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

Duke University

Status: Completed

Conditions: Fever; Malaria

Treatments: Behavioral: Malaria RDT & conditional voucher for ACT from retail sector

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02461628

Pro00063384

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

Details and patient eligibility

About

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.

Enrollment: 40,340 patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40,340 participants in 2 patient groups

Malaria RDT & conditional voucher

Experimental group

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.

Treatment:

Behavioral: Malaria RDT & conditional voucher for ACT from retail sector

Comparison Arm

No Intervention group

Description:

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