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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02199977
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : December 15, 2015
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Moi University
Information provided by (Responsible Party):
Duke University

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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).




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199977


Locations
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Kenya
Moi University
Eldoret, Kenya
Sponsors and Collaborators
Duke University
National Institute of Allergy and Infectious Diseases (NIAID)
Moi University
Investigators
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Principal Investigator: Wendy O'Meara, PhD Duke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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:
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Malaria
Protozoan Infections
Parasitic Diseases