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

• ClinicalTrials.gov Identifier: NCT02199977
• Recruitment Status: Completed
• First Posted: July 25, 2014
• Last Update Posted: December 15, 2015
• Sponsor: Duke University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Moi University
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fever; Malaria	Other: Free Malaria Rapid Diagnostic Test; Other: Conditional ACT voucher; Other: Malaria Rapid Diagnostic test for a charge	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 444 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector
• Study Start Date: June 2014
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

Arm	Intervention/treatment
test only (free); The participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher.	Other: Free Malaria Rapid Diagnostic Test; 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.	Other: Free Malaria Rapid Diagnostic Test; Malaria RDT is offered free if patients choose to be tested; 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.
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.	Other: Malaria Rapid Diagnostic test for a charge; 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.	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.; Other: Malaria Rapid Diagnostic test for a charge; Participants can receive a malaria RDT for a set amount (i.e., not for free).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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 ]

Eligibility Criteria

• Ages Eligible for Study: 1 Year and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Kenya

Moi University

Eldoret, Kenya

Sponsors and Collaborators

Duke University

National Institute of Allergy and Infectious Diseases (NIAID)

Moi University

Investigators

• Principal Investigator: Wendy O'Meara, PhD; Duke University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02199977
• Other Study ID Numbers: Pro00052602; 1R01AI110478-01 ( U.S. NIH Grant/Contract )
• First Posted: July 25, 2014
• Last Update Posted: December 15, 2015
• Last Verified: December 2015

Keywords provided by Duke University:

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

Additional relevant MeSH terms:

Malaria; Protozoan Infections; Parasitic Diseases