Antiretroviral therapy (ART) is needed across the lifetime to maintain viral suppression for people living with HIV. In South Africa, obstacles to reliable access to ART persist and are magnified in rural areas, where HIV services are also typically costlier to deliver. A recent pilot randomized study (the Deliver Health Study) found that home-delivered ART refills, provided at a low user fee, effectively overcame logistical barriers to access and improved clinical outcomes in rural South Africa. In the present costing study using the payer perspective, we conducted retrospective activity-based micro-costing of home-delivered ART within the Deliver Health Study and when provided at-scale (in a rural setting), and compared to facility-based costs using provincial expenditure data (covering both rural and urban settings). Within the context of the pilot Deliver Health Study which had an average of three deliveries per day for three days a week, home-delivered ART cost (in 2022 USD) $794 in the first year and $714 for subsequent years per client after subtracting client fees, compared with $167 per client in provincial clinic-based care. We estimated that home-delivered ART can reasonably be scaled up to 12 home deliveries per day for five days per week in the rural setting. When delivered at scale, home-delivered ART cost $267 in the first year and $183 for subsequent years per client. Average costs of home delivery further decreased when increasing the duration of refills from three-months to six- and 12-month scripts (from $183 to $177 and $135 per client, respectively). Personnel costs were the largest cost for home-delivered refills while ART drug costs were the largest cost of clinic-based refills. When provided at scale, home-delivered ART in a rural setting not only offers clinical benefits for a hard-to-reach population but is also comparable in cost to the provincial standard of care.

RVB declares support from the U.S. National Institutes of Health, and the Bill and Melinda Gates Foundation. Regeneron Pharmaceuticals covered the cost of abstract and manuscript writing outside the submitted work. RVB serves on a Gilead Sciences Data Monitoring Committee for which she receives an honorarium. AVH declares support from the U.S. National Institutes of Health, and the Bill and Melinda Gates Foundation. Outside the submitted work, MS declares payments to institution from the National Pharmaceutical Council and consulting fees for data analysis used by the Pharmaceutical Care Management Association. For the remaining authors none were declared.

ClinicalTrials.gov Identifier: NCT04027153

The Deliver Health Study was funded by the U.S. National Institute of Mental Health (NIMH) (R21MH115770) and awarded to RVB and AVH. AST received support through an administrative diversity supplement from NIMH (R01MH124465-02S1). The funder had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Human Sciences Research Council Research Ethics Committee in South Africa (REC 1/21/11/18) and the University of Washington Institutional Review Board in Seattle, Washington, U.S. approved this study (STUDY00005739). All study participants provided written informed consent per local Institutional Review Board requirements.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

The Deliver Health Study human research participant data cannot be shared publicly because of participant locator information. Data are available from Mr. Torin Schaafsma (ttss@uw.edu) at the University of Washington International Clinical Research Center for researchers who meet the criteria for access to confidential data.