iVY: Comprehensive, Tailored, Technology-based Intervention to Improve Virologic Suppression Among Youth and Young Adults Living With HIV
Overview
- Phase
- Not Applicable
- Intervention
- Standard of Care
- Conditions
- HIV/AIDS
- Sponsor
- University of California, San Francisco
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- HIV Viral Load Suppression Comparison Evaluated Using Home-collected Hemaspot Device
- Status
- Active, not recruiting
- Last Updated
- yesterday
Overview
Brief 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:
- virologic "non-responders" in the intervention arm to intensified video-counseling+app for 16 more weeks,
- 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Unable or unwilling to provide consent.
- •Evidence of severe cognitive impairment, active psychosis, or substance use that may impede ability to provide informed consent during the consent process.
- •Those with a history of hemophilia or unable to conduct finger prick at home for the HIV viral load testing.
Arms & Interventions
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.
Intervention: Standard of Care
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.
Intervention: Video-counseling+app
Outcomes
Primary Outcomes
HIV Viral Load Suppression Comparison Evaluated Using Home-collected Hemaspot Device
Time Frame: 16 weeks
Investigators will compare HIV virologic suppression of those randomized to the intervention vs control arm. HIV virologic suppression will be evaluated using home collected Hemaspot test.
HIV Viral Load Suppression Comparison Evaluated Using Home-collected Hemaspot Device
Time Frame: 16 weeks
Investigators will compare HIV virologic suppression of those randomized to the intervention vs control arm. HIV virologic suppression will be evaluated using home collected Hemaspot test.
Secondary Outcomes
- Clinical Impact: Alcohol Use Comparison(16 weeks)
- Clinical Impact: Depression Comparison(16 weeks)
- Clinical Impact: PTSD (Post Traumatic Stress Disorder) Comparison(16 weeks)
- Clinical Impact: Frequency of Substance Use Comparison(16 weeks)
- Severity of Substance Use Comparison(16 weeks)
- Clinical Impact: Anxiety Comparison(16 weeks)