NCT02401867

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Fenway Community Health · Academic / Other
• Sex: Female
• Age: 21 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Uterine Cervical Neoplasms
• Sexually Transmitted Diseases

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-03-30
• Last updated: 2017-06-28
• Results posted: 2017-06-28

Locations

1 site across 1 country: United States