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Seasonal Malaria Chemoprevention Rapid Assessment Study Mozambique

NCT06337253 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2024-03-29

No results posted yet for this study

Summary

Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections caused by Plasmodium falciparum in areas where the burden of malaria is high and malaria transmission is seasonal. SMC is commonly seen as a success story in the Sahel region, however, there are regions in east and southern Africa where malaria transmission is seasonal, and the burden is high. However, the same decision-making frameworks that was used in the Sahel are unlikely to be applicable to east and southern Africa due to higher pre-existing resistance to the drugs used, seasonality heterogeneity, contextual difference, and unknown cost-effectiveness, amongst others. This study aims to estimate the chemoprevention efficacy, potential upscale impact, acceptability, and feasibility of SMC with sulfadoxine-pyrimenthamine + amodiaquine (SP+AQ) medicines in Niassa Province in Mozambique.

The study is divided into two separate components with different objectives which outputs feed into each other: a non-randomized controlled trial to estimate the chemoprevention efficacy of SP+AQ; and a qualitative study that will evaluate the feasibility and acceptability of the intervention.

These will be the first studies analysing the chemoprevention efficacy, feasibility, acceptability, and potential scale-up impact of SMC in Niassa Province, Mozambique The outcomes of these studies aim to guide future policy changes at local, national, and international levels and potentially allow for a historically successful program to expand in a sustained and cost-effective way beyond the Sahel region.

Conditions

  • Malaria,Falciparum
  • Chemoprevention

Interventions

DRUG

Sulfadoxine/pyrimethamine plus amodiaquine

Seasonal Malaria Chemoprevention with SPAQ has not been trialed or introduced in Malawi yet. This intervention trial is different from others because of the location and because, traditionally, a full round of SMC with SPAQ that involves between 3-5 cycles is administered. Our trial is the first one that will only distribute one cycle of SMC with SPAQ. The data collected during the 42 days after SMC distribution will be used to estimate the medicines chemoprevention effectiveness at preventing malaria in children aged 3-59 months. This data, together with the resistance markers data will then be fed into a dynamical model that collaborators at Imperial College London have developed that will predic the potential impact of upscaling SMC in similar geographies.

Sponsors & Collaborators

  • Malaria Consortium

    lead OTHER

Principal Investigators

  • Sam Gudoi · Malaria Consortium

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-26
Primary Completion
2024-05-26
Completion
2024-11-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06337253 on ClinicalTrials.gov