Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)

October 8, 2019 updated by: Duke University

Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector

The overall objective of this study is to evaluate the public health impact of targeted antimalarials subsidies through scale-up by determining the community-wide effects of targeting an antimalarial subsidy through a partnership between Community Health Volunteers (CHVs) and the private retail sector. The primary hypothesis to be tested is that offering a fixed-price voucher that reduces the cost for artemisinin combination therapy (ACT) purchase in the retail sector conditional on a positive malaria test (targeted subsidy) can improve uptake of testing for malaria and will increase the proportion of fevers tested for malaria before treatment. The study will be carried out in two sub-counties in Kenya with similar malaria burden but different access to health services; the investigators will use a cluster-randomized design to assign community units (CUs) in each sub-county to either an intervention or control arm. CHVs will be trained to use malaria rapid diagnostic tests (RDTs) to diagnose malaria in household members with documented or reported fever; households in intervention CUs will be informed of the intervention and encouraged to contact the CHV for any febrile illness in the home. There are minimal risks associated with receiving an RDT. Households with a positive RDT will be given a serialized voucher that will entitle the holder to purchase a quality assured ACT in the retail sector at a reduced, fixed price. The primary and secondary outcome measures will be compared at baseline and 12 months post-baseline through population-based surveying. The primary aim is to determine whether there is significant difference between the 2 study arms in the proportion of clients with fever who are tested prior to any treatment after adjusting for relevant covariates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Eldoret, Kenya
        • Moi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

Intervention participation 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 2 days
  • Client or their parent/legal guardian (if under 18) consents to participate

Cross sectional survey participation criteria:

  • Household representative in the intervention or control arm
  • At least one member in the respondent's household with a history of fever or feeling unwell with a malaria like illness within the last four weeks
  • Respondent is older than 18 years

EXCLUSION CRITERIA

Intervention exclusion criteria:

  • Client has signs of severe disease or other problem requiring immediate referral to a health facility
  • Client has already visited a health facility, taken or purchased antimalarials for the current illness.

Cross sectional survey exclusion criteria:

• Households not in the intervention or control arms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Malaria RDT & conditional voucher
In the intervention arm, trained community health volunteers (CHVs) will offer eligible household members a free malaria rapid diagnostic test (RDT) and a voucher allowing the purchase of a qualified artemisinin combination therapy (ACT) at a reduced fixed price in the retail sector conditional on a positive test.
Behavioral: Malaria RDT & conditional voucher for ACT from retail sector
Trained community health volunteers will offer eligible household members free malaria rapid diagnostic tests and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test
No Intervention: Comparison Arm
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source
Time Frame: 6 months, 12 months, 18 months
6 months, 12 months, 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Using ACT Who Had a Positive Test
Time Frame: 6 months, 12 months, 18 months
6 months, 12 months, 18 months
Number of Participants Using an ACT Who Did Not Have a Test
Time Frame: 6 months, 12 months, 18 months
6 months, 12 months, 18 months
Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)
Time Frame: 6 months, 12 months, 18 months
Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.
6 months, 12 months, 18 months
Number of Subjects With Fever That Received Correct Treatment
Time Frame: 6 months, 12 months, 18 months
The number of people with fever that report receiving correct treatment with regards to malaria (i.e., received an RDT test and took ACTs if the result was positive, or did not take ACTs if the test result was negative).
6 months, 12 months, 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

May 26, 2017

Study Completion (Actual)

July 12, 2017

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00063384
  • 5R01AI110478 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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