Point-of-care viral load testing to manage HIV viraemia during the rollout of dolutegravir-based ART in South Africa: a randomised feasibility study (POwER).

Abstract

Data is required regarding the feasibility of conducting a randomised trial of point-of-care viral load (VL) testing to guide management of HIV viraemia, and to provide estimates of effect to guide potential future trial design. Two public South African clinics during the dolutegravir-based antiretroviral therapy (ART) rollout. We randomised adults receiving first-line ART, with recent VL ≥1000 copies/mL, in a 1:1 ratio to receive point-of-care Xpert HIV-1 VL versus standard-of-care laboratory VL testing, after 12 weeks. Feasibility outcomes included proportions of eligible patients enrolled and completing follow-up, and VL process outcomes. Estimates of effect were assessed using the trial primary outcome of VL <50 copies/mL after 24 weeks. From August 2020-March 2022 we enrolled 80 eligible participants, an estimated 24% of those eligible. 47/80 (58.8%) were women, and median age was 38.5 years (IQR 33-45). 44/80 (55.0%) were receiving dolutegravir and 36/80 (465.0%) were receiving efavirenz. After 12 weeks, point-of-care participants received VL results after median 3.1 hours (IQR 2.6-3.8), versus 7 days (IQR 6-8, p<0.001) in standard-of-care. 12-week follow-up VL was ≥1000 copies/mL in 13/39 (33.3%) point-of-care participants and in 16/41 (39.0%) standard-of-care participants; 11/13 (84.6%) and 12/16 (75.0%) switched to second-line ART respectively. After 24 weeks, 76/80 (95.0%) completed follow-up. 27/39 (69.2% [95%CI 53.4-81.4]) point-of-care participants achieved VL <50 copies/ml versus 29/40 (72.5% [57.0-83.9]) standard-of-care participants. Point-of-care participants had median 3 (IQR 3-4) clinic visits versus 4 (IQR 4-5) in standard-of-care (p<0.001). It was feasible to conduct a trial of point-of-care VL testing to manage viraemia. Point-of-care VL lead to quicker results and fewer clinical visits, but estimates of 24-week VL suppression were similar between arms.