Addressing Psychosocial Comorbidities in HIV Treatment and Prevention (APPROACH)

August 2, 2019 updated by: Steven Safren, University of Miami

Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33146
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Therapy
Integrating CBT for any substance use or mental health problems with CBT for adherence/self-care
Behavioral: Cognitive Behavioral Therapy
Integrating CBT for mental health and substance issues concern with CBT for health behavior change

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
Time Frame: 4 months assessment
Attaining viral suppression
4 months assessment
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
8 month assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to antiretroviral therapy via real time monitoring
Time Frame: 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.
Changes over time from baseline to 8 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

September 18, 2018

Study Completion (Actual)

September 18, 2018

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150383
  • 1K24MH094214-01 (U.S. NIH Grant/Contract)
  • 9K24DA040489-07 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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