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Behavioural Intervention
Ingestible Sensor System for HIV/AIDS (Sensor-SBDOH Trial)
Phase 2
Waitlist Available
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HIV-infected individuals in HIV care
Greater than 17 years of age
Must not have
Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 5, 10, 15, 20, 25, and 30
Awards & highlights
No Placebo-Only Group
Summary
"This trial combines technology-based tools to track medication adherence and alerts for social and behavioral factors to improve HIV treatment outcomes. It will involve 110 adult patients from an HIV clinic in Los Angeles who are at
Who is the study for?
This trial is for adults with HIV from a Los Angeles County clinic, particularly those who struggle to stick to their treatment. Participants must be willing to use a pill sensor system that tracks medication intake and alerts for social and behavioral health issues.
What is being tested?
The study tests an integrated intervention using a pill ingestible sensor system (ISS) combined with support for social and behavioral determinants of health (SBDOH). It compares usual care against this new approach in terms of adherence, viral load control, and risky sexual behavior reduction.
What are the potential side effects?
Since the intervention focuses on monitoring systems rather than medications, side effects are not typical drug reactions but may include privacy concerns or discomfort with technology use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HIV positive and currently receiving treatment for it.
Select...
I am older than 17 years.
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I can take ARV medication as prescribed.
Select...
I am on antiretroviral therapy with specific medications.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am mentally and physically able to follow the study's procedures without confusion or risky behavior.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 5, 10, 15, 20, 25, and 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 5, 10, 15, 20, 25, and 30
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability to the integrated intervention
Adherence to ART--percent of prescribed medication taken
Frequency and timeliness of SBDOH intervention, level of challenges of SBDOH in HIV treatment
+2 moreSecondary study objectives
Concentration of Plasma HIV viral load
Number of condomless sex
number of sexual partners
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ISS-SBDOH armExperimental Treatment1 Intervention
Ingestion Sensor System (ISS) - Social and Behavioral Determinants of Health (SBDOH) arm
Group II: Usual Care (UC) armActive Control1 Intervention
Usual Care (UC) arm
UC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,567 Previous Clinical Trials
10,266,890 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
438 Previous Clinical Trials
1,379,296 Total Patients Enrolled
2 Trials studying Social Determinants of Health
1,266 Patients Enrolled for Social Determinants of Health
EtectRX, Inc.Industry Sponsor
2 Previous Clinical Trials
49 Total Patients Enrolled
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterOTHER
104 Previous Clinical Trials
46,473 Total Patients Enrolled