The COMEBACK Study: Social Determinants of Health Impact on Virologic Suppression in a 48-Week Low-Barrier-Care Study of Rapid Antiretroviral Therapy Reinitiation Among Persons With HIV Lost to Care.

Background: Effectively preventing transmission is critical to ending the HIV epidemic (EHE). The primary objective of the COMEBACK study, a 48-week single-center study, was to reengage lost-to-care persons with HIV and rapidly reinitiate antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alefenamide (B/F/TAF) in a low-barrier-care model to promote virologic suppression (VS). Methods: Adults off ART for ≥2 weeks, without significant B/F/TAF resistance or renal impairment, were started on B/F/TAF upon reengagement after same-day baseline labs (n = 100). Participants self-screened into case management (CM) tiers: minimal, moderate, or advanced. Participants requiring additional support (tier escalation) were identified during the study. The associations of baseline characteristics and 5 social determinants of health (SDoH) assessments with VS status at study end were analyzed. Results: At baseline, the median age was 37 years, with 90% Black and 68% cisgender male. Median CD4+ was 310 cells/mm Conclusions: VS was high for participants with rapid ART reinitiation retained in care. CM escalation and baseline adherence concerns were associated with non-VS at study end. Achieving VS among high-risk populations disenfranchised from care will likely require further innovation in intense individualized CM and retention approaches to capitalize on low-barrier-care models toward EHE.