Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector

Not Applicable

Completed

• Conditions: Fever; Malaria
• Interventions: Other: Free Malaria Rapid Diagnostic Test; Other: Malaria Rapid Diagnostic test for a charge; Other: Conditional ACT voucher

• Registration Number: NCT02199977
• Lead Sponsor: Duke University

Brief Summary

There are compelling medical and public health reasons to reduce unnecessary consumption of antimalarials and strong evidence to support the use of RDTs in malaria case management. The primary study hypothesis to be tested is that clients who know they will receive a subsidy conditional on a positive test are more likely to opt for testing before deciding which drug to buy. The primary endpoint is whether subjects choose to be tested for malaria with a rapid diagnostic test. The secondary endpoint is whether they purchased an artemisinin combination therapy (ACT) or not. The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test (Group A compared to Group B) compared to those without the offer of a conditional subsidy. The investigators will use an experimental design that randomly assigns clients to one of four groups. Field workers will canvas households in the study area looking for individuals who have fever or history of fever or illness in the last 24 hours (current illness) who have not yet taken drugs or sought treatment outside the home. Clients who meet the inclusion criteria and give verbal consent to participate will be randomly assigned to one of the four groups. They will be given the location and contact information for their local community health worker who can provide a malaria rapid diagnostic test if they choose to be tested. They will also complete a survey tool. One week later, the field worker will return to interview the participant and determine whether they were tested, what action they took for their illness, what medicine they purchased and how much they paid. The investigators will summarize clients' choice by the four randomized study groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-25
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 444

Inclusion Criteria

• Client is older than 1 year
• Client has fever or history of fever or feeling unwell with a malaria-like illness within the last 24 hours
• Client or their parent/legal guardian consents to participate

Exclusion Criteria

• Client has signs of severe disease or other problem requiring immediate referral to a community health worker (CHW) / health facility
• Client has already sought treatment, purchased medicine or taken medicine for the current illness.

Note:

If more than one febrile person who meet the inclusion criteria are found in a single household, all of the individuals will be enrolled in the same group, but only one individual (the first enrolled) will be used for the purposes of the analysis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test (free) & conditional ACT voucher	Conditional ACT voucher	The participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result.
test (not free) & conditional ACT voucher	Conditional ACT voucher	The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), and an ACT voucher conditional on a positive test result.
test (free) & conditional ACT voucher	Free Malaria Rapid Diagnostic Test	The participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result.
test only (free)	Free Malaria Rapid Diagnostic Test	The participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher.
test only (not free)	Malaria Rapid Diagnostic test for a charge	The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), but no ACT voucher.
test (not free) & conditional ACT voucher	Malaria Rapid Diagnostic test for a charge	The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), and an ACT voucher conditional on a positive test result.

Primary Outcome Measures

Name	Time	Method
Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test	Within two days of group assignment	The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test compared to those without the offer of a conditional subsidy.

Secondary Outcome Measures

Name	Time	Method
Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.	Within 2 days of group assignment
Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)	Within 2 days of group assignment

Trial Locations

Locations (1)

Moi University; 🇰🇪 Eldoret, Kenya