Next-Day HIV Viral Load Test Result and Linkage to Care Among Persons Living With or at Risk of HIV: A Randomized Clinical Trial.

Importance: HIV viral load (VL) testing is essential for monitoring responses to antiretroviral therapy (ART) among people with HIV (PWH) and prior to the initiation of HIV preexposure prophylaxis (PrEP). In the US, the potential benefit of implementing HIV VL testing in these scenarios on linkage to care (LTC) has not been evaluated. Objectives: To investigate whether providing laboratory-based HIV VL test results changed LTC rates or time to linkage for ART or PrEP across 12 weeks. Design, Setting, and Participants: This randomized clinical trial was conducted from August 18, 2021, to February 2, 2023, with 12 weeks of follow-up. Participants were a convenience sample of adults with risk factors for HIV acquisition or PWH not taking daily ART, all of whom were recruited from an academic center emergency department in Baltimore, Maryland, and via social media advertising. Interventions: Participants were randomized 1:1 to receive a laboratory-based plasma HIV VL test with next-day results in addition to the standard of care HIV antigen/antibody test result (intervention) or to receive the standard of care HIV antigen/antibody assay alone (control). Main Outcomes and Measures: The primary outcome was LTC for ART or PrEP within 12 weeks of enrollment. Secondary outcomes included time to LTC and differences in LTC by HIV status. Analyses were conducted using the intention-to-treat population. Results: Of 1105 potential participants screened, 195 (17.6%) were enrolled (median [IQR] age 36, [27-47] years; 119 [61.0%) male; 112 [57.4%] Black or African American, 51 (26.2%) White, and 32 (16.4%) other race and ethnicity; and 34 [17.4%] PWH). By week 12, 93 participants (47.7%) completed follow-up, and 69 (35.4%) were linked to care (38 of 69 [55.1%] in the intervention group vs 31 of 69 [44.9%] in the control group). Overall, there was no statistically significant difference in LTC between the intervention and control group (hazard ratio, 1.28 [95% CI, 0.80-2.05]; P = .31]). In a modified intention-to-treat analysis, time to LTC was significantly less for PWH in the intervention group (log-rank P = .03). Conclusions and Relevance: In this randomized clinical trial assessing the effects of HIV VL test results on LTC, providing a next-day HIV VL test result did not change LTC overall. More data are required to ascertain whether a rapid point-of-care HIV VL test would improve LTC. Trial Registration: ClinicalTrials.gov Identifier: NCT04793750https://clinicaltrials.gov/study/NCT04793750.