Clinical trial NCT04163341: Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States
Official title: Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Depression
Anxiety
Post-traumatic Stress Disorder
Substance Use Disorders
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2019-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Recruitment
timeFrame: Duration of recruitment phase (9 months)
measure: Client Acceptability
timeFrame: At treatment exit (approximately 9 months post-baseline)
measure: Fidelity
timeFrame: At the end of CETA completion or withdrawal, across all CETA participants
Secondary outcomes:
measure: Number of Participants Suppressed HIV RNA Viral Load
timeFrame: 4 months post-baseline
measure: Number of Participants With Suppressed HIV RNA Viral Load
timeFrame: 9 months post-baseline
measure: HIV Appointment Attendance
timeFrame: From baseline to 12 months post-baseline
measure: Depressive Symptoms
timeFrame: 4 months post-baseline
measure: Anxiety Symptoms
timeFrame: 4 months post-baseline
measure: Post-traumatic Stress Symptoms
timeFrame: 4 months post-baseline
measure: Substance Use Symptoms
timeFrame: 4 months post-baseline
measure: HIV Kept Visit Attendance
timeFrame: From baseline to 12 months post-baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: UNC-Chapel Hill
name: Brian Pence, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC-Chapel Hill
name: Bradley Gaynes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Doyane Darnell, PhD
role: PRINCIPAL_INVESTIGATOR
References: