CBT for HIV with Mental Health Issues
(Synk2b Trial)
MP
ER
Overseen ByElliott R Weinstein, MPH, M.S.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to learn about ways to better support people living with HIV with their HIV treatment and cope with mental health challenges and/or substance use concerns.
Research Team
SA
Steven A Safren, Ph.D.
Principal Investigator
University of Miami
Eligibility Criteria
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.Inclusion Criteria
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.
Evidence of uncontrolled virus (e.g., > 200 copies/ml) within the past 12 months as verified by medical record
HIV positive
Exclusion Criteria
You have a severe mental illness that is not being treated and could affect your ability to take part in the study.
Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
Opinion of the PI that the participant would be at risk for harm to self or others
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Cognitive Behavioral Therapy (CBT) for Syndemics and Adherence Factors intervention for a total of 14 sessions
4 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 months
Treatment Details
Interventions
- CBT for Syndemics and Adherence Factors
Trial Overview 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.
Participant Groups
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 Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Trials
976
Recruited
423,000+
National Institute on Drug Abuse (NIDA)
Collaborator
Trials
2,658
Recruited
3,409,000+
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