Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by the Mobile
Phase: NA
Conditions: Cervical Cancer
Sponsor: University of Virginia

 
Clinicaltrails.gov Identifier: NCT03551028 
 
OFFICIAL TITLE: HPV DNA Testing through Mobile Mammography Unit 
 
Principal Investigator: Emma McKim Mitchell, PhD, MSN, RN 
 
 
 
Assistant Professor 
 
 
 
University of Virginia School of Nursing 
 
Date of Approval: July 12, 2016 
Date of Most Recent Review: June 27, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Objectives: The purpose of this study was to explore the acceptability and feasibility of pairing 
self-collection of samples for HPV testing with mammography screening on UVA’s mobile 
mammography unit. 
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.  
Several barriers exist to women engaging in cervical cancer screening as recommended, 
including time, cost, distance, and clinic barriers.  Self-collection of samples for HPV DNA 
testing has been found to be acceptable and feasible to implement in several geographic 
locations. Studying delivery methods for this technology is important to promote implementation. 
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 pairing the HPV self-collection kits with mobile mammography could increase 
access to cervical cancer screening in women seeking mobile mammography. 
Several barriers to accessing clinic-based care exist in this targe geographic area.  This region 
is host to an annual episodic clinic organized by local partners and the organization Remote 
Area Medical (RAM).  The UVA Mobile Mammography unit is a service offered at these episodic 
clinics. 
Patient Selection: 
 
Eligibility Criteria: 
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 worked with the UVA mobile 
mammography unit to screen women seeking mobile mammography for eligibility. The research 
team documented eligibility screening, obtained informed consent, and performed teaching 
related to collecting a self-sample for HPV testing. Participants used a private exam room on the 
mobile mammography unit to collect their own sample. 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.  
 
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 7/12/2016. 
This study was closed by the PI on 4/12/2022.  Results supported the hypothesis.  Records to 
be retained for 6 years.