Home delivery costs and monitoring of antiretroviral therapy for HIV infection compared to standard clinical services in South Africa: a randomized controlled trial

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Background

Home administration and monitoring of antiretroviral therapy (ART) is convenient, overcomes logistical barriers, and may increase individual adherence to ART and viral suppression. With client payment and sufficient health benefits, this strategy could be scalable. The aim of the Deliver Health study was to test the acceptability and effectiveness of user fees for home ART monitoring and delivery.

Methods

We conducted a randomized trial, the Deliver Health study, of fees for home ART delivery versus free clinic ART delivery in South Africa. HIV-positive individuals aged 18 years or older and clinically stable (including CD4 count >100 cells per μL and WHO HIV stages 1-3) were randomly assigned to: (1) fee for home delivery and monitoring of ART, including community ART initiation if needed; or (2) clinic-based ART (standard of care). One-time fees for home delivery (ZAR 30, 60 and 90; equivalent to USD 2, 4, 6) were tiered based on participants’ income. The primary endpoints were payment of recorded fees and acceptability assessed by means of a questionnaire. The key virological secondary outcome was viral suppression with the difference between study groups assessed by robust Poisson regression including participants with viral load measured at discharge (modified intention-to-treat analysis). This trial is registered on ClinicalTrials.gov (NCT04027153) and is comprehensive, with ongoing analyses.

Results

From October 7, 2019 to January 30, 2020, 162 participants were registered; 82 were randomly assigned to the paid-for-homebirth group and 80 to the clinic group, with similar characteristics at baseline. Overall, 87 (54%) participants were men, 101 (62%) were on ART and 98 (60%) were unemployed. In the home delivery group, 40 (49%), 33 (40%) and nine (11%) participants qualified for the ZAR 30, 60 and 90 fee, respectively. The median follow-up was 47 weeks (IQR 43–50) with 96% retention. 80 (98%) participants paid user fees, with high acceptability and willingness to pay. In the modified intention-to-treat analysis of 155 (96%) participants who completed follow-up, charges for home birth and monitoring statistically significantly increased viral suppression from 74% to 88% in the together (RR 1 21, 95% CI 1 02–1 42); and 64% to 84% in men (1 31, 1 01–1 71).

Interpretation

Among South African adults living with HIV, fees for home birth and ART follow-up significantly increased viral suppression compared to clinic-based ART. Clients paying fees for home delivery and follow-up of ART was quite acceptable in a low-income, high-unemployment setting, and improved health outcomes accordingly. Home-based ART delivery and monitoring, possibly with user fees to offset costs, should be evaluated as a differentiated service delivery strategy to increase access to care.

Funding

National Institutes of Mental Health.

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