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

Sari L Reisner, Madeline B Deutsch, Sarah M Peitzmeier, Jaclyn M White Hughto, Timothy Cavanaugh, Dana J Pardee, Sarah McLean, Elliot J Marrow, Matthew J Mimiaga, Lori Panther, Marcy Gelman, Jamison Green, Jennifer Potter, Sari L Reisner, Madeline B Deutsch, Sarah M Peitzmeier, Jaclyn M White Hughto, Timothy Cavanaugh, Dana J Pardee, Sarah McLean, Elliot J Marrow, Matthew J Mimiaga, Lori Panther, Marcy Gelman, Jamison Green, Jennifer Potter

Abstract

Background: Cervical 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.

Methods: This 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.

Discussion: This 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 registration: ClinicalTrials.gov ID: NCT02401867.

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

Figures

Fig. 1
Fig. 1
Diagram of study visit flow

References

    1. Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999;189(1):12–19. doi: 10.1002/(SICI)1096-9896(199909)189:1<12::AID-PATH431>;2-F.
    1. Center for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines. 2010. . Accessed 15 Feb 2017.
    1. Center for Disease Control and Prevention (CDC). Other Sexually Transmitted Diseases. 2011. . Accessed 15 Feb 2017.
    1. Hariri S, Unger ER, Sternberg M, Dunne EF, Swan D, Patel S, Markowitz LE. Prevalence of genital human papillomavirus among females in the United States, the National Health and Nutrition Examination Survey, 2003-2006. J Infect Dis. 2011;204(4):566–573. doi: 10.1093/infdis/jir341.
    1. National Cancer Institute (NCI). Fact sheet: HPV and Cancer. 2013. . Accessed 16 Feb 2017.
    1. Institute of Medicine (IOM) The health of lesbian, gay, bisexual, and transgender people: building a Foundation for Better Understanding. Washington, DC: The National Academic Press; 2011.
    1. Peitzmeier SM, Reisner SL, Harigopal P, Potter J. Female-to-male patients have high prevalence of unsatisfactory Paps compared to non-transgender females: implications for cervical cancer screening. J Gen Intern Med. 2014;29(5):778–784. doi: 10.1007/s11606-013-2753-1.
    1. Reisner SL, Murchison GR. A global research synthesis of HIV and STI biobehavioural risks in female-to-male transgender adults. Glob Public Health. 2016;11(7–8):866–887. doi: 10.1080/17441692.2015.1134613.
    1. Bauer GR, Travers R, Scanlon K, Coleman TA. High heterogeneity of HIV-related sexual risk among transgender people in Ontario, Canada: a province-wide respondent-driven sampling survey. BMC Public Health. 2012;12:292. doi: 10.1186/1471-2458-12-292.
    1. Schulden JD, Song B, Barros A, Mares-DelGrasso A, Martin CW, Ramirez R, Smith LC, Wheeler DP, Oster AM, Sullivan PS, et al. Rapid HIV testing in transgender communities by community-based organizations in three cities. Public Health Rep. 2008;123(Suppl 3):101–114. doi: 10.1177/00333549081230S313.
    1. Reisner SL, Perkovich B, Mimiaga MJ. A mixed methods study of the sexual health needs of New England transmen who have sex with nontransgender men. AIDS Patient Care STDs. 2010;24(8):501–513. doi: 10.1089/apc.2010.0059.
    1. American College of Obstetricians and Gynecologists (ACOG) Committee opinion no. 512: health care for transgender individuals. Obstet Gynecol. 2011;118(6):1454–1458. doi: 10.1097/AOG.0b013e31823ed1c1.
    1. UCSF Department of Family and Community Medicine. Primary care protocol for transgender patient care. 2011. . Accessed 15 Feb 2017.
    1. Peitzmeier SM, Khullar K, Reisner SL, Potter J. Pap test use is lower among female-to-male patients than non-transgender women. Am J Prev Med. 2014;47(6):808–812. doi: 10.1016/j.amepre.2014.07.031.
    1. Dutton L, Koenig K, Fennie K. Gynecologic care of the female-to-male transgender man. J Midwifery Womens Health. 2008;53(4):331–337. doi: 10.1016/j.jmwh.2008.02.003.
    1. Reisner SL, Conron K, Scout N, Mimiaga MJ, Haneuse S, Austin SB. Comparing in-person and online survey respondents in the U.S. National Transgender Discrimination Survey: implications for transgender Health Research. LGBT Health. 2014;1(2):98–106. doi: 10.1089/lgbt.2013.0018.
    1. Driak D, Samudovsky M. Could a man be affected with carcinoma of cervix?--the first case of cervical carcinoma in trans-sexual person (FtM)--case report. Acta medica (Hradec Kralove)/Universitas Carolina. Facultas Medica Hradec Kralove. 2005;48(1):53–55.
    1. Feldman JL. Preventive care of the transgendered patient: an evidence-based approach. In: Ettner R, Monstrey S, Eyler E, editors. Principles of transgender medicine and surgery. Binghampton: Haworth Press; 2007. pp. 33–72.
    1. Kaufman R. Introduction to transgender identity and health. In: Makadon H, Mayer KH, Potter J, Goldhammer H, editors. The Fenway Guide to lesbian, gay, bisexual, and transgender health. Philadelphia: American College of Physicians; 2008. pp. 331–363.
    1. Kenagy GP. Transgender health: findings from two needs assessment studies in Philadelphia. Health Soc Work. 2005;30(1):19–26. doi: 10.1093/hsw/30.1.19.
    1. O'Hanlan KA, Dibble SL, Young-Spint M. Total laparoscopic hysterectomy for female-to-male transsexuals. Obstet Gynecol. 2007;110(5):1096–1101. doi: 10.1097/01.AOG.0000286778.44943.5a.
    1. Rachlin K, Green J, Lombardi E. Utilization of health care among female-to-male transgender individuals in the United States. J Homosex. 2008;54(3):243–258. doi: 10.1080/00918360801982124.
    1. van Trotsenburg MAA. Gynecological aspects of transgender healthcare. Int J Transgenderism. 2009;11:238–246. doi: 10.1080/15532730903439484.
    1. Dannecker C, Siebert U, Thaler CJ, Kiermeir D, Hepp H, Hillemanns P. Primary cervical cancer screening by self-sampling of human papillomavirus DNA in internal medicine outpatient clinics. Ann Oncol. 2004;15(6):863–869. doi: 10.1093/annonc/mdh240.
    1. Nobbenhuis MA, Helmerhorst TJ, van den Brule AJ, Rozendaal L, Jaspars LH, Voorhorst FJ, Verheijen RH, Meijer CJ. Primary screening for high risk HPV by home obtained cervicovaginal lavage is an alternative screening tool for unscreened women. J Clin Pathol. 2002;55(6):435–439. doi: 10.1136/jcp.55.6.435.
    1. Wright TC, Stoler MH, Behrens CM, Sharma A, Zhang G, Wright TL. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol. 2015;136(2):189–197. doi: 10.1016/j.ygyno.2014.11.076.
    1. Chernesky MA, Hook EW, 3rd, Martin DH, Lane J, Johnson R, Jordan JA, Fuller D, Willis DE, Fine PM, Janda WM, et al. Women find it easy and prefer to collect their own vaginal swabs to diagnose Chlamydia trachomatis or Neisseria gonorrhoeae infections. Sex Transm Dis. 2005;32(12):729–733. doi: 10.1097/01.olq.0000190057.61633.8d.
    1. Garland SM, Tabrizi SN. Diagnosis of sexually transmitted infections (STI) using self-collected non-invasive specimens. Sex Health. 2004;1(2):121–126. doi: 10.1071/SH03014.
    1. Hobbs MM, van der Pol B, Totten P, Gaydos CA, Wald A, Warren T, Winer RL, Cook RL, Deal CD, Rogers ME, et al. From the NIH: proceedings of a workshop on the importance of self-obtained vaginal specimens for detection of sexually transmitted infections. Sex Transm Dis. 2008;35(1):8–13. doi: 10.1097/OLQ.0b013e31815d968d.
    1. Holland-Hall CM, Wiesenfeld HC, Murray PJ. Self-collected vaginal swabs for the detection of multiple sexually transmitted infections in adolescent girls. J Pediatr Adolesc Gynecol. 2002;15(5):307–313. doi: 10.1016/S1083-3188(02)00197-3.
    1. Huppert JS, Hesse EA, Bernard MA, Xiao Y, Huang B, Gaydos CA, Kahn JA. Acceptability of self-testing for trichomoniasis increases with experience. Sex Transm Infect. 2011;87(6):494–500. doi: 10.1136/sextrans-2011-050037.
    1. Knox J, Tabrizi SN, Miller P, Petoumenos K, Law M, Chen S, Garland SM. Evaluation of self-collected samples in contrast to practitioner-collected samples for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis by polymerase chain reaction among women living in remote areas. Sex Transm Dis. 2002;29(11):647–654. doi: 10.1097/00007435-200211000-00006.
    1. Stewart CM, Schoeman SA, Booth RA, Smith SD, Wilcox MH, Wilson JD. Assessment of self taken swabs versus clinician taken swab cultures for diagnosing gonorrhoea in women: single centre, diagnostic accuracy study. BMJ. 2012;345:e8107. doi: 10.1136/bmj.e8107.
    1. Gok M, van Kemenade FJ, Heideman DA, Berkhof J, Rozendaal L, Spruyt JW, Belien JA, Babovic M, Snijders PJ, Meijer CJ. Experience with high-risk human papillomavirus testing on vaginal brush-based self-samples of non-attendees of the cervical screening program. Int J Cancer. 2012;130(5):1128–1135. doi: 10.1002/ijc.26128.
    1. Clements-Nolle K, Bachrach A. Community based participatory research with a hidden population: the transgender community health project. In Minkler M & Wallerstein N, editors. Community-based participatory research for health. New Jersey: Jossey-Bass Publishing, a Wiley & Sons Company; 2002.
    1. Leung MW, Yen IH, Minkler M. Community based participatory research: a promising approach for increasing epidemiology's relevance in the 21st century. Int J Epidemiol. 2004;33(3):499–506. doi: 10.1093/ije/dyh010.
    1. McPhee SJ, Nguyen TT, Shema SJ, Nguyen B, Somkin C, Vo P, Pasick R. Validation of recall of breast and cervical cancer screening by women in an ethnically diverse population. Prev Med. 2002;35(5):463–473. doi: 10.1006/pmed.2002.1096.
    1. Pizarro J, Schneider TR, Salovey P. A source of error in self-reports of pap test utilization. J Community Health. 2002;27(5):351–356. doi: 10.1023/A:1019888627113.
    1. Suarez L, Goldman DA, Weiss NS. Validity of pap smear and mammogram self-reports in a low-income Hispanic population. Am J Prev Med. 1995;11(2):94–98.
    1. Boekeloo BO, Schiavo L, Rabin DL, Conlon RT, Jordan CS, Mundt DJ. Self-reports of HIV risk factors by patients at a sexually transmitted disease clinic: audio vs written questionnaires. Am J Public Health. 1994;84(5):754–760. doi: 10.2105/AJPH.84.5.754.
    1. Mackenzie SL, Kurth AE, Spielberg F, Severynen A, Malotte CK, St Lawrence J, Fortenberry JD. Patient and staff perspectives on the use of a computer counseling tool for HIV and sexually transmitted infection risk reduction. J Adolesc Health. 2007;40(6):572.e9-16. doi: 10.1016/j.jadohealth.2007.01.013.
    1. Center for Disease Control and Prevention (CDC): A Guide to Taking a Sexual Health History, 2005. . Accessed 15 Feb 2017.
    1. Hologic, Inc . Re: lubricant use during pap sample collection. 2012.
    1. Hologic, Inc . ThinPrep pap test, application FAQs. 2012.
    1. Igidbashian S, Boveri S, Spolti N, Radice D, Sandri MT, Sideri M. Self-collected human papillomavirus testing acceptability: comparison of two self-sampling modalities. J Women's Health (Larchmt) 2011;20(3):397–402. doi: 10.1089/jwh.2010.2189.
    1. Rosenstock IM. The health belief model: explaining health behavior through expectancies. In: Glanz K, Lewis FM, Rimer BK, editors. Health behavior and health education: theory, research, and practice. San Francisco: Jossey-Bass; 1990. pp. 39–61.
    1. Scambler G. Re-framing stigma: felt and enacted stigma and challenges to the sociology of chronic and disabling conditions. Soc Theor Health. 2004;2(1):29–46. doi: 10.1057/palgrave.sth.8700012.
    1. Rosner B. Fundamentals of biostatistics. Belmont: Thomson Higher Education; 2006.
    1. McNemar Q. Note on the sampling error of the difference between correlated proportions or percentages. Psychometrika. 1947;12(2):153–157. doi: 10.1007/BF02295996.
    1. Durkalski VL, Palesch YY, Lipsitz SR, Rust PF. Analysis of clustered matched-pair data. Stat Med. 2003;22(15):2417–2428. doi: 10.1002/sim.1438.
    1. Winer RL, Feng Q, Hughes JP, Yu M, Kiviat NB, O'Reilly S, Koutsky LA. Concordance of self-collected and clinician-collected swab samples for detecting human papillomavirus DNA in women 18 to 32 years of age. Sex Transm Dis. 2007;34(6):371–377.
    1. Fleiss JH. Statistical methods for rates and proportions. 2nd. New York: Wiley; 1981. The measurement of interrater agreement; pp. 211–236.
    1. Petignat P, Faltin DL, Bruchim I, Tramer MR, Franco EL, Coutlee F. Are self-collected samples comparable to physician-collected cervical specimens for human papillomavirus DNA testing? A systematic review and meta-analysis. Gynecol Oncol. 2007;105(2):530–535. doi: 10.1016/j.ygyno.2007.01.023.
    1. Marrazzo JM. Genital human papillomavirus infection in women who have sex with women: a concern for patients and providers. AIDS Patient Care STDs. 2000;14(8):447–451. doi: 10.1089/108729100416669.
    1. Betancourt TS, Speelman L, Onyango G, Bolton P. A qualitative study of mental health problems among children displaced by war in northern Uganda. Transcult Psychiatry. 2009;46(2):238–256. doi: 10.1177/1363461509105815.
    1. Strauss A, Corbin J. Grounded theory in practice. Thousand Oaks: Sage Publishing; 1997.
    1. Dedoose [program], Version 7.0.23. Los Angeles, CA: SocioCultural Research Consultants, LLC. 2016.

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