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

NCT ID: NCT04163341

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-23
• Study Completion Date: 2022-12-13

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Common Elements Treatment Approach (CETA) protocol

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.

Group Type: EXPERIMENTAL

Adapted Common Elements Treatment Approach

Intervention Type: 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.

Enhanced Usual Care (EUC)

Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adapted Common Elements Treatment Approach

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Michael J Mugavero, MD

OTHER

Sponsor Role: lead

Responsible Party

Michael J Mugavero, MD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brian Pence, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC-Chapel Hill

Bradley Gaynes, MD

Role: PRINCIPAL_INVESTIGATOR

UNC-Chapel Hill

Doyane Darnell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

Pence BW, Darnell D, Ranna-Stewart M, Psaros C, Gaynes BN, Grimes L, Henderson S, Parman M, Filipowicz TR, Gaddis K, Dorsey S, Mugavero MJ. Provocative Findings From a Transdiagnostic Counseling Intervention to Improve Psychiatric Comorbidity and HIV Care Engagement Among People With HIV: A Pilot Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2024 Sep 1;97(1):68-77. doi: 10.1097/QAI.0000000000003457.

Reference Type: DERIVED

PMID: 39116333 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB-300004217

Identifier Type: -

Identifier Source: org_study_id