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

Sexually Transmitted Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401867
• Other study ID #: CER-1403-12625
• Status: Completed
• Phase: N/A
• First received: January 30, 2015
• Last updated: November 7, 2016
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 64 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
United States	Fenway Community Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Fenway Community Health	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between vaginal self-swab and provider-collected cervical swab for HPV DNA among sexually active FTM adults	Quantitatively assess the non-inferiority of vaginal self-swab for HPV DNA compared to provider-collected cervical swab for HPV via laboratory confirmed testing in sexually active FTM adults. Specimens will be analyzed using a 13 strain qualitative high-risk HPV assay (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68).	1 day	No