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NCT03222817 Clinical Trial

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

Cervical Cancer Screening Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03222817
Other study ID # 20170329
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 12, 2018
Est. completion date October 17, 2018

Study information
Verified date May 2019
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date October 17, 2018
Est. primary completion date October 17, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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