Clinical trial NCT02199977: Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector
Official title: Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Malaria
Keywords: Malaria
Antimalarial subsidy
Malaria rapid diagnostic test (RDT)
public-private partnership
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Moi University
First posted: 2014-07-25
Enrollment: 444
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test
timeFrame: Within two days of group assignment
Secondary outcomes:
measure: Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)
timeFrame: Within 2 days of group assignment
measure: Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.
timeFrame: Within 2 days of group assignment
Other outcomes:
measure: Percent of clients with a negative test, a positive test or no test who choose to purchase an ACT in all four groups.
timeFrame: Within 2 days of test results
Locations:
city: Eldoret
country: Kenya
facility: Moi University
Study officials:
affiliation: Duke University
name: Wendy O'Meara, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.