A Randomized Controlled Trial of an Intervention to Improve Engagement in HIV Care

Massachusetts General Hospital, Boston MA

Investigators

Linked publications & trials

Abstract

Latin Americans with HIV in the U.S. often experience challenges in maintaining consistent engagement in care, leading to compromised clinical outcomes and ongoing public health challenges. While effective antiretroviral medications are widely available, only half of Latin American patients with HIV are retained in care with regular access to treatment. The ADELANTE study will use successfully piloted strategies to help patients problem-solve obstacles to care compliance, develop greater patient activation and self-efficacy, and facilitate access to resources on the pathway to treatment adherence and viral suppression. ADELANTE will be tested in two Ryan White-supported clinics in US Ending the HIV Epidemic Plan-identified geographic areas. We will leverage existing clinic resources, community partnerships, and multidisciplinary expertise in clinical trial implementation and analysis to accomplish the following aims. In Aim 1, we will randomize 250 Latin Americans with HIV in a controlled trial to contrast clinical effectiveness of ADELANTE (5-session, health worker-delivered video-based intervention) versus enhanced care condition (ECC, 5 reminder phone calls). Eligible participants are Latin Americans ≥ age 18 with viral non-suppression (HIV RNA ≥200 copies/ml) at least 6 months past their HIV index visit. We hypothesize that ADELANTE participants will have higher rates of viral suppression (HIV RNA <200 copies/ml) at month-12 and fewer emergency department visits and hospitalizations compared with ECC. In Aim 2, we will examine potential mechanisms by which ADELANTE impacts viral suppression. We hypothesize that participants in ADELANTE will have increased rates of patient activation, self-efficacy for retention in care, and referrals for non-clinical services and that these variables will mediate the relationship of ADELANTE with viral suppression. In Aim 3, we will identify impediments and facilitators to implementation readiness of ADELANTE through in-depth semi-structured interviews with 40 RCT participants and focus groups with local stakeholders involved with implementation. These qualitative data will add value in explaining findings, ensuring relevance, and facilitating future uptake and reach. Our approach focuses on refining and testing strategies for enhancing care engagement as a core driver of improving treatment outcomes. We anticipate that the merger of technology through a video-based health communication tool with health workers delivering population-tailored content will improve outcomes for people with HIV.