Interpretation
viral suppression, viremia
RECRUITMENT, VIREMIA
The major feasibility challenge was enrolment, with an estimated 23.7% of potentially eligible patients enrolled. Disruptions during COVID-19 waves, with staff shortages due to illness/self-isolation, sometimes halted recruitment efforts and hampered clinical processes to track and call back patients with viremia for referral to study staff. It also led to delays that meant we were only able to open the second study site once we had nearly enrolled to target. Therefore, only 2 participants were enrolled at this site. Among participants who were enrolled, retention was good. It may be that these participants were more engaged in the clinic, and therefore more likely to be retained in care, than the average person with viremia.This study was not powered to detect an improvement in the primary outcome of viral suppression between the point-of-care and standard laboratory testing arms, where we cannot rule out a difference. However, the point estimates were very similar between the 2 arms. Point-of-care testing was generally conducted in a timely manner, but there are several reasons which could explain why this did not translate into a difference in the point estimates of 24-week viral resuppression. First, viremia was managed well in the standard-of-care arm. The results were provided to participants after a median 7 days and those requiring second-line ART were switched after a median 10 days. These results contrast sharply with other South African studies that found long delays of 14–68 weeks until switching to second-line ART.Among participants who were receiving efavirenz-based regimens at enrolment, a higher proportion were transitioned/switched to dolutegravir in the intervention arm. This was likely because of the higher proportion of participants with 12-week VL <50 copies/mL in this arm, making clinicians more comfortable to transition to dolutegravir. Reasons for the difference in 12-week VL suppression between the point-of-care and laboratory assay are not clear because we have found the Xpert HIV-1 VL to be sensitive and specific at a VL threshold of 50 copies/mL.