NCT02696681CompletedNot Applicable
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Cognitive Behavioral Therapy
Experimental
Integrating CBT for any substance use or mental health problems with CBT for adherence/self-care
Intervention: Cognitive Behavioral Therapy (Behavioral)
Outcomes
Primary Outcomes
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
Time Frame: 8 month assessment
Attaining viral suppression
Secondary Outcomes
- Adherence to antiretroviral therapy via real time monitoring(Changes over time from baseline to 8 month follow-up)
Investigators
Steven Safren
Professor
University of Miami
Study Sites (2)
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