Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States (TRACE)

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.

Study Overview

• Status: Completed
• Conditions: Depression; HIV/AIDS; Anxiety; Substance Use Disorders; Post-traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Adapted Common Elements Treatment Approach

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35222
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >= 18 years.
2. Patient receiving HIV care at UAB 1917 Clinic.

3. Elevated symptoms of depression, anxiety, post-traumatic stress, or substance use disorder: At least one of the following:

   1. Patient Health Questionnaire-9 score >= 10;
   2. Generalized Anxiety Disorder 7-Item Scale score >= 10;
   3. Post-Traumatic Stress Symptoms Checklist for DSM-5 score >= 33;
   4. ASSIST score >=11 for alcohol or >=4 for any other substance

4. At risk for suboptimal HIV care engagement: At least one of the following:

   1. Engaged in HIV care for the first time within the past 6 months;
   2. Have an HIV RNA viral load >1,000 copies/mL within the past 6 months;
   3. Antiretroviral regimen was changed due to treatment failure within the past 6 months;
   4. No-showed to an HIV primary care appointment within the past year.
5. Willing to provide written informed consent.

Exclusion Criteria:

• 1. Non-English speaking 2. Unable to attend counseling sessions 3. Unwilling to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CETA protocol	Behavioral: Adapted Common Elements Treatment Approach; 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.
No Intervention: Enhanced Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	Number of patients approached in order to accrue the final sample	Duration of recruitment phase (9 months)
Client acceptability	Client Satisfaction Questionnaire-8	At treatment exit (approximately 3 months post-baseline)
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	At each CETA treatment session, over the approximately 3 months of each client's CETA treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suppressed HIV RNA viral load	HIV RNA viral load <200 copies/mL	3 months post-baseline
Suppressed HIV RNA viral load	HIV RNA viral load <200 copies/mL	9 months post-baseline
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.	From baseline to 12 months post-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.	3 months post-baseline
Anxiety symptoms	Hopkins Symptom Checklist (HSCL) anxiety subscale score; minimum score is 1, maximum score is 4, with higher scores meaning a worse outcome.	3 months post-baseline
Post-traumatic stress symptoms	Harvard Trauma Questionnaire (HTQ) score; minimum score is 1, maximum score is 4, with higher scores meaning a worse outcome.	3 months post-baseline
Substance use symptoms	Timeline Follow-Back	3 months post-baseline
HIV appointment attendance	Kept visit proportion: Total number of kept visits divided by total number of missed plus kept visits	From baseline to 12 months post-baseline

Collaborators and Investigators

• Sponsor: Michael J Mugavero, MD
• Collaborators: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Brian Pence, PhD, UNC-Chapel Hill; Principal Investigator: Bradley Gaynes, MD, UNC-Chapel Hill; Principal Investigator: Doyane Darnell, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Substance-Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: IRB-300004217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No