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.

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Key information

Conditions

Cervical Cancer Screening

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV self-sampling

Behavioral

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jul 19, 2017
Registry last updated: May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed