Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol

BMC Infectious Diseases

Study Protocol

Lori Panther¹  Sari L. Reisner²  Madeline B. Deutsch³  Jennifer Potter⁴  Sarah McLean⁵  Dana J. Pardee⁵  Timothy Cavanaugh⁵  Elliot J. Marrow⁵  Marcy Gelman⁵  Matthew J. Mimiaga⁶  Sarah M. Peitzmeier⁷  Jaclyn M. White Hughto⁸  Jamison Green⁹ 

[1] Beth Israel Deaconess Medical Center, 330 Brookline Ave, 02215, Boston, MA, USA;Boston Children’s Hospital, 300 Longwood Avenue, 02215, Boston, MA, USA;Harvard Medical School, 25 Shattuck St, 02215, Boston, MA, USA;Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, 02215, Boston, MA, USA;The Fenway Institute, Fenway Health, 1340 Boylston Street, 02215, Boston, MA, USA;Department of Family & Community Medicine, University of California, 2356 Sutter Street, 94115, San Francisco, CA, USA;UCSF Center of Excellence for Transgender Health, 2356 Sutter Street, 94115, San Francisco, CA, USA;Harvard Medical School, 25 Shattuck St, 02215, Boston, MA, USA;The Fenway Institute, Fenway Health, 1340 Boylston Street, 02215, Boston, MA, USA;Beth Israel Deaconess Medical Center, 330 Brookline Ave, 02215, Boston, MA, USA;The Fenway Institute, Fenway Health, 1340 Boylston Street, 02215, Boston, MA, USA;The Fenway Institute, Fenway Health, 1340 Boylston Street, 02215, Boston, MA, USA;Brown University School of Public Health, 121 S Main St, 02903, Providence, RI, USA;Alpert Medical School, Brown University, 222 Richmond St, 02903, Providence, RI, USA;Center for Health Equity Research (CHER), 121 S Main St, 02903, Providence, RI, USA;The Fenway Institute, Fenway Health, 1340 Boylston Street, 02215, Boston, MA, USA;Johns Hopkins School of Public Health, 1340 Boylston Street, 02215, Boston, MA, USA;The Fenway Institute, Fenway Health, 1340 Boylston Street, 02215, Boston, MA, USA;Yale School of Public Health, New Haven, CT, USA;World Professional Association for Transgender Health, 2420 Clover St, 94587, Union City, CA, USA;

关键词: Transgender;    Female-to-male;    Cervical cancer;    HPV;    Sexually transmitted infections (STIs);    Screening;    Testing;    Prevention;   

DOI  :  10.1186/s12879-017-2539-x

 received in 2017-05-25, accepted in 2017-06-09,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundCervical cancer, nearly all cases of which are caused by one of several high-risk strains of the human papillomavirus (hr-HPV), leads to significant morbidity and mortality in individuals with a cervix. Trans masculine (TM) individuals were born with female reproductive organs and identify as male, man, transgender man, or another diverse gender identity different from their female assigned sex at birth. Routine preventive sexual health screening of TM patients is recommended, including screening for cervical cancer and other sexually transmitted infections (STIs); however, as many as one in three TM patients are not up-to-date per recommended U.S. guidelines. Among cisgender (non-transgender) women, self-swab hr.-HPV DNA testing as a primary cervical cancer screening method and self-swab specimen collection for other STIs have high levels of acceptability. No study has yet been conducted to compare the performance and acceptability of self- and provider-collected swabs for hr.-HPV DNA testing and other STIs in TM patients.MethodsThis article describes the study protocol for a mixed-methods biobehavioral investigation enrolling 150 sexually active TM to (1) assess the clinical performance and acceptability of a vaginal self-swab for hr.-HPV DNA testing compared to provider cervical swab and cervical cytology, and (2) gather acceptability data on self-collected specimens for other STIs. Study participation entails a one-time clinical visit at Fenway Health in Boston, MA comprised of informed consent, quantitative assessment, venipuncture for syphilis testing and HIV (Rapid OraQuick) testing, randomization, collection of biological specimens/biomarkers, participant and provider satisfaction survey, and qualitative exit interview. Participants are compensated $100. The primary study outcomes are concordance (kappa statistic) and performance (sensitivity and specificity) of self-collected vaginal HPV DNA specimens vs provider-collected cervical HPV swabs as a gold standard.DiscussionThis study addresses critical gaps in current clinical knowledge of sexual health in TM patients, including comparing alternative strategies for screening and diagnosis of cervical cancer, hr.-HPV, and other STIs. Findings have implications for improving the delivery of sexual health screening to this often overlooked and underserved patient population. Less-invasive patient-centered strategies may also generalize to other at-risk cisgender female populations that face barriers to timely and needed STI and cervical cancer screening.Trial registrationClinicalTrials.gov ID: NCT02401867

【 授权许可】

CC BY   
© The Author(s). 2017