Abstract

Background: The scale-up of “HIV test and treat” has rapidly increased the number of persons on antiretroviral therapy (ART) requiring treatment monitoring in low-resource settings. Decentralized point-of-care (POC) testing for ART monitoring may alleviate burden on centralized laboratories and improve clinical outcomes, but its cost-effectiveness is unknown. Methods: We used primary cost and effectiveness data from the STREAM trial in South Africa, which assessed the impact of POC testing for viral load, CD4 count, and creatinine, with task-shifting from professional to lower-cadre registered nurses compared to laboratory-based testing without task-shifting. We parameterized an agent-based network model, EMOD-HIV, to project the impact of implementing this intervention in South Africa. We assumed POC monitoring increased viral suppression by 9%, enrollment into community-based ART delivery by 25%, and switching to second-line ART by 1%, as reported in STREAM. We evaluated POC scale-up in varying clinic sizes (10-50 patient initiating ART/month) over a 20-year time horizon. We used a cost-effectiveness threshold of $500 USD/disability adjusted life year (DALY) averted for our main analysis. Results: Implementing POC testing at 70% coverage of ART patients was projected to reduce HIV infections by 4.5% and HIV-related deaths by 3.9%. In clinics with 30 ART initiations/month, the intervention was associated with an incremental cost-effectiveness ratio (ICER) of $197/DALY averted; results remained cost-effective when varying background viral suppression, ART dropout, and intervention effectiveness within the 95% confidence bound of the trial results. Assuming POC testing did not increase enrollment into community ART delivery produced an ICER of $1,149, exceeding the cost-effectiveness threshold. At higher clinic volumes (≥40 ART initiations/month), POC testing was cost-saving compared to standard-of-care. At lower clinic volumes (20 patients initiated on ART/month) the ICER was $734/DALY averted. Conclusions: POC testing for ART monitoring with task-shifting is projected to be cost-effective in moderately-sized clinics in South Africa. Funding Statement: This study was funded by the U.S. National Institute of Allergy and Infectious Diseases (R21AI124719 and R01AI147752). MS received support from NIMH K01MH115789 Declaration of Interests: Dr. Paul Drain reports receiving consulting or speaking fees from Gilead Science and Cepheid, and research support from the NIH, CDC, Gilead Sciences, and the Bill and Melinda Gates Foundation, during the conduct of the study. Dr. Abdool Karim reports grants from the NIH during the conduct of the study. All authors declare that they have no competing interests. Ethics Approval Statement: Missing.

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