Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector
2 other identifiers
interventional
444
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 22, 2014
CompletedFirst Posted
Study publicly available on registry
July 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedDecember 15, 2015
December 1, 2015
1.1 years
July 22, 2014
December 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)
Within 2 days of group assignment
Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.
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.
Within 2 days of test results
Study Arms (4)
test only (free)
OTHERThe participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher.
test (free) & conditional ACT voucher
OTHERThe participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result.
test only (not free)
OTHERThe 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
OTHERThe 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.
Interventions
Malaria RDT is offered free if patients choose to be tested
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.
Participants can receive a malaria RDT for a set amount (i.e., not for free).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Moi Universitycollaborator
Study Sites (1)
Moi University
Eldoret, Kenya
Related Publications (1)
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.
PMID: 28588946DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy O'Meara, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2014
First Posted
July 25, 2014
Study Start
June 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
December 15, 2015
Record last verified: 2015-12