Back to resultsHPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women
Primary Purpose
Cervical Cancer Screening
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HPV self-sampling
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer Screening
Eligibility Criteria
Inclusion Criteria:
- Self-identify as lesbian, bisexual, or queer woman
- Assigned female sex at birth
- English speaking
- ages 25-65 years
- report not having had a pap smear in the last three years (per USPSTF guidelines)
- if age 30 or over, report not having a pap smear/HPV co-test within the past 5 years (per USPSTF guidelines)
Exclusion Criteria:
- report having had a hysterectomy
- report having history of cervical cancer
- unable to consent
- Pregnant women
- Prisoners
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HPV Self-sampling
Arm Description
All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.
Outcomes
Primary Outcome Measures
HPV Self-sampling uptake
Percentage of eligible women who complete HPV self-sampling
Secondary Outcome Measures
Full Information
NCT ID
NCT03012932
First Posted
January 3, 2017
Last Updated
September 24, 2018
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT03012932
Brief Title
HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women
Official Title
HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
March 24, 2018 (Actual)
Study Completion Date
March 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed study will examine the implementation of a Human Papilloma Virus (HPV) self-sampling intervention for under screened LBQ women living in South Florida. The study will enroll participants to receive the self-sampling intervention in community venues. The purpose of this study is to pilot the self-sampler for feasibility and acceptability within this underserved population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer Screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPV Self-sampling
Arm Type
Other
Arm Description
All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.
Intervention Type
Behavioral
Intervention Name(s)
HPV self-sampling
Intervention Description
All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.
Primary Outcome Measure Information:
Title
HPV Self-sampling uptake
Description
Percentage of eligible women who complete HPV self-sampling
Time Frame
through study completion, up to 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Self-identify as lesbian, bisexual, or queer woman
Assigned female sex at birth
English speaking
ages 25-65 years
report not having had a pap smear in the last three years (per USPSTF guidelines)
if age 30 or over, report not having a pap smear/HPV co-test within the past 5 years (per USPSTF guidelines)
Exclusion Criteria:
report having had a hysterectomy
report having history of cervical cancer
unable to consent
Pregnant women
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Seay, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women
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