Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators (HPVhometest)

August 28, 2024 updated by: Emma McKim Mitchell, University of Virginia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HPV home testing kit
The procedures will be recruitment of under-screened women in Health Districts 1, 2 and 3 of Southwest Virginia to complete HPV home 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.
Device: Viba collection brush
HPV home collection kit using the viba collection brush to collect cervical cells for HPV DNA testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of At-home Self-collection for HPV Testing Among Under-screened Women in Southwest Virginia.
Time Frame: 1 month
ACCEPTABILITY was measured through: uptake of self-collection kit (yes/n).
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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: 1 month
FEASIBILITY was measured by: uptake of self-collection kits (y/n), and whether that sample was sufficient for processing a result. If acceptability (uptake) was high but sufficiency of sample collection was low, there would be decreased feasibility of this approach.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Emma Mitchell, PhD, Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

August 29, 2019

Study Completion (Actual)

August 29, 2019

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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