RECRUITING

An Integrated Intervention Using a Pill Ingestible Sensor System

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Conditions

HIV/AIDSMedication AdherenceSocial Determinants of Health (SDOH)SDOH

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Integrated Intervention Using a Pill Ingestible Sensor System to Trigger Actions on Multifaceted Social and Behavioral Determinants of Health Among PLWH

Quick Facts

Study Start:2024-12-19
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06480578

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. HIV-infected individuals in HIV care
  2. 2. Greater than 17 years of age
  3. 3. Demonstrated ability to take co-encapsulated ARVs at the time of screening
  4. 4. Able to provide informed consent
  5. 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. 6. Currently receiving antiretroviral treatment that includes one of the following:
  7. * TDF/FTC (Truvada)
  8. * TAF/FTC (Descovy)
  9. * EFV/FTC/TDF (Atripla)
  10. * ABC/3TC (Epzicom)
  11. * DTG/ABC/3TC (Triumeq)
  12. * RPV/TAF/FTC (Odefsey)
  13. * EVG/c/FTC/TAF (Genvoya)
  14. * BIC/FTC/TAF (Biktarvy)
  15. 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.
  16. 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
  17. 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
  18. 3. participants report having undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation/hysteroscopic tubal occlusion).
  1. 1. Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior
  2. 2. Pregnancy (Evaluated during the screening visit through a pregnancy test.)

Contacts and Locations

Study Contact

Jie Shen, PhD
CONTACT
3105917541
shenjie@ucla.edu
Yilan Huang, M.S.
CONTACT
4244404370
yilanh19@g.ucla.edu

Study Locations (Sites)

Lundquist
Los Angeles, California, 90502
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-19
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-12-19
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • HIV/AIDS
  • Medication Adherence
  • SDOH

Additional Relevant MeSH Terms

  • HIV/AIDS
  • Medication Adherence
  • Social Determinants of Health (SDOH)