DOI: 10.5061/dryad.59p4111
title: Data from: Improving rational use of ACTs through diagnosis-dependent subsidies: evidence from a cluster-randomized controlled trial in western Kenya

description: Background: More than half of artemisinin combination therapies (ACTs)
 consumed globally are dispensed in the retail sector where diagnostic
 testing is uncommon, leading to overconsumption and poor targeting. In
 many malaria-endemic countries, ACTs sold over-the-counter are available
 at heavily subsidized prices, further contributing to their misuse.
 Inappropriate use of ACTs can have serious implications for the spread of
 drug resistance and leads to poor outcomes for non-malaria patients
 treated with incorrect drugs. We evaluated the public health impact of an
 innovative strategy that targets ACT subsidies to confirmed malaria cases
 by coupling free diagnostic testing with a diagnosis-dependent ACT
 subsidy. Methods and Findings: We conducted a cluster-randomized
 controlled trial in 32 community clusters in western Kenya (population
 ~160,000). Eligible clusters had retail outlets selling ACTs and existing
 community health worker (CHW) programs and were randomly assigned 1:1 to
 control and intervention arms. In intervention areas, CHWs were available
 in their villages to perform malaria rapid diagnostic tests on demand for
 any individual &gt;1 year of age experiencing a malaria-like illness.
 Malaria RDT positive individuals received a voucher for a discount on a
 quality-assured ACT, redeemable at a participating retail medicine outlet.
 In control areas, CHWs offered a standard package of health education,
 prevention and referral services. We conducted four population-based
 surveys, at baseline, 6 months, 12 months and 18 months, of a random
 sample of households with fever in the last 4 weeks to evaluate
 predefined, individual-level outcomes. The primary outcome was uptake of
 malaria diagnostic testing at 12 months. The main secondary outcome was
 rational ACT use, defined as the proportion of ACTs used by test-positive
 individuals. Analyses followed the intention-to-treat principle using
 generalized estimating equations to account for clustering with
 pre-specified adjustment for gender, age, education and wealth. All
 descriptive statistics and regressions were weighted to account for
 sampling design. Between July 2015 and May 2017, 32,404 participants were
 tested for malaria and 10,870 vouchers were issued. 7416 randomly-selected
 participants with recent fever from all 32 clusters were surveyed. The
 majority of recent fevers were in children under 18 years (62.9%, n=4653).
 The gender of enrolled participants was balanced in children (50.0%,
 n=2318 v 50.2%, n=2335), but more adult women were enrolled than men
 (78.0%, n=2139 v 22.0%, n=604). At baseline, 67.6% (n=1362) of
 participants took an ACT for their illness and 40.3% (n=810) of all
 participants took an ACT purchased from a retail outlet. At 12 months,
 50.5% (n=454) in the intervention arm and 43.4% (n=389) in the control arm
 had a malaria diagnostic test for their recent fever (Adjusted Risk
 Difference=9 percentage points [pp], 95%CI: 2-15pp, p=0.015; Adjusted Risk
 Ratio=1.20, 95%CI:1.05-1.38, p=0.015). By 18-months, the ARR had increased
 to 1.25 (95%CI:1.09-1.44, p=0.005). Rational use of ACTs in the
 intervention area increased from 41.7% (n=279) at baseline to 59.6%
 (n=403) and was 40% higher in the intervention arm at 18 months (Adj RR
 1.40, 95%CI: 1.19-1.64). While intervention effects increased between 12
 and 18 months, we were not able to estimate longer-term impact of the
 intervention and could not independently evaluate the effects of the free
 testing and the voucher on uptake of testing. Conclusions:
 Diagnosis-dependent ACT subsidies and community-based interventions that
 include the private sector can have an important impact on diagnostic
 testing and population-wide rational use of ACTs. Targeting of the ACT
 subsidy itself to those with a positive malaria diagnostic test may also
 improve sustainability and reduce the cost of retail sector ACT subsidies.
  
description: R01_Coupon_Aim_2_Analysis_Data_MAIN_OUTCOMES_v12_20180321Main data file