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

Study Overview
=================
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.

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

Conditions
-----------------
HIV/AIDS, Depression, Anxiety, Post-traumatic Stress Disorder, Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Adapted Common Elements Treatment Approach


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CETA protocol<br> | Behavioral: Adapted Common Elements Treatment Approach<br>* 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.<br>|
| No Intervention: Enhanced Usual Care<br> | |

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 |