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Completed

NCT Number: NCT02199977

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

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.

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moi University

Eldoret, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Free Malaria Rapid Diagnostic Test

Other

Malaria RDT is offered free if patients choose to be tested

Conditional ACT voucher

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

Other

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

Primary outcomes

  1. Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test

    Time frame: 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 outcomes

  1. Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)

    Time frame: Within 2 days of group assignment

  2. Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.

    Time frame: Within 2 days of group assignment

Other outcomes

  1. Percent of clients with a negative test, a positive test or no test who choose to purchase an ACT in all four groups.

    Time frame: Within 2 days of test results

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Moi University
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 25, 2014
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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