Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b

Study Overview
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Brief Summary
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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.

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

Conditions
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Medication Adherence, Mental Health Issue

Intervention / Treatment
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* Behavioral: CBT for Syndemics and Adherence Factors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years or older HIV positive Evidence of uncontrolled virus (e.g., > 200 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention 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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Medication Adherence, Mental Health