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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer Screening
• Intervention / Treatment: Behavioral: HPV self-sampling

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: HPV self-sampling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This questionnaire will be administered immediately after participants self-sample

Collaborators and Investigators

• Sponsor: University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2018
• Primary Completion (Actual): October 17, 2018
• Study Completion (Actual): October 17, 2018

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: 20170329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No