Intervention for Virologic Suppression in Youth

NCT05877729 | Active Not Recruiting DMC

• 2 other identifiers: 22-37017R01MH131415
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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:

1. 1.virologic "non-responders" in the intervention arm to intensified video-counseling+app for 16 more weeks,
2. 2.virologic "responders" in the intervention arm to continue only app use for 16 more weeks.

Conditions

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

Keywords

Young Adults; Telehealth; Health Disparity; HIV; Mobile App

Outcome Measures

Primary Outcomes (1)

• HIV Viral Load Suppression Comparison Evaluated Using Home-collected Hemaspot Device

  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.

  16 weeks

Secondary Outcomes (6)

• Clinical Impact: Frequency of Substance Use Comparison

  16 weeks

• Severity of Substance Use Comparison

  16 weeks

• Clinical Impact: Alcohol Use Comparison

  16 weeks

• Clinical Impact: Depression Comparison

  16 weeks

• Clinical Impact: PTSD (Post Traumatic Stress Disorder) Comparison

  16 weeks

Study Arms (2)

Standard of Care Arm

ACTIVE COMPARATOR

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.

Other: Standard of Care

Intervention Arm: Video-Counseling+app

EXPERIMENTAL

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.

Behavioral: Video-counseling+app

Interventions

Standard of Care 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.

Also known as: SOC

Standard of Care Arm

Video-counseling+app 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).

Also known as: iVY

Intervention Arm: Video-Counseling+app

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• AIDS Healthcare Foundation: collaborator
• University of California, San Francisco: lead
• RTI International: collaborator

Study Sites (1)

Division of Prevention Science, Center for AIDS Prevention Studies (CAPS)

San Francisco, California, 94143, United States

Location

Related Publications (7)

• Saberi P, Ming K, Dawson-Rose C. What does it mean to be youth-friendly? Results from qualitative interviews with health care providers and clinic staff serving youth and young adults living with HIV. Adolesc Health Med Ther. 2018 Apr 24;9:65-75. doi: 10.2147/AHMT.S158759. eCollection 2018.

  PMID: 29731672 BACKGROUND

• Wootton AR, Legnitto DA, Gruber VA, Dawson-Rose C, Neilands TB, Johnson MO, Saberi P. Telehealth and texting intervention to improve HIV care engagement, mental health and substance use outcomes in youth living with HIV: a pilot feasibility and acceptability study protocol. BMJ Open. 2019 Jul 16;9(7):e028522. doi: 10.1136/bmjopen-2018-028522.

  PMID: 31315868 BACKGROUND

• McCuistian C, Wootton AR, Legnitto-Packard D, Gruber VA, Dawson-Rose C, Johnson MO, Saberi P. Addressing HIV care, mental health and substance use among youth and young adults in the Bay Area: description of an intervention to improve information, motivation and behavioural skills. BMJ Open. 2021 Apr 8;11(4):e042713. doi: 10.1136/bmjopen-2020-042713.

  PMID: 38058024 BACKGROUND

• Saberi P, McCuistian C, Agnew E, Wootton AR, Legnitto Packard DA, Dawson-Rose C, Johnson MO, Gruber VA, Neilands TB. Video-Counseling Intervention to Address HIV Care Engagement, Mental Health, and Substance Use Challenges: A Pilot Randomized Clinical Trial for Youth and Young Adults Living with HIV. Telemed Rep. 2021 Jan 7;2(1):14-25. doi: 10.1089/tmr.2020.0014. eCollection 2021.

  PMID: 33575683 BACKGROUND

• Erguera XA, Johnson MO, Neilands TB, Ruel T, Berrean B, Thomas S, Saberi P. WYZ: a pilot study protocol for designing and developing a mobile health application for engagement in HIV care and medication adherence in youth and young adults living with HIV. BMJ Open. 2019 May 5;9(5):e030473. doi: 10.1136/bmjopen-2019-030473.

  PMID: 31061063 BACKGROUND

• Saberi P, Lisha NE, Erguera XA, Hudes ES, Johnson MO, Ruel T, Neilands TB. A Mobile Health App (WYZ) for Engagement in Care and Antiretroviral Therapy Adherence Among Youth and Young Adults Living With HIV: Single-Arm Pilot Intervention Study. JMIR Form Res. 2021 Aug 31;5(8):e26861. doi: 10.2196/26861.

  PMID: 34463622 BACKGROUND

• Saberi P, Stoner MCD, McCuistian CL, Balaban C, Ming K, Wagner D, Chakraborty B, Smith L, Sukhija-Cohen A, Neilands TB, Gruber VA, Johnson MO. iVY: protocol for a randomised clinical trial to test the effect of a technology-based intervention to improve virological suppression among young adults with HIV in the USA. BMJ Open. 2023 Oct 6;13(10):e077676. doi: 10.1136/bmjopen-2023-077676.

  PMID: 37802624 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Parya Sabari, PharmD

  UCSF School of Medicine, Division of Prevention Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 26, 2023
• Study Start: November 29, 2023
• Primary Completion: April 24, 2026
• Study Completion (Estimated): December 4, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)