Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b

Not Applicable

• Conditions: Medication Adherence; Mental Health Issue
• Interventions: Behavioral: CBT for Syndemics and Adherence Factors

• Registration Number: NCT05352061
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-28
• Study Start: 2022-08-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors Group	CBT for Syndemics and Adherence Factors	Participants in this group will receive the CBT for Syndemics and Adherence Factors intervention for a total of 14 sessions over 4 months.

Primary Outcome Measures

Name	Time	Method
Percentage of participants who completes the follow up assessment	8 months	Feasibility will be reported as the percentage of participants who completes the study follow up assessment.

Secondary Outcome Measures

Name	Time	Method
ART Medication Adherence	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.
Percentage of participants with undetectable viral load	Up to 8 months	As assessed via serum blood samples.
Percentage of participants with improvement in syndemic, behavioral health outcomes	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States