Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer
Phase: NA
Conditions: HIV/AIDS, Cancer
Sponsor: University of Miami

 
 
 
 
A Culturally Tailored Web-Based Cognitive Behavioral Stress Management for 
Latino Sexual Minority Men living with HIV and Cancer 
 
 
Principal Investigator Sara St. George, PhD  
Funding Agency National Institute on Minority Health and Health Disparities 
IRB Protocol ID 20200127 
ClinicalTrials.gov ID NCT03993054 
 
 

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A Culturally Tailored Web-Based Cognitive Behavioral 
Stress Management for Latino Sexual Minority Men living 
with HIV and Cancer
eProst#: 20200127
Principal Investigator
Sara St. George, PhD 
University of Miami
Department of Public Health Sciences 
1120 NW 14th Street
Miami, FL 33136
(305) 243-0726
stgeorge@miami.edu
Funding Agency
National Institute on Minority Health and Health Disparities
Version
12
Version Date
05/21/2024
Confidentiality Statement
All information contained in this document is privileged and confidential. Any distribution, 
copying, or disclosure is strictly prohibited without prior written approval by the Sponsor.
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LIST OF STUDY CONTACTS
Principal 
Investigator
Sara St. George, PhD
University of Miami
Department of Public Health Sciences
1120 NW 14th Street
Miami, FL 33136
(305) 243-0726
stgeorge@miami.edu
Biostatistician
Deukwoo Kwon, PhD 
University of Miami
Division of Biostatistics, Department of 
Public Health Sciences
Sylvester Biostatistics and Bioinformatics 
Shared Resource (BBSR)
1120 NW 14th Street, Room 1068
Miami, FL 33136
(305) 243-0181
dkwon@med.miami.edu
Project Manager
Marta Salazar 
University of Miami
Department of Public Health Sciences 
1120 NW 14th Street, Room 1087
Miami, FL 33136
305-243-3021
marta.salazar@miami.edu
Funding Agency:
National Institute on Minority Health and
Health Disparities
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PROTOCOL REVISION HISTORY
Version 
Number
Version Date
Summary of Revisions Made:
1.0
10-09-2020
Initial Submission
2.0
02-01-2022
Inclusion and exclusion criteria
3.0
05-17-2022
Procedures schema and timeframes
Inclusion and exclusion criteria
4.0
12-02-2022
Inclusion and exclusion criteria
5.0
12-07-2022
Updated recruitment and compensation procedures
6.0
04-20-2023
Added a new recruitment location
7.0
07-21-2023
Added secondary avenues for participant 
recruitment (i.e., online recruitment platforms)
8.0
08-25-2023
Update for procedure of withdrawal of subjects
9.0
10-26-2023
Updated Jackson Health System recruitment 
procedures
10.0
02-22-2024
Included MyChart Research Recruitment Tool
11.0
04/25/2024
Removed Jackson Health System as a site
12.0
05/21/2024
Added a final interview 
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STATEMENT OF COMPLIANCE
The trial will be conducted in accordance with International Council on Harmonization Good 
Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations 
(CFR), and the National Institute on Minority Health and Health Disparities Terms and 
Conditions of Award. The Principal Investigator will assure that no deviation from, or changes 
to the protocol will take place without prior agreement from the funding agency and 
documented approval from the Institutional Review Board (IRB), and the Investigational New 
Drug (IND) or Investigational Device Exemption (IDE) sponsor, if applicable, except where 
necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved 
in the conduct of this study have completed Human Subjects Protection and ICH GCP 
Training.
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. 
All changes to the consent form(s) will be IRB approved; a determination will be made 
regarding whether a new consent needs to be obtained from participants who provided 
consent, using a previously approved consent form.
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TABLE OF CONTENTS
LIST OF STUDY CONTACTS...............................................................................................................................2
PROTOCOL REVISION HISTORY .......................................................................................................................3
STATEMENT OF COMPLIANCE.........................................................................................................................4
1
PROTOCOL SUMMARY ...........................................................................................................................7
1.0
SCHEMA ...................................................................................................................................................8
2
BACKGROUND........................................................................................................................................9
2.0
STUDY RATIONALE ......................................................................................................................................9
2.1
BACKGROUND............................................................................................................................................9
3
OBJECTIVES AND ENDPOINTS ...............................................................................................................10
3.0
OBJECTIVES.............................................................................................................................................10
3.1
ENDPOINTS .............................................................................................................................................10
4
STUDY DESIGN .....................................................................................................................................10
4.0
OVERALL DESIGN......................................................................................................................................10
4.1
STUDY TIMELINES......................................................................................................................................11
5
STUDY POPULATION.............................................................................................................................11
5.0
INCLUSION CRITERIA .................................................................................................................................11
5.1
EXCLUSION CRITERIA.................................................................................................................................12
5.2
RECRUITMENT AND RETENTION METHODS.....................................................................................................12
6
STUDY PROCEDURES ............................................................................................................................15
7
PARTICIPANT WITHDRAWAL.................................................................................................................16
7.0
PARTICIPANT WITHDRAWAL FROM THE STUDY................................................................................................16
7.1
LOST TO FOLLOW UP..................................................................................................................................17
8
RISKS AND BENEFITS ............................................................................................................................17
8.0
RISKS ..........................................................................................................................................................................................17
8.1
POTENTIAL FOR BENEFITS...........................................................................................................................18
9
UNANTICIPATED PROBLEMS.................................................................................................................18
9.0
DEFINITION OF UNANTICIPATED PROBLEMS ...................................................................................................18
9.1
UNANTICIPATED PROBLEM REPORTING .........................................................................................................18
9.2
REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS ................................................................................18
10
DATA REPORTING.................................................................................................................................18
10.0
DATA SUBMISSION....................................................................................................................................18
10.1
DATA AND SAFETY MONITORING .................................................................................................................18
11
STATISTICAL METHODS ........................................................................................................................19
11.0
STATISTICAL HYPOTHESIS............................................................................................................................19
11.1
SAMPLE SIZE DETERMINATION.....................................................................................................................19
11.2
STATISTICAL ANALYSES...............................................................................................................................20
11.2.1
General Approach .......................................................................................................................20
11.2.2
Analysis of the Primary Endpoint(s).............................................................................................20
11.2.3
Analysis of the Secondary Endpoint(s).........................................................................................21
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11.2.4
Planned Interim Analyses............................................................................................................21
11.2.5
Sub-Group Analyses ....................................................................................................................21
12
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS...............................................22
12.0
INFORMED CONSENT PROCESS AND DOCUMENTATION.....................................................................................22
12.0.1
Consent Process..........................................................................................................................22
12.1
CONFIDENTIALITY AND PRIVACY...................................................................................................................23
12.2
RESOURCES AVAILABLE..............................................................................................................................23
12.3
STUDY AUDITING AND MONITORING ............................................................................................................24
12.3.1
Study Monitoring, Auditing, and Inspecting................................................................................24
12.4
QUALITY ASSURANCE AND QUALITY CONTROL................................................................................................24
12.5
DATA HANDLING AND RECORD KEEPING........................................................................................................24
12.5.1
Data Collection and Management Responsibilities .....................................................................24
12.5.2
Study Records Retention .............................................................................................................24
12.6
COMPLIANCE WITH PROTOCOL....................................................................................................................25
12.7
PUBLICATION AND DATA SHARING ...............................................................................................................25
12.8
CONFLICT OF INTEREST POLICY ....................................................................................................................25
14
REFERENCES.........................................................................................................................................26
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1
PROTOCOL SUMMARY
Title
A Culturally-Tailored Web-Based Cognitive Behavioral Stress 
Management for Latino Sexual Minority Men living with HIV and 
Cancer
Background
HIV infection is associated with increased risk for several types of 
cancer, including but not limited to Kaposi’s sarcoma, non-Hodgkin 
lymphoma, and anal cancer. With an increasing aging HIV-positive 
(HIV+) population, which includes large proportions of ethnic and 
sexual minority individuals, there has also been a substantial 
increase in the proportion of these individuals who develop and 
survive cancer.
Living with a dual-diagnosis of HIV and cancer can increase distress, 
as well as affect multiple aspects of health-related quality of life 
(HRQoL). Moreover, among dually-diagnosed individuals, those who 
are ethnic and sexual minorities may experience more substantial 
cancer survivorship disparities. For example, prior research indicated 
sexual minority cancer survivors experience higher distress and 
poorer self-rated health than their heterosexual counterparts.
Our prior research demonstrated the efficacy of a cognitive 
behavioral stress management (CBSM) intervention in improving 
psychosocial and health outcomes for individuals living with HIV or 
cancer. Thus, we propose a single-arm feasibility trial of a culturally- 
tailored web-based CBSM intervention for dually-diagnosed 
(HIV/cancer) Latino sexual minority men (SMM).
Objectives/Endpoints
Objectives
Endpoints
Primary: To examine the 
feasibility and acceptability of the 
culturally-tailored web-based 
SmartManage intervention 
among dually-diagnosed Latino 
SMM.
Secondary: To evaluate the 
preliminary efficacy of the 
culturally-tailored web-based 
SmartManage intervention 
among dually-diagnosed Latino 
SMM.
Feasibility will be examined via 
retention (> 85%) and attendance 
(> 70%) rates. We will evaluate 
acceptability via quantitative 
assessment as well as open- 
ended feedback.
Intended effects will be evaluated 
via examining pre-post changes 
in health-related quality of life, 
general stress, and disease/dual- 
diagnosis related distress using 
the following measures: 
Functional Assessment of Cancer 
Therapy Scale-General, Medical 
Outcomes Study HIV Survey, 
Perceived Stress Scale, and 
Impact of Event Scale.
Study Design
Single-arm feasibility trial
Number of Patients/ 
Target Study Population
30 Latino sexual minority men living with both HIV and cancer
Description of Sites 
Enrolling Participants
University of Miami Health System 
Study duration
1 year
Statistical Analysis
The analyses will be primarily descriptive. A paired t test statistic and 
linear regression model will be used to compare outcome variables 
pre- to post-intervention. We will also estimate effect sizes for the 
outcome variables, which will be selected depending on which 
statistical test was performed and variance assumptions.
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Pre-screened by study staff
(via Consent to Contact List request or 
Chart review) *
Pre-screened via self-report
(online pre-screener) *
Online Advertising
(via social media)
Community 
Partners
Phone screening call (to confirm eligibility) *
Verbal consent to phone or online screener*
(Patients eligible after initial pre-screening)
Electronic consent signed*
(Patients eligible after confirmatory phone screening)
Enrollment, Intake Questionnaire, 
and Group Assignment*
Culturally-tailored 
SmartManage
1.0
Schema
Exit Questionnaire and Final Interview
*Data collected is 
entered into REDCap
University affiliates 
Recruitment
Pre-Screening
Supplementary 
Screening
Enrollment
Intervention
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2
BACKGROUND
2.0
Study Rationale
Given the health disparities Latino SMM living with HIV and cancer experience, 
interventions to improve health and psychosocial outcomes are warranted. Cognitive 
behavioral stress management (CBSM) intervention is efficacious in reducing distress, as 
well as in improving overall quality of life. Prior studies have demonstrated the efficacy of 
CBSM in Latino men living with prostate cancer or Latino SMM living with HIV but have not 
included content specific to dually-diagnosed (cancer & HIV) SMM. The co-management of 
HIV and cancer presents a series of challenges that (a) critically impact health related quality 
of life and (b) have not been adequately addressed in evidence-based psychosocial 
interventions. The availability of culturally-tailored, evidence-based interventions that 
include techniques to enhance cognitive restructuring, emotion regulation, and 
communication, with favorable effects on psychosocial and physiological adjustment, and 
overall quality of life have been documented. Given that these prior intervention 
components have demonstrated efficacy, the current study will examine the feasibility, 
acceptability, and preliminary efficacy of content that has not been specifically tailored to 
this unique, yet growing subgroup, of Latino HIV+ SMM cancer survivors. Thus, our 
proposed work involves the development and testing of content that is of clinical and 
cultural relevance to this group: co-management of HIV and cancer, strategies for self-
advocacy, partnering with the health system and health providers, intimacy and disclosure 
concerns regarding both conditions, assertiveness and communication skills, and self-
efficacy in care coordination. This content will be grouped into 10 weekly sessions, which 
will be culturally-tailored to Latino SMM.
2.1
Background
With the advent of highly active antiretroviral therapy (HAART), HIV-infected individuals 
in the US are living substantially longer and have a life expectancy that now 
approximates that of the uninfected population. As such, an increasing number of 
individuals living with HIV, as they age, are being diagnosed with cancer.1-3 Moreover, 
HIV infection may increase the risk for certain types of cancer, such as non-Hodgkins 
lymphoma and Kaposi’s sarcoma.1-3 Unfortunately, medical management of individuals 
dually-diagnosed with both HIV and cancer may be more complex, which may also 
increase potential for significant stress and its sequelae.1-3 For example, medications 
used for HIV and cancer treatment may interact, increasing possibility for toxicity and 
detrimental side effects.1, 2 Moreover, it may be difficult to distinguish whether a drop in 
CD4 count and/or constitutional symptoms among those dually-diagnosed are due to 
HIV infection or cancer treatment, further complicating medical management.1, 2 All in all, 
dually-diagnosed individuals are at greater risk of experiencing stress due to the 
complex medical management of these diseases, as well as to the uncertainty 
associated with living with two life-threatening conditions. Furthermore, the stress of 
living with a dual diagnosis of HIV and cancer is likely compounded for ethnic and 
sexual minorities, who experience disparities in both HIV and cancer outcomes. 
HIV is disproportionately represented among ethnic and sexual minority men (SMM).4, 5 
The CDC estimates approximately 1 in 4 Latino SMM will be diagnosed with HIV in their 
lifetime.5 Thus, while current estimates of dually-diagnosed individuals are forthcoming, 
Latino SMM are likely to make up a substantial proportion of individuals living with both 
HIV and cancer. This is particularly alarming, given that, as described in detail below, 
Latino SMM experience a variety of health disparities, including those associated with 
the negative impact of stress, in the experience of living with each of these diseases.1 
While there has been little to no research examining health outcomes among dually- 
diagnosed Latino SMM, there are studies indicating Latino SMM experience disparities 
in both HIV and cancer-related outcomes, outlined below.
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In addition to being more likely to be diagnosed with HIV than non-Latino white SMM, 
Latino SMM experience poorer HIV-related health outcomes once infected. For 
example, Latino SMM demonstrate poorer access to care than their non-Latino white 
counterparts.6 Moreover, Latino SMM may experience higher levels of HIV-associated 
stigma than their non-Latino counterparts.7 HIV stigma, in turn, has been associated 
with increased depression, lower levels of social support, and poorer physical health.8
Relative to heterosexual men, SMM living with cancer generally report heightened 
symptom bother as well as poorer sexual functioning, greater psychological 
distress, and worse health related quality of life (HRQoL).9-14 Evidence also 
suggests that SMM are more likely to engage in risky health behaviors, including 
inadequate exercise and greater rates of smoking and alcohol use, which may persist 
following a cancer diagnosis.9 SMM also report lower satisfaction with their cancer-
related medical care and poor treatment satisfaction has been associated with fear of 
recurrence.15, 16 This of particular importance since fear of recurrence is one of the most 
common and distressing concerns reported by cancer survivors and a prior study found 
SMM with prostate cancer generally report greater fear of recurrence than heterosexual 
men.10-17 Additionally, Latino men experience poorer quality of life than their non-Latino 
white counterparts following a cancer diagnosis.18 Latino SMM may have less access to 
healthcare and resources for coping, which may be exacerbated by multiple minority 
status.6 Moreover, while prior research has shown that cultural values play a significant 
role in health and wellness among Latino populations living with HIV and cancer, no 
interventions have been tailored for Latino SMM.
3
OBJECTIVES AND ENDPOINTS
3.0
Objectives
Primary objective: To examine the feasibility and acceptability of the culturally-tailored 
web- based SmartManage intervention among dually-diagnosed Latino SMM.
Secondary objective: To evaluate the preliminary efficacy of the culturally-tailored web- 
based SmartManage intervention among dually-diagnosed Latino SMM.
3.1
Endpoints
Feasibility will be examined via retention (> 85%) and attendance (> 70%) rates. 
Acceptability will be evaluated via quantitative assessment as well as open-ended 
feedback. These assessments will measure standard dimensions of acceptability 
including relative advantage, compatibility, and complexity.
Intended effects will be evaluated via examining between-group pre-post changes in 
health- related quality of life, general stress, and disease/dual-diagnosis related distress.
4
STUDY DESIGN
4.0
Overall Design
This is a single-arm feasibility trial of a culturally-tailored web-based SmartManage 
(Stress Management and Relaxation Training Management) intervention. For this study, 
staff will utilize these primary avenues for participant recruitment: 1) the University of 
Miami Medicine system and its University of Miami affiliates (e.g., Sylvester 
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Comprehensive Cancer Center, consent to contact lists from other University of Miami 
investigators), 2) online advertising, via social media, and 3) collaboration with external 
partnering community-based organizations.
Culturally-Tailored Web-Based SmartManage Intervention: Through our prior work 
with cancer survivors and HIV+ SMM, we have developed, implemented, published and 
disseminated evidence-based manuals to managing prostate cancer survivorship or HIV 
infection in sexual minority men. CBSM is and evidence based, chronic disease 
management program, from which we derived content for the web-based SmartManage 
intervention for HIV+ SMM cancer survivors. The web-based SmartManage intervention 
includes ten 90-minute weekly therapist delivered group sessions (4-6 participants) via 
video conference. In the first 30 minutes, participants are taught/discuss a new stress 
reduction technique whereas the latter 60 minutes focus on stress- and self-
management. Disease course, symptom burden, communication with intimate partner 
and/or family members and health care provider, impact of stress on physical and 
mental health and symptoms, and management of symptom burden and decrements in 
HRQoL are used for educational purposes and as catalysts for CBSM techniques. 
Participants describe stressors with an emphasis on symptoms and disruption, HRQoL 
and their coping responses for in-session role-plays. The SmartManage web platform 
has all intervention material, resources, and exercises.
We will adapt each of the SmartManage intervention components to be compatible with 
our participants’ cultural beliefs and context by including culturally-relevant content and 
examples within both the didactic (website) and interactive (session) portions of the 
SmartManage intervention. Specifically, our intervention will be adapted to reflect the 
values of familism, allocentrism, health stigma, power distance, external locus of control, 
and male gender roles. Our adaptation will be guided by previous cultural concepts and 
adaptations used to inform similar CBSM studies.
4.1
Study timelines
The study will last approximately 16-20 weeks for all participants (factoring in time for 
recruitment, enrollment, assessment, and intervention). We anticipate it will take 
approximately 6 months to recruit our full sample, and study will last no more than 1 year 
in total.
5
STUDY POPULATION
This pilot study will include a total of 30 sexual minority Latino men who are HIV+ and 
survivors of cancer.
5.0
Inclusion Criteria
Participants must:
a) Be ≥ 18 years of age.
b) Be fluent in English.
c)
Have evidence of at least one form of metastatic or non-metastatic solid tumor 
cancer and/or hematologic malignancy, including, but not limited to, the following 
types:
i.
Oral cavity and pharynx (i.e. tongue, mouth, pharynx, etc.)
ii.
Digestive system (i.e. esophagus, stomach, small intestine, colon, etc.)
iii. Respiratory system (i.e. larynx, lung, bronchus, etc.)
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iv. Urinary system (i.e. kidneys, bladder, urethra, ureters)
v.
Bone and joint
vi. Soft tissue (including heart)
vii. Breast (male)
viii.Genital system (male, i.e. prostate, testis, penis, etc.)
ix. Endocrine (i.e. thyroid, adrenal glands, pancreas, etc.)
x.
Melanoma skin cancer
d) Be ≥ 30 days post active primary treatment (i.e. surgery, radiation, and/or 
chemotherapy*) for their cancer. (Note: Adjuvant therapies, such as hormone 
therapy for prostate cancer, etc. are not considered exclusionary).
e) Self-identify as a cisgender male
f)
Self-identify as Hispanic or Latino
g) Have been diagnosed with HIV.
h) Have reliable access to a computer/device with internet accessibility.
5.1
Exclusion Criteria
Participants must not:
a) Have had one of the following exclusionary cancer types:
i.
Non-melanoma skin cancer only (not in combination with another type listed 
in the inclusion criteria above)
ii.
Brain cancer
iii. Eye cancer
iv. Any form of pediatric cancer (if the pediatric cancer is the only cancer 
diagnosis the patient has had)
b) Currently be undergoing primary treatment for their cancer
c)
Have had inpatient treatment for severe mental illness in the past 12 months or 
have overt signs of psychopathology (i.e. psychosis) and/or suicidality at the time 
of screening.
d) Be experiencing active alcohol dependence or have had inpatient treatment 
for alcohol abuse within the past 12 months.
e) Be experiencing active substance dependence or have had inpatient treatment 
for substance abuse within the past 12 months.
f)
Have any other medical conditions resulting in a predicted life expectancy 
<12 months.
5.2
Recruitment and Retention Methods
For this 1-year pilot, we plan to recruit 30 Latino HIV+ cancer survivors who are sexual 
minority men. By working with a variety of UM and UM-affiliated groups, including 
Sylvester Comprehensive Cancer Center as well as our external partners we hope to 
enroll HIV+ cancer survivors of diverse backgrounds, in terms of age, education, and 
socioeconomic status. We acknowledge that recruiting this many patients from such a 
unique population and within the proposed timeframe may present several challenges. 
However, study staff will capitalize on their working relationships with University of Miami 
Medicine affiliates and their connections to community partners.
Screening and Recruitment: Participants for this pilot will be recruited remotely (online 
or by phone). For this study, staff will utilize these primary avenues for participant 
recruitment: 1) the University of Miami Medicine system and its University of Miami 
affiliates (e.g., Sylvester Comprehensive Cancer Center, consent to contact lists from 
other University of Miami investigators), 2) online advertising via social media, and 3) 
collaboration with external partnering community-based organizations.
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University of Miami Medicine and its UM affiliates (UHealth Clinics, UM Consent to 
Contact Database, or Other UM Investigators’ Consent to Contact Lists)
A partial HIPAA waiver is requested for screening and recruitment purposes (See section 
12.1.3 for HIPPA Waiver). Such a waiver is appropriate for the following reasons:
a) This study is of no more than minimal risk to prospective patient/participants, as 
their participation simply involves undergoing a psychosocial intervention and 
providing questionnaires and does not utilize drugs, medical devices, or medical 
procedures of any kind.
b) Personal identifiers obtained via the report will be used to determine patients’ 
eligibility for enrollment only and will be destroyed as soon as possible after the 
determination of eligibility is made.
c) All other personal health information (PHI) collected from patients will be obtained 
by self-report only. For the purpose of this pilot, study staff is not requesting 
access to enter patients’ electronic medical records beyond the pre-screening.
d) Given the timeline of the recruitment for the project (less than 1 year), it would be 
impracticable for the study team to rely solely on direct referrals from healthcare 
providers to enroll the desired number of patients for the pilot (50). Conducting a 
chart review will enable the study team to obtain a larger number of patient names 
in a shorter amount of time, thus rendering the recruitment timeline feasible.
A limited amount of PHI will be reviewed from patient charts in order to pre-screen 
patients. Patients to be pre-screened will be determined from the scheduled list of 
patients on a given day within the study period in the appropriate disease teams (i.e., 
Infectious Diseases, AIDS Clinical Research Unit, etc.). The research personnel will 
review charts for the following information: whether the person is male, 18 years or 
older, Hispanic, speaks English, has a metastatic or non-metastatic solid tumor cancer, 
and is ≥ 30 days post active primary treatment. Patients who are identified through 
UChart review will be approached through their treating physician. We will advise their 
treating physician and direct medical staff of the possible eligibility to our study, and 
further request for them to introduce our study to the patient. If the patient is interested, 
they will be instructed to either call us or provide their verbal consent to be contacted by 
the study team for screening.
We will also obtain a list of potentially eligible participants from the UM Consent to 
Contact Database. The following criteria will be used to generate the patient contact list: 
male, 18 years or older, Hispanic, speaks English, a metastatic or non-metastatic solid 
tumor cancer (by ICD-10/ICD-9 codes), and not receiving active treatment (by CPT 
codes). Additionally, we will be utilizing MyChart Research Recruitment as a tool to 
identify and safely communicate with participants who agreed to be contacted if they 
meet the initial study eligibility criteria from the EMR.
In addition, our research team will partner with other UM investigators doing work in HIV 
and/or cancer who have obtained informed consent from prior or current study 
participants to be contacted for future studies. Requesting these lists from other 
investigators will enable the study team to obtain a larger number of patient names in a 
shorter amount of time, thus rendering the recruitment timeline feasible.
After receiving the lists of potentially eligible participants, study staff will contact 
individuals via phone using the Consent to Contact Script. If the prospective participant 
declines to provide verbal consent for screening, the study team member will thank 
them for their time and end the call. However, if the prospective participant does provide 
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verbal consent, the study team member will proceed with the screening process, giving 
the individual the option of completing the full screener either by phone or online. For 
those screened by phone, study staff will enter patient’s responses into REDCap and 
confirm the prospective participants’ eligibility (or lack thereof) for the study. For those 
who complete the online eligibility screener (also REDCap), study staff will confirm 
eligibility during a follow-up phone call.
Online Advertising via Social Media
As most individuals are now using social media, such as Facebook, Instagram, and 
Twitter to stay connected with friends and family, it makes sense for the study team to 
advertise this potential research opportunity in this manner. Those who learn of the 
study via Facebook advertisements or other social media, will be directed to a brief 
online eligibility pre-screener, the responses to which will be captured in REDCap. On 
other similar studies utilizing Facebook ads, staff have noted that a number of people 
have clicked on the pilot’s Facebook ads and either “liked” them or shared them on 
their personal pages. However, these same individuals have not then proceeded to 
complete the online pre-screener.
Moving forward, study staff will send a brief message to those individuals who comment 
explicitly on their Facebook pages that they are interested in taking part, but who have 
been unsuccessful in finishing the online pre-screener. If an individual simply shares or 
“likes” an ad for the pilot, study staff will not message them. Same procedures will be 
utilized for the other social media channels. Study staff will review all completed online 
pre- screeners and determine whether respondents appear to meet preliminary 
eligibility criteria. If respondents do meet these preliminary criteria, UM study staff will 
call these respondents to complete the screening process by phone or online.
Partnership with External Collaborator
Potential participants may also be recruited remotely via the study team’s collaboration 
with local community-based organizations serving LGBT individuals. These community- 
based organizations provide social services specifically for sexual minority men living 
with HIV and have longstanding relationships with university investigators. These 
organizations may advertise the study to their patrons. If someone who is not currently 
a UM patient, or who is a UM patient that has not been identified by the staff as a 
potential participant, calls our external community partners to inquire about general 
research opportunities, they will be redirected to our staff who will provide them with 
information about the study and ask for their verbal consent to complete the screening 
process by phone or online. In addition, we will recruit participants through referrals from 
enrolled participants. Enrolled participants will receive $20 for every referral of a 
potentially eligible person (i.e., adult male with HIV and cancer).
Other avenues for participant recruitment
We will advertise this trial in online recruitment platforms (e.g., ResearchMatch) that 
help connect researchers with individuals interested in learning about research study 
opportunities. First, we will enter our inclusion criteria to generate a list of potentially 
eligible participants. Then, we will send a contact message to these individuals (See 
ResearchMatch message). Once the individual has authorized to release their contact 
information to our study team, we will call these respondents to complete the screening 
process by phone or online.
Financial Compensation:
Participants will receive a $75 electronic payment (e.g., Zelle, digital gift card) at each of 
two assessments (baseline, post-intervention), and additional $25 for participating in a 
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final interview (A total of $175 for study participation).
6
STUDY PROCEDURES
Study staff will follow guidelines from the CTSI on e-consenting using REDCap. After 
consent has been obtained, study staff will instruct the participant to complete the intake 
questionnaire.
Intake questionnaire:
a) Demographics and Disease Information: Participants will complete: a 
demographic survey which will include factors such as age, race, education, 
employment status, income, nativity, years in the US, and relationship status. 
Participants will also complete a disease information form, which will collect 
medical history relevant to their cancer and HIV diagnoses. Finally, participants 
will complete ACTG HIV medication Adherence measure,19 and the Barriers to 
HIV Care survey.20
b) Psychosocial Factors: Participants will complete the Coping Self-Efficacy 
scale,21 Interpersonal Support Evaluation List (ISEL),22 the Bidimensional 
Acculturation Scale for Hispanics,23 and the Computer Proficiency Questionnaire 
(CPQ).24
c)
Intervention Outcomes: Participants will complete: the Perceived Stress 
Scale (General Stress),25 the Impact of Event Scale (Disease/Dual-
diagnosis-related Distress),26 and The Functional Assessment of Cancer 
Therapy scale-General (FACT-G; HRQoL)),27 and Medical Outcomes Study 
HIV Survey (MOS-HIV; HRQoL).19
d) COVID-19 Questions: Participants will complete the COVID-19 Impact of 
the Pandemic and HRQOL in Cancer Patients and Survivors measure.
e) Computer Proficiency: Measured with the Computer Proficiency Questionnaire.
Once participants complete the intake questionnaire, they will be prompted to register 
on the culturally-tailored SmartManage intervention website. Study staff members who 
have previous experience and expertise in delivering CBSM interventions to Latino 
populations will conduct the study intervention interactive sessions. Following the 
intervention, participants will be prompted to complete their exit questionnaire in 
REDCap.
Exit Questionnaire. For the exit questionnaire, the participants will complete all intake 
measures (excluding the Demographics and Disease Information) and will also complete 
a measure of acceptability. As standard acceptability constructs include relative 
advantage, compatibility, and complexity, the acceptability evaluation measure will cover 
ease of use of the culturally-tailored web-based SmartManage intervention, including 
participants’ confidence in their ability to successfully complete the intervention, as well 
as general comfort with the intervention process.28 Additionally the acceptability 
evaluation measure will gauge preference web-based vs. in-person interventions, as well 
as willingness to complete the culturally-tailored web-based SmartManage intervention 
again or refer a friend to the intervention. The acceptability evaluation measure will also 
allow participants to give open- ended comments/feedback about the intervention.
Final Interview. Participants will be asked to participate in a final interview to discuss the 
challenges or factors that influenced their participation in the program, the impact of the 
program on their health, and suggestions for improvement. The interview will be 
conducted by phone or videoconference, will last about 30 minutes, and will be video or 
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audio-recorded and then transcribed by study team members (See Final Interview 
Guide).
7
PARTICIPANT WITHDRAWAL
7.0
Participant Withdrawal from the Study
Although we will seek to minimize participant withdrawal, participants will be told that this 
study is completely voluntary and that they have the right not to participate in any 
intervention procedure. They also can completely withdraw from the study at any time 
without any negative consequences.
If, for some unforeseen reason, a situation arises in which a participant experiences more 
harm than good during the study, the PI may choose to withdraw this participant. Though 
highly unlikely, such situations could include excessive physical, psychological, or 
emotional suffering. Other circumstances under which participants will be withdrawn from 
the study may include: the participant no longer meet the eligibility criteria, providing 
fraudulent data, or other reasons deemed appropriate by the Primary Investigator. If a 
participant is arrested, reports suicidal ideation, or some other extreme adverse event, a 
qualified study staff member (i.e., Dr. Sara St. George, a licensed psychologist) may ask 
them to withdraw from the study, and if appropriate, refer them to necessary services. 
According to IRB, if a participant becomes incarcerated while enrolled in a study, all 
research interactions and interventions with that participant, and the obtaining of identifiable 
private information about the participant must cease. When participants withdraw from the 
research, study staff will update their data set to reflect this change. Study team members 
will no longer contact participants to schedule future study activities, depending on the time 
point at which the participants withdraw.
Unless participants expressly request the destruction of whatever data that has already 
been collected, and unless participants request no further data be collected about them 
whatsoever, study staff may continue to gather certain information at the other time points 
at which the participants would have been seen had they remained active in the study. 
Unless otherwise instructed by these participants, study staff may also continue using their 
previously collected data for analysis purposes.
7.1
Lost to follow up
Participants will be considered lost to follow-up after five failed attempts to contact them. 
To minimize loss to follow-up and missing data, we will contact participants by phone if they 
miss intervention sessions. We will ask about barriers to participation and brainstorm ways 
to facilitate their participation and accommodate their unique circumstances so they can 
fulfill their participation in the study.
8
RISKS AND BENEFITS
8.0
Risks
Though we regard the risks of participating in this pilot project to be low, we will take 
care that every member of the research study team is trained to handle all situations 
with sensitivity and empathy. All research staff is required to complete UM-mandated 
training on the Protection of Human Research Participants, which must be renewed on 
a yearly basis. Certificates for all research staff will be kept on file. Since the 
anticipated risks associated with this pilot are relatively low, and since the potential 
benefits for participants are significant, the balance of risks-to-benefits seems 
reasonable to us.
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While taking part in this project, participants may be exposed to information related to 
cancer survivorship and HIV, and they may be asked to discuss sensitive topics, both 
of which may lead some participants to experience transient, mild anxiety. In these 
cases, every attempt will be made to provide relief to participants and to ameliorate the 
source of their discomfort. Should participants experience extreme acute or persisting 
affective reactions at any point during the study, they will be referred to a psychiatrist or 
clinical psychologist associated with the study site in question.
In the event that a participant reports symptoms or concerns of extreme distress (i.e., 
severe symptoms of depression and/or anxiety, suicidality, etc.), the PI will assess the 
severity of such distress by meeting individually with the participant at an appropriate 
juncture either after completion of the study activities scheduled for that time point, or 
potentially immediately, in emergencies. If it is then determined that the participant 
needs individual care, our research staff will be prepared to refer the patient to an 
additional source of clinical intervention. Participants may be referred to the 
appropriate channels within University of Miami health system. They will also be 
provided with a list of community resources in the Miami area that serve individuals 
experiencing extreme distress.
In addition, group sessions provide a particular challenge to confidentiality because it 
is possible that participants may repeat comments outside the group. Research staff 
will remind participants not to talk to people outside the group about what was said in 
the group sessions and to keep it confidential. Research staff will ask participants to 
attend the group sessions alone from a quiet, private, confidential room with no 
background noise.
There is the potential for participants to be bothered by the questions asked during 
the final individual interviews, which may make them feel uncomfortable, angry, sad, 
embarrassed or fatigued.
Lastly, confidentiality during internet communication activities cannot be guaranteed. 
The study team will provide participants with internet privacy tips and show them how 
to log in to and use the program. Also, participants will be completing all 
questionnaires online using a secure and unique log in REDCap (See section 12.6 for 
Data Handling and Record Keeping).
8.1
Potential for Benefits
There may not be any direct benefit. However, participants taking part in this pilot may 
benefit from exposure to information about cancer and HIV with which they were previously 
unfamiliar. They may also get exposed to basic cognitive-behavioral stress management 
techniques while reviewing the web-based platform. As mentioned earlier, our culturally- 
tailored SmartManage platform will be specifically designed to ameliorate the distress, 
general stress, and health-related quality of life challenges experienced among HIV+ 
sexual minority male cancer patients. Thus, participants may absorb information about 
ways to decrease distress, cope with challenges related to symptom management, and 
improve their HRQoL, all through exposure to an innovative new online tool.
9
UNANTICIPATED PROBLEMS
9.0
Definition of Unanticipated Problems
The Office for Human Research Protections (OHRP) considers unanticipated problems 
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involving risks to participants or others to include, in general, any incident, experience, or 
outcome that meets all of the following criteria:
•
Unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
Institutional Review Board (IRB)-approved research protocol and informed consent 
document; and (b) the characteristics of the participant population being studied;
•
Related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and
•
Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized.
9.1
Unanticipated Problem Reporting
The investigator will report unanticipated problems (UPs) to the reviewing Institutional 
Review Board (IRB) as per institutional guidelines.
9.2
Reporting Unanticipated Problems to Participants
Not Applicable
10
DATA REPORTING
10.0 Data submission
Electronic case report forms for study data entry will be developed by staff at the University 
of Miami using Velos and REDCap, a HIPAA AND 21 CFR part 11 compliant database. 
Only investigators and assigned research staff will have access to study data. The 
electronic case report forms will be available to the sponsor, IRB or regulatory authorities in 
event of an audit
10.1 Data and Safety Monitoring
The Sylvester Comprehensive Cancer Center (SCCC) Data and Safety Monitoring 
Committee (DSMC) will monitor this clinical trial according to the Cancer Center’s data and 
safety monitoring (DSM) plan to assure the well-being of patients enrolled on Investigator-
Initiated Trials that do not have an outside monitoring review. In its oversight capacity, 
the DSMC bears responsibility for suspending or terminating this study. The activities of 
this committee include ongoing review of accrual, periodic review of response adverse 
events including SAEs, important medical events, significant revisions or amendments to 
the protocol, and approval of cohort/dose escalations. The DSMC also reviews reports from 
internal audits of protocol compliance and data integrity conducted by the University of 
Miami, Office of Research Compliance Assessment. If the DSMC and/or the PI have 
concerns about unexpected safety issues, the study will be stopped and will not resume 
until the issues are resolved. The DSMC will review reports from all audits, site visits, or 
study reviews pertaining to this clinical trial and take appropriate action. The guidelines 
appearing in this section are offered for DSMC consideration in assessing adverse events 
and response to study treatment. The SCCC DSM Plan to which this study is subject can 
also be found at www.sylvester.org.
11
STATISTICAL METHODS
11.0 Statistical Hypothesis
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Primary research question: To examine the feasibility and acceptability of the culturally- 
tailored web-based SmartManage intervention among dually-diagnosed Latino SMM.
Primary Hypothesis: The culturally-tailored web-based SmartManage intervention will 
be feasible and acceptable to dually-diagnosed Latino SMM.
Secondary research question: To evaluate the preliminary efficacy of the culturally- 
tailored, web-based SmartManage intervention among dually-diagnosed Latino SMM.
Secondary Hypothesis: The culturally-tailored web-based SmartManage will show 
preliminary reductions in stress and disease-related distress and improvements quality of 
life among dually-diagnosed Latino SMM.
11.1  Sample Size Determination
We expect that, within this subgroup of HIV+ sexual minority men, rates of prevalence of 
cancer will likely be greater or equal to 30% (i.e. the rate of prevalence observed in the 
general older male population). This estimate, along with consultations with our co- 
investigators and community partners has informed our recruitment goals. Based on our 
institution accrual capacity, we are able to enroll 30 subjects in the study. In accordance 
with Leon et al. 2011,29 we assert that the main goal of our pilot study is to examine the 
feasibility and acceptability of a culturally-tailored SmartManage intervention and based 
our sample size on the number of participants that could feasibly be recruited within our 
time frame. Thirty participants will be assessed for retention and attendance rates. As 
detailed here, 30 participants provide reasonable 
precision for estimating the above rates. Table 1 
illustrates study precision for estimating the true 
attendance rate. If we observe 21 participants 
among 30 who attend all intervention sessions, 
the estimated attendance rate will be 70% and 
the corresponding 95% confidence interval will 
be 50.6% to 85.3%. If the number of participants 
who attend all intervention sessions is 27, then 
the estimated attendance rate will be 90% with a 
corresponding 95% confidence interval of 73.5% 
and 97.9%. Furthermore, with 30 participants, a 
one-sided binomial test with 5% significance will 
have power >80% to detect improvement to 
18.6% attendance relative to a null rate of 70%.
11.2 Statistical Analyses
11.2.1 General Approach
All data will be inspected for quality assurance prior to analysis. Data screening will 
focus on: (a) Missing data: we will determine the amount, the pattern, and randomness; 
(b) Outliers: we will identify observations that appear to be very high or very low and 
decide how to proceed based on the presumed cause; and (c) Inconsistencies: we will 
identify inconsistencies within a single variable and between variables. Initially, we will 
perform an exploratory data analysis and calculate descriptive statistics. 
Transformations of the data in order to meet statistical assumptions will be undertaken 
when indicated. Type-1 error will be set to 5% (α = .05) for calculating confidence 
intervals and performing hypothesis testing and all tests will be two-sided. If needed, 
Table 1. Possible study findings for 
attendance rate with 30 subjects
Number (%) of 
attended subjects
95% CI*
21 (70%)
50.6% - 85.3%
24 (80%)
61.4% - 92.3%
27 (90%)
73.5% - 97.9%
* CI: confidence interval, binomial 
method.
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alphas will be adjusted accordingly for multiple comparisons using Bonferroni 
correction. Standard statistical goodness-of-fit measures will be used assessing any of 
the model fittings. Missing values will be handled with appropriate statistical methods. 
Last observation carried forward (LOCF) and multiple imputation will be considered for 
missing values.
Demographic and disease characteristic variables will be summarized using descriptive 
statistics. Counts and percentages will be used to summarize the distribution of categorical 
variables. Median, range, mean, and standard deviation will be used for continuous 
variables. Categorical variables will be tested using Fisher’s exact test. Continuous 
variables will be tested using Student’s t-test and/or Mann-Whitney U test. For correlation 
coefficients, Pearson’s correlation coefficients and Spearman’s correlation coefficients will 
be estimated along with corresponding 95% confidence interval. All statistical analyses will 
be carried out using SAS or SPSS, all of which are available to investigators through the 
University of Miami.
11.2.2 Analysis of the Primary Endpoint(s)
Feasibility will be analyzed using attendance and retention rates. For the proposed study 
to be considered feasible, we will need to uphold all the following criteria: 70% of 
participants attend all intervention sessions and 85% of participants are retained 
throughout the study (from pre-intervention to post-intervention assessment). These 
proportions are based on previously successful CBSM trials in other populations.
We will also perform descriptive analyses to better understand the feasibility of our future 
R01 trial, including:
1) Personnel time: This will include personnel time that is devoted to assessing 
eligibility, managing contacts, and recruiting, conducting the intervention, and 
administrative time.
2) Space: We will collect information on any space used that is needed to conduct 
the intervention, including administrative space.
3) Supplies: We will collect information on all supplies that are needed and any 
costs associated with maintaining the SmartManage website.
Acceptability will be analyzed using the proportion of the number of participants who agree 
to participate in the intervention. We will evaluate the acceptability of the intervention two 
ways:
1) via the proportion of eligible SMM who agree to participate vs. decline and 2) via the exit 
survey that will measure acceptability of the intervention.
We will explore whether feasibility and acceptability differ by sociodemographic, medical, 
and psychosocial factors via Fisher’s exact tests. These analyses will be primarily 
descriptive and will provide the basis for future randomized trials to formally evaluate the 
efficacy of the culturally-tailored web-based SmartManage intervention among dually-
diagnosed Latino SMM.
11.2.3 Analysis of the Secondary Endpoint(s)
Preliminary Efficacy: The main outcomes will be health-related quality of life, general 
stress, and disease/dual-diagnosis related distress all of which will be continuous total 
scores. We will examine descriptive statistics (e.g., means, medians, standard 
deviations) among study variables. Based on the distribution of the data, we will select 
either paired t- tests or the Wilcoxon signed-rank test for paired samples to examine 
whether the following variables improve significantly following the intervention using total 
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scores and scores from subdomains. Linear regression will be used to examine study 
variables and the following change of endpoints between pre- and post-intervention:

The Functional Assessment of Cancer Therapy Scale-General: This instrument 
will used to assess HRQOL. This 5-point Likert scale instrument includes 27 items 
and yields four subscales (physical, social, emotional, and functional well-being) 
and a total score, with higher scores indicating better HRQOL (Cronbach's α from 
.85 to .92)27.

The Medical Outcomes Study HIV Survey: This is a widely accepted instrument to 
assess HRQOL in individuals living with HIV. The instrument includes 35 items that 
assess the ten dimensions of health, including mental health, quality of life, health 
distress, cognitive function, energy/fatigue, overall health, role function, physical 
function, pain, and social function. The subscales are scored as summated rating 
scales on a 0–100 scale where higher scores indicate better health (all Cronbach's α 
> .75)19.

Perceived Stress Scale: This instrument will be used to assess the degree to 
which participants appraise their lives as stressful. It consists of 14 items, with 
seven positive items and seven negative items rated on a 5-point Likert scale. 
Positive items will be reversed coded and all items will be summed to generate a 
total score, with higher scores indicating greater stress (Cronbach's α =.86)25.

The Impact of Event Scale: This instrument will be used to measure dual-
diagnosis- related distress. This 5-point Likert scale instrument includes 22 items 
and it was developed to assess post-traumatic stress disorder symptom clusters 
associated to a life-threatening event. It yields 3 subscales (intrusion, avoidance, and 
hyperarousal) and a total score. Higher scores indicate greater distress (Cronbach's 
α from .79 to .97)26.
11.2.4 Planned Interim Analyses
We do not plan to do interim analysis.
11.2.5 Sub-Group Analyses
Not Applicable
11.3 Qualitative Data Analysis
Qualitative data will be analyzed using a rapid qualitative analysis or general inductive 
approach.32, 33 Findings will be directly derived from the raw data, specifically 
participants’ comments. Study team members will meticulously read all transcripts and 
participate in an iterative group process to develop a coding manual that outlines 
category labels and descriptions. Independent raters will code all data and inter-rater 
agreement will be calculated. The qualitative software Dedoose will be employed for 
content analysis and extracting coded participant responses.
12
SUPPORTING DOCUMENTATION AND 
OPERATIONAL CONSIDERATIONS
12.0 Informed Consent Process and Documentation
12.0.1 Consent Process
Informed consent is a process that is initiated prior to the individual’s agreeing to participate 
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in the study and continues throughout the individual’s study participation. The consent 
process will take place remotely via videoconference on e-consenting using REDCap. 
Consent forms will be Institutional Review Board (IRB)-approved and the participant will be 
asked to read and review the document before the videoconference call. At the beginning 
of the meeting, the research staff will confirm the identity of the potential participant by 
viewing their driver’s license or another form of identification. Then, research staff will 
explain the research study to the participant and answer any questions that may arise. A 
verbal explanation will be provided in terms suited to the participant’s comprehension of the 
purposes, procedures, and potential risks of the study and of their rights as research 
participants. Participants will be given as much time as needed for them to be comfortable 
with participating in this study. Participants will have the opportunity to carefully review the 
consent form and ask questions prior to electronically signing. The participants should have 
the opportunity to discuss the study with their family or surrogates or think about it prior to 
agreeing to participate. The participant will electronically sign and date the informed 
consent document prior to any procedures being done specifically for the study. 
Participants must be informed that participation is voluntary and that they may withdraw 
from the study at any time, without prejudice. An electronic copy of the informed consent 
document will be given to the participants for their records. The informed consent process 
will be conducted, and the form signed before the participant undergoes any study-specific 
procedures. The rights and welfare of the participants will be protected by emphasizing to 
them that the quality of their medical care will not be adversely affected if they decline to 
participate in this study.
12.0.2 Process to Document Consent in Writing
We will follow procedures outlined in HRP-093 Electronic Signatures for Documentation 
of Consent.
12.0.3 Process to Document Notification of Participants
Former and current participants will be notified regarding the addition of a final interview. 
We will reach out to all participants via phone, making up to five contact attempts. If a 
participant agrees to participate in a final interview, we will ask him to sign the revised 
version of the informed consent. The notification will be documented in an electronic form 
in REDCap (See Notification of final interview). 
12.0.4 HIPPA Waiver
Type of Request:
 Waiver of Authorization for access to medical record for subject 
identification/recruitment. 
 Waiver of Authorization for access to medical record to 
obtain data for the research.
Confirm that you will destroy or de-identify the information you collect at the earliest 
opportunity. 
 I confirm
Confirm that the information you collect will not be reused or disclosed to any other person 
or entity, except as required by law, for authorized oversight of the research study or for 
other research for which the use or disclosure of PHI is permissible.   
 I confirm
12.1 Confidentiality and Privacy
Information collected will not be reused or disclosed to any other person or entity, except 
as required by law, for authorized oversight of the research study or for other research for 
which the use or disclosure of PHI is permissible. Procedures to protect confidentiality of 
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information being sent are the following: de-identifying/coding reports, sending emails via 
secure transmittal, and password-protected files.
Participant confidentiality and privacy is strictly held in trust by the participating 
investigators, their staff, the safety and oversight monitor(s), and the sponsor(s) and 
funding agency. This confidentiality is extended to the data being collected as part of this 
study. Data that could be used to identify a specific study participant will be held in strict 
confidence within the research team. No personally identifiable information from the study 
will be released to any unauthorized third party without prior written approval as per 
institutional policies.
The study participant’s contact information will be securely stored in the University of 
Miami’s password-protected electronic devices and University of Miami approved cloud-
based storage systems for internal use during the study. At the end of the study, all records 
will continue to be kept in a secure location for as long a period as dictated by the reviewing 
IRB, Institutional policies, or funding agency requirements.
Electronic case report forms for study data entry will be developed by staff at the University 
of Miami using Velos and RedCap, a HIPAA compliant database. Only Investigators and 
assigned research staff will have access to study data.
12.2 Resources Available
Prior to their exposure to any sort of personal health information (such as patient names 
and dates of birth, HIV status, etc.), study staff members will undergo training in the 
proper handling of sensitive medical information. Study staff will also be trained to 
respond to participants in a sensitive and empathic manner. In addition, all research 
staff will be required to complete University of Miami University’s annual training on the 
Protection of Human Research Subjects.
In relation to the social, emotional, and psychological resources that participants might 
need, any study participant who experiences extreme or persistent affective reactions 
at any point during the pilot will receive appropriate care referrals to a psychiatrist or 
psychologist associated with their respective study site. As needed, participants will 
also be provided with a list of community resources in the Miami area that are prepared 
to deal with individuals in distress.
12.3 Study Auditing and Monitoring
This study will be monitored (as applicable) and may be audited according to the 
University of Miami requirements. See also
http://research.med.miami.edu/clinical-research/crors/monitoring
Following the monitoring plan, the monitors will verify that the study is conducted, and data 
are generated and biological specimens are collected, documented (recorded), and 
reported in compliance with the protocol, International Conference on Harmonization Good 
Clinical Practice (ICH GCP), and applicable regulatory requirements.
12.3.1 Study Monitoring, Auditing, and Inspecting
The investigator will permit study-related monitoring, quality audits, and inspections by, 
government regulatory authorities, of all study-related documents (e.g., source documents, 
regulatory documents, data collection instruments, case report forms). The investigator will 
ensure that the study monitor, or any other compliance or QA reviewer is given access to 
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all study-related documents and study-related facilities.
12.4 Quality Assurance and Quality Control
In addition to the Study Monitoring component of this protocol, Quality Assurance (QA) will 
be implemented to assess compliance with GCP and applicable regulatory requirements. 
Data or documentation audited shall be assessed for compliance to the protocol, accuracy 
in relation to source documents and compliance to applicable regulations.
12.5 Data Handling and Record Keeping
12.5.1 Data Collection and Management Responsibilities
Data collection is the responsibility of the study staff under the supervision of the PI. The PI 
is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data 
reported.
All research data (including unanticipated events data) will be entered into Velos and 
RedCap, HIPAA AND 21 CFR Part 11-compliant data capture systems provided by the 
University of Miami. These data systems include password protection and internal quality 
checks, such as automatic range checks, to identify data that appear inconsistent, 
incomplete, or inaccurate.
12.5.2 Study Records Retention
All records and documents relating to research studies and participants must be kept 
confidential to the extent permitted by law; however, records and documents shall be 
available in a timely manner to the University authorized employees or other agents 
authorized by the University including IRB members and HSRO staff and appropriate 
governmental agencies.
Although PIs are responsible for the creation and maintenance of research records and 
documents, such records and documents (including data collected pursuant to research) 
are the property of the University. Until the temporal requirements for record/document 
retention are met, investigators or others may not remove or destroy research records or 
documents (or copies of such records or documents) without written permission from the 
Vice Provost of Research. This permission requirement extends to investigators leaving 
the University even if they plan to continue the research at another institution.
12.6 Compliance with Protocol
The investigator/institution should conduct the study in compliance with the protocol agreed 
to by the sponsor and, if required, by the regulatory authorities and which was given 
approval opinion by the IRB.
The investigator should not implement any deviation from, or changes of the protocol 
without agreement by the sponsor if applicable, and prior review and documented approval 
opinion from the IRB of an amendment, except where necessary to eliminate an immediate 
hazard to subjects, or when the changes involves only logistical or administrative aspects 
of the study (e.g. change in monitors, change of telephone numbers).
The investigator, or designee, should document and explain any deviation from the 
approved protocol.
The investigator may implement a deviation from, or change of, the protocol to eliminate 
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an immediate hazard to subjects without prior IRB approval opinion. As soon as possible, 
the implemented deviation or change, the reasons for it, and if appropriate, the proposed 
protocol amendments should be submitted:
a. To the IRB for review and approval opinion;
b. To the funding agency for agreement, if required,
c.
To the regulatory authorities
12.7 Publication and Data Sharing
This study will be conducted in accordance with the following publication and data sharing 
policies and regulations.
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of 
NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results 
Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and 
results information from this trial will be submitted to ClinicalTrials.gov. In addition, every 
attempt will be made to publish results in peer-reviewed journals. Data from this study may 
be requested from other researchers by contacting the PI. Considerations for ensuring 
confidentiality of these shared data are described in Section Confidentiality.
12.8 Conflict of Interest Policy
The independence of this study from any actual or perceived influence is critical. Therefore, 
any actual conflict of interest of persons who have a role in the design, conduct, analysis, 
publication, or any aspect of this study will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts 
managed in a way that is appropriate to their participation in the design and conduct of this 
research. The study leadership in conjunction with the National Institute on Minority Health 
and Health Disparities has established policies and procedures for all study group members 
to disclose all conflicts of interest and will establish a mechanism for the management of 
all reported dualities of interest.
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14
REFERENCES
1.
Reid E, Suneja G, Ambinder RF, et al. Cancer in people living with HIV, version 1.2018, 
NCCN clinical practice guidelines in oncology. Journal of the National Comprehensive 
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