Trial record 2 of 10 for:    Open Studies | "Transgendered Persons"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Fenway Community Health
Sponsor:
Collaborator:
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
Sari Reisner, Fenway Community Health
ClinicalTrials.gov Identifier:
NCT02401867
First received: January 30, 2015
Last updated: March 24, 2015
Last verified: February 2015
  Purpose

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.


Condition
Uterine Cervical Neoplasms
Sexually Transmitted Diseases

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients

Resource links provided by NLM:


Further study details as provided by Fenway Community Health:

Primary Outcome Measures:
  • Concordance between vaginal self-swab and provider-collected cervical swab for HPV DNA among sexually active FTM adults [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 150
Study Start Date: January 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

This study aims to enroll 150 female-to-male (FTM) individuals, ages 21-64. Participants will be recruited from the existing FTM patient population at Fenway Health, as well as via community outreach in the greater Boston area. A diverse sample is anticipated; the aim is to recruit 40% racial/ethnic minority FTMs.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02401867

Contacts
Contact: Sari Reisner, ScD 617-927-6017 sreisner@fenwayhealth.org
Contact: Dana Pardee 617-927-6371 dpardee@fenwayhealth.org

Locations
United States, Massachusetts
Fenway Community Health Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sari Reisner, ScD    617-927-6017    sreisner@fenwayhealth.org   
Contact: Dana Pardee    617-927-6371    dpardee@fenwayhealth.org   
Principal Investigator: Sari Reisner, ScD         
Sponsors and Collaborators
Fenway Community Health
Patient Centered Outcome Research Institute
Investigators
Principal Investigator: Sari Reisner, ScD Fenway Community Health
  More Information

No publications provided

Responsible Party: Sari Reisner, Research Scientist, Fenway Community Health
ClinicalTrials.gov Identifier: NCT02401867     History of Changes
Other Study ID Numbers: CER-1403-12625
Study First Received: January 30, 2015
Last Updated: March 24, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Fenway Community Health:
transgender
female-to-male
cervical cancer
HPV
sexual health

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female
Infection
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Virus Diseases

ClinicalTrials.gov processed this record on June 30, 2015