Addressing Psychosocial Comorbidities in HIV Treatment and Prevention

NCT ID: NCT02696681

Last Updated: 2019-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-09-18

Brief Summary

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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

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Conditions

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Human Immunodeficiency Virus Depression Mental Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive Behavioral Therapy

Integrating CBT for any substance use or mental health problems with CBT for adherence/self-care

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Integrating CBT for mental health and substance issues concern with CBT for health behavior change

Interventions

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Cognitive Behavioral Therapy

Integrating CBT for mental health and substance issues concern with CBT for health behavior change

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Steven Safren

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven A Safren, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

References

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Safren SA, Harkness A, Lee JS, Rogers BG, Mendez NA, Magidson JF, Blashill AJ, Bainter S, Rodriguez A, Ironson G. Addressing Syndemics and Self-care in Individuals with Uncontrolled HIV: An Open Trial of a Transdiagnostic Treatment. AIDS Behav. 2020 Nov;24(11):3264-3278. doi: 10.1007/s10461-020-02900-7.

Reference Type DERIVED
PMID: 32410049 (View on PubMed)

Other Identifiers

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1K24MH094214-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9K24DA040489-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20150383

Identifier Type: -

Identifier Source: org_study_id

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