Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States (TRACE)
Primary Purpose
HIV/AIDS, Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adapted Common Elements Treatment Approach
Sponsored by
About this trial
This is an interventional treatment trial for HIV/AIDS
Eligibility Criteria
Inclusion Criteria:
- Age >= 18 years.
- Patient receiving HIV care at UAB 1917 Clinic.
Elevated symptoms of depression, anxiety, post-traumatic stress, or substance use disorder: At least one of the following:
- Patient Health Questionnaire-9 score >= 10;
- Generalized Anxiety Disorder 7-Item Scale score >= 10;
- Post-Traumatic Stress Symptoms Checklist for DSM-5 score >= 33;
- ASSIST score >=11 for alcohol or >=4 for any other substance
At risk for suboptimal HIV care engagement: At least one of the following:
- Engaged in HIV care for the first time within the past 6 months;
- Have an HIV RNA viral load >1,000 copies/mL within the past 6 months;
- Antiretroviral regimen was changed due to treatment failure within the past 6 months;
- No-showed to an HIV primary care appointment within the past year.
- Willing to provide written informed consent.
Exclusion Criteria:
- 1. Non-English speaking 2. Unable to attend counseling sessions 3. Unwilling to provide informed consent
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CETA protocol
Enhanced Usual Care
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of recruitment
Number of patients approached in order to accrue the final sample
Client acceptability
Client Satisfaction Questionnaire-8
Fidelity
Counselor adherence to CETA content and skill in delivery will be rated by supervisor based on review of audiorecordings of a subset of sessions
Secondary Outcome Measures
Suppressed HIV RNA viral load
HIV RNA viral load <200 copies/mL
Suppressed HIV RNA viral load
HIV RNA viral load <200 copies/mL
HIV appointment attendance
HRSA attendance measure: Engaged in care if attended >=2 HIV primary care visits >= 90 days apart in the 12 months after baseline.
Depressive symptoms
Hamilton Rating Scale for Depression (HAM-D) score; minimum score is 0, maximum score is 52, with higher scores meaning a worse outcome.
Anxiety symptoms
Hopkins Symptom Checklist (HSCL) anxiety subscale score; minimum score is 1, maximum score is 4, with higher scores meaning a worse outcome.
Post-traumatic stress symptoms
Harvard Trauma Questionnaire (HTQ) score; minimum score is 1, maximum score is 4, with higher scores meaning a worse outcome.
Substance use symptoms
Timeline Follow-Back
HIV appointment attendance
Kept visit proportion: Total number of kept visits divided by total number of missed plus kept visits
Full Information
NCT ID
NCT04163341
First Posted
November 12, 2019
Last Updated
January 25, 2023
Sponsor
Michael J Mugavero, MD
Collaborators
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT04163341
Brief Title
Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States
Acronym
TRACE
Official Title
Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 23, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
December 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael J Mugavero, MD
Collaborators
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot randomized clinical trial will randomize 60 participants 1:1 to either enhanced usual care or to adapted CETA, a counseling intervention for HIV care engagement plus depression, anxiety, PTSD, and/or substance use.
Detailed Description
Patient participants in this study will be randomized 1:1 to either enhanced usual care or the adapted CETA intervention. Enhanced usual care will include provision of feedback about psychiatric diagnoses to the HIV provider and the clinic's behavioral health team for follow-up according to the clinic's standard care. Participants randomized to the adapted CETA arm will initiate CETA with the trained counselor. The number of CETA sessions will depend on the patient's presentation but will range from 7-13 weekly in-person 1-hour sessions.Before randomization, enrolled participants will complete a baseline assessment including sociodemographic information; self-reported health; standardized assessments of depressive, anxiety, and post-traumatic stress symptoms and substance use; and key related structural and psychosocial factors including housing stability,intimate partner violence (IPV), other violence in the home, coping, social support, and experiences of stigma related to mental health.
Participants in the Enhanced Contact arm will complete a follow-up research assessment at 3 months post baseline.Participants in the adapted CETA arm will complete this assessment after the final CETA session,also expected to be at approximately 3 months post-baseline. All participants will complete a final research assessment at 9 months post-baseline (approximately 6 months post-treatment exit for those in the adapted CETA arm). These follow-up assessments will assess the same domains as the baseline assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Depression, Anxiety, Post-traumatic Stress Disorder, Substance Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CETA protocol
Arm Type
Experimental
Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Adapted Common Elements Treatment Approach
Intervention Description
The intervention is a transdiagnostic cognitive behavioral therapy approach to treating any combination of depression, anxiety, post-traumatic stress, or substance use disorder that has been adapted the needs of adults with HIV and to additionally address HIV care engagement.
Primary Outcome Measure Information:
Title
Feasibility of recruitment
Description
Number of patients approached in order to accrue the final sample
Time Frame
Duration of recruitment phase (9 months)
Title
Client acceptability
Description
Client Satisfaction Questionnaire-8
Time Frame
At treatment exit (approximately 3 months post-baseline)
Title
Fidelity
Description
Counselor adherence to CETA content and skill in delivery will be rated by supervisor based on review of audiorecordings of a subset of sessions
Time Frame
At each CETA treatment session, over the approximately 3 months of each client's CETA treatment
Secondary Outcome Measure Information:
Title
Suppressed HIV RNA viral load
Description
HIV RNA viral load <200 copies/mL
Time Frame
3 months post-baseline
Title
Suppressed HIV RNA viral load
Description
HIV RNA viral load <200 copies/mL
Time Frame
9 months post-baseline
Title
HIV appointment attendance
Description
HRSA attendance measure: Engaged in care if attended >=2 HIV primary care visits >= 90 days apart in the 12 months after baseline.
Time Frame
From baseline to 12 months post-baseline
Title
Depressive symptoms
Description
Hamilton Rating Scale for Depression (HAM-D) score; minimum score is 0, maximum score is 52, with higher scores meaning a worse outcome.
Time Frame
3 months post-baseline
Title
Anxiety symptoms
Description
Hopkins Symptom Checklist (HSCL) anxiety subscale score; minimum score is 1, maximum score is 4, with higher scores meaning a worse outcome.
Time Frame
3 months post-baseline
Title
Post-traumatic stress symptoms
Description
Harvard Trauma Questionnaire (HTQ) score; minimum score is 1, maximum score is 4, with higher scores meaning a worse outcome.
Time Frame
3 months post-baseline
Title
Substance use symptoms
Description
Timeline Follow-Back
Time Frame
3 months post-baseline
Title
HIV appointment attendance
Description
Kept visit proportion: Total number of kept visits divided by total number of missed plus kept visits
Time Frame
From baseline to 12 months post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >= 18 years.
Patient receiving HIV care at UAB 1917 Clinic.
Elevated symptoms of depression, anxiety, post-traumatic stress, or substance use disorder: At least one of the following:
Patient Health Questionnaire-9 score >= 10;
Generalized Anxiety Disorder 7-Item Scale score >= 10;
Post-Traumatic Stress Symptoms Checklist for DSM-5 score >= 33;
ASSIST score >=11 for alcohol or >=4 for any other substance
At risk for suboptimal HIV care engagement: At least one of the following:
Engaged in HIV care for the first time within the past 6 months;
Have an HIV RNA viral load >1,000 copies/mL within the past 6 months;
Antiretroviral regimen was changed due to treatment failure within the past 6 months;
No-showed to an HIV primary care appointment within the past year.
Willing to provide written informed consent.
Exclusion Criteria:
1. Non-English speaking 2. Unable to attend counseling sessions 3. Unwilling to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Pence, PhD
Organizational Affiliation
UNC-Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley Gaynes, MD
Organizational Affiliation
UNC-Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doyane Darnell, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35222
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States
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