Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b

Medication Adherence Clinical Trial

— Synk2b  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05352061
• Other study ID #: 20210836
• Secondary ID: 9K24DA040489
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age: 18 years or older

2. HIV positive

3. Evidence of uncontrolled virus (e.g., > 200 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.

Related Conditions & MeSH terms

• Medication Adherence
• Mental Health Issue

Intervention

Behavioral:
• CBT for Syndemics and Adherence Factors
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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who completes the follow up assessment	Feasibility will be reported as the percentage of participants who completes the study follow up assessment.	8 months
Secondary	ART Medication Adherence	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.	Up to 8 months
Secondary	Percentage of participants with undetectable viral load	As assessed via serum blood samples.	Up to 8 months
Secondary	Percentage of participants with improvement in syndemic, behavioral health outcomes	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.	Up to 8 months