An Integrated Intervention Using a Pill Ingestible Sensor System to Trigger Actions on Multifaceted Social and Behavioral Determinants of Health Among PLWH
University of California, Los Angeles
Summary
This study integrates technology-based adherence measures with alerts for social and behavioral determinants of health (SBDOH) to improve HIV treatment outcomes. It involves 110 adult patients from a Los Angeles County HIV clinic, focusing on those at risk for poor adherence. Participants will be randomized into intervention or usual care groups, with endpoints including intervention acceptability, SBDOH interventions, adherence to ART, viral load, and high-risk sexual activity. The study aims to assess the effectiveness of the integrated intervention in improving adherence, virologic outcomes, and reducing high-risk behavior among PLWH.
Description
Undetectable equals Untransmittable (U=U) reduces HIV stigma, empowers people living with HIV (PLWH), and has become a pillar in the goal of ending the HIV epidemic. Viral suppression eliminating risk of sexual HIV transmission emphasizes the importance of adherence to antiretroviral therapy (ART). Strategies to enhance adherence have typically not intervened in real-time and have focused on pill-taking reminders without interventions that address adverse social and behavioral determinants of health (SBDOH) associated with poor adherence and engagement in care. The complex multifactorial pathw…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. HIV-infected individuals in HIV care 2. Greater than 17 years of age 3. Demonstrated ability to take co-encapsulated ARVs at the time of screening 4. Able to provide informed consent 5. Receiving ART with sub-optimal adherence estimated by patient (self-reports \< 90% adherence over last 28 days) or treating clinician \[e.g., based on gaps in treatment (e.g. missed appointments) or viral load elevations within 6 months\], or at high risk for sub-optimal adherence, or with known challenges with SBDOH (e.g. unstable housing, substance use disorder, and poverty 6. Currentl…
Interventions
- BehavioralISS-SBDOH arm
Once the ID-Cap ISS system has identified a participant who has missed his/her prescribed ARVs for five (5) consecutive days, a member of the multidisciplinary team will be informed automatically by the system and reach out to the participant immediately. The team will work with the primary provider and the participant to evaluate and understand the patient's SBDOH profile and status and develop a coordinated plan that fits the patient's specific need to address the patient's particular challenges in SBDOH. This plan (all SBDOH interventions) is considered standard of care and would be initiated in the same manner regardless of participation. Participation in this study will not alter the planned interventions determined by the HIV Care team.
Location
- LundquistLos Angeles, California