NCT05352061

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Aug 2022May 2027

First Submitted

Initial submission to the registry

April 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

4.7 years

First QC Date

April 22, 2022

Last Update Submit

May 22, 2025

Conditions

Medication AdherenceMental Health Issue

Keywords

HIV Medication AdherenceMental Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

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.

Behavioral: CBT for Syndemics and Adherence Factors

Interventions

CBT for Syndemics and Adherence FactorsBEHAVIORAL

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.

Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors Group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThree distinct groups will be recruited: 1) Men who have sex with men who use stimulants, 2) transgender women, 3) emerging adults (ages 18-26 years).
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Medication AdherencePsychological Well-Being

Interventions

Syndemic

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Epidemiologic FactorsPublic HealthEnvironment and Public Health

Study Officials

  • Steven A Safren, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 28, 2022

Study Start

August 15, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)