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

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Presentation transcript:

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 Phase IV studies in real life conditions (drug development pipeline) Accelerate the uptake of new antimalarial drugs

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.

Specific objectives 1.To develop and maintain Phase IV effectiveness studies Platform in Africa 2.To assess the effectiveness of new malaria treatment and its determinants in real life health systems

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)

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

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

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

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)

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 Roll in of Mozambique and Burkina Faso planned early next year

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 Generation and sharing of evidence will be on continuous bases

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

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

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