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

Michael J Mugavero, MD60 enrolled

Overview

This pilot randomized clinical trial will randomize 60 participants 1:1 to either enhanced usual care or to adapted Common Elements Treatment Approach (CETA), a counseling intervention for HIV care engagement plus depression, anxiety, PTSD, and/or substance use.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Adapted Common Elements Treatment ApproachBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>= 18 years. 2. Patient receiving HIV care at University of Alabama at Birmingham (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 Diagnostic and Statistical Manual of Mental Disorders (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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Feasibility of Recruitment

We defined feasibility as the total number of patients approached in order to accrue the final study sample size of n=60.

Time frame: Duration of recruitment phase (9 months)

Client Acceptability

Client acceptability will be assessed via the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item questionnaire, with a minimum value of 8 and a maximum score of 32. A higher score indicates greater client acceptability.

Time frame: At treatment exit (approximately 9 months post-baseline)

Fidelity

Counselor fidelity to CETA will be rated by the trainer based on the trainer's supervisory experience working with CETA counselors. After all CETA patients complete the study, the trainer will rate up to 5 cross-cutting aspects of CETA delivery and 13 CETA components targeting specific symptoms for fidelity. The trainer will rate the degree of confidence on a scale of 0 ("Not at all") to 4 ("Completely") that the counselor was routinely delivering each cross-cutting aspect or component of CETA with fidelity, for those aspects and components that the trainer had experience supervising the counselor in. The fidelity rating will be calculated separately for the 2 CETA counselors and reported as the mean score across the number of CETA aspects and components rated by the trainer. Higher scores indicate greater fidelity to CETA.

Time frame: At the end of CETA completion or withdrawal, across all CETA participants

Secondary Outcomes

Number of Participants Suppressed HIV RNA Viral Load

HIV RNA viral load \<200 copies/mL

Time frame: 4 months post-baseline

Number of Participants With Suppressed HIV RNA Viral Load

HIV RNA viral load \<200 copies/mL

Time frame: 9 months post-baseline

Data from ClinicalTrials.gov

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