NCT04163341: TRACE

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

Completed NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing Adapted Common Elements Treatment Approach in HIV/AIDS in 60 participants. Completed in 13 December 2022.

Timeline

23 October 2020

Primary endpoint
1 September 2022

13 December 2022

Quick facts

Lead sponsor	Michael J Mugavero, MD
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	23 October 2020
Primary completion	1 September 2022
Estimated completion	13 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Adapted Common Elements Treatment Approach

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →
• Post-traumatic Stress Disorder — all drugs for Post-traumatic Stress Disorder →

Sponsor

Michael J Mugavero, MD

Who can join

18 and older, any sex, with HIV/AIDS or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Recruitment Primary · 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.

Group	Value	95% CI
No Arm Assignment in Screening Phase	92

Client Acceptability Primary · 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.

Group	Value	95% CI
CETA Protocol	29.3	± 3.0

Fidelity Primary · 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 couns

Group	Value	95% CI
CETA Counselor 1	3.3	± 0.72
CETA Counselor 2	3.0	± 0

Number of Participants Suppressed HIV RNA Viral Load Secondary · 4 months post-baseline

HIV RNA viral load \<200 copies/mL

Group	Value	95% CI
CETA Protocol	13
Enhanced Usual Care	18

Number of Participants With Suppressed HIV RNA Viral Load Secondary · 9 months post-baseline

HIV RNA viral load \<200 copies/mL

Group	Value	95% CI
CETA Protocol	17
Enhanced Usual Care	17

HIV Appointment Attendance Secondary · 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.

Group	Value	95% CI
CETA Protocol	22
Enhanced Usual Care	22

Depressive Symptoms Secondary · 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.

Group	Value	95% CI
CETA Protocol	11.1	± 6.8
Enhanced Usual Care	9.8	± 6.9

Anxiety Symptoms Secondary · 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.

Group	Value	95% CI
CETA Protocol	10.4	± 5.4
Enhanced Usual Care	9.3	± 5.9

Post-traumatic Stress Symptoms Secondary · 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.

Group	Value	95% CI
CETA Protocol	33.7	± 19.2
Enhanced Usual Care	28.9	± 17.3

Substance Use Symptoms Secondary · 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.

Group	Value	95% CI
CETA Protocol	10.0	± 8.1
Enhanced Usual Care	7.9	± 7.5

HIV Kept Visit Attendance Secondary · 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 p

Group	Value	95% CI
CETA Protocol	0.74	± 0.27
Enhanced Usual Care	0.70	± 0.27

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Provocative Findings From a Transdiagnostic Counseling Intervention to Improve Psychiatric Comorbidity and HIV Care Engagement Among People With HIV: A Pilot Randomized Clinical Trial.
   Pence BW, Darnell D, Ranna-Stewart M, Psaros C, et al · · 2024 · PMID 39116333 · DOI 10.1097/qai.0000000000003457