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

Depression Clinical Trial

— TRACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163341
• Other study ID #: IRB-300004217
• Status: Completed
• Phase: N/A
• Start date: October 23, 2020
• Est. completion date: December 13, 2022

Study information

• Verified date: January 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 13, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Disease
• HIV/AIDS
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Michael J Mugavero, MD	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	Number of patients approached in order to accrue the final sample	Duration of recruitment phase (9 months)
Primary	Client acceptability	Client Satisfaction Questionnaire-8	At treatment exit (approximately 3 months post-baseline)
Primary	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	Suppressed HIV RNA viral load	HIV RNA viral load <200 copies/mL	3 months post-baseline
Secondary	Suppressed HIV RNA viral load	HIV RNA viral load <200 copies/mL	9 months post-baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Substance use symptoms	Timeline Follow-Back	3 months post-baseline
Secondary	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