Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
Phase: NA
Conditions: Human Papilloma Virus
Sponsor: University of Virginia

Clinicaltrails.gov Identifier: NCT03139669 
 
OFFICIAL TITLE: Cultural Acceptability and Feasibility of HPV Cervical Self-Collection Aided by 
Lay Navigators 
 
Principal Investigator: Emma McKim Mitchell, PhD, MSN, RN 
 
 
 
Assistant Professor 
 
 
 
University of Virginia School of Nursing 
Objectives: The purpose of this study was to explore the acceptability and feasibility of at-home 
self-collection of samples for HPV testing through a lay navigator delivery network. 
Background: Cervical cancer is preventable, and caused almost exclusively by high risk 
genotypes of the Human Papillomavirus (hrHPV).  Strong tools exist for prevention of 
developing this slow-growing cancer, including vaccination against hrHPV, screening through 
Pap testing/cytology and/or HPV testing, and treatment options for pre-cancerous and 
cancerous lesions.  In far Southwest Virginia, particularly in Appalachian counties, there are 
higher incidence and mortality rates of cervical cancer than in non-Appalachian counties.   
Based on a long-term research network through the University of Virginia’s Cancer Center 
Without Walls Initiative, the research team worked closely with a Community Advisory Board 
(CAB) made up of representative stakeholders from this target geographic area in order to 
inform study procedures, recruitment, and the delivery model of the screening strategy.  The 
goal was to see if at-home self-collection when kits were distributed by a lay navigator from the 
target communities could be a feasible and acceptable way to increase cervical cancer 
screening. 
Patient Selection: 
 
Eligibility Criteria: 
Lay Navigators: 
18+ years of age 
Received UVA delivered lay navigator training 
Living in Virginia Planning Districts/Health Department Districts 1 and 2 
Participants: 
Women 
30-64 years of age 
Living in Virginia Planning Districts/Health Department Districts 1 and 2 
 
Exclusion Criteria: 
Pregnant 

History of hysterectomy 
History of cervical cancer 
Screened by Pap test/cytology within the last 3 years/HPV test within the last 5 years 
 
Inclusion of Women: Only women were targeted for recruitment.  
 
Inclusion of Children: HPV testing is not recommended for women younger than 30 
years of age in the US. 
Study Procedures: 
 
Recruitment and screening: The research team trained 64 lay navigators with the 
University of Virginia lay navigator training, including cancer prevention resources beyond 
cervical cancer prevention only. Lay navigators received study-specific training and materials, 
including participant screening checklists, informed consent documents, and a kit for 
participants (once documented as eligible and once informed consent was received) to collect 
their own sample for HPV testing. Participants also completed a paper-based survey, including 
sub-scales on attitudes/beliefs about cervical screening prevention, including self-collection of 
samples, health literacy, and relevant demographics. Each kit also contained a survey for lay 
navigators to complete, documenting the number of participants they attempted to recruit and 
their feedback on study procedures. Consents and completed kits were mailed back to the 
University of Virginia for sample processing. 
 
Procedures: All participants were called by phone to deliver results.  If a participant who 
tested negative could not be reached after 5 attempts on the primary and secondary phone 
number provided, a mailed letter was sent to the address they had provided.  All participants 
who tested positive for hrHPV were contacted by phone and navigated to a local clinic for follow 
up testing. 
Statistical Considerations: 
 
Sample size: This study was a feasibility pilot in order to help generate relevant data for 
future study designs. Endpoints included number of kits distributed and number of kits 
completed. 
 
Analysis plan: Descriptive statistics included age (years/median), parity, hrHPV 
positivity rate, caregiver status (children/parent/other), smoker (yes/no), recipient of social 
assistance (yes/no), health literacy (adequate/marginal/limited), having seen a healthcare 
provider in the last year (yes/no), having a healthcare provider recommend a Pap in the last 
year (yes/no), cost perception, and awareness of Virginia’s Every Women’s Life program.  
 
This study was approved by the University of Virginia IRB on 10/27/2015. 
This study was closed by the PI on 8/27/2019.  Results supported the hypothesis.  Records to 
be retained for 6 years.