Randomized controlled trial of 60-Minutes-for-Health with rapid antiretroviral therapy to re-engage persons with HIV who are out of care

Many persons with HIV remain out of care (PWH-OOC). We evaluated InstaCare, a complex intervention integrating the brief behavioral intervention 60-Minutes-for-Health with rapid re-start of antiretroviral therapy (rapid-ART). Prospective open-label randomized controlled trial among PWH-OOC in San Diego, USA PWH-OOC were randomized 1:1 to InstaCare or a time-and-attention control integrating a diet-and-nutrition behavioral intervention also with rapid-ART initiation (restart ≤7 days from enrolment). All participants had access to support services (free transport, HIV peer-navigation, adherence counseling and linkage to care) and primary care services (mental health, case management, social work, medication assisted treatment, and specialist pharmacy). The primary outcomes were viral suppression (<50 copies/ml) and re-engagement with care (≥2 HIV care visits >90 days apart) by 24 weeks. Outcomes were reported on an intention-to-treat basis. Between November 2020 and August 2022, 52 PWH-OOC were enrolled. Baseline substance use in the preceding month (49%), unstable housing (51%), moderate/severe depression (49%), and moderate/severe anxiety (41.7%) were prevalent. Rapid-ART was provided for all participants. At week 24, the proportion with HIV viral load <50 copies/ml was 37.3% (19/51) (InstaCare 28.0%, control 46.2%, p=0.25). Fourteen (27.5%) were engaged with care (InstaCare 7/25 [28.0%], control 7/26 [26.9%], p=1.00). Most participants (94%) reported low or very low emotional distress associated with rapid-ART. Study lost to follow-up by week 24 was high (23/51, 45%). The InstaCare complex intervention did not improve viral suppression or re-engagement with care among PWH-OOC. Investigation of high-intensity, individually-adapted interventions are needed among PWH-OOC.