An Integrated Intervention Using a Pill Ingestible Sensor System
Sensor-SBDOH
1 other identifier
interventional
110
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2024
CompletedFirst Posted
Study publicly available on registry
June 28, 2024
CompletedStudy Start
First participant enrolled
December 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
February 13, 2026
February 1, 2026
2.5 years
March 15, 2024
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 4, 8, 12, and 16
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 4, 8, 12, 16, 20, and 28
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 4, 8, 12, 16, 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 4, 8, 12, 16, 20, and 28
Patterns of dosing
Patterns of dosing such as Patterns of consecutive missed doses in the past two weeks,
week 4, 8, 12, 16, 20, and 28
Secondary Outcomes (3)
Concentration of Plasma HIV viral load
baseline, week 4, 8, 12, 16, 20, and 28
number of sexual partners
baseline, week 8, 16, and 28
Number of condomless sex
baseline, week 8, 16, and 28
Study Arms (2)
ISS-SBDOH arm
EXPERIMENTALIngestion Sensor System (ISS) - Social and Behavioral Determinants of Health (SBDOH) arm
Usual Care (UC) arm
NO INTERVENTIONUsual Care (UC) arm UC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
- Currently receiving antiretroviral treatment that includes one of the following:
- TDF/FTC (Truvada)
- TAF/FTC (Descovy)
- EFV/FTC/TDF (Atripla)
- ABC/3TC (Epzicom)
- DTG/ABC/3TC (Triumeq)
- RPV/TAF/FTC (Odefsey)
- EVG/c/FTC/TAF (Genvoya)
- BIC/FTC/TAF (Biktarvy)
- For participants of reproductive potential, negative serum or urine pregnancy test with a sensitivity of ≤25 mIU/mL at screening. This will be repeated again at study entry.
- +4 more criteria
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lundquist
Los Angeles, California, 90502, United States
Related Publications (1)
Liu H, Shen J, Wang Y, Carnes TC, Hamilton AB, Witt MD, Daar ES. 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. BMC Public Health. 2025 Oct 31;25(1):3719. doi: 10.1186/s12889-025-24909-0.
PMID: 41174603DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 15, 2024
First Posted
June 28, 2024
Study Start
December 19, 2024
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Raw data for additional analysis will be available to outside individuals through contacting the MPIs at two different times. The first will be after all of the baseline data is collected. The second will be after the publication and release of the primary outcome paper(s). The MPIs will store the data indefinitely and allow access for pooled data analysis projects, or projects for outside individuals.
- Access Criteria
- Raw data for additional analysis will be available to outside individuals through contacting the MPIs. The investigators will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, the investigators will welcome this collaboration.
It is anticipated that this data will be presented annually based on data collected after the third year, once sufficient baseline data is collected. Most of the papers and data-based projects/presentations are expected to occur in year 4, when all baseline data is collected, and the 30-week outcome has occurred for all participants. Sharing of the findings will involve a primary paper describing the study outcome and a paper that describes the intervention. Additionally, there will be submissions to lead workshops on the intervention approach at relevant national meetings and conferences. Raw data for additional analysis will be available to outside individuals through contacting the MPIs. Information regarding the availability of data for analysis will be listed on the MPIs' web pages, and contact information for the MPIs will be provided in all manuscripts and publications as another means of accessing data.