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Studies

Interventional Recruiting Phase 4

NCT06601712 on ClinicalTrials.gov

Post-discharge Malaria Chemoprevention Implementation Trial in Benin

Official title: Delivery Strategies for Malaria Chemoprevention in the Post-discharge Management of Children Hospitalised With Severe Anaemia or Severe Malaria: a Cluster Randomised Controlled Implementation Trial in Benin

  • Sponsor: Institut de Recherche Clinique du Benin
  • Collaborators: Liverpool School of Tropical Medicine, Kenya Medical Research Institute, Epicentre, Paris, France and Mbarara University of Science and Technology, Faculty of Medicine, Mbarara, Uganda, Institut de Recherche pour le Developpement, Training Research Unit of Excellence, Blantyre, Malawia, Centres for Disease Control and Prevention, Kenya.
  • Enrollment: 648 (Estimated)
  • Study start: 2025-07-02 (Actual)
  • Primary completion: 2026-11-30 (Estimated)
  • Study completion: 2026-12-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: A multi-centre cluster randomized implementation trial with three arms at health facilities and their catchment communities (clusters) to enhance end-user adherence to post-discharge malaria chemoprevention (PDMC) compared to a control arm of PDMC without specific adherence support strategies.
  • Masking: None
  • PrimaryPurpose: Prevention

Brief Summary

The proposed research aims to conduct implementation trials in Benin, co-designed with national stakeholders, to evaluate different delivery strategies for optimizing health system delivery of post-discharge malaria chemoprevention (PDMC) drugs and adherence to PDMC. This chemoprevention strategy is effective in reducing hospital readmissions and deaths after discharge. However, there is no clear delivery platform for PDMC, and adherence to the 3-day dosing regimen, provided monthly three times after discharge, is a potential limitation. The current trial will provide evidence-based data on acceptability, feasibility, and cost-effectiveness to aid decision-makers. The evidence generated will be used to support the effective implementation and scale-up of PDMC in high malaria-endemic areas such as Benin.

Conditions

  • Severe Malaria
  • Severe Anaemia

Intervention / Treatment

  • Other: Adherence support strategy A
  • Other: Adherence support strategy B
  • Other: Control

Primary Outcome Measures

  • Number of children with incomplete adherence to 9 doses of PDMC by the end of week 14 post-discharge (Administration of PDMC courses at 2, 6 and 10 weeks post discharge)
    Adherence to the PDMC strategy: Proportion of children with incomplete adherence to 9 doses of PDMC (three courses of 3-day treatments 3x3=9) i.e. the number of children who do not receive the total of 9 doses of PDMC tablets by the end of week 14 after discharge out of the total sample size.

Countries

Benin

Locations and Investigators

  • Goho Departmental Hospital Centre, Abomey, Benin (Not yet recruiting)
    • Natacha Nouwakpo, MD
  • Centre Hospitalier Universitaire de la Mere et de l'Enfant Lagune (CHU-MEL), Cotonou, Benin (Recruiting)
    • Jules Alao, MD

Study Officials