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

NCT04163341 | Completed Results

• 1 other identifier: IRB-300004217
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Secondary Outcomes (8)

• Number of Participants Suppressed HIV RNA Viral Load

  4 months post-baseline

• Number of Participants With Suppressed HIV RNA Viral Load

  9 months post-baseline

• HIV Appointment Attendance

  From baseline to 12 months post-baseline

• Depressive Symptoms

  4 months post-baseline

• Anxiety Symptoms

  4 months post-baseline

Study Arms (2)

Common Elements Treatment Approach (CETA) protocol

EXPERIMENTAL

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.

Behavioral: Adapted Common Elements Treatment Approach

Enhanced Usual Care (EUC)

NO INTERVENTION

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.

Interventions

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.

Common Elements Treatment Approach (CETA) protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Non-English speaking 2. Unable to attend counseling sessions 3. Unwilling to provide informed consent

Sponsors & Collaborators

• Michael J Mugavero, MD: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35222, United States

Location

Related Publications (1)

• 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.

  PMID: 39116333 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Substance-Related Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Dr. Michael Mugavero
• Organization: University of Alabama at Birmingham

mmugavero@uab.edu

202-966-5822

Study Officials

• Brian Pence, PhD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

• Bradley Gaynes, MD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

• Doyane Darnell, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 14, 2019
• Study Start: October 23, 2020
• Primary Completion: September 1, 2022
• Study Completion: December 13, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)