Addressing Psychosocial Comorbidities in HIV Treatment and Prevention (APPROACH)
Primary Purpose
Human Immunodeficiency Virus, Depression, Mental Health
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus
Eligibility Criteria
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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive Behavioral Therapy
Arm Description
Integrating CBT for any substance use or mental health problems with CBT for adherence/self-care
Outcomes
Primary Outcome Measures
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
Attaining viral suppression
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
Attaining viral suppression
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02696681
First Posted
February 18, 2016
Last Updated
August 2, 2019
Sponsor
University of Miami
Collaborators
National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02696681
Brief Title
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention
Acronym
APPROACH
Official Title
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
September 18, 2018 (Actual)
Study Completion Date
September 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Depression, Mental Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Integrating CBT for any substance use or mental health problems with CBT for adherence/self-care
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Integrating CBT for mental health and substance issues concern with CBT for health behavior change
Primary Outcome Measure Information:
Title
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
Description
Attaining viral suppression
Time Frame
4 months assessment
Title
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
Description
Attaining viral suppression
Time Frame
8 month assessment
Secondary Outcome Measure Information:
Title
Adherence to antiretroviral therapy via real time monitoring
Description
Adherence to ART will be measured using a real time monitoring devices that tracks when a pill box is opened and closed.
Time Frame
Changes over time from baseline to 8 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A Safren, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32410049
Citation
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.
Results Reference
derived
Learn more about this trial
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention
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