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Aziza Mwisongo INDEPTH AGM PUNE , INDIA October 2009

INDEPTH Effectiveness and Safety studies of antimalarials in Africa (INESS ) IMPLEMENTATION SO FAR. Aziza Mwisongo INDEPTH AGM PUNE , INDIA October 2009. Background and rationale. Rationale approach for malaria treatment policy

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Aziza Mwisongo INDEPTH AGM PUNE , INDIA October 2009

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  1. INDEPTH Effectiveness and Safety studies of antimalarials in Africa (INESS )IMPLEMENTATION SO FAR Aziza Mwisongo INDEPTH AGM PUNE , INDIA October 2009

  2. Background and rationale • Rationale approach for malaria treatment policy • Phase IV studies in real life conditions (drug development pipeline) • Accelerate the uptake of new antimalarial drugs

  3. Goal • Overall Goal • To provide national, regional and international health decision makers with independent and objective evidence on the safety and effectiveness of new anti-malarial drugs as a basis for malaria treatment policy.

  4. Specific objectives • To develop and maintain Phase IV effectiveness studies Platform in Africa • To assess the effectiveness of new malaria treatment and its determinants in real life health systems

  5. Design and Implementation • Phase IV studies will be multi-center studies in (Ghana, Tanzania, Burkina Faso and Mozambique) • Large well documented population at risk of malaria residing in DSS sites • Previous experience in interventions(Vit A, ITN, malaria treatment guidelines) • District wide implementation of new registered antimalarials(Dihydroartemesinin-piperaquine, Pyronaridine artesunate)

  6. INESS Milestones- Objectives Two major objectives ; • To develop and maintain a Phase IV Effectiveness and Safety Studies of antimalarials in Africa • To asses the effectiveness of new malaria treatments and its determinants in real life

  7. Objectives and Activities • Objective 1: • Activity1a: Activation of the consortium governance, structures, task teams and clearances across the platform • Activity 1b:Developing training approaches and field protocols • Activity 1c:Population and Health System Observatory functions • Objective 2: • Activity 2a:Determine effectiveness and Safety determinants of antimalarials in real life health systems • Activity 2b: HDSS and Health System Data Linkage

  8. Activity 1:Activation of the consortium governance, structures, task teams and clearances across the platform - Governance structures are in place and fully functional • Task teams established and spearheading research on health system effectiveness and safety • INESS research approved and granted both national and Institutional IRBs in Ghana and Tanzania • Fully functional INESS secretariat based in Tanzania

  9. Activity 1b: Developing training approaches and field protocols - Key stakeholder consultation and by in of INESS work obtained both in Ghana and Tanzania - SOPs and specific research tools have been developed , piloted and rectified • TOTs on research methods and tools of health system effectiveness and safety have been completed for Tanzanian and Ghanaian DSS sites • Data collection on access, cost , adherence is ongoing both in Ghana and Tanzania( Tapping on DSS rounds)

  10. Activity 1c: Population and Health System Observatory functions • First planning meeting on data analysis and management recently concluded • First joint analysis meeting scheduled in Feb 2010( Core DSS data and INESS data ) • Post TOT mentoring planned scheduled in Feb 2010 • Roll in of Mozambique and Burkina Faso planned early next year

  11. Activity 2a: Determine effectiveness and safety determinants in real life health systems • Standard procedures for phase IV evaluation of anti malarials already developed and further updates during implementation • Development of frameworks to aid drug choices and policy changes for antimalarials will be developed in 2010 • Generation and sharing of evidence will be on continuous bases

  12. Activity 2b: DSS and Health System Data Linkage • Innovative data collection equipments(PDAs and Tablet pcs) have been purchased, tested and are being configured • Plan for data collection using PDAs and Tablet Pc next rounds for (access, cost, adherence and health provider compliance questionnaires) • Three softwares of data linkage have been developed ( identification of DSS members, capturing of health facility data and linkages between HF and DSS data ) • Testing of operation of softwares planned in November • Application of data linkage mechanism is expected early next year

  13. Other related progress • INESS launched internationally • Website formed and already uploaded • Brochure designed and is being printed for wide distribution , • International and national collaborations formed ( Drug authorities, Roll Back Malaria, AFMs( Global Fund) • National Communication Working Group identified in Ghana • Negotiation to support Malaria Media groups in place

  14. Challenges and lessons • Long set up time ( at least 6 months )-ample time • Variation of expertise and availability of core staffing in sites and secretariat- capacity building • Deployment of new drugs- earlier negotiations with drug companies ( MMV) and NMCPs

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