Journal Article

Test performance and acceptability of self- versus provider-collected swabs for high-risk HPV DNA testing in female-to-male trans masculine patients

Pardee, Dana J., McLean, Sarah A., Panther, Lori A., Gelman, Marcy, Cavanaugh, Timothy P., Reisner, Sari L., Potter, Jennifer E., Mimiaga, Matthew J., White Hughto, Jaclyn M., Peitzmeier, Sarah M., Deutsch, Madeline B.

2018

Overview

High-risk human papillomavirus (hrHPV) causes virtually all cervical cancers. Trans masculine (TM) people (those assigned female at birth who identify with a gender other than female) have low uptake of conventional cervical cancer screening. Self-collected hrHPV DNA testing has high levels of acceptability among cisgender (non-transgender) females and may support increased cervical cancer screening uptake in TM individuals. To assess the test performance and acceptability of self-collected vaginal specimens in comparison to provider-collected cervical swabs for hrHPV DNA detection in TM individuals ages 21-64 years. Between March 2015-September 2016, 150 TM participants with a cervix (mean age = 27.5 years; SD = 5.7) completed a one-time study visit comprised of a self-report survey, self-collected vaginal HPV DNA swab, clinician-administered cervical HPV swab, and brief interview on acceptability of clinical procedures. Participants were randomized to complete either self- or provider-collection first to minimize ordering effects. Self- and provider-collected samples were tested for 13 hrHPV DNA types using a DNA Hybridization Assay. The primary outcome variable was the concordance (kappa statistic) and performance (sensitivity, specificity) of self-collected vaginal HPV DNA specimens versus provider-collected cervical HPV swabs as the gold standard. Of the 131 participants completing both the self- and provider-collected HPV tests, 21 cases of hrHPV were detected by the provider cervical swab (gold standard; 16.0% hrHPV prevalence); 15 of these cases were accurately detected by the self-collected vaginal swab (71.4% concordance) (Kappa = 0.75, 95% Confidence Interval [CI]: 0.59, 0.92; p<0.001). Compared to the provider-collected cervical hrHPV DNA sample (gold standard), the self-collected vaginal hrHPV DNA test demonstrated a sensitivity of 71.4% (95% CI: 0.52, 0.91; p = 0.0495) and specificity of 98.2% (95% CI: 0.96, 1.00; p<0.0001). Over 90% of participants endorsed a preference for the self-collected vaginal swab over provider-collected cervical swab. Self-collected vaginal swabs are highly acceptable to TM as a means to test for hrHPV DNA. Test performance of this self-collection method for hrHPV detection in TM is consistent with previous studies in cisgender females. Self-collected vaginal swab testing for hrHPV DNA represents a reasonable and patient-centered strategy for primary cervical cancer screening in TM patients unwilling to undergo provider collection of specimens via speculum exam.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Acceptability / Adult / Biology and life sciences / Cancer / Cancer screening / Care and treatment / Cellular biology / Cervical cancer / Collection / Confidence intervals / Deoxyribonucleic acid / Diagnosis / DNA / DNA testing / DNA, Viral / Early Detection of Cancer - methods / Epidemiology / Female / Females / Gender identity / Genetic aspects / Health aspects / Human papillomavirus / Humans / Hybridization / Infections / Interviews as Topic / Male / Medical screening / Medicine and Health Sciences / Middle Aged / Papillomaviridae - genetics / Papillomavirus / Papillomavirus Infections - diagnosis / Papillomavirus Infections - epidemiology / Papillomavirus Infections - virology / Patient Acceptance of Health Care / Patients / Pediatrics / Prevalence / Public health / Research and analysis methods / Screening / Self Care / Sensitivity / Sensitivity and Specificity / Statistical analysis / Statistical methods / Task forces / Transgender people / Transgender persons / Transgender Persons - psychology / Transsexualism - epidemiology / Transsexualism - psychology / Transsexualism - virology / Uterine Cervical Neoplasms - diagnosis / Uterine Cervical Neoplasms - virology / Vagina / Vaginal Smears - methods / Womens health / Young Adult