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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 17, 2018

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Acceptability of HPV self-sampling Questionnaire
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Participants must be assigned female sex at birth and identify as transgender male or transmasculine.

Minimum Age: 25 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Miami
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julia Seay, Research Assistant Professor – University of Miami

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.