Clinical trial NCT02401867: Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients
Official title: Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Cervical Neoplasms
Sexually Transmitted Diseases
Keywords: transgender
female-to-male
cervical cancer
HPV
sexual health
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-03-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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 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

Primary outcomes:
measure: Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
Study officials:
affiliation: Fenway Community Health
name: Sari Reisner, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.