Back to resultsHPV Self-Sampling for Cervical Cancer Screening Among Transgender Men and Transmasculine Individuals
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 transgender male or as transmasculine
- Assigned female sex at birth
- English speaking
- ages 25-65 years
- report not having had a pap smear in the last three years
- if age 30 and over, report not having a Pap smear/HPV co-test in the past 5 years
Exclusion Criteria:
• Those who report having had a hysterectomy
- Those who report having history of cervical cancer
- Adults unable to consent
- Those who are pregnant
- Prisoners
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HPV Self-sampling
Arm Description
All participants will receive HPV self-sampling. HPV self-sampling allows an individual to screen themselves for cervical cancer in private, using a device that is similar to a tampon.
Outcomes
Primary Outcome Measures
Acceptability of HPV self-sampling Questionnaire
This questionnaire, designed with substantial input from community partners, will gauge how acceptable the participants find HPV self-sampling through both closed and open-ended questions regarding ease of use, preference of self-sampler vs. physician-collected Pap smear, as well as open-ended inquiries regarding the self-sampling process.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03222817
Brief Title
HPV Self-Sampling for Cervical Cancer Screening Among Transgender Men and Transmasculine Individuals
Official Title
HPV Self-Sampling for Cervical Cancer Screening Among Transgender Men and Transmasculine Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 12, 2018 (Actual)
Primary Completion Date
October 17, 2018 (Actual)
Study Completion Date
October 17, 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 Papillomavirus (HPV) self-sampling intervention for unscreened and under-screened transgender men and transmasculine individuals living in South Florida. The study will enroll participants to receive this cervical cancer screening 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
Experimental
Arm Description
All participants will receive HPV self-sampling. HPV self-sampling allows an individual to screen themselves for cervical cancer in private, using a device that is similar to a tampon.
Intervention Type
Behavioral
Intervention Name(s)
HPV self-sampling
Intervention Description
Participants will be provided with education regarding cervical cancer screening, as well as instructions regarding how to use the HPV self-sampler. Participants will also receive referrals to trans-competent healthcare providers for follow-up screening and care.
Primary Outcome Measure Information:
Title
Acceptability of HPV self-sampling Questionnaire
Description
This questionnaire, designed with substantial input from community partners, will gauge how acceptable the participants find HPV self-sampling through both closed and open-ended questions regarding ease of use, preference of self-sampler vs. physician-collected Pap smear, as well as open-ended inquiries regarding the self-sampling process.
Time Frame
This questionnaire will be administered immediately after participants self-sample
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants must be assigned female sex at birth and identify as transgender male or transmasculine.
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 transgender male or as transmasculine
Assigned female sex at birth
English speaking
ages 25-65 years
report not having had a pap smear in the last three years
if age 30 and over, report not having a Pap smear/HPV co-test in the past 5 years
Exclusion Criteria:
• Those who report having had a hysterectomy
Those who report having history of cervical cancer
Adults unable to consent
Those who are pregnant
Prisoners
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
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 Transgender Men and Transmasculine Individuals
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