Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients



Status:Recruiting
Conditions:Cervical Cancer, Infectious Disease, Women's Studies
Therapuetic Areas:Immunology / Infectious Diseases, Oncology, Reproductive
Healthy:No
Age Range:21 - 64
Updated:8/11/2016
Start Date:January 2015
End Date:December 2016
Contact:Sari Reisner, ScD
Email:sreisner@fenwayhealth.org
Phone:617-927-6017

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The purpose of this study is to assess the acceptability and effectiveness of utilizing
vaginal self-swabs for HPV DNA testing as compared to provider-collected cervical swabs for
HPV, as well as to investigate the prevalence of other Sexually Transmitted Infections
(STIs) among sexually active female-to-male (FTM) transgender adults.

This observational study will examine sexual health in a bio-behavioral cross-sectional
mixed-methods design among 150 FTM patients in Boston, Massachusetts, and will determine the
acceptability as well as collect epidemiologic data on the comparative performance
characteristics of several biological screening modalities in this patient population.
Patients and stakeholders are key partners throughout the project and are involved in all
phases of study development, implementation, and plans for dissemination.

Eligible participants will participate in a one-time clinical visit. Following written
consent, the one-time clinical visit will include: 1) Quantitative assessment; 2) Collection
of biological specimens/biomarkers (HPV DNA vaginal self-swab, HPV DNA cervical swab
collected by provider, Pap test with cytology, STI testing self- and provider-collected); 3)
Qualitative Interview.

A series of national, online focus groups with FTMs, providers, and key stakeholders will
occur to gather information on the sexual health needs of FTM individuals outside the Boston
area and to ensure that the dissemination of study findings take differing demographic
concerns into consideration.

Inclusion Criteria:

- Age 21-64

- Assigned a female sex at birth and now self-identifies as a man, trans masculine,
trans man, FTM, transgender, genderqueer/non-binary, transsexual, male, and/or
another diverse transgender identity or expression

- Have a cervix

- Sexually active in the past 36 months (with sexual partner(s) of any gender)

- Able to speak and understand English

- Willing and able to provide informed consent

Exclusion Criteria:

- Unable to provide informed consent due to severe mental or physical illness

- Substance intoxication at the time of interview
We found this trial at
1
site
Boston, Massachusetts 02215
Principal Investigator: Sari Reisner, ScD
Phone: 617-927-6017
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Boston, MA
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