Principal Investigator: Dominic Mosha
Project leader/ Coordinator: Dominic Mosha
Project Administrator: Priscilla Mlay
Funding Partner: European and Developing Countries Clinical Trials Partnership Programme (EDCTP)
Start date: April 1, 2019
End date: Dec. 31, 2022
Monitoring safety to single-low dose primaquine co-administered with AL in routine healthcare practices: Addressing potential implementation challenges and policy options for effective roll out
The project aims to determine readiness, challenges and policy options for effective roll out of recommended malaria treatment regimen in routine healthcare. This is a repeated cross-sectional study involving clinicians as a primary study, population treating uncomplicated malaria patients with ACT+PQ regardless 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 roll out 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, needs for a successful rollout of ACT + PQ treatment regimen will be determined by key informants’ interview which will involve officers from the Ministry of Health, National Malaria Control Program (NMCP), and safety drug monitoring board. #