Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
Invasive cervical cancer incidence and mortality can be dramatically reduced through early
 detection and treatment, but many women do not complete screening at recommended intervals.
 Many low-income women in Virginia remain uninsured and are at significant risk of being
 medically underserved and failing to complete regular cervical cancer screening. At-home
 self-collection of specimens for HPV testing is an innovative approach that may increase
 access to cervical cancer screening in populations that do not participate in traditional
 clinic-based screening. The proposed community based participatory study aims to determine
 whether offering at-home self-collection for HPV testing through a lay navigator network is
 an acceptable and feasible method to increase access to cervical cancer screening for
 under-screened women in the Tobacco Footprint in rural far Southwest Virginia (Health
 Districts 1, 2 and 3). The procedures will be recruitment of under-screened women in Health
 Districts 1, 2 and 3 of Southwest Virginia to complete HPV testing using self-collection kits
 distributed by lay navigators. Regardless of HPV positivity, all women will be provided with
 information about cervical cancer screening (locations, cost, etc.), and will be encouraged
 to complete Pap screening by a clinician.
The catchment area for the University of Virginia Health System and Emily Couric Clinical
 Cancer Center (EC4) extends throughout Southwest Virginia and into neighboring West Virginia,
 encompassing a portion of Appalachia. State-wide incidence of cervical cancer was 6.6 cases
 per 100,000 from 2005-2009, but variation exists county by county: Cumberland (Health
 District 2), Roanoke, and Southside were among those with the highest incidence. The
 significant decrease in cervical cancer incidence and mortality rates in the US and in
 Virginia since 1950 is directly attributed to increased early detection and screening. The
 Virginia Department of Health's Comprehensive Cancer Control Program found that patient level
 barriers to screening for women in this region include lower education, lower income, and
 lack of health insurance. Systems-level barriers in this region include decreased access to
 screening services, financial barriers, and transportation barriers. This study will assess a
 novel approach to addressing patient level and systems-level barriers to accessing cervical
 cancer screening in Virginia Health Districts 1, 2 and 3, and utilizes an innovative
 technology (self-collection for HPV testing) and delivery model (distributed by lay
 navigators).

 Self-collection for HPV testing paired with a community health worker program is a model that
 has been found to have great utility in accessing at risk women in Little Haiti, South
 Florida, as well as in rural Haiti. Community health workers often have training in a variety
 of health issues and conditions. Patient navigators trained in cervical cancer screening and
 treatment specifically have been utilized to understand patient barriers to in-clinic
 screening. The lay navigator program the investigators will work with in Health Districts 1,
 2 and 3 involves cancer-specific training (including but not limited to cervical cancer
 training), and training on facilitating access to screening and treatment resources available
 in Health Districts 1, 2 and 3, as well as at the University of Virginia Health System. Lay
 navigators are therefore uniquely poised to provide education to women around the use of HPV
 self-collection, and to navigate women to in-clinic Pap screening, treatment, and support
 services as needed.

 Reach of Current Lay Navigators Trained using the "Understanding Cancer" curriculum
 (developed by partners listed above), lay navigators in Russell County (Cumberland Health
 District) reported 312 encounters between 2/10/14 and 12/17/14 classified as "preventative"
 specific to breast cancer. Between 1/23/14 and 9/24/14, navigators across Lenowisco Health
 District provided 233 cancer-related encounters, including navigation services for 4 women
 diagnosed with cervical cancer. The lay navigator program has the potential to be a rich
 resources for community based research in Southwest Virginia.

 Protocol Development Dr. Mitchell is currently a Co-I on the NCI-funded project P30CA044579
 (PI: Thomas Loughran, MD, 2014-2015). Through this work, the investigators are developing a
 list of key stakeholders, which will be consulted in Phases I and II of this study.
 Additionally, the community advisory board (CAB) of the Cancer Center Without Walls
 initiative will be consulted throughout protocol development.

 Dr. Mitchell has developed a collaboration with Dr. Jennifer S. Smith, Associate Professor of
 Epidemiology at the University of North Carolina at Chapel Hill. Dr. Smith and her research
 team have extensive experience and expertise with HPV screening and prevention, specifically
 exploring delivery models for HPV self-collection in medically underserved areas of North
 Carolina. The investigators are planning to collaborate on this pilot study, and based on
 these findings, to develop a proposal for an NIH/NCI R01 grant as co-PIs. Dr. Smith and the
 research team have conducted two previous studies assessing the acceptability, feasibility,
 and validity of HPV self-collection. Through these studies, the investigators have identified
 brush designs that are minimally invasive, well-accepted, and effective for self-collection
 and sample preservation media that is non-toxic, safe for mailing, and stable at a range of
 temperatures; and have developed well-validated, field-tested illustrated instructions for
 self-collection that are comprehensible to low-literacy women.
Inclusion Criteria:

 -  30-65 years old

 -  Female

 -  Live in southwest VA

 -  Not pregnant-self reported

 Exclusion Criteria:

 -  History of Papanicolaou test in the last 3 years

 -  History of hysterectomy or pelvic radiation

 -  Co-testing (pap test and HPV test at the same time) in the last 5 years

 -  English speaking