A Phase 4 interventional study of Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positive in Malaria Falciparum, sponsored by Clinton Health Access Initiative Inc.. Completed at 1 site in Nigeria. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by Clinton Health Access Initiative Inc. · Phase 4, Interventional, and Treatment
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:
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.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 20 is below the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →Clinton Health Access Initiative Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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: Standard practice
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.
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.
Time frame: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)
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)
Time frame: 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
Time frame: 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
Time frame: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)
Plan to share: No
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Ran from Dec 2023 to primary completion in Jul 2024, 7 months.
Of 23 phase 4 interventional studies under Malaria, Falciparum, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 29. This study's 7 months is below that.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Clinton Health Access Initiative Inc.