An Integrated Intervention Using a Pill Ingestible Sensor System
NCT Number: NCT06480578
Acronym: Sensor-SBDOH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: HIV/AIDS|Medication Adherence|Social Determinants of Health (SDOH)
Interventions: BEHAVIORAL: ISS-SBDOH arm
Sponsor: University of California, Los Angeles
Collaborators: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center|EtectRX, Inc.|National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07
Completion Date: 2027-12
Locations: Lundquist, Los Angeles, California, 90502, United States

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.

Primary Outcome Measures: Acceptability to the integrated intervention, Acceptability to the integrated intervention will be evaluated by quantitative measures interviews. The items in the quantitative measure will be rated on five-item Likert scales ranging from very strongly disagree to very strongly agree. Domains to be assessed will include overall satisfaction (would recommend to friend, would use outside of study setting, satisfied with system), utility, and specific items such as helpfulness and convenience. In addition, the investigators will ask participants to rate items specific to the ID-Cap system (comfort of wristband, comfort receiving text messages)., week 5, 10, 15, and 20.|Frequency and timeliness of SBDOH intervention, level of challenges of SBDOH in HIV treatment, The investigators will collect SBDOH measures, such as economic stability (e.g., food security), health (e.g., gap in health coverage), neighborhood and built environment (e.g. transportation needs), social and community context (e.g., violence, and criminal justice involvement), and substance and alcohol use, sexual behavior, and other health related behaviors. Challenges of SBDOH will be measured as (i) the count of SBDOH issues one is facing, and (ii) the degree of each issue (e.g., low/medium/high with housing challenge) with summary scores. Frequency and timeliness of SBDOH intervention are measured as number of sessions, and time to first, and subsequent sessions, if applicable, from baseline, and others. This information will also be collected when intervention if triggered by the monitoring system., week 5, 10, 15, 20, 25, and 30.|Adherence to ART--percent of prescribed medication taken, Adherence to ART measured by ID(identification)-Cap system for up to 20 weeks, defined as percent of prescribed medication taken, week 5, 10, 15, and 20.|Self-Reported Medication Adherence--percent of prescribed dose taken, The investigators will use a widely used measure of percent of prescribed dose taken during the preceding seven days. This measure is easy to use and has been significantly associated with virological and immunological outcomes., week 5, 10, 15, 20, 25, and 30|Patterns of dosing, Patterns of dosing such as Patterns of consecutive missed doses in the past two weeks,, week 5, 10, 15, 20, 25, and 30
Secondary Outcome Measures: Concentration of Plasma HIV viral load, Concentration of Plasma HIV viral load, baseline, week 5, 10, 15, 20, 25, and 30|number of sexual partners, number of sexual partners, baseline, week 10, 20, and 30|Number of condomless sex, Number of condomless sex, baseline, week 10, 20, and 30