Clinical trial NCT06928207: Private Medicine Retailer-based Trial of Malaria Tests and Conditional Treatment Subsidies Among Patients With Fever
Official title: A Randomized Experiment of Malaria Diagnostic Testing and Conditional Treatment Subsidies to Increase the Proportion of Malaria Patients Receiving an ACT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria Falciparum
Keywords: Malaria
Private sector
Private Medicine Retailers
Drug shops
Subsidies
Case management
RDT
ACT
Nigeria
Lead sponsor: Clinton Health Access Initiative Inc.
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ACT uptake among patients testing positive for malaria during the exit interview
timeFrame: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)
Secondary outcomes:
measure: Case management of patients visiting the PMR suspected of having malaria
timeFrame: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approximately 30 min)]
measure: Out of pocket expenses incurred by patients suspected of having malaria
timeFrame: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approximately 30 min)]
measure: Proportion of untested clients who purchase ACTs
timeFrame: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)
Other outcomes:
Locations:
city: Igabi and Kajuru LGA
country: Nigeria
facility: Private Medicine Retailers
state: Kaduna
Study officials:
References: