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

Tracking Information

• First Submitted Date: July 22, 2014
• First Posted Date: July 25, 2014
• Last Update Posted Date: December 15, 2015
• Study Start Date: June 2014
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 23, 2014)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 23, 2014)

• Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT) [ Time Frame: Within 2 days of group assignment ]
• Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free. [ Time Frame: Within 2 days of group assignment ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: July 23, 2014): 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 ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Fever
• Malaria

Intervention

• 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.
• Other: Malaria Rapid Diagnostic test for a charge
  Participants can receive a malaria RDT for a set amount (i.e., not for free).

Study Arms

• test only (free)
  The participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher.
  Intervention: Other: Free Malaria Rapid Diagnostic Test
• 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.
  Interventions:

  • Other: Free Malaria Rapid Diagnostic Test
  • Other: Conditional ACT voucher
• 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.
  Intervention: Other: Malaria Rapid Diagnostic test for a charge
• 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.
  Interventions:

  • Other: Conditional ACT voucher
  • Other: Malaria Rapid Diagnostic test for a charge

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 14, 2015): 444
• Original Estimated Enrollment (submitted: July 23, 2014): 500
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Kenya

Administrative Information

• NCT Number: NCT02199977
• Other Study ID Numbers: Pro00052602; 1R01AI110478-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Duke University
• Study Sponsor: Duke University

Collaborators

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

Investigators

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

• PRS Account: Duke University
• Verification Date: December 2015