An Integrated Intervention Using a Pill Ingestible Sensor System
Recruiting
Phase 2Interventional Study
HIV/AIDSMedication AdherenceSocial Determinants of Health (SDOH)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
110 (estimated)
Sponsor
University of California, Los Angeles · Other
Who this trial is looking for
This trial is looking for adults living with HIV who are having trouble sticking to their treatment. Participants will receive support using a special monitoring system to help improve their medication adherence and health outcomes.
Are You a Good Fit for This Trial?
Must be takingTDF/FTCTAF/FTCEFV/FTC/TDFABC/3TCDTG/ABC/3TCRPV/TAF/FTC
You may be able to join if
I am living with HIV
I am over 17 years old
I can take my HIV medications as prescribed
I can give my consent to participate
I have been told I do not take my medications regularly
I receive treatment for HIV
I have specific challenges such as unstable housing or substance use
You may not be able to join if
I have mental confusion or disorganization
I am pregnant
I show risky or threatening behavior
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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 Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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% adheren…
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. 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)
7. 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.
NOTE: Participants are considered to be NOT of reproductive potential if:
1. participants have had amenorrhea for at least 12 consecutive months prior to study entry (i.e., who have had no menses within 12 months prior to study entry), and have a documented FSH \>40 IU/mL; OR
2. an FSH level is not available, but participants have had 24 consecutive months of amenorrhea (in the absence of medications known to induce amenorrhea); OR
3. participants report having undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation/hysteroscopic tubal occlusion).
Exclusion Criteria:
1. Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior
2. Pregnancy (Evaluated during the screening visit through a pregnancy test.)
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.