NCT06480578 An Integrated Intervention Using a Pill Ingestible Sensor System
| NCT ID | NCT06480578 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Los Angeles |
| Condition | HIV/AIDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 110 participants in total. It began in 2024-12-19 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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% 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.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06480578 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV/AIDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06480578 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06480578 currently recruiting?
Yes, NCT06480578 is actively recruiting participants. Contact the research team at shenjie@ucla.edu for enrollment information.
Where is the NCT06480578 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06480578 clinical trial?
NCT06480578 is sponsored by University of California, Los Angeles. The trial plans to enroll 110 participants.
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