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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03222817
Enrollment
10
Registered
2017-07-19
Start date
2018-05-12
Completion date
2018-10-17
Last updated
2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer Screening

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.

Interventions

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.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of HPV self-sampling QuestionnaireThis questionnaire will be administered immediately after participants self-sampleThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026