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Effectiveness of Seasonal Malaria Chemoprevention in Nampula Province, Mozambique: Type Two Hybrid Implementation Study

NCT05186363 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3156

Last updated 2023-11-02

No results posted yet for this study

Summary

We describe a Type II hybrid effectiveness-implementation study design which evaluates the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the drugs used. The study consists of three components: 1) Conducting a cluster randomized controlled trial (cRCT) through household surveys establishing confirmed malaria cases in children; 2) Conducting a prospective cohort study to determine the chemoprevention efficacy of sulfadoxine-pyrimethamine and amodiaquine (SPAQ) and whether drug concentrations or parasite resistance influence the duration of protection; and 3) Conducting a resistance markers study in children 3-59 months to measure changes in resistance marker prevalence over time.

Conditions

Interventions

DRUG

Chemopreventive Agent - SPAQ

Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections in areas where the malaria burden is high and transmission occurs mainly during the rainy season. It involves administering monthly courses of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) during this peak transmission period to those most at risk: children 3-59 months.

DRUG

Control Test - no drugs given

This is where children aged 3-59 months do not receive any chemoprevention drugs but do receive health promotion messages and visit from health workers similar to the chemoprevention SPAQ arm.

Sponsors & Collaborators

  • Malaria Consortium

    lead OTHER

Principal Investigators

  • Baltazar Candrinho, MD · National Malaria Control Programme, Ministry of Health Mozambique

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-01-08
Primary Completion
2022-06-21
Completion
2023-12-01

Countries

  • Mozambique

Study Locations

More Related Trials

Entities

Diseases

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 NCT05186363 on ClinicalTrials.gov