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

NCT ID: NCT02199977

Last Updated: 2015-12-15

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

NA

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Fever Malaria

Keywords

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Malaria Antimalarial subsidy Malaria rapid diagnostic test (RDT) public-private partnership

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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test only (free)

The participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher.

Group Type OTHER

Free Malaria Rapid Diagnostic Test

Intervention Type OTHER

Malaria RDT is offered free if patients choose to be tested

test (free) & conditional ACT voucher

The participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result.

Group Type OTHER

Free Malaria Rapid Diagnostic Test

Intervention Type OTHER

Malaria RDT is offered free if patients choose to be tested

Conditional ACT voucher

Intervention Type OTHER

Participants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test. When a conditional subsidy is offered, it is valid for use on a "Green Leaf" approved malaria drug.

test only (not free)

The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), but no ACT voucher.

Group Type OTHER

Malaria Rapid Diagnostic test for a charge

Intervention Type OTHER

Participants can receive a malaria RDT for a set amount (i.e., not for free).

test (not free) & 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.

Group Type OTHER

Conditional ACT voucher

Intervention Type OTHER

Participants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test. When a conditional subsidy is offered, it is valid for use on a "Green Leaf" approved malaria drug.

Malaria Rapid Diagnostic test for a charge

Intervention Type OTHER

Participants can receive a malaria RDT for a set amount (i.e., not for free).

Interventions

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Free Malaria Rapid Diagnostic Test

Malaria RDT is offered free if patients choose to be tested

Intervention Type OTHER

Conditional ACT voucher

Participants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test. When a conditional subsidy is offered, it is valid for use on a "Green Leaf" approved malaria drug.

Intervention Type OTHER

Malaria Rapid Diagnostic test for a charge

Participants can receive a malaria RDT for a set amount (i.e., not for free).

Intervention Type OTHER

Eligibility Criteria

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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:
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Moi University

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy O'Meara, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Moi University

Eldoret, , Kenya

Site Status

Countries

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Kenya

References

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Prudhomme O'Meara W, Mohanan M, Laktabai J, Lesser A, Platt A, Maffioli E, Turner EL, Menya D. Assessing the independent and combined effects of subsidies for antimalarials and rapid diagnostic testing on fever management decisions in the retail sector: results from a factorial randomised trial in western Kenya. BMJ Glob Health. 2016 Sep 28;1(2):e000101. doi: 10.1136/bmjgh-2016-000101. eCollection 2016.

Reference Type DERIVED
PMID: 28588946 (View on PubMed)

Other Identifiers

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1R01AI110478-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00052602

Identifier Type: -

Identifier Source: org_study_id