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

Fenway Community Health

Status: Completed

Conditions: Sexually Transmitted Diseases; Uterine Cervical Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT02401867

CER-1403-12625

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 patients

Sex: Female

Ages: 21 to 64 years old

Volunteers: Accepts Healthy Volunteers

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