Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05352061

Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Medication Adherence Behavior Health Behavior Mental Health Issue Patient Acceptance of Health Care Patient Compliance Personal Satisfaction Psychological Well-Being Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 years or older
  • HIV positive
  • Evidence of uncontrolled virus (e.g., > 20 copies/ml) within the past 12 months as verified by medical record
  • 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)

Exclusion criteria

  • Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
  • Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation
  • Opinion of the PI that the participant would be at risk for harm to self or others
  • Currently receiving CBT for a psychiatric disorder, or received a course of CBT in the past year.

Treatment and study plan

CBT for Syndemics and Adherence Factors

Behavioral

Each hour-long session is conducted via zoom or in person with a study clinician. Sessions focus on HIV medication adherence, coping with life stressors, and managing other challenging situations (e.g., possible traumatic experiences, drug and alcohol use and sexual behavior) that may affect mental or HIV-related health.

Primary outcomes

  1. Percentage of participants who completes the follow up assessment

    Time frame: 8 months

    Feasibility will be reported as the percentage of participants who completes the study follow up assessment.

Secondary outcomes

  1. ART Medication Adherence

    Time frame: Up to 8 months

    Antiretroviral Therapy (ART) adherence will be reported as the percentage of participants who reports taking > 80% of their ART from baseline up to follow up visit.

  2. Percentage of participants with undetectable viral load

    Time frame: Up to 8 months

    As assessed via serum blood samples.

  3. Percentage of participants with improvement in syndemic, behavioral health outcomes

    Time frame: Up to 8 months

    Participants with a 2-point reduction in their Diagnostic Interview for Anxiety, Mood and Obsessive Compulsive Disorder (OCD) Related Neuropsychiatric Disorders (DIAMOND) scores from baseline will be reported as having improvement in behavioral health outcome. DIAMOND has a total score ranging from 1-7 with the higher score indicating greater severity.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2b

Acronym: Synk2b

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 28, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.