NCT05877729Active, not recruiting
Intervention for Virologic Suppression in Youth
iVY: Comprehensive, Tailored, Technology-based Intervention to Improve Virologic Suppression Among Youth and Young Adults Living With HIV
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 4 May 2023
- Start date
- 29 Nov 2023
- Primary completion date
- 24 Apr 2026
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT05877729
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 29 Nov 2023 to the primary completion date, 24 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Unable or unwilling to provide consent.
Who the study is looking for
- 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
Age in the registry: 18 years to 29 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Prevention Science, Center for AIDS Prevention Studies (CAPS) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.