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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04163341
Other study ID # IRB-300004217
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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