Last Updated

18 Mar 2019

Optimization of Seasonal Malaria Chemoprevention (SMC) delivery and its effects on the acquisition of malaria immunity

Objectives

The objectives of the study are to identify the most effective method to deliver Seasonal Malaria Chemoprevention (SMC) and to obtain information on the long-term impact of SMC on malaria immunity.

The investigators aim to i) determine the optimal mode (fixed-point (FPD) vs door-to-door delivery (DDD); directly observed treatment (DOT) vs. non-DOT (NDOT)) and frequency (3 vs. 4 doses per season) of SMC delivery; ii) to compare quantitative measures of immunity in children who do and do not receive SMC over a three year period.

Principal Investigator
Rationale and Abstract

ClinicalTrials.gov NCT02646410

Study Design
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

 

To determine the optimal mode fixed-point (FPD) vs door-to-door delivery (DDD); directly observed treatment (DOT) vs. non- directly observed treatment (NDOT)), 31 villages in four health sub-districts were randomized to receive three rounds of SMC with Sulfadoxine-pyrimethamine plus Amodiaquine (SP+AQ) at monthly intervals using one of the following methods: FPD+DOT; FPD+NDOT; DDD+DOT; DDD+NDOT. The primary endpoint was SMC coverage assessed by cross-sectional survey of 2,035 children at the end of intervention period.

Date

2014 Oct - 2019 Apr

Funding Details

$443,000
USAID Partnerships for Enhanced Engagement in Research program
Project Site