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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02696681
Other study ID # 20150383
Secondary ID 1K24MH094214-019
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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