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Clinical Trials/NCT03551028
NCT03551028
Completed
Not Applicable

Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by the Mobile

University of Virginia1 site in 1 country33 target enrollmentJuly 2016
ConditionsCervical Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
University of Virginia
Enrollment
33
Locations
1
Primary Endpoint
Acceptability of Self-Collection Paired With Mobile Mammography
Status
Completed
Last Updated
last year

Overview

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. 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. Innovative delivery models are needed to reach at-risk populations. This study seeks to explore the acceptability and feasibility of pairing self-collection of HPV samples for DNA testing with mobile mammography in women living in rural Virginia.

Detailed Description

The proposed study aims to determine whether offering self-collection for HPV testing through the mobile mammography unit is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in rural Virginia. The procedures will be recruitment of under-screened women in rural Virginia to complete HPV testing using self-collection kits distributed through the mobile mammography unit. 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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
March 31, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emma McKim Mitchell

Assistant Professor

University of Virginia

Eligibility Criteria

Inclusion Criteria

  • not pregnant

Exclusion Criteria

  • history of hysterectomy or pelvic RT non English speaking

Outcomes

Primary Outcomes

Acceptability of Self-Collection Paired With Mobile Mammography

Time Frame: 1 month (to allow for time to process samples and communicate results)

Assess the cultural acceptability of self-collection for HPV testing among under-screened women in Southwest Virginia specifically who were seeking a mammogram at an episodic clinic. The outcome measure of ACCEPTABILITY was measured through: participants who opted in, or uptake of HPV self collection (yes/no); and intention to follow up upon learning of result.

Feasibility of Self-Collection for HPV Paired With Mobile Mammography

Time Frame: 1 month (to allow for time to process samples and communicate results)

Assess the feasibility of self-collection for HPV testing among under-screened women in Southwest Virginia who were seeking a mammogram at an episodic clinic. FEASIBILITY was measured through: participant uptake of HPV self collection (yes/no); observations of clinic flow (i.e. how did this additional screening fit in with existing mammography services); and quality of samples collected (were any collected inaccurately or in a way that was impossible to detect).

Study Sites (1)

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