Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b (Synk2b)

University of Miami

Status: Invitation-only

Conditions: Medication Adherence; Mental Health Issue

Treatments: Behavioral: CBT for Syndemics and Adherence Factors

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05352061

20210836

9K24DA040489 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: 18 years or older
2. HIV positive
3. Evidence of uncontrolled virus (e.g., > 20 copies/ml) within the past 12 months as verified by medical record
4. 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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

75 participants in 1 patient group

Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors Group

Experimental group

Description:

Participants in this group will receive the CBT for Syndemics and Adherence Factors intervention for a total of 14 sessions over 4 months.

Treatment:

Behavioral: CBT for Syndemics and Adherence Factors