Addressing Psychosocial Comorbidities in HIV Treatment and Prevention

Study Overview
=================
Brief Summary
-----------------
Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for individuals with HIV with various psychological comorbidities, which the investigators call syndemics. Syndemics are co-occurring psychosocial problems that interact with each other and with health behavior such as HIV sexual transmission risk behavior and adherence to self care.

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

Conditions
-----------------
Human Immunodeficiency Virus, Depression, Mental Health

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV+ individuals Uncontrolled virus (plasma HIV RNA concentrations that reach detectable limits) or being diagnosed with a sexually transmitted infection (STI) (gonorrhea, chlamydia, syphilis, trichomoniasis (female only)) currently or within the past 3 months. Exclusion Criteria: Unable or unwilling to provide informed consent 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 himself or others as a result of study participation, Under the age of 18 or over the age of 65, Current CBT for a psychiatric disorder, or a course of CBT in the past year.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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<br>Integrating CBT for any substance use or mental health problems with CBT for adherence/self-care | Behavioral: Cognitive Behavioral Therapy<br>* Integrating CBT for mental health and substance issues concern with CBT for health behavior change<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load | Attaining viral suppression | 4 months assessment | 
| Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load | Attaining viral suppression | 8 month assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to antiretroviral therapy via real time monitoring | Adherence to ART will be measured using a real time monitoring devices that tracks when a pill box is opened and closed. | Changes over time from baseline to 8 month follow-up |