NCT04163341

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Michael J Mugavero, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2020-10-23
• Primary completion: 2022-09-01
• Completion: 2022-12-13
• First posted: 2019-11-14
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States