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Preventive sexual health screening among female-to-male (FTM) transgender adult patients
Investigator (PI): Reisner, Sari
Performing Organization (PO): (Current): Fenway Health / (617) 927-6450
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2014
Final Year: 2018
Record Source/Award ID: PCORI/CER-1403-12625
Funding: Total Award Amount: $812,901
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background: Female-to-male (FTM) transgender men are individuals born with female reproductive organs who identify as male. The majority of FTM transgender men do not undergo complete sex reassignment surgery and therefore retain their female natal reproductive organs (e.g., cervix). Cervical cancer, human papillomavirus (HPV), and other sexually transmitted infections (STIs) lead to significant morbidity and mortality in U.S. However, basic clinical data are lacking on the prevalence of abnormal cervical cytology and biologically confirmed prevalence of HPV and other STIs in FTM patients. Further, our team's formative research suggests that more than 1 in 3 (36%) of FTM patients are not up-to-date on screening. Objectives: The study objective is to assess acceptability and non-inferiority of alternative preventive sexual health screening technologies for cervical cancer, HPV screening, and biologically confirmed STIs in FTM transgender patients, including self-/provider-swab concordance for HPV and other STIs. Methods: We will conduct a cross-sectional, observational mixed-methods biobehavioral study of preventive sexual health screening with 100 sexually active FTMs recruited through Fenway Health in Boston, MA. Aim 1 is to quantitatively and qualitatively assess the acceptability, feasibility, and non-inferiority of vaginal self-swab for HPV DNA testing compared to provider cervical swab and compared to Pap test results (cervical cytology) among FTMs. Aim 2 is to investigate the prevalence of other STIs among FTMs, concordance of self- and provider-swabs for STIs, and descriptively examine risk and protective factors for STI diagnosis. Patient outcomes: For aim 1 the outcomes are 1) concordance of vaginal self-swab and provider cervical swab for HPV DNA; 2) concordance of each HPV DNA swab with Pap test results (cervical cytology); and 3) acceptability of self-swab technologies for HPV DNA testing for cervical cancer screening. For aim 2 the outcomes are 1) clinically confirmed prevalence of HIV, syphilis, gonorrhea, chlamydia, bacterial vaginosis, trichomoniasis; 2) concordance of each self-swab with provider-swab for STIs; 3) any biologically confirmed STI; and 4) any self-reported lifetime STI. Patient and stakeholder engagement: This project was conceptualized by and for FTMs patients. Patients and stakeholders are key personnel. The team includes representatives from the National Center of Excellence for Transgender Health (CoE), the World Professional Association for Transgender Health (WPATH), and the National LGBT Health Education Center. Future engagement includes a project-specific task force, website, and focus groups. Anticipated impact: This project will have a national and international impact on sexual health screening for FTMs, a hard-to-reach and underserved patient group at Fenway Health and beyond. The project will lead to potential alternative screening strategies, as well as less invasive STI detection practices, that may generalize to other at-risk natal female populations not being screened.
MeSH Terms:
  • Boston
  • Cross-Sectional Studies
  • DNA, Viral /analysis
  • Female
  • Humans
  • Male
  • Mass Screening /methods
  • Papanicolaou Test
  • Papillomaviridae
  • Prevalence
  • Preventive Medicine /*methods
  • Sexually Transmitted Diseases /*diagnosis
  • /*prevention & control
  • * Transgender Persons
  • United States
  • Vagina /virology
Country: United States
State: Massachusetts
Zip Code: 02215
UI: 20152202
CTgovId: NCT02401867
Project Status: Completed
Record History: ('2017: Project extended to 2018.',)