Addressing Psychosocial Comorbidities in HIV Treatment and Prevention

Depression Clinical Trial

— APPROACH  

Official title:

Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696681
• Other study ID #: 20150383
• Secondary ID: 1K24MH094214-019
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: September 18, 2018

Study information

• Verified date: August 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 18, 2018
• Est. primary completion date: September 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Depression
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Mental Health

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Integrating CBT for mental health and substance issues concern with CBT for health behavior change

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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