BridgeMD
New treatment option for HIV/AIDS
Official title An Integrated Intervention Using a Pill Ingestible Sensor System
ClinicalTrials.gov ID: NCT06480578
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join if
- Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal...
- Pregnancy (Evaluated during the screening visit through a pregnancy test.)
See the full eligibility criteria
- 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...
- 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. NOTE: Participants are considered to be NOT...
- 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
- 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
- participants report having undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation/hysteroscopic tubal occlusion).
- 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.)
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.