TRACE: Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Feasibility of recruitment [Duration of recruitment phase (9 months)]
Number of patients approached in order to accrue the final sample
- Client acceptability [At treatment exit (approximately 3 months post-baseline)]
Client Satisfaction Questionnaire-8
- Fidelity [At each CETA treatment session, over the approximately 3 months of each client's CETA treatment]
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 [3 months post-baseline]
HIV RNA viral load <200 copies/mL
- Suppressed HIV RNA viral load [9 months post-baseline]
HIV RNA viral load <200 copies/mL
- HIV appointment attendance [From baseline to 12 months post-baseline]
HRSA attendance measure: Engaged in care if attended >=2 HIV primary care visits >= 90 days apart in the 12 months after baseline.
- Depressive symptoms [3 months post-baseline]
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 [3 months post-baseline]
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 [3 months post-baseline]
Harvard Trauma Questionnaire (HTQ) score; minimum score is 1, maximum score is 4, with higher scores meaning a worse outcome.
- Substance use symptoms [3 months post-baseline]
Timeline Follow-Back
- HIV appointment attendance [From baseline to 12 months post-baseline]
Kept visit proportion: Total number of kept visits divided by total number of missed plus kept visits
Eligibility Criteria
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:
-
- Non-English speaking 2. Unable to attend counseling sessions 3. Unwilling to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35222 |
Sponsors and Collaborators
- Michael J Mugavero, MD
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-300004217