Intervention for Virologic Suppression in Youth — iVY  

HIV/AIDS Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

In the US, youth and young adults living with HIV (YLWH) have the lowest level of virologic suppression compared to older age groups and experience significant health disparities with regard to HIV treatment initiation and clinical outcomes. Additionally, mental health (MH) and substance use (SU) impact every step of the HIV care continuum from diagnosis to virologic suppression and exacerbate socioeconomic challenges of linkage and sustained access to healthcare.

The proposed study aims to address these barriers in a tailored manner using a differentiated care approach that is "youth-friendly". The iVY intervention is grounded in the Information Motivation Behavioral Skills (IMB) Model and developed with and for YLWH using a Human-Centered Design (HCD) approach. The goal is to test the effect of the technology-based intervention with differing levels of resource requirements (i.e., financial and personnel time) in a randomized clinical trial (RCT) with an Adaptive Treatment Strategy (ATS) among YLWH (18-29 years old). Using pre-defined algorithms, ATSs adapt a treatment to an individual's unique and changing needs as opposed to a one-size-fits-all approach.

Video-counseling will be delivered by clinical social workers trained to provide MH and SU counseling to YLWH. Video-counseling sessions will focus on the needs of the participant and potential linkage to further MH and SU treatment, as needed. The app will allow for medication management, identification of community resources, and online networking with other YLWH. Therefore, the primary goal of this approach is to address important, distinct, and changing barriers to HIV care engagement (e.g., MH, SU, forgetting, social isolation) among YLWH.

HIV virologic suppression (primary outcome) will be evaluated using home-collected Hemaspot test. To increase generalizability and geographic, demographic, and economic diversity and decrease logistics- or stigma-related barriers to research participation, all study activities will be conducted remotely. This study will provide valuable data about 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05877729
• Study type: Interventional
• Source: University of California, San Francisco
• Contact: Kristin Ming
• Phone: 415-735-1507
• Email: kristin.ming@ucsf.edu
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Completion date: April 2026