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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199977
• Other study ID #: Pro00052602
• Secondary ID: 1R01AI110478-01
• Status: Completed
• Phase: N/A
• First received: July 22, 2014
• Last updated: December 14, 2015
• Start date: June 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKenya: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Fever
• Malaria

Intervention

Other:
• Free Malaria Rapid Diagnostic Test
Malaria RDT is offered free if patients choose to be tested
• 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.
• Malaria Rapid Diagnostic test for a charge
Participants can receive a malaria RDT for a set amount (i.e., not for free).

Locations

Country	Name	City	State
Kenya	Moi University	Eldoret

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Moi University, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent of clients with a negative test, a positive test or no test who choose to purchase an ACT in all four groups.		Within 2 days of test results	No
Primary	Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test	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.	Within two days of group assignment	No
Secondary	Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)		Within 2 days of group assignment	No
Secondary	Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.		Within 2 days of group assignment	No