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Introduction. More than half of persons living with HIV (PLWH) in the U.S. are insufficiently engaged in HIV care and not well established on antiretroviral therapy (ART); most are African American/Blacks and Latinos (AABL). A set of multi-level factors impede both HIV care and ART initiation with good adherence for AABL-PLWH, primary among them individual (e.g., substance use, distrust, fear), social (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). This study uses the MOST framework and a fractional factorial design to conduct an optimization trial examining five distinct, culturally appropriate intervention components, all grounded in self-determination and social-cognitive theories: counseling sessions, pre-adherence preparation, focused support groups, peer mentorship, and patient navigation.
Methods. Participants were recruited through a hybrid sampling approach including direct outreach in community-based organizations, media ads (free newspapers), and peer-to-peer recruitment. Eligibility criteria included age 18-65 years, African American/Black and Latino race/ethnicity, poor engagement in HIV care in the past year, taking ART ≤ 50% of the time or not at all in the past 6 weeks, and HIV viral load (VL) ≥ 1000 copies/mL. Participants completed a structured baseline interview on background and health factors, and then were randomly assigned to one of 16 experimental conditions, each comprised of a different combination of intervention components (most received 3-4 components). A randomly selected subset received qualitative interviews and all engaged in follow-up assessments (interviews, CD4, and HIV VL tests) at 4-, 8-, and 12-months post baseline.
Results. Peer-to-peer contact was the most effective recruitment method. Of the 72 participants enrolled to date, 34.7% were female; 69.4% African American/Black and 26.4% Latino; 61.7% of males and 12.0% of females were sexual minority; and participants were 46 years old on average (SD= 11 years). Serious vulnerabilities were common (e.g., 43.1% currently homeless, 59.7% incarcerated in the past, and 90.3% unemployed/disabled). Almost all (97.2%) took ART in the past (median 5 times stopping and re-starting ART). Past (84.7%) and current (40.3%) substance use problems were common. Intervention acceptability and retention were high. Preliminary qualitative and quantitative results, as well as lessons learned about administrating a factorial optimization trial with REDCap will be described.
Conclusions. AABH-PLWH “off the cascade” are challenging to locate, due to stigma, distrust, fear, and competing priorities. Study procedures and intervention components designed in keeping with self-determination theory can foster engagement, high retention, and intervention acceptability and efficacy. REDCap is an effective tool for managing a factorial optimization trial conducted in a field setting.