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

Study Overview
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Brief Summary
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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.

Official Title
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Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector

Conditions
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Fever, Malaria

Intervention / Treatment
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* Behavioral: Malaria RDT & conditional voucher for ACT from retail sector


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Malaria RDT & conditional voucher<br>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<br>* 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<br>|
| No Intervention: Comparison Arm<br>Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With a Fever Who Receive a Malaria Test From Any Source |  | 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 |  | 6 months, 12 months, 18 months | 
| Number of Participants Using an ACT Who Did Not Have a Test |  | 6 months, 12 months, 18 months | 
| 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. | 6 months, 12 months, 18 months | 
| 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). | 6 months, 12 months, 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community health workers, Malaria, Antimalarial subsidy, Malaria rapid diagnostic test (RDT), Public-private partnership