SUCCEED: Engaging Black Men in Colorectal Cancer Screening (CRC) Screening
Phase: NA
Conditions: Colorectal Cancer, CRC, Behavior
Sponsor: Virginia Commonwealth University

CLINICAL STUDY PROTOCOL 
 
 
 
 
 MCC-21-18632  
SUCCEED: Engaging Black Men in CRC 
Screening  
NCT05980182  
9/08/2021 
 
 
 

 
Protocol Number HM20023066 
8 September 2021 - version 3 
 
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SUCCEED: Engaging Black Men in CRC 
Screening  
Protocol Number 
HM20023619 
Principal Investigators 
Maria Thomson (VCU) 
Larry Keen (VSU) 
Protocol Version 
8 September 2021 
 
 
 
 
 
 
 
 
 
 
 

 
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VCU Study Personnel 
Principal Investigator 
Maria Thomson 
Email: mthomson2@vcu.edu 
  
Co-Investigator 
 
Research Assistant  
 
Student/RA                                                             
 
 
 

 
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Synopsis 
Purpose 
To determine the unmet needs, attitudes, barriers and facilitators of AA/Black men use of colorectal 
cancer screening and describe how community leaders such as barbers may act as Community 
Champions to educate and facilitate    screening participation. 
Objectives 
Aim 1. Determine factors associated with self-reported CRC screening behaviors among (n=175) 
AA/Black men in Petersburg, VA. 
Aim 2. Develop tailored S2S content for AA/Black men to be delivered using a combination of short 
video and text-based information optimized for delivery via QR codes for smartphones. 
Aim 3. Test intervention on a sample of n=30 AA/Black men who are due for CRC screening.  The 
primary aim is: completed CRC screening (any type) at 3months.  Secondary aims are:  
 to collect process date to assess satisfaction and feasibility.   
H1. Preliminary effectiveness of the intervention will be shown with >60% of men enrolled obtaining a 
CRC screen (any modality) by 12 weeks 
H2. At Week 2 >80% of men enrolled will endorse an intention to be screened 
H3. We will be able to recruit a sample of n=30 men into the intervention and maintain a retention rate 
(completion of baseline, 2 and 12 week surveys) >75% 
Study Population 
Survey Eligibility Criteria: Men aged 45-75 who reside in Petersburg and surrounding counties, and 
identify as AA/Black and have no personal history of cancer. 
 
Intervention: For Aim 3 and additional criterion is that men have to be due for CRC screening upon 
study enrollment 
Number of Participants 
Survey: n=175 
Intervention n=30 
Study Design 
Survey: Cross sectional; qualitative,  
Intervention: single arm, pre-post Social behavioral intervention    
Study Duration 

 
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Survey: 36 months total 
Intervention: Aim 3: 12 months (once enrolled men are on study for three months) 
Outcome Variables 
Please see survey measures 
 
Intervention: Aim 3:  
Primary Outcome:  CRC screening status at 3 months (>60%) 
Secondary Outcomes:  
● Intention to screen at 2 weeks (>80%) 
● Enrollment (target of n=30) 
● Maintain a retention rate (completion of baseline, 2 and 12 week surveys) >65% at 12 weeks 
● Viewing videos (# views, # repeat views) 
● Completion of baseline and follow up questionnaires (retention) 
● Responding to request to contact clinic/navigation services 
● Sharing any content with social network 
 
Locations/Facilities 
Surveys will be completed online 
Recruitment for surveys will take place in-person, using social media, flyers in public spaces 
Intervention: Aim 3: Recruitment will take place with flyers, word or mouth and presentations to 
introduce the study at partner and CAB member places of business and worship. These include 
community health clinics, local gyms, barbershops, stores, churches.  We will use social media, 
newsletters and text messaging avenues of communication as utilized by out community and clinic 
partners.  We will also use radio announcements on local health focused radio shows.   
 
1 - Background/Literature Review 
1.1 Background 
Colorectal Cancer Disparities. In the US, CRC is the third most commonly diagnosed cancer and the 
second most deadly cancer. The CRC incidence (45 vs 39 per 100,000) and mortality (16 vs 14 per 
100,000) in the Virginia Commonwealth University (VCU) Massey Cancer Center (MCC) Catchment 
Area are slightly higher than the US. Compared to whites in the catchment, AA/Blacks experience higher 
incidence of colorectal (42 vs. 37 per 100,000). Notably, 26 of the 65 counties in the MCC catchment area 
are part of Southside VA and it is recognized as a national "hot spot" for CRC where Petersburg City, our 

 
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pilot site is located. Moreover, Petersburg has a large AA/Black population, many of whom experience 
poverty or lower socioeconomic status. 
AA/Black Men's Barriers to CRC Screening. Factors associated with CRC screening include physician 
recommendation, social support, medical mistrust, perceived discrimination, and avoidance. While many 
of these factors (e.g., physician recommendation) are relevant for AA/Black men, several factors such as 
medical mistrust and discrimination may exacerbate screening behaviors. For AA/Black men, avoidance, 
fear, and perceived discrimination contribute to low screening and play a critical role in their healthcare 
utilization, health behaviors, and mortality. Though acknowledged, the extent to which cultural attitudes 
related to avoidance and medical mistrust dissuade participation in preventive CRC screening is unclear. 
Mistrust of the healthcare system and experiences of racial discrimination are associated with lower health 
services utilization among AA/Black patients and is a widely cited attitudinal barrier to CRC screening. 
AA/Black men expressed explicit fears of medical experimentation and uneasiness about the invasiveness 
of colorectal cancer screening procedures (e.g., colonoscopy). Therefore, CRC interventions tailored for 
AA/Black men must address concerns of medical mistrust and discrimination. Studies have indicated that 
social support is correlated with having a colonoscopy. Kinney et al., found that the association between 
social connection and CRC screening was stronger for AA/Blacks than for whites. Interventions 
promoting CRC screening exist but few addressed the unique needs of AA/Black men. 
 
2 - Rationale/Significance/Problem Statement 
2.1 Rationale 
This project will address CRC screening among AA/Black men within the MCC catchment area. This is 
significant because AA/Black men remain a dramatically underserved group that has not equally 
benefited from existing colorectal cancer (CRC) education or screening interventions. Moreover, within 
the MCC catchment area is one of three enduring national CRC hotspots. 
2.2 Significance 
Clinically, this is significant because AA/Black men remain a dramatically underserved group that has not 
equally benefited from existing colorectal cancer (CRC) education or screening interventions. Moreover, 
as MCC is a member of the National Outreach Network (NON), an efficacious mHealth Screen to Save 
(S2S) for AA/Black men would have population-level impact through scalability to all NON CHEs. The 
proposed study will fill a gap in translational research by conducting qualitative and survey research pilot 
work to inform the tailoring of an existing screening intervention, Screen 2 Save, to develop and test an 
enhanced mHealth S2S intervention culturally tailored for African American (AA)/Black men. The 
testing of the intervention will be conducted as part 2 and will not begin until an amendment is approved 
by the IRB. 
3.1 Purpose 
While many factors associated with CRC screening (e.g., clinician recommendation) in the general 
population may also be relevant for AA/Black men, certain factors may be exacerbated and/or unique to 

 
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them. For example, medical mistrust and expectations of poor care due to perceived discrimination and 
racism, attitudes about the value of preventive care and concerns about test invasiveness and fear can 
dissuade screening, particularly for colonoscopies, as screening can be considered intrusive and 
embarrassing. Supportive social networks (e.g., friends, community leaders) may endorse and encourage 
the prioritization of personal preventive health behaviors while simultaneously attenuating fear and 
embarrassment that impede screening uptake. The lack of detailed empirical data about relationships 
among these factors and how they influence CRC in AA/Black men has hampered progress in the field. 
This study will collect in-depth information about AA/Black men's CRC screening practices and collect 
data necessary for the adaptation and development of a mHealth Screen 2 Save intervention to increase 
CRC screening among AA/Black men in Petersburg and Richmond, VA.   
3.2 Hypothesis 
H1.1. Lack of social support, higher medical mistrust, and perceived discrimination will be negatively 
associated with self-reported guideline concordant screening behaviors. 
H2.2. Higher engagement in preventive care behaviors and greater perceived risk will be associated with 
higher completion of CRC screening. Subaim1a. Examine potential interactions between perceived 
discrimination, medical mistrust and engagement in preventive care behaviors. 
H1.3. Increased perceptions of discrimination and greater medical mistrust will attenuate the relationship 
between preventive care and guideline concordant screening. 
3.3 Objectives 
Aim 1. Determine factors associated with self-reported CRC screening behaviors among (n=175) 
AA/Black men in Petersburg, VA. 
 
Aim 2. Develop tailored S2S content for AA/Black men to be delivered using a combination of short 
video and text-based information optimized for delivery via smartphones. 
 
Aim 3. Test intervention on a sample of n=30 AA/Black men who are due for CRC screening.  The 
primary aim is completed CRC screening (any type) at 3months.  Secondary aims are to collect process 
date to assess satisfaction and feasibility.   
 
4 - Study Participants 
4.1 Study Population 
AA/Black men remain a dramatically underserved group that has not equally benefited from existing 
colorectal cancer (CRC) education or screening interventions. African American/Black men experience 
20% higher incidence, 45% higher mortality, have the shortest CRC survival rates of all racial/ethnic 
groups. CRC screening participation rates among Black men are 10%-30% lower than other groups. The 
focus of this project is to: PART 1: identify risk factors associated with screening behaviors in Black men 

 
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and, PART 2 (not submitted yet): develop a scalable mobile Health (mHealth) tailored S2S intervention to 
address those factors that keep Black men from completing CRC screening. Therefore, we focus on 
recruiting Black men only. 
4.2 Number of Participants 
 We require 8-10 men for the Community Advisory Board and we require n=175 Black or African 
American for survey in PART1.  The intervention component will require n=30 men  
 Total study n=225 
The survey component was powered on the interaction term "discrimination*preventive care 
engagement", both continuous, using a simulation study of 1000 runs of a logistic regression model, with 
the binary screening behavior response (1 = screened, 0 = not screened). A sample size of 175 subjects 
generates 80% power to detect a "small to moderate" effect size of 0.38 (corresponding odds ratio = 2.01, 
using R package "effect size") for the interaction term (continuous*continuous), at 5% level of 
significance, using a one-sided Z-test. To account for individuals who start but do not complete the 
survey we have added a buffer of 20% which gives a sample size of n=210 for the survey.  The sample 
size has been chosen for the intervention to support an initial examination of intervention effectiveness 
using a one-arm design. This is a typical size that will generate pilot data on the feasibility of our 
approach. 
4.3 Selection Criteria 
Survey Eligibility Criteria: Men aged 45-75 who reside in Petersburg and identify as AA/Black and have 
no personal history of cancer. 
CAB/Focus Group Criteria: adult men, identify as Black or African American, work or live in a 
Petersburg VA or surrounding counties and are interested in participating. They do not need to meet 
requirements for population based CRC screening. 
 
Intervention Aim 3:  adult men, identify as Black or African American, work or live in a Petersburg VA, 
aged 45-74, eligible for CRC screen at study enrollment  
4.4 Recruitment Procedures 
Recruitment Procedures Survey: 
Recruitment will use a multipronged approach including community advertising, social media, word of 
mouth and leveraging of our community partners. 
 
1.) Onsite at barbershops, Health Living and Learning Center (HLLC) and other community partner sites: 
Supervised by the research team, graduate and undergraduate students will be introduced to community 
partners and trained to introduce the study to potential participants who visit partnership businesses and 
organizations across the City of Petersburg. Project personnel will have a regular, weekly presence at each 
community partner site to build recognition and recruit to the survey. 
 

 
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2.) Additional recruitment pathways include distribution of study advertisements. These will be posted 
physically at various community locations and include a URL and QR code that enable access to the 
survey. We will also leave study information postcards (same URL and QR code) for distribution by 
community partners. We will also ask community partners with email lists, regular newsletters and other 
similar distribution lists to send out information about the study on their listservs. 
 
3.) Social Media: distribution of study and survey advertising (including a link to the survey) using various 
social media platforms(e.g., direct recruitment via Facebook ads, posting information on VCU, VSU, and 
community partner social media accounts). 
 
4.) Referral of friends (snowball) participants who complete the survey will have the option of completing 
a quick and seamless electronic recommendation for friends or family to consider participating. 
 
5) Clinic partners.  We have partnered with CVHS which has 4 clinics in the Petersburg city and 
surrounding counties.  We will advertise in the clinic waiting rooms, staff at the clinics will hand out flyers 
for the study, and we will use any newsletters distributed by the clinic including playing our video on the 
television in the waiting rooms and sending invites to learn more via the text messaging system the clinic 
uses to distribute public health information, updates and health messages.  
 
4.5 Risks 
Subject confidentiality will be protected by storage of all data (survey data, focus group recordings) using 
a unique research identification number. Data will be stored in a VCU secure database with limited, 
monitored access by the research team only. Identifiable information will not be collected for survey 
participants. We believe that the unauthorized or accidental release of study data is extremely unlikely 
given the precautions that will be taken to minimize such an event. 
Confidentiality with focus groups will be maintained using the VCU ZOOM account, storage of the 
recordings on VCU secure servers with limited access by study staff only on password protected and 
VCU owned computers. Participants will be asked to identify themselves using any made up name they 
choose. 
Personal discomfort is a possibility given the subject matter. If someone is uncomfortable they do not 
have to continue to participate or answer any survey or focus group questions that they do not want to. 
They can also opt to obtain assistance with navigation to screening services without participating in the 
study. 
 
4.6 Anticipated Benefits 
No direct anticipated direct benefits beyond learning new information about CRC prevention and 
screening.  

 
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The screening intervention may identify previously unknown precancerous lesions or CRC that need to 
be treated.  
4.7 Vulnerable Populations 
NA 
4.8 Consent/Assent Procedures 
1. We will use an information form that covers all basic elements of consent.  We are requesting 
waiver of all elements of consent for both the survey and the focus group. The survey collects 
non-identifiable information about attitudes, beliefs and behaviors related to cancer prevention 
and CRC cancer screening. This will be collected anonymously. The focus groups are small, 
completed using video conferencing (VCU ZOOM) and will use pseudonyms. The content of 
the focus groups will be to understand what barbers think the the training needs for becoming a 
CRC CHamP (i.e., a community resource for information), insights about program marketing 
and recruitment, how COVID-19 may affect their ability and interest in participating and 
recruiting. The focus group evaluating the initial QR code intervention will inform the research 
team on how to tailor the intervention to Black men age 45-75. These are not private 
information. The consent form would be the only identifying information being collected for the 
survey participants. The survey responses will be anonymous. 
2. The intervention will use a self-administered consent form that participants will complete on 
their own through the mHealth application (the app).  
 
5 - Study Design 
5.1 Study Design 
Cross sectional survey and focus groups 
Aim 3: single arm, pre-post intervention 
5.2 Study Duration 
36 months 
5.3 Outcome Variables 
Please see the survey measures 
Aim 3:  
Primary Outcome:  CRC screening status at 3 months 
Secondary Outcomes:  
● Enrolment  
● Viewing videos (# views, # repeat views) 
● Completion of baseline, 2 week and 12 week questionnaires (retention) 
● Completing values elicitation activity  

 
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● Responding to request to contact clinic/navigation services 
● Sharing any content with social network 
 
5.4 Study Procedures 
Survey  
The survey will be a self-administered electronic survey (e-survey) expected to take 15-20 minutes to 
complete. Using a secure HIPAA compliant VCU Redcap survey housed on a VCU server, a unique 
survey link will be provided to interested participants (via email or QR code available on flyers and social 
media messaging). The secure, unique link will include a screener to determine eligibility, a self-
administered information form with consent elements followed by the survey. Participants who complete 
surveys will receive an electronic gift card of $20 sent to an email provided by the respondent.  
 
Focus Groups: 
Local barbers currently working in a Petersburg or Richmond Barbershop; will be recruited for focus 
groups.  Barbershops are an excellent way to gain intervention 'reach' among our target population, Black 
men. Barbers within the Petersburg area will be recruited from one of the four community partner 
barbershops that agree to participate in the study. Barbers will be approached in-person at the shop by a 
member of the research team) who will visit shops to introduce the study and ask permission to leave 
study information and/or come back to talk to the group. Focus groups will be conducted virtually using 
smartphone accessible VCU Zoom and will be video recorded, with permission. Participants will engage 
in a 60-90-minute discussion. 
 
Aim 3 Intervention:  
Men will be invited to participate using all methods outlined above.  Men who are interested will be 
directed to download the app to their personal device.  Once the app is downloaded participants are able 
to self-direct through the screening process.  If requested, a study member can assist with downloading 
the app and navigating through to the study screener.   
Potential participants will be asked to complete a screener to ensure all eligibility criteria are met.  Those 
who do not meet eligibility will be thanked for their time and navigated to an exit screen.  For those who 
are eligible, they will next be asked to complete the consent process.  After they consent, they will be 
navigated to the baseline questionnaire.  Once completed, they will be able to access all other content 
(videos, infographics, request link to receive a call from screening navigation, additional surveys for values 
elicitation).   
 
One week after enrollment, men who have not engaged with the materials, completed the baseline 
questionnaire, or the navigation request will receive a text message aligned with the CRC risk perception 
and/or values elicitation that they shared with us at baseline.  See table below.  

 
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Question:  Which best describes your thoughts about colorectal cancer?  
PARTICIPANT RESPONSE 
AUTOMATED, TAILORED ANSWER 
Never heard of it 
Video # may interest you because it talk about 
CRC is and why screening can save your life! 
  
Heard of it but not interested in screening  
  
You might be interested to hear about the 
experiences of a CRC survivor.  Video xx is 
“name” telling his story.  
Heard of it and thinking about getting screened 
  
You may want to check out video #, because it 
goes over the different types of screening options.  
The best one is the one that gets done! 
Decided not to get screened 
  
You might be interested to hear about the 
experiences of a CRC survivor.  Video # is 
“name” telling his story.  Video # also describes 
the many different screening options.   
Decided to get screened 
  
Inside the app there is a way to ask for a local 
clinic or screening navigator to call you directly. 
Check it out! 
Have been screened in the past, but not recently 
The best CRC screening test is the one that gets 
done!  You may be interested in talking to a 
screening navigator. Inside there is a way to 
request a phone call from a local clinic. 
 
Follow up:  A three months after enrollment men will receive the final survey in their app and a text 
message notifying them that it is ready to be completed.  Anyone who does not complete this survey 
within two weeks will be contacted by telephone by a study team member and given the option to 
complete it over the phone, have it emailed to them or to complete it in the app.    
 
 

 
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Table 2. Measures for intervention  
Timing 
CRC 
risk 
percepti
on  
Demogr
aphics  
Health 
literacy 
(1 item)  
Reg 
source 
of 
primary 
care  
(1 item) 
Health 
status 
Intentio
n to 
screen 
Screen 
status  
CRC 
knowled
ge  
Medical 
mistrust  
 
Baseline 
X 
x 
x 
x 
x 
x 
 
x 
x 
 
2 weeks 
X 
 
 
 
 
x 
 
x 
x 
 
12 
weeks  
X 
 
 
 
 
x 
x 
x 
 
 
 
 
5.5 Withdrawal Procedures 
Participants can exit the browser at any time for both the survey and focus groups. Once the data has 
been collected participants will not be able to have their data erased (surveys are collected anonymously).  
 
To withdraw from the intervention participants must contact one of the study PIs in writing.  
5.6 Locations/Facilities 
All study procedures will occur online 
5.7 Data Collection 
The survey will be a self-administered electronic survey (e-survey) expected to take 15-20 minutes to 
complete. Using a secure HIPAA compliant VCU Redcap survey housed on a VCU server, a unique 
survey link will be provided to interested participants (via email or QR code available on flyers and social 
media messaging).  
Focus Groups: Participants (n=16) will be barbers employed at one of the four community partner 
barbershops. Two virtual focus groups of 6-8 barbers will be conducted. Focus groups will be conducted 
virtually using smartphone accessible VCU Zoom and will be video recorded, with permission. 
Participants will receive a $20 honorarium for the 60-90-minute discussion. 
Intervention: Baseline, 2 and 12 week follow up surveys will be collected on the app.  If men do not 
respond to the follow up survey on the app they will be contacted by a study team member and provided 
alternatives for completion (see study procedures above).  
5.8 Data Collection Sources 
Survey Measures. The survey has been designed to obtain key information while minimizing participant 
burden. Demographics: age, sex, highest attain ed education, annual household income, employment status, 
and marital status; health literacy (1 item); health status (1 item). 

 
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Medical Mistrust. measures (1) suspicion, (2) group (racial) disparities in health care, (3) lack of support 
from health care providers.  
Perceived Racial Discrimination. Everyday Discrimination Scale reflect day-to-day experiences of unfair 
treatment. Higher scores corresponded to more frequent experiences of racial discrimination; 
Preventive health care behaviors: The Good Health Practice Scale,63 a 16-item scale that measures key 
preventive health behaviors. This scale has been shown to assess the avoidance of preventive health 
behaviors. 
Social Support: MOS-SSS aims to assess the extent to which a person has the support of others to face 
stressful situations. 
CRC Test fear and invasiveness and Cultural Attitudes about Masculinity: Males Role Norms Inventory-Short 
Form (MRNI-SF) is a 21-item questionnaire that assesses conformity to dominant cultural norms of 
masculinity (avoidance of femininity, negativity towards sexual minorities, self-reliance through 
mechanical skills, toughness, dominance, importance of sex, restrictive emotions). High total scores 
indicate greater conformity to traditional norms of masculinity 
CRC Risk Perceptions. Lifetime risk of developing CRC will be asked on a 0-100% scale and a likert 
response adapted from the NIH HINTS. 
Colorectal Cancer Screening Behaviors. Assessed using questions vetted by the national Behavioral Risk Factor 
Surveillance System we will measure those who have ever been screened and those who are up-to-date 
with screening 
 
Focus Group: A focus group interview guide has been developed to inform how the barbers can be 
engaged to introduce the intervention, be empowered to have conversations about the need for CRC 
screening among Black men and encourage men to engage with the QR code and intervention materials. 
 
Intervention.  
1. Measures.  See Table 2 above for all measures and timing of collection for the intervention. 
a. Outcomes measures 
i. CRC screening status (>60%) OR 
ii.  Intention to screen (>80%): from S2S  
b. Covariates 
i. Perceived CRC risk: CRC Risk Perceptions. Lifetime risk of developing CRC will 
be asked on a 0-100% scale and a likert response adapted from the NIH HINTS 
ii. CRC knowledge: from S2S 
iii. Medical mistrust: Medical Mistrust. measures (1) suspicion, (2) group (racial) 
disparities in health care, (3) lack of support from health care providers. 
iv. Value elicitation 
v. Health Literacy-1 item 
vi. Regular source of primary care -1 item 

 
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vii. Health status -1 item 
 
Demographic information: age, highest attained education, annual household income, employment status, 
and marital status; family history of cancer)   
2. User engagement data collected from Pattern Health to determine the number times, number of 
minutes and which content pieces were interacted with in the app environment.  
a. Enrolment  
b. Videos viewed (# views, # repeat views) 
c. Completion of baseline and follow up questionnaires (retention) 
Completing values elicitation activity  
d. Responding to request to contact clinic/navigation services 
e. Sharing any content with social network 
5.9 Standard Tools 
See survey measures for complete list 
 
6 - Statistical Analysis 
6.1 Sample Size 
The survey component was powered on the interaction term "discrimination*preventive care 
engagement", both continuous, using a simulation study of 1000 runs of a logistic regression model, with 
the binary screening behavior response (1 = screened, 0 = not screened). A sample size of 175 subjects 
generates 80% power to detect a "small to moderate" effect size of 0.38 (corresponding odds ratio = 2.01, 
using R package "effect size") for the interaction term (continuous*continuous), at 5% level of 
significance, using a one-sided Z-test. To account for individuals who start but do not complete the 
survey we have added a buffer of 20% which gives a sample size of n=210 for the survey. 
We will also conduct focus groups with n=16 men. 
Total project sample size n=226 
Intervention Sample Size: To perform an initial test of efficacy, satisfaction and feasibility, we will test 
the intervention on 30 men.  
 
6.2 Intervention Planned Analyses 
 
Analysis. All variables will be described using standard methods for continuous and discrete variables 
and examined for completeness. An interaction effect of discrimination and engagement in preventive 
care will be assessed, controlling for other confounders, using a logistic regression model with the binary 

 
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response (cancer screening). Additional analysis will be conducted, controlling for demographics, via a 
random intercept logistic regression model. Parameter significance will be determined at the 5% level.  
Research measures collected at baseline, exit and 12 weeks post are: CRC knowledge, risk 
perception, medical mistrust, preventive health behaviors. At 12 week only, CRC screening or 
intent to screen, and participant satisfaction with the intervention will be asked. Process 
evaluation will assess any change in CRC knowledge, risk perception, medical mistrust, and 
preventive health behaviors at 12 weeks. 
  
Feasibility will be assessed using a priori benchmarks for recruitment and retention. The  
recruitment benchmark will be consenting 100% of the recruitment goal. Acceptance rates and 
reasons for declining participation will be tracked. Information on refusals will be used to modify 
recruitment methods as needed. Retention benchmarks will be supported if >=65% complete 
both weeks 2 and 12 follow up. Engagement benchmarks will be supported if >=65% of 
intervention completers who do not have a primary care provider chose to receive navigation 
services; 80% of those consented view intervention materials (e.g., click on text/graphical data, 
view videos, complete risk assessment). 
  
Preliminary Efficacy. A signal for efficacy will be considered positive if among those who 
complete the intervention a) most (≥60%) complete CRC screening and b) >80% acknowledge 
their intent to get screened.  
  
Follow-up interviews.  Interviews will be conducted with all participants to collect in-depth, 
descriptive feedback on satisfaction with the intervention content, delivery modalities, ease of 
use and usefulness. We will also interview clinic staff and Community Champions to gain insight 
into facilitators and barriers to recruitment efforts and response of the community to the 
intervention.  Suggestions for additions and alterations will be solicited from all interviews.    
 
6.3 Data Relevance 
Please see Section 2 
6.4 Data Coding 
Data analysis plan for focus groups. Video recorded focus groups will be analyzed using Max QDA, a 
qualitative data analysis software that enables seamless coding of text, video and picture based media. 
Qualitative analysis will proceed using Corbin and Strauss' constant comparative method. This method 
involves several coders (n=3), breaking down the data into discrete units and coding them to categories 
that reflect the language and concepts of the study participants. Weekly coding meetings will occur to 
discuss coding progress. Disagreements will be discussed until resolved. 
6.5 Data Analysis Tools 

 
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MaxQDA for Focus groups 
Statistical packages for survey and intervention (e.g., SAS, SPSS, R)  
6.6 Data Monitoring 
Redcap will be enabled to allow participants to skip questions (non-response option available) but they 
cannot advance through unless a choice is made. This will eliminate missing data while ensuring 
participants the ability to skip questions they do not want to answer. Incomplete surveys will be mitigated 
by survey creation to keep the survey short, use known presentation methods to ensure usability,  
comprehension and comfort reading.  Missing data will be assessed and managed using standard 
procedures.  
Verbatim transcripts will be produced form the focus groups.  
 
7 - Data Handling and Record Keeping 
7.1 Subject Data Confidentiality 
 
Survey: Will be completed without collection of identifying information (names, contact, IP address). 
Electronic gift cards will be issued after completion of the survey to an email address provided by the 
participant and will not be linked to the data collected.  
Focus group: we will use pseudonyms for the recorded VCU ZOOM focus groups 
 
No link between the focus group participant PHI and data will be made. We will not keep a key that links 
the pseudonym with the demographic data collected. 
7.2 Data Quality Assurance 
See above 
7.3 Data Storage/Security 
The survey will be a self-administered electronic survey (e-survey) expected to take 15-20 minutes to 
complete. Using a secure HIPAA compliant VCU Redcap survey housed on a VCU server, a unique 
survey link will be provided to interested participants (via email or QR code available on flyers and social 
media messaging). The secure, unique link will include a screener to determine eligibility, a self-
administered information letter outlining consent items followed by the survey.  
7.4 Study Records 
VCU Redcap and VCU secure servers will be used to store all study data.  Only study personnel will have 
access to the study data.  
7.5 Retention of Records 
The records will be kept secured and for the length of time necessitated by funder/sponsor.  

 
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8 - Study Considerations 
8.1 Research Personnel Training 
All personnel will  maintain CITI training and records will be kept by study coordinator. 
Dr. Thomson will oversee training of the focus group moderators.  
8.2 Unanticipated Problems and Protocol Deviations 
Will be reported to the IRB according to regulations.