PDMC Implementation Trial in Kenya

NCT06624631 | Recruiting Phase 4 DMC

• 1 other identifier: 24-023
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Proportion of eligible children who received 3 courses of PDMC

  Proportion of eligible participants who received all 3 indicated PDMC courses from Ministry of Health staff

  2, 6 and 10 weeks post discharge

• Proportion of study children who adhered to 3 PDMC courses (9 doses)

  Proportion of children with complete adherence to the full PDMC regimen (3 courses × 3 doses = 9 total doses)

  2, 6 and 10 weeks (days 1-3) post discharge

Secondary Outcomes (6)

• Proportion of children who are readmitted with malaria

  0-14 weeks post discharge

• Proportion of children who are readmitted with any cause

  0-14 weeks post discharge

• Proportion of children who die within 14 weeks of discharge

  0-14 weeks post discharge

• Incidence of serious adverse events

  0-14 weeks post discharge

• Cost-effectiveness

  0-14 weeks post discharge

Study Arms (2)

Decentralized, monthly delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs (Arm A)

EXPERIMENTAL

Delivery of initial course of PDMC at discharge from the admitting facility. Referral to caregiver's peripheral facility of choice for delivery of subsequent monthly courses

Other: SMS reminders; adherence support strategy a; Other: Community Health Promoters (CHP) home visits; adherence support strategy b; Other: No reminders; adherence support strategy c

Centralised delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge (Arm B)

ACTIVE COMPARATOR

Delivery of all three courses of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge from the admitting facility.

Other: SMS reminders; adherence support strategy a; Other: Community Health Promoters (CHP) home visits; adherence support strategy b; Other: No reminders; adherence support strategy c

Interventions

SMS reminders; adherence support strategy a OTHER

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

Centralised delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge (Arm B); Decentralized, monthly delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs (Arm A)

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

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)

Centralised delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge (Arm B); Decentralized, monthly delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs (Arm A)

No reminders; adherence support strategy c OTHER

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

Centralised delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge (Arm B); Decentralized, monthly delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs (Arm A)

Eligibility Criteria

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

You may qualify if:

• CLUSTERS
• Health facilities with blood transfusion services offering in-patient care for children with severe anaemia and severe malaria.
• \>=40 children per year admitted with severe anaemia or severe malaria
• Agreement to participate by facility management
• Located in areas with moderate to high malaria transmission
• INDIVIDUAL PARTICIPANTS
• Aged \<10 years of both sexes
• Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin \<5.0 g/dl or PCV \<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/or the presence of microscopy or RDT confirmed Plasmodium infection

You may not qualify if:

• CLUSTERS
• \- Health facilities without subservient lower-level health facilities
• INDIVIDUAL PARTICIPANTS
• 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 \<5 kg

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• Kenya Medical Research Institute: collaborator
• Institut de Recherche Clinique du Benin (IRCB), Benin: collaborator
• Epicentre, Paris, France.: collaborator
• Institute of Research for Development, France: collaborator
• Training Research Unit of Excellence, Blantyre, Malawi: collaborator
• Makerere University: collaborator
• Centres for Disease Control and Prevention, Kenya.: collaborator

Study Sites (1)

Kemri, Cghr

Kisumu, 40 100, Kenya

RECRUITING

MeSH Terms

Conditions

Malaria; Anemia

Interventions

somatostatin, cyclic hexapeptide(Phe-Phe-Trp-Lys-Thr-Phe)-; House Calls

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Feiko ter Kuile, MD, PhD

  LSTM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Hill, MSc, PhD

CONTACT

+44 7732 161 353; jenny.hill@lstmed.ac.uk

Juliet Otieno, MD, PhD

CONTACT

+254 721432548; Juliet.Otieno@lstmed.ac.uk

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, 2-arm, cluster-randomised trial evaluating two health system delivery strategies and a 3-arm nested individually randomised trial evaluating two new intervention strategies to enhance end-user adherence to post-discharge malaria chemoprevention (PDMC) with dihydroartemisinin-piperaquine compared to the standard of care without adherence strategies

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: October 3, 2024
• Study Start: September 5, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

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

KE (1)