Using a pill sensor system to improve HIV treatment adherence
An Integrated Intervention Using a Pill Ingestible Sensor System to Trigger Actions on Multifaceted Social and Behavioral Determinants of Health Among PLWH
PHASE2 · University of California, Los Angeles · NCT06480578
This study is testing a new pill sensor system to see if it helps adults with HIV stick to their treatment better and improve their health.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06480578 on ClinicalTrials.gov |
What this trial studies
This study integrates a technology-based pill ingestible sensor system with interventions addressing social and behavioral determinants of health to enhance adherence to HIV treatment. It involves 110 adult patients from an HIV clinic in Los Angeles County, who will be randomized into intervention or usual care groups. The study aims to evaluate the effectiveness of this integrated approach on medication adherence, viral load suppression, and reduction of high-risk sexual behavior. Key endpoints include the acceptability of the intervention and its impact on social determinants affecting health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-infected individuals over 17 years old who demonstrate sub-optimal adherence to antiretroviral therapy and face challenges related to social determinants of health.
Not a fit: Patients who are not currently receiving antiretroviral treatment or those with optimal adherence may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve adherence to HIV treatment and health outcomes for patients living with HIV.
How similar studies have performed: Other studies have shown promise in using technology to enhance medication adherence, but this integrated approach addressing social determinants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Los Angeles, California
- Lundquist — Los Angeles, California, United States (RECRUITING)
Study contacts
- Study coordinator: Jie Shen, PhD
- Email: shenjie@ucla.edu
- Phone: 3105917541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV/AIDS, Medication Adherence, Social Determinants of Health, SDOH