Study protocol to evaluate an integrated intervention using a pill ingestible sensor system to trigger actions on multifaceted social and behavioral determinants of health among PLWH: an open-label, usual care-controlled, randomized trial.

backgroundA pillar in the effort to end the HIV epidemic, the "Undetectable equals Untransmittable" (U = U) campaign has led to reduced HIV stigma and empowered people living with HIV (PLWH). Viral suppression, which eliminates risk of sexual HIV transmission, highlights the crucial role of adherence to antiretroviral therapy (ART). Strategies to enhance adherence have primarily focused on pill-taking reminders, often without real-time monitoring or interventions to address social and behavioral determinants of health (SBDOH). Suboptimal adherence to antiretroviral therapy often requires interventions from multidisciplinary teams, including nurses, social workers, and case managers to address SBDOH. These interventions often only occur weeks to months after adherence problems are identified, leading to delays in addressing patient needs and adherence to ART.

methodsIn this protocol paper, we describe the design and procedures for a National Institutes of Health-funded randomized controlled trial that tests an innovative, integrated intervention combining the latest pill ingestible sensor system (the ID-Cap from etectRx) and strategies to address SBDOH. The intervention will trigger real-time actions to rapidly address SBDOH-related barriers when pre-specified patterns of poor adherence are detected (antiretroviral doses missed on three days within a five-day period). A cohort of 110 PLWH who have, or are at high risk for, sub-optimal adherence will be recruited from an HIV clinic in Los Angeles County. Participants will be randomized into the ingestible sensor intervention arm or the usual care arm. The intervention will run for 16 weeks, followed by a 12-week post-intervention period to evaluate sustainability. The primary outcomes are acceptability of the integrated intervention, frequency and timeliness of SBDOH intervention, level of challenges of SBDOH in HIV treatment, adherence to ART measured by ID-Cap system, and self-reported medication adherence. Secondary outcomes are plasma HIV viral load and high risk sexual activity, DISCUSSION: Real-time monitoring of adherence will enable multidisciplinary teams to promptly address difficulties of SBDOH with tailored content to fit each individual's unique challenges and needs. When completed, this trial will define the potential role of ingestible sensor system in a comprehensive program to address barriers to adherence and improve control of the HIV epidemic. TRIAL REGISTRATION NUMBER: NCT06480578. Date registration: June 28, 2024.