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Official websites use. Share sensitive information only on official, secure websites. This work is licensed under a Creative Commons Attribution 4. The license allows for commercial use. ACTs are responsible for a substantial proportion of the global reduction in malaria mortality over the last ten years. These reductions would not have been possible without publicly-funded subsidies making these drugs accessible and affordable in the private sector. However, inexpensive ACTs available in retail outlets have contributed substantially to their overconsumption. We test an innovative, scalable, and sustainable strategy to target ACT subsidies to clients with a confirmatory diagnosis. We supported point-of-care malaria testing mRDTs in 39 retail medicine outlets in western Kenya and randomized them to three study arms; control arm offering subsidized RDT testing for 0. Our primary outcome was the proportion of ACT dispensed to individuals with a positive diagnostic test. Secondary outcomes included proportion of clients tested at the outlet and adherence to diagnostic test results. Test results informed treatment decisions and resulted in targeting of ACTs to confirmed malaria cases — Clients were often unaware of the price they paid for the ACT leading to uncertainty in whether the ACT subsidy was passed on to the client. We conclude that mRDTs could reduce ACT overconsumption in the private retail sector, but incentive structures are difficult to scale and their value to private providers is uncertain. Each year, approximately one third of the more than million cases of malaria world-wide 1 , and hundreds of millions of cases of non-malaria febrile illness, seek care at chemists, pharmacies and drug shops, often referred to collectively as the private retail health sector. In most malaria-endemic countries, first-line artemisinin combination therapies ACTs for malaria treatment are widely available over-the-counter OTC in the retail health sector. When first introduced in the s, prices for ACTs were very high, requiring subsidies to make them accessible to most malaria patients. Curbing inappropriate use and targeting ACTs to malaria cases requires parasitological diagnosis which is virtually absent in the retail sector in most endemic countries 5. Several studies have explored the potential role of malaria rapid diagnostic tests mRDTs in improving case management in the retail sector, with mixed results 10 , Uptake of testing was found to be very sensitive to both the price of the mRDT itself as well as the price of the ACT. Higher testing rates were observed when the price of the drug was very high relative to the price of the test. These studies show that fixed low prices of the ACT and the mRDT are not sufficient to ensure adequate testing uptake or adherence to the test result. Previous studies in retail outlets share two important features — 1 ACTs were heavily subsidized for all customers and 2 there was no relationship between the mRDT result and the ACT subsidy. We hypothesized that the use of price differentials could attract the provider and the client toward the right diagnostic and treatment course. First, the cost of the mRDT was set below that of the first-line ACT which makes the test an affordable option to determine the need for a more expensive drug. Second, we also used a conditional ACT subsidy whereby clients received a fully subsidized free ACT conditional on a positive malaria diagnostic test result. In the context of a conditional ACT subsidy, information from an mRDT becomes more valuable; a negative test would alleviate the need for an unsubsidized ACT and a positive test would ensure they receive an effective ACT for free. Forty retail medicine outlets clusters were enrolled and randomized to one of three arms: a control arm, a client-directed conditional subsidy arm CD , and an arm with a combined conditional subsidy plus provider incentive CDPD arm. Full details of the study design were previously reported in the study protocol 12 and accompanying amendment by Woolsey et al 13 and are summarized here. The study was conducted in Bungoma and Trans Nzoia counties in western Kenya, where malaria transmission is perennial with seasonal peaks. Previously, we documented in this region that Despite the very large volume of ACTs being obtained in the private retail sector, these outlets are not permitted to conduct mRDTs in Kenya The app was downloaded on a mobile phone offered to all participating outlets. Each outlet received KES 5. Client-directed CD intervention arm: in addition to the interventions implemented in the control outlets, clients visiting retail outlets in this arm who purchase an mRDT and receive a positive test result were eligible to receive a free ACT which was to be provided by the outlet. The outlet would be reimbursed by the study conditional subsidy; cost equivalent to KES or 1. The primary outcome was ACT consumption by parasitologically confirmed malaria cases, defined as the proportion of ACTs that were dispensed to malaria test-positive clients, including those who were tested at the outlet and those who came with documentation of a positive test result either microscopy or mRDT from another provider. Use of malaria rapid diagnostic test: Proportion of suspected malaria cases that received an mRDT at the outlet, where a suspected case was any client who was tested with an mRDT or was untested but purchased an antimalarial AM of any type. Appropriate case management: Proportion of all suspected malaria cases defined as in 1 above that were for malaria with an mRDT at the outlet and adhered to the test results. The primary and secondary outcomes were collected during exit interviews of a random sample of eligible clients leaving retail outlets see Data collection below. Table S1 summarizes the numerator and denominator for each outcome measure. All power calculations were based on a formula from Moulton and Hayes for comparing two proportions under a cluster-randomized trial design with details previously published 12 , Using the conservative Bonferroni correction for our two pre-specified comparisons and using pre-randomization data on malaria testing and treatment behavior reported in the app, we expected to achieve Outlets were mapped, surveyed and enrolled as described in Woolsey et al 12 , Following enrollment, retail outlets were randomized to arms by the study statistician. We started with a list of 40 participating outlets which were randomized to 3 arms. Given 40 outlets cannot be equally allocated to 3 arms, the extra outlet was assigned to the control arm. To avoid potential contamination of treatment effects, randomization was constrained such that any outlets in close proximity were assigned to the same arm. We defined this proximity based on being able to see one outlet when standing at the other, or about 0. In practice, only two pairs of outlets met this criteria, one pair in the control arm and one pair in the CDPD arm. The final number of outlets that completed the study was Two outlets exited after initiation of the intervention, both from the CD arm - one exited after declining to permit exit interviews, and one relocated outside of the study area. One outlet was moved from the control arm to the CD arm and a new outlet was recruited into the CD arm giving 39 outlets equally distributed across the arms. All changes were made within the first five months of data collection and data from the exited outlets is not included in the analysis. Only data from the period following the change of arms is included for the outlet which was moved from control to CD arm. Enrolled outlets were trained on malaria case management guidelines, correct mRDT procedures, and the use of the study mobile app to record client encounter data and take photos of mRDT results. During a brief pilot period, the outlets started collecting data on the mobile app and performing mRDTs. Outlets were monitored closely to make sure testing and app issues were resolved before initiating the intervention. After the three month pilot period, outlets were trained in arm-specific groups on the intervention guidelines for conditional subsidies and provider-directed incentives, as applicable. They were also informed of the exit interview process being conducted outside of their outlet, independently of the client-outlet interaction. Outlets were provided with a small monthly stipend with which they were encouraged to engage a laboratory technician to perform RDTs at the outlet. The study team conducted regular supervision visits over the first six months to deliver mRDT kits, ensure good adherence to testing and safety procedures, troubleshoot challenges with the mobile app and provide onsite mentorship to all outlets. Thereafter, outlets ordered replenishment of mRDT kits as needed with deliveries on one scheduled day each week. Supervision and mentorship were conducted if outlets raised concerns or if there were any abnormal mRDT photographs observed in the encounters submitted via the app. Subsidies and incentives were paid weekly to mobile money accounts of the owners of the intervention outlets. Payments were calculated based on photographs of RDTs uploaded to the study app. For this study, reimbursable AL was any brand of artemether lumefantrine in a tablet formulation not syrup. Outlets were trained how to identify the drug ingredients and most common brands of AL. During the intervention period, we observed that testing rates were lower in our ongoing study than in the pilot study To ensure that clients were aware of the opportunity for testing and the conditional subsidy if applicable , we deployed a client-facing sensitization at approximately the midpoint of the intervention period October , after 10 months of intervention monitoring. For the remaining 9 months, we enlisted local community health workers CHWs to distribute fliers to all clients entering a study outlet on randomly selected days, regardless of why they were visiting the outlet. The message on the flier was tailored to each arm and CHWs were instructed to keep their interaction with entering clients very brief and refer them to the outlet attendant if there were questions. The goal was to ensure clients were aware of the availability of testing and, in the intervention arms, the opportunity for a free AL conditional on a positive test. Interviews were conducted between January 1, and August 31, with clients departing from participating retail outlets on random days of the week. Interviewers were blinded to arm assignment. All clients exiting the outlet that day were eligible to be screened. Clients were invited to participate in the exit interview if the patient experiencing symptoms was present at the outlet and older than 1 year; they were seeking treatment for malaria-like symptoms but did not have any symptoms of severe malaria; and they had not already taken an antimalarial in the last 7 days. For patients under the age of 18, an accompanying parent or guardian was asked to participate as the responding client. Data for participant exit interviews was collected electronically via tablet. Statisticians were blinded to arm identity until analysis was complete. Baseline characteristics were summarized by study arm using means and standard deviations for continuous variables, and counts and percentages for categorical variables. We analyzed all client-level self-reported primary and secondary outcomes using the modified Poisson approach 19 , 20 with Kauermann-Carroll corrected robust standard errors 21 , 22 , with log link to estimate risk ratios RRs and identity link to estimate risk differences RDs. We intended to estimate correlation parameters using the matrix-adjusted estimating equation MAEE approach 26 , but since this approach did not converge, we reverted to standard GEE with method of moments estimation of correlation parameters. All models included fixed effects for the intervention arm indicators, the stratification variable county , and time in months, including linear, quadratic, and cubic terms to account for potential imbalanced recruitment over the month study period referred to as minimally adjusted models. We also present fully adjusted models which include the following variables which may be imbalanced by intervention arm potential confounder variables : client gender, client age, level of schooling, and wealth index. In addition, we pre-specified several sensitivity analyses for the primary outcome. Specifically, 1 to restrict ACT to only AL which was subsidized in the study, 2 to evaluate outcomes before and after expansion of the list of ALs that qualified for the study subsidy, 3 to evaluate outcomes before and after client-facing sensitization. Inference for intervention effects was based on the t -statistic with degrees of freedom given by I — p , where I was the number of clusters retail outlets and p was the number of parameters in the mean model specifically of the cluster-level covariates, including the intercept, treatment indicator, county, and time variables. Given that we have two pre-specified comparisons for each outcome, namely CDPD vs. All analyses were based on the intention-to-treat principle. Since we did not have longitudinal follow-up of clients, we did not need to account for missing data due to attrition of clients. Clients missing specific data elements were excluded from models requiring those variables as indicated in the tables. Overall, missing data was minimal and highest for the household asset questions where 5. The study is registered in ClinicalTrials. Verbal informed consent was obtained from all participants and logged in the REDCap data collection form. Between January and August , data were collected from customers exiting participating retail outlets on 5, outlet-days of observation. Out of 11, individuals approached when exiting the retail outlets, 5, were eligible to participate Of those eligible, 5, consented Participant characteristics were similar across arms. Includes only interviewees who consented and met all inclusion criteria. One participant did not complete enough of the interview to contribute to any of the outcomes, and is not included in this table. Testing rates were similar across wealth quintiles Table S3b , however, the lowest wealth quintiles had lower testing proportions at the outlet Table S2. This number includes 58 interviewees who reported a test from elsewhere and also tested at the outlet. Specifically, ACT consumption was markedly lower among those with a negative malaria test at the outlet Although adult female clients were more likely to test, they did not have higher adherence to test results Table S2. Malaria testing and antimalarial consumption by arm. ACT includes AL plus all other artemisinin-combination therapies. Our primary outcome was chosen to measure the effect of the interventions on both improving testing uptake and targeting of ACTs which should result in a higher proportion of ACTs sold appropriately to test-positive clients. Minimally adjusted and fully adjusted estimates of intervention effects for pre-specified study outcomes. As with the primary outcome, we did not observe any differences between arms for the secondary outcome of malaria testing. Similarly, there was no measurable effect of the intervention on other secondary outcomes of appropriate management and ACT use among untested clients. These changes were not statistically distinguishable from the control arm. In order to understand whether there was variability in the adoption of mRDTs at the study outlets, we examined differences in testing and treatment at the outlet cluster level. The outlets were very diverse with respect to their case management strategy Figure 3. Although integration of testing into their business practices was highly heterogenous, the use of ACT by untested clients was uniformly high with much less variation between clusters Figure 3. Outlets are grouped in columns by arm and ordered by proportion tested from highest top to lowest bottom. Likewise, ACT dispensing to test-negative patients showed stark differences between shops. Less heterogeneity is observed in ACT dispensed to untested clients. Each outlet is shown as a gray line with the arm-specific means shown in color. Few shops declined in testing rates after sensitization but impact on adherence was much more variable. Outlets agreed to offer mRDT testing at a low fixed price to suspected malaria cases. Intervention outlets agreed to implement the intervention by providing free AL to clients who had a positive mRDT result at the outlet. In order to understand the extent to which outlets adhered to these conditional subsidies, we examined the proportion of mRDT-positive clients who reported receiving free AL. Among those reporting a positive malaria diagnostic test at the outlet, the total spent inclusive of test and all drugs, was on average 75— KES higher in the intervention arms in control vs or KES, in CDPD and CD respectively Table 4. Only clients who confirmed receiving a free AL paid less than clients in the control arm KES or 1. Other malaria case management practices may have created competition between the intervention and other services provided by the outlet. Oral ACT was not commonly dispensed with an injection. The goal of the TESTsmART trial was to improve antimalarial stewardship in the retail sector, which has the largest market share of antimalarials in sub-Saharan Africa. In our study, we demonstrate robust testing rates among clients with suspected malaria and substantially improved ACT targeting among tested clients. This could indicate that further reducing the price of the test may increase uptake, as was seen in some studies which offered free mRDTs at retail outlets. Information from the mRDT improved targeting of ACTs, particularly reducing consumption among those with a negative test. The adherence to test results observed in our study is comparable to studies from the formal health sector 33 adding to the evidence that case management is not compromised in retail venues compared to formal health facilities. This was particularly unexpected in intervention arms where AL treatment should have been free to the client. This points to either low confidence in AL as an effective therapy among providers and their clients or, more likely, inconsistent adherence to the subsidy program. We did not find evidence that the client- or provider-directed incentives offered in our study were effective in improving case management in intervention outlets as compared to the outlets in the control arm. However, it is possible that the lack of effect of the conditional subsidy is attributable primarily to poor adherence to the study prescribed subsidy program. There seems to have been very little pass-through of the conditional ACT subsidy to the client based on client reporting of out-of-pocket costs. Given the favorable results from a community-based testing program that distributed a conditional ACT subsidy to the client via retail sector vouchers, we conclude that well-designed incentive programs could be effective but might require direct delivery of the conditional subsidy to the client rather than through the outlet. It is also possible that the provider-directed testing incentives were too modest to increase testing beyond that observed in the control arm, particularly if it was not enough to offset the lost sale of an ACT. Anecdotal feedback from the outlets suggests that this delay could have led outlets to dissociate payments from dispensing behavior. The possibility that outlets pocketed reimbursements intended for clients is consistent with results from a study in Uganda that described outlet owners as surviving in a very competitive and crowded sector. The differences in out-of-pocket costs for clients with a test are striking and are worth examining in light of 1 discussion regarding how incentives might reduce out of pocket costs for clients in the retail sector and 2 the concern on the part of retailers that performing mRDTs could reduce revenue from sales of ACTs. Furthermore, those with a positive test spend on average more than three times more than those without a test. It is possible that clients choose not to test if they have a limited budget that can only cover the cost of the ACT and we cannot assume that, if tested, they would spend as much as other clients who chose to be tested. Overall, these results cast doubt on the concern about lost revenue due to testing or on the prospect of reducing out-of-pocket costs through testing. Although these observations seem like they would encourage providers to offer testing, the increase in testing rates following the client-directed sensitization suggests that testing was not being offered consistently by the outlet attendants. A strength of our study design is the use of exit interviews of randomly selected clients on the day of their visit to the outlet. There are important limitations to consider both in our intended approach and in the study. First, interventions designed to bolster testing in retail outlets can only reach people who visit the outlet and will always miss a significant proportion of suspected malaria cases being treated with drugs purchased on their behalf, for example parents buying medication for a sick child. With respect to our study, we were unable to determine whether the intervention failed to lead to measurable improvement in case management because the incentives were not valuable enough ineffective intervention or because the intervention as it was designed was not implemented. In our previous trial, information from a diagnostic test was given directly to the client as was the voucher for AL conditional incentive. In addition, test results and out of pocket costs were self-reported by the client and may be inaccurate if communication with the client was not clear or was incomplete. A sizable proportion of clients visiting retail outlets are willing to test for malaria resulting in better targeting of ACTs among tested clients. Yet, providing client-directed subsidies through outlets or financial incentives to outlets may not result in additional improvements in testing and treatment if the incentives are not well understood or well aligned with outlet priorities. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funders had no role in study design, execution or analysis of the data. As a library, NLM provides access to scientific literature. This is a preprint. It has not yet been peer reviewed by a journal. Find articles by J Laktabai. Find articles by E Kimachas. Find articles by J Kipkoech. Find articles by D Menya. Find articles by D Arthur. Find articles by Y Zhou. Find articles by T Chepkwony. Find articles by L Abel. Find articles by E Robie. Find articles by M Amunga. Find articles by G Ambani. Find articles by M Woldeghebriel. Find articles by E Garber. Find articles by Nwamaka Eze. Find articles by Pamela Mudabai. Find articles by JA Gallis. Find articles by Chizoba Fashanu. Find articles by I Saran. Find articles by A Woolsey. Find articles by T Visser. Find articles by EL Turner. PMC Copyright notice. The complete version history of this preprint is available at medRxiv. Open in a new tab. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. Interviewees, N 1. Tested b at outlet, n. Primary — ACTs sold to malaria test-positive clients. Secondary 1 -- Suspected malaria cases that receive a mRDT testing uptake. Secondary 2 — Malaria tested clients whose treatment adhered to test results. Secondary 3 — Suspected malaria cases that are managed appropriately. Secondary 4 — Untested clients taking ACT. Positive test at outlet and free AL confirmed. Unknown price of ACT, Positive test at outlet. Unknown price of ACT, Negative test at outlet.

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