RECRUITING
I'm interested ...!!
Intervention for Virologic Suppression in Youth
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.
Conditions:
🦠 HIV/AIDS 🦠 Young Adult 🦠 Mobile Health 🦠 Mental Health Issue 🦠 Substance Use
🗓️ Study Start (Actual) 29 November 2023
🗓️ Primary Completion (Estimated) August 2025
✅ Study Completion (Estimated) April 2026
👥 Enrollment (Estimated) 200
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Receive care at an AIDS Healthcare Foundation (AHF) California or Florida-based healthcare center
    • 2. HIV seropositive
    • 3. 18-29 years of age
    • 4. Have an unsuppressed HIV viral load in the past 3 months.
    • 5. Able to speak English
    • 6. Have access to smartphone

    Exclusion Criteria:

    • 1. Unable or unwilling to provide consent.
    • 2. Evidence of severe cognitive impairment, active psychosis, or substance use that may impede ability to provide informed consent during the consent process.
    • 3. Those with a history of hemophilia or unable to conduct finger prick at home for the HIV viral load testing.
Ages Eligible for Study: 18 Years to 29 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 4 May 2023
  • First Submitted that Met QC Criteria 17 May 2023
  • First Posted 26 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 January 2024
  • Last Update Posted 24 January 2024
  • Last Verified January 2024
I'm interested ...!!