Reducing Barriers and Sustaining Utilization of a Cervical Cancer Screening Program in Rural Senegal
Phase: NA
Conditions: Cervical Cancer, Behavior
Sponsor: University of Illinois at Chicago

 
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Reducing barriers and sustaining utilization of a  
cervical cancer screening program in rural Senegal 
 
 
PI: Andrew Dykens, MD, MPH 
 
 
Affiliation(s) 
 
University of Illinois at Chicago 
Institute for Health Research and Policy 
Department of Family Medicine, College of Medicine,  
Center for Global Health 
1919 W. Taylor Chicago IL USA 
Tel (573) 355 - 0452 
Andrew Dykens [ jdykens@uic.edu ] 
 
Université Cheikh Anta Diop, Dakar, Senegal 
Cancer Institute & Institute of Health and Development 
BP: 16390, Dakar, Sénégal 
Pr. Abdoul Aziz Kasse, MD [ aakasse@me.com ] 
 
Sénégal Ministère de la Santé et l‘Action Sociale Département de Recherche 
Fann Résidence. Rue Aimé Césaire. BP 4024, Dakar, Sénégal 
Youssoupha N’Diaye, MD, MPH, PhD [ youlebou@gmail.com ]  
 
 
 
 
 
Sponsor 
NIH FIC 1K01TW010494-01 
 
 
 
 

 
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PERFORMANCE SITES 
University of Illinois at Chicago (LEAD SITE) 
Institute for Health Research and Policy 
Department of Family Medicine, College of Medicine,  
Center for Global Health 
1919 W. Taylor Chicago IL USA 
Tel (573) 355 - 0452 
Andrew Dykens [ jdykens@uic.edu ] 
 
Université Cheikh Anta Diop, Dakar, Senegal 
Cancer Institute & Institute of Health and Development 
BP: 16390,  
Dakar, Sénégal 
Pr. Abdoul Aziz Kasse, MD [ aakasse@me.com ]  
 
Sénégal Ministère de la Santé et l‘Action Sociale Département de Recherche 
Fann Résidence. Rue Aimé Césaire. BP 4024, Dakar, Sénégal 
Youssoupha N’Diaye, MD, MPH, PhD [ youlebou@gmail.com ]  
 
 
 
 
 

 
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List of Abbreviations  
 
 
ANOVA 
 
Analysis of Variance 
BL 
 
 
Baseline 
CG  
 
 
Care Group 
CITI 
 
 
Collaborative Institutional Training Initiative 
CHW  
 
Community health workers 
Co-I 
 
 
Co-Investigator 
Co-PI  
 
Co-Principal Investigator 
COPE  
 
Client-Oriented, Provider-Efficient Quality Improvement Program 
DCI 
 
 
Data Collection Instrument 
FG 
 
 
Focus group 
FIC 
 
 
Fogarty International Center 
IC 
 
 
Informed Consent 
IRB 
 
 
Institutional Review Board 
ISED  
 
Institut de Santé et Développement (Institute of Health and Development) 
LMIC  
 
Low- and Middle-Income Country 
MD 
 
 
Medical Doctor 
MG 
 
 
Moderator Guide 
MPH  
 
Master of Public Health 
MSAS  
 
Sénégal Ministère de la Santé et l‘Action Sociale  
NIH 
 
 
National Institutes of Health 
OPRR  
 
Federal Office for Protection from Research Risks 
OPRS  
 
Office for the Protection of Research Subjects 
PCV 
 
 
Peace Corps Volunteer 
PhD 
 
 
Doctor of Philosophy 
PI 
 
 
Principal investigator 
RA 
 
 
Research assistant 
RIS 
 
 
Research Information Sheet 
RS 
 
 
Recruitment Script 
SAE 
 
 
Serious Adverse Event 
SD 
 
 
Standard Deviation 
SSL EV  
 
Secure Sockets Layer Extended Validation 
UCAD  
 
Université Cheikh Anta Diop, Dakar, Senegal 
UIC 
 
 
University of Illinois at Chicago 
US / USA 
 
United States of America 
VIA  
 
 
Visual inspection of the cervix with acetic acid 
WHO  
 
World Health Organization 
 
 

 
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1.0 
Research Summary/Abstract 
GOAL: The goal of this study is to strengthen the implementation of a cervical cancer screening service in a 
decentralized, low-resource area of Senegal naïve to any cancer screening programs by investigating the 
barriers and facilitators of initial uptake and developing and adapting a peer education health promotion 
intervention to diverse and dynamic contexts to achieve sustained utilization. 
RATIONALE: Equitable Access to many women’s health services is lacking in low and middle income 
countries (LMIC), especially cancer prevention programs. Two of the top five World Health Organization 
priorities in cancer control and prevention research are to 1) reduce access barriers to the diagnosis of curable 
cancers and 2) apply cancer prevention strategies in the context of local culture and resources. Senegal ranks 
15th in the world in cervical cancer incidence. However, the estimated participation rate for cervical cancer 
screening in Senegal (where incidence peaks between the ages of 45 and 54) is very low; 1.9% for women 
ages 40 to 49 and 0% for women over the age of 50. Since 2010 a partnership between the rural Kedougou 
Regional health system, the Cheikh Anta Diop University, the University of Illinois at Chicago, and the U.S. 
Peace Corps that has implemented a cervical cancer screening program. We have implemented a technical 
approach that has been proven affordable and effective in low-resource settings: visual inspection of the cervix 
with acetic acid (VIA). We made the screening service available to over 18,300 women region-wide by 2014. 
However, the utilization by eligible women, especially the high-risk older cohort, was very low. In 2014, only 
509, roughly 5% of eligible women targeted through a mass campaign that year, were screened and only 10% 
were 45 years or older. I am currently conducting research investigating the supply-side (health service level) 
determinants of cervical cancer screening access in the Kedougou region to determine the extent to which 
screening availability is responsible for the low screening rates.  
This research project will investigate the determinants of cervical cancer screening uptake and sustained 
utilization in this region and develop and evaluate a context-specific peer education behavioral intervention to 
improve uptake. Research supports the effectiveness of peer education in increasing cancer screening rates 
but, currently, no cervical cancer screening peer education program specific to rural Senegal exists. To inform 
the participatory development of this program, we will assess barriers and facilitators of screening at multiple 
levels: individuals (women aged 30 to 59), households (family or principle social unit of at-risk women), and the 
community (immediate village or neighborhood with common amenities of at-risk women). We hypothesize 
that a peer education program that adapts to changing contexts over time and is targeted at a multi-
level audience will result in early, widespread uptake and sustained use of the VIA cervical cancer 
screening program. Study findings will inform programmatic planning in Kedougou and the peer education 
curriculum we develop can serve as a template for maximizing early impact of new cervical cancer screening 
services implemented in other areas of rural Senegal. Our long-term goal is to inform national-level policy to 
guide the implementation of cervical cancer screening programs in other rural Senegal regions. 

 
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BACKGROUND 
Globally, there are over a half a million new cases of cervical cancer yearly, with nearly 90% of these cases in 
less developed nations.31 The cervical cancer incidence rate in Senegal (41.1)33 is over five times greater than 
that of the U.S. and Senegal ranks 15th in the world in the age-standardized incidence rate of cervical cancer.34 
When detected at an early stage, invasive cervical cancer is one of the most successfully treated cancers. The 
five year cervical cancer survival rate ranges from 60% to 70% in most countries.35 Furthermore, technological 
innovation and efficacy testing of health service interventions including screening programs36,37 has led to clear 
recommendations for improving cancer control.38-40 However, the implementation of evidence-based cervical 
cancer screening programs is slow. Because of this, the estimated participation rate for cervical cancer 
screening in Senegal is low (6.9% of all women ages 18 to 69), especially in rural areas and in older age 
groups (1.9% of women ages 40 to 49 and 0% of women 50 or above).42,43 Cervical cancer is an indicator of 
larger health system problems including poor access and the lack of culturally competent communication; 
factors that disproportionately affect poor women.44 This is illustrated by the large majority of rural 
Senegalese women currently having no access to cervical cancer screening. 
Preliminary Work in Kedougou: The University of Illinois at Chicago (UIC) has partnered with Kedougou, 
Senegal Regional Direction of the Ministry of Health and Social Affairs (MSAS) and Peace Corps Senegal 
since 201011 to improve access to cervical cancer screening. Between 2010 and 2013, this partnership worked 
to provide cervical cancer screening access to an estimated 18,305 women across the far southeastern rural 
Kedougou region. We implemented regional-level cervical cancer clinical guidelines, introduced the 
EngenderHealth-developed Client Oriented Provider Efficient (COPE®) cervical cancer quality improvement 
process,45-47 and trained 63 health workers in the evidence-based screening technique of visual inspection of 
the cervix with acetic acid (VIA). VIA is performed by applying a vinegar solution to the cervix followed by a 
“naked-eye” visual inspection to identify precancerous lesions which are then treated through freezing. The VIA 
screening test has a sensitivity of 80% (79-82%) and a specificity of 92% (range, 91-92%)48 and has been 
proven to be safe and cost-effective.49-51  

 
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Scientific Rationale 
The goal of this study is to inform the sustainable implementation of cervical cancer screening services in low-
resource areas of Senegal naïve to cancer screening programs by  
1) investigating the access barriers and determinants of initial uptake and  
2) developing and adapting a peer education health promotion intervention to diverse and dynamic contexts to 
achieve sustained utilization.  
The study goal will be achieved through a partnership between the local communities and health system in 
Kedougou, Senegal; Peace Corps Senegal; the Cancer Institute and the Institute of Health and Development 
(ISED) at Cheikh Anta Diop University in Dakar, Senegal; and the University of Illinois at Chicago (UIC).  
Framework: Implementation Science is the study of how proven technical solutions are applicable to real 
world settings. We will study how the implementation of VIA, as a proven intervention, can be optimized and 
how the screening service can best “fit” into the local context.58 Established complementary frameworks will 
guide our study. We will apply  
1) the Patient-Centered Access Framework to assess the demand-side barriers and facilitators of uptake 
in aim 1,  
2) the Integrated Theory of Health Behavior Change to evaluate how a peer education program facilitates self-
management behavior of women in aim 2, and  
3) the Dynamic Sustainability Framework to evaluate the initial uptake and sustained utilization of the 
health service in aim 3.  
We seek to understand the dynamic nature of the influential factors within the local context and the process by 
which we can facilitate responsive adaptations to the intervention in order to reduce barriers, maximize early 
uptake, and sustain utilization.  
Overview of Study Data Collection: To achieve all aims, we will conduct a cluster-randomized stepped 
wedge study across three representative clusters (each containing a district center and two rural sites) in the 
Kedougou region.  For each aim we will collect data at baseline and at 6-month intervals in each cluster (data 
collection intervals coincide with the initiation of the intervention in a new cluster). In aim 1, we will develop 
(through a participatory approach), pilot, and conduct surveys and interviews of eligible clients as well as focus 
groups (FG) (women ages 30-44 and 45-59) and interviews of men (ages 30-59). For aim 2, we will describe 
the development, piloting, implementation, and adaptation of an aim 1-informed context-specific multi-level 
peer education curriculum across clusters through the stepped wedge approach59,60 in the Kedougou region. 
We will collect quantitative program reach data and qualitative process evaluation data at each time period. 
These data will be used to adapt the intervention over time. To achieve aim 3, we will collect aggregated health 
service level utilization data and individual surveys.   
 

 
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Research Goals and Aims 
BROAD GOALS OF THE RESEARCH 
The goal of this study is to strengthen the implementation of a cervical cancer screening service in a 
decentralized, low-resource area of Senegal naïve to any cancer screening programs by investigating the 
barriers and facilitators of initial uptake and developing and adapting a peer education health promotion 
intervention to diverse and dynamic contexts to achieve sustained utilization. 
Through the SPECIFIC AIMS, we will  
Aim 1: Assess cervical cancer screening access determinants in Kedougou, Senegal by identifying barriers 
and facilitators of service uptake over time at the person, household, and community levels;  
Aim 2: Develop and deploy a wide-reaching, multi-level responsive peer education curriculum aimed at 
motivating eligible women to seek cervical cancer screenings in Kedougou, Senegal;  
Hypothesis: A cervical cancer peer education curriculum developed, implemented, and adapted 
through a Care Group model will reach 75% of the target audience, improve cervical cancer knowledge, 
and establish the rate of women and men recommending this screening service to others to 30% over 
the course of 24 months in the region of Kedougou, Senegal; and 
Aim 3: Evaluate the impact of the peer education intervention on initial screening uptake and re-screening 
rates. 
Hypothesis: A context-specific peer education cervical cancer screening curriculum will increase the 
cervical cancer screening initial uptake rate (first 6 months) in target age women to 35% and will ensure 
2 year re-screening rates of 30% in the Kedougou, Senegal study sites. 
 

 
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Figure 2: Stepped Wedge Trial 
Design  
Clusters 
3  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1  
 
 
 
 
 
 
 
1  
2  
3  
4 
 
Time Periods 
Shaded cell represent intervention periods 
STUDY DESIGN AND PROCEDURES 
TABLE 1: Primary Research Questions 
AIM 
Research Questions 
AIM 1 
What individual, household, and community factors influence a woman’s decision to seek or not to seek cervical cancer 
screening in Kedougou, Senegal? How do these identified determinants change with time? How does age and gender 
specifically influence screening program opinions and motivations for screening? 
AIM 2 
What is the structure, process, and content of a peer education program that empowers eligible women to initially seek 
cervical cancer screening services in Kedougou, Senegal? What programmatic factors predict the reach and positive 
reception by a relevant audience of such a health promotion intervention? 
AIM 3 
How does a peer education program impact the cervical cancer screening service initial uptake by eligible women seeking 
a first-time screening and ensure sustained utilization and continuing impact of the cervical cancer screening service? 
 
Study Design: Figure 2 is a schematic example for this trial design. In 
this example, Cluster 1 (randomly selected) crosses to the intervention 
arm at Period 2, Cluster 2 (randomly selected) crosses over to the 
intervention arm at Period 3, and so on. By the end of the study, all 
clusters will cross over to the intervention arm (one-way), though in 
random order. At the end of the final time period, the outcome of 
interest is compared between the intervention and control periods within 
each cluster. Differences in service utilization and recommendation will 
be compared, whereby clusters serve as their own controls as they 
cross over from the control to intervention group. 
Peer Education: In Senegal, matrones are women who are selected by the community to provide outreach for 
women’s health issues. These women are formally trained through the health system, are literate in French 
and the local languages, work closely with the Community Health Workers (CHW), and live permanently in the 
communities where they work. Our partnership has a strong existing relationship with matrones, with whom we 
will work through “Care Groups,” (CG) a model of peer education developed by World Relief in 1995 and used 
extensively globally.62-64 CGs are established in many Kedougou communities though none in our study area 
are conducting cervical cancer screening education. In our study, a CG will comprise 10-15 volunteer, 
community-based health educators at 3 health structures within each cluster who regularly meet together with 
a lead matrone for training and supervision.  Each CG volunteer is responsible for regularly visiting 10-15 of 
her neighbors each month, sharing what she has learned and facilitating behavior change at the household- 
and individual-levels. Matrone led CGs will also develop and implement community-level interventions such as 
town hall discussions, radio announcements, and theatrical performances. The CGs will have only female 
membership but will work closely with the Health Committees (who are principally men) to facilitate the peer 
education of men in the community by working through the Elder’s council (advisors to the village chief) and 
the youth group. One PCV per district will work with a district-level CG coordinator and a CG manager at the 
regional level will oversee the program. A representative group of CG administrators, leaders (matrones), and 
volunteers will meet biannually for a CG Meeting in the Kedougou regional capital. This group, through a 
participatory approach65, will develop, deploy, and adapt a multi-modal peer education curriculum directed at a 

 
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multi-level audience and aimed at motivating women to seek cervical cancer screening services.66 This group 
alongside PCVs will also develop and pilot all instruments and conduct the multi-level data collection.67  
 

 
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Research Procedures by AIM 
AIM 1: Assess cervical cancer screening access determinants by qualitatively identifying barriers and 
facilitators of service uptake over time at the person, household, and community levels. (Table 2) 
 
TABLE 2: Aim 1 - Demand-Side Access Data Collection 
Methodology 
Measures 
Variables 
 
Quant 
a 
Individual 
Baseline 
Survey 
BL / End 
 
DCI: 1601, 
1602 
Systematic sampled 
individuals  
(Women: 75 / cluster) 
(Men: 30 / cluster) 
Sample size: n = 315 
Demographics: # of people / roles in household, genders, # of eligible women, # of 
women seeking screening, health seeking decision making 
process / power, cost concern, facility proximity, health practices 
and opinions, knowledge and opinions of partners of eligible 
clients. 
b 
Individual  
Interval 
Interview  
 
DCI: 1603, 
1604 
Systematic sampled 
individuals  
(Women: 45 / cluster) 
(Men: 30 / cluster 
of sample a 
Socio-demographics: 
Behavioral risk 
factors: 
Clinical risk factors: 
Health literacy / 
seeking: 
Age, gender, marital type/status, education level 
Sexual debut, lifetime sexual partners, gravity, parity, age at first 
birth, number of children, smoking status, diet 
History of STI, weight, long-term oral contraceptive use 
Cervical cancer screening history & knowledge, preventative care 
opinions, health service utilization 
Qual 
C 
Women’s 
Focus 
Groups 
 
DCI: 1605 
Purposive-sampled 
groups (women, 30-44 
or 45-59) of sample a  
Demand-side access 
Ability to perceive: 
Ability to seek: 
Ability to reach: 
Ability to pay: 
Ability to engage: 
ref Instruments 42 
Health literacy, Health beliefs, Trust and expectations 
Personal and social values, culture, gender, autonomy 
Living environments, Transport, Mobility, Social support 
Income, Assets, Social capital, Health insurance 
Empowerment, Information, Adherence, Caregiver support 
 
To achieve Aim 1, we will orient 3 CGs in each cluster. Through a participatory process involving CG leaders, 
health service leaders, midwives, and community members (women and men) we will develop, field test, and 
refine quantitative individual-level surveys that gather access barriers data corresponding to the variables listed 
in Table 2. We will conduct quantitative a) Individual Baseline Surveys with the same enrolled women (up to 
25) and the same 10 men in each site per cluster. These data will be collected at baseline and at the end of the 
study period (after 3 years). We will also conduct b) Individual Interval Interviews with the same women (up 
to 25) and the same 10 men in each site per cluster. These data will be collected at baseline and every six 
months through the end of the study period (after 3 years). Therefore, these data will be collected six (6) times. 
These pre-tested, approved standard individual-level questionnaires (close ended) will be administered (face-
to-face) by an RA of the same gender as the participant in the participants’ preferred language (Malinke, 
Pulaar, or French). We will also conduct c) Women’s Focus Groups. Through these FGs we will collect 
qualitative data, from women stratified by age, describing demand-side access barriers and facilitators (Table 
2). The Research Assistant will moderate the 45 minute FGs in the preferred language (Malinke, Pulaar, or 
French) and two PCVs will observe and record written observations in real time. We will audio record the 
sessions (to be transcribed into both French and English). The Research Assistant and PCVs will review the 
audio record and confirm all notes. Below are described the recruitment and enrollment procedures for these 
data collection events. 
 
Recruitment and Enrollment of Participants Followed within Households 
We will utilize a random cluster sampling method to select ten (10) households in each of the three (3) sites 
per cluster. We will convenience sample one woman and one man in each of the households among those 

 
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who express a willingness to participate. We will ensure that the ten (10) chosen households fall within the 
households where the educational Care Group intervention takes place. Given that each Care Group will cover 
between 80 and 100 households, we are expecting to enroll participants from 10% of the households where 
the Care Group intervention occurs.  
Detailed household sampling: The range of eligible households will be defined by the immediate community 
surrounding the health facility in each of the three sites per cluster. Using a map of the community, we will 
divide the community geographically into five clusters. We will designate one household on the map as the 
starting location. We will randomly select a number between one and the number of households in that section 
of the community. The Research Assistant (RA) will begin counting at the starting location and will approach 
the household corresponding to the random number. Eligible households must have at least one screening 
eligible woman (age 30 to 59) and one man (age 30 to 59). The RA will ensure that the household is eligible. 
The RA will follow the designated procedures for recruiting men and women into the study. This includes 
reading the RESEARCH INFORMATION SHEET and reading the RECRUITMENT SCRIPT. The RA will begin 
by asking if there is one woman AND one man in the house who would like to participate. From among those 
that express willingness to participate, the RA will convenience sample participants by alternate recruiting of a 
younger woman (Age 30 to 44) and an older woman (age 45 to 59) from households. By doing this, half of the 
homes (5) will have younger women participants and half (5) will have older women participants. Not all 
women and men participants from a home need to be married to each other, but it is preferable if at least half 
of the participating households have married partners as participants. The RA will recruit men between the 
ages of 30 and 59, with no differentiation between the number of younger and older men participating. If BOTH 
a man AND a woman in the same household agree to participate, the RA will continue with enrollment by 
reading the INFORMED CONSENT and obtain a signature with the SHORT FORM. IF the RA is NOT ABLE to 
recruit BOTH a man and a woman in the same household, this household and any individuals in it will be 
unable to participate in the study. The RA will thank them for their time and continue to the NEXT HOME 
designated through a randomly selected number to recruit participants until two households with one woman 
and one man each are included in the study. The RA will read the INFORMED CONSENT to each of the 
chosen participants separately and privately. The RA will obtain participant written consent with the SHORT 
FORM and will then enroll each participant by entering their contact information in the PARTICIPANT 
REGISTER. The RA will inform them separately of the data collection schedule. 
 
Recruitment and Enrollment of Participants Followed within Care Groups 
We will utilize a random sampling method to select five (5) Care Group Volunteers in the Care Group of each 
the three (3) sites per cluster. We will seek to enroll, longitudinally follow, and collect data on three (3) younger 
woman (age 30 to 44) and two (2) older women (age 45 to 59) in each care group over the course of the study. 
Given that each Care Group has between 8 to 15 volunteers, we are expecting to enroll 1/3 to 1/2 of all Care 
Group Volunteers across all sites.  
Detailed Care Group Volunteer sampling: While visiting a care group meeting, the RA will read the 
RESEARCH INFORMATION SHEET. The RA will then read the RECRUITMENT SCRIPT and ask the women 
if they are interested to participate. The RA will record the names of each younger woman (age 30 to 44) who 
is interested in participating on separate pieces of paper. The RA will fold each piece of paper separately and 
place into a container. The RA will blindly draw three names. The RA will then record the names of each older 
woman (age 45 to 59) who is interested in participating on separate pieces of paper. The RA will fold each 
piece of paper separately and place them into a container. The RA will blindly draw two names. The RA will 

 
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read the INFORMED CONSENT and SHORT FORM to each of the chosen participants separately and 
privately. The RA will obtain participant written consent with the SHORT FORM and will then enroll each 
participant by entering their contact information in the PARTICIPANT REGISTER. The RA will inform them 
separately of the data collection schedule. 
 
Recruitment and Enrollment of Participants for Women’s Focus Groups 
We will conduct two focus groups every six (6) months. Five (5) care group members will be convenience 
selected from each care group AND two to three (2-3) household women participants will be convenience 
sampled to participate in a younger women’s (age 30 to 49) and an older women’s (age 45 to 59) focus group 
every six (6) months over the course of the study. 
 
Detailed Women’s Focus Group Sampling: Recruiting from Household Participants: The RA will contact 
enrolled household women participants every six months to convenience sample women for both a Younger 
and an Older Women’s Focus Group. Younger women’s focus group: The RA will read the FOCUS GROUP 
RECRUITMENT SCRIPT and ask for interest to participate. The RA will invite the first two to three younger 
women (age 30 to 44) among those already enrolled in the study who express interest to participate in a focus 
group.  The RA will provide instructions on where and when to go for the focus group. Older women’s focus 
group: The RA will read the FOCUS GROUP RECRUITMENT SCRIPT and ask for interest to participate. The 
RA will invite the first two to three younger women (age 30 to 44) who express interest to participate in a focus 
group.  The RA will provide instructions on where and when to go for the focus group. Recruiting from Care 
Group Participants: The RA will contact Care Group women participants. Younger women’s focus group: 
The RA will read the FOCUS GROUP RECRUITMENT SCRIPT and ask for interest to participate. The RA will 
invite the first two to three younger women (age 30 to 44) among enrolled Care Group participants who 
express interest to participate in a focus group.  The RA will provide instructions on where and when to go for 
the focus group. Older women’s focus group: The RA will read the FOCUS GROUP RECRUITMENT 
SCRIPT and ask for interest to participate. The RA will invite the first two to three younger women (age 30 to 
44) who express interest to participate in a focus group.  The RA will provide instructions on where and when 
to go for the focus group. The RA will read the INFORMED CONSENT and SHORT FORM to each of the 
chosen participants separately and privately. The RA will obtain participant written consent with the SHORT 
FORM and will then inform them separately of the data collection schedule. 
 
 
 
 
Aim 2: Develop and deploy a peer education curriculum to motivate eligible women to seek screenings. 
(See Table 3) 
TABLE 3: Aim 2  - Peer Education Data Collection 
Methodology 
Measures 
Variables 
 
Quant e 
Document 
Review 
 
DCI: 1611 
No human participants. Review of 
peer education program 
implementation records. 
Program 
Reach 
A. # of individuals, households, communities 
directly receiving intervention 
B. # of peer educators 
C. # of peer education sessions per educator 
 
b 
Individual Convenience and purposive-
Program 
A. Number/% of women and men recommending 

 
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Interval 
Interview 
 
DCI: 1603, 
1604 
sampled individuals followed over 
time.                     of sample a 
Recommendation 
& Knowledge 
the service (age-stratified study participants) 
B. Knowledge of cervical cancer 
 
Qual 
f 
Focus 
Groups 
 
DCI: 1606 
Purposively-sampled Peer 
Educators and Individuals 
of sample a 
Process & 
Program 
Satisfaction 
A. Recipient and peer educator evaluation 
including Implementation, Mechanisms of 
Impact, Contextual Factors. 
B. Recommendations for adapting or improving the 
Peer Education Program 
 
 
Through aim 2 we will develop a curriculum intended for a multi-level audience to motivate women to seek 
cervical cancer screening services. The curriculum (informed by aim 1) will be adapted from the WHO 
“Comprehensive Guide to Cervical Cancer Control: A guide to essential practice. 2nd edition68” materials by key 
individuals (including health leaders, midwives, matrones, CHWs, screening eligible women, men, religious 
leaders, traditional healer, and PCVs). The curriculum will be comprised of educational materials in French and 
local language (Malinke and Pulaar). CGs will deliver the curriculum content. We will orient the CG leaders on 
the curriculum and provide comprehensive guidance on the research protocol throughout the study period. 
Each CG will transmit general health education from the initiation of the study. Only CGs within clusters that 
have crossed over into the intervention arm will be provided with the cervical cancer screening curriculum. We 
will collect quantitative program reach and recommendation data and qualitative process and program 
satisfaction data at each time period. The Individual Interval Interview data contributing to this aim will be 
collected through the same data collection event described for AIM 1. All data contributing to this AIM will be 
used to adapt the intervention over time. We will collect quantitative data through document review of CG 
records (number of individuals, households, and communities directly receiving the intervention) or through 
individual survey or interview (Table 3). We will also conduct one FG per site (3 per cluster) per data collection 
period (at baseline and every six months) through the end of the study (3 years) for aim 2 to gather qualitative 
data that describe the peer educator (volunteers from each CG) opinion of the peer education program (Table 
3). The RA will moderate the 45 minute focus groups in the preferred language (French, Malinke or Pulaar) 
and two PCVs will observe and record written observations in real time. We will audio record the sessions (and 
transcribe into French and English). The moderating CG district coordinator and PCVs will review the audio 
record and confirm all notes. 
 
Recruitment and Enrollment of Participants for Care Group Focus Groups 
We will conduct one focus group every six (6) months in each site. All present Care Group members will be 
invited to participate. 
 
Detailed Care Group Focus Group Sampling: At the beginning of a Care Group Meeting, the RA will explain 
that she will be conducting a short focus group. The RA will read the FOCUS GROUP RECRUITMENT 
SCRIPT and ask for interest to participate. The RA will invite all present members of the Care Group who 
express interest to participate in a focus group. The RA will read the INFORMED CONSENT and SHORT 
FORM to each of the chosen participants separately. The RA will obtain participant written consent with the 
SHORT FORM, separately and privately, and will invite them into the private focus group area and introduce 
them to the observers. 
 

 
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Aim 3: Evaluate the impact of the intervention on initial screening uptake and re-screening rates. (See 
Table 4) 
TABLE 4: Aim 3 - Initial & Sustained Change Data Collection 
Methodology 
Measures Variables 
 
Quant 
g 
Document 
Review 
 
DCI: 1612 
No human participants. Review of 
aggregated health service records. 
 
Initial 
Uptake/ 
Sustained 
utilization 
A. Number/% of women screened for the first time, age 
stratified   1 
B. Number/% of women being re-screened, age 
stratified 
C. Number/% of positive screened women 
referred/treated (aggregated data only) 
 
a 
Individual 
Interval 
Interview 
 
DCI: 1603, 
1604 
Systematic sampled individuals 
followed over time. 
Sample size: n = 0 new  
of sample a 
 
 
To achieve aim 3, we will follow cluster-wide trends through aggregated health service data69 and participant-
level impact through individual interviews. Health service data (# of initial and re-screenings stratified by age 
and number of referred women who completed treatment) will be reported by each cluster to the district center 
through the standard reporting structure. These de-identified data are reported to the regional level where they 
will be collected. Through the individual interviews described in aim 1 above (Table 2), we will collect impact 
data within our participant population in the form of first-time and re-screenings.  
 

 
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4.0 
Recruitment, Eligibility and Enrollment   
Recruitment 
The PI (Dykens) and Senegalese Co-I’s (Ndiaye and Dioukhane) will train all research assistants, matrones 
and community health committee leaders at a designated intervention cluster in the Kedougou Region, 
Senegal. Through our prior work, we have worked directly with each of these individuals. The research 
assistants, with oversight by the Peace Corps Volunteer research assistants and the Co-I’s and PI, will recruit 
individuals, households, and focus group participants (as described above in section one). The lead Peace 
Corps Volunteer who is in charge of recruitment, informed consent, participant tracking, and data collection is a 
UIC MPH trainee (in Senegal as a Peace Corps Volunteer). She is listed as a key personnel on the protocol. 
These individuals will explain the purpose and activities of the study, and select those who: 1) are confirmed to 
meet the criteria; and 2) are able to give informed consent. See Inclusion Criteria above. 
 
After the participants give consent, they will participate in the surveys, interviews or focus groups during each 
data collection period. Drs. Dykens and Dioukhane and a Peace Corps Volunteer (MPH level) will oversee 
preparation of the RA’s for the moderation of interviews and focus groups. See detailed description of sources 
of material. 
 
Human Subjects Involvement and Characteristics. 
Throughout this discussion of Human Subjects, “subjects” are referred to as “participants.” Inclusion criteria 
and procedures for each aim of the study are described below. 
 
 
Determination of Subject Eligibility 
The Principal Investigator, Co-Investigators, and onsite Research Personnel will oversee subject eligibility. 
Eligibility will be determined at the time of recruitment and consent. The Senegalese Co-Investigators (Ndiaye, 
Dioukhané), in collaboration with the U.S. Principal Investigator (Dykens) and Project Coordinator, will oversee 
recruitment. No compensation will be awarded for direct involvement in focus groups or for completion of 
surveys. However, refreshments may be provided at the time of the focus group. An eligibility checklist in the 
form of a recruitment script is attached. 
 
Inclusion Criteria 
 
The inclusion criteria are as follows: 
 
Women. Criteria for inclusion include: 1) female Senegal citizen between the ages of 30 and 59, 2) 
Resident in Kedougou Region, 3) eligible to seek cervical cancer prevention services at a designated 
health structure in the Kedougou Region, Senegal, 4) willing to participate in survey or interview 
assessments; and 5) able to give informed consent. 
 
Men. Criteria for inclusion include: 1) male Senegal citizen between the ages of 30 and 59, 2) Resident in 
Kedougou Region, 3) living in a household with at least one woman eligible to seek cervical cancer 
prevention services at a designated health structure in the Kedougou Region, Senegal, 4) willing to 
participate in survey or interview assessments; and 5) able to give informed consent. 
 
Care Group Volunteer. Criteria for inclusion include: 1) Senegal citizen participating as a Care Group 
volunteer, 2) Resident in the Kedougou Region, Senegal, 3) willing to participate in survey or interview 
assessments, and 4) able to give informed consent. 

 
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Exclusion Criteria 
Participants will be excluded if they are 
• 
No additional exclusion criteria exist. 
 
Excluded or Vulnerable Populations 
Special considerations of the involvement of women and minorities and the justification of the exclusion of 
minors are detailed below.  
 
The total planned enrollment / Inclusion of Women and Minorities 
 
1. Planned distribution of participants by sex/gender, race, and ethnicity  - The total planned enrollment is:  
a. Aim 1: 15 women from Care Groups for each site (3) per cluster (3) = 135. Ten women from 
households for each site (3) per cluster (3) = 90. Ten men from households per site (3) per 
cluster (3) = 90. This equals a total of 315 individuals (225 women and 90 men). There are no 
new participants in the focus groups. 
b. Aim 2: Individual interview (no new participants) + Focus Groups (no new participants) + 
Document Review (no human participants) = 0 new participants 
c. Aim 3: Individual interview (no new participants) + Document Review (no human participants) = 
0 
 
Total participants = 315 
 
Of these we estimate that there will be 225 women and 90 men.  Based on general population 
numbers for the Kedougou Region in the country of Senegal, we anticipate that 100% of 
participants will be from African descent. All participants (women and men) will be African and have 
been included in the "Black" category. 
 
 
2. Subject selection criteria and rationale for selection –  
a. No exclusions will be made on the basis of gender for the baseline surveys or longitudinal 
individual interval interviews described in Aims 1, 2, and 3.  
b. Men will be excluded from the focus groups (these will be women only) described in Aims 1 and 
2. 
c. No exclusions will be made on the basis of race for all Aims. 
 
3. Rationale for proposed sample –  
a. The focus groups proposed in Aim 1 and 2 are intended to gather the perspectives of women. 
Therefore, men will be excluded from participation in this activity. 
 
4. Outreach programs for recruiting 
a. Males are excluded from the Aim 1&2 focus groups in this study because:  
i. the research question addressed is relevant to only women;  
b. No racial and/or ethnic groups or subgroups are excluded from the study 
 
 

 
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Inclusion of Children. 
 
This study will not involve the recruitment of participants under the age of 30 years. Therefore, no children will 
be recruited for data collection or involved in the study. The study will focus on the opinions and behaviors of 
women within the target age range (30 to 59 years old) for cervical cancer screening as stated in the 
Kedougou, Senegal Cervical Cancer Screening Health Service Regional Guidelines. We will also collect data 
on men in the corresponding age range (30 to 59 yo).  
 
Sex as a biological variable.  
Sex as a biological variable does not apply to this research as the proposed study is not pre-clinical or 
biomedical research that affects both sexes. Given that cervical cancer affects only women, our principal data 
collection and investigation will be directed at women within the guideline age range for screening. We will be 
collecting data from women outside this age range and from men but only to provide perspectives on how 
affected and targeted women make decisions and to provide insights into how gender and stigma impact 
decision making in target-age women.22,23 
 
Addressing Gender and Stigma.  
Gender roles and stigma are of significant consideration in our proposed research. By investigating the social 
context of the uptake of this newly implemented cervical cancer screening service we intend to describe as a 
primary question in aim 1, “How does age and gender specifically influence screening program opinions and 
motivations for screening?” In addition, in aim 2, we will be collecting data from both men and women 
describing the number and percent of women and men recommending the service to others. In addition to 
analyzing the process of a) the role of the social spread of information and b) the value of establishing societal 
norms (especially among peer groups that don’t readily access health services) we intend to provide a deeper 
understanding on how gender roles in households impact service uptake. We will also describe how social 
acceptance of a new health service such as cervical cancer screening that has potential stigma considerations 
(reflecting religious, cultural, or community norms and notions) impact service uptake and sustained utilization.  
 
 

 
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5.0 
Sources of Material, Protection Against Risks and Informed Consent   
Sources of Material. 
Sources of research material will include: 1) Individual Baseline surveys of adults (21 and above) in 
households with screening eligible women, 2) Individual Interval Semi-structured Interviews: semi-
structured interviews with target age women eligible for screening and receiving cervical cancer prevention 
services or men living in a household with target age eligible women, 3) Focus Groups with women or Care 
Group Volunteers, and 4) Document Review: de-identified, aggregated health service or care group data,  
 
Individual Baseline surveys 
The baseline survey will gather information through adults (age 30 to 59) willing and able to provide the 
requested information. Once surveyed, individuals from the same households will be followed over time 
and re-surveyed at each data collection period. The pre-tested standard individual baseline surveys (close 
ended) will be administered (face-to-face) in the participants’ preferred language (Malinke, Pulaar, or 
French). These will be administered by a Senegalese Research Assistant with assistance by PCV research 
assistants. This data collection will occur at baseline and at the end of the data collection period. Peace 
Corps Volunteers will assist the PI and Co-I’s in ensuring the fidelity of this data collection. 
 
Individual Interval Semi-structured Interviews 
All screening-eligible women and all men aged 30 to 59 in all selected households will be interviewed. The 
pre-tested standard individual-level questionnaires (semi-structured) will be administered (face-to-face) in 
the participants’ preferred language (Malinke, Pulaar, or French). These will be administered by a 
Senegalese Research Assistant with assistance by PCV research assistants. Aim 1 (access determinants, 
cervical cancer risk), Aim 2 (screening recommendation), and Aim 3 (screening uptake / utilization) data 
will be collected through this interview. All sites will be monitored for consistent and accurate collection of 
this data. The data collection instrument will be employed at baseline and every 6 months during the data 
collection period. Peace Corps Volunteers will assist the PI and Co-I’s in ensuring the fidelity of this data 
collection. 
 
Focus Groups 
 
Aim 1 Focus Groups: 
There will be two FGs (women ages 30 to 44 and ages 45 to 59) per cluster every 6 months throughout the 
study period. Through FGs we will collect qualitative data, from women stratified by age, which describe 
demand-side access barriers and facilitators (Table 2). The Senegalese research assistant will moderate 
the 45 minute FGs in the preferred language (Malinke, Pulaar, or French) and two PCVs will observe and 
record written observations in real time. We will audio record the sessions (to be transcribed into both 
French and English). The Research Assistant and PCVs will review the audio record and confirm all notes. 
The women enrolled as individuals will make of the focus groups. There will be no new women enrolled for 
this data collection activity. 
 
Aim 2 Focus Groups: 
We will conduct two FGs per cluster per data collection period for aim 2. Through the FGs we will gather 
qualitative data that describe the peer educator (matrone and the volunteers from each CG) opinion of the 
peer education program (Table 3). The CG district coordinators will moderate the 45 minute focus groups 
in the preferred language (French, Malinke or Pulaar) and two PCVs will observe and record written 
observations in real time. We will audio record the sessions (and transcribe into French and English). The 
moderating CG district coordinator and PCVs will review the audio record and confirm all notes. 

 
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Participants will include 15 CG volunteers that comprise the FGs in each cluster (no new participants). The 
women participants are not newly enrolled and are the same as described in the FG activity in Aim 1. 
This data collection will occur at baseline and every 6 months during the data collection period. Peace 
Corps Volunteers will assist the PI and Co-I’s in ensuring the fidelity of this data collection. 
 
Document Review – Uptake Data 
At initiation of the study, all partners will identify and agree on specific population- and service-level 
quantitative outcomes indicators (Tables 2, 3, and 4) to guide the creation of a health service level data 
collection instrument to address Aim 3. These indicators will fall within current expected data collection at 
all sites. All sites will be monitored for consistent and accurate collection of this data. The data collection 
instrument will be employed at baseline and every 6 months during the data collection period. Peace Corps 
Volunteers will assist the PI and Co-I’s in ensuring the fidelity of this data collection.  All screening data will 
be de-identified, aggregated data. 
 
Document Review – Care Group Data 
Care Group Volunteers will document data describing program reach (number of households reached, 
number of individuals counselled, number and types of community-level interventions, etc.) These 
indicators will fall within current expected data collection by all Care Groups. All sites will be monitored for 
consistent and accurate collection of this data. The data collection instrument will be employed at baseline 
and every 6 months during the data collection period. Peace Corps Volunteers will assist the PI and Co-I’s 
in ensuring the fidelity of this data collection.  All screening data will be de-identified, aggregated data. 
 
c. Potential Risks. 
The important general concern that applies to our approach is Confidentiality. Patients, Care Group 
Volunteers, and Partners may worry that others (spouses, partners, families, colleagues or friends) may find 
out about their expressed opinions and personal reflections. It is also possible that, for service providers, 
advocates, and policymakers, there may be repercussions from their employers if their employers found out 
something about their work performance or attitudes that they found unfavorable. All participants will be 
assured their participation is voluntary and private. 
 
ADEQUACY OF PROTECTION AGAINST RISKS 
 
a. Recruitment and Informed Consent. 
For all parts of the study, informed consent will be obtained by trained, experienced, and supervised 
interviewers who have been directly trained by the Co-I’s of the research team. All participants will be told that 
they are free to withdraw from the study at any point in time should they desire to do so, and that this will not 
jeopardize their relationship with any of the collaborating organizations. 
 
Because we anticipate the enrollment of participants whose primary language is not English, we will make 
specific accommodations to the consent procedures. We will prepare informed consent documents that are 
translated into French, Malinké, and Pulaar, the primary languages of the participants. We will prepare these 
informed consent documents with qualified translators using back translation. The translated consent 
documents will be submitted to the Senegal IRB and the UIC IRB for approval before their use. The Senegal 
team members responsible for recruitment, informed consent, and moderating interviews are fluent in the 
participants’ languages. 
 
WRITTEN CONSENT 
Informed consent for participants will be obtained using a written consent procedure in a language 
understandable to the subject, usually either Malinke, Pulaar, or French. The Informed Consent Documents 

 
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are available in English, French, Malinke, and Pulaar. The Research Assistants consenting participants in the 
local languages. Since we are following the same participants over time, the written informed consent with the 
SHORT FORM will be completed upon study initiation and the informed consent will be confirmed prior to 
EACH data collection event.  
 
The written consent will be conducted with the presentation to the potential participant of a short form written 
consent document that states the required elements of informed consent have been presented orally to the 
participant with an accompanying witness to the oral presentation, when the participant is illiterate. The witness 
can be a family member, friend, patient advocate, or someone independent of the research team. 
 
PARTICIPANT REGISTRATION AND DE-IDENTIFICATION 
For the Baseline Surveys and the Interval Surveys, we will be collecting data from the same participants over 
time. For this reason, we will need to register these participants. To ensure these individual’s privacy, we will 
follow the procedures as described here. At the end of each data collection event, the RA will review all data 
collection sheets. The RA will ensure that the participant’s name appears only on the last page of the data 
collection instrument. The RA will record the participants name and phone number on a single copy of the 
PARTICIPANT REGISTER. This PARTICIPANT REGISTER will be kept by the RA in a private, locked room 
and will be taken out and consulted only when data collection events are being scheduled or tracked. After 
each survey, the RA will update the PARTICIPANT REGISTER confirming completion of each data collection 
event during the present data collection time period. Each month, the RA will hand deliver the completed data 
collection sheets to the Lead Data Manager. The Lead Data Manager will review all data for completion and 
copy or update the information from the PARTICIPANT REGISTER into the PARTICIPANT DE-
IDENTIFICATION KEY. This will assign each participant a unique random number (unique codes are already 
in place). The PARTICIPANT DE-IDENTIFICATION KEY will remain only with the Lead Data Manager and will 
not be consulted by anyone else. This key will be kept in a locked safe in a private location. The key will be 
consulted only at the time of delivery of data or during data cleaning and entry. On each submitted data 
collection form, the Lead Data Manager will look up the participant name (found on the last page of the data 
collection form) on the DE-IDENTIFICATION KEY. The Lead Data Manager will write the corresponding 
PARTICIPANT CODE onto top of page one Administrative area of the data collection form. She will double 
check the name and code. She will then tear off the final page of the data collection form (which has the 
participant name written on it) and destroy it. The Lead Data Manager will then update the DE-
IDENTIFICATION KEY confirming completion of the data collection event for EACH participant for whom a 
completed data collection instrument was submitted during the present month. She will locate the correct row 
for data entry into the Data Aggregation Sheet and record the Participant CODE. She will then assign the data 
collection form an event number corresponding to the event number on the Data Aggregation Sheet Row of 
entry. The Lead Data Manager will then go through the data collection form and enter the Administrative and 
Participant Responses into the appropriate column of the Data Aggregation Sheet corresponding to the Data 
Collection Instrument. She will save the electronic Data Aggregation Sheet. She will then mark the hard copy 
data collection form as Data Entry Completed by writing the Date. 
 
The PARTICIPANT REGISTER for each district will be collected at the end of the three-year study by the Lead 
Data Manager. The PARTICIPANT REGISTERS and the DE-IDENTIFICATION KEY will be destroyed at the 
completion of the study by the Lead Data Manager. All hard copy completed Data Collection Instruments will 
be retained but will no longer contain any personal identifiers of any type. 
 
 
b. Protection Against Risk. 
The procedures for protecting against the above risks are as follows: 
Confidentiality. Because participants are likely to have concerns about confidentiality, we will take many 
precautions against breach of confidentiality. All participants will be told that data will not be disclosed 

 
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(including for service recipients, with their husband or families and for providers, within their organizations) 
unless their written permission is given to do so. Participants may elect at any point to terminate interviews or 
the experience sampling. 
 
All members of the project staff will be asked to sign a confidentiality pledge. Access to all research data 
including completed assessments, data files, and analyzed data, will be strictly limited to the Principal 
Investigator and specifically designated members of the project team. All data access will be on a need-to 
know basis. No file will be permitted to leave the project office without careful analysis of potential 
confidentiality problems and no one will be given access to project data who has not signed a confidentiality 
pledge. Actual names and addresses (include that of other organizations) will never be on a file that contains 
data. Separate tracking files containing addresses and similar information will be kept to a minimum and tightly 
controlled. Only the Principal Investigator and project coordinator will have simultaneous access to identities 
and sensitive data. Since it may sometimes be possible, even without access to names, to identify some 
participants. Access to these files will be password protected. All data files sent via email or Internet will be 
encrypted. All team members will keep strictly confidential the identity and location of research participants. All 
data obtained by this research team will be kept confidentially in secure offices on secure servers. The data will 
not be transferred until they are encrypted. Doing so will minimize the risk of disclosing individual’s 
confidentiality and privacy. 
 
Throughout data collection, field notes and audiotapes will be either in direct possession of the investigators or 
secured in a locked location. When field notes and tapes are transcribed, no identifying information will be 
included. In Chicago, all data will be kept in the locked offices of the research team at Dr. Dykens’ office at UIC 
(1919 W. Taylor Street). In Senegal, all data will be kept in the locked office of Dr. Elhadji Dioukhane. 
Research materials from field sites will be transferred weekly to these research sites via encrypted email. At all 
project offices, all paper data will be stored in locked files. Audio tapes will be held by the project in a separate 
locked cabinet at the same office. All laptops, external hard drives, and flash drives will be encrypted. 
Participants will be told that the surveys, interviews, raw field notes, transcripts, and audiotapes will be kept 
indefinitely by the Principal Investigator for documentary purposes. Every effort will be made to disguise the 
identity of participants in reports, publications, and/or presentations. However, because qualitative writing often 
includes individual data excerpts as evidence, it is possible that participants may be recognized by those who 
know them well. Research results will not be written up in a way that could produce harm through placing the 
participants at risk of criminal or civil liability or that could be damaging to participants’ financial standing, 
employability, or reputation. Prior to publication or presentation of any documents, copies of manuscripts or 
other materials will be distributed to all members of the research team to assure that participants are not 
identifiable and to verify the interpretations and conclusions. 
 
c. Training in the Responsible Conduct of Research. 
The Federal Office for Protection from Research Risks (OPRR) has mandated that, "all UIC IRB members, IRB 
staff and research investigators are appropriately educated, on an ongoing basis, about the ethical principles 
and regulatory requirements for the protection of human subjects." To satisfy this requirement, UIC's Human 
Subjects Protection Program has established an investigator training program for all investigators who plan to 
conduct research with human subjects. All university-based investigators involved in this study have already 
attended an initial training session (Investigator Training 101) at UIC or their institution. We will take additional 
steps for this project.  
 
In Month 1 and every 6 months, Dr. Dykens will also conduct a four-hour training on human subjects’ issues for 
all new and current staff that will cover the ethical conduct of human subjects research, FG, survey, and 
interview data collection. The training will include discussion and role playing and will occur at the beginning of 
each study year. Issues related to human subjects’ will be discussed at each ongoing supervision meeting with 

 
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the interviewers and facilitators. Staff will be encouraged to pose questions or concerns about human subjects’ 
issues at any time. 
 
d. Plans for Adverse Events. 
Possible adverse events, both anticipated and unanticipated, will be brought to the attention of both the 
Principal Investigator and the Senegal Co-Investigators. Possible adverse events might include, but are not 
limited to the need to violate confidentiality due to an urgency. The researchers will promptly report all adverse 
events and unanticipated problems to the local ethics committee which will evaluate them and advise the 
researchers whether changes are required. All adverse events will also be reported both to the local IRB and to 
the IRBs of UIC. The local IRB include persons with sufficient depth of expertise to assess adverse events, and 
they know how to contact the UIC IRB if indicated. Local staff members will be urged to discuss all adverse 
events with Dr. Dioukhane, who can exercise judgment in deciding upon the appropriate course of action. Dr. 
Dioukhane will discuss all adverse events with Dr. Dykens. The IRBs will determine whether it is appropriate to 
stop the study protocol temporarily or will provide modifications to the study procedures. In addition, it is 
especially important for the local IRB and especially the Community Advisory Board to monitor for possible 
adverse impacts of the study activities upon the women-focused service organizations and communities. 
 
POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE PARTICIPANTS AND OTHERS 
There are potential benefits to the participants for participating in the research. Health providers and health 
services may improve their provided care. For the other participants, there are not benefits to participating in 
the research.  Some participants, depending on degree of participation, will receive modest financial 
compensation for their time. Overall, the risks to participants are reasonable in relation to the anticipated 
benefits to participants and others. 
 
Note Regarding Reimbursement: In some cases, we are providing reimbursements to participants for time, 
effort, and transportation costs. No compensation will be awarded for direct involvement in focus groups or for 
completion of surveys or interviews. We will provide refreshments during interviews and focus groups. Our 
seven years of experience conducting research in Senegal indicates that participants expect such 
reimbursements. They facilitate the research work and did not present practical or ethical problems. We do not 
expect that the modest amounts proposed per day of meeting participation (e.g. $10 in per diem and up to $10 
in reimbursed travel expenses) would unduly impact possible participants. 
 
IMPORTANCE OF THE KNOWLEDGE TO BE GAINED 
Participants will be contributing to the development of knowledge about improving the quality of cervical cancer 
prevention services in Senegal and the ways in which a community-Peace Corps- academic partnership can 
impact health services implementation research. This knowledge is critical to the development of accessible 
primary health care services for this population and others. The potential significance of this research is 
substantial, including: providing detailed data and analysis on the determinants to accessing the local cervical 
cancer prevention service. Overall, the risks to participants are minimal in relation to the importance of the 
knowledge that reasonably may be expected to result. 
 
DATA SAFETY MONITORING PLAN 
a. Ensuring Safety of Staff, Participants, and Third Parties 
Staff members conducting interviews or recruiting contacts will carry a cell phone at all times while in the field. 
Prior to going into the field, staff members will leave the name of the research contact and the address of the 
location where the meeting will occur at the project office in a designated location. We will ensure that other 
staff members are informed of the location of the staff member in the field and the participant contact in case 
the staff member should experience an unforeseen emergency. 
 

 
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It is possible that an unexpected situation may occur during the course of meeting with participants that 
present a threat to the safety of a staff member. In all such cases, the staff member will extricate him- or 
herself from the situation and notify the Principal Investigator and one of the Senegalese Co-Investigators at 
the site as soon as practicable to debrief and review the situation. In order to maximize the safety of staff, 
participants, and third parties to the fullest extent possible, staff is instructed not to indicate acquaintance with 
a research participant or third party known to them from their study participation, if they are seen outside of the 
context of the study activities. Instead, staff is to watch for signals from the participant or third party suggesting 
that they may be acknowledged. This will also serve to maintain participant privacy. 
 
b. Participant Referrals 
Participants may request referrals for a variety of services such cervical cancer screening or treatment 
services. Participants will be provided with a listing of the location of these requested services to the extent that 
such services exist. Staff will contact the Senegalese Site Coordinator and Co-Investigators for instances in 
which a participant requests services that appear to be unavailable. In all situations in which a participant 
requests a referral, the staff member will note the date of this request and the staff member response and 
referral. In order to ensure the well-being of the participants, all such requests will be handled as professionally 
and expeditiously as possible. 
 
c. Handling Emergency Situations 
It is possible that several types of situations might arise during the course of the interviews. Whenever 
possible, the interviewers will try to reach the Principal Investigator and one of the other local Co-Investigators 
to discuss these situations as they arise. We acknowledge, however, that this may not always be possible 
during crisis situations or those that require immediate decisions. These situations might include: 
• 
A participant threatens to injure himself/herself or another person and has the means to do so, 
• 
A participant has become acutely ill during the course of an interview and appears to be in need of 
immediate medical attention, or 
• 
An individual is threatening to harm the participant. 
If the interviewer believes that a participant is in immediate danger to herself/himself or to another, or is having 
a medical crisis, the interviewer will inform the participant of this and seek help from another local Co-
Investigator, who are all medically trained physicians. If possible, he/she will stay with the participant until help 
arrives. We acknowledge, however, that this may not always be possible during crisis situations or those that 
require immediate decisions. 
 
Interviewers are not under any legal obligation to report illegal conduct. Illegal conduct will not be reported 
unless it falls within the immediate harm exceptions above. In all cases, all emergency situations will be 
reported to the Principal Investigator as soon as possible after their occurrence and within 24 hours of their 
occurrence. As noted above, the Principal Investigator will also promptly report all adverse events and 
unanticipated problems to the community advisory board, the local IRB (Senegal Ministry of Health), and the 
UIC IRB. The Principal Investigator will maintain a listing of all such occurrences and their disposition. 
 

 
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6.0 
Data Analysis and Statistical Considerations   
Quantitative Analysis: All survey and interview data will be presented using basic descriptive statistics such 
as the frequency, % and mean (SD). To compare the intervention effect (screening rate, awareness, etc) within 
same participants before and after the intervention, Mixed-effects logistic regression model will be utilized. The 
mixed-effect model will also account for multilevel clusters such as households and districts. The between-
subject effects to compare the impact of different regions with and without intervention implemented treating 
them as intervention and control group will be tested using Chi-squared test for single level samples and 
mixed-effects logistic for multilevel data. Outcome related factors such as demographic information and other 
barriers will be measured using descriptive statistics and to test the intervention effect by using multiple 
regression models. 
Qualitative Analysis: For the qualitative data gathered for aims 1 and 2, we will use an iterative analysis 
approach based upon grounded theory70 using Dedoose.  We will transcribe recorded interviews and field 
notes into French and English (languages of the research team) and enter both into Dedoose. We will conduct 
the grounded theory analytic methods in steps.72-75 Step 1: Initial Review of the Data.  We will divide the 
entire data set among research team members and identify initial overarching concepts. We will develop the 
coding scheme as we label, define, and group concepts into categories corresponding to the initial conceptual 
framework.  We will track demographic, contextual, and experiential items that are important to understanding 
1) how age or gender impacts the opinion of cervical cancer screening eligible women or their contacts or 2) 
how perceptions of the educational curriculum may differ between trainer and trainee. Step 2: Developing a 
Coding Scheme. Next, we will develop a codebook consisting of the labels, definitions, and illustrations of 
categories formulated in Step 1. We will circulate the codebook for review by the entire team, which we will 
then pilot and revise by using selections of text from the data. When it is clear that the coding scheme is 
appropriate, two coders each from UIC and Senegal/UCAD will be trained to use it.  We will repeatedly code 
the same sections of text and compare the results, discussing and resolving disagreements, until we reach a 
level of .80 agreement. Step 3: Coding. We will code the data using the coding scheme by first reviewing the 
interview transcripts and field notes and assigning sections of text to the corresponding coding categories. All 
staff at the UIC and Senegal/UCAD sites will code all data to lay the groundwork for analysis and reporting.  
We will also code for missing data patterns. Step 4: Pattern Coding.  We will examine the relationship within 
and between codes in order to identify overarching themes and patterns of variation. We will continue pattern 
coding until saturation, when no new quotations appear.74 Step 5: Memoing. At each of the aforementioned 
steps we will write short, descriptive statements to a) document ideas during preliminary data review, b) define 
codes during coding, c) concisely describe items not coded, and d) describe the outcomes of specific Atlas/ti 7 
queries. We will then scan memos and sort them to form clusters, categories, and causal networks.72  
Mixed methods Analysis and Writing.  Mixed methods involves integrating the multiple types of data using 
well-accepted designs including: triangulation, explanation, transformation, and exploration.75 We will use both 
SAS and Atlas/ti to further analyze data that will have already been collected, coded, and analyzed. Key to this 
integrated analysis is looking for intersections across levels that may explain: 1) Which access facilitators best 
address barriers to seeking cervical cancer screening services among women who are most at risk? 2) What 
benefits do interventions at each level of intervention (individual, household, or community) provide? 3) What 
role does gender or age play in affecting barriers to accessing screening? 4) What are the most influential 
sources that change motivation of screening eligible women change over time? 5) What will most likely predict 

 
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that screening eligible women recommend screening to their peers? The analyzed data will be used to 
generate mixed methods publications responding to these key themes and will add to the body of knowledge 
for improving initial uptake and sustained utilization of cervical cancer screening services. 
 
Power calculations  
 
Clusters and Population: There will be three clusters comprising separate districts (Kedougou, Salemata, 
and Saraya) in Kedougou. Using two independent proportion method of cluster randomization power analysis 
(PASS13), to obtain the power 80% under significance level 0.05, the 10% difference of the screening rate with 
assumed ICC 0.01 requires n=15 per each of 3 clusters. Tables 2, 3, and 4 outline the data collection 
methodology for each aim. These data will be collected within each cluster at baseline and every six months - 
coinciding with a crossover of a new (random) cluster. Our selected sites are comprised of zones 
representative of region including rural, district center, semi-urban, and urban. Contamination is unlikely given 
distance (the distance between sites ranges from 32 kilometers / 45 minutes by car to 3 ½ hours by car). 
 

 
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Quality Control and Quality Assurance   
Dr. Andrew Dykens and Dr. Youssoupha Ndiaye will serve as the project directors. The project coordinator 
research assistant in Senegal has been previously trained in the appropriate conduct of focus groups and  
interviews in Senegal. The entire co-investigative team specified in this protocol will be involved in data 
analysis. 
 
Data will be shared with the investigative team members electronically through online collaborative document 
software through a Google Apps secure Domain at https://drive.google.com/a/uic.edu/ . This data is secure 
under the SSAE 16 and ISAE 3402 auditing industry standards and is available to investigators only. No one 
other than approved research personnel specified within this protocol will have access to the data. 
The online software to be used for qualitative data analysis, Dedoose, uses Secure Sockets Layer Extended 
Validation (SSL EV) Encryption. SSL EV is the highest tier of encryption and validation offered on the internet. 
This protects data while travelling over the internet with utmost security. Dedoose uses JungleDisk, a cloud 
based file storage system. Powered by Amazon and Rackspace, this system is responsible for keeping 
backup's of all of Dedoose’s data and is an encrypted, distributed file system. This ensures that even in a worst 
case catastrophic failure, data is still safe and secure. 
 
Local Familiarity: Given our entire team’s significant familiarity and experience working in Senegal, we feel 
confident that this study will proceed as expected. We have measures in place (regular research meetings, 
clearly defined roles, oversight, and reporting structure) to diagnose and deal with problems as they arise.  
  
 
 

 
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