DOI: 10.7910/dvn/eggbjh
title: Replication Data for: Preventive Sexual Health Screening Among Female-to-Male (FTM) Adult Patients (PCORI CER-1403-12625)

description: Replication Data for: Preventive Sexual Health Screening Among Female-to-Male (FTM) Adult Patients (PCORI CER-1403-12625)

ClinicalTrials.gov Identifier: NCT02401867

Abstract
Background: 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. 
Objective: 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. 
Methods: 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. 
Results: 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&lt;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&lt;0.0001). Over 90% of participants endorsed a preference for the self-collected vaginal swab over provider-collected cervical swab. 
Conclusion: 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.
description: Study Protocol Citation:
Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol.
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.
BMC Infect Dis. 2017 Jun 23;17(1):444. doi: 10.1186/s12879-017-2539-x.
PMID: 28645254