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Completed

NCT Number: NCT06928207

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

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.

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Key information

Conditions

Malaria Falciparum Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Private Medicine Retailers

Igabi and Kajuru LGA, Kaduna State, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Case management of patients visiting the PMR suspected of having malaria

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

    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)

  2. Out of pocket expenses incurred by patients suspected of having malaria

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

    The out-of-pocket expenses incurred in the PMR by patients suspected of having malaria for ACTs and RDTs

  3. Proportion of untested clients who purchase ACTs

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

    Proportion of clients visiting the PMR that did not test in the drugshop and purchased ACTs

Sponsors and collaborators

Lead sponsor

Clinton Health Access Initiative Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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