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Behavioral Intervention
Video-Counseling + App for HIV/AIDS Management (iVY Trial)
N/A
Recruiting
Led By Parya Sabari, PharmD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
iVY Trial Summary
This trial is testing the effect of a technology-based intervention to improve HIV care engagement in young adults living with HIV.
Who is the study for?
This trial is for young adults aged 18-29 with HIV who are not virologically suppressed, can speak English, and have a smartphone. They must be patients at certain healthcare centers in California or Florida. People with severe cognitive issues, active psychosis, hemophilia, or those unable to consent or do home finger prick tests cannot join.Check my eligibility
What is being tested?
The study compares two methods: standard care versus a combination of video-counseling and an app designed to help manage mental health issues, substance use problems, and improve HIV treatment adherence. Participants will be randomly assigned to one of these groups to see which is more effective at achieving viral suppression.See study design
What are the potential side effects?
Since the interventions involve counseling and app usage rather than medication, traditional side effects are not expected. However, participants may experience discomfort discussing personal issues during counseling sessions.
iVY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HIV Viral Load Suppression Comparison Evaluated Using Home-collected Hemaspot Device
Secondary outcome measures
Clinical Impact: Alcohol Use Comparison
Clinical Impact: Anxiety Comparison
Clinical Impact: Depression Comparison
+3 moreiVY Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Arm: Video-Counseling+appExperimental Treatment1 Intervention
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 II: Standard of Care ArmActive Control1 Intervention
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.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,509 Total Patients Enrolled
3 Trials studying Young Adults
304 Patients Enrolled for Young Adults
University of California, San FranciscoLead Sponsor
2,507 Previous Clinical Trials
15,238,375 Total Patients Enrolled
2 Trials studying Young Adults
113 Patients Enrolled for Young Adults
AIDS Healthcare FoundationOTHER
18 Previous Clinical Trials
146,371 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.I am between 18 and 29 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Arm: Video-Counseling+app
- Group 2: Standard of Care Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical research include participants of advanced age?
"To be qualified to participate in this clinical trial, one must fall within the age group of 18 and 29. Additionally, research reveals that there are 117 medical trials suitable for those under eighteen years old while 388 exist for patients above the age of 65."
Answered by AI
Is this experiment presently enrolling participants?
"According to clinicaltrials.gov, this trial is no longer accepting patients for enrollment. Initially posted on May 1st 2023 and updated last on the 17th of that same month, there are 543 other trials recruiting today despite this one being closed-off from further participants."
Answered by AI
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