Self-Sampling to Optimize Anal Lesion Outcomes (SOLO) Pilot
Phase: NA
Conditions: Squamous Cell Carcinoma of the Anus
Sponsor: Medical College of Wisconsin

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Self-sampling to Optimize anal Lesion Outcomes (SOLO) Pilot 
 
 
 
 
Short Title 
SOLO Pilot 
 
 
 
 
Pilot Study Principal Investigator 
Alan G. Nyitray, PhD 
 
 
 
ClinicalTrials.gov Number 
NCT07085845 
 
 
 
 
Version 1.2 Pilot 
10SEP2025 
 
 
 
Proprietary and Confidential 
The information in this document is considered privileged and confidential and may not be 
disclosed to others except to the extent necessary to obtain Institutional Review Board approval 
and informed consent, or as required by federal and state laws. Persons to whom this 
information is disclosed should be informed that this information is privileged and confidential 
and that it should not be further disclosed. 
 

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PILOT STUDY INVESTIGATORS’ CONTACT INFORMATION 
PILOT STUDY FUNDING 
Pilot is supported by the parent SOLO study which is funded by the National Cancer 
Institute (R01CA298844)  
 
 
Project Long Title: Self-sampling to Optimize anal Lesion Outcomes (SOLO) Pilot 
MCW Protocol No.: PRO00054186 (for parent SOLO study) 
Principal Investigator: 
Alan G. Nyitray, PhD  
Associate Professor Epidemiology 
Center for Cancer Discovery 
Division of Community Health and Intervention Research 
Department of Psychiatry and Behavioral Medicine 
Medical College of Wisconsin 
8701 Watertown Plank Road, N4643 
Milwaukee WI 53189 
Phone: 414-955-7701 
Email: anyitray@mcw.edu 

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VERSION HISTORY 
Date Submitted 
Date Approved 
Version 
Revisions 
Author 
22MAY2025 
15JUL2025 
1.0 Pilot 
None: This is the initial pilot 
protocol sent to the MCW IRB. 
Nyitray AG 
25JUL2025 
30JUL2025 
Amendment 
to 
the 
ICF, 
protocol, and smartform to 
notify individuals that we will 
collect their street address to 
support payment using the 
MCW visa card. 
10SEP2025 
12SEP2025 
-Add letter to participants who 
receive inadequate / 
unsatisfactory results 
-Modify letter to participants 
who receive an abnormal 
cytology result with HPV test 
results. 
-Change address of PI to new 
office address 
 
 

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Table of Contents 
PILOT STUDY INVESTIGATORS’ CONTACT INFORMATION ................................................ 2 
PILOT STUDY FUNDING .......................................................................................................... 2 
VERSION HISTORY .................................................................................................................. 3 
PILOT PROTOCOL SUMMARY ................................................................................................ 7 
LIST OF ABBREVIATIONS ....................................................................................................... 9 
A 
Background and Rationale ..........................................................................................10 
B 
Pilot Study Objective and Endpoints ..........................................................................11 
B.1 
Pilot Study Objective ................................................................................................11 
B.2 
Pilot Study Endpoints ...............................................................................................11 
C 
Pilot Study Eligibility ................................................................................................11 
C.1 
Inclusion Criteria ..........................................................................................................11 
C.2 
Exclusion Criteria .....................................................................................................12 
D 
Pilot Study Accrual Goals and Study Duration ..........................................................12 
E 
Subject Recruitment and Registration ........................................................................12 
E.1 
Recruitment ...............................................................................................................12 
E.2 
Consenting ................................................................................................................12 
F 
Pilot Study Design and Intervention............................................................................13 
F.1 
Study Design .............................................................................................................13 
F.2 
Randomization ..........................................................................................................13 
F.3 
Cytology Sampling ...................................................................................................13 
F.4 
Kit Processing, Cytopathology, and Genotyping ...................................................14 
F.5 
Subject Withdrawal Criteria......................................................................................14 
F.6 
End of Pilot Study Definition ....................................................................................15 
G 
Pilot Study Team, Assessments, and Procedures .....................................................15 
G.1 
Pilot Study Team Structure ......................................................................................15 
G.2 
Pilot Study Schedule of Events ...............................................................................16 
G.3 
Pilot Study Procedures to be Conducted by Site ...................................................16 
H 
Statistical and Epidemiological Considerations ........................................................17 
H.1 
Pilot Study Primary Endpoints .................................................................................17 

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H.2 
Power for Endpoints .................................................................................................17 
H.3 
Analysis Plan ............................................................................................................17 
I 
ADVERSE EVENTS AND OTHER REPORTABLE INCIDENTS ....................................18 
I.1.1 
Adverse Event (AE) ...................................................................................................18 
I.1.2 
Serious Adverse Event (SAE) ..................................................................................19 
I.1.3 
Attribution of an Adverse Event ..............................................................................19 
I.2 
Expectedness of an Adverse Event .........................................................................20 
I.3 
Collection and Reporting Requirements for Adverse and Serious Adverse Events
 
20 
I.4 
Institutional ...............................................................................................................20 
Table 1. AE and SAE Reporting Requirements .....................................................................21 
I.5 Unanticipated Problem Involving Risk to Subject or Other (UPIRSO) ........................21 
I.6 Participant Complaints ...................................................................................................21 
I.7 Protocol Deviations ........................................................................................................22 
I.7.1 Definitions ........................................................................................................................22 
I.7.2 Reporting Protocol Deviations .......................................................................................22 
J 
DATA AND SAFETY MONITORING PLAN ...................................................................22 
K 
REGULATORY COMPLIANCE, ETHICS, AND STUDY MANAGEMENT ......................22 
K.1 
Ethical Standard ........................................................................................................23 
K.2 
Regulatory Compliance ............................................................................................23 
K.3 
Staff Training .............................................................................................................23 
K.3.1 Informed Consent Process ......................................................................................23 
K.4 
Subject Confidentiality and Access to Source Documents and Data ...................24 
K.5 
Risk-Benefit Assessment .........................................................................................24 
K.5.1 
Potential Risks ..........................................................................................................24 
K.5.2 
Potential Benefits ......................................................................................................24 
K.6 
Protection of Human Subjects .................................................................................25 
K.6.1 
Protection from Unnecessary Harm ........................................................................25 
K.6.2 
Protection of Privacy ................................................................................................25 
K.6.3 
Protection Against Additional Risks .......................................................................25 
K.7 
Required Education on the Protection of Human Subjects ...................................26 

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K.8 
Changes in the Protocol ...........................................................................................26 
K.9 
Investigator Compliance ..........................................................................................26 
L 
DATA HANDLING AND RECORD KEEPING ................................................................27 
 
 
 
 

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PILOT PROTOCOL SUMMARY 
Title 
Self-sampling to Optimize anal Lesion Outcomes (SOLO) Pilot 
Principal Investigator 
Alan G. Nyitray, PhD 
Pilot Study Site 
Milwaukee, WI   
a. Medical College of Wisconsin (MCW) Cancer Center 
/ MCW Center for AIDS Intervention Research will 
enroll, randomize, collect data, and analyze all pilot 
data. 
b. Wisconsin Diagnostic Labs will perform 
cytopathology and HPV reflex testing for anal 
cytology swabs collected. 
 
Tampa, FL – Moffitt Cancer Center will conduct HPV genotyping on 
all swabs used in the pilot. 
Clinical Trial Phase 
Phase I 
Pilot Study Population 
Sexual and gender minorities (SGM) who have sex with men living 
with and without HIV. 
Primary Objective 
To ensure the use of a swab in SOLO that is comparable to the 
originally proposed swab for SOLO, determine the preliminary 
performance characteristics of the new NF swab in a feasibility 
study. 
Primary Endpoints 
1. A comparison of the proportions of individuals who collect 
squamocolumnar cells when using a NF swab with a 5 cm 
vs. a 3 cm insertion depth. 
2. A comparison of the proportions of individuals who collect 
cytologically adequate specimens when using a NF swab 
with a 5 cm vs. a 3 cm insertion depth. 
3. A comparison of the proportions of individuals who collect 
adequate specimens for molecular genotyping when using 
the new NF swab vs. the original swab used in the PAC Self-
Swab Study. 
4. A comparison of the acceptability and pain performance of 
the new NF swab vs. the original swab and the 5 cm and 3 
cm insertion depth. 
Pilot Study Design 
Two-arm, randomized controlled trial 
Eligibility Criteria 
Eligibility See section 3.0 
Pilot Study Intervention Swabbing with a new nylon-flocked swab with an insertion depth of 
5 cm. 

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Number of Subjects 
60 participants 
Estimated Time to 
Complete Accrual 
Approximately 2 months 
Subject Participation 
Duration 
Approximately 30 minutes 
Estimated Time to 
Primary Completion 
Approximately 4 months 
Estimated Time to Pilot 
Study Completion 
Within 6 months of accrual initiation. 
 
 
 
 

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LIST OF ABBREVIATIONS 
AE 
adverse event 
CASI 
computer-assisted self-interview 
HPV 
human papillomavirus 
IRB 
institutional review board 
NF 
nylon-flocked 
PHI 
protected health information 
PAC 
Prevent Anal Cancer 
SAE 
serious adverse event 
SCJ 
squamocolumnar junction 
SGM 
sexual and gender minorities 
SOLO 
self-sampling to optimize anal lesion outcomes 
UPIRSO 
unanticipated problem involving risk to subject or other 
 
 
 
 
 

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A 
Background and Rationale 
An important component of SOLO is the testing of two different kinds of swabs, nylon-flocked and 
Dacron, for molecular and cytological adequacy and end user acceptability within a self-sampling 
and clinician-sampling context. We chose a nylon-flocked (NF) swab for use in SOLO given its 
high adequacy in our prior study: the Prevent Anal Cancer (PAC) Self-Swab Study (R01 
CA215403, PI: Nyitray); however, this NF swab is unlikely to be available for clinical use in the 
future due to recent changes in the manufacturer’s priorities. Since SOLO results need to be 
widely generalizable and relevant to anal cancer screening, we need to use a different NF swab 
model and assess its cytological and molecular performance characteristics in a pilot study before 
beginning SOLO. Given our prior success with a NF swab developed by Copan Italia s.p.a. 
(Brescia, Italy) we will test the feasibility of a new Copan swab developed for anal cancer 
screening. 
We will test the cytological performance of the swab at two insertion depths, 3 cm and 5 cm, to 
determine which insertion depth is better at collecting cells from the squamocolumnar junction 
(SCJ), an anatomic site that is particularly vulnerable to carcinogenic transformation. We 
hypothesize that the 5 cm insertion will result in a higher quality specimen with cells from the SCJ. 
However, the deeper swab insertion may affect end user acceptability without increasing 
adequacy or quality.  
We will test the new swab with 60 individuals who were participants in the PAC Self-Swab Study 
and who agreed be contacted for follow-up studies. Individuals will be randomized to use the new 
NF swab with either a 3 cm or 5 cm insertion depth. After consenting, individuals will receive 
written instructions and then conduct the self-sampling in private. Staff will take the swab in 
PreservCyt to the Medical College of Wisconsin Tissue Bank where it will be aliquoted for 
assessment of cytology and reflex HIV testing at Wisconsin Diagnostic Labs and HPV genotype 
at Moffitt Cancer Center. We have one objective: To ensure the use of a swab in SOLO that is 
comparable to the originally proposed swab for SOLO, determine the preliminary performance 
characteristics of the new NF swab. We have three hypotheses within the objective: 
• 
H1: A higher proportion of the new NF swabs with 5 cm insertion will have SCJ cells 
compared to the NF swab for 3 cm insertion. 
• 
H2: A higher proportion of the new NF swabs with 5 cm insertion will be adequate for 
cytopathology interpretation compared to the NF swab for 3 cm insertion. 
• 
H3: The new NF swab will have molecular adequacy that is commensurate with the 
original NF swab used in the PAC Self-Swab Study.  
• 
H4: The new NF swab will have acceptability/pain performance commensurate with the 
originally proposed NF swab and the 5 cm insertion depth will have similar 
acceptability/pain performance as the 3 cm insertion depth. 
Our expected outcomes are cytological and molecular preliminary performance characteristics of 
the new NF swab in addition to user acceptability. These outcomes will help ensure the use of a 
viable swab in SOLO that is relevant in future anal cancer screening programs. 

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B 
Pilot Study Objective and Endpoints 
B.1 
Pilot Study Objective 
To ensure the use of a swab in SOLO that is comparable to the originally proposed swab for 
SOLO, determine the preliminary performance characteristics of the new NF swab.  
B.2 
Pilot Study Endpoints 
1. A comparison of the proportions of individuals who collect squamocolumnar cells when 
using a NF swab with a 5 cm vs. a 3 cm insertion depth. 
2. A comparison of the proportions of individuals who collect cytologically adequate 
specimens when using a NF swab with a 5 cm vs. a 3 cm insertion depth. 
3. A comparison of the proportions of individuals who collect adequate specimens for 
molecular genotyping when using the new NF swab vs. the original swab used in the 
PAC Self-Swab Study. 
4. A comparison of the acceptability and pain performance of the new NF swab vs. the 
original swab and the 5 cm and 3 cm insertion depth. 
C Pilot Study Eligibility 
The pilot study team will evaluate eligibility according to the following criteria. Individuals must 
meet all inclusion and none of the exclusion criteria to be registered on to the pilot study. Any 
questions or concerns regarding eligibility should be directed to the PI, Dr. Nyitray 
(anyitray@mcw.edu). 
C.1 
Inclusion Criteria 
A potential pilot study subject who meets all of the following inclusion criteria is eligible to 
participate in the pilot study. Note that these criteria apply regardless of HPV vaccination status 
or disability status. 
1. Aged ≥ 35 years. 
2. Must be either: 
a) A cisgender or transgender sexual minority man, or 
b) A transgender woman who has sex with men. 
3. Resides in the Milwaukee metropolitan area. 
4. Speak and understand English. 
5. Ability to understand a written informed consent document, and the willingness to sign it. 
NOTE: this inclusion criterion is mandatory unless a waiver of the informed consent 
process and document is being requested. 

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C.2 
Exclusion Criteria 
A potential pilot study subject who meets any of the following exclusion criteria is ineligible to 
participate in the pilot study. 
1. Presence of any contraindicating severe anal disease or condition, e.g., anal stenosis. 
D 
Pilot Study Accrual Goals and Study Duration 
A total of 60 SGM will be recruited from the greater Milwaukee metropolitan area. Accrual will last 
for approximately 2 months.  
The pilot study will reach pilot study completion within 4 months of the beginning of accrual. 
E 
Subject Recruitment and Registration 
E.1 
Recruitment 
Potential SGM participants will be recruited first from the group of individuals who consented into 
the PAC Self-Swab Study (PRO00032999) and then indicated an interest in a follow-up study 
(n=126). We will enroll those aged ≥ 35 years. Persons reporting no sex with men during the last 
five years will be included if they identify as an SGM individual. 
If the initial recruitment results in fewer than 60 people, we will recruit by other means: 
1. Advertising on geo-located social/dating apps commonly used by older SGM, e.g., Scruff, 
Growlr, and Jack’d. We will run advertisements on the apps using a 25-mile radius from 
the city center in Milwaukee to reach people throughout the city’s metro area.  
2. The use of print materials in gay-friendly business and a website (mindyourbehind.org) 
used in the PAC Self-Swab Study. The material will mention the study is recruiting for an 
anal cancer screening study. 
Recruitment material will be approved by an MCW Institutional Review Board (IRB). The SOLO 
Study Coordinator in Milwaukee will oversee recruitment activity. We will record recruitment 
activities. 
E.2 
Consenting 
Potential participants will be screened using an online computer-assisted self-interview (CASI). 
Those who are eligible will be asked to leave contact information. Study staff will contact eligible 
individuals, provide an overview of the pilot study, and invite the individual to a schedule a 
consenting session which will be followed by the cytology screening at the Curative Building on 
the MCW campus. Those who are not eligible will be thanked for their interest and provided links 
to vetted anal cancer education websites. Minimal Protected Health Information (PHI) will be 
collected in the eligibility survey. 
At the consenting session staff will first ask the eligible individual to confirm their email address, 
name, and birthdate. The session will occur in a closed office and include information about 1) 
high rates of anal cancer in SGM, 2) anal cancer screening and the role of swabbing, 3) pilot study 
activities, and 4) the potential harms and benefits of participation. The staff member obtaining 
consent will emphasize that participation is voluntary and that participants can choose to join and, 

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if desired, leave the pilot study at any point without any repercussions. The ICF will also notify 
individuals that we will collect their street address to support payment using the MCW visa card. 
Prior to obtaining their signature, the staff member will ask the individual if they have any 
questions and, if not, to briefly review their understanding of their participation by asking simple 
questions about the pilot study to be sure the information was clearly understood. 
Individuals agreeing to provide consent will sign an ICF hard copy. It will be photocopied with the 
copy given to the participant. 
F 
Pilot Study Design and Intervention 
F.1 
Study Design 
This pilot feasibility study will use a 
randomized controlled trial design. 
Figure 1 illustrates the pilot study 
design. 
F.2 
Randomization 
Consented 
individuals 
will 
be 
randomized to either the intervention 
(5 cm insertion depth) or the control (3 
cm insertion depth) arm using a 
number generator in REDCap. If the 
number is .0000 to .4999, the 
individual will be assigned to the 
intervention condition. If the number is 
.5000 to .9999, the individual will be 
assigned to the control condition.  
The participant is considered enrolled 
in the pilot study when they sign a 
consent form and are randomized to 
either the intervention or control arm. 
F.3 
Cytology Sampling 
The cytology sampling will occur immediately after randomization. In preparation, staff will have 
created two cytology collection kits (labeled as Kit A or Kit B) each containing swabbing 
instructions, a swab, ThinPrep vial, and gloves. Kit A and Kit B will have identical contents except 
that Kit A will have a swab with a colored mark 5 cm from the swab tip and Kit B will have a swab 
with a colored mark 3 cm from the swab tip.  
Clinical staff will review the sampling instructions with the individual and then show them to a 
bathroom in Curative with a locking door where they will do the self-sampling with sampling 
instructions available. Individuals will be instructed to take the cap off the vial, put on gloves, 
remove the swab from the packaging, hold the swab at the marker on the shaft of the swab (which 
corresponds to either 3 cm or 5 cm), get in a comfortable position, insert the swab gently all the 
way to the mark, begin to twirl the swab clockwise and counterclockwise, and apply pressure to 
the anal canal walls, while removing the swab as they count slowly to 10. 
 
Figure 1. Pilot study schema.  

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After swabbing, the participant will put the swab in 20 mL of PreservCyt® solution, agitate and 
twirl it in the solution for 10 seconds, and then remove the swab while pressing against the sides 
of the vial. The swab will be discarded, the vial cap replaced, and the vial inserted back into the 
Kit and returned to the staff member. Participants will be instructed to wash their hands. 
Participants will complete a short CASI in the consenting office in private on their phone (or hard 
copy if they prefer) immediately after their self-sampling to assess the swabbing experience, 
including discomfort and pain, using validated questions. Clinic staff will assist individuals with 
technology limitations. Participants will then receive $40. 
For those who do not show up for their consenting and cytology appointment, a member of the 
study team will contact them twice to reschedule within 2 months of their original appointment 
date. 
F.4 
Kit Processing, Cytopathology, and Genotyping 
Staff will walk the cytology kit to the MCW Tissue Bank who will process the PreservCyt liquid by 
removing a 0.5 mL aliquot for HPV genotyping. The remaining specimen will be kept in the original 
vial for cytopathology. 
The remaining specimen will be delivered to Wisconsin Diagnostic Labs (Milwaukee, Wisconsin) 
which uses the COBAS 4800 system for cytology reading. Cytology findings will use the Bethesda 
System39 with classification as follows: negative for intraepithelial lesions; atypical squamous cells 
of undetermined significance (ASCUS) or atypical squamous cells, cannot rule out high-grade 
squamous intraepithelial lesion; low-grade squamous intraepithelial lesion; or high-grade 
squamous intraepithelial lesion. Reflex HPV testing will be conducted for all abnormal (i.e., ≥ 
ASCUS) specimens. 
Anal cytology is approved for use in anal cancer screening. Thus, individuals will be given the 
cytopathology results (either abnormal, normal, or inadequate/unsatisfactory) and any HPV reflex 
testing results through the individual’s preferred mode of communication; however, regardless of 
the result, all individuals will be encouraged to seek medical advice about their results. Currently, 
there is no FDA approval for anal self-sampling, thus, the cytology results should not be used to 
guide care or referrals. 
The 0.5 mL aliquot will be batch-shipped to the Moffitt Cancer Center for HPV genotyping. Moffitt 
will extract DNA from the 0.5 mL aliquot (MDx Media Kit, QIAGEN) and then use the SPH10-LiPA25 
kit according to the manufacturer’s instructions to first test for adequacy of the specimen, defined 
by the presence of human RNase P, and second to test for HPV DNA, and HPV genotypes.34 
HPV genotyping results from Moffitt will not be available for several months after the cytology 
screening since the specimens will be batched shipped only after all 60 individuals complete the 
screening. In addition, participants with abnormal cytology results will also have HPV reflex testing 
which would indicate if a high-risk HPV type is detected in the cytology specimen. Thus, the 
results of the HPV genotyping will not be provided to the participant after genotyping is completed 
and results are available. 
F.5 
Subject Withdrawal Criteria 
F.5.1 Subject-initiated Withdrawal 
A participant may decide to withdraw from the study at any time. 

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F.5.2 Investigator-initiated Withdrawal 
The investigator may withdraw a participant whenever continued participation is no longer in 
their best interests. Reasons for withdrawing a participant include, but are not limited to, a 
participant’s noncompliance, or simply significant uncertainty on the part of the investigator that 
continued participation is prudent. 
F.5.3 Replacement Policy and Data Usage 
Individuals who sign the informed consent form and are randomized, but subsequently withdraw, 
will be replaced. Data collected from individuals that withdraw or discontinue from the study will 
be used.  
F.6 
End of Pilot Study Definition 
An individual is considered to have completed the study if they have completed the post-cytology 
survey. Those who participated in the pilot study will not be eligible or involved in the parent SOLO 
study. 
G 
Pilot Study Team, Assessments, and Procedures 
G.1 
Pilot Study Team Structure 
 
 
 
INVESTIGATOR 
NAME 
DISCIPLINE 
UNIQUE ROLE ON PILOT STUDY 
Nyitray, PhD 
Epidemiology 
PI 
Project Coordinator 
Brzezinski 
Data Analysis 
Data Analysis: Jenna Nitkowski, PhD 
Data Management: Lisa Rein, MS & Farheen Chunara, MS 
Data Repository Site: MCW 

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G.2 
Pilot Study Schedule of Events 
Procedures and Events 
Recruitment 
Consent & 
Cytology 
Appointment  
End of Pilot 
Study  
Eligibility Screening 
X 
 
 
Informed Consent 
 
X 
 
Randomization and Enrollment1 
 
X 
 
INTERVENTION 
Self-sampling with a 5 cm nylon-flocked swab 
 
X 
 
CONTROL 
Self-sampling with a 3 cm nylon-flocked swab 
 
X 
 
RESEARCH PROCEDURES 
Adverse Events Collection2 
(SAEs only) 
AEs collected from the start of 
the intervention to 30 days after 
the end of the intervention 
Cytology Appointment Computer-Assisted Self-
Interview (CASI)3 
 
 
X 
1 After an individual has signed the informed consent form and been randomized to one of the 
study arms, they are considered enrolled in the study. 
2 Refer to Section 7.2 for adverse event (AE) collection and reporting requirements. 
3 The cytology CASI will be given to participants immediately after they complete cytology 
collection. 
G.3 
Pilot Study Procedures to be Conducted by Site 
Activity 
Milwaukee 
Tampa 
Medical College of 
Wisconsin 
Wisconsin Diagnostic 
Labs 
Moffitt Cancer 
Center 
Funding 
Primary Award 
Service contract 
Service contract 
Recruitment 
X 
- 
- 
Consenting 
X 
- 
- 
Randomization 
X 
- 
- 
Participant interaction 
X 
- 
- 
Obtaining PHI 
X 
- 
- 
Surveying 
X 
- 
- 
Access to PHI 
X 
X 
- 
Supplying cytology kits 
X 
- 
- 
Cytology reading 
- 
X 
- 
HPV genotyping 
- 
- 
X 

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Activity 
Milwaukee 
Tampa 
Medical College of 
Wisconsin 
Wisconsin Diagnostic 
Labs 
Moffitt Cancer 
Center 
Key personnel 
X 
- 
- 
H 
Statistical and Epidemiological Considerations 
H.1 
Pilot Study Primary Endpoints 
1. A comparison of the proportions of individuals who collect squamocolumnar cells when 
using a NF swab with a 5 cm vs. a 3 cm insertion depth. 
2. A comparison of the proportions of individuals who collect cytologically adequate 
specimens when using a NF swab with a 5 cm vs. a 3 cm insertion depth. 
3. A comparison of the proportions of individuals who collect adequate specimens for 
molecular genotyping when using the new NF swab vs. the original swab used in the 
PAC Self-Swab Study. 
4. A comparison of the acceptability and pain performance of the new NF swab vs. the 
original swab. 
H.2 
Power for Endpoints 
This pilot feasibility study does not have the power to make conclusive statements about the 
study endpoints.  
H.3 
Analysis Plan 
H.3.1 Preliminary analyses 
We will assess the success of randomization. For surveys, we will calculate item response rates 
for each arm of the study and for subgroups based on HIV status, race/ethnicity, and education.43  
After evaluating missing survey data, we will use multiple imputation44 to maintain the maximum 
sample size if data are missing at random. Sensitivity analyses will compare results if data are 
not missing at random.45  
In each study arm, we will analyze frequencies of survey items, demographics, other domains, 
adverse events, and serious adverse events. 
H.3.2 Primary Endpoint 1 
The presence of cells from the squamocolumnar junction will be assessed in each specimen 
(Yes/No). Proportions of specimens with squamocolumnar cells will be compared for the 5 cm 
and 3 cm swabs.  
H.3.3 Primary Endpoint 2 
Cytologic adequacy is defined as the presence of ~2000-3000 nucleated squamous cells. 
Proportions of adequate specimens will be compared for the 5 cm and 3 cm swabs. 

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H.3.4 Primary Endpoint 3 
The PAC Self-Swab Study molecular adequacy estimates, given study size, were quite precise 
with narrow confidence limits. The estimates derived from this pilot study will have wider 
confidence limits. The original and new swabs will be considered to have commensurate 
molecular adequacy if the exact confidence limits of the original PAC Self-Swab Study swab are 
covered by the exact confidence limits of the piloted swab. 
H.3.5 Primary Endpoint 4 
Each participant will receive a short cytology CASI immediately after the cytology screening to 
rate their acceptability of the cytology screening on a Likert scale and pain on a visual scale.37 
Proportions of individuals’ ratings for adequacy and pain will be compared for  
1) the 5 cm and 3 cm swabs, and 
2) the new NF swab vs the original swab. 
 
The Exact 95% confidence limits surrounding proportions for acceptability and pain will be 
compared for overlap for 5 cm vs 3 cm insertion depths. 
The comparison of acceptability/pain between the new NF swab and the original swab will be 
analyzed as in H.3.4. 
I 
ADVERSE EVENTS AND OTHER REPORTABLE INCIDENTS 
This study is low risk to participants due to its design and the nature of the intervention being 
tested (i.e., cancer screening and behavioral interventions). No investigational drugs or devices 
are involved. 
Even though this study does not test a therapeutic intervention, this study will follow the Cancer 
Therapy Evaluation Program (CTEP) guidelines for reporting of adverse events. All expedited 
adverse event reports are required to be submitted to the MCW Institutional Review Board (IRB). 
I.1  
Definitions 
I.1.1 
Adverse Event (AE) 
Any untoward medical occurrence in an individual or clinical investigation subject administered 
an interventional product and which does not necessarily have to have a causal relationship with 
this intervention. 
This study will utilize the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 
5.0, located on the CTEP web site: 
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm 
AEs may be spontaneously reported by the subject and/or in response to an open question from 
study personnel or revealed by observation, physical examination or other diagnostic procedures. 

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I.1.2 
Serious Adverse Event (SAE) 
 
Serious Adverse Event (SAE) means any untoward medical occurrence that results in any of the 
following outcomes: 
• 
Death. Results in death. 
• 
Life-threatening. Is life-threatening (refers to an AE in which the participant was at risk of 
death at the time of the event. It does not refer to an event which hypothetically might have 
caused death if it were more severe). 
• 
Hospitalization. Requires inpatient hospitalization ≥24 hours or prolongation of an 
existing hospitalization. 
• 
Disability/incapacity. Results in persistent or significant disability or incapacity. 
(Disability is defined as a substantial disruption of a person’s ability to conduct normal life 
functions). 
• 
Pregnancy 
• 
Medically important event. This refers to an AE that may not result in death, be 
immediately life-threatening, or require hospitalization, but may be considered serious 
when, based on appropriate medical judgment, may jeopardize the participant, require 
medical or surgical intervention to prevent one of the outcomes listed above, or involves 
suspected transmission via a medicinal product of an infectious agent. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an 
emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse; any organism, 
virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform 
encephalopathy), pathogenic or nonpathogenic, is considered an infectious agent. 
I.1.3 
Attribution of an Adverse Event 
An assessment of the relationship between the adverse event and the medical intervention, using 
the following categories:  
• 
Definitely Related: The AE is clearly related to the intervention. There is clear evidence 
to suggest a causal relationship, and other possible contributing factors can be ruled out.  
• 
Probably Related: The AE is likely related to the intervention. There is evidence to 
suggest a causal relationship, and the influence of other factors is unlikely.  
• 
Possibly Related: The AE may be related to the intervention. There is some evidence to 
suggest a causal relationship (e.g., the event occurred within a reasonable time after 
administration of the trial medication). However, the influence of other factors may have 
contributed to the event (e.g., the subject’s clinical condition, other concomitant events).  
• 
Unlikely: The AE is doubtfully related to the intervention. A clinical event, including an 
abnormal laboratory test result, whose temporal relationship to drug administration makes 
a causal relationship improbable (e.g., the event did not occur within a reasonable time 
after administration of the trial medication) and in which other drugs or chemicals or 
underlying disease provides plausible explanations (e.g., the subject’s clinical condition, 
other concomitant treatments). 

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• 
Unrelated: The AE is clearly NOT related to the intervention. The AE is completely 
independent of study drug administration, and/or evidence exists that the event is 
definitely related to another etiology.  
I.2 
Expectedness of an Adverse Event 
The study investigator will be responsible for determining whether an AE is expected or 
unexpected as indicated in the protocol. An AE will be considered unexpected if the nature, 
severity, or frequency of the event is not consistent with the risk information previously described 
for the study intervention. 
I.3 
Collection and Reporting Requirements for Adverse and Serious Adverse Events 
AEs that are Grade 3 or higher and are related (possibly, probably, or definitely) to the intervention 
will be collected from the time the subject starts the intervention through conclusion of the 
intervention, which comprises the cytology self-sampling and CASI. AEs will be tracked and 
followed until resolution, the subject withdraws consent or is lost to follow-up (including individuals 
who discontinue early). SAEs that occur after the subject has signed the consent form through 30 
days after the conclusion of the intervention will be collected. Adverse events collected per the 
protocol should be followed with appropriate medical management. 
AEs will be collected as reported. In the case of an adverse event, participants will be instructed 
to contact study staff and/or investigators as soon as possible, ideally within 24 hours. All Grade 
3 and higher adverse events will be discussed with the PI and appropriate study staff. The PI will 
oversee that all AEs, SAEs, and UPIRSOs, are reported appropriately. Information about adverse 
events experienced by study individuals will be monitored by the following means:  
• 
Report given by study participants to study staff, either in person or by telephone.  
• 
Report given to study staff by study participants’ family or friends, either in person or by 
telephone.  
• 
Report by the participant’s physician or other health care provider involved in the subject’s 
care.  
• 
Report from a hospital or other healthcare facility where the study participant is being 
treated for the serious adverse event. 
• 
Other persons who may have knowledge of such a serious adverse event.  
The PI will consult with other investigator(s) to assign event attribution category (unrelated, 
unlikely, possible, probable, or definite).  
I.4 
Institutional 
Adverse and serious adverse events are not expected. If such events occur, AEs and SAEs will 
be reported per MCW Institutional Review Board (IRB) guidelines and the MCWCC Data and 
Safety Monitoring Plan (DSMP). 
Institutional Review Board (IRB). For routine reporting, the events will be reported to the IRB as 
part of the annual continuing progress report. Events requiring expedited reporting to the IRB 
include: 1) any AE or SAE that is unexpected, related (possibly, probably, or definitely) to the 

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research, and places research participants or others at a greater risk of physical or psychological 
harm than was previously known or recognized, and 2) unanticipated problems or any incident, 
experience, or outcome that are unexpected with reference to the procedure and risks defined in 
the initial IRB application, related (possibly, probably, or definitely) to participation in the research 
project, and suggests the research places participants or others at greater risk or harm than was 
previously known or recognized. Events that meet expedited reporting requirements must be 
reported to the IRB no later than five calendar days after the study team becomes aware of the 
event.  
Data Safety and Monitoring Committee (DSMC). The study team will report AEs and SAEs to the 
DSMC according to Table 1. For routine reporting, the events will be reported at the time of 
scheduled monitoring. For expedited reporting, the study team must notify the DSMC via email 
(DSMC_MCWCC@mcw.edu) within five days of the team’s knowledge. This email should include 
the subject ID, date of event, grade, relatedness, expectedness, and a short narrative. 
Table 1. DSMC AE and SAE Reporting Requirements 
I.5 Unanticipated Problem Involving Risk to Subject or Other (UPIRSO) 
Unanticipated problems will be submitted to the IRB of record according to local policies and 
procedures. An unanticipated problem is one that is unexpected, possibly, probably, or definitely 
related to the research described in the paragraph above and suggests the research places 
research participants or others at a greater risk of physical or psychological harm than was 
previously known or recognized.  
Since this is an investigator-initiated study, the principal investigator is responsible for reporting 
unanticipated problems to any regulatory agency and to the IRB. Any unanticipated problems 
detected will be promptly documented by the study coordinator and submitted to the IRB within 
five calendar days of study staff’s knowledge. These reviews would pick up any unanticipated 
negative trends among participants. 
I.6 Participant Complaints 
If a complaint is received by anyone on the study staff, it will be discussed with the study staff and 
will be addressed on a case-by-case basis. The PI will be notified of any complaints. Complaints 
will be reported to the IRB if indicated.  
If the subject has questions about their rights as a study subject, wants to report any problems or 
complaints, obtain information about the study or offer input, the subject can call the Medical 
College of Wisconsin/Froedtert Hospital research subject advocate at 414-955-8844. This 
information is provided to the subject in their consent. 
Attribution 
SAE 
AE 
Grade 1, 2 & 3 
Grade 4 and 5 
Grade 3 
Grade 4 
Expected 
Unexpected 
Expected 
Unexpected 
Expected 
Unexpected 
Expected 
Unexpected 
Possible 
Probable 
Definite 
Routine 
Review 
Expedited: 
Within 5 
calendar 
days 
Expedited: 
Within 5 
calendar 
days 
Expedited: 
Within 5 
calendar 
days 
Routine 
Review 
Expedited: 
Within 5 
calendar 
days 
Expedited: 
Within 5 
calendar 
days 
Expedited: 
Within 5 
calendar 
days 

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I.7 Protocol Deviations 
This pilot is a study of swab performance characteristics. 
I.7.1 Definitions 
• 
Protocol Deviations. A protocol deviation is any change, divergence, or departure from 
the study design or procedures of a research protocol that is under the investigator’s 
control and that has not been approved by the IRB.  
• 
Significant Protocol Deviations. Significant protocol deviations are those that increase 
the risk to participants or others, decrease potential benefits of the project, undermine the 
scientific integrity of the project, or occur more than once.  
• 
Planned Protocol Deviations. Planned protocol deviations are any temporary protocol 
deviation acknowledged by the IRB prior to its initiation. Any permanent change to the 
protocol constitutes an amendment that must be submitted to the IRB for approval prior to 
initiation.  
I.7.2 Reporting Protocol Deviations 
Any deviations from the protocol must be fully documented in the source documents. A summary 
of all protocol deviations must be reported to the DSMC at the time of scheduled monitoring. Per 
the most recent MCW Office of Research SOP, the following events meet the MCW IRB expedited 
reporting criteria; any other deviation is to be reported in a timely manner. 
• 
Significant Protocol Deviations. Examples include but are not limited to the following: 
o Any departure from the protocol (deviation or violation) where participants or others 
were harmed or might be at increased risk of harm. 
o Any departure from the protocol that compromises the integrity of the research 
data. 
o Any change made to the research without prior IRB approval in order to eliminate 
apparent immediate harm. 
• 
Planned Protocol Deviations. Planned protocol deviations that increase the risk to 
participants or others, decrease potential benefits of the project, or undermines the 
scientific integrity of the project are considered events that meet MCW’s prompt reporting 
criteria. For example, enrolling an individual who does not meet the eligibility criteria. 
J 
DATA AND SAFETY MONITORING PLAN 
The Medical College of Wisconsin (MCW) Cancer Center (MCWCC) places the highest priority 
on ensuring the safety of patients participating in clinical trials. Every cancer interventional trial 
conducted at MCW includes a plan for safety and data monitoring. 
More information can be found related to the MCWCC Data and Safety Monitoring Plan at the 
MCWCC website: https://cancer.mcw.edu/.  
This study will be reviewed by the MCWCC Data and Safety Monitoring Committee (DSMC). A 
summary of the MCWCC DSMC activities are as follows:  

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1. Periodically review progress reports and evaluate the clinical trial for safety and data 
integrity. 
2. Provide recommendations on trial continuation, suspension, or termination.  
This study was categorized as low risk by the MCW Cancer Center Scientific Review Committee. 
The DSMC will perform scheduled monitoring at a frequency commensurate with the risk level (at 
least annually), and the study will be subject to review by Cancer Center Quality Assurance staff 
according to the MCWCC Data and Safety Monitoring Plan. 
All DSMC letters will be submitted to the IRB of record as required. 
K 
REGULATORY COMPLIANCE, ETHICS, AND STUDY 
MANAGEMENT 
K.1 
Ethical Standard 
This pilot study will be conducted in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki, consistent with Good Clinical Practice (GCP) and all applicable 
regulatory requirements. 
K.2 
Regulatory Compliance 
This pilot study will be conducted in compliance with: 
• 
The protocol. 
• 
Federal regulations, as applicable, including 21 CFR 50 (Protection of Human 
Subjects/Informed Consent); 21 CFR 56 (Institutional Review Boards) and 45 CFR 46 
Subparts A (Common Rule), B (Pregnant Women, Human Fetuses and Neonates), C 
(Prisoners), and D (Children), GCP/ICH guidelines, and all applicable regulatory 
requirements. The IRB must comply with the regulations in 21 CFR 56 and applicable 
regulatory requirements. 
K.3 
Staff Training 
K.3.1 Informed Consent Process  
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in 
the pilot study and continues throughout the individual’s pilot study participation. Extensive 
discussion of risks and possible benefits of this therapy will be provided to the subjects and their 
families. Informed consent forms (ICF) describing in detail the pilot study intervention, pilot study 
procedures, and risks are given to the subject and written documentation of informed consent is 
required prior to starting intervention/administering pilot study product. 
ICFs will be IRB-approved and the subject (and legally authorized representative, if necessary) 
will be asked to read and review the document. Upon reviewing the document, the investigator 
will explain the research pilot study to the subject and answer any questions that may arise. In 
accordance with 46 CFR 46.111, the subject will sign and date the informed consent document 
prior to any procedures being done specifically for the pilot study.  

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K.4 
Subject Confidentiality and Access to Source Documents and Data 
Subject confidentiality is strictly held in trust by the principal investigator and staff. This 
confidentiality includes the information relating to participating individuals, as well as any genetic 
or biological testing. 
The pilot study protocol, documentation, data and all other information generated will be held in 
strict confidence. No information concerning the study data will be released to any unauthorized 
third party without the prior written approval of the principal investigator.  
The conditions for maintaining the confidentiality of the individuals’ records are required for the 
life of the data. These rules apply equally to any and all MCW Cancer Center (MCWCC) projects.  
The principal investigator will allow access to all source data and documents for the purposes of 
monitoring, audits, IRB review and regulatory inspections.  
The study monitor or other authorized representatives of the principal investigator may inspect all 
documents and records required to be maintained by the investigator. 
K.5 
Risk-Benefit Assessment 
K.5.1 Potential Risks 
HIV and anal cancer screening information is sensitive. All staff will have adequate training to 
appropriately handle participant data. The packaging of any needed mailings will comply with 
confidentiality standards. CASI data collection will use a web platform by REDCap with data 
stored on a secure web-based server at the Medical College of Wisconsin.  
Potential risks to participants can be divided into three areas: 1) data collection using CASI, 2) 
concerns about disclosure of confidential, sensitive information, and 3) collection of anal canal 
cells and test results. These risks are described below. 
1. CASI. This pilot study will ask sensitive questions of participants that may make some 
participants uncomfortable. 
2. Potential disclosure of confidential, sensitive information. Some people may fear that 
unauthorized persons who may discriminate might obtain personal medical information 
or otherwise cause a change in the participant’s social status or access to benefits to 
which participants would otherwise be entitled.  
3. Collection of anal canal cells and test results. Some persons may feel embarrassed 
about inserting a swab into the anal canal. The swab can be uncomfortable, and 
occasionally there can be minor bleeding. Individuals will be notified of cytology results. 
4.  
There are no alternative screening procedures that are FDA-approved for anal cancer; however, 
cytology is now recommended by national and international bodies.  
K.5.2 Potential Benefits 
There is no benefit of this research to participants. However, they will learn about anal cancer and 
receive anal cytology results. Thus, the risk of discomfort during study procedures (either physical 
discomfort during clinical procedures or psychological discomfort due to sensitive survey 

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questions) is reasonable within the context of important educational and personal health 
information gained by the participant. The knowledge gained by this research will benefit science 
by determining the utility of a 3 cm or 5 cm swab for use in the parent SOLO study. If SOLO finds 
that self-sampling supports clinic attendance, that will benefit the performance of anal cancer 
screening procedures in society. For these reasons, the potential benefits of the pilot study are 
reasonable in relation to the anticipated benefits to the pilot study participants.  
K.6 
Protection of Human Subjects 
K.6.1 Protection from Unnecessary Harm 
MCW is responsible for protecting all individuals involved in human experimentation. This is 
accomplished through the IRB mechanism and the informed consent process. The IRB reviews 
all proposed studies involving human experimentation and ensures that the subject’s rights and 
welfare are protected and that the potential benefits and/or the importance of the knowledge to 
be gained outweigh the risks to the individual. The IRB also reviews the informed consent 
document associated with each study to ensure that the consent document accurately and clearly 
communicates the nature of the research to be done and its associated risks and benefits. 
K.6.2 Protection of Privacy 
To ensure confidentiality, each participant is assigned an anonymous study ID, which is then used 
on all pilot study forms that collect participant data. Study IDs are linked to participant names and 
other private identifiable information in only one location, on an encrypted, firewall-protected, 
electronic document housed on MCW’s server. All study forms are kept on the MCW server or 
HIPAA-compliant MCW data-sharing platform and access is restricted to authorized study 
personnel. 
K.6.3 Protection Against Additional Risks 
All procedures in the proposed pilot study involve minimal risk. The SOLO pilot uses very similar 
procedures as did our prior Prevent Anal Cancer Self-Swab Study. When a participant provides 
consent, they will be thoroughly informed of all pilot study procedures, potential risks, and 
benefits, and that they can discontinue participation in the study at any time without risk to 
subsequent care at the place(s) they receive health care. The participant, in a confidential space, 
will complete the consent in-person. The PI will do the initial consents while being observed by 
the study coordinator and other study staff; thereafter, the study coordinator and other trained 
study staff will perform the consents. Before signing, we will ask participants to answer three 
simple questions that will indicate the participant has understood the consent. 
ICFs will be documented in hard copy with participant signatures kept on file in a locked cabinet 
at the Medical College of Wisconsin. 
1. Self-swabbing. When the participant performs a self-swabbing, they will be provided 
instructions written at a 6th grade reading level, modeled after already-tested self-
sampling instructions in the Prevent Anal Cancer Self-Swab Study.17  
2. Sensitive nature of questions. This pilot study will ask sensitive questions about, sexual 
behavior and disease status during the computer-assisted self-interviews. Thus, names 
will be kept separate from coded identifiers. All computers will require a password to 
access files. Computer-assisted self-interviewing will be used so participants can 
confidentially report sensitive behaviors while minimizing feelings of shame or 
embarrassment discussing sexual histories. The survey items will mainly come from the 

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PAC Self-Swab Study surveys, which, in turn, were adapted from validated cervical 
cancer screening instruments. 
3. PHI access. Access to all PHI-protected pilot study data will be limited to the PI, study 
coordinator, other trained and CITI-certified study staff, and clinicians. Data will be 
destroyed after the pilot study is completed according to federal regulations. 
Persons with HIV may be vulnerable; thus, we will ensure that the highest ethical standards will 
be respected and followed so that benefits are maximized for a diverse set of persons while harms 
are minimized for all participants. For example, we include a very wide age range of people in 
enrollment, i.e., 35 years and older.  
K.7 
Required Education on the Protection of Human Subjects 
In accordance with federal guidelines, all research personnel involved in these studies have 
completed and will periodically complete coursework in the Protection of Human Subjects as 
mandated by the Medical College of Wisconsin. These programs meet NIH requirements. 
This study will be submitted for review to the Medical College of Wisconsin IRB prior to 
implementation. The IRB will oversee any human participants’ concerns during the study. 
K.8 
Changes in the Protocol 
Once the protocol has been approved by the MCW IRB, any changes to the protocol must be 
documented in the form of an amendment. The amendment must be signed by the investigator 
and approved by the IRB prior to implementation.  
If it becomes necessary to alter the protocol to eliminate an immediate hazard to individuals, an 
amendment may be implemented prior to IRB approval. In this circumstance, however, the 
investigator must then notify the IRB in writing within five working days after implementation.  
The IRB may provide expedited review and approval/favorable opinion for minor change(s) in 
ongoing studies that have the approval /favorable opinion of the IRB. The investigator will submit 
substantial protocol modifications to the NIH in accordance with the governing regulations. 
Changes to the protocol may require approval from the NIH. 
K.9 
Investigator Compliance 
The investigator will conduct the study in compliance with the protocol given approval/favorable 
opinion by the IRB. 
Onsite Audits: Auditing is essential to ensure that research conducted at the Medical College of 
Wisconsin (MCW) Cancer Center is of the highest quality and meets MCW and regulatory agency 
standards.  
Regulatory authorities, the IRB, and/or sponsor may request access to all source documents, 
data capture records and other study documentation for onsite audit or inspection. Direct access 
to these documents must be guaranteed by the investigator, who must always provide support 
for these activities. 

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The PI will follow the procedures as outlined above, which will serve as part of the quality control 
procedure. To ensure the validity and integrity of pilot study data, the PI will discuss data 
management with the research team on a regular basis. 
L 
DATA HANDLING AND RECORD KEEPING 
The study team, including the PI, study coordinator, and other study staff will have weekly 
meetings. At each weekly meeting after enrollment starts, the study coordinator will provide the 
following information: number of participants entering the pilot study and completing cytology self-
sampling, the number of dropouts, and reasons for dropout. Information about any adverse events 
also will be presented, including potential anxiety from cytology results. These participants will be 
managed using standard-of-care practices. By examining this information, the team will keep 
abreast of critical issues regarding reconsenting and data integrity.  
• 
Participant Records. The computer-assisted self-interviews themselves will be identified 
only by ID number and do not contain personal identification information. Information 
linking the participants’ identity to the study data will be kept on password-protected 
secure servers, while signed ICFs will be archived separately at the Medical College of 
Wisconsin.  
• 
Computer records. Passwords and dual authentication will be used to limit access to 
computer records and pilot study data. No information that could lead to personal 
identification of participants will be included in any of the reports or given to any non-
authorized person. 
All raw data, data figures, data interpretation, models, and conclusions drawn from this pilot study 
will be managed by the principal investigator. The findings from this study may be presented at 
relevant conferences/meetings, published in a respectable peer-reviewed journal, or used as 
preliminary data in a grant application to justify extramural funding.  
For any manuscript that is to be published in a journal, the role of authors/contributors, the 
disclosure of financial/non-financial relationships and activities, and the report of perceived 
conflicts of interest should largely adhere to the recommended guidelines set forth by the 
International Committee of Medical Journal Editors (ICMJE; Defining the Role of Authors and 
Contributors, Disclosure of Financial and Non-Financial Relationship and Activities and Conflicts 
of Interest). The PI, in consultation with the study co-investigators, should determine who will be 
listed as first, senior, corresponding authors, and co-authors. Study team members who have 
made substantial and significant intellectual contributions to the study and its findings should be 
listed as co-authors or, in certain circumstances, acknowledged. Funding sources and any conflict 
of interests, perceived or actual, should be disclosed and stated within the appropriate section of 
the manuscript at submission. 
In accordance with the MCW Human Research Protection Program and Federal regulations 
FDAAA 801 and 42 CFR Part 11 (per the Final Rule, effective 1/18/2017), information about and 
results collected from this study are registered on ClinicalTrials.gov under NCT07085845, the 
clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of 
the National Institutes of Health (NIH). All informed consent documents include a specific 
statement relating to the posting of study information in ClinicalTrials.gov.