HPV Self-Sampling for Cervical Cancer Screening Among Transgender Men and Transmasculine Individuals

Not Applicable

Completed

• Conditions: Cervical Cancer Screening
• Interventions: Behavioral: HPV self-sampling

• Registration Number: NCT03222817
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-19
• Study Start: 2018-05-12
• Primary Completion: 2018-10-17
• Study Completion: 2018-10-17
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-01
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HPV Self-sampling	HPV self-sampling	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of HPV self-sampling Questionnaire	This questionnaire will be administered immediately after participants self-sample	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States