ANNEX 3 CCM-Thailand Round 9 malaria proposal to the GFATM Snapshot information to interested partners Draft October 1 st, 2008 I. Context Huge strides have been made in the last 10 years to reduce the burden of one of the major killer diseases in the world. Progress has been possible through a combination of political will, availability of funding and provision of new effective tools for prevention and treatment far more widely than before. For treatment, the key tool is artemisinin-based drugs. These are highly effective compared to other drugs for treating both uncomplicated malaria and life-threatening disease as well as reducing gametocyte carriage rate which may contribute to reducing transmission. Together with large-scale use of treated mosquito nets they are contributing to substantial impact on malaria morbidity and mortality. Their use only in combination as artemisinin-based combination therapy (ACT) has been widely accepted as essential to limit the probability of resistant mutations spreading, but there have been challenges to implement this strategy. There is increasing evidence that artemisinin tolerant malaria parasites are present on the Thai- Cambodian border. The spread of artemisinin resistance, if confirmed, through Asia to Africa, where most of the world s burden of malaria remains, would set back global efforts to control malaria. The implications would be extremely serious. The current situation is a global emergency and we must act now to stop further spread, but the response to date has not been as vigorous as the threat demands. Figures 1a and 1b summarize the data from therapeutic efficacy studies in Cambodia and Thailand on prolonged parasite clearance times, which have been used to define target areas for immediate containment:
Figure 1a: Proportion of positive cases in Cambodia at day 3 following artesunate (ASU) 12mg/kg over 3 days + mefloquine (M) 25 mg/kg over 2 days (Source: WHO) Proportion of positive cases on day 3 (2001-2007) Figure 1b: Proportion of positive cases at Day 3 in Thailand following ASU 12mg/kg over 2 days and M25mg/kg over 2 days (green bars) (Source: Bureau of Vectorborne Disease, MoPH Thailand) แผนภพท 1 25 20 15 10 5 0 Tak 1997 2003 2004 2005 2006-25 20 15 10 5 0 Trat: 19971998 2002 2003 20042005 2006 2007 World Health Organization 2
It may be possible to prevent the spreading of artemisinin tolerant parasites by rapidly eliminating malaria in the malaria endemic area of Western Cambodia and Eastern Thailand. This has never been done before, and will require extraordinary effort and an unprecedented level of coordination among donors, international agencies, control programs, NGOs, academics and others. II. Rationale to submit Round 9 malaria proposal to the GFATM Recent exceptional progress in controlling malaria is raising hopes globally that this major burden on a large proportion of the poorest people in the world really can be beaten. This has been achieved through serious investment of effort and funds in ensuring wide-scale access to effective interventions. The shift over the last few years away from failing drugs to the highly effective artemisinin-based combination therapies (ACTs) has been a breakthrough, and it was hoped that their design as combinations of two efficacious drugs with different modes of action would preserve them for many years of use. However, recent evidence from the BMGF funded Artemisinin Resistance Confirmation, Characterization and Containment (ARC3) programme and other studies indicates that artemisinin tolerant Plasmodium falciparum parasites are present on the Thai-Cambodian border. The spread of artemisinin resistance, if confirmed, through Asia to Africa would be a catastrophic setback to global efforts to control malaria, as there are not yet any equally effective alternative drugs. It is therefore essential to mount a vigorous response to stop further spread from areas where artemisinin tolerance has been identified, whilst simultaneously undertaking further research to define the nature and geographical extent of the problem. The Thai CCM is already scaling up malaria control interventions countrywide thanks to Government (MOPH) and partners effort and thanks to additional funds provided by the GFR7. These interventions are routine interventions expected to take place in all endemic villages till 2013 and do not include containment or elimination measures to address artemisinin tolerant parasites growing in importance on the Cambodia-Thailand border. R9 is expected to complement existing interventions by scaling up specific containment / elimination measures in the 7 provinces bordering Cambodia (see map further), The MOPH Cambodia (CNM) is also working on a R9 proposal talking the same issue in 10 Cambodian provinces bordering Thailand 9see map further). WHO is coordinating the development of the 2 country proposals to be submitted to the GFATM. Since there is a need to act quickly in a context where GFR9 funds will be available only by the end of 2010, WHO has encouraged the 2 countries to submit joint proposal to alternative donors like the BMGF which could make funds available to start operations early 2009. GFR9 is expected to expand from January 2011 onwards the BMGF-supported project and build on successful containment interventions / lessons learnt from that project. In 2008, a carefully 2-year conceived plan has been developed through collaboration of the two countries and a wide range of committed experts and partners led by the World Health Organization (WHO). The approach combines intensifying interventions (see further) known to be effective with innovative additional initiatives, which will be thoroughly evaluated in order to lose no opportunity to overcome this setback. The lessons learnt from this effort will be fully documented and highly relevant to the development of approaches to eliminate malaria. III. Proposed Project goal, objectives and critical milestones The goal of GF R9 is to contain artemisinin-tolerant Plasmodium falciparum (Pf) parasites by removing selection pressure and reducing and ultimately eliminating falciparum malaria. The objectives are: 1: To eliminate artemisinin tolerant parasites by detecting all malaria cases in target areas and ensuring effective treatment and gametocyte clearance 2: To decrease drug pressure for selection of artemisinin tolerant malaria parasites 3: To prevent transmission of artemisinin tolerant malaria parasites by mosquito control and personal protection World Health Organization 3
4: To limit the spread of artemisinin tolerant malaria parasites by mobile/migrant populations 5: To support containment/elimination of artemisinin tolerant parasites through comprehensive behavior change communication (BCC), community mobilization and advocacy 6: To undertake basic and operational research to fill knowledge gaps and ensure that strategies applied are evidence-based 7: To provide effective management, surveillance and coordination to enable rapid and high quality implementation of the strategy Through these objectives it is anticipated that by the end of the project the percentage of parasite positive cases on day 3 amongst Pf-infected patients treated with ACT by direct-observed treatment (DOT) will decrease from a baseline of about 5-10% to 0% by 2015 and malaria will continue to decline from current very low rates towards elimination in 2015 (reaching pre-elimination targets by 2010). World Health Organization 4
IV. Expected contributions from interested partners in that project. The R9 proposal through CCM is a collaborative effort of agencies with the range of key skills and capacity to mount the necessary response in Thailand bearing in mind that parallel efforts are made in Cambodia requesting strong coordination at national and international level led by the World Health Organization, national task forces and partners. Containment efforts will primarily focus on 7 provinces in Thailand bordering Cambodia. Interested partners are invited to contribute to address challenges and achievement of one or more containment objectives listed above according to their recognized skills / performance in various domains including M&E, operational research or cross country operations. V. DRAFT Project Framework for partners to plug in A. Project Framework Table Project Overview Indicators of Success Monitoring & Evaluation Assumptions Strategic Area: Malaria Investments in malaria control globally will be protected by avoiding loss of one of the most important tools Lessons learnt on surveillance strengthening will accelerate progress towards malaria elimination Global malaria control progress Regional surveillance for artemisinin tolerance, initiated in this proposal, will be continued The recent global malaria elimination initiative will be able to continue, unthwarted by artemisinin tolerance Project Goal: To contain artemisinintolerant Plasmodium falciparum parasites by removing selection pressure and reducing and ultimately eliminating falciparum malaria. Objective 1: To eliminate artemisinin tolerant parasites by detecting all 1. Artemisinin efficacy levels in Cambodia and Thailand revert to the high levels prior to of tolerance: % parasite positive patients on day 3 amongst Pf infected patients treated with ACT by DOT decreased from baseline of around 10% to 0% by 2015 2. Malaria incidence and prevalence rates continue to decline from current low rates towards elimination in 2015 1.1 100% of malaria treatments by public, community and recognized private providers are based on parasite-based diagnosis 1.2 100% symptomatic Pf cases effectively Annual global malaria drug efficacy ; regional artemisinin tolerance surveillance data Drug efficacy data from routine sentinel sites; routine case follow-up in all malaria endemic areas; active investigation of day3 positive patients at community level to identify transmission foci Incidence data from strengthened surveillance system; prevalence data from mass screening and other population surveys; seroprevalence surveys Health facility, drug outlet and household surveys Surveillance (weekly Artemisinin tolerant parasites are not widespread beyond project target area Even if there is a low frequency of tolerant parasites outside, the intense efforts proposed will be sufficient to delay significantly the spread of tolerant parasites Patients with artemisinin tolerant parasites have contact with official services World Health Organization 5
malaria cases in target areas and ensuring effective treatment and gametocyte clearance Objective 2: To decrease drug pressure for selection of artemisinin tolerant malaria parasites Objective 3: To prevent transmission of artemisinin tolerant malaria parasites by mosquito control and personal protection Objective 4: To limit the spread of artemisinin tolerant malaria parasites by mobile/migrant populations treated according to containment protocol in public and private sector by end 2011 and beyond 1.3 100% of target population (including mobile population see further- have easy access to diagnosis and treatment 1.4 100% of parasite positive are followed up by active investigation at home village level. 2.1 All uncomplicated Pf malaria are treated by atovaquone-proguanil plus primaquine in the containment zone 2.2 Drug inspections are regularly carried out and regulatory action is taken and disseminated through appropriate channels to province and district authorities and across the border 2.3 % of fake or substandard ACTs is towards zero countrywide by 2015. 3.1. 100% coverage of resident population by ITNs in all endemic villages in Thailand at the rate of 1 person per net by 2015 4.1 Situational analysis of migrants completed 4.2 Number of long-lasting insecticidal hammock nets (LLIHN)/LLINs distributed to population for overnight stays in the forest increased to reach 100% in 2015 4.3 At least 80% of people who stayed in the forest during the previous night used an ITN for personal protection 4.4 Number of contact points established (based on initial situation analysis) to provide malaria diagnosis, treatment, prevention and messages to mobile/migrant populations 4.5 Number of organizations working in forested areas along the border which are engaged in malaria control activities targeting mobile/migrant populations. in Zone1, monthly in Zone 2) and programme monitoring Routine supervision Health facility, drug outlet/availability (private facilities /vendors and public sector) and household surveys Exit interviews and mystery client studies Drug inspection Household surveys of LLIN and LLIHN coverage, retention and use with linked seroprevalence and parasitological surveys VHV monthly (including coverage and usage) Situation analysis report Monthly from community workers/volunteers Monthly from peripheral public health facilities, provincial and project Survey Human resources can be rapidly mobilized and trained to effectively implement activities Companion drugs to artemisinin derivatives are protecting against survival of tolerant mutations No bottlenecks in the supply chain (public and private) for goodquality ACTs New treatment products can be procured (availability, manufacturer consent) Insecticide treated materials contribute significantly to reducing transmission in Southeast Asia No LLIN shortage Significant populations are not missed Political circumstances allow development of cross-border activities and the work with unrecorded migrants World Health Organization 6
Objective 5: To support containment/elimin ation of artemisinin tolerant parasites through comprehensive behavior change communication (BCC), community mobilization and advocacy Objective 6: To undertake basic, operational research to fill knowledge gaps and ensure that strategies applied are evidencebased 5.1 Proportion of household respondents aware of key messages on new treatment policy and use of ITN reaching >90% by 2012 5.2 Percentage of cross-border mobile /migrant populations aware of key messages at least 50% by 2011, 80% by 2015 5.3 Number of private companies where malaria corners are running is increasing by xx% per year 5.4 Behaviour of mobile/migrant populations changes in terms of seeking malaria diagnosis and treatment and prevention/personal protection by end 2015 5.5 Number of provincial and district government meetings held for advocacy and progress of containment operations 5.6 Number of media promoting containment operations and advocacy, locally and internationally. Operational research: (examples) 6.1 Extent of artemisinin tolerance is defined/mapped, using a simplified in vivo protocol for cases from public health facilities 6.2 Effectiveness and acceptability studies of LLINs and LLIHNs completed including mobile population and interim results available 6.3 Insecticide resistance 6.4 Screening of migrant workers in private companies 6.5 Key issues where further evidence is needed to adapt and refine strategies are identified, priority research agenda agreed and research initiated 6.6. active surveillance system including cross border mapping / exchange and analysis of data Household surveys, exit surveys, mystery clients, qualitative methods Survey among persons crossing Cambodia-Thailand border Monthly from mobile workers and volunteers Qualitative research Baseline data and final project evaluation Advocacy meeting Media monitoring Research protocols, and papers External clinical trial monitors Meeting including indication of how research results feed into strategy development and year 2 workplan District surveillance/ mapping (consolidated 3 monthly provincial ) Report of Research Steering Committee Change in knowledge will lead to a change in behavior Involved governments facilitate this research Full access of project and related staff to the research sites Continued willingness of partners to cooperate Objective 7: To provide effective management and coordination to enable rapid and high quality implementation of the strategy 7.1 Functional harmonized cross-border surveillance systems in Cambodia and Thailand produce regular monthly data (based on weekly case reporting from communities and peripheral facilities 7.2 All operational levels are fully staffed for the containment project, according to HR plan 7.3 All peripheral staff (health facility and community level) are fully trained according to plan 7.4 Proportion of community level staff (village health volunteers/ village malaria workers/ malaria clinics / malaria posts) are aware of key training messages and Health management information system Surveys Project Quarterly stock VHV/VMW surveys at monthly meetings and supervision Continued support of the national governments at all levels to the Project Political situation allows crossborder collaboration World Health Organization 7
Project Management perform according to TOR: 100% by 2012 7.5 100% of diagnosis and new treatment available at health facility level 7.6 National, provincial and district management teams submit timely progress (monthly from all levels, national consolidation to project management three-monthly) 7.7 National Task Force meetings organized according to national plans. 1. All Project staff recruited and project structures established 2. All sub grants signed 3. Project launching meeting organized 4 technical meetings organized 5 International Containment Task Force meetings organized 6. Project evaluation report 7. Project film documentary Sub grantee quarterly Meeting Consultant Project evaluation report Project documentary film available Continued willingness of partners to cooperate Political situation allows collaboration between the 2 countries Full access of project and related staff to the project sites Activities: Objective 1: Intensify malaria case detection and effective parasite-based case management (including radical cure with single dose primaquine for pf infections) through increasing access to free-of-charge early diagnosis and appropriate treatment at health facility and community levels (Village Malaria Workers in Cambodia, malaria posts and clinics in Thailand) strengthening staff capacities and quality of case management; conduct active case detection and investigate and follow up malaria index cases. Objective 2: Change 1 st line treatment for uncomplicated malaria from co-blistered A+M to co-formulated DHA/PIP in Cambodia and to atovaquone-proguanil in Thailand. Update existing guidelines accordingly and train health staff. Objective 3: Ensure 100% coverage of resident population with long-lasting insecticidal nets (LLIN) in all endemic villages in Thailand a the rate of one person per LLIN; retreat all existing mosquito nets (~50% of population currently sleep under a net in endemic villages) ; undertake focal indoor residual spraying (IRS) for transmission control targeting active foci; undertake health promotion and community mobilization to ensure high turnout of ITN campaign and appropriate net use. Objective 4: Undertake situation analysis and design of targeted interventions for mobile and migrant populations; distribute long-lasting insecticidal hammock nets (LLIHN) to populations staying overnight in the forest (estimated at 5% of the resident population); promote use of repellents for personal protection and provide them in Thailand; enhance malaria control activities along and across the borders. Objective 5: Support containment through Behavior Change Communication, health promotion and community mobilization; harmonize and coordinate BCC for cross border populations; deliver communitybased prevention measures; implement sensitization and advocacy for political support. Objective 6: Undertake operational research to map the extent of the spread of artemisinin tolerance, ensure learning while doing and evaluate new interventions, especially the feasibility and effectiveness of Mass Screening operations when planned, Objective 7: Strengthen national health systems needed to deliver the response: implement spatial malaria case management system (mapping and surveillance) preferably with a cross-border component; strengthen overall and technical coordination and build capacity at all levels including performance-based salary support/incentives; actively promote inter-sectoral cooperation and support; provide logistics World Health Organization 8
support; collect, analyse and use information (including surveys) for intense monitoring and evaluation; organize necessary support for active participation of local authorities; ensure cross-border coordination and communication. Project Management: Establish project management structure; recruit project staff and provide short term technical assistance; make project sub grants and closely coordinate with sub grantees and subcontract holders; organize project, technical and International Task Force meetings; conduct project monitoring, regular reporting and evaluation; develop and implement project communications plan (incl. film documentary). B. Targeted proposal areas / provinces The map below shows the districts and provinces targeted for containment operations in Cambodia and Thailand. C. Major Assumptions It is believed that artemisinin tolerant parasites may exist outside of the proposed containment area, and the proposed approach is pragmatic aiming to start as quickly as possible in areas of known occurrence where operations are feasible. In the future additional interventions might be needed to intensify malaria control on the Thai-Myanmar border and in neighboring Myanmar, where data on tolerance have recently been reported, though showing less consistent prolonged parasite clearance time, and the potential for amplification and transfer are high. The activities undertaken in the current R9 proposal will benefit from BMGF-supported activities experience for tackling foci of tolerance with optimal speed and efficiency, if they are detected elsewhere, so careful documentation and rigorous assessment of strategies deployed here are a strong element of the proposal. VI. Organizational Capacity and Management Capability Interested partners are invited to submit a short concept note (3-5 pages) note highlighting their areas of interventions and expected budget. A section should express experiences, skills, advantages and any other values added from their contribution to containment proposal achievements. World Health Organization 9