Perennial Malaria Chemoprevention (PMC) Effect Study

NCT06155448 | Active Not Recruiting DMC

• 2 other identifiers: PMCEFFECTNGINV-004302
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The Malaria Consortium Nigeria (MC) will coordinate a trial of PMC in Osun State, Nigeria with strategic support from the National Malaria Elimination Programme of the Government of Nigeria (NMEP) and financial support from the BMGF. The primary purpose of the study is to provide evidence of the impact of PMC on malaria burden and related clinical outcomes, and its operational feasibility for policy decision and the inclusion of PMC into upcoming programme and funding cycles for its National Malaria Control Strategic Plan. The objectives are:

1. 1.To evaluate the impact of PMC in children aged 2-18 months on key child health outcomes including malaria burden, hospitalisations, and anaemia.
2. 2.To describe indicators of operational feasibility of PMC by identification and measurement of key determinants of successful uptake and implementation of PMC.

Conditions

Malaria

Keywords

PMC; Chemoprevention; Malaria; Integrated delivery

Outcome Measures

Primary Outcomes (2)

• . Incidence rate of clinical malaria

  Incidence rate of parasitologically-confirmed clinical malaria cases in children 2-18 months presenting to selected sentinel facilities over 18 months\* of implementation.

  18 months

• Protective effectiveness of SP

  Protective effectiveness of SP treatments as measured by the percentage reduction in the incidence of malaria associated with receipt of SP in the last 28 days over 18 months\* of implementation

  18 months

Secondary Outcomes (11)

• Prevalence of malaria infection

  18 months

• Prevalence of anaemia

  18 months

• Incidence rate of all-cause hospitalisations

  18 months

• Incidence rate of clinical malaria (rebound period)

  12 months following implementation

• Coverage of scheduled SP doses

  18 months

Study Arms (2)

PMC intervention

EXPERIMENTAL

The PMC intervention is designed to deliver a core regimen of six paediatric doses of sulphadoxine pyrimethamine linked to the EPI delivery platform in children 10 weeks to 15 months of age through trained health facility staff, plus additional 'pragmatic' monthly doses offered outside of the EPI schedule to children up to 18 months of age. Additional social mobilisation and social behaviour change (SBC) activities will be conducted throughout the implementation period to increase demand and uptake of vaccination and PMC services in the study population. at EPI scheduled touchpoints, plus additional monthly doses at non-scheduled monthly intervals up to age 18 months. The primary source of delivery will be government-run primary care health facilities in intervention arm wards. Coordination of implementation of the study within intervention and control arm wards will take place at the LGA level (unit of implementation).

Other: Perennial Malaria Chemoprevention effect

Control

NO INTERVENTION

The control sites will have normal immunization as business as usual. However, the same sentinel site surveillance happening in the intervention arm will also be carried out in this arm. Pharmacovigilance will be passive in the control arm.

Interventions

Perennial Malaria Chemoprevention effect OTHER

Assessing the effectiveness and feasibility of Perennial malaria chemoprevention delivery through EPI platform.

Also known as: PMC effect

PMC intervention

Eligibility Criteria

• Age: 10 Weeks - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 10 weeks to 24 months
• Healthy

You may not qualify if:

• severe acute malnutrition, or
• allergic to sulphur containing medication,
• HIV positive,
• taking cotrimoxazole as prophylaxis or treatment, or SP, or other sulphur-containing medication in the previous 4 weeks, and
• children with a positive malaria RDT

Sponsors & Collaborators

• Malaria Consortium: lead
• Nigerian Institute of Medical Research: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• Northwestern University: collaborator

Study Sites (1)

Ministry of Health

Oshogbo, Osun State, Nigeria

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• James Tibenderana, PhD

  Malaria Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention arm will comprise PMC-plus: A 6-scheduled dose regimen administered to eligible children at 10 weeks, 14 weeks, 6 months, 9 months, 12 months and 15 months of age concurrently with EPI vaccinations DTP2/Penta2, DTP3/Penta3, vitamin A, and measles immunisation where appropriate. Eligible children attending the participating health facilities for other reasons beyond EPI would be invited to receive additional monthly doses between scheduled EPI-linked visits up until the child reaches 18 months of age

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 4, 2023
• Study Start: August 8, 2023
• Primary Completion: August 7, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

NG (1)