HPV DNA Testing Through Mobile Mammography Unit

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Device: HPV self collection

• Registration Number: NCT03551028
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-06-11
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Results First Submitted: 2023-08-24
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Results First Posted: 2024-11-04
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• not pregnant

Exclusion Criteria

• history of hysterectomy or pelvic RT non English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HPV self collection	HPV self collection	Pairing self-collection of HPV samples for DNA testing with women seeking mobile mammography.

Primary Outcome Measures

Name	Time	Method
Acceptability of Self-Collection Paired With Mobile Mammography	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	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).

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States