Private Medicine Retailer-based Trial of Malaria Tests and Conditional Treatment Subsidies Among Patients With Fever

NCT06928207 | Completed Phase 4

• 1 other identifier: NHREC/01/01/2007- 19/05/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study observational study is to test the effect of conditional subsidies for Rapid Diagnostic Tests (RDT) and Artemisinin Combination Therapies (ACT) on improving the management of malaria fevers that seek care in the retail sector. The main question it aims to answer is: • Would a conditional subsidy scheme increase the proportion of clients with malaria receiving an ACT? Researchers will compare the proportion of patients with malaria receiving an ACT in the intervention arms to the control arm. Retail providers in the intervention arm have access to free RDTs and subsidized ACTs distributed by the research team and are asked to use a recommended retail price for the RDT and ACT. In addition, the providers in the intervention arm are trained in the use of RDTs and a mobile app that will prompt them to take and upload a picture of the RDT result. Retail providers in the control arm are trained in the use of RDTs but do not receive free RDTs or subsidized ACTs.

Conditions

Malaria Falciparum

Keywords

Malaria; Private sector; Private Medicine Retailers; Drug shops; Subsidies; Case management; RDT; ACT; Nigeria

Outcome Measures

Primary Outcomes (1)

• ACT uptake among patients testing positive for malaria during the exit interview

  The proportion of patients with malaria that purchased an ACT during their visit to the PMR. For this outcome, a patient with malaria is anyone who has a malaria RDT performed and tests positive at the exit interview.

  From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)

Secondary Outcomes (3)

• Case management of patients visiting the PMR suspected of having malaria

  From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approximately 30 min)]

• Out of pocket expenses incurred by patients suspected of having malaria

  From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approximately 30 min)]

• Proportion of untested clients who purchase ACTs

  From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)

Study Arms (2)

Intervention arm

EXPERIMENTAL

Free RDTs and conditional ACT subsidy: Patients visiting PMRs in this arm will receive a low-cost ACT if they use a low-cost RDT and have a positive test result.

Combination Product: Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positive

Control

NO INTERVENTION

Control: Standard practice

Interventions

Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positive COMBINATION_PRODUCT

To promote the use of the recommended first line drug, we implement a conditional subsidy. The retail provider is given the malaria diagnostic for free and is instructed to test clients suspected of having malaria. Only if the test is positive, the provider is instructed to provide the ACT at a low cost.

Intervention arm

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who tested in the Private Medicine Retailer and/or purchased antimalarial (s) for themselves.
• Individuals with malaria-like illness must be present at recruitment.
• Older than one year of age.

You may not qualify if:

• Any individual with signs of severe illness requiring immediate referral.
• Individuals who have taken an antimalarial in the last seven days, including for the current illness.
• Patients \<18 years without a parent or legal guardian present.
• Adults who are unable to consent for themselves

Sponsors & Collaborators

• Clinton Health Access Initiative Inc.: lead

Study Sites (1)

Private Medicine Retailers

Igabi and Kajuru LGA, Kaduna State, Nigeria

Location

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcome data is collected through Exit Interviewers. Exit interviews are conducted on randomly selected days each month and data collectors will be randomly assigned to participating private retailer.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Private medicine retailers are recruited through a readiness assessment survey. A total of 60 licensed PMRs (based on a list provided by Pharmacy council Nigeria and NAPPMED) in the two targeted LGAs will be randomly selected and visited by trained data collectors and asked to participate in a short survey. The purpose of the survey is to determine (i) whether they are registered and (ii) willingness to participate in the study. Following the readiness assessment, a random sample of 24 PMRs are selected from eligible PMRs. Out of these 20 PMRs will be randomly selected for inclusion in the study with the remaining 4 PMRs serving as backups.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: April 15, 2025
• Study Start: December 31, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)