Community Health Outreach to Increase Cervical Cancer Education and Self-Collection Screening (CHOICESS) Program for Southeast Asian Immigrant and Refugee Women in Wisconsin
Phase: NA
Conditions: Cervical Cancer Screening
Sponsor: University of Wisconsin, Madison

 
 
 
 
Cervical Cancer Self-Collection for Southeast 
Asian Immigrant and Refugee Women 
NCT05286749 
8-8-2023 

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Title:  
Community Health Outreach to Increase Cervical Cancer Education and Self-Collection Screening 
(CHOICESS) Program for Southeast Asian Immigrant and Refugee Women in Wisconsin 
 
Team Members 
 
Primary Investigator 
Jessica Dalby, MD 
Associate Professor 
University of Wisconsin SMPH 
Department of Family Medicine and Community Health 
1100 Delaplaine Ct., Madison, WI 53715 
Phone: (608) 263-3111  
Email: jessica.dalby@fammed.wisc.edu 
 
 
Collaborators 
Organization 
Role on Project 
Email 
Tana Chongsuwat, 
MD 
UW-Madison SMPH 
Postdoctoral 
Research Associate  
chongsuwat@wisc.edu 
Mayhoua Moua 
Milwaukee Consortium for 
Hmong Health 
Community Partner 
mkehmonghealth@gmail.c
om 
Kaitlin Sundling, MD 
UW-Madison SMPH/Wisconsin 
State Laboratory of Hygiene 
Cytologist 
ksundling@wisc.edu 
Joshua Faulkes 
UW-Madison Wisconsin State 
Laboratory of Hygiene 
Cytology Supervisor 
jdfaulkes@slh.wisc.edu 
 
Protocol Version History 
 
Protocol 
Version 
Version 
Date 
Summary of Revisions Made 
Rationale 
1.0 
11/16/21 
Initial version 
 
2.0 
08/02/22 
Study site location change 
Timeline 
 Sample handling and analysis 
Sharing of Data 
Incentives 
Capacity and equipment 
Feasibility and recruitment 
Original lab lacking LDT validation required 
Additional of laboratory with necessary LDT 
validation 
Change in gift card amount 
3.0 
03/22/23 
Timeline 
Study personnel 
 
Simplicity of timeline 
Increase FTE for Jessica Dalby and 
removal of Megan Fitzpatrick as Co-PI 
4.0 
08/08/23 Expansion of inclusion ethnicities 
Consent process 
Expansion of recruitment pool for feasibility 
in enrolling enough participants 
Accommodations for special ethnic groups 
with limited English proficiency and low 
reading literacy 

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Table of Contents 
 
Statement of Compliance .................................................................................................................................. 4 
SYNOPSIS ........................................................................................................................................................ 5 
1. 
INTRODUCTION ........................................................................................................................................ 6 
1.1 
Background ......................................................................................................................................... 6 
1.2 
Rationale ............................................................................................................................................. 6 
2. 
STUDY OBJECTIVES AND ENDPOINTS .................................................................................................. 7 
3. 
STUDY PARTICIPANTS ............................................................................................................................ 7 
4. 
NUMBER OF PARTICIPANTS ................................................................................................................... 7 
5. 
INCLUSION AND EXCLUSION CRITERIA................................................................................................. 7 
5.1 
Inclusion Criteria .................................................................................................................................. 7 
5.2 
Exclusion Criteria ................................................................................................................................ 7 
6. 
SPECIAL POPULATIONS .......................................................................................................................... 7 
7. 
RECRUITMENT METHODS ....................................................................................................................... 8 
7.1 
Recruitment through Clinical Practice ................................................... Error! Bookmark not defined. 
7.2 
Verbal Communication ........................................................................................................................ 8 
7.3 
Posters/Flyers/Brochures ..................................................................... Error! Bookmark not defined. 
7.4 
Mailed Letters ....................................................................................... Error! Bookmark not defined. 
7.5 
Telephone Recruitment ....................................................................................................................... 8 
7.6 
Participant Remuneration .................................................................................................................... 8 
8. 
CONSENT PROCESS ............................................................................................................................... 8 
9. 
PROCESS TO DOCUMENT CONSENT IN WRITING ............................................................................... 9 
10. 
SETTING ................................................................................................................................................ 9 
11. 
STUDY INTERVENTION ...................................................................................................................... 10 
12. 
STUDY TIMELINES .............................................................................................................................. 12 
13. 
PROCEDURES INVOLVED .................................................................................................................. 15 
13.1 
Project Activities............................................................................................................................. 15 
14. 
COMPARISON OF USUAL CARE AND STUDY PROCEDURES ......................................................... 19 
15. 
WITHDRAWAL OF PARTICIPANTS ..................................................................................................... 20 
16. 
DATA MANAGEMENT AND CONFIDENTIALITY ................................................................................. 20 
16.1 
Project Data Collection................................................................................................................... 20 
16.2 
Data Storage and Maintenance ...................................................................................................... 20 
16.3 
Confidentiality ................................................................................................................................ 20 
17. 
Provisions to Protect the Privacy Interests of Participants ..................................................................... 21 
18. 
SHARING OF RESULTS ...................................................................................................................... 21 
19. 
DATA AND SPECIMEN BANKING ....................................................................................................... 21 

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20. 
STUDY ANALYSIS ............................................................................................................................... 21 
20.1 
Statistical Hypothesis ..................................................................................................................... 21 
20.2 
Sample Size Justification ............................................................................................................... 22 
20.3 
Statistical Methods ......................................................................................................................... 22 
21. 
POTENTIAL BENEFITS TO PARTICIPANTS ....................................................................................... 22 
22. 
RISKS TO PARTICIPANTS .................................................................................................................. 23 
23. 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF THE PARTICIPANTS ......... 23 
24. 
ECONOMIC BURDEN TO PARTICIPANTS .......................................................................................... 23 
25. 
RESOURCES AVAILABLE ................................................................................................................... 23 
26. 
MULTI-SITE RESEARCH ..................................................................................................................... 24 
27. 
REFERENCES ..................................................................................................................................... 24 
28. 
APPENDICES ....................................................................................................................................... 26 
 
 
 

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STATEMENT OF COMPLIANCE 
 
I confirm that I have read this protocol. I will comply with the IRB-approved protocol, and applicable 
regulations, guidelines, laws, and institutional policies.  
 
I agree to ensure that all staff members involved in the conduct of this study are informed about their 
obligations in meeting the above commitment.  
 
Name 
Signature 
Date 
 
 
Name 
Signature 
Date 
 
Jessica Dalby 
 
08/08/23 
__________________________________ 
_____________________________ 
___________________ 
Jessica Dalby, MD 
Principal Investigator 
 
 

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SYNOPSIS 
 
Study Title 
Community Health Outreach to Increase Cervical Cancer Education and Self-
Collection Screening (CHOICESS) Program for Southeast Asian Immigrant and 
Refugee Women in Wisconsin 
Brief Summary 
The primary purpose of this study is to determine whether educational workshops 
paired with self-collected high-risk human papillomaviruses (hrHPV) screening will 
increase participation in cervical cancer screening among Southeast Asian refugee 
and immigrant populations in Wisconsin compared with offering clinician-collected 
screening (total sample size: 250 participants). We hypothesize that participation in 
cervical cancer screening will be higher among women in the intervention group as 
compared to the control group. 
Number of study 
sites 
1 
Study Design 
Workshops are randomized to either a control or intervention group. 
Primary Objective 
To evaluate whether educational workshops paired with self-collected hrHPV 
screening will increase participation in cervical cancer screening among  Southeast 
Asian refugee and immigrant populations in Wisconsin compared with offering 
clinician-collected screening. 
Secondary 
Objective(s) 
To evaluate participant satisfaction with the educational workshops using satisfaction 
surveys. 
Research 
Intervention(s) 
Control workshops are workshops where participants are provided education on 
standard-of-care for cervical cancer screening such as pap smear and HPV testing 
through clinician-collection methods using speculum and cervical swabs. 
Intervention workshops are workshops where participants are provided all the same 
education as control as well as additional education on self-collection for HPV-only 
testing using vaginal swab as an additional method.  
After each workshop, each group will be offered to participate in their assigned 
group’s screening method (clinician-collected or self-collected).  
Device used on study 
(including any 
IND/IDE #)  
Evalyn® Brush (Rovers® Medical Devices, Netherlands) 
Regulation Number# 884.4530 
 
Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, 
Switzerland) 
Study Population 
Southeast Asian Immigrant and Refugee (Karenni, Karen, Burmese, and Hmong) 
Women in Wisconsin, aged 25-65, eligible for cervical cancer screening. 
Sample Size 
240 
Study Duration for 
individual 
participants 
Subject participation is limited to the workshop session, post-workshop cervical 
cancer screening, and follow-up contact on results of screening tests. 
Study Specific 
Abbreviations/ 
Definitions  
ASCCP, Society for Colposcopy and Cervical Pathology; CHW, community health 
worker; FDA, Food and Drug Administration; HCP, health care provider; hrHPV, 
high-risk human papillomaviruses; LMP, last menstrual period; MCHH Milwaukee 
Consortium for Hmong Health; ROI, release of information 
 
 
 

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1. INTRODUCTION  
 
1.1 
Background 
 
Despite effective screening and early treatment options, 311,000 women die of cervical cancer worldwide 
every year.1 In the United States, Hmong-American immigrant women experience incidence and mortality rates 
four times those of their non-Latina white counterparts and have alarmingly low participation in cervical cancer 
screening.2 With the third highest Hmong population in the US, Wisconsin’s minority communities face similar 
health disparities.1 Factors such as modesty, fatalism, lack of knowledge, and lack of access impede 
participation in screening and treatment for cervical cancer. These barriers can be attributed to cultural beliefs, 
patriarchal family/clan structure, language barriers, and mistrust or lack of experience in the Western medical 
system.3,4  
 
In women 25 and over, screening for cervical cancer screening through testing for high-risk human 
papillomaviruses (hrHPV) has been found to be more sensitive than cytology and effective in preventing 
cervical cancer.5 Self-collection has been a proposed strategy to reach under-screened women worldwide. 
Recent systematic reviews and meta-analyses have shown that offering hrHPV self-collection at home to non-
attendees can significantly increase attendance and the detection of high-grade cervical lesions, compared to 
currently widely-used reminder letters for clinician-based screening.6,7 Most studies have found at least a 
doubled response rate to submitting a self-sample versus scheduling an on-site pap smear, even among 
under-screened populations.8-10 Furthermore, with improved hrHPV polymerase chain reaction (PCR)-based 
testing technology, the sensitivity for detection of human papillomavirus (HPV) infections is comparable in most 
self-collect samples when compared to clinician-collected samples. Kaiser Permanente ran a similar study 
across 20,000 women who were behind on their screening and found that 50% more women chose to return a 
self-sample than schedule an in-office screen. A large population-based cervical cancer self-collected study in 
Argentina found that HPV-based screening doubles the detection rate ratio (DRR) for HPV screening.9 These 
studies have led some countries, such as Australia, to institute a self-collection option nationally.8,10 
Furthermore, our previous work in rural Zimbabwe found that community-based screening using self-collected 
samples increased participation in cervical cancer screening from a baseline of 5% to 82% participation.11-13 As 
part of a comprehensive cervical cancer screening program, the utilization of self-collected samples has 
advantages from both a public health and individual participant perspective. Some of the barriers to screening 
can be mitigated by self-collection, and resources can be better allocated to participants at the highest risk of 
developing cervical cancer. 
 
1.2 
Rationale 
 
The effectiveness of offering self-collection sampling options to Southeast Asian refugee and immigrant 
populations to improve cervical cancer screening participation has not been investigated. The Milwaukee 
Consortium for Hmong Health (MCHH), supported by the Well Woman Program, has had success increasing 
participation in breast cancer screening through outreach and education activities. However, it continues to 
have limited success engaging women in cervical cancer screening. We have established a partnership with 
MCHH to develop innovative cervical cancer workshops that combine community health worker (CHW)-led 
engagement with self-collected hrHPV screening, with the primary objective of increasing participation, 
awareness, and engagement in cervical cancer screening and treatment activities among this population. 
 
 
 
 
 
 
 
 

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2. STUDY OBJECTIVES AND ENDPOINTS 
 
Objectives 
Endpoints 
Primary 
• 
To evaluate whether educational 
workshops paired with self-collected 
hrHPV screening will increase 
participation in cervical cancer 
screening among Southeast Asian ( 
Hmong, Burmese, Karen, and 
Karenni) refugee and immigrant 
populations in Wisconsin compared 
with offering clinician-collected 
screening. 
• 
Uptake of cervical cancer screening using a 
self-collect device vs. clinician-based 
screening. 
Secondary 
• 
To evaluate participant satisfaction 
with the educational workshops using 
satisfaction surveys. 
• 
Participant satisfaction as determined using 
qualitative methods. 
 
• 
To evaluate participant willingness to 
use self-collection as method for 
screening. 
• 
General willingness to use a HPV self-collect 
device at home and/or as the preferred 
collection method for cervical cancer 
screening, assessed via mixed methods 
survey. 
 
3. STUDY PARTICIPANTS 
 
Study participants in this project include participants recruited for cervical cancer CHW-led educational 
workshops led by MCHH. Participants can be either Hmong, Karen, Burmese or Karenni speaking and are 
recruited by MCHH with a particular focus on those who are behind or have never had cervical cancer 
screening. The main objective is to provide education to these participants on cervical cancer prevention and 
screening with subsequent invitation for immediate post-workshop sample collection for cervical cancer 
screening. 
 
4. NUMBER OF PARTICIPANTS 
 
Total number of study subjects: 250. 
 
5. INCLUSION AND EXCLUSION CRITERIA 
 
5.1 
Inclusion Criteria 
• 
Female (assigned female at birth, regardless of gender identity) 
• 
Ages 25-65 
• 
Fluent understanding in English, Karen, Burmese, Hmong or Karenni.  
5.2 
Exclusion Criteria 
• 
Prior hysterectomy 
• 
Impaired decision-making capacity 
• 
Pregnancy 
 
6. SPECIAL POPULATIONS 
 
Those who lack consent capacity, the mentally ill, prisoners, cognitively impaired persons, children, and 
employees will not be included in this research study. 
 

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7. RECRUITMENT METHODS 
 
Participants will be identified and recruited by MCHH using several recruitment strategies.  
 
 
7.1 
Verbal Communication 
 
Word of mouth among participants, family members, and the Southeast Asian community will be used. 
Participants will be encouraged to contact MCHH for further details and specifics about the research study.  
 
Announcements at church service will be done by CHWs at local churches frequented by Southeast Asian 
immigrant and refugee communities. Announcements will be scripted and will include key eligibility, criteria, 
length of workshop, location of study site, type of remuneration, and contact details for further information. 
 
 
7.2 
Telephone Recruitment 
 
The study team will call potential participants using a list of community members who have previously sought 
services through MCHH. Attempts to reach participants will be two times over a two-week period. All initial 
discussion with participants from recruitment lists, or when potential subjects contact the study team via other 
recruitment methods, will include a brief description of the study’s purpose, eligibility criteria, and participant 
involvement will be reviewed. This must also include a statement that participation is voluntary. The screener 
will ask the caller if she has any questions and whether they are interested in participating. After all questions 
have been answered, the study team member will ask if the potential subject is interested in proceeding to the 
next step in recruitment for the study. Potential subjects will answer pre-screening questions using an IRB-
approved script. Information collected from potential subjects who fail pre-screening will be destroyed at the 
end of the study period. Potential subjects who meet all pre-screening criteria will be invited to a particular 
workshop day in order to go through the consent process.  
 
 
 
7.3 
Participant Remuneration 
 
All participants regardless of their participation in the post-workshop screening for cervical cancer or the post-
workshop satisfaction survey will receive a $25 gift card. 
 
8. CONSENT PROCESS 
 
The informed consent process will make clear that participation in any and all aspects of the study are 
voluntary, and that participants may end their participation at any time.  
 
The informed consent process will be conducted following all federal and institutional regulations relating to 
informed consent. Informed consent will be obtained at the beginning of participation through the following 
process: 
- 
A link to a pre-record video will be provided to each participant at the time of recruitment. This video will 
be created prior to the start of the study which CHWs employed through MCHH will provide consent 
information using the pre-approved oral script.  
o If the CHW does not speak the spoken language, then an the CHW would follow the script in 
English and a translator would then translate the information to the participant language. 
- 
Upon arrival to the study, participants will be asked if they have seen the pre-recorded video: 
o If any participant reports the video was not viewed – it will be shown to all participants. 
o CHW provides a summary about the study, study activity, and consent items, then answering 
any questions which may arise. 

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 
If the CHW does not speak the spoken language, then an the CHW would provide the 
information in English and a translator would then translate the information to the 
participant language. Questions or comments will also be translated back to the CHW to 
be answered. The translator will serve as witness to ensure that study materials and 
consent were understood by the participant. 
- 
It will be noted in a participant’s study record noting they provided verbal consent.  
 
.  
 
Participants will be informed of random assignment into two groups: standard-of-care control group and 
intervention group. Due to the nature of this study, we will not disclose which group the participant belongs to 
although will provide a debrief session at the end of the study about what information could not be given at the 
time of consenting, and why they could not be told at that time.  
 
Participants will not be told the full procedures prior to enrollment due to the need to test the hypothesis in this 
study. Participants in the control group are initially only provided educational materials about the standard of 
care for cervical cancer screening. While self-collection may or may not be known by the workshop participants 
in the control group, this is not standard of practice nor usually recommended by clinicians. Whereas the 
intervention group is provided additional materials about self-collection in the core educational material and is 
offered as a screening option immediately at the end of the workshop. The uptake of cervical cancer screening 
by workshop participants at the end of the workshop will then be compared between these two groups to 
determine.  
 
The informed consent process will include contact information for the PI, who can be contacted if participants 
or potential participants have questions or concerns.. Informed consent forms will be available in written 
English, Hmong, or Karenni for reference only. All participants will have access to the pre-recorded video in 
their native language for reference.  
 
9. PROCESS TO DOCUMENT CONSENT IN WRITING 
 
This study requests of waiver of written documentation of consent  
- 
A written script of the information will be provided orally. 
- 
Pre-recorded video of oral script will be available to all participants for future reference. 
- 
Research presents no more than minimal risk of harm to subjects. 
- 
The research involves no procedures for which written consent is normally required outside of the research 
context. 
 
This consent requests an alteration of the consent process (HRP-410) due to the following criteria: 
- 
The study involves no more than Minimal Risk to the participants based on clinical standard of care.  
- 
The study could not be practically carried out without the alteration. Participants will be blinded to which 
group they are randomized in order measure participation rates based on which type of screening 
method they are offered (clinician-collection vs self-collection) 
- 
The alteration will not adversely affect the rights and welfare of the subjects. Participants will be 
provided the risks of each collection method in detail during the workshops. If a participant declines the 
type of screening they are offered will then be offered the other screening method.  
- 
Subjects will be provided the additional pertinent information after participation. 
- 
High proportion of participants in this study population have no or low reading or writing literacy in 
English or the native language.  
 
10. SETTING 
 
The location where the research team will conduct the research will be at MCHH’s community center (1802 W 
Walnut St, Milwaukee WI 53205). The space has been previously used by MCHH to conduct larger workshops 

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in-person and can accommodate any necessary physical spacing needed for respiratory infection control. In 
addition, the community space has two private rooms to accommodate needs for participant privacy. 
 
 
11. STUDY INTERVENTION 
 
This randomized controlled trial will be done in partnership with MCHH. Previous partnership with MCHH and 
UW-Madison researchers developed cervical cancer educational workshops designed by CHWs to provide 
innovative mixed-modality education consisting of pictographs, flipcharts, videos, and hands-on models. These 
workshops to be conducted in Hmong, Karen, and Burmese and Karenni languages were tested in mock 
workshops with Hmong and Karenni participants and through a community advisory panel prior to 
dissemination. This approach caters to the unique culture and communication styles of Southeast Asian 
immigrant and refugee populations.  
 
All workshops will be conducted by the CHWs on the study team. If the CHW is not fluent in the target 
language (such as Karen or Burmese), then the CHW will conduct all study activities in English with a 
translator available to translate all activities.  
 
All participants attending a workshop will be randomized as a group to either a control or intervention group. 
Workshops in the control group will provide education recommending standard of care (clinician-collected 
hrHPV testing and cytology screening). Workshops in the intervention group will be offered the same education 
with additional education on the option of self-collection (HPV testing only) for their screening method. All 
participants will have the same basic demographic information collected in MCHH’s standard intake form with 
an additional question on current barriers to screening.  
 
Participants will self-select which workshop day they would like to attend depending on their preferred 
language. Participants can attend any available date a workshop is being offered until filled. Participants will be 
blinded to knowing which workshops are control or intervention groups. Participants during consent will be 
made aware there are two different groups and the difference between the intervention and control group is the 
education provided and screening method offered at the end of the education session. Participants will be 
provided the full study details at the end of their participation.  
 
We anticipate a total of thirty workshops, fifteen of which will be control and fifteen of which will be intervention, 
will be planned in total over a sixteen-month period (Table 1). All workshops will have 8 participants recruited 
due to limited space of the community center, time, and to accommodate physical spacing needs. There will be 
two workshop sessions per day (one in the morning and one in the afternoon). 
 
Table 1. Planned Number of Hmong and Karenni Participants in the Intervention and Control 
Workshops 
 
Intervention Workshop 
1 
2 
3 
4 
5 
Total 
Hmong 8 
8 
8 
8 
8 
40 
Karenni 8 
8 
8 
8 
 
36 
Karen 8 
8 
8 
 
 
24 
Burmese 8 
8 
8 
 
 
24 
Control Workshop 
 
 
 
 
 
 
Hmong 8 
8 
8 
8 
8 
40 
Karenni 8 
8 
8 
8 
 
36 
Karen 8 
8 
8 
 
 
24 
Burmese 8 
8 
8 
 
 
24 
 
 
 
 
 
 
 
 
 
 
 
  

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After workshop conclusion, participants will be offered same-day on-site cervical cancer screening depending 
on assignment in the control or intervention group (clinician-collected screening or self-collection screening, 
respectively). Participants, regardless of engagement in screening, will then complete a post-evaluation 
workshop survey (consisting of two surveys, see Appendix C).  
 
Due to ethical concerns and our hypothesis that this population is less likely to do cervical cancer screening if 
offered clinician-collected screening only. Participants in the control workshops who answer “yes” on the 
survey to the question “If given the option, instead of having a clinician collect the sample, would you want to 
collect the sample on your own?,” will be subsequently offered self-collection for their screening method. 
CHWs will provide to these participants a 5-minute 1-on-1 instruction tutorial on self-collection, translated 
handout, private room to collect a sample, and then samples sent to the laboratory per protocol.  
 
Similarly, participants will be made aware during the education of the self-collection method, that this is not a 
usual method that is offered in many clinical practices. If a participant were to visit their usual primary care 
doctor for an exam, a pelvic examination to obtain a clinician-collected cervical swab for HPV testing and pap 
smear is the usual method which they should anticipate. We are offering self-collection as studies show 
growing validity of HPV self-sampling, particularly among hard-to-reach populations.14-18 With this 
understanding, self-collection will be offered and encouraged although if participants desire clinician-collection 
instead this is option will also made available. 
 
The final part of the study is to fully explain the purpose of the study to each participant, including why subjects 
could not be informed of all study procedures prior to, and during the study up to that point. The study 
procedures in question were providing standard-of-care education on cervical cancer screening to both groups 
and additional information on self-collection for HPV screening to the intervention group. The education on the 
option for self-collection is withheld from the control group. This information could not be disclosed to the study 
participants prior to the end of the study to effectively measure participations rates for self-swab if they are 
provided the education or education is withheld. 
 
Full workflow of design for participation in workshops and post-workshop screening is outlined in Figure 1.  

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12. STUDY TIMELINES 
 
Subject participation is limited to the workshop session, post-workshop cervical cancer screening and surveys, 
and follow up call from CHWs on results of screening tests (if indicated).  
- 
Duration of participation involvement is estimated to be between two to three hours. 
- 
Activities involved is primarily attendance at a 45-minute workshop followed by post-workshop survey 
(estimate to complete in three- to five-minutes) 
- 
Participants who opt for screening for cervical cancer after workshop completion will spend an 
additional 30 to 60 minutes waiting for sample collection. Actual time for sample collection will be 
between five- to ten- minutes.  
- 
Participants will be contacted by phone regarding their results on screening tests by MCHH CHWs. 
Those with positive results will be asked to return to the community center to discuss the results in-
person with CHWs, with a clinician available by virtual methods.  
 
Anticipated duration to enroll all study participants will be over 16 months. Estimated date for researchers to 
complete this study (including primary analysis) is over 24 months starting from IRB approval. 
 

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A research subject will be defined as “enrolled” in the study when they meet the following criteria: 
• 
The subject has been consented by study staff.  
• 
The PI has verified that the subject meets all of the inclusion criteria. 
• 
The PI has verified that subject meets none of the exclusion criteria. 
• 
The subject has been assigned to the protocol by study staff.  
 
The project period is estimated to be two years from date of IRB approval. Table 2 summarizes the activities 
and evaluations that will take place during the project, over a 24-month time period, and which subject 
participants are involved with them.

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Table 2. Study Calendar  
Month 
1 
2 3 4 5 6 7 8 9 10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
Activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop Recruitment Strategy 
X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment 
 
 
X X X X X X X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Monthly Workshops 
 
 
 
 
X X X X X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Follow-up on Screening Results 
 
 
 
 
X X X X X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Evaluation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participation Rates 
 
 
 
 
X X X X X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Post Workshop Surveys 
 
 
 
 
X X X X X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 

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13. PROCEDURES INVOLVED 
 
13.1 
Project Activities 
 
13.1.1 Pre-Participation Intake  
 
Intake will be done upon recruitment, after informed consent it obtained and prior to start the assigned 
workshop. Forms to be used are the standard intake forms used by MCHH for previous workshop 
participations and gathers information such as demographics, primary care physician (PCP), and insurance 
coverage (full intake form in Appendix A). Intake forms are assigned an ID # which will be used to extract data 
for this research program. Ms. Mayhoua (MCHH Director) will maintain original intake forms at the MCHH 
community center and  participant identities to the study ID separately from other data. Following information 
from the intake form will be collected for this research program: 
• 
ID Number 
• 
First and last initials 
• 
Workshop Date 
• 
Ethnicity 
• 
Date of Birth 
• 
Gender 
• 
Month and year of previous Pap Test 
• 
Type of Insurance 
• 
Answer to the following question “What reasons may be stopping you from getting a Pap Test?” 
(options below) 
[ ] No symptoms 
[ ] No transportation 
[ ] Too expensive/No insurance 
[ ] I don’t know where to go 
[ ] Spouse will not allow it 
[ ] I’m too busy/No time 
[ ] I am afraid it will hurt 
[ ] I don’t want to know the results 
[ ] Childcare 
[ ] No family history of cervical cancer 
[ ] My doctor never mentioned it 
[ ] Embarrassed 
[ ] Long wait to get an appointment 
[ ] None 
 
 
If a participant has a PCP, MCHH can fax or mail the results of their screening tests directly to their PCP. For 
participants who do not have a PCP and would like to establish with one, a list of available providers in the 
area accepting new patients will be obtained prior to the start of the research study.  
 
Providers accepting new patients will be oriented by phone by a research team member prior to the start of the 
study. They will be provided with a brief overview of the research study and purpose. In addition, when 
receiving participant results on cervical cancer screening, cover letter will include a brief overview of the 
research project, purpose, recommend follow-up, and need for patient to establish as a new patient to their 
clinic. 
 
 
 
13.1.2 Workshops 
 
All workshop materials were previously developed through a partnership with Dr. Chongsuwat and MCHH, with 
support through a community advisory panel. Workshops consist of translated materials into Hmong, Burmese, 
Karen and Karenni, with methods that include flip charts, video, and hands-on models to provide education on 
cervical cancer screening and prevention. Materials were developed to target mother-daughter pairs although 
for this research will target only women age 25 to 65 which is the target for HPV only screening (versus co-
testing HPV and pap smear). Participants self-select which workshop day they would like to participate in 

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although are blinded which group the workshop belongs to. Workshops are differentiated based on belonging 
to the control or intervention group. 
• 
Control workshops are workshops where participants are provided education on standard-of-care 
for cervical cancer screening such as pap smear and HPV testing through clinician-collection 
methods using speculum and cervical swabs. 
• 
Intervention workshops are workshops where are participants are provided all the same education 
as control as well as additional education on self-collection for HPV only testing using vaginal swab 
as an additional method.  
 
13.1.3  Post-Workshop Survey Collection 
 
All participants after education session, regardless of participation in post-workshop screening for cervical 
cancer, will answer questions on two separate surveys. The MCHH post-workshop evaluation survey (MCHH-
PES) has been used previously after workshops that were hosted by MCHH. The UW Health Post-Workshop 
Satisfaction Survey (UW-PSS) will be an additional survey done to cover remaining questions on participant 
satisfaction.  
 
13.1.3.1 
MCHH Post-Workshop Evaluation Survey (MCHH-PES) 
 
Data collected on the original intake form by MCHH includes the following questions (Figure 3) and will be 
collected in this study in the same format. Survey will be administered verbally by CHWs in the participants 
native language. Paper copies of the survey will remain with MCHH and responses copied into Qualtrics 
survey and continued with questions in the next section (13.2.2. UW Health Researchers Post-Workshop 
Satisfaction Survey).  
 
 
 
 
 
 
13.1.3.2 
UW Health Post-Workshop Satisfaction Survey (UW-PSS) 
 
Additional survey questions will be administered verbally by CHWs and answers recorded in Qualtrics for data 
collection. Responses will not be linked to the study ID or other identifiable information. Theme of survey 
questions is below (full survey in Appendix C): 
 
- 
Comfort with method (either self-collection or clinician-collection) 
- 
How likely would the participant get screening for cervical cancer again? 
- 
If self-collection (or clinician-collection) was an option, would they have preferred this method. 
Figure 3. MCHH-PES Questions 

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- 
If not getting screening today, will they go for screening in the near future? 
o If not why? Where? 
- 
Understanding of instructions (self-collection) 
 
13.1.4 Post-Workshop Sample Collection 
 
Immediately after workshops, participants will be offered same-day opportunity to engage in cervical cancer 
screening either through clinician collection (if in the control) or self-collection (if in the intervention group). 
Participants who do not desire screening through the program will be encouraged to attend cervical cancer 
screening with their local health department or provider.  
 
Pregnant women will be excluded from this study if they are known to be pregnant at the time of screening, 
although additional measures will be taken prior to sample collection for women unaware of pregnancy status. 
All participants will be asked the date of their last menstrual period (LMP). Participants will be requested to 
provide a urine sample for on-site urine pregnancy testing if more than six weeks from LMP unless post-
menopausal or meeting criteria of relative certainty a woman is not pregnant. CDC 2016 Selective Practice 
Recommendations for reasonable certainty states, a health care provider can be reasonably certain that 
women is not pregnant if she has no symptoms or signs of pregnancy and meets any one of the following 
criteria:  
- 
is ≤7 days after the start of normal menses 
- 
has not had sexual intercourse since the start of last normal menses 
- 
has been correctly and consistently using a reliable method of contraception 
- 
is ≤7 days after spontaneous or induced abortion 
- 
is within 4 weeks postpartum 
- 
is fully or nearly fully breastfeeding (exclusively breastfeeding or the vast majority [≥85%] of feeds are 
breastfeeds), amenorrheic, and <6 months postpartum14 
 
Results of the urine pregnancy test will be provided immediately to the participant and if positive, excluded 
from the remaining of the study although still counted as a participant. Due the possibility that participants who 
are pregnant and included in the study (educational workshops only, will not be included in either screening 
method– clinician-collected or self-collection). For risks involved with the educational workshop portion of the 
study: 
- 
The research involves no more than minimal risk to pregnant women and fetuses. 
- 
The research holds prospect of direct benefit to the pregnant women, the prospect of direct benefit both 
to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus. 
- 
The educational workshops on cervical cancer provided potential benefit by prevention of cervical 
cancer in the woman and reduction of morbidity and mortality which may have subsequent benefit to 
the fetus.  
 
Physicians from UW- Madison will be made available to assist in either group with CHWs as approved 
translators to guide collection.  
 
13.1.4.1 
Self-Swab Vaginal Samples 
Participants will be provided a private area of their choice (exam room or bathroom) to self-
collect vaginal samples. Device which will be used is the Evalyn® Brush (Rovers Medical 
Devices, Netherlands) which has FDA and CLIA approval. The device is self-directed by the 
participant and will include translated instructions in Hmong, Karen, and Burmese and 
Karenni. Instructions will also be provided to all participants orally. The device is neither 
implanted nor creates a potential for serious risk to the health, safety, or welfare of the 
subject. A picture of the device and instructions for self-collected provided by the 
manufacturer are included in Appendix B. There are no known potential serious risks to the 
health, safety, or welfare of the subject. Dr. Chongsuwat will be available onsite to answer 
any questions or concerns participants have during the self-collection process.  
 

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13.1.4.2 
Clinician-Collected Cervical Samples 
The provider (Dr. Chongsuwat) will obtain a sample in the normal standard fashion using 
speculum to collect cervical samples. Samples will be collected in ThinPrep vials for Pap 
smear and HPV testing. 
 
Self-collected samples will be packaged for disposition and transported to the Penn State Health Medical 
Group Laboratory for processing and evaluation. Clinician-collected samples will be packaged for disposition 
and transport to the WSLH lab for processing and evaluation. There are no known potential serious risks to the 
health, safety, or welfare of the subject. 
 
If participants have a primary care provider and did not sign a ROI form at intake and at this time would like 
their results sent to their provider, a ROI form will be offered to be filled out and signed. 
 
13.1.5 Sample handling and analysis  
 
Clinician-collected samples will be labeled with study ID, participant initials, date of collection and source of 
collection (cervix) and transported via approved courier to the Wisconsin State Laboratory of Hygiene (WSLH). 
 
Self-collected samples collected using the Evalyn self-collection device will be transferred to a ThinPrep vial for 
storage and transport. The vial will be labeled with study ID, participant initials, date of collection and source of 
collection (vaginal self) and transported via approved courier to the Penn State Health Medical Group 
Laboratory. 
 
13.1.5.1 
HPV testing  
All samples will be processed at the WSLH (if cervical clinician-collected) or Penn State Health Medical Group 
Laboratory (if vaginal self-collected) and tested for the presence of 14 oncogenic/high-risk HPV genotypes 16, 
18, and other (31,33,35,39,45,51,52,56,58,59,66,68) using the CLIA-certified Roche Cobas4800 HPV Test 
System (Roche Molecular Systems Inc., Rotkreuz, Switzerland) according to the manufacturer’s instructions. 
Negative samples with the process control (β-globin) DNA concentration that does not fall within Roche's pre-
determined range will be considered technically inadequate.  
 
Samples will be pre-aliquoted into properly barcoded 13ml round bottomed sarstedt tubes (2ml) for HPV 
primary testing according to the Roche Cobas HPV Test package insert. All samples will be run on the Roche 
Cobas 4800 (for a full HPV workflow following the package insert guidelines). Unsatisfactory results will be run 
a second time per laboratory standard operating procedure. Results of the sample will be reported to MCHH 
using standard operating and HIPAA procedures. All HPV Test run results will be analyzed and checked for 
quality by the Cytology Supervisor. 
 
13.1.5.2 
Pap Smear testing 
Cytological studies, including cell counts, will be performed on the remaining material in the ThinPrep vials 
following WSLH standard operating procedure, summarized as follows. Mono-layer smears will be generated 
on the CLIA-certified Hologic T-5000 platform and stained with Hologic PAP stain using WSLH stain quality 
controls. Initial screening will be performed by WSLH staff cytotechnologists and quality control screening will 
be performed by a qualified QC Technologist with five years or more of experience in GYN cytology. Abnormal 
slides will be reviewed by staff pathologists. Unsatisfactory study samples will be reprocessed at the discretion 
of the WSLH Cytology Director. All cytology samples will be assessed for 1) adequacy (>5,000 cells per slide, 
estimated based on ten fields counted at 400x magnification) and, 2) diagnoses according to Bethesda 
System. Clinician-collected cytology cases will be evaluated as part of the routine clinical flow and results 
reported to MCHH. Cytological results will be grouped as the diagnosis of atypical squamous cells of 
undetermined significance or higher (ASC-US+) and as high-grade dysplasia (HG cytology). Histological 
results will be grouped as the diagnosis of cervical intraepithelial neoplasia 2 or higher (CIN2+), cervical 
intraepithelial neoplasia 3 or higher (CIN3+), and cervical carcinoma (CA). 

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13.1.5.3 
Reporting of results 
All results of the samples will be reported to MCHH using standard operating procedures.  
For vaginal self-collected samples collected using the Evalyn self-collection device, processed by the Penn 
State Health Medical Group Laboratory, additional wording will include “This test was developed and its 
performance characteristics determined by Penn State Health Milton S. Hershey Medical Center laboratory. It 
has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that 
such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded 
as investigational or for research. This lab is certified under CLIA-88 as qualified to perform high complexity lab 
testing. .” 
For cervical samples collected by a clinician using the Dacron Brush and stored in ThinPrep vials, CLIA-
certified and FDA-approved analysis of the liquid cytology on Hologic T-5000 platform and HPV genotype 
analysis on the Roche COBAS platform will be used. 
13.1.6 Follow-up on results 
 
Samples from screening will be sent via courier to the respective laboratory and results forwarded to MCHH to 
follow up on results. All participants will be contact by phone regarding their results. Participants with positive 
results will be asked to return to the community center to discuss the results in-person with MCHH CHWs with 
a clinician from the study team available virtually to answer any questions. Two attempts will be made to call 
the participant via phone and if still not reached, a letter will be mailed to the participant’s home.  
 
All participants regardless of results will be provided a printed copy of their results via mail or in-person. If a 
participant does not have a preferred primary care clinic, additional resources will be given on available 
providers in the area accepting new patients. If participants filled out an ROI form at intake, all results as well 
as brief letter describing the study will be faxed or mailed to the health care clinic. Guidelines for appropriate 
follow up by Society for Colposcopy and Cervical Pathology (ASCCP) standards are outlined through an online 
web application, mobile app, and website (asccp.org/management-guidelines). These management guidelines 
will be followed for interpreting risk of pathology and recommendation of follow up needs.  
 
14. COMPARISON OF USUAL CARE AND STUDY PROCEDURES 
 
Standard of care for women recommended by the ASCCP is screening for cervical cancer starting at age 21 
with pap smear every three years and then co-testing (HPV and pap smear) starting at age 30. American 
Cancer Society (ACS) recommends screening starting at age 25 with primarily HPV only every five years. Both 
societies recommend for screening to continue until age 65 unless history of abnormal results or hysterectomy 
unrelated to cervical dysplasia. 
 
These research procedures follow standard of care as expected for care delivered to participant population at 
UW-Madison/UW Health, regarding clinician collection of samples for cervical cancer screening. In both the 
intervention and control arms of the study, participants will be offered the opportunity for cervical cancer 
screening via a licensed health care professional. The intervention is education and use of self-collection for 
HPV only testing using vaginal swab as an additional method to usual care, i.e., pap smear and HPV testing 
through clinician-collection methods using speculum and cervical swabs (control).  
 
Overall, research has shown self-collection HPV testing as an acceptable method for screening especially in 
hard-to-reach populations, although concerns remain on potential for false negative results.15-19 Participants 
will be informed of this risk and encouraged if opting for self-collection through this method to follow-up with 
their primary care physician for additional screening per recommended guidelines. Reporting of results will 
further specify this comparison to standard procedure (outlined in section 13.1.5.3 Reporting of Results).  
 

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Otherwise follow up recommendations based on results for clinician-collection (outlined in section 13.1.5 
Follow up on Results) is also standard of care, and there will be no delay in care or treatment as a result of 
being in this study.  
 
If patients have a primary care clinic, their results will not automatically flow into their electronic health record. If 
an ROI for the PCP has been filled out (see section 13.1.1 and 13.1.3), copy of the results and 
recommendation for next steps will be provided for continuity of care. Participants will also receive a paper 
copy of their results to maintain for their own records.  
 
15. WITHDRAWAL OF PARTICIPANTS 
 
Subjects are free to withdraw from participation in the study at any time upon request. 
 
Subjects who sign the informed consent form and who do not attend the workshop will be replaced. Subjects 
who sign the informed consent form, and who attend some or all of the workshop, but do not complete surveys 
or screening, or are withdrawn or discontinued from the study, will not be replaced. 
 
16. DATA MANAGEMENT AND CONFIDENTIALITY 
 
16.1 
Project Data Collection 
 
Standardized data collection forms (e.g., source documents, standardized assessment forms, etc.) are used to 
ensure data collected are consistent and compliant with the protocol and IRB application.  
 
Data collection is the responsibility of study team members under the supervision of the Principal Investigator 
(PI). The PI is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the recorded 
and reported data. 
 
All data collection forms must be completed in a legible manner; any missing data will be explained. Data entry 
errors will be corrected with a single line through the incorrect entry and the correct data is entered above/near 
the correction. All changes will be initialed and dated. 
 
16.2 
Data Storage and Maintenance 
 
Data will be stored in compliance with HIPAA regulations on encrypted UW research servers in the Department 
of Family Medicine and Community Health All records including study enrollment information will be housed in 
compliance with regulations indefinitely until the analysis is complete. The process of destroying of these 
records post-analysis will comply with applicable UW or policies for research records. 
 
The study ID, date of workshop attendance, age, zipcode, type of screening done, and screening results will be 
stored in REDCap Institute for Clinical and Translational Research (ICTR). Portable devices will be used to 
access secure web-based application of ICTR’s RedCap. No data will be stored locally on the device. Only 
encrypted devices will be used. 
 
Research Electronic Data Capture (REDCap) is a largely self-service, secure, web-based application for 
building and managing data collection forms. REDCap provides data management functionality by allowing the 
development of instrument and surveys to support data capture for research studies. 
 
Post-workshop survey results will be stored in Qualtrics and not linked to study ID, results will be entirely 
anonymous. Paper copies of the intake form will be stored in a locked location at the Milwaukee Consortium for 
Hmong Health.  
 
16.3 
Confidentiality 
 

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There is a slight risk of loss of confidentiality of participant information to subjects enrolled on study. Records 
will be linked to study ID. Participant identification information will be stored separately and maintained with 
MCHH for purposes of contacting follow up results. Any information regarding participations will be kept 
confidential, and to the extent permitted, will not be publicly available. Information collected will be stored on 
secure, password-protected electronic systems and access will be limited to those involved directly on study.  
 
17. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS 
 
Subject confidentiality and privacy are strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples in addition to 
the demographic information relating to subjects. Therefore, the study protocol, documentation, data, and all 
other information generated will be held in strict confidence.  
 
All research activities will be conducted in as private a setting as possible. Individual rooms will be available at 
the research site for answering intake questions, obtaining informed consent, survey data collection, and for 
sample collection. During workshops, participants will be asked to not to disclose any comments, questions, or 
feedback provided by other participants to anyone outside of the study setting.  
 
All study staff engaged in the conduct of this project have completed training on the protection of human 
subjects and the Health Insurance Portability and Accountability (HIPAA) Privacy Rule. In addition, all key 
personnel (i.e., Principal Investigator, individuals involved in identifying/recruiting subjects, obtaining informed 
consent, or interacting and intervening with subjects) have undergone Good Clinical Practice (GCP) training. 
 
Information about study subjects will be kept confidential and managed according to HIPAA requirements. All 
subjects will sign a combined informed consent and HIPAA authorization form that includes specific privacy 
and confidentiality rights. Study data will be maintained per federal, state, and institutional data policies. 
 
Authorized representatives of the following groups may need to review this research as part of their 
responsibilities to protect research subjects: representatives of the IRB and UWCCC (funding agency). The 
clinical study site will permit access to such records. 
 
18. SHARING OF RESULTS 
Each participant who undergoes cervical cancer screening after the workshop, either through clinician 
collection (if in the control) or self-collection (if in the intervention group), will be contacted by a CHW or 
other staff member of MCHH, and the participant’s results will be given to her. Recommendations will 
be for all women to present in-person although if declines, results will be given via telephone. All results 
will also be mailed to the participant and preferred primary care provider (if applicable).  
Dissemination of findings in this study will be made available in a journal that is yet to be determined 
although will be funded through the sponsor agency and in an open access journal. Authorship plans 
will include at minimum, Drs. Tana Chongsuwat, Megan Fitzpatrick, Jessica Dalby, and Ms. Mayhoua 
Moua as authors, order of authorship to be determined. Subject’s identity will remain confidential on 
presentation of data or publication. 
 
19. DATA AND SPECIMEN BANKING 
 
NA 
 
20. STUDY ANALYSIS 
 
20.1 
Statistical Hypothesis 
 
Participation in cervical cancer screening will be higher among women in the intervention group as compared 
to the control group. 

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20.2 
Sample Size Justification 
 
For this pilot study, we will enroll 250 participants, which is based on the feasibility of the number of workshops 
possible during the program length, funding, and resources available through MCHH.9 Power estimates are 
based on comparing the rate of participation between the intervention arm (participants offered self-collected 
hrHPV) and the control arm (participants offered clinician-collected screening). Estimates of screening rates for 
the Hmong women population (percent that have had a clinician-collected screening in the last 2-3 years) 
range from 61- 81%. As we do not have estimates for rates for Karenni, Karen, Burmese, or Hmong women, 
we will use these estimates for participation rates in the control arm. The table below shows the detectable 
participation rates (and differences between proportions) for the intervention arm for different combinations of 
power (1-β) and values for the control arm from 0.61-0.81, for the hypotheses H0: P ≤ p0 vs. H1: P > p0, where 
p0 is the rate of participation in the control arm, for a sample size of 250 (125/arm), with a one-sided level 0.05 
binomial test.  
 
Detectable Participation Rate (Difference) 
Control 
Participation Rate 
Power 
0.80 
0.85 
0.90 
0.61 
0.77 (0.16) 
0.78 (0.17) 
0.79 (0.18) 
0.71 
0.85 (0.14) 
0.86 (0.15) 
0.87 (0.16) 
0.81 
0.93 (0.12) 
0.93 (0.12) 
0.94 (0.13) 
 
As an example, if there is a participation rate of 0.81 for those offered clinician-collected screening, we will be 
able to detect a rate of 0.93 (a difference of 0.12) in the participants offered self-collected hrHPV with a one-
sided level 0.05 binomial test with a power of 0.85. 
 
20.3 
Statistical Methods 
 
20.3.1 Primary Outcome Measures and Analysis: 
 
The primary outcome measure is uptake of cervical cancer screening. The results will be reported through 
summary statistics of the number of participants in each group subsequently engaging or seeking out cervical 
cancer screening either through services offered after workshop education or self-reported desire to follow up 
through their community health care provider. Comparisons between the study arms will be based on a 
binomial test. The analysis will indicate if participants offered additional self-collection education would be more 
willing to engage in cervical cancer screening. Summary statistics will also include uptake of screening 
differentiated by reported ethnicity.  
 
20.3.2 Secondary Outcome Measures and Analysis 
Qualitative survey data will be obtained through pre- and post-workshop surveys to evaluate the impact of the 
educational workshops.  
 
Further statistical support for this program will be obtained through consultation with statisticians in the UW-
Madison SMPH and/or UW Carbone Cancer Center Biostatistics Shared Resource. For quantitative data, 
differences will be tested with Wilcoxon Rank-Sum tests for continuous or ordinal categorical data, Chi-
Squared tests for unordered categorical data, and binomial tests for dichotomous data.  
 
21. POTENTIAL BENEFITS TO PARTICIPANTS 
 
Potential benefits of the study are linked to the goal of the project – providing access to an alternative method 
for cervical cancer screening through self-collection for HPV testing. In addition, all participants will benefit by 
participating and attending cervical cancer workshops in their native language, led, and sponsored by a trusted 
community organization. This research has the potential to reduce barriers to screening for vulnerable 

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populations such as immigrant and refugee women or other women who do not feel comfortable with clinician-
collection for screening. 
 
22. RISKS TO PARTICIPANTS 
 
This protocol is considered to have a minimal risk to participants. Potential risks of the both collection methods 
(clinician-collected and self-collection)are mild physical discomfort, pain and temporary increase in vaginal 
spotting lasting 1 - 2 days. Risks will be minimized by explicit translated instructions on how to use the device. 
Additional risk of undetected cervical dysplasia is dependent on screening test sensitivity.  
 
This research protocol does subject participants to increased risk of false negative screening tests than usual 
standard of care.  Self-collection has a small increase in false negatives compared to clinician collection due 
sample errors. In a study by Tranberg et al., concordance for HPV detection between self-collected samples and 
clinician-collected samples shows 89% agreement (81% sensitivity, 92% specificity), which is an acceptable 
concordance to justifying offering self-collection to participants in this study.20 
 
23. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF THE PARTICIPANTS 
 
The Principal Investigators (Drs. Fitzpatrick and Dalby) will be responsible for reviewing and monitoring all 
study data and any adverse events. The Principal Investigator will meet with study personnel at least monthly 
to evaluate study progress, including periodic assessments of data quality and timeliness, participant 
recruitment, accrual and retention, participant risk versus benefit, and other factors that can affect study 
outcomes. All unanticipated problems and adverse events that require reporting to the IRB will be reported to 
the University of Wisconsin Madison (UW) Health Sciences-IRB (HS-IRB).  
 
24. ECONOMIC BURDEN TO PARTICIPANTS  
 
Potential costs to participants is travel to and from the community center. 
 
25. RESOURCES AVAILABLE 
 
Will the research be conducted outside School of Medicine and Public 
Health or UW Hospitals and Clinics (e.g. the researcher does not have 
an SMPH research feasibility attestation for this study)?    
X☐ YES (complete 25.1) 
☐ NO (remove text below, but 
retain this section) 
 
Feasibility of recruiting: 
- 
Estimates of Hmong, Karen, and Burmese and Karenni women in the Milwaukee area was calculated 
by using published data from 2019 by the Pew Research Center and population estimate of 50.52% in 
the US population are women.  
- 
Number of Hmong women in the Milwaukee area age 30 to 64 is approximately 2001. 
- 
Number of Burmese women in the Milwaukee area age 30 to 64 is approximately 1273.  
- 
Estimate recruitment will be 80 Hmong, 48 Karen, 48 Burmese and 64 Karenni participants 
- 
These are not true estimates of the number of women in the population we are recruiting from due to 
age and specific ethnicity. Inclusion of women in this study is between age 25-65 and Hmong, Karen, 
Burmese or Karenni. Karenni and Karen is a smaller ethnic group commonly grouped together with 
other ethnic groups categorized in the general Burmese ethnic group. 
- 
Potential participants the research team has access to is not yet determined, although MCHH routinely 
recruits for and conducts educational workshops in which 368 participants were recruited between July 
1, 2020 and June 30, 2021. 
- 
Additional resources and networks will be provided through collaboration with the City of Milwaukee 
Health Department. 
 
Personnel: 

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- 
All personnel who will engage in the study will have appropriate experience, credentials, and training. 
- 
All personnel will have sufficient time available to conduct the research: 
o  
o Primary Investigator Dr. Jessica Dalby will commit 5% of FTE to the research project. 
o Collaborators Dr. Tana Chongsuwat and Mayhoua Moua will commit 20% of FTE each to the 
research. 
- 
All personnel will perform study activities commensurate with their job description and scope of practice 
and will be appropriately supervised and monitored. 
 
Space and Facilities: 
- 
Appropriate approvals and safeguards are/will be in place for both clinical and non-clinical space and 
facilities where study activities may occur. Type and risk-level of procedures have been accounted for 
when selecting space and facilities. 
- 
Location of research activities will be at MCHH’s community center with adequate space to conduct 
workshops activities as well as post-workshop cervical cancer screening. 
 
Availability of medical or psychological resources: 
- 
There will be a medical professional on site for support during and after workshop activities. 
- 
There will be referral to primary care clinicians or other community providers for support of any 
additional medical or psychological needs as a result of this research study. Anticipated psychological 
need will be minimal. More than minimal medical need is anticipated for follow-up of abnormal results, 
this is anticipated and addressed in the protocol.  
 
 
26. MULTI-SITE RESEARCH 
 
NA 
 
27. REFERENCES 
 
1. Wisconsin Department of Health Services. Wisconsin Cancer Data Bulletin. January 2018. 
https://www.dhs.wisconsin.gov/publications/p0/p00379.pdf 
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9. Arrossi S, Paolino M, Laudi R, Gago J, Campanera A, Marín O, et al. Programmatic human papillomavirus 
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https://doi.org/10.1186/s12879-018-3254-y 
 
 

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28. APPENDICES 
APPENDIX A: Milwaukee Consortium for Hmong Health Cervical Cancer Workshop Intake Form 
 
 

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APPENDIX B: Evalyn® Brush (Rovers® Medical Devices, Netherlands) and Instructions 
 
 
 

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APPENDIX C: UW Health Researchers Post-Workshop Satisfaction Survey (UW-PSS) 
 
Due to the number of skip logics, the survey is best viewed through Qualtrics  
Link: https://uwmadison.co1.qualtrics.com/jfe/form/SV_bQT22KcJ9g7Qklw  
 
 

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