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

Preprint

Background Community antiretroviral therapy (ART) delivery programmes allow people living with HIV (PLWH) to collect treatment nearer to home rather than having to attend clinics. However, delays in laboratory based viral load (VL) testing can prevent timely assessment of eligibility for community ART prescription renewals. We aimed to determine if point-of-care VL testing in the clinic could prevent delayed renewal of community ART prescriptions within the Centralised Chronic Medication Dispensing and Distribution programme (CCMDD) in South Africa.

Methods We conducted an open-label, randomised controlled trial of point-of-care VL testing versus standard laboratory-based VL testing among PLWH who needed renewal of their community ART CCMDD prescription in a single clinic in Durban, South Africa. The primary outcome was renewal of community ART CCMDD prescription by three weeks.

Results We enrolled 200 participants between August 15th, 2022 and August 24th, 2023. Median age was 44 years (interquartile range [IQR] 37-49), and 65.5% were female. In the intervention arm, 93/100 (93.0%) of participants had a community ART CCMDD prescription renewal within three weeks, compared to 81/100 (81.0%) in the standard-of-care arm (risk difference [RD] 12.0%, 95% confidence interval [CI] 2.9 to 21.2%, p=0.021). Participants received their enrolment VL results after a median of 0 days (IQR 0 to 0) in the intervention arm 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). The mean number of clinic visits required for community ART CCMDD prescription renewal 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 travel cost to participants to have their CCMDD prescription renewed (South African Rands [ZAR] 47.7 versus ZAR 72.8, RD ZAR -25.1 [95% CI -9.2 to -41.1]).

Conclusions Point-of-care VL testing improved renewal of community ART prescriptions in South Africa, by reducing time to results for healthcare workers and clients, and reducing the number of clinic visits and associated travel costs.

Trial registration Pan-African Clinical Trials Registry: PACTR202002785960123

Authors: Dorward, J; Tlhaku, K; Sookrajh, Y; Munatsi, P; Naidoo, J

• Publication status: Published
• Peer review status: Not peer reviewed
• Preprint server: medRxiv
• Publication date: 2025-05-21
• DOI: 10.1101/2025.05.20.25327934
• Language: English
• Keywords: CCMDD; HIV; point-of-care; viral load; differentiated antiretroviral therapy delivery; primary care