Addressing Psychosocial Comorbidities in HIV Treatment and Prevention

Not Applicable

Completed

• Conditions: Mental Health; Depression; Human Immunodeficiency Virus

• Registration Number: NCT02696681
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-18
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-02
• Primary Completion: 2018-09-18
• Study Completion: 2018-09-18
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load	8 month assessment	Attaining viral suppression

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States