Medication Adherence, Mental Health Issue
Conditions
Keywords
HIV Medication Adherence, Mental Health
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.
Interventions
BEHAVIORALCBT 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.
Sponsors
University of Miami
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: 18 years or older 2. HIV positive 3. Evidence of uncontrolled virus (e.g., \> 20 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who completes the follow up assessment | 8 months | Feasibility will be reported as the percentage of participants who completes the study follow up assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ART Medication Adherence | 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. |
| Percentage of participants with undetectable viral load | Up to 8 months | As assessed via serum blood samples. |
| Percentage of participants with improvement in syndemic, behavioral health outcomes | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteven A Safren, PhD
University of Miami
Outcome results
None listed