Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
Condition: Human Papilloma Virus
MeSH terms: Papilloma
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Viba collection brush
Intervention type(s): Device
Intervention description(s): HPV home collection kit using the viba collection brush to collect cervical cells for HPV DNA testing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening