NCT05352061Enrolling By InvitationNot Applicable
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2b
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Miami
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Percentage of participants who completes the follow up assessment
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors Group
Experimental
Participants in this group will receive the CBT for Syndemics and Adherence Factors intervention for a total of 14 sessions over 4 months.
Intervention: CBT for Syndemics and Adherence Factors (Behavioral)
Outcomes
Primary Outcomes
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
- ART Medication Adherence(Up to 8 months)
- Percentage of participants with undetectable viral load(Up to 8 months)
- Percentage of participants with improvement in syndemic, behavioral health outcomes(Up to 8 months)
Investigators
Steven Safren
Professor
University of Miami
Study Sites (2)
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