N/A N=60 Randomized Double-blind Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT04163341 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Feasibility of Recruitment — 92 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Adapted Common Elements Treatment Approach (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Michael J Mugavero, MD
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Recruitment	92	—
PRIMARY Client Acceptability	29.3	—
PRIMARY Fidelity	3.3; 3.0	—
SECONDARY Number of Participants Suppressed HIV RNA Viral Load	13; 18	—
SECONDARY Number of Participants With Suppressed HIV RNA Viral Load	17; 17	—
SECONDARY HIV Appointment Attendance	22; 22	—
SECONDARY Depressive Symptoms	11.1; 9.8	—
SECONDARY Anxiety Symptoms	10.4; 9.3	—
SECONDARY Post-traumatic Stress Symptoms	33.7; 28.9	—
SECONDARY Substance Use Symptoms	10.0; 7.9	—
SECONDARY HIV Kept Visit Attendance	0.74; 0.70	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04163341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.