Clinical Trial: Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
Brief 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 Summary:
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
Sponsor: University of Virginia
Current Primary Outcome: Acceptability of at-home self-collection for HPV testing among under-screened women in Southwest Virginia. [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Feasibility of utilizing lay navigators to offer at-home HPV self-collection as a strategy to increase cervical cancer screening among under-screened women in Southwest Virginia. [ Time Frame: 24 months ]
Original Secondary Outcome: Same as current
Information By: University of Virginia
Dates:
Date Received: January 27, 2016
Date Started: June 2016
Date Completion:
Last Updated: May 1, 2017
Last Verified: May 2017
