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Improving rational use of ACTs through diagnosis-dependent subsidies: Evidence from a cluster-randomized controlled trial in western Kenya.
PLoS Med. 2018 07; 15(7):e1002607.PM

Abstract

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 nonmalaria 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 approximately 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 (RDTs) on demand for any individual >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 4 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 (GEEs) to account for clustering with prespecified 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. A total of 7,416 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 = 4,653). The gender of enrolled participants was balanced in children (49.8%, n = 2,318 boys versus 50.2%, n = 2,335 girls), but more adult women were enrolled than men (78.0%, n = 2,139 versus 22.0%, n = 604). At baseline, 67.6% (n = 1,362) 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 [RD] = 9 percentage points [pp]; 95% CI 2-15 pp; p = 0.015; adjusted risk ratio [RR] = 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 (ARR 1.40; 95% CI 1.19-1.64; p < 0.001). 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.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02461628.

Authors+Show Affiliations

Department of Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America. Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America. Moi University School of Public Health, College of Health Sciences, Eldoret, Kenya.Moi University School of Public Health, College of Health Sciences, Eldoret, Kenya.Moi University School of Medicine, College of Health Sciences, Eldoret, Kenya. Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya.Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America. Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, United States of America.Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America.Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America. Department of Economics, Duke University, Durham, North Carolina, United States of America.Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya.Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America. Department of Economics, Duke University, Durham, North Carolina, United States of America. Sanford School of Public Policy, Duke University, Durham, North Carolina, United States of America.Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America. Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, United States of America.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

30016316

Citation

Prudhomme O'Meara, Wendy, et al. "Improving Rational Use of ACTs Through Diagnosis-dependent Subsidies: Evidence From a Cluster-randomized Controlled Trial in Western Kenya." PLoS Medicine, vol. 15, no. 7, 2018, pp. e1002607.
Prudhomme O'Meara W, Menya D, Laktabai J, et al. Improving rational use of ACTs through diagnosis-dependent subsidies: Evidence from a cluster-randomized controlled trial in western Kenya. PLoS Med. 2018;15(7):e1002607.
Prudhomme O'Meara, W., Menya, D., Laktabai, J., Platt, A., Saran, I., Maffioli, E., Kipkoech, J., Mohanan, M., & Turner, E. L. (2018). Improving rational use of ACTs through diagnosis-dependent subsidies: Evidence from a cluster-randomized controlled trial in western Kenya. PLoS Medicine, 15(7), e1002607. https://doi.org/10.1371/journal.pmed.1002607
Prudhomme O'Meara W, et al. Improving Rational Use of ACTs Through Diagnosis-dependent Subsidies: Evidence From a Cluster-randomized Controlled Trial in Western Kenya. PLoS Med. 2018;15(7):e1002607. PubMed PMID: 30016316.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improving rational use of ACTs through diagnosis-dependent subsidies: Evidence from a cluster-randomized controlled trial in western Kenya. AU - Prudhomme O'Meara,Wendy, AU - Menya,Diana, AU - Laktabai,Jeremiah, AU - Platt,Alyssa, AU - Saran,Indrani, AU - Maffioli,Elisa, AU - Kipkoech,Joseph, AU - Mohanan,Manoj, AU - Turner,Elizabeth L, Y1 - 2018/07/17/ PY - 2018/02/08/received PY - 2018/06/08/accepted PY - 2018/7/18/entrez PY - 2018/7/18/pubmed PY - 2019/4/10/medline SP - e1002607 EP - e1002607 JF - PLoS medicine JO - PLoS Med VL - 15 IS - 7 N2 - 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 nonmalaria 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 approximately 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 (RDTs) on demand for any individual >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 4 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 (GEEs) to account for clustering with prespecified 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. A total of 7,416 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 = 4,653). The gender of enrolled participants was balanced in children (49.8%, n = 2,318 boys versus 50.2%, n = 2,335 girls), but more adult women were enrolled than men (78.0%, n = 2,139 versus 22.0%, n = 604). At baseline, 67.6% (n = 1,362) 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 [RD] = 9 percentage points [pp]; 95% CI 2-15 pp; p = 0.015; adjusted risk ratio [RR] = 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 (ARR 1.40; 95% CI 1.19-1.64; p < 0.001). 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02461628. SN - 1549-1676 UR - https://www.unboundmedicine.com/medline/citation/30016316/Improving_rational_use_of_ACTs_through_diagnosis_dependent_subsidies:_Evidence_from_a_cluster_randomized_controlled_trial_in_western_Kenya_ L2 - https://dx.plos.org/10.1371/journal.pmed.1002607 DB - PRIME DP - Unbound Medicine ER -