HPV DNA Testing Through Mobile Mammography Unit

NCT03551028 | Completed Results FDA Device

• 1 other identifier: 19110
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Acceptability of Self-Collection Paired With Mobile Mammography

  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.

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

• Feasibility of Self-Collection for HPV Paired With Mobile Mammography

  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).

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

Study Arms (1)

HPV self collection

OTHER

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

Device: HPV self collection

Interventions

HPV self collection DEVICE

The proposed community based participatory 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 Southwest Virginia.

HPV self collection

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• not pregnant

You may not qualify if:

• history of hysterectomy or pelvic RT non English speaking

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (2)

• Gravitt PE, Belinson JL, Salmeron J, Shah KV. Looking ahead: a case for human papillomavirus testing of self-sampled vaginal specimens as a cervical cancer screening strategy. Int J Cancer. 2011 Aug 1;129(3):517-27. doi: 10.1002/ijc.25974.

  PMID: 21384341 BACKGROUND

• Balasubramanian A, Kulasingam SL, Baer A, Hughes JP, Myers ER, Mao C, Kiviat NB, Koutsky LA. Accuracy and cost-effectiveness of cervical cancer screening by high-risk human papillomavirus DNA testing of self-collected vaginal samples. J Low Genit Tract Dis. 2010 Jul;14(3):185-95. doi: 10.1097/LGT.0b013e3181cd6d36.

  PMID: 20592553 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Emma Mitchell
• Organization: University of Virginia

emm6z@virginia.edu

4342433962

Study Officials

• Emma M Mitchell, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: June 11, 2018
• Study Start: July 1, 2016
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: November 4, 2024
• Results First Posted: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)