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Enrolling by invitation NCT05352061

Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b

No phase Interventional Medication Adherence Mental Health Issue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CBT for Syndemics and Adherence Factors.
Who it may be relevant to
Registry conditions: Medication Adherence, Mental Health Issue. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Percentage of participants who completes the follow up assessment [Time frame: 8 months]
Secondary outcome measures (3)
  • ART Medication Adherence [Time frame: Up to 8 months]
  • Percentage of participants with undetectable viral load [Time frame: Up to 8 months]
  • Percentage of participants with improvement in syndemic, behavioral health outcomes [Time frame: Up to 8 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT05352061 · 20210836 · 9K24DA040489

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗