Clinical trial NCT03139669: Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
Official title: Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 45
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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 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 several rural and remote areas around the world. 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 Virginia 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 was a Co-I on the NCI-funded project P30CA044579 (PI: Thomas Loughran, MD, 2014-2015). Through this work, the investigators developed 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 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. Dr. Smith and the research team have conducted multiple 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of At-home Self-collection for HPV Testing Among Under-screened Women in Southwest Virginia.
timeFrame: 1 month
Secondary outcomes:
measure: 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.
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Faculty
name: Emma Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
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