An Integrated Intervention Using a Pill Ingestible Sensor System
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HIV-infected individuals in HIV care
Greater than 17 years of age
Demonstrated ability to take co-encapsulated ARVs at the time of screening
Able to provide informed consent
Disqualifiers
Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior
Pregnancy (Evaluated during the screening visit through a pregnancy test.)
Trial design
Design model
Parallel
Treatments tested in this trial
ISS-SBDOH arm
BehavioralOnce 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: ISS-SBDOH armExperimental treatment 1 intervention
Group B: Usual Care (UC) armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
week 4, 8, 12, and 162
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.
Time frame
week 4, 8, 12, 16, 20, and 283
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
Time frame
week 4, 8, 12, 16, and 204
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.
Time frame
week 4, 8, 12, 16, 20, and 28Secondary outcomes
1
Concentration of Plasma HIV viral load
Concentration of Plasma HIV viral load
Time frame
baseline, week 4, 8, 12, 16, 20, and 282
number of sexual partners
number of sexual partners
Time frame
baseline, week 8, 16, and 283
Number of condomless sex
Number of condomless sex
Time frame
baseline, week 8, 16, and 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborator
EtectRX, Inc.
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov