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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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.

Eligibility Criteria

• 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.

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

Locations

United States, Massachusetts

Fenway Community Health

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Fenway Community Health

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Sari Reisner, ScD; Fenway Community Health

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Suarez NA, Peitzmeier SM, Potter J, Samandur A, Reisner SL. Preliminary findings for adverse childhood experiences and associations with negative physical and mental health and victimization in transmasculine adults. Child Abuse Negl. 2021 Aug;118:105161. doi: 10.1016/j.chiabu.2021.105161. Epub 2021 Jun 16.

Pletta DR, White Hughto JM, Peitzmeier S, Deutsch MB, Pardee D, Potter J, Reisner SL. Individual- and Partnership-Level Correlates of Protective Barrier Use in a Sample of Transmasculine Adults with Diverse Sexual Partnerships. AIDS Patient Care STDS. 2020 May;34(5):237-246. doi: 10.1089/apc.2019.0296.

McDowell MJ, Hughto JMW, Reisner SL. Risk and protective factors for mental health morbidity in a community sample of female-to-male trans-masculine adults. BMC Psychiatry. 2019 Jan 9;19(1):16. doi: 10.1186/s12888-018-2008-0. Erratum In: BMC Psychiatry. 2019 Jan 28;19(1):45.

Agenor M, White Hughto JM, Peitzmeier SM, Potter J, Deutsch MB, Pardee DJ, Reisner SL. Gender identity disparities in Pap test use in a sample of binary and non-binary transmasculine adults. J Gen Intern Med. 2018 Jul;33(7):1015-1017. doi: 10.1007/s11606-018-4400-3. No abstract available.

Reisner SL, Deutsch MB, Peitzmeier SM, White Hughto JM, Cavanaugh T, Pardee DJ, McLean S, Marrow EJ, Mimiaga MJ, Panther L, Gelman M, Green J, Potter J. Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol. BMC Infect Dis. 2017 Jun 23;17(1):444. doi: 10.1186/s12879-017-2539-x.

• 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
• 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:

transgender; female-to-male; cervical cancer; HPV; sexual health

Additional relevant MeSH terms:

Sexually Transmitted Diseases; Uterine Cervical Neoplasms; Communicable Diseases; Infections; Disease Attributes; Pathologic Processes; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases