Post-discharge Malaria Chemoprevention Implementation Trial in Benin

NCT06601712 | Recruiting Phase 4 DMC

• 1 other identifier: 191-20231218
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 2

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

Keywords

Children; Antimalarial; Prevention; Chemoprevention; Caregivers; Patient discharge; Health care providers; Health economics; Qualitative research; Feasibility; Cost-effectiveness; Benin; Artemisinins; School age; Pre-school

Outcome Measures

Primary Outcomes (1)

• Number of children with incomplete adherence to 9 doses of PDMC by the end of week 14 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.

  Administration of PDMC courses at 2, 6 and 10 weeks post discharge

Secondary Outcomes (7)

• Number of children readmitted to hospital from all-cause and malaria-specific by the end of week 14 post-discharge

  14 weeks post discharge

• Number of sick-child clinic visits from all-cause and malaria-specific by the end of week 14 post-discharge

  14 weeks post discharge

• Number of children who die within 14 weeks post-discharge

  14 weeks post discharge

• Number of serious adverse events following PDMC administration within 14 weeks post-discharge

  14 weeks post discharge

• Cost per Disability adjusted life years (DALY) averted for each intervention versus control arm

  14 weeks post discharge

Study Arms (3)

Arm A

EXPERIMENTAL

All PDMC drugs will be given to the caregivers at discharge with reminder support

Other: Adherence support strategy A

Arm B

EXPERIMENTAL

All PDMC drugs will be given by the community health workers (CHWs) to the caregivers at home, with reminder support

Other: Adherence support strategy B

Arm C

ACTIVE COMPARATOR

All PDMC drugs will be given to the caregivers at discharge with no other adherence support approaches (no reminder)

Other: Control

Interventions

Adherence support strategy A OTHER

Community health worker (CHW) support through monthly home visits to remind the caregiver to administrate the PDMC drugs

Arm A

Adherence support strategy B OTHER

SMS/phone reminders from the qualified community health officers (ASCQ) to the community health workers (CHW) to administrate the PDMC drugs

Arm B

Control OTHER

No reminders

Arm C

Eligibility Criteria

• Age: Up to 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged below 10 years of both sexes
• Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin below 5.0 g/dl or PCV below 15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and the presence of microscopy or RDT confirmed Plasmodium infection

You may not qualify if:

• Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)
• Sickle cell anaemia/sickle cell disease
• Body weight below 5 kg

Sponsors & Collaborators

• Institut de Recherche Clinique du Benin: lead
• Liverpool School of Tropical Medicine: collaborator
• Kenya Medical Research Institute: collaborator
• Epicentre, Paris, France and Mbarara University of Science and Technology, Faculty of Medicine, Mbarara, Uganda: collaborator
• Institut de Recherche pour le Developpement: collaborator
• Training Research Unit of Excellence, Blantyre, Malawia: collaborator
• Centres for Disease Control and Prevention, Kenya.: collaborator

Study Sites (2)

Goho Departmental Hospital Centre

Abomey, Benin

NOT YET RECRUITING

Centre Hospitalier Universitaire de la Mere et de l'Enfant Lagune (CHU-MEL)

Cotonou, Benin

RECRUITING

Related Publications (1)

• Hill J; PDMC Saves Lives Consortium. Implementation of post-discharge malaria chemoprevention (PDMC) in Benin, Kenya, Malawi, and Uganda: stakeholder engagement meeting report. Malar J. 2024 Mar 27;23(1):89. doi: 10.1186/s12936-023-04810-0.

  PMID: 38539181 BACKGROUND

MeSH Terms

Conditions

Malaria; Anemia

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jenny Hill, MSc, PhD

  Liverpool School of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manfred Accrombessi, MD, PhD

CONTACT

22966033138; accrombessimanfred@gmail.com

Achille Massougbodji, MD

CONTACT

22996807027; massougbodjiachille@yahoo.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: September 19, 2024
• Study Start: July 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be shared once the publication is accepted by a journal
• Access Criteria: Applications to access data are assessed as per the choice of the data contributor, either by: 1. An independent IDDO Data Access Committee (DAC) 2. A contributor-controlled process - where the data contributor assesses each data access application that requests the re-use of their data

Locations

BE (2)