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

Primary Purpose

Fever, Malaria

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Malaria RDT & conditional voucher for ACT from retail sector
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, Community health workers

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Moi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Malaria RDT & conditional voucher

Comparison Arm

Arm Description

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.

Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.

Outcomes

Primary Outcome Measures

Number of Subjects With a Fever Who Receive a Malaria Test From Any Source

Secondary Outcome Measures

Number of Participants Using ACT Who Had a Positive Test
Number of Participants Using an ACT Who Did Not Have a Test
Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)
Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.
Number of Subjects With Fever That Received Correct Treatment
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).

Full Information

First Posted
May 28, 2015
Last Updated
October 8, 2019
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
NCT02461628
Brief Title
Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)
Official Title
Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 26, 2017 (Actual)
Study Completion Date
July 12, 2017 (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
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.

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, Community health workers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Malaria RDT & conditional voucher
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison Arm
Arm Type
No Intervention
Arm Description
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
Intervention Type
Behavioral
Intervention Name(s)
Malaria RDT & conditional voucher for ACT from retail sector
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source
Time Frame
6 months, 12 months, 18 months
Secondary Outcome Measure Information:
Title
Number of Participants Using ACT Who Had a Positive Test
Time Frame
6 months, 12 months, 18 months
Title
Number of Participants Using an ACT Who Did Not Have a Test
Time Frame
6 months, 12 months, 18 months
Title
Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)
Description
Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.
Time Frame
6 months, 12 months, 18 months
Title
Number of Subjects With Fever That Received Correct Treatment
Description
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).
Time Frame
6 months, 12 months, 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
30016316
Citation
Prudhomme O'Meara W, Menya D, Laktabai J, Platt A, Saran I, Maffioli E, Kipkoech J, Mohanan M, Turner EL. Improving rational use of ACTs through diagnosis-dependent subsidies: Evidence from a cluster-randomized controlled trial in western Kenya. PLoS Med. 2018 Jul 17;15(7):e1002607. doi: 10.1371/journal.pmed.1002607. eCollection 2018 Jul.
Results Reference
derived
PubMed Identifier
28320794
Citation
Laktabai J, Lesser A, Platt A, Maffioli E, Mohanan M, Menya D, Prudhomme O'Meara W, Turner EL. Innovative public-private partnership to target subsidised antimalarials: a study protocol for a cluster randomised controlled trial to evaluate a community intervention in Western Kenya. BMJ Open. 2017 Mar 20;7(3):e013972. doi: 10.1136/bmjopen-2016-013972.
Results Reference
derived

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

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