Clinical trial NCT05877729: Intervention for Virologic Suppression in Youth
Official title: iVY: Comprehensive, Tailored, Technology-based Intervention to Improve Virologic Suppression Among Youth and Young Adults Living With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Young Adult
Mobile Health
Mental Health Issue
Substance Use
Keywords: Young Adults
Telehealth
Health Disparity
HIV
Mobile App
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: AIDS Healthcare Foundation
name: RTI International
First posted: 2023-05-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 18-29 years of age
2. HIV seropositive
3. Live and receive HIV care in California
4. HIV VL test result of \>20 copies at some point in the last 12 months
5. Able to speak English
6. 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.

Primary outcomes:
measure: HIV Viral Load Suppression Comparison Evaluated Using Home-collected Hemaspot Device
timeFrame: 16 weeks
Secondary outcomes:
measure: Clinical Impact: Frequency of Substance Use Comparison
timeFrame: 16 weeks
measure: Severity of Substance Use Comparison
timeFrame: 16 weeks
measure: Clinical Impact: Alcohol Use Comparison
timeFrame: 16 weeks
measure: Clinical Impact: Depression Comparison
timeFrame: 16 weeks
measure: Clinical Impact: PTSD (Post Traumatic Stress Disorder) Comparison
timeFrame: 16 weeks
measure: Clinical Impact: Anxiety Comparison
timeFrame: 16 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Division of Prevention Science, Center for AIDS Prevention Studies (CAPS)
state: California
Study officials:
affiliation: UCSF School of Medicine, Division of Prevention Science
name: Parya Sabari, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.