Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States
- Conditions
- AnxietyPost-traumatic Stress DisorderSubstance Use DisordersDepressionHIV/AIDS
- Interventions
- Behavioral: Adapted Common Elements Treatment Approach
- Registration Number
- NCT04163341
- Lead Sponsor
- Michael J Mugavero, MD
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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Age >= 18 years.
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Patient receiving HIV care at UAB 1917 Clinic.
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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
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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.
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Willing to provide written informed consent.
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- Non-English speaking 2. Unable to attend counseling sessions 3. Unwilling to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Common Elements Treatment Approach (CETA) protocol Adapted Common Elements Treatment Approach Adapted Common Elements Treatment Approach (CETA): 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 Outcome Measures
Name Time Method Feasibility of Recruitment 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.
Client Acceptability 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.
Fidelity 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 Outcome Measures
Name Time Method Number of Participants Suppressed HIV RNA Viral Load 4 months post-baseline HIV RNA viral load \<200 copies/mL
Number of Participants With 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 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.
Depressive Symptoms 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.
Anxiety Symptoms 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.
Post-traumatic Stress Symptoms 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.
Substance Use Symptoms 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.
HIV Kept Visit Attendance 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.
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States