undertake operations research directly related to the implementation of the CDTI. 8.1.3 Monitoring, Impact Assessment, REMO and REA: Subtotal: US$ 2,575,000 APOC will continue the support of monitoring per year, 10 to 14 CDTI projects of ivermectin distribution projects. Two additional rounds of impact assessment studies will be also conducted during Phase II and the Phasing-out Period of APOC. Furthermore, an amount of US$ 375,000 has been budgeted for the completion of the REMO and the REA exercises in the countries, and for the integration of these REMO and REA data into the Geographical Information System (GIS). For the above activities (Monitoring, Impact assessment, REMO and REA), US$ 2.575 million (3% of the total budget) have been budgeted. 8.1.4 Training/IEC/Advocacy: Subtotal: US$ 2,700,000 Training, IEC and Advocacy are critical to the success of APOC and to its sustainability as highlighted above. The external evaluation team has recommended that these activities should be intensified during Phase II to ensure that each country has a reservoir of the technical expertise that onchocerciasis control needs at senior management level; that more appropriate IEC messages are prepared and disseminated at all levels in the countries. A total amount of US$ 2.7 million have been budgeted for these activities. This represents 3% of the total expenditures. 8.1.5 Personnel Services: Subtotal: US$ 14,005,000 As already mentioned, the number of staff members currently foreseen for 2001 will be maintained in 2002 but should be increased to 46 from 2003 after the closure of OCP. As stated in the plan of operations, the Personnel costs shall significantly decrease during the Phasing-out Period (Figure 9). The total cost of the Personnel services during Phase II and the Phasing-out Period will reach US$ 14,005,000. This amount represents 15% of the total amount budgeted. 8.1.6 Administrative Support-Operating cost-Equipment-Supplies: Subtotal: US$ 4,310,000 As already highlighted in the plan of operations, this budget line item covers the cost of the support to the Programme from the liaison office, the Headquarters Administration units and the NGDOs coordination office in Geneva, as well as the cost of the administrative and technical support provided by the WHO offices in APOC countries; the costs of the maintenance of office buildings and Programme vehicles, office supplies, data processing equipment and two new vehicles, all at the Programme Headquarters. For these expenses, an amount of US$ 4,310,000 representing 5% of the total budget is foreseen for the Phase II and the Phasing-out Period of the Programme. JAF7.8 Page 36 8.1.7 Consultancy: Subtotal: US$ 4,400,000 The above mentioned amount of US$ 4,400,000 covers about 70 man/month of consultancy which represents 5.5% of the total Phase II and the Phasing out period costs. As in the past, APOC will continue counting on the expertise provided by the Consultants to assist the Programme at the Headquarters level as well as in the field. 8.1.8 Operational Travel: Subtotal: US$ 1,300,000 For advocacy, training of trainers, management of the funds and evaluations, APOC personnel as well as the NGDO Coordinator will have to make several visits to the countries where the projects are being implemented. An amount of US$ 1.3 millions has been budgeted for these visits. 8.1.9 Statutory meetings: Subtotal: US$ 1,400,000 For the organization of the two regular sessions of the TCC, as well as two to three sessions of the CSA and the JAF meeting, an amount of US$ 150,000 has been budgeted for each year to cover the human resource costs (travel and per diem) as well as the cost for the production of related documents. 8.1.10 Macrofil Project: Subtotal: US$ 4,070,000 APOC contribution to the Macrofil Project will be US$ 570,000 in 2002, OCP and TDR contributing for the same amount each. From 2003 to 2007, after the closure of OCP, it is anticipated that APOC will contribute each year, US$ 700,000. The total contribution of APOC will therefore be US$ 4,070,000 representing 5% of the total budget. 8.2 Summary annual budgets per category of expenditures On the basis of the detail provided above concerning the expenditures planned for the Programme during Phase II and the Phasing-out Period, table 4 and figures 7 illustrate the annual budgets per category of expenditures. JAF7.8 Page 37 Table 4: Summary annual budgets* per category of expenditures for APOC Phase II and the Phasing-out Period (US$ x 1000) *=budget related to donors contributions only Phase 2 Phasing-out Period Budget line items 2002 2003 2004 2005 2006 2007 Total Phase 2 2008 2009 2010 Total Phasing out Grand total Ivermectin distribution Projects 9,183 8,229 7,078 5,719 3,964 2,724 36,897 2,041 1,245 368 3,654 40,551 Vector elimination Projects 860 740 560 430 80 80 2,750 0 0 0 0 2,750 Operational research 375 350 350 350 320 300 2,045 250 250 300 800 2,845 Monitg + Impact assesst, + REMO & REA 375 220 700 170 110 100 1,675 150 600 150 900 2,575 Training + IEC + Advocacy 550 400 350 350 300 250 2,200 250 150 100 500 2,700 Personnel Services 1,245 1,595 1,595 1,595 1,595 1,595 9,220 1,235 1,000 800 3,035 12,255 Operating costs, Adminis. support and Equipment 430 580 580 580 580 580 3,330 430 300 250 980 4,310 Consultants 300 750 650 650 600 500 3,450 350 300 300 950 4,400 Operational travel 200 200 200 150 150 100 1,000 100 100 100 300 1,300 Statutory meetings 200 150 150 150 150 150 950 150 150 150 450 1,400 Macrofil projects 570 700 700 700 700 700 4,070 0 0 0 0 4,070 TOTAL 14,288 13,914 12,913 10,844 8,549 7,079 67,587 4,956 4,095 2,518 11,569 79,156 JAF7.8 Page 38 Figures 7 : Budgets per category of expenditures (7 a): Phase II (2002-2007) (7 b): Phasing-out Period (2008-2010) (7 c): Total (2002 - 2010) 55% (1) 4% (2) (3) 3% (4) 3% (5) 15% (6) 5% (7) 6% (8) 2% (9) 2% 5% (10) LEGEND 1 = National Projects (CDTI + Vector Elimination) 2 = Operational Research 3 = Monitoring, Impact Assessment, REMO and REA 4 = Train., IEC, Advocacy 5 = Personnel Services 6 = Operating cost, Admin support and Equipmt. 7 = Consultants 8 = Operational Travels 9 = Statutory meetings 10 = Macrofil Project 32% (1) 4% (9) 7% (2) 8% (3) 4% (4) (5) 26% (6) 8% (7) 8% (8) 3% (2) 3% 59% (1) (6) 5% (5) 14% 6% (10) (3) 2% (4) 3% (7) 6% (8) 1% (9) 1% JAF7.8 Page 39 8.3 Evolution of APOC Budgets estimates from 1996 to 2010 and of Personnel services costs in Phase II and the Phasing-out Period Figures 8 and 9 show respectively the evolution of the budgets estimates of APOC from 1996 to 2010 and the trend of Personnel services costs during Phase II and the Phasing-out Period. Figure 8 : Evolution of APOC budgets estimates from 1996 to 2010 Figure 9 : Evolution of APOC Personnel services cost during Phase II (2002-2007) and Phasing-out Period (2008-2010) 0 2'000 4'000 6'000 8'000 10'000 12'000 14'000 16'000 18'000 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 U S $ x 10 00 Phase I Phase II Phasing out period 0.5 0.7 0.9 1.1 1.3 1.5 1.7 2002 2003 2004 2005 2006 2007 2008 2009 2010 US$ Millions Phasing Out Period JAF7.8 Page 40 9. RISKS AND SAFEGUARDS 9.1 Decline in commitment to CDTI Although onchocerciasis control through the CDTI approach is now recognized in the participating countries as the preferred method of eliminating the disease as a public health problem, a relaxation in the commitment and support to its control cannot be excluded, in particular given that CDTI may need to be continued regularly for up to 20 years after the cessation of APOC support. Early integration of CDTI activities in the national health systems, as promoted and supported by the Programme, will, by itself, to a large extent counteract any possible deterioration of the regularity of treatment. It will, however, be necessary for the national health authorities to institute long-term monitoring of the CDTI process - in conjunction with monitoring of the implementation of other health development programmes – and to institute corrective action whenever needed, including enhanced advocacy as a means to enhance motivation at the various levels of support to, and implementation of, community-directed ivermectin treatment. 9.2 Civil unrest During Phase I of the Programme, civil unrest periodically disrupted ivermectin distribution in a few projects and delayed the establishment of CDTI projects in a number of areas. Special arrangements and efforts were able to overcome such difficulties with good results. APOC has demonstrated that Programme success can be achieved even in areas of civil unrest. 9.3 Resistance to ivermectin As in any program that relies on the extensive and prolonged use of a single pharmacological agent, the emergence of ivermectin resistance must be considered as a possibility. Currently there is no scientific basis (experimental or field induced) to claim that ivermectin resistance in Onchocerca volvulus exists. But APOC does, and will continue to, support the development of an ivermectin resistance detection tool and, when available, will ensure its systematic application. The search for a macrofilaricide and alternative microfilaricide(s) will continue to be encouraged and supported by the Programme. 9.4 Shortage of financial resources In the event of insufficient resources, all APOC partners will take responsibility to secure resources to meet Programme goals. Further, all APOC partners will ensure that operations be continued keeping in mind the need for strict and efficient use of available resources. 10. POST-APOC INTER-COUNTRY COLLABORATION There will be a continued need for intercountry collaboration in the field of onchocerciasis control after the closure of APOC. The annual sessions of the WHO Regional Committee for Africa provides an opportunity for the representatives of "former" APOC and OCP countries (in addition to Sudan) to meet. This would allow for a continued exchange of the CDTI experience and the organization of any other activity that may require intercountry collaboration. Since the setting for the meetings is the consideration of overall health development in the Region, onchocerciasis control would be considered in a multi-disease control context by the WHO Regional Office for Africa (AFRO). During the post-APOC period, this support to intercountry collaboration will be maintained and strengthened by WHO/AFRO, with assistance from all other interested health development partners of WHO and the countries. JAF7.8 Page 41 At the operational level, intercountry collaboration is facilitated by meetings of representatives of National Onchocerciasis Task Forces and of “former” APOC Partners. These meetings provide the opportunity to work together, to share experiences, to identify operational problems, and seek solutions to them. The wide distribution of monitoring and evaluation reports facilitates a common understanding and collaboration among Participating Countries. 28.10.01 JAF7.8 Page 42 ANNEX 1 Results of Rapid Epidemiological Mapping Of Onchocerciasis (REMO): CDTI areas in APOC Countries as at December 2000 Legend Zones outside APOC/Zones non APOC Definites CDTI/Zones prioritaires CDTI likely/TIDC probable No CDTI areas/ non TIDC Excluded Zones/exclues (desert, parks...) No REMO yet/ REMO non encore réalisé Lakes/lacs KM 10005000 SUDAN Ethiopia Kenya Chad Cameroon Nigeria Gabon Congo D.R. Congo Angola Malawi Mozambique CAR Uganda Tanzania Liberia Eq. Guinea Rwanda Burundi This document was created with Win2PDF available at http://www.daneprairie.com. The unregistered version of Win2PDF is for evaluation or non-commercial use only.