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Behavioral Intervention

CBT for HIV with Mental Health Issues (Synk2b Trial)

N/A
Waitlist Available
Led By Steven A Safren, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Group 1: (Men who have sex with men (MSM) who have used stimulants within the past 4 months (approximately 10 participants))OR Group 2: transgender women (approximately 10 participants) OR Group 3: Emerging adults between the ages of 18 and 26 (inclusive; approximately 10 participants)
Age: 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights

Synk2b Trial Summary

This trial is testing different ways to help people with HIV manage their treatment and mental health/substance use.

Who is the study for?
This trial is for HIV-positive adults with uncontrolled virus levels in the past year. It includes men who have sex with men (MSM) using stimulants, transgender women, and young adults aged 18-26. Participants must not be severely ill or impaired at consent time, nor currently/recently in CBT treatment.Check my eligibility
What is being tested?
The study tests Cognitive Behavioral Therapy (CBT) tailored to address both mental health issues and medication adherence among people living with HIV. The goal is to improve their ability to manage HIV treatment alongside coping with psychological and substance use challenges.See study design
What are the potential side effects?
While CBT generally does not cause physical side effects, participants may experience emotional discomfort discussing personal issues during therapy sessions. Increased stress or anxiety can occur when confronting difficult topics.

Synk2b Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The study is looking for three specific groups of people: (1) men who have sex with men and have used stimulants in the past 4 months, (2) transgender women, and (3) young adults between the ages of 18 and 26.
Select...
I am 18 years old or older.

Synk2b Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants who completes the follow up assessment
Secondary outcome measures
ART Medication Adherence
Percentage of participants with improvement in syndemic, behavioral health outcomes
Percentage of participants with undetectable viral load

Synk2b Trial Design

1Treatment groups
Experimental Treatment
Group I: Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors GroupExperimental Treatment1 Intervention
Participants in this group will receive the CBT for Syndemics and Adherence Factors intervention for a total of 14 sessions over 4 months.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
409,185 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,447 Previous Clinical Trials
2,593,991 Total Patients Enrolled
Steven A Safren, PhDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
796 Total Patients Enrolled

Media Library

CBT for Syndemics and Adherence Factors (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05352061 — N/A
Medication Adherence Research Study Groups: Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors Group
Medication Adherence Clinical Trial 2023: CBT for Syndemics and Adherence Factors Highlights & Side Effects. Trial Name: NCT05352061 — N/A
CBT for Syndemics and Adherence Factors (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05352061 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the public have access to this experiment at present?

"According to the information posted on clinicaltrials.gov, this particular trial is not presently enrolling patients. This investigation was initially put up for recruitment in August of 2022 and last updated at the end October of that same year. Despite this study no longer being open, there are 127 other trials recruiting participants currently active research opportunities."

Answered by AI
~30 spots leftby May 2025