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Project Title: Monitoring safety of single-low dose primaquine co-administered with AL in routine healthcare practices: addressing potential implementation challenges and policy options for effective roll out.

Project Description: The project aims to determine readiness, challenges, and policy options for the effective roll-out of recommended malaria treatment regimens in routine healthcare. This is a repeated cross-sectional study involving clinicians as a primary study, a population treating uncomplicated malaria patients with ACT+PQ regardless of their G6PD status, 7 days follow up, and management of adverse events (secondary study population, malaria patients). It will involve the following process Needs assessment survey of 16 random selected facilities... The project aims to determine readiness, challenges, and policy options for the effective roll-out of recommended malaria treatment regimens in routine healthcare. This is a repeated cross-sectional study involving clinicians as a primary study, a population treating uncomplicated malaria patients with ACT+PQ regardless of their G6PD status, 7 days follow up, and management of adverse events (secondary study population, malaria patients). It will involve the following process Needs assessment survey of 16 random selected facilities in two rural districts including human resources, laboratory capacity, and medical supplies Equip 6 random sampled intervention facilities with basic tools and supplies essential for monitoring and managing G6PD adverse events Training health care providers on PQ rollout monitoring pharmacovigilance tool (PROMPT), Adoption of the PROMPT tool by healthcare providers in malaria treatment using ACT+PQ for the period of 6 months with minimal provider supervision, Assess healthcare providers' challenges and revise the training package by validating the PROMPT, Piloting the revised training package and safety monitoring tool for 4 months. Finally, a comprehensive safety training package will be produced. To improve the training manual, in-depth interviews will be conducted to determine providers' and clients' experience. Furthermore, the need for a successful rollout of the ACT + PQ treatment regimen will be determined by key informants interview which will involve officers from the Ministry of Health, the National Malaria Control Program (NMCP), and the safety drug monitoring board.


Principal Investigator : Dominic Mosha

Department Name :

Time frame: (2019-01-01) - (2020-12-31)

Funding Partners
European and Developing Countries Clinical Trials Partnership Programme (EDCTP) (Normal)
External Collaborating Partners
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