PDMC Implementation Trial in Kenya

Summary

The goal of this implementation trial is to evaluate at least two alternative delivery strategies and adherence support for malaria chemoprevention with dihydroartemisinin-piperaquine in the post-discharge management of children hospitalised with severe anaemia or severe malaria to optimise adherence in Kenya.

The actual interventions to be evaluated have been co-designed with national stakeholders during an initial formative research stage.

Conditions

• Severe Malaria
• Severe Anemia

Interventions

OTHER

SMS reminders; adherence support strategy a

Monthly SMS reminders sent to participants allocated to this adherence support intervention in both drug delivery arms (Centralized and decentralized arms)

OTHER

Community Health Promoters (CHP) home visits; adherence support strategy b

Community Health Promoters' (CHPs) monthly reminder home visits conducted for participants allocated to this adherence support intervention in both drug delivery arms (Centralized and Decentralized arms)

OTHER

No reminders; adherence support strategy c

No monthly reminders sent for participants allocated to this control adherence support intervention group in both drug delivery arms (Centralized and Decentralized arms)

Sponsors & Collaborators

• Kenya Medical Research Institute

  collaborator OTHER

• Institut de Recherche Clinique du Benin (IRCB), Benin

  collaborator UNKNOWN

• Epicentre, Paris, France.

  collaborator UNKNOWN

• Institute of Research for Development, France

  collaborator OTHER_GOV

• Training Research Unit of Excellence, Blantyre, Malawi

  collaborator UNKNOWN

• Makerere University

  collaborator OTHER

• Centres for Disease Control and Prevention, Kenya.

  collaborator OTHER

• Liverpool School of Tropical Medicine

  lead OTHER

Principal Investigators

• Feiko ter Kuile, MD, PhD · LSTM

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-05

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• Kenya

Study Locations