Intervention for Virologic Suppression in Youth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-29

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

The 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 149 SOC participant responses to examine acute need for referral for medical, psychological, or substance use services. In between assessments, the investigators will also do monthly check-ins to improve retention and check contact information.

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.

Group Type EXPERIMENTAL

Video-counseling+app

Intervention Type BEHAVIORAL

The intervention tailors the telehealth counseling according to the individual's needs. Tailoring occurs based on the participant's baseline MH, SU, and HIV knowledge/outcomes and assessment responses inform the sessions on these topics. Participants choose from a list identified in the menu sessions: HIV care, MH, SU, lifestyle, health, social support, family of origin, romantic and sexual relationships, self-identity and disclosure, subsistence needs, education and vocation, and a "wildcard" session.

WYZ contains 3 main features: My Health, My Team, and My Community. Tailoring is achieved based on the individual's needs at a given time (e.g., My Community may be used more if social isolation is a barrier).

Interventions

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Standard of Care

The 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 149 SOC participant responses to examine acute need for referral for medical, psychological, or substance use services. In between assessments, the investigators will also do monthly check-ins to improve retention and check contact information.

Intervention Type OTHER

Video-counseling+app

The intervention tailors the telehealth counseling according to the individual's needs. Tailoring occurs based on the participant's baseline MH, SU, and HIV knowledge/outcomes and assessment responses inform the sessions on these topics. Participants choose from a list identified in the menu sessions: HIV care, MH, SU, lifestyle, health, social support, family of origin, romantic and sexual relationships, self-identity and disclosure, subsistence needs, education and vocation, and a "wildcard" session.

WYZ contains 3 main features: My Health, My Team, and My Community. Tailoring is achieved based on the individual's needs at a given time (e.g., My Community may be used more if social isolation is a barrier).

Intervention Type BEHAVIORAL

Other Intervention Names

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SOC iVY

Eligibility Criteria

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Inclusion Criteria

1. 18-29 years of age
2. HIV seropositive
3. Live and receive HIV care in California or Florida
4. Diagnosed with HIV more than 3 months ago
5. HIV VL test result of ≥20 copies at some point in the last 12 months (excluding tests within 3 mo of diagnosis)
6. Able to speak English
7. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No