Clinical trial 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 wants to find out if using a special pill sensor and alerts about social and health needs helps people stick to their HIV treatment plan.
- Who it's for
- The study is looking for adults with HIV who are at risk of missing their medication doses.
- What's involved
- Participants will take a pill with a sensor that tracks when it is swallowed. They will also receive alerts about health and social needs and have regular check-ups.
- Time commitment
- The study involves regular visits to the clinic for testing and check-ins over the course of the trial.
- 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.
- 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)
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.