HPV Self-sampling Among Women at the Penn State Hershey Colposcopy Clinics
Phase: NA
Conditions: HPV
Sponsor: Milton S. Hershey Medical Center

Pennsylvania State University, College of Medicine, 
Department of Family and Community Medicine Research 
Division 
Official 
Study Title 
HPV self-sampling among women at the PSH 
Colposcopy Clinics  
Official 
Document 
Title  
HRP-591 Protocol for Human Subject Research  
Document 
date 
April 20, 2023 
NCT  
04585243 
 

Page 1 of 20 (V.01/21/2019) 
                                                                                       
HRP-591 - Protocol for 
Human Subject Research
Protocol Title:
HPV self-sampling among women at the PSH colposcopy clinics
Principal Investigator:
Name: Jennifer Moss, PhD 
Department: Family & Community Medicine
Telephone: 717-531-0003 x 323429
E-mail Address: jmoss1@pennstatehealth.psu.edu
Version Date:
April 22, 2021
Clinicaltrials.gov Registration #:
NCT04585243
Important Instructions for Using This Protocol Template:
This template is provided to help investigators prepare a protocol that includes the necessary information needed by the 
IRB to determine whether a study meets all applicable criteria for approval.
1.
GENERAL INSTRUCTIONS:  

Prior to completing this protocol, ensure that you are using the most recent version by verifying the 
protocol template version date in the footer of this document with the current version provided in the 
CATS IRB Library.

Do not change the protocol template version date located in the footer of this document.

Some of the items may not be applicable to all types of research.  If an item is not applicable, please 
indicate as such or skip question(s) if indicated in any of the instructional text. 

GRAY INSTRUCTIONAL BOXES: 
o
Type your protocol responses below the gray instructional boxes of guidance language.  If the 
section or item is not applicable, indicate not applicable.
o
Penn State College of Medicine/Penn State Health researchers: Delete the instructional boxes 
from the final version of the protocol prior to upload to CATS IRB (http://irb.psu.edu).  
o
Penn State researchers at all other campuses: Do NOT delete the instructional boxes from the 
final version of the protocol.

Add the completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic 
Information” page.  
2.
CATS IRB LIBRARY: 

Documents referenced in this protocol template (e.g. SOP’s, Worksheets, Checklists, and Templates) can be 
accessed by clicking the Library link in CATS IRB (http://irb.psu.edu).
3.
PROTOCOL REVISIONS: 

When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in 
the Study Submission Guide available in the Help Center in CATS IRB (http://irb.psu.edu) for using track 
changes. 

Update the Version Date on page 1 each time revisions are made.
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If you need help…
University Park and other campuses:
Office for Research Protections Human Research 
Protection Program
The 330 Building, Suite 205
University Park, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: irb-orp@psu.edu
College of Medicine and Penn State Health:
Human Subjects Protection Office
90 Hope Drive, Mail Code A115, P.O. Box 855
Hershey, PA 17033
(Physical Office Location: Academic Support Building 
Room 1140)
Phone: 717-531-5687
Email: irb-hspo@psu.edu  
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Table of Contents
1.0
Objectives
2.0
Background
3.0
Inclusion and Exclusion Criteria
4.0
Recruitment Methods
5.0
Consent Process and Documentation
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
7.0
Study Design and Procedures
8.0
Subject Numbers and Statistical Plan
9.0
Data and Safety Monitoring Plan
10.0
Risks
11.0
Potential Benefits to Subjects and Others
12.0
Sharing Results with Subjects
13.0
Subject Payment and/or Travel Reimbursements
14.0
Economic Burden to Subjects
15.0
Resources Available
16.0
Other Approvals
17.0
Multi-Site Study
18.0
Adverse Event Reporting
19.0
Study Monitoring, Auditing and Inspecting
20.0
Future Undetermined Research: Data and Specimen Banking
21.0
References
22.0
Confidentiality, Privacy and Data Management
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1.0
Objectives
1.1
Study Objectives
The main objective is to compare the test characteristics of the human papillomavirus (HPV) self-
sampling kit versus clinician-sampled HPV testing for cervical cancer screening. This study seeks to find 
out if the HPV self-sampling kit is non-inferior to standard clinician-sampling practices.
1.2
Primary Study Endpoints
The primary outcomes of this study are to analyze the screening results on self-sampling kits compared 
to clinician-collected HPV test, Pap smear results, and colposcopy.
1.3
Secondary Study Endpoints
Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. 
These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and 
ascertain whether self-sampling is a viable alternative.  
2.0
Background 
2.1
Scientific Background and Gaps
The American Cancer Society estimates that 4,170 women in the United States (US) will die from cervical 
cancer in 2018.1 Screening can reduce cancer mortality by (1) detecting malignancies when they are 
more treatable2 and (2) for some tests, identifying precancerous lesions for removal. Guidelines 
recommend cytology and/or HPV testing for cervical cancer screening among women ages 30-65 years, 
but screening rates are suboptimal. 3, 4 
To help bridge these gaps in screening, HPV self-sampling would be an alternative to clinical screening. 
However, there are concerns about the efficacy and comparability of self-sampling kits as an effective 
tool to detect cervical cancer.
2.2
Previous Data
There have been previous studies about the effectiveness of self-collected samples as an alternative to 
clinician collected samples. Some studies state that HPV testing is more sensitive than Pap testing.5 
There is a possibility that these to samples have similar sensitivity.6 Based on this information, examining 
test characteristics and acceptability of each technique is necessary to support larger efforts to make 
self-sampling available.
2.3
Study Rationale
The impact of the proposed project is to compare HPV self-screening results with Pap smear results, 
clinician-collected HPV test, and colposcopy to ultimately improve the uptake of HPV screening.
3.0
Inclusion and Exclusion Criteria
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3.1
Inclusion Criteria
1.
Ages 30-65 years
2.
Penn State Health (PSH) patient
3.
Female
4.
Has an intact cervix
5.
With abnormal findings on Pap/HPV test that requires a colposcopy for follow-up
6.
Speaks, reads, or writes well in English or Spanish
3.2
Exclusion Criteria
1.
Pregnant
2.
Cognitively impaired
3.
Incarcerated
4.
Complete hysterectomy
5.
History of cervical treatment for abnormal Pap/HPV test (i.e., cryotherapy, Loop electrosurgical 
excision procedure(LEEP))
3.3
Early Withdrawal of Subjects
3.3.1 Criteria for removal from study
If the subjects becomes pregnant or does not complete the study activities they will be removed 
from the study. 
3.3.2 Follow-up for withdrawn subjects
The withdrawal will be documented and the subject will be replaced if the timeline allows.
4.0
Recruitment Methods
4.1
Identification of subjects
Potential participants will be identified from participating Family and Community Medicine (FCM) and 
OBGYN clinics at Penn State Health when they are determined to have abnormal findings on Pap/HPV 
test that requires a colposcopy for follow-up. Potential participants will be identified in one of three 
ways:
(1) A member of the study team will access the electronic medical records (EMR) for Dr. Ramirez’s and 
Dr. Wright’s OBGYN patients that meet the study criteria and have an upcoming colposcopy 
appointment. Then, a member of the study team will call the participant about possible involvement in 
the study. 
(2) Clinicians will provide general information (via recruitment cards) about the study during the 
colposcopy appointment (if the patient was not previously contacted or was scheduled less than two 
weeks from their appointment). Patients will be advised to contact the study team using the information 
on the card if interested in participating.
(3) After a patient’s appointment, if the clinician believes the individual could meet eligibility criteria for 
the study, the clinician will send the contact information for these patients to the study team members 
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through a secure message in the Electronic Medical Record. For this option, patients would not have 
been presented with the research opportunity during their appointment; clinicians may not have had a 
recruitment card available to give to their patient or may simply have forgotten to share the study 
opportunity. 
4.2
Recruitment process
4.2.1 How potential subjects will be recruited.
Clinicians will identify potential participants they think would be eligible for the study and 
provide some general information (via the recruitment cards) to the participants. Members of 
the study team (non-clinical staff) will prospectively review clinic schedules in order to identify 
potential participants, and clinicians may also identify patients after their scheduled 
appointment. This will ensure that enrollment numbers are met and that all potentially eligible 
participants are provided with a recruitment card by their clinician or contacted directly by a 
study team member. 
4.2.2 Where potential subjects will be recruited.
Potential subject will be recruited from Penn State Health Family & Community Medicine and 
OBGYN clinics.
4.2.3 When potential subjects will be recruited.
Participants will be recruited at their colposcopy appointment in the clinician’s office or over the 
phone by a study team member. The participant will be screened for eligibility and provide 
verbal implied consent.
4.2.4 Describe the eligibility screening process and indicate whether the screening process will 
occur before or after obtaining informed consent. Screening begins when the investigator 
obtains information about or from a prospective participant in order to determine their 
eligibility.  In some studies, these procedures may not take place unless HIPAA Authorization 
is obtained OR a waiver of HIPAA Authorization when applicable for the screening procedures 
is approved by the IRB.  [For FDA regulated studies, consent for any screening activities would 
need to be obtained prior to screening unless specifically waived by the IRB.]
Initial screening may occur before obtaining implied consent.  A member of the research team 
will review the EMR for FCM/ OBGYN patients that meet the study criteria. Then a study team 
member will call the person to complete the screening process and then obtain verbal consent. 
A study team member will mail the participant the study materials and a summary explanation 
of research. 
5.0
Consent Process and Documentation 
5.1
Consent Process:
Check all applicable boxes below:
Informed consent will be sought and documented with a written consent form [Complete Sections 
5.2 and 5.6] 
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Implied or verbal consent will be obtained – subjects will not sign a consent form (waiver of 
written documentation of consent) [Complete Sections 5.2, 5.3 and 5.6] 
  Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception). [Complete section 5.2, 5.4 and 5.6]
Informed consent will not be obtained – request to completely waive the informed consent 
requirement. [Complete Section 5.5]
The following checkbox is for all locations EXCEPT Penn State Health and College of Medicine: 
Exempt Research at all Locations Except Penn State Health and the College of Medicine: If you 
believe that the research activities outlined meet one or more of the criteria outlined in “HRP-312- 
Worksheet- Exemption Determination.” Please verify by checking this box that if conducting an 
exempt research study, the consent process will disclose the following (all of which are included in 
“HRP-590- Consent Guidance for Exempt Research”):
Penn State affiliation; name and contact information for the researcher and advisor (if the 
researcher is a student); the activities involve research; the procedures to be performed; 
participation is voluntary; that there are adequate provisions to maintain the privacy interests of 
subjects and the confidentiality of the data; and subjects may choose not to answer specific 
questions.  
Note: If this box has been checked, skip the remainder of section 5 and proceed to section 6 of this 
protocol. If the investigator’s assessment is inaccurate, an IRB Analyst will request revision to the 
protocol and that an informed consent form be submitted for review and approval. Except for 
exemptions where Limited IRB Review (see “HRP-312- Worksheet- Exemption Determination”) is 
required or where otherwise requested by the IRB, informed consent forms for research activities 
determined to be exempt without Limited IRB Review are generally not required to be submitted 
for review and approval by the University Park IRB. 
5.2
Obtaining Informed Consent 
5.2.1 Timing and Location of Consent 
Participants will be consented up to 21 days before or after their colposcopy appointment over 
the phone and answers will be input into REDCap by a member of the study team. Once the 
participant has been screened and gives verbal consent, participants will be mailed a paper copy 
of the summary explanation of research with the HPV self-sampling kit.
5.2.2 Coercion or Undue Influence during Consent 
After a review of the research study via the Summary Explanation of Research, subjects will be 
asked if they give consent to participate in the survey. Subjects will be reminded that they may 
refuse to answer any question and end their participation at any time, and their decision on 
whether or not to participate in this research will not affect their medical care.
5.3
Waiver of Written Documentation of Consent 
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5.3.1 Indicate which of the following conditions applies to this research:
  The research presents no more that minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context.
OR
  The only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality. Each subject 
will be asked whether the subject wants documentation linking the subject with the research, 
and the subject’s wishes will govern. (Note: This condition is not applicable for FDA-regulated 
research. If this category is chosen, include copies of a consent form and /or parental 
permission form for participants who want written documentation linking them to the 
research.)
OR
  If the subjects or legally authorized representatives are members of a distinct cultural group 
or community in which signing forms is not the norm, that the research presents no more 
than minimal risk of harm to subjects and provided there is an appropriate alternative 
mechanism for documenting that informed consent was obtained.  (Note: This condition is not 
applicable for FDA-regulated research.)
Describe the alternative mechanism for documenting that informed consent was obtained:
5.3.2 Indicate what materials, if any, will be used to inform potential subjects about the research 
(e.g., a letter accompanying a questionnaire, verbal script, implied consent form, or summary 
explanation of the research)
Verbal script (including summary explanation of the research)
5.4
Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception).
5.4.1 Indicate the elements of informed consent to be omitted or altered
Not applicable.
5.4.2 Indicate why the research could not practicably be carried out without the omission or 
alteration of consent elements
Not applicable.
5.4.3 Describe why the research involves no more than minimal risk to subjects.
Not applicable.
5.4.4 Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects.
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Not applicable.
5.4.5 If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format.
Not applicable.
5.4.6 Debriefing
Not applicable.
5.5
Informed consent will not be obtained – request to completely waive the informed consent 
requirement
5.5.1 Indicate why the research could not practicably be carried out without the waiver of consent
Not applicable.
5.5.2 Describe why the research involves no more than minimal risk to subjects.
Not applicable.
5.5.3 Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects.
Not applicable.
5.5.4 If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format.
Not applicable.
5.5.5 Additional pertinent information after participation
Not applicable.
5.6
Consent – Other Considerations 
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5.6.1 Non-English-Speaking Subjects
The study will include Spanish-speaking participants. Staff who speak Spanish fluently will 
communicate with these subjects during the study procedures. Alternatively, if the preferred 
language is Spanish, LanguageLine can be utilized for translation.
5.6.2 Cognitively Impaired Adults
5.6.2.1 Capability of Providing Consent
Not applicable.
5.6.2.2
Adults Unable to Consent
Not applicable.
5.6.2.3 Assent of Adults Unable to Consent
Not applicable.
5.6.3 Subjects who are not yet adults (infants, children, teenagers) 
5.6.3.1 Parental Permission
Not applicable.
5.6.3.2 Assent of subjects who are not yet adults
Not applicable.
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
6.1
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
Check all that apply:
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable]
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable]
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3]
Full waiver is requested for entire research study (e.g., medical record review studies).
[Complete all parts of sections 6.2 and 6.3]
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3]
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6.2
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
6.2.1 Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual
6.2.1.1
Plan to protect PHI from improper use or disclosure
Information is included in the “Confidentiality, Privacy, and Data 
Management” section of this protocol. 
6.2.1.2
Plan to destroy identifiers or a justification for retaining identifiers 
Protected health information (PHI) will be used for recruitment through the 
EMR by members of the study team. All EMR data and study data will be 
input into REDCap (i.e., insurance status, and date and results of previous 
Pap/HPV tests). There will be two databases for participant data. The first 
linking list will contain the medical record number (MRN) and the unique 
study ID number. This list will be destroyed after data collection. The second 
linking list will have the study ID with all study data. This second linking list 
will be kept for up to two years after data collection. 
Identifiers will be destroyed after the completion of data analysis.
6.2.2 Explanation for why the research could not practicably be conducted without access to and 
use of PHI
The proposed study requires enrollment of participants who have abnormal findings on 
Pap/HPV tests to compare those results with the findings from a self-sampled HPV test. 
Identification of these participants would be infeasible using other methods.
6.2.3 Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization
Prospective identification of participants with abnormal findings on Pap/HPV tests using PHI 
prior to consent will be more practical and efficient than obtaining consent prior to determining 
whether a potential participant had abnormal findings on these tests.
Having participants provide implied consent by using the Summary Explanation of Research 
Is more practical because it allows the study team to send a kit to participants prior to their 
appointment, and therefore gives the participant more time to complete study procedures. 
This process also makes it easier to participate in the study since all materials are mailed to the 
participants home, and they will not take up any extra clinic time during their appointment. 
6.3
Waiver or alteration of authorization statements of agreement
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Protected health information obtained as part of this research 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 permitted uses and disclosures according to federal regulations. 
The research team will collect only information essential to the study and in accord with the 
‘Minimum Necessary’ standard (information reasonably necessary to accomplish the objectives 
of the research) per federal regulations. 
Access to the information will be limited, to the greatest extent possible, within the research 
team. All disclosures or releases of identifiable information granted under this waiver will be 
accounted for and documented.
7.0
Study Design and Procedures
7.1
Study Design
After the participant is screened and informs the study team member that they would like to enroll in 
the study,  an HPV self-sampling kit, the instructions on how to use it, a summary explanation of 
research, PSH lab Pathology Services Special Account Requisition form, and a letter from the principal 
investigator (PI) (see “Moss Self-sampling Letter”) will be mailed to study participants. Participants will 
be asked to complete the HPV self-sampling kit within a week. 3-5 days before the colposcopy 
appointment a study team member will reach out to check if study participants have completed their 
HPV self-sampling kit. Those that have completed the kit will complete a survey 
(HPVSelfSamplingAcceptabilityAn) over the phone and get an appointment reminder. They will mail 
their HPV self-sampling kit and PSH lab Pathology Services Special Account Requisition form to the lab. 
On the day of their appointment, their clinician will perform a colposcopy following normal clinical 
procedures. 
Participants who have not completed their HPV self-sampling kit will get instructions not to use the HPV 
self-sampling kit before the colposcopy and get an appointment reminder. They will then go to their 
appointment where the clinician will perform the colposcopy. After their visit, the participant will 
receive a reminder to use the HPV self-sampling kit within two weeks. The participant will receive a 
maximum of three phone calls after their colposcopy appointment to remind them to return their 
completed self-sampling kit. Seven days after the colposcopy appointment the research project manager 
will call the participant to determine if she completed the HPV self-sampling kit and, if so, they will 
complete a survey (HPVSelfSamplingAcceptabilityAn) over the phone. If the participant has not 
completed the kit or does not respond, a second phone call will then occur 10 days after the colposcopy 
appointment. A final phone call will up to 21 days after the colposcopy appointment. If the self-sampling 
kit is not collected 21 days after the colposcopy or if the study team is unable to reach the participant, 
their participation will be considered incomplete. 
Participants must complete the self-sampling kit within 14 days before or after their colposcopy visit, 
meaning that there is a 28 day window for participants to collect the sample. A 2nd HPV self-sampling kit 
will only be mailed if the participant states that she lost or did not receive the first one. Participants will 
receive a maximum of 2 HPV self-sampling kits.
Once the HPV self-sampling kit has been returned and the survey completed, the study participants will 
be mailed an incentive in the form of a Greenphire ClinCard, and a thank you letter from the PI. Analysis 
of the self-sampling specimens will be conducted to determine HPV DNA positivity to compare to the 
results of the previous Pap test, HPV test, and colposcopy. EMR data will be used to check insurance 
status, and the date and result of Pap test, HPV test, and colposcopy.
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7.2
Study Procedures
Survey and HPV self-sampling kit
7.2.1 Up to 21 days before the colposcopy appointment
A study team member will obtain implied verbal consent from the participants and mail the HPV 
self-sampling kit with the instructions, a summary explanation of research, PSH lab Pathology 
Services Special Account Requisition form, and Moss Self-sampling Letter. 
7.2.2 3-5 days before the colposcopy appointment
A study team member will call study participants to provide a reminder to attend their 
colposcopy appointment and, if they completed their HPV self-sampling kit, take a survey 
(HPVSelfSamplingAcceptabilityAn) over the phone. Those that did not complete the HPV self-
sampling kit will get an appointment reminder and be told not to use the self-sampling kit 
before the colposcopy.
7.2.3 Up to 21 days after colposcopy appointment
Seven days after their colposcopy visit, a study team member will call those participants who did 
not complete the HPV self-sampling kit prior to the colposcopy appointment to complete a 
survey (HPVSelfSamplingAcceptabilityAn) over the phone. If they still have not completed the 
HPV self-sampling kit, they will be reminded to complete the self-sampling kit and a study team 
member will schedule another phone call to complete the survey 
(HPVSelfSamplingAcceptabilityAn) up to 21 days post-colposcopy. Once the HPV self-sampling 
kit has been returned and the survey completed, the study team will mail out the participant’s 
incentive and the Thank You Letter. If the participant did not complete the kit then no further 
contact will be made after day 21, and the participant will not receive a gift card nor will they be 
included in the goal of 30 total completers. 
7.3
Duration of Participation
Participants will be in the study for up to five weeks.
7.4
Test Article(s) (Study Drug(s) and/or Study Device(s))
7.4.1 Description
The Evalyn® Brush is a self-sampling kit that screens for HPV, a leading cause of cancer death 
among women. This tool has recently been FDA approved, but has not been incorporated into 
national clinical guidelines. This product is a small pink capped brush that can be used to take a 
sample of cervical cells. 
7.4.2 Treatment Regimen
Participants will take a sample of their cervix cells that amounts to a few millimeters of bio 
specimen.
7.4.3 Method for Assigning Subject to Treatment Groups
Not applicable
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7.4.4 Subject Compliance Monitoring
Subject compliance will be confirmed once their lab results are received from the PSH lab. 
7.4.5 Blinding of the Test Article
Not applicable
7.4.6 Receiving, Storage, Dispensing and Return 
7.4.6.1
Receipt of Test Article 
1 HPV self-sampling kit will be sent to the PSH lab in a prepaid mailing. 
Inside the mailing will be the HPV self-sampling kit with the instructions 
and a PSH lab Pathology Services Special Account Requisition form. The kits 
will be supplied by the Department of Family and Community Medicine. 
7.4.6.2
Storage
Before HPV self-sampling kits are sent to study participants, they will be 
stored in a locked cabinet in the Department of Family and Community 
Medicine offices at 134 Sipe Ave. Kits mailed to the lab will be disposed of 
after analysis. 
7.4.6.3
Preparation and Dispensing
Before it is sent to the participant, the PSH lab Pathology Services Special 
Account Requisition document will be labeled with the participant’s ID #, 
date of birth, and sex. The Mailing will include the HPV self-sampling kit 
with the instructions, a summary explanation of research, PSH lab 
Pathology Services Special Account Requisition form and Moss_Self-
sampling Letter. Also, the package will include a prepaid and labeled 
mailing to send the kit and Pathology Services Special Account Requisition 
document to the PSH lab. Participants will need to include the date and 
time of sample collection on the Requisition form.
7.4.6.4
Return or Destruction of the Test Article
HPV self-sampling kits not be returned to participants. The samples will be 
analyzed and the kits will be destroyed by the PSH lab once analysis is 
complete.
7.4.6.5
Prior and Concomitant Therapy
Not applicable
8.0
Subject Numbers and Statistical Plan
8.1
Number of Subjects
We expect to consent and screen no more than 60 women to achieve a final sample size of 30 
participants after accounting for potential screen failures.
8.2
Sample size determination
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Assuming p<.05 and beta>0.80, we need 30 participants to determine concordance/non-inferiority of 
test results across the two different methods using a Fisher’s exact test and Cohen’s kappa coefficient.
8.3
Statistical methods
We will conduct Fisher’s exact tests to examine our primary study outcome, i.e., concordance/non-
inferiority of HPV self-sampling test results versus clinician-sampled test results. Additional analyses of 
the concordance across test will use Cohen’s kappa coefficient. In addition, we will summarize survey 
results using descriptive analysis, including calculating means, Pearson’s correlation coefficients, and 
Fisher’s exact tests.
9.0
Data and Safety Monitoring Plan
9.1
Periodic evaluation of data
Not applicable.
9.2
Data that are reviewed
Not applicable.
9.3
Method of collection of safety information
Not applicable.
9.4
Frequency of data collection
Not applicable.
9.5
Individuals reviewing the data
Not applicable.
9.6
Frequency of review of cumulative data
Not applicable.
9.7
Statistical tests
Not applicable.
9.8
Suspension of research
Not applicable.
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10.0
Risks
Potential risks associated with this research are minimal. Loss of confidentiality is a risk of participation. All 
information entered into REDCap will be password protected with limited access to specific members of the 
study team. There may also be risks from participants misusing the self-sampling kit. This may cause minor 
discomfort if used improperly. 
11.0
Potential Benefits to Subjects and Others 
11.1
Potential Benefits to Subjects
None
11.2
Potential Benefits to Others
Understanding how the results of the HPV self-sampling kit compare to clinician-collected HPV tests, Pap 
smears, and colposcopies will ultimately help to create a better screening process. If the findings are 
similar across tests, HPV self-sampling may emerge as an effective option for cervical cancer screening 
among underserved populations without routine access to preventive healthcare.
12.0
Sharing Results with Subjects
Not applicable.
13.0
Subject Payment and/or Travel Reimbursements
$15 via Greenphire ClinCard. After the participant completes the follow-up survey they will be asked to provide 
the information necessary in order to set up the Greenphire Clincard. Once the study team receives 
confirmation that their completed kit was received by PSH, the study team will mail the clincard to the 
participant at their preferred address along with the thank you letter. 
14.0
Economic Burden to Subjects
14.1
Costs
Not applicable
14.2
Compensation for research-related injury
Not applicable
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15.0
Resources Available 
15.1
Facilities and locations
Participants will be identified from participating Family and Community Medicine and OBGYN clinics at 
PSH when they are determined to have abnormal findings on Pap/HPV test that requires a colposcopy 
for follow-up. Physicians will perform the colposcopy per standard clinical guidelines. Self-sampling kits 
will be mailed into a PSH lab for analysis with supplies given by the study team. Afterwards, a study 
team member will collect survey data from participants over the phone.
15.2
Feasibility of recruiting the required number of subjects
Among the PSH study clinics, at least 18 potentially-eligible patients receive a colposcopy each month. 
All potentially-eligible patients will be invited to join the study, and they will be screened and consented 
if there are eligible. 30 subjects will be enrolled into the study. Among the 120 invited to participate in 
this study, we expect 50% (60) to agree to participate and meet eligibility. This should provide a large 
enough sample size to obtain 30 participants who complete all study procedures. Based on these 
figures, it will take approximately 7 months to invite 120 subjects and enroll 30 participants who 
complete all study procedures.
15.3
PI Time devoted to conducting the research
The PI will use dedicated research time to conduct this research.
15.4
Availability of medical or psychological resources
Not applicable.
15.5
Process for informing Study Team
The research team will meet regularly to discuss this study, its procedures, and any issues that may 
arise.
16.0
Other Approvals
16.1
Other Approvals from External Entities
Not applicable.
16.2
Internal PSU Committee Approvals
Check all that apply:
  Anatomic Pathology – Penn State Health only – Research involves the collection of tissues or use of 
pathologic specimens. Upload a copy of “HRP-902 - Human Tissue For Research Form” in CATS IRB. 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals
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  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA 
or gene therapy).
  Clinical Laboratories – Penn State Health only – Collection, processing and/or storage of extra tubes 
of body fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids 
that had been collected for clinical purposes but are no longer needed for clinical use. Upload a copy 
of “HRP-901 - Human Body Fluids for Research Form” in CATS IRB. 
  Clinical Research Center (CRC) Advisory Committee – All campuses – Research involves the use of 
CRC services in any way.
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest.
  Radiation Safety – Penn State Health only – Research involves research-related radiation 
procedures. All research involving radiation procedures (standard of care and/or research-related) 
must upload a copy of “HRP-903 - Radiation Review Form” in CATS IRB. 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE.
  Scientific Review – Penn State Health only – All investigator-written research studies requiring 
review by the convened IRB must provide documentation of scientific review with the IRB 
submission. The scientific review requirement may be fulfilled by one of the following: (1) external 
peer-review process; (2) department/institute scientific review committee; or (3) scientific review by 
the Clinical Research Center Advisory committee.  NOTE: Review by the Penn State Health Cancer 
Institute (PSCI) Protocol Review Committee or the PSCI Disease Team is required if the study 
involves cancer prevention studies or cancer patients, records and/or tissues. For more information 
about this requirement see the IRB website.
17.0
Multi-Site Study
17.1
Other sites 
Not applicable.
17.2
Communication Plans
Not applicable.
17.3
Data Submission and Security Plan
Not applicable.
17.4
Subject Enrollment
Not applicable.
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17.5
Reporting of Adverse Events and New Information
Not applicable.
17.6
Audit and Monitoring Plans
Not applicable.
18.0
Adverse Event Reporting
18.1
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures.
19.0
Study Monitoring, Auditing and Inspecting
19.1
Auditing and Inspecting
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g., pharmacy, diagnostic laboratory, etc.).
20.0
Future Undetermined Research: Data and Specimen Banking
20.1
Data and/or specimens being stored
Not Applicable
20.2
Location of storage
Not Applicable
20.3
Duration of storage
Not Applicable
20.4
Access to data and/or specimens
Not Applicable
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20.5
Procedures to release data or specimens
Not Applicable
20.6
Process for returning results
Not Applicable
21.0
References
1. Siegel, RL, Miller, KD, Jemal, A. Cancer statistics, 2018. CA Cancer J Clin 2018;68(1):7-30.
2. Shieh, Y, Eklund, M, Sawaya, GF, et al. Population-based screening for cancer: hope and hype. Nature 
Reviews Clinical Oncology 2016.2.
3. U. S. Preventive Services Task Force. Final recommendation statement: Cervical cancer: Screening; 
2018. 
https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/cervica
l-cancer-screening2. Accessed 2018.
4. Saslow, D, Solomon, D, Lawson, HW, et al. American Cancer Society, American Society for 
Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines 
for the prevention and early detection of cervical cancer. CA Cancer J Clin 2012;62(3):147-172.
5. Mayrand, Marie-Helene, Duarte-Franco, Aliane, Rodrigues, Isabel, Walter, Stephen, Hanley, James, 
Ferenczy, Alex, Ratman, Sam, Coutlee, Franciis, Franco, Eduardo. Human Papillomavirus DNA versus 
Papanicolaou Screening Tests for Cervical Cancer. The New England Journal of Medicine
6. Polman, Nicole, Ebisch, Renee, Heideman, Danielle, Melchers, Willem, Bekkers, Ruud, Molijn, Anco, 
et al. Performance of human papillomavirus testing on self-collected versus clinician-collected samples 
for the detection of cervical intraepithelial neoplasia of grade 2 or worse: a randomised, paired screen-
positive, non-inferiority trial. The Lancet Oncology’s 2019, 20(2): 229-238.
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