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Trial record 1 of 1 for:    NCT02401867
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Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients

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ClinicalTrials.gov Identifier: NCT02401867
Recruitment Status : Completed
First Posted : March 30, 2015
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Sari Reisner, ScD, Fenway Community Health

Brief 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.

Condition or disease
Uterine Cervical Neoplasms Sexually Transmitted Diseases

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.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients
Study Start Date : January 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults [ Time Frame: 1 day ]
    Quantitatively assessed 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. Compared the concordance of the positive self-swab HPV DNA test results to the positive cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401867

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United States, Massachusetts
Fenway Community Health
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Fenway Community Health
Patient-Centered Outcomes Research Institute
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Principal Investigator: Sari Reisner, ScD Fenway Community Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sari Reisner, ScD, Research Scientist, Fenway Community Health
ClinicalTrials.gov Identifier: NCT02401867    
Other Study ID Numbers: CER-1403-12625
First Posted: March 30, 2015    Key Record Dates
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sari Reisner, ScD, Fenway Community Health:
cervical cancer
sexual health
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Uterine Cervical Neoplasms
Communicable Diseases
Disease Attributes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases