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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 29
Healthy Volunteers: f
View:

• 18-29 years of age

• HIV seropositive

• Live and receive HIV care in California or Florida

• Diagnosed with HIV more than 3 months ago

• HIV VL test result of ≥20 copies at some point in the last 12 months (excluding tests within 3 mo of diagnosis)

• Able to speak English

• Have access to smartphone

Locations
United States
California
Division of Prevention Science, Center for AIDS Prevention Studies (CAPS)
RECRUITING
San Francisco
Contact Information
Primary
Kristin Ming
ivy@ucsf.edu
415-735-1507
Time Frame
Start Date: 2023-11-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 200
Treatments
Active_comparator: Standard of Care Arm
The Standard of Care (SOC) arm will include the current care delivery model: regularly scheduled visits with a healthcare provider and lab testing every 3-6 months or more/less frequently depending on the individual's HIV health outcomes (e.g., VL suppression) . At each assessment, the investigators will review participant responses to examine acute need for referral for medical, psychological, or substance use services. In between assessments, researchers will also do monthly check-ins to improve retention and check contact information.
Experimental: Intervention Arm: Video-Counseling+app
The video-counseling+app arm will receive 12 brief weekly counseling sessions (given over 16 weeks) with a social worker, along with access to the WYZ app to use based on their needs. After 16 weeks, participants receive another assessment and based on VL, those in the video-counseling+app arm will be categorized as intervention responders or non-responders (responder= virologically suppressed; non-responder= virologically unsuppressed. Responders in video-counseling+app arm will continue to use the app only. Non-responders in the intervention arm will continue with intensified video-counseling+app for 16 more weeks.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: RTI International, National Institute of Mental Health (NIMH), AIDS Healthcare Foundation

This content was sourced from clinicaltrials.gov