Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States
Phase: NA
Conditions: HIV/AIDS, Depression, Anxiety, Post-traumatic Stress Disorder, Substance Use Disorders
Sponsor: Michael J Mugavero, MD

 
                                                        
 
 
 
 
                                                                                            
 
  
Tailored Response to Psychiatric Comorbidity  
to Improve HIV Care Engagement in the United States 
(TRACE) 
 
 
 
 
 
 
 
STUDY PROTOCOL 
 
DATE: February 6th, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
2 
 
 
I. 
STUDY OVERVIEW 
Few protocols address treating patients with multiple mental health disorders in 
patients living with HIV. These psychiatric conditions are major barriers to HIV 
treatment engagement and success. This study hopes to address this gap in 
research by adapting the Common Elements Treatment Approach (CETA) for the 
particular needs of adults receiving HIV care in the US and pilot-test the adapted 
intervention to assess its acceptability and effectiveness to improve the mental 
health of patients with multiple psychiatric condition and increase their HIV care 
engagement.   
 
II. 
OBJECTIVES      
The long-term goal of our research program is to develop and disseminate effective, 
resource-efficient strategies to address psychiatric comorbidities as barriers to HIV 
care engagement and treatment success.  The overall objective of this proposal is to 
adapt CETA for the particular needs of adults receiving HIV care in the US and pilot-
test the adapted intervention to assess acceptability, feasibility, fidelity, and 
preliminary indications of impact.  Our hypotheses are that the adapted CETA 
intervention will be acceptable to patients and providers, will prove feasible to 
integrate in a busy HIV primary care setting, will be delivered with fidelity, and will 
demonstrate preliminary indications of impact in improving HIV (primary) and mental 
health (secondary) outcomes.  To achieve our objective, our specific aims are to: 

 
 
3 
 
 
Aim 1. Adapt the proven CETA protocol to (1) integrate content addressing ART 
adherence and HIV care engagement and (2) be optimized for delivery by staff such 
as LCSWs to patients with HIV in the US. 
 
Aim 2. Pilot the adapted CETA protocol in a small two-arm individually 
randomized trial.  
 
Aim 3. Assess the feasibility, acceptability, and fidelity of delivery of the adapted 
CETA protocol as well as preliminary indicators of its impact in improving both HIV 
(primary) and mental health (secondary) outcomes.   
 
The CETA approach has the potential to make an important contribution to 
addressing the overlap between common mental health disorders and barriers to 
HIV treatment success.  This proposal will generate critical evidence to guide the 
design of a full-scale RCT to test the effectiveness of the adapted CETA protocol in 
improving both HIV treatment and mental health outcomes for this vulnerable 
population. This clinical site for this study is the 1917 Clinic at University of Alabama 
at Birmingham (UAB). 
III. 
STUDY ACTIVITIES 
a) CETA MANUAL ADAPTATION 
Aim 1: Our team has an established manual for CETA, and procedures for adapting 
the CETA manual for specific settings and contexts. We will follow the ADAPT-ITT 
model to adapt the CETA protocol for our population and outcomes. In the third of 
eight steps in the model, entitled Adaptation, we will add a session to CETA for all 
participants explicitly targeting HIV medication adherence and care engagement, 
based on the evidence-based single-session LifeSteps intervention. Then we will 

 
 
4 
 
modify the existing CETA sessions so as to integrate HIV-specific examples and 
content).   
The second stage of adaptation will formally involve feedback from both potential 
clients and counselors.  We will present the modified CETA protocol to three groups 
each including 4-5 individuals: one of male patients with HIV, one of female patients 
with HIV, and one of LCSWs and other behavioral health providers from the clinic - 
the cadre who would deliver CETA.  We will solicit their feedback through recorded 
discussion and written surveys. 
b) STUDY POPULATION  
The target population for the pilot trial and the eventual full trial will be patients with 
elevated symptoms of depression, anxiety, post-traumatic stress, and/or substance use, 
who are also at risk for suboptimal HIV care engagement. 60 participants will be 
enrolled.  
Inclusion Criteria 
1. Age >= 18 years. 
2. Patient receiving HIV care at UAB 1917 Clinic. 
3.  Elevated symptoms of depression, anxiety, post-traumatic stress, or substance 
use disorder: At least one of the following:  
 
i. Patient Health Questionnaire-9 score >= 10;  
ii.    Generalized Anxiety Disorder 7-Item Scale score >= 10;  
iii.  . Post-Traumatic Stress Symptoms Checklist for DSM-5 score >= 33; 
iv.    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: 

 
 
5 
 
i. Engaged in HIV care for the first time within the past 6 months; 
ii.  Have an HIV RNA viral load >1,000 copies/mL within the past 6 months; 
iii. . Antiretroviral regimen was changed due to treatment failure within the 
past 6 months; 
iv. No-showed to an HIV primary care appointment within the past year. 
5.  Willing to provide written informed consent.   
 
Exclusion Criteria 
1. Do not speak or understand English 
2. Unable to attend counseling sessions 
3. Unwilling to provide informed consent 
 
Participants will be recruited via e-mail solicitation to clinic providers (NPs, MDs), 
counselors and social workers, as well as referrals 
c) PRE-SCREENING (phone) 
Potential participants will be prescreened over the phone using our prescreening phone 
script If the individual passes the telephone prescreen, he or she will be scheduled for a 
screening and enrollment visit via phone. The date and time of the pre-screening visit 
along with the participant contact information and preferred method of contact will be 
recorded on the Prescreening Log. If the participant is eligible for enrollment, a 
Screening and Enrollment Visit will be scheduled and recorded on a Screening and 
Enrollment Visit form. A separate excel log will collect data from the screening and 
enrollment visit form for tracking purposes.  

 
 
6 
 
d) SCREENING AND ENROLLMENT 
The Screening and Enrollment Visit will be scheduled based on the patient and 
research staff’s availability and be recorded on a Screening and Enrollment Visit log. 
Participants will receive a reminder call at about a week and 48 hours prior to the 
scheduled screening and enrollment visit. The following scales will be administered to 
the patient to confirm eligibility. If symptoms are elevated in any one of the following, 
proceed to do the verbal informed consent and complete the baseline questionnaire. If 
the participant isn’t eligible, thank them for their time and pay them $25.  
a. Depression:  PHQ-9 
b. Anxiety:  GAD-7 
c. PTS:  Trauma Questionnaire + PCL-5 
d. Alcohol/Drugs:  WHO ASSIST 
 
Informed Consent Procedures 
Informed consent will be administered by staff trained in accordance to the University of 
Alabama at Birmingham Institutional Review Board guidelines for obtaining informed 
consent. The staff member obtaining consent must verify the following: protocol name, 
version number, dates for use, and institution. The Study team member will also ensure 
that the most recent informed consent is being used for the study. Initial informed 
consent must be completed and documented before any other study related procedures 
are done. 
Comprehension will be assessed by asking the participant to summarize the study 
activities or some general open ended questions will be asked like what can you tell me 

 
 
7 
 
about this study, can you tell me about how long the study may last, etc. The consent 
process is estimated to take around 15-20 minutes. The staff member will document the 
verbal consent on the verbal consent form. 
 
Baseline Assessment 
If a participant is ineligible based on screening assessment, they will be given a $25 
incentive and thanked for their time, and they will not be considered to have been 
enrolled in the study at any point. If a participant is eligible, the baseline assessment will 
then be completed. Completion of Baseline assessment will be recorded in excel logs. 
 
RANDOMIZATION 
Our team will utilize a 1:1 ratio for allocation to the CETA intervention and Enhanced 
Usual Care (UC) conditions. Importantly, the PIs and outcomes assessor will be blinded 
to intervention vs. comparison allocation. Participants in the intervention and 
comparison conditions will have full access to all available clinical services at their 
respective sites. 
e) INTERVENTION 
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, including the new LifeSteps session, will range from 7-13 weekly in-person 1-hour 
sessions.   
f) COMPARISON CONDITION 

 
 
8 
 
The comparison group will receive “treatment as usual” as described above.  The 
comparison group will also be provided with the intervention manual, however, no 
additional treatment will be provided to participants allocated to the control group.  
Assessments 
Type 
Name 
Time Frame 
Description 
Primary 
Feasibility of recruitment 
Duration of recruitment 
phase (9 
months) 
Number of patients 
approached in 
order to accrue the final 
sample 
Primary 
Client acceptability 
9 months post-baseline  
 
Client Satisfaction 
Questionnaire-8 
Primary 
Fidelity 
At end of study 
 
Supervisor rating of each 
counselor’s overall 
fidelity to each core 
component that the 
counselor routinely 
employed, averaged into 
a single overall fidelity 
score 
Secondary 
Suppressed HIV RNA 
viral load 
4 months post-baseline 
HIV RNA viral load <200 
copies/mL 
Secondary 
Suppressed HIV RNA 
viral load 
9 months post-baseline 
HIV RNA viral load <200 
copies/mL 
Secondary 
HIV appointment 
attendance 
From baseline to 12 
months 
post-baseline 
Kept visit proportion: 
Total 
number of kept visits 
divided by total number 
of missed plus kept visits 
Secondary 
Depressive symptoms 
4 months post-baseline 
PHQ-9 
Secondary 
Anxiety symptoms 
4 months post-baseline 
GAD-7 
Secondary 
Post-traumatic stress 
symptoms 
4 months post-baseline 
PCL-5 
Secondary 
Substance use 
symptoms 
4 months post-baseline 
ASSIST 
 
The primary outcomes of the pilot trial will be the feasibility, acceptability, and fidelity 
of delivery of the adapted CETA protocol.  Secondary outcomes will include 
preliminary indicators of impact of the adapted CETA protocol in improving HIV-related 

 
 
9 
 
outcomes (eventual R01 primary outcomes) and mental health outcomes (eventual R01 
secondary outcomes).   
 
Feasibility will be evaluated by examining the recruitment rate (number of 
patients approached in order to accrue the final sample), reasons for non-participation, 
proportion of CETA sessions attended, reasons for non-attendance, and total counselor 
time per session and per patient including preparation, documentation, and supervision.   
 
Acceptability among CETA participants will be assessed via the Client 
Satisfaction Questionnaire (CSQ)-8 at treatment exit.  Acceptability among providers will 
be assessed using a version of the CSQ-8 modified to elicit provider rather than client 
satisfaction.  These semi-structured interviews will also include open-ended questions 
about providers’ experiences with and perceptions of the usefulness of the adapted 
CETA protocol.  Providers interviewed will include CETA counselors, other behavioral 
health providers in the clinic, and HIV providers treating patients in the CETA protocol.  
A total of 10 providers will be interviewed prior to study launch, at study midpoint, and 
after study completion.   
 
Fidelity will be defined as the counselors’ adherence to each session’s content 
and their competence in delivering that session content.  This assessment will be 
completed by the clinical supervisor once for each counselor after all counseling 
sessions have concluded.  The primary fidelity measure will be the supervisor’s rating of 
the extent to which the counselor was doing each CETA core component with high 
fidelity, averaged across all core components that the counselor did regularly.   
 

 
 
10 
 
 
HIV-related outcomes (the primary outcomes for the eventual full-scale trial) will 
be defined as (a) suppressed HIV RNA viral load at 4 and 9 months and (b) HIV 
appointment adherence between baseline and 12 months.  Viral load will be captured 
from clinical records when possible; if no viral load is scheduled at the requisite time 
point for the study, then the study will order and pay for a viral load test.  Suppressed 
viral load will be defined as a value <200 copies/mL.  HIV appointment attendance will 
be defined using the HRSA attendance measure (primary) and the kept-visit proportion 
(secondary).  Mental health outcomes (the secondary outcomes for the eventual full-
scale trial) will be defined as depressive, anxiety, post-traumatic stress, and substance 
use symptom severity measured at 4 months and 9 months. Depressive symptom 
severity will be measured using the Patient Health Questionnaire-9 (PHQ-9), anxiety 
symptom severity by the GAD-7, post-traumatic stress symptoms by the PTSD 
Checklist for DSM-5 (PCL-5), and substance use using the Alcohol, Smoking and 
Substance Involvement Screening Test (ASSIST).  We will consider both the simple 
severity level at follow-up as well as the percentage reduction in symptoms from 
baseline.  We will also create a measure of global symptom improvement which will be 
the average of the percentage reduction in symptoms from baseline across all of the 
domains which were elevated at baseline (which could be 1-4 domains depending on 
the participant’s initial presentation).   
Assessments will be conducted 4 and 9 months after study enrollment. Participants will 
receive up to 3 reminder calls at about a week and 48 hours prior to the next outcome 
assessment. 
RETENTION PROCEDURES 

 
 
11 
 
However, consistent with standard clinical practice at UAB, participants will be eligible 
for gas vouchers or bus tickets to facilitate counseling session attendance. 
g) FIDELITY AND SUPERVISION  
Supervision will take place weekly, led by Dr. Darnell.  Supervision will include a brief 
review of all sessions held since the last supervision as well as detailed discussion and 
feedback on at least one audio-recorded session per week.  Sessions will be audio 
recorded with clients’ permission and will be shared via a secure shared drive.  Remote 
supervision will be facilitated by use of the Evidence-Based Practices Toolkit 
(www.ebptoolkit.com), a secure web-based platform that allows tracking and 
supervision of a growing number of evidence-based interventions; CETA has been built 
into the EBP Toolkit already.  Counselors log each session including key metrics 
(symptom severity scores), and supervisors and counselors can then review cases 
together.   
 
Fidelity monitoring will include methods successfully used in previous CETA 
RCTs. Both clinician adherence (completion of required treatment components) and 
competence (degree of skill) in delivering CETA will be monitored and systematically 
rated by Dr. Darnell. Dr. Darnell will review clinician documentation of sessions through 
the EBP Toolkit to monitor adherence and observe a subset of recorded CETA 
sessions representing the full range of CETA components to rate both clinician 
adherence and competence. Any observations of low adherence or competence will 
result in additional clinician training. Dr. Darnell will also review cases with clinicians 
and provide feedback on adherence and competence during weekly supervision. 
h) TRACKING OF STUDY PATIENTS 

 
 
12 
 
Study staff will use Qualtrics to capture baseline, 4 and 9 month assessments, as well 
as viral loads, CETA therapy attendance, HIV care and mental health visits.  Study 
staff will use excel logs to capture prescreening, enrollment, randomization, 
timeline/window of outcome assessments, status of assessments, reminder call status 
for assessments. All study staff will be trained in Human Subjects Protections, and this 
data will be handled in accordance with UAB electronic storage and data transfer 
guidelines. 
The program manager at the University of North Carolina-Chapel Hill will provide 
oversight of data quality and will conduct monthly audits.  
i) MANAGEMENT AND INTEGRATION OF UAB AND UCSD SITES 
Study PI Dr. Brian Pence will conduct regular video conference communication with the 
UAB staff. Additionally, there will be monthly study team meetings with staff across 
UAB, UNC-Chapel Hill, Harvard, and the University of Washington. The purpose of 
these weekly meetings will be to track progress with study milestones, troubleshoot 
issues that may arise, and discuss any adverse events. 
j) SUMMARY OF COMPENSATION 
Intervention and Control groups 
Screening/Enrollment (Baseline) visit 
 
$50  
4, and 9 month assessments 
 
 
$50 each 
 
Participants in the CETA arm will not receive compensation for attending CETA 
counseling sessions, but will be eligible for gas vouchers or bus tickets to facilitate 
attendance at counseling sessions, as is standard practice at UAB for all patients. 
 
IV. 
DATA COLLECTION AND MANAGEMENT 

 
 
13 
 
All study documentation will be kept in locked file cabinets in in study personnel’s offices 
at UAB. The Qualtrics database can only be accessed by TRACE personnel using UAB 
and UNC-Chapel Hill computers or encrypted laptops. 
V. 
DATA ANALYSIS 
Analyses of primary feasibility, acceptability, and fidelity outcomes will focus on 
reporting summary statistics with confidence intervals.  Analyses of secondary health 
outcomes will be intent-to-treat analyses between arms comparing each of the 
secondary outcomes using a generalized linear regression model with link and error 
distribution appropriate for the specific outcome (i.e., log link and binomial error 
distribution for binary outcomes; identity link and normal error distribution for continuous 
outcomes).  Intent-to-treat results will be reported as risk or mean differences with two-
sided confidence intervals and P values, setting the Type I error probability to 5%.   
 
VI. 
SAFETY PROTOCOL 
The study safety protocol is to be used if a participant indicates thoughts of self-harm 
during the screening or follow-up study assessments. 
 
VII. 
PROTECTION OF HUMAN SUBJECTS 
Our team has devised a comprehensive plan for ensuring protection of human subjects 
throughout the course of the proposed study. We will utilize an English-language 
consent form with common phrasing that describes that no special privileges or 
considerations will be conferred as a result of study participation, and that access to 
medical care will not be affected by the potential participant’s decision to enroll in the 

 
 
14 
 
study. The procedures listed in the following sections detail procedures that have been 
approved and utilized during recent years of clinical and behavioral trials at each site for 
collaborative research that utilizes sensitive information from participants. Our team will 
make every effort to protect all participants’ confidential and private information in order 
to minimize possible study-associated risks.  
All findings related to this research will be available and provided to study participants in 
accordance with standard practices. Clinical and measurement data used for research 
studies will be released only in de-identified fashion. 
In addition, all study personnel are required to renew Human Subjects trainings 
annually, or in accordance with their site regulatory mandates.  
VIII. 
KEY PERSONNEL AND ROLES 
Principal Investigators: 
Brian Pence 
 
Principal Investigator    
University of North Carolina-Chapel Hill 
Bradley Gaynes 
Co-Investigator    
 
University of North Carolina-Chapel Hill 
Doyanne Darnell         Co-Investigator    
 
University of Washington 
Michael Mugavero       Co-Investigator     
 
University of Alabama at Birmingham 
Christina Psaros 
 Co-Investigator    
 
Harvard Medical School 
Shannon Dorsey 
 Consultant 
 
 
University of Washington 
Research Team: 
Bernadette Johnson           Program Director     
University of Alabama at Birmingham 
Mariel Parman                 Coordinator 
 
University of Alabama at Birmingham                                    
LaKendra Grimes 
    CETA Counselor                        University of Alabama at Birmingham 
Savannah Henderson     CETA Counselor 
       
        University of Alabama at Birmingham       
Minu Ranna-Stewart     CETA Counseling Supervisor    University of Washington 

 
 
15 
 
Tess Filipowicz       Graduate Assistant/Data Manager    University of North Carolina-Chapel Hill