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

University of Miami1 site in 1 country75 target enrollmentAugust 15, 2022

ConditionsMedication Adherence Mental Health Issue

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Medication Adherence
Sponsor: University of Miami
Enrollment: 75
Locations: 1
Primary Endpoint: Percentage of participants who completes the follow up assessment
Status: Enrolling By Invitation
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 15, 2022

End Date

May 2027

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Steven Safren

Professor

University of Miami

Eligibility Criteria

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.

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)