Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')
Phase: NA
Conditions: Human Immunodeficiency Virus, Depression, Anxiety
Sponsor: Baylor College of Medicine

 
 
 
Study Protocol 
 
 
Targeting HIV Retention and Improved Viral load through Engagement  
Short Title: THRIVE 
Principal Investigators:  
Thomas Giordano, M.D., M.P.H. 
Lilian Dindo, Ph.D. 
Supported by: 
National Institutes of Health 
R34MH122294 
Clinicaltrials.gov: NCT04481373 
Baylor College of Medicine IRB number: H-47444 
IRB approval date: May 13, 2021 

Overview 
Objective: To conduct a pilot randomized clinical trial (RCT) of the THRIVE intervention (N=35) compared 
to treatment as usual (TAU; N=35) to 1) to evaluate feasibility and acceptability for a full-scale RCT; and 
2) examine trends in outcomes of interest (VL improvement and retention in care) for the definitive RCT.  
Study Design: The study is a two-arm, randomized, controlled pilot trial. Participants will be randomly 
assigned to one of two groups: 1) The THRIVE intervention; or 2) Treatment as Usual (TAU). Primary and 
secondary outcomes will be measured at 3 months and 6 months post-discharge.   
Scientific Rationale 
Antiretroviral therapy (ART) has transformed HIV infection into a treatable, chronic condition. However, 
about 40% of people diagnosed with HIV infection are not regularly engaged in HIV primary care in the 
US. Hospitalization presents a rare opportunity to find out-of-care people with HIV (PWH) since it 
remains relatively common in PWH, especially in persons with uncontrolled or advanced HIV infection 
and in the US South. Unfortunately, few interventions effectively retain PWH in HIV care. How to better 
retain out-of-care PWH with unsuppressed HIV RNA viral load (VL) remains one of the most important 
questions in HIV care and solutions are critical to end the HIV epidemic. 
Avoidance coping is a maladaptive coping strategy whereby people avoid uncomfortable internal states 
and situations that trigger such states. Avoidance coping, which may arise from stigma, distrust, low 
self-efficacy and other factors, is predictive of poor clinical outcomes in PWH. In fact, among PWH, 
avoidance coping is common and predicts poor re-engagement in care after hospitalization. Thus, a 
psychotherapeutic intervention that targets maladaptive avoidant coping strategies, which are barriers 
to care, could improve clinical outcomes for a targeted population. 
Acceptance and Commitment Therapy (ACT) is a behavioral intervention that targets avoidance and has 
the capacity to address psychosocial and behavior-related issues that PWH experience. The ACT 
framework posits that avoidance, particularly avoidance of uncomfortable internal states and situations 
that trigger such states, influences multiple types of difficulties. ACT helps patients to overcome 
avoidance by promoting acceptance-based coping and engagement in valued life activities. ACT has one 
of the strongest bases of empirical support among specific therapies with demonstrated efficacy or 
effectiveness across an array of conditions, including anxiety, depression, and importantly, dealing with 
chronic disease. ACT also holds promise for non-diagnostic phenomena such as stigma and ACT is 
feasible and acceptable among outpatient PWH. Innovative brief ACT interventions appear to be 
feasible, acceptable, and at least preliminarily, have efficacy. Thus, ACT content and delivery processes 
have been meaningfully adapted to the specific needs of different populations, but they have not been 
adapted for out-of-care PWH. 
We propose to pilot test an ACT intervention for out-of-care PWH who present with avoidant coping. 
'Targeting HIV Retention and Improved Viral load through Engagement' (THRIVE) will aim to help out-of-
care PWH overcome the cycle of avoidance coping which can keep PWH out of care and 
exacerbate/maintain stigma and comorbid mental health difficulties that are common in PWH. 
Delivering THRIVE in the hospital will increase behavioral therapy initiation and completion, the lack of 
which is often the greatest obstacle to effective delivery of mental health services for PWH. 

Study Flow Diagram   
 
 
Inclusion and Exclusion Criteria 
The target study population is people with HIV who are out-of-care.  
Inclusion Criteria 
Participants must meet all the following inclusion criteria to participate in this study: 
 
Hospitalized at Ben Taub Hospital (BTH), Houston, Texas 
 
At least 18 years of age 

 
Able to speak English or Spanish 
 
HIV infection, confirmed by medical record review 
 
Able to provide informed consent and participate in the study (patients who are temporarily 
unable to participate will be followed and approached for enrollment if and when they are 
cognitively and physically capable of consenting and participating) 
 
HIV VL>1000 c/mL 
 
Never in care or currently out of HIV care for HIV, defined as not meeting the 'visit constancy' 
measure (completed HIV primary care visit in a Houston area clinic in each of the three 4-month 
intervals preceding admission); or 2 or more "no shows" to HIV primary care visits in a Houston 
area clinic in the last year. All persons with VL>1000 c/mL would be expected to be seen 3 times 
in a given year, and "no shows" to clinic visits have been independently predictive of increased 
morbidity and mortality, especially in Black PWH.  
 
Endorse one of the two avoidance coping statements with the highest factor loadings on the 
Avoidant Coping Subscale from the Coping with HIV/AIDS scale. 
Exclusion Criteria 
All candidates meeting any of the exclusion criteria will be excluded from study participation.  
Exclusion criteria are: 
 
Intending to use a source of HIV primary care other than Thomas Street Health Center (TSHC) 
after discharge, because their outcomes cannot be evaluated (>70% of PWH hospitalized at BTH 
intend to use TSHC after discharge) 
 
In the opinion of the primary medical team caring for the patient, likely to be discharged to an 
institutional setting, die in the hospital or enter hospice 
 
Incarcerated or expected to be discharged to prison or jail 
 
Enrolled in another research study with prospective follow-up 
 
Pregnant, since pregnant women receive additional efforts to be linked and retained in care 
 
Admitted with acute psychosis which would preclude informed consent or meaningful 
participation with the intervention. 
 
Sample Size 
Since hypothesis testing is not recommended for pilot studies, no formal hypothesis testing on the 
efficacy of the intervention will be performed in this pilot trial for the primary and secondary outcomes. 
However, estimates of the difference or the relative ratio between arms, with 95% confidence intervals, 
will be obtained that will provide information on the direction and possible range of the intervention 
effect which may be used as a basis to support a larger RCT. We will compare the ACT group to the TAU 
group on retention in care and undetectable VL 6 months after hospital discharge with descriptive 
statistics calculated for these primary outcomes. Assuming a composite outcome (retention in care and 
VL improvement) of between 30% and 65%, a sample size of N=35/group will allow us to estimate the 
outcome rate for each group to within 15 to 17 percentage points (95% CI). Estimates of the difference 
between treatment arms will also be assessed for exploratory outcomes, including mental health, 
stigma, and coping. Likewise, descriptive statistics will be computed for the demographic, clinical, and 
baseline variables to describe the characteristics of the pilot study sample population. These analyses 

will also help validate our methods and data gathering techniques. These descriptive analyses will also 
be performed for the sub-populations that we anticipate will have more difficulty relinking to outpatient 
HIV care (e.g., substance abuse).  
 
Study Timeline 
Timeline 
Yr 1 
Yr 2 
Recruit 70 pts (10/m): follow for 6m  
X 
X 
X 
X 
X 
 
 
 
Review EMR, analyze data, finalize 
protocols, publish  
 
 
 
 
X 
X 
 
 
 
We anticipate enrolling 8-10 persons per month and should complete enrollment in < 9 months. We will 
need 6 months to follow the last participants. We will also need time for data analysis and final protocol 
revisions. The pilot study will be completed within 18 months.  
Recruitment, Consent, and Enrollment 
Screening 
With an IRB-approved waiver to review records, the research coordinator will use an EMR-based 
application that identifies all patients currently hospitalized at BTH who have HIV listed as a diagnosis in 
their "problem list" or have a positive HIV test result. The coordinator will maintain regular contact with 
the HIV Service Linkage Worker (SLW) at the hospital, who sees all patients with HIV in the hospital. The 
coordinator will then perform a brief chart review of patients to preliminary assess inclusion/exclusion 
criteria. If the patient appears eligible for enrollment, a member of the care team will ask the patient if 
he/she is interested in learning about a research project. Care providers who have legitimate access to a 
patient's HIV status for patient-care purposes include physicians, nursing staff, social workers, and case 
managers.  
If the patient declines screening or is ineligible by chart review or in-person screening, the coordinator 
will record the patient's age, race, and sex, and, temporarily, his or her medical record number to ensure 
that we do not inadvertently approach the patient again during that hospital stay. 
Consent 
If the patient appears eligible for enrollment, a member of the care team will ask the patient if he/she is 
interested in learning about a research project. Care providers who have legitimate access to a patient's 
HIV status for patient-care purposes include physicians, nursing staff, social workers, and case 
managers. Care providers at BTH will be informed of the study and encouraged to obtain the permission 
of their patients for identification for recruitment. Care providers will be encouraged to remind patients 
that any participation in research is voluntary. The research staff will not be informing patients of their 
HIV diagnosis. If the patient is interested in learning more about the study, the care provider will 
introduce the research coordinator to the patient. The coordinator will describe the study in detail and 
initiate the screening and informed consent process. 
If the patient is willing to participate, all sections of the informed consent document and the HIPAA 
authorization form will be reviewed with the patient, including sections on risks and benefits and 

voluntary nature of the study. The research coordinator will be prepared to answer any questions. 
Potential participants will be told that their decision to participate in the study or not will not affect the 
clinical care he/she receives. If the patient is still interested, they will be asked to provide consent. In 
addition, the patient will sign a HIPPA authorization form. 
Randomization  
This study will randomize at the participant level. Randomization will occur following enrollment in the 
study. The study statistician will generate the randomization sequence to ensure adequate distribution 
of the two interventions over the study period. The randomization sequence will be maintained by the 
statistician in a password protected file.  
Blinding  
Neither participants nor study personnel are blinded in this study.  
Study Intervention 
A therapist trained in Acceptance and Commitment Therapy (ACT) will provide the ACT based 
intervention individually at the bedside as 4 individual, 30-40 minute sessions. If study participants 
complete the THRIVE intervention sessions, he or she will have opportunities to 1) reflect on personal 
values and personal barriers that could prevent them from living out those values on a day-to-day basis, 
2) receive education specific to HIV and managing HIV, 3) HIV stigma, and 4) coping skills. Subjects will 
be asked to document a goal that will be reviewed at the booster session.  
A research team member will work with each participant prior to discharge to schedule the booster 
session and follow-up assessments. Prior to the participant’s first scheduled outpatient follow-up visit 
with TSHC, the therapist will call participants to check on them and conduct an individualized phone 
booster session. This phone call will last 20-40 minutes. Participants will receive a reminder call/message 
approximately 1 day before the session.  
Therapist Training 
A master-level therapist will be trained over a 2-day period on the entire protocol and intervention 
manual. Training methods will include didactics on the ACT model, demonstration of each of the ACT 
processes through examples, and role-playing each of the ACT sessions. In the final training step, the 
therapist will conduct the intervention with a standardized patient learning case, using professional 
actors as standardized patients. Each session will be monitored live via video and video-recorded. 
Fidelity and competence will be assessed by three raters and immediate feedback will be provided. The 
therapist will be certified to work with patients when his/her adherence and competence ratings are 6 
or higher (`good' on a 0-8 scale).  
Therapist Fidelity  
Sessions with participants will be audio-recorded by a digital recorder or by Zoom. The recordings will be 
used for therapist's evaluation and training. Fidelity and competence will be assessed by the 
investigators on 10% of intervention sessions for each therapist. We will modify the therapist training 
and provide additional training as needed based on the evaluation of the recordings. Participants will be 

informed during the consent process that the sessions will be audio-recorded to evaluate the therapists. 
If a participant declines the audio recording of the session, their eligibility to participate will not be 
affected. 
Intervention Sessions 
Participants are provided a handbook that includes the key concepts, exercises and homework for each 
session.  
THRIVE Sessions Description 
Session  
Session Name 
Description 
Exercises 
Homework 
1 
Find Direction 
 
Introduce study 
 
Establish and clarify values 
 
Discuss internal barriers to 
engaging in values-based 
action 
 
Your Life Now 
 
80-year-old birthday  
 
“What if I asked you to 
run into a fire?” 
The Bull’s Eye 
2 
Doing What 
Matters 
 
Provide HIV education 
 
Introduce willingness and 
“how to face the difficult” 
 
5-senses mindfulness 
exercise 
 
Care of HIV blocks 
 
BOLD technique 
Willingness 
and Action 
Plan 
3 
Stuff That Gets 
in the Way 
 
Review HIV stigma and 
education 
 
Introduce and explore self-
compassion 
 
Review previous modules 
and foster committed action 
 
Discuss automaticity of 
thoughts/feelings and how 
to move from autopilot to 
conscious choice 
 
A Compassionate 
Hand mindfulness 
exercise 
BOLD: A Way 
to Get off 
Autopilot 
4 
Do It Anyway 
 
Acceptance 
 
Teach defusion skills 
 
Share goals and principles of 
ACT 
 
Conclusion 
 
Drop Anchor 
mindfulness exercise 
 
“I can’t walk” or “I 
can’t raise my hand” 
exercise 
 
“But” versus “And” 
 
Be Like the Sky 
N/A 
 
MODULE 1: Introduce Study and ACT Matrix 
• Establish rapport between interventionist and patient, introduce study, introduce Acceptance and 
Commitment Therapy (ACT), and establish patient’s values (i.e. who or what is important to them). 
Values will be the motivation for changing behaviors. Discuss negative experiences patient is avoiding 
and what behaviors s/he uses to avoid (e.g. drug use, denial). Avoidance strategies will be specifically 
targeted throughout the intervention to increase likelihood of remaining in care. 
• Establish the difference between internal experiences (thoughts and feelings) and external 
experiences (objectively observed through 5-senses). Highlight the difference in moving away from 

negative experiences (avoidance) versus moving towards values (value-driven behavior). Use examples 
about HIV care [not talking about status due to shame (avoidance) versus taking HRT medication (health 
value-driven behavior)]. 
• Discuss the short-and long-term effects of avoidance. Specifically, we will go over examples of how 
avoidance reduces immediate contact with distressing experiences and thus provides short-term relief 
(e.g., drinking alcohol to reduce anxiety). In the long term, however, avoidance leads to greater 
dysfunction (e.g. dependence on alcohol) and increased distress. Elicit examples of patient’s own 
avoidant coping. 
MODULE 2: Review ACT Matrix, Discuss HIV Stigma & Education about HIV Care 
• Review ACT Matrix from previous session. 
• Discuss HIV stigma using the matrix framework (internal/external and avoidance/value-driven 
behavior) – how does stigma act as a barrier and create avoidance? What value-driven behavior can 
patients engage in even when HIV stigma is high? Patients will also be encouraged to examine the costs 
or non-workability of stigmatization on their life (e.g. avoidance of medical care, sense of isolation). 
• Encourage willingness to confront uncomfortable stimuli, especially those connected to HIV care. 
• Teach alternative skills to avoidance-based coping, including acceptance and defusion, that will help a 
patient cope with difficult emotions and thoughts that may interfere with living a values-driven life. 
• Teach BOLD technique for perspective taking: Breath to take a minute to slow down; Observe what 
you are feeling; Listen to your values; Decide how to react. 
• The interventionist will provide brief education on the beneficial impact of medical care, substance use 
care, and mental health care on overall health, and will inform participants about the comprehensive 
medical and social services available at TSHC (including services they may not be aware of, such as care 
for general medical issues, mental health issues, substance use issues, diabetes and hypertension, case 
management, physical therapy, hepatitis C treatment, gynecology, and others) to address health needs 
related to comorbidities. 
MODULE 3: Review Matrix, HIV Stigma & Education, Discuss Acceptance & Defusion 
• Review ACT Matrix and HIV education from previous sessions. Review avoidance-based coping versus 
willingness to confront uncomfortable stimuli. Review acceptance and defusion techniques. 
• In order to increase a sense of acceptance toward themselves, participants will be asked to think 
about how they would treat someone else they know and love with HIV, to notice the differences 
between their reactions to their own struggles (e.g., self-stigma) and to those of others, and to examine 
which is more adaptive. 
• Teach “Urge Surfing” by (1) acknowledging the urge/craving, (2) observe the urge and accompanying 
sensations, (3) rather than avoid the sensations; sit with them, (4) notice fluctuations in the urge, (5) 
connect to values. 

• Practice mindfulness exercise to connect to present moment. Connection to present moment through 
their body/5 senses may be difficult for PWH as they may experience their body negatively (fused with 
thoughts of self-stigma). 
MODULE 4: Committed Action & Wrap up 
• Review material and skills learned throughout the intervention. 
• Consider values from first session and what action can be taken in the service of them now (and as 
discharged from the hospital). 
• Teach SMART goals (specific, meaningful, achievable, realistic, time-limited) to assist patient in making 
a concrete plan to incorporate value-driven behavior and decrease avoidant coping in their life. 
PHONE BOOSTER 
• Discuss any difficulties patient has had connecting with care. Use ACT skills and matrix framework to 
conceptualize any barriers. 
• Review ACT Matrix and key points from intervention.  
 
Post-Intervention Evaluations 
Evaluation Overview 
Participants will receive the THRIVE intervention or treatment as usual. Treatment is assigned by 
random allocation. Participants will receive the intervention during their hospital stay. For evaluation 
purposes, enrolled patients will provide baseline demographic, clinical, and behavioral data. The 
information will be self-report or gathered through medical record review. Follow-up assessments will 
occur 3- and 6-months post-discharge. Assessments will include coping skills, stigma, depression, 
anxiety, stress, substance use, and client satisfaction. Medical record data will include HIV laboratory 
testing results and medications as well as data on kept and missed HIV primary care appointments. The 
medical record review will include retrospective data and data for the year after enrollment. The 
baseline survey contains 85 items and should take 30 minutes, while the 3- and 6-month follow-up 
surveys contains 70 and 60 items, respectively.  
 
To avoid bias, the 3- and 6-month assessments will take place in the field, e.g., at the patient's 
residence, at a Harris Health facility other than the HIV clinic, or at other mutually agreed upon and safe 
places. They will not be allowed to occur at TSHC. Any self-reported use of health resources external to 
Harris Health System will be verified by medical record review. 
 
All patients have a VL done as standard of care in the hospital. We will obtain 6-month VL by study 
phlebotomy in the field (not at the clinic, to avoid biasing participants to return to the clinic to obtain 
the compensation for the assessment visit) and review the EMR for additional VLs to minimize missing 
data. About 10 mL of blood will be drawn per participant at the 6-month evaluation. All VL assays will be 
conducted by the BTH laboratory, a fully certified clinical laboratory that performs all HIV-related 

laboratory studies for TSHC and BTH. 
 
Participants will provide detailed contact information and permissions at enrollment (e.g., what 
numbers are OK for text messages and voice messages, whether contacts are aware of the participant's 
HIV status, etc.). All contact with the participants' associates and family will not reveal that the 
participant has HIV or is involved in research. Contact information will be updated at all follow-up 
interviews. 
 
Participants will also complete a brief phone call with the research coordinator to verify and update 
contact information at 2, 8 and 18 weeks after hospital discharge. These calls are to promote retention 
in assessment visits. Participants will be given a card with the study's telephone number (no information 
traceable to HIV will be included). Phone interviews will be used for follow-up assessments as a last 
resort.  
The 2-week call will also include the CSQ and satisfaction self-report assessments for participants in the 
THRIVE arm.  
3-month Follow-up Self-Report 
At 3 months, the survey will include: Coping; IARSS; DASS-21; AUDIT-C; ASSIST.  
6-month Follow-up Self-Report 
At 6 months, the survey will include: Coping; IARSS; DASS-21; AUDIT-C; ASSIST; Chart Review; and HIV 
VL. 
6-month Chart Review 
The Harris Health EMR, an Epic product, is accessible via Citrix on any computer. Researchers can review 
the entire EMR from their research offices, including discharge summaries, inpatient and outpatient 
notes, laboratory results, all appointment schedules, and prescriptions. Epic data include appointment, 
laboratory, and ART data on all patients seen at BTH, TSHC or one of its satellite HIV clinics from 2002 to 
present. Appointment data include all visits at TSHC, including HIV primary care, mental health, and 
chemical dependency counselor visits. Clinic visit data include whether the visit was kept, missed, 
cancelled, or rescheduled. Dates of hospitalization at BTH are included. Completed and missed visit data 
will be abstracted from Epic. The Centralized Patient Care Data Management System (CPCDMS) is a 
regional database in which clients must be registered to receive medical and case management services 
funded by the 6-county Ryan White Part A funds. CPCDMS will indicate if participants have transferred 
care from TSHC to other Ryan White-funded providers, substantially reducing the chance of 
misclassifying patients regarding care re-engagement. 
6-month Viral Load  
All patients have a VL done as standard of care in the hospital. We will obtain 6-month VL by study 
phlebotomy in the field (not at the clinic, to avoid biasing participants) if none are available in the EMR, 
and review the EMR for additional VLs to minimize missing data. All VL assays will be conducted by the 
BTH laboratory, a fully certified clinical laboratory that performs all HIV-related laboratory studies for 
TSHC and BTH. 

Data Collection and Quality Assurance 
REDCap 
All data collection forms will be available through a REDCap (Research Electronic Data Capture) database 
and patients can directly enter data into these forms. They will enter data into a central database 
through a study computer. This will eliminate error in data entry, and reduce time necessary for data 
entry, cleaning and analysis. Range checks will be programmed into the data entry system when the 
nature of the data allows so that it will not permit invalid values to be entered into the database.  
When a data collection session is completed, the research coordination will review electronic forms for 
completeness and validity. The research coordinator will resolve all queries and will enter an override 
for all values that have been confirmed as being accurate. Reports will also be run periodically to 
confirm or correct questionable values. All changes will be tracked through the REDCap audit trail. 
Assessments completed on paper will be entered into REDCap by the research coordinator. 
The data entered into the REDCap database is stored on servers at Baylor College of Medicine and is 
backed-up on a regular basis. 
Strategies for minimizing missing data 
1. Reviewing all surveys for completeness before finalizing. 
2. Reviewing all electronic medical records for internal and external records. 
3. Requesting medical records for participants who report use of external facilities. 
Protocol Deviations 
Protocol deviations will be recorded as they are known to happen on a hard-copy form and then 
entered in the study’s Tracking Database to compile an electronic log for reporting purposes. Quarterly 
hard- copy-to-electronic-copy audits of Protocol Deviation forms and audits of consent forms will be 
performed. 
Monitoring 
Data will be routinely monitored at the time of data collection. REDCap will be used to collect data and 
the researchers will be prompted at the end of each session to check missing entries. Regular team 
meetings will be held where researchers can report ongoing data collection concerns to ensure proper 
adherence to the protocols and high-quality data collection. Audio files will be stored on a secure BCM 
server.  Only the participants’ ID will be used to identify the participants. Coordinators will ensure the 
data is de-identified.  
 
 

Summary of Measures at Each Evaluation 
 
Type of Measure  Measures 
Baseline  
Visit 
 
 
Post-discharge  
 2 wk.       3 mo.        6 mo. 
Characterize 
Sample. Possible 
Covariates 
Demographic/ 
Medical 
Information 
X 
 
Coping Skills 
X 
 
X 
X 
Primary 
Outcomes 
Retention in HIV 
Care 
X 
 
 
X 
HIV VL 
X 
 
 
X 
Exploratory: 
Stigma & Mental 
Health 
Stigma 
X 
 
X 
X 
Depression, 
Anxiety, and Stress 
X 
 
X 
X 
Substance Use 
X 
 
X 
X 
Treatment 
Satisfaction  
Client Satisfaction 
 
X 
 
 
 
Data Collection Instruments  
Demographics/Medical Information 
Description: Demographic information will be collected via a questionnaire including age, sex, race, 
ethnicity, marital status, education, household income, and when participant was first told they were 
HIV positive.  
Coping with HIV/AIDS 
Description: Coping with HIV/AIDS scale is a 16-item scale that measures avoidance coping, positive 
coping, and seeking social support in patients with HIV (Fleishman and Fogel, 1994). The measure asks 
questions focuses on positive coping (items a-e), avoidance coping (items f-n), and seeking social 
support (items o-p). Items include, “Since your HIV diagnosis, did you... try to learn more about HIV or 
aids” or “tell yourself to accept it.” Items are rated on a 3-point scale (from 1= never to 3= often or a lot 
of the time. The measure has been well validated and widely used including internationally.  
IARSS 
Description: Stigma will be measured with Internalized AIDS-Related Stigma Scale (IARSS) (Kalichman, et 
al., 2009), a 6-item measure that has been validated in US and international populations. (Kalichman et 
al., 2009; Tsai et al., 2013). It focuses on internalized stigma, e.g., “I hide my HIV status from others” and 
“Being HIV positive makes me feel dirty,” which is the focus of our treatment model. Responses are 
“agree” and “disagree” and the score is a count of the affirmative responses (range 0-6). The scale is 
used in the US national Medical Monitoring Project (Baugher et al., 2017) and many other studies, 
allowing direct comparison to national and international populations. 
THRIVE: In-hospital sessions (4hrs.) 
THRIVE: Phone booster session (.5 hrs.) 

Depression Anxiety and Stress Scale (DASS-21) 
Description: The DASS is a self-report scale to measure the negative emotional states of depression, 
anxiety and stress. It contains 21 items, 7 items per subscale (depression, anxiety and stress) (Lovibond 
& Lovibond, 1995). Participants are asked to rate the extent to which they have experienced each state 
over the past week with a 4-point scale (from 0 = did not apply to me at all to 3 = applied to me very 
much). Scores are summed per subscale and then multiplied by 2 for possible scores on each subscale 
ranging from 0 to 42 (Lovibond & Lovibond, 1995). Higher scores indicate more severe symptoms of 
depression, anxiety and stress. Internal consistency of the DASS-21 subscales in a non-psychiatric sample 
were high (0.88 for Depression, 0.83 for Anxiety, and 0.85 for Stress) (Osman et al., 2012). Depression, 
Anxiety and Stress subscales also showed adequate convergent validity (r = 0.55, 0.44, and 0.61, 
respectively) with Affective Distress subscale of the Multidimensional Pain Inventory and adequate 
discriminant validity (r = -0.67, -0.50, and -0.63, respectively) with Mental Health subscale of the SF-36 in 
elderly patients with persistent pain (Wood et al., 2010).   
AUDIT-C 
Description: The AUDIT-C is a self-report scale to measure problematic alcohol use in both men and 
women (Bush et al., 1998). It contains 3 items that focuses on alcohol use, e.g., “How many drinks did 
you have on a typical day when you were drinking in the past year?” The Audit-C is scored on a scale of 
0-12, with each question having five answer choices (each scored from 0 to 4 points). In men, a score if 4 
or more is considered “positive,” or optimal for identifying hazardous drinking or active alcohol use 
disorders. In women, a score of 3 or more is considered “positive.” Psychometric properties for 
identifying patients with heavy/hazardous drinking and/or active-DSM alcohol abuse or dependence 
were high (men=.86; women=.66), and for identifying patients with active alcohol abuse or dependence 
(men=.90; Women=.80) (Bradley et al., 2003).  
ASSIST 
Description: The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed 
for the World Health Organization (WHO) by an international group of substance abuse researchers to 
detect psychoactive substance use and related problems (Group WAW, 2002). The ASSIST is short 
screener that includes eight questions.  
Client Satisfaction Questionnaire 
The Client Satisfaction Questionnaire (CSQ) (Larsen et al., 1979), is an 8-item, empirically derived, self-
report measure is widely used to assess patient satisfaction with services. The instrument was designed 
to assess satisfaction with a specific service, rather than health care in general (Atkisson et al., 1999) and 
thus is appropriate for measuring participants’ satisfaction with THRIVE. The CSQ’s psychometric 
properties are strong, and it has been widely used in adults and adolescents with HIV, including persons 
with substance use and mental health problems (Fals-Stewart, 2010; Hosek, 2011). In addition, we will 
include a single-item measure of overall satisfaction with the intervention and a single-item measure of 
likelihood of recommending the intervention to others. 
Chart Review 
The Harris Health EMR, an Epic product, is accessible via Citrix on any computer. Researchers can review 
the entire EMR from their research offices, including discharge summaries, inpatient and outpatient 
notes, laboratory results, all appointment schedules, and prescriptions. Epic data include appointment, 

laboratory, and ART data on all patients seen at BTH, TSHC or one of its satellite HIV clinics from 2002 to 
present. Appointment data include all visits at TSHC, including HIV primary care, mental health, and 
chemical dependency counselor visits. Clinic visit data include whether the visit was kept, missed, 
cancelled, or rescheduled. Dates of hospitalization at BTH are included. Completed and missed visit data 
will be abstracted from Epic. The Centralized Patient Care Data Management System (CPCDMS) is a 
regional database in which clients must be registered in order to receive medical and case management 
services funded by the 6-county Ryan White Part A funds. CPCDMS will indicate if participants have 
transferred care from TSHC to other Ryan White-funded providers, substantially reducing the chance of 
misclassifying patients regarding care re-engagement. 
Blood Draw  
All patients have a VL done as standard of care in the hospital. Then at 6-month, a VL by study 
phlebotomy in the field (not at the clinic, to avoid biasing participants) will be conducted if there is not 
one in the EMR, and a review the EMR for additional VLs to minimize missing data. All VL assays will be 
conducted by the BTH laboratory, a fully certified clinical laboratory that performs all HIV-related 
laboratory studies for TSHC and BTH. 
Data Analysis Plan 
Analysis Methods 
A randomized clinical trial (RCT) pilot of the refined THRIVE intervention (N=35) will be compared to 
treatment as usual (TAU; N=35). An N=70 is sufficient to establish feasibility and acceptability of a 
treatment procedure. Feasibility and acceptability are the primary aims of the randomized controlled 
trial.  
 
The primary goal is to demonstrate the feasibility and acceptability of the THRIVE intervention. Findings 
from this pilot study will provide useful data that will serve as a basis for enrollment time estimates, 
attrition estimates, and outcome estimates to support a definitive RCT designed to investigate the 
efficacy of the THRIVE intervention compared to TAU on retention and VL in hospitalized, out-of-care 
PWH. The data will also inform sample size and power calculations. We will generate summary statistics 
of the feasibility and acceptability data. Our pre-defined outcomes (i.e., "benchmarks of success") are: at 
least 8 participants per month recruited on average (10 per month is the goal); <20% refusal rate among 
eligible persons; at least 80% receive the outpatient booster phone call; at least 80% of participants alive 
at 6 months have appointment and 6-month VL data (needed to construct the primary outcome for the 
definitive full-scale trial); at least 90% of persons who initiate an assessment survey complete it; and at 
least 80% of the participants in the THRIVE arm rate the intervention positively on the client satisfaction 
questionnaire. 
 
Suicide Risk Management  
If at any time during the assessments, intervention or booster session a participant indicates suicidal 
ideation, a research team member will inform the crisis team and/or Dr. Giordano of the crisis who will 
assess the participant at the time of the research visit. If the patient does not have a plan or intent, they 

will be provided with resources appropriate for the clinical setting (Ben Taub Hospital or Thomas Street 
Health Center). If they do have a plan or intent, they will be handled by emergency clinical services.  
Participant Rights & Confidentiality 
Institutional Review Board (IRB) Review 
The study protocol and the informed consent document and any subsequent modifications will be 
reviewed and approved by the IRB at Baylor College of Medicine. 
Informed Consent  
Informed consent will be obtained from each participant. The consent form describes the purpose of the 
study, the procedures to be followed, and the risks and benefits of participation. The study will be 
conducted during the COVID-19 pandemic and, to reduce the risk to participants and personnel posed 
by fomites, verbal consent to participate will be obtained.  
Participant Confidentiality 
The consenting process will include all required elements (e.g., nature of the intervention, risks, 
confidentiality) and patients will be given the opportunity to ask questions. Study personnel will give 
participants more time if there are any uncertainties or discomforts on the part of the participant or 
family member. The participant will be reminded that consent can be revoked at any time over the 
course of the study.  
Data collection as part of the study will be kept confidential in accordance with state and federal laws. 
Participants will be further assured of their right not to answer particular questions.  
 
Data collected from patients/participants is in the form of medical record abstraction and self-report 
through questionnaire completion. All data forms, audio-tapes and questionnaires will be coded and 
stored separately from identifying information. Hardcopy data will be kept in a locked filing cabinet in 
the research office. Electronic data will be kept on a secure server in which only team members will have 
access.  
All participants will be assigned a research number (or study identification number). A master list of all 
participants and their corresponding number will be in a study folder on the BCM server. The list will be 
maintained on a computer that requires an access code. All data entered in the computer will be 
entered by participant’s study identification number. The data will be encrypted and password 
protected. Only the PI and research coordinators will have access to the file linking participant study ID 
and participant identifiers. Data shared with the data manager and statistician will be coded data. 
Study Discontinuation  
The study may be discontinued at any time by BCM, the IRB, NIH or other government agencies as part 
of their duties to ensure that research participants are protected. 
Compensation 
Participants in Aim2 will receive up to $125 over the course of their participation in the study according 
to the following schedule: 
Completion of baseline assessment: $20 

Completion of 3-month assessment: $30 
Completion of 6-month assessment: $40 
Blood draw at 6-month: $20 
Verify contact information at two weeks: $5 
Verify contact information at eight weeks: $5 
Verify contact information at eighteen weeks: $5 
Payment Processing 
A ClinCard will be used for study payments. Participants will complete and sign an authorization form. 
Study compensation will be loaded to the same card as the participants completes assessments.  
Payments will be loaded onto the ClinCard within 2 to 3 days of visit completion. The research 
coordinator will provide a handout to the participants about the ClinCard. An email address and/or cell 
phone number will be collected in the event the participant wants email or text notification when 
payments are loaded to the ClinCard. Baylor College of Medicine (BCM) and Greenphire (the ClinCard 
Company) have entered into an agreement that requires Greenphire to protect personal information. 
 
Verbal Informed Consent Script 
 
Some people with HIV have a hard time staying in medical care.  A Baylor College of Medicine (BCM) 
research team is doing a research project to see whether talking with a counselor about HIV can help 
improve your health and quality of life. The name of the study is THRIVE. As a participant, you are a 
volunteer. You might work with a counselor. Whether you work with the counselor or not will be 
decided at random, like by the flip of a coin. If you work with the counselor, you will spend about 3-4 
hours (over several sessions) with the counselor at the hospital before discharge and will also talk to the 
counselor by phone once a couple weeks after discharge. You will complete surveys while in the hospital 
and then 3 months after discharge. Coded survey responses will be shared with the study team at BCM, 
University of Iowa, Brown University, and the University of Texas Health Science Center. You will also 
complete another visit 6 months after discharge, and a blood sample will be obtained to measure HIV 
viral load. The 6-month blood draw will measure your HIV RNA copies or viral load. The results will be 
recorded in your medical record. The research coordinator can give you the results of your viral load, at 
your request. The 3 and 6- month visit, will be at any safe location, but won't be at the hospital or the 
clinic. The researchers will also call you three times after discharge, to make sure we stay in touch. 
Surveys and interviews will either be completed in person, by phone or Zoom video conference. The 
visits will take up to 1 hour to complete.  
 
Researchers will also review your medical records from the past and up to 12 months from now. This will 
include medical records from all the Harris Health System facilities you used and were scheduled to have 
used. The medical record reviews will gather information on your HIV disease and any other diseases 
you have, which might include hepatitis, sexually transmitted diseases, psychiatric diseases, and 
problems with the use of illegal substances and alcohol. The medical record review will also gather 
laboratory and other test results, information about your visits to health care providers, your prescribed 
treatments, your use of prescribed treatments and other health care resources, and how well those 
treatments are working for you. Coded data from the medical record and surveys will be sent securely to 
a study investigator at the University of Iowa for analysis. 

 
The risks of participating in the study include anxiety from thinking about HIV and loss of confidentiality. 
If you express suicidal thoughts, we will discuss how you are feeling and refer you to services if needed. 
The researchers have strict measures to protect confidentiality and the risk to you is low. By 
participating in the research, you may learn some skills to better care for your health, but it is possible 
that you will not benefit from participating in the research. Participation in the study is completely 
voluntary, and if you decide to not participate in the research the care you receive will not be affected. 
 
You will receive compensation on a pre-paid card after each survey. You will receive $20 after 
completing the baseline survey in the hospital, $30 after completing the 3-month survey, and $40 after 
completing the 6-month survey. You will receive $20 for completing the 6-month blood draw. You will 
receive $5 for completing a phone call to verify and update your contact information at weeks 2, 8, and 
18 after discharge. The call at 2 weeks after discharge will also include a brief survey of 10 questions. 
The maximum total compensation is $125. A ClinCard will be used for study payments. Payments will be 
loaded onto the ClinCard within 2 to 3 days of visit completion. The research study team will provide you 
with a handout about the ClinCard. Your email address and/or cell phone number will be collected in the 
event you want email or text notification when payments are loaded to your ClinCard. Baylor College of 
Medicine (BCM) and Greenphire (the ClinCard Company) have entered into an agreement that requires 
Greenphire to protect your personal information. BCM will replace your ClinCard free of charge if your 
first card is lost or stolen. After that, there is a $7 ClinCard replacement fee. This replacement fee will be 
charged to the balance on your ClinCard at the time of replacement. Your ClinCard has an expiration 
date. If your ClinCard expires while you are participating in this study, BCM will provide you with a new 
ClinCard at no cost to you. For a period of three months following your final study visit, you may request 
replacement of an expired ClinCard at no cost to you.  
 
Payments for research participation are considered taxable income per Internal Revenue Service (IRS) 
regulations. If the total amount of payment received by you, your parent, guardian or Legally Authorized 
Representative (LAR) reaches or exceeds $600 in a calendar year, BCM will send an IRS Form 1099 to 
that person for tax purposes. In order to issue the IRS Form 1099, BCM will collect your first and last 
name, social security number, date of birth and home address. The name you provide should match the 
social security number. Please note study payments are considered income and may or may not affect 
government or public assistance benefit programs you or your parent, guardian or LAR may be 
participating in, such as SSI (Supplemental Security Income) or TANF (Temporary Assistance for Needy 
Families). 
 
Can you summarize the study? 
 
What are your questions or concerns? 
 
Do you give consent for study participation?  
 
If you have questions, contact the Baylor College of Medicine study coordinators at (XXX) XXX-XXXX. 
 
 

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