CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40,340 enrolled
Drug / intervention
Malaria RDT & conditional voucher for ACT from retail sectorbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT02461628
NCT02461628N/ACompleted

Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector

Duke University·interventional·Posted Jun 3, 2015·Updated Oct 29, 2019

In Brief

A clinical study evaluating Malaria RDT & conditional voucher for ACT from retail sector for Fever and Malaria. Completed, enrolled 40,340 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFever, Malaria
CountriesKenya

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 3, 2015
Enrollment StartJul 1, 2015
Primary CompletionMay 26, 2017
Study CompletionJul 12, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.1 years ago

Interventions

Malaria RDT & conditional voucher for ACT from retail sectorbehavioral

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