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Completed

NCT Number: NCT04163341

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years.
  • Patient receiving HIV care at University of Alabama at Birmingham (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 Diagnostic and Statistical Manual of Mental Disorders (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

Treatment and study plan

Adapted Common Elements Treatment Approach

Behavioral

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.

Primary outcomes

  1. Feasibility of Recruitment

    Time frame: Duration of recruitment phase (9 months)

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

  2. Client Acceptability

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

    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.

  3. Fidelity

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

    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.

Secondary outcomes

  1. Number of Participants Suppressed HIV RNA Viral Load

    Time frame: 4 months post-baseline

    HIV RNA viral load <200 copies/mL

  2. Number of Participants With Suppressed HIV RNA Viral Load

    Time frame: 9 months post-baseline

    HIV RNA viral load <200 copies/mL

  3. HIV Appointment Attendance

    Time frame: From baseline to 12 months post-baseline

    Health Resources and Services Administration (HRSA) attendance measure: Engaged in care if attended >=2 HIV primary care visits >= 90 days apart in the 12 months after baseline.

  4. Depressive Symptoms

    Time frame: 4 months post-baseline

    Patient Health Questionnaire-9 (PHQ-9) score; minimum score is 0, maximum score is 27, with higher scores meaning a worse outcome.

  5. Anxiety Symptoms

    Time frame: 4 months post-baseline

    Generalized Anxiety Disorder-7 (GAD-7) anxiety subscale score; minimum score is 0, maximum score is 21, with higher scores meaning a worse outcome.

  6. Post-traumatic Stress Symptoms

    Time frame: 4 months post-baseline

    PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5); minimum score is 0, maximum score is 80, with higher scores meaning a worse outcome.

  7. Substance Use Symptoms

    Time frame: 4 months post-baseline

    The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); each substance is scored separately. The minimum score is 0, maximum score is 39, with higher scores meaning a worse outcome. For this outcome, we will report substance use symptoms at 4 months post-baseline for the substance with the highest score at baseline only.

  8. HIV Kept Visit Attendance

    Time frame: From baseline to 12 months post-baseline

    Mean kept visit proportion: Total number of kept visits HIV clinical care visits divided by total number of missed plus kept HIV clinical care visits.

    For one individual: The numerator in this proportion is all the scheduled HIV clinical care visits a participant attended from baseline to 12-months post-baseline.The denominator in this proportion is all the scheduled HIV clinical care visits a participant attended plus all the scheduled HIV clinical care visits a participant did not attend or 'missed' from baseline to 12-months post-baseline.

    For each arm: We calculated the mean kept visit proportion per study arm by adding each individual kept visit proportion and dividing by the total number of participants in each arm.

Sponsors and collaborators

Lead sponsor

Michael J Mugavero, MD

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Acronym: TRACE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 14, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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