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

Not Applicable

Completed

Conditions: Fever
Malaria

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

Registration Number: NCT02461628

Lead Sponsor: Duke University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Malaria RDT & conditional voucher	Malaria RDT & conditional voucher for ACT from retail sector	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source	6 months, 12 months, 18 months

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Fever That Received Correct Treatment	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).
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)	6 months, 12 months, 18 months	Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.