Point-of-care HIV viral load testing in a community antiretroviral therapy delivery programme: A randomised controlled trial (PHILA).

Community antiretroviral therapy (ART) delivery programmes allow people with HIV (PWH) to collect treatment nearer to home instead of from clinics. However, delays in laboratory-based viral load (VL) testing can prevent timely community ART prescription renewals. We aimed to determine if clinic point-of-care VL testing could expedite community ART prescription renewals within the Centralised Chronic Medication Dispensing and Distribution programme (CCMDD) in South Africa. We conducted an open-label, randomised controlled trial of point-of-care versus laboratory-based VL testing among PWH who needed community ART CCMDD prescription renewal in one clinic in Durban, South Africa. The primary outcome was community ART CCMDD prescription renewal by three weeks. We enrolled 200 participants between August, 2022 and August, 2023. Median age was 44 years (interquartile range [IQR] 37-49), and 65.5% were female. 93/100 (93.0%) intervention arm participants had a community ART CCMDD prescription renewal within three weeks, versus 81/100 (81.0%) standard-of-care participants (risk difference [RD] 12.0%, 95% confidence interval [CI] 2.9 to 21.2%, p = 0.021). Participants received VL results after a median 0 days (IQR 0-0) in the intervention and 20 days (IQR 7 to not received) in the standard-of-care arm. There was no difference between arms in the proportion retained-in-care between 8 and 16 weeks (89.0% versus 87.0%, RD 2.0% 95% CI -8.0 to 12.0). For community ART CCMDD prescription renewal the mean number of clinic visits required was lower in the intervention arm (1.06) versus the standard-of-care arm (1.60, RD -0.54, 95% CI -0.40 to -0.68), as was the total participant travel cost to participants (South African Rands [ZAR] 47.7 versus ZAR 72.8, RD ZAR -25.1 [95% CI -9.2 to -41.1]). Point-of-care VL testing improved community ART prescription renewals, by reducing time to results, and reducing the number of clinic visits and associated travel costs. Pan-African Clinical Trials Registry: PACTR202002785960123.