ACTIVE_NOT_RECRUITING

Intervention for Virologic Suppression in Youth

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

The goal of this randomized clinical trial is to test the effect of a technology-based intervention with an Adaptive Treatment Strategy (ATS) among youth living with HIV (YLWH) (18-29 years old). This piloted and protocolized intervention combines: (1) brief weekly sessions with a counselor via a video-chat platform (video-counseling) to discuss mental health (MH), substance use (SU), HIV care engagement, and other barriers to care; and (2) a mobile health application (app) to address barriers such as ART forgetfulness and social isolation. Individuals who are not virologically suppressed will be randomized to video-counseling+app or standard of care (SOC). Through this study, the investigators will be able to: Aim 1: Test the efficacy of video-counseling+app vs SOC on virologic suppression in YLWH.The investigators will compare HIV virologic suppression of those randomized to the intervention vs control arms at 16 weeks via an RCT. Aim 2: Assess the impact of video-counseling+app vs SOC on MH and SU in YLWH. The investigators will evaluate the MH and SU differences between the intervention vs control arms at 16 weeks via an RCT. Aim 3: Explore an ATS to individualize the intervention by assigning the: 1. virologic "non-responders" in the intervention arm to intensified video-counseling+app for 16 more weeks, 2. virologic "responders" in the intervention arm to continue only app use for 16 more weeks. Researchers will compare the characteristics of virologic responders and non-responders to the intervention, individualization of the intervention based on these variables, and linkage to MH and SU treatment services among those in need to see if delivery of care is enhanced and impact on virologic suppression.

Official Title

iVY: Comprehensive, Tailored, Technology-based Intervention to Improve Virologic Suppression Among Youth and Young Adults Living With HIV

Quick Facts

Study Start:2023-11-29
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05877729

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 to 29 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18-29 years of age
  2. 2. HIV seropositive
  3. 3. Live and receive HIV care in California or Florida
  4. 4. Diagnosed with HIV more than 3 months ago
  5. 5. HIV VL test result of ≥20 copies at some point in the last 12 months (excluding tests within 3 mo of diagnosis)
  6. 6. Able to speak English
  7. 7. Have access to smartphone
  1. 1. Unable or unwilling to provide consent.
  2. 2. Evidence of severe cognitive impairment, active psychosis, or substance use that may impede ability to provide informed consent during the consent process.
  3. 3. Those with a history of hemophilia or unable to conduct finger prick at home for the HIV viral load testing.

Contacts and Locations

Principal Investigator

Parya Sabari, PharmD
PRINCIPAL_INVESTIGATOR
UCSF School of Medicine, Division of Prevention Science

Study Locations (Sites)

Division of Prevention Science, Center for AIDS Prevention Studies (CAPS)
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Parya Sabari, PharmD, PRINCIPAL_INVESTIGATOR, UCSF School of Medicine, Division of Prevention Science

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 Date2023-11-29
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-11-29
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Young Adults
  • Telehealth
  • Health Disparity
  • HIV
  • Mobile App

Additional Relevant MeSH Terms

  • HIV/AIDS
  • Young Adult
  • Mobile Health
  • Mental Health Issue
  • Substance Use