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Trial Status
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Before
in_development
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on_going
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Abstract
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Before
We investigate the impact of targeted subsidies and incentives for malaria rapid diagnostic testing (RDT) and treatment on demand, sales and stocking decisions, and patient health outcomes, using a novel digital platform in Kenya. We propose a two-phased randomized trial to evaluate the effectiveness of patient subsidies and provider performance incentives on uptake of RDTs and medication targeting in private sector Kenyan pharmacies. The first phase will test four patient subsidies for RDTs and diagnosis-conditional subsidies for qualified ACTs (compared to no subsidy) in an RCT with interventions assigned at the patient level in a sample of eligible pharmacies. In a second phase, we will introduce patient subsidies and pharmacist/attendant performance incentives and compare their effectiveness to each other and to the status quo in a cluster-randomized control trial, with interventions at the pharmacy level. Our findings will contribute to the literature on the use of subsidies, performance incentives, and digital technology on targeted treatments.
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After
We investigate the impact of targeted subsidies and incentives for malaria rapid diagnostic testing (RDT) and treatment on demand, sales and stocking decisions, and patient health outcomes, using a novel digital platform in Kenya. This study investigates the impact of differentially targeted incentives for malaria rapid diagnostic testing (RDT) and appropriate malaria treatments on RDT uptake and medication targeting. We use a novel digital platform designed for use in a network of private pharmacies in Kenya. We cross-randomize patient subsidies and pharmacy performance incentives and compare their effectiveness to each other and to the status quo in a cluster-randomized control trial. Our findings will contribute to the literature on the use of subsidies, performance incentives, and digital technology on targeted treatments.
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Trial Start Date
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November 16, 2020
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June 02, 2021
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Last Published
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Before
December 16, 2020 09:49 AM
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After
July 09, 2021 10:51 AM
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Intervention (Public)
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Before
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After
The four intervention arms are as follows:
1. Control group: pharmacy is an active user of the basic sales and inventory management digital platform, and pharmacy manages own stock of malaria diagnostic tests and treatments
2. Patient subsidy group: In addition to the features present at control pharmacies, the clients who seek care for suspected malaria cases (for themselves or a household member present with them) will be eligible for a subsidized mRDT (90% subsidy) and a subsidized qualified ACT (80% subsidy) conditional on a confirmed positive malaria diagnosis. Pharmacies in this group will register all patients who elect to access these subsidies in the malaria case management digital platform
3. Pharmacy incentive group: In addition to the features present at control pharmacies, the pharmacies will receive an incentive to administer the mRDT (90 Kes), and an additional incentive to prescribe qualified ACTs to malaria-positive patients (80 Kes). Pharmacy staff will receive a 30 Kes incentive for recording transaction information in the malaria case management platform.
4. Combined group: In addition to the features present at control pharmacies, the clients are eligible for discounted mRDTs (60% subsidy) and discounted qualified ACTs conditional on a positive test result (60% subsidy). Pharmacies will receive an incentive to administer the mRDT (20 Kes), and an additional incentive to prescribe qualified ACTs to malaria-positive patients (15 Kes). Pharmacy staff will receive a 30 Kes incentive for recording transaction information in the malaria case management platform.
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Intervention Start Date
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Before
November 16, 2020
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After
July 19, 2021
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Intervention End Date
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Before
August 31, 2021
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After
December 31, 2021
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Primary Outcomes (End Points)
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Before
The primary endpoints are uptake of malaria diagnostic tests (RDTs) and WHO-prequalified ACTs in pharmacies.
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After
The primary endpoints are uptake of malaria diagnostic tests (RDTs) and the proportion of ACTs that are sold to malaria-positive patients as measured through RDT result (appropriate treatment targeting).
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Experimental Design (Public)
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Before
Phase 1: A sample of 60 pharmacies that are active users of a digital sales/inventory management platform will be selected from malaria-endemic areas in Kenya. Patients who seek care at participating pharmacies will be randomized into one of four possible subsidy groups or a control group which receives no subsidy for RDTs and qualified ACTs. Subsidies on qualified ACTs are conditional on a positive malaria diagnosis by RDT.
Phase 2: A sample of 200 eligible pharmacies in malaria-endemic areas in Kenya will be randomized into one of four study arms: (1) a control group, (2) a patient subsidy group, which offers subsidized prices for RDTs and qualified ACTs, (3) a performance incentive group, which provides small financial incentives to pharmacists/attendants for adhering to malaria clinical guidelines when making treatment recommendations to clients, and (4) a hybrid group, which includes both the performance incentive and patient subsidy.
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After
A sample of 180 eligible pharmacies in malaria-endemic areas in Kenya will be randomized into one of four study arms: (1) a control group, (2) a patient subsidy group, which offers subsidized prices for RDTs and qualified ACTs, (3) a pharmacy incentive group, which provides small financial incentives to pharmacists/attendants for adhering to malaria clinical guidelines when making treatment recommendations to clients, and (4) a hybrid group, which includes both the pharmacy incentive and patient subsidy.
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Randomization Method
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Before
Randomization is done by random number generator.
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Stratified randomization will be conducted using the randtreat package in Stata 16.
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Randomization Unit
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Before
Phase 1: individual-level randomization for subsidy levels for RDTs and qualified ACTs.
Phase 2: cluster-level randomization at the pharmacy level
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After
Cluster-level randomization at the pharmacy level (stratified by lake endemic county, urbanicity, and malaria sales volumes)
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Planned Number of Clusters
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Before
Phase 1: 10,000 individuals (not clustered)
Phase 2: 200 pharmacies
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180 pharmacies
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Planned Number of Observations
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Before
Phase 1: 10,000 individuals
Phase 2: 12,000 individuals
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After
14,400 eligible pharmacy clients (3,600 per arm)
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Sample size (or number of clusters) by treatment arms
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Before
Phase 1: 2000 individuals control (no subsidy offer), 2000 individuals high RDT + high ACT subsidy offer, 2000 individuals high RDT + low ACT subsidy offer, 2000 individuals low RDT + high ACT subsidy offer, 2000 individuals low RDT + low ACT subsidy offer.
Phase 2: 50 sites control, 50 sites patient subsidy, 50 sites performance incentive, 50 sites hybrid patient subsidy & performance incentive
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After
45 sites control, 45 sites patient subsidy, 45 sites pharmacy incentive, 45 sites hybrid patient subsidy & pharmacy incentive
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Power calculation: Minimum Detectable Effect Size for Main Outcomes
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Before
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With 180 pharmacies, and 80 eligible pharmacy clients with suspected malaria/site (and assuming that 80% of these clients receive an ACT), we expect to have a final sample of 14,400 individuals (3,600 per group). Assuming an intra-class correlation (ICC) of 0.16 for RDT uptake and 0.14 for ACT targeting, we will be able to detect a minimum of a 15-percentage point increase in each of our two main outcomes between each group.
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Keyword(s)
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Health
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Health
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Secondary Outcomes (End Points)
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Before
Other key endpoints are the proportion of malaria-positive patients that take ACTs (appropriate treatment targeting) and the proportion of malaria-negative patients that take ACTs (over-treatment).
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After
Other key endpoints are uptake of WHO-prequalified ACTs and the proportion of antimalarials that are sold to malaria-negative patients as measured through RDT result.
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