Using a pill sensor system to improve HIV treatment adherence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Lundquist
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Jie Shen, PhD
• Email: shenjie@ucla.edu
• Phone: 3105917541

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.