| Summary: | <p><strong>Background:</strong> Data is required regarding the feasibility of conducting a randomised trial of <span data-value="point-of-care">point-of-care</span> <span data-value="viral load">viral load</span> (VL) testing to guide management of <span data-value="HIV">HIV</span> viraemia, and to provide estimates of effect to guide potential future trial design.</p>
<p><strong>Setting:</strong> Two public South African clinics during the dolutegravir-based antiretroviral therapy (ART) rollout.</p>
<p><strong>Methods:</strong> We randomised adults receiving first-line ART, with recent VL ≥1000 copies/mL, in a 1:1 ratio to receive <span data-value="point-of-care">point-of-care</span> Xpert <span data-value="HIV">HIV</span>-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.</p>
<p><strong>Results:</strong> 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, <span data-value="point-of-care">point-of-care</span> 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%) <span data-value="point-of-care">point-of-care</span> 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]) <span data-value="point-of-care">point-of-care</span> participants achieved VL <50 copies/ml versus 29/40 (72.5% [57.0-83.9]) standard-of-care participants. <span data-value="Point-of-care">Point-of-care</span> participants had median 3 (IQR 3-4) clinic visits versus 4 (IQR 4-5) in standard-of-care (p<0.001).</p>
<p><strong>Conclusions:</strong> It was feasible to conduct a trial of <span data-value="point-of-care">point-of-care</span> VL testing to manage viraemia. <span data-value="Point-of-care">Point-of-care</span> VL lead to quicker results and fewer clinical visits, but estimates of 24-week VL suppression were similar between arms.</p>
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