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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Malaria Falciparum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Control

Control: Standard practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No