Aziza Mwisongo
INDEPTH AGM
PUNE , INDIA
October 2009

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

• 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.

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

• 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)

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

• 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

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

:
-
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 )

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

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

- 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

• 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

• Long set up time ( at least 6 months )ample time
• Variation of expertise and availability of core staffing in sites and secretariatcapacity building
• Deployment of new drugsearlier negotiations with drug companies ( MMV) and NMCPs