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

October 13, 2023 updated by: Steven Safren, University of Miami

Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 8 months
Percentage of participants with undetectable viral load
Time Frame: Up to 8 months
As assessed via serum blood samples.
Up to 8 months
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.
Up to 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Steven A Safren, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20210836
  • 9K24DA040489 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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