Improving HIV outcomes in Miami’s Black populations with clinic-based community health workers protocol: The integrated navigation and support for treatment adherence, counseling, and research (INSTACARE) randomized controlled trial

Abstract

Miami-Dade is an HIV epicenter where Black populations experience excess AIDS-related deaths due to poor medication adherence, which prevents achieving an undetectable HIV viral load (VL). A promising approach to improving HIV outcomes in Black populations has been the use of community health workers (CHWs). Evidence shows CHWs trained in motivational interviewing (MI) may further improve outcomes, however little data exists about Black CHWs trained in MI who support Black patients with HIV. While CHWs traditionally help address social determinants of health in nonclinical locations, there is less information on CHWs who provide support in clinical settings, which may result in even greater improvements in HIV outcomes. To examine effects of CHWs trained in MI who provide HIV care in both clinic and community settings, a randomized controlled trial (RCT) is being conducted in Miami-Dade’s largest public hospital. The Integrated Navigation and Support for Treatment, Adherence, Counseling, and Research intervention is a RCT of 300 Black adults with an unmanaged HIV VL ( > 200 copies/mL). CHWs trained in MI are embedded into HIV clinical care teams and participate in hospital rounds with clinicians treating inpatients. Participants randomized into the CHW intervention arm receive 12 months of CHW-led health education and assistance with health care navigation and social services. The primary outcome is change in HIV viral load suppression at 12 months. Secondary outcomes include changes in medication adherence and social determinants of health. Study enrollment began in 2023 and will be completed by 2027. The first results are expected to be submitted for publication in 2025. INSTACARE is one of the first RCTs to examine effects of clinic-based support provided by CHWs trained in MI on Black populations with an unmanaged VL and will provide evidence on the impact of such strategies on medication adherence and social determinants of health. Trial registration ClinicalTrials.gov NCT04663152 .