Back to resultsHPV DNA Testing Through Mobile Mammography Unit
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HPV self collection
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- not pregnant
Exclusion Criteria:
- history of hysterectomy or pelvic RT non English speaking
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HPV self collection
Arm Description
Pairing self-collection of HPV samples for DNA testing with women seeking mobile mammography.
Outcomes
Primary Outcome Measures
Cultural Acceptability of Self-Collection for HPV among women seeking a mammogram at a mobile mammogram unit
Assess the cultural acceptability of self-collection for HPV testing among under-screened women in Southwest Virginia who were seeking a mammogram at an episodic clinic. Variables therefore include: uptake of HPV self collection (yes/no); and intention to follow up upon learning of result.
Feasibility of Self-Collection for HPV among women seeking a mobile mammogram
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. Variables therefore include: uptake of HPV self collection (yes/no); and intention to follow up upon learning of result.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03551028
Brief Title
HPV DNA Testing Through Mobile Mammography Unit
Official Title
Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by the Mobile
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPV self collection
Arm Type
Other
Arm Description
Pairing self-collection of HPV samples for DNA testing with women seeking mobile mammography.
Intervention Type
Device
Intervention Name(s)
HPV self collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cultural Acceptability of Self-Collection for HPV among women seeking a mammogram at a mobile mammogram unit
Description
Assess the cultural acceptability of self-collection for HPV testing among under-screened women in Southwest Virginia who were seeking a mammogram at an episodic clinic. Variables therefore include: uptake of HPV self collection (yes/no); and intention to follow up upon learning of result.
Time Frame
4 Years
Title
Feasibility of Self-Collection for HPV among women seeking a mobile mammogram
Description
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. Variables therefore include: uptake of HPV self collection (yes/no); and intention to follow up upon learning of result.
Time Frame
4 Years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
not pregnant
Exclusion Criteria:
history of hysterectomy or pelvic RT non English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma M Mitchell, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21384341
Citation
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.
Results Reference
background
PubMed Identifier
20592553
Citation
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.
Results Reference
background
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HPV DNA Testing Through Mobile Mammography Unit
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