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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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