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

Primary Purpose

Fever, Malaria

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Free Malaria Rapid Diagnostic Test
Conditional ACT voucher
Malaria Rapid Diagnostic test for a charge
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Fever focused on measuring Malaria, Antimalarial subsidy, Malaria rapid diagnostic test (RDT), public-private partnership

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Moi University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

test only (free)

test (free) & conditional ACT voucher

test only (not free)

test (not free) & conditional ACT voucher

Arm Description

The participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher.

The participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result.

The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), but no 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)
Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.

Full Information

First Posted
July 22, 2014
Last Updated
December 14, 2015
Sponsor
Duke University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Moi University
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1. Study Identification

Unique Protocol Identification Number
NCT02199977
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Moi University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Malaria
Keywords
Malaria, Antimalarial subsidy, Malaria rapid diagnostic test (RDT), public-private partnership

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test only (free)
Arm Type
Other
Arm Description
The participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher.
Arm Title
test (free) & conditional ACT voucher
Arm Type
Other
Arm Description
The participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result.
Arm Title
test only (not free)
Arm Type
Other
Arm Description
The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), but no ACT voucher.
Arm Title
test (not free) & conditional ACT voucher
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Free Malaria Rapid Diagnostic Test
Intervention Description
Malaria RDT is offered free if patients choose to be tested
Intervention Type
Other
Intervention Name(s)
Conditional ACT voucher
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Malaria Rapid Diagnostic test for a charge
Intervention Description
Participants can receive a malaria RDT for a set amount (i.e., not for free).
Primary Outcome Measure Information:
Title
Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test
Description
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.
Time Frame
Within two days of group assignment
Secondary Outcome Measure Information:
Title
Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)
Time Frame
Within 2 days of group assignment
Title
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 Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy O'Meara, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moi University
City
Eldoret
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
28588946
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.
Results Reference
derived

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

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