Project: 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

Acronym	PRIMAQUINE Roll out (Reference Number: TMA2017CDF-1878)
Duration	01/01/2019 - 31/12/2020
Project Topic	The success of malaria control programmes have contributed to a decrease in malaria mortality rates by approximately 50% worldwide over the past 15 years. To maintain this gain, WHO recommends use primaquine, in conjunction with artemisinin-based combination therapy (ACT), to block Plasmodium falciparum transmission in areas approaching malaria elimination and/or facing artemisinin resistance. East Africa including Tanzania has latter properties which may justify relevance of this recommendation. Primaquine (PQ) may cause haemolytic side effects in individual who have G6PD deficiency; the potential for haemolysis depends on the dose. The current WHO recommended dose of 0.25mg/kg is low enough to mitigate the side risk of haemolysis in G6PD deficiency individuals. This low dose also enables treatment without requiring G6PD testing. Only 18 countries worldwide have included PQ as part of a first line treatment for P. falciparum in their national policy. Only one African country, Swaziland, appears in this list. Concerns related to safety monitoring of this new treatment recommendation is a key barrier that may explain failure for its consideration in malaria policy in nearly all sub Saharan countries. 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; (i) needs assessment survey of 16 random selected facilities in two rural districts including human resources, laboratory capacity and medical supplies, (ii) Equip 6 random sampled intervention facilities with basic tools and supplies essential for monitoring and managing G6PD adverse events (iii) Training health care providers on ‘PQ roll out monitoring pharmacovigilance tool (PROMPT)’, (iv) adoption of the PROMPT tool by healthcare providers in malaria treatment using ACT+PQ for a period of 6 month with minimal provider supervision, (v) assess healthcare providers challenges and revise the training package by validating the PROMPT, (vi) piloting the revised training package and safety monitoring tool for 4 months. Finally, comprehensive safety training package will be produced. To improve the training manual, in-depth interview will be conducted to determine providers and clients experience. Furthermore, needs for successful roll out of ACT+PQ treatment regimen will be determined by Key Informant interview which will involve officers from ministry of health, national malarial control program (NMCP), and safety drug monitoring board. The study findings will therefore provide useful evidence to facilitate PQ roll out.
Network	EDCTP2
Call	Career Development Fellowships 2017

Project partner

Number	Name	Role	Country
1	Ifakara Health Institute Trust	Coordinator	Tanzania