Chemoprevention Efficacy Study in Burkina Faso

This cohort study aims to evaluate the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation.

The study uses pragmatic implementation research with the objective of contributing to the development of practical recommendations for health policy, practice and potential scale up. It is designed as an implementation study to determine effectiveness and protective efficacy to gather evidence of the potential impact on health outcomes. Five monthly cycles of SMC will be implemented between July and October 2022 in one district, Nanoro, in Centre Ouest region.

The study will comprise the following two components:

1. A prospective protective efficacy cohort study to determine if SPAQ provides 28 days of protection from infection and whether drug concentrations and/or resistance influence the duration of protection
2. A resistance markers study in children 3-59 months in the two research districts plus the two standard intervention districts to measure changes in resistance marker prevalence over time (pre and post within the same year and between years)

• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Cohort
• Masking: None (Open Label)
• Primary Purpose: Prevention

ClinicalTrials.gov Identifier: NCT05478954

Clinical trial registration

Drug Resistance
Impact of Interventions

Jul 2022 — Oct 2022

$300,000

Burkina Faso

Seasonal Malaria Chemoprevention (SMC)