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

A Randomized Experiment of Malaria Diagnostic Testing and Conditional Treatment Subsidies to Increase the Proportion of Malaria Patients Receiving an ACT

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.

Study Overview

• Status: Completed
• Conditions: Malaria Falciparum
• Intervention / Treatment: Combination product: Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positive

Detailed Description

The ultimate goal of the conditional subsidy scheme is to increase the proportion of patients with malaria that receives an artemisinin combination therapy (ACT) at the point of sale.

The objective of this study is to test the effect of providing low-cost malaria rapid diagnostic tests (RDT) and Artemisinin Combination Therapies (ACTs) to patients on improving the management of malaria fevers that receive care in private medicine retailers (PMR). During the study, malaria RDTs are provided free of charge to the private provider to conduct malaria-RDT testing at a low cost (at a set recommended retail price) for patients with a malaria-like illness. Subsidized ACTs are provided to the provider, conditional on the provider conducting the malaria RDT and selling the ACT at a low cost to patients testing positive for malaria. Outcomes will be measured by exit interviews on random days each month at participating PMRs.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Nigeria
  • Kaduna
    • Igabi and Kajuru LGA, Kaduna, Nigeria
      • Private Medicine Retailers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; 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; 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.
No Intervention: Control; Control: Standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Case management of patients visiting the PMR suspected of having malaria	The proportion of patients suspected of malaria cases that are managed appropriately (tested for malaria in the PMR or elsewhere but with proof and purchase any ACT following a positive RDT test result or do not purchase an ACT after a negative RDT rest result)	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	The out-of-pocket expenses incurred in the PMR by patients suspected of having malaria for ACTs and RDTs	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	Proportion of clients visiting the PMR that did not test in the drugshop and purchased ACTs	From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)

Collaborators and Investigators

• Sponsor: Clinton Health Access Initiative Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Malaria; ACT; Nigeria; Case management; Drug shops; RDT; Private sector; Private Medicine Retailers; Subsidies
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; Protozoan Infections; Parasitic Diseases; Malaria; Malaria, Falciparum
• Other Study ID Numbers: NHREC/01/01/2007- 19/05/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No