Human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States, and high-risk HPV (hr-HPV) is the cause of nearly all cervical cancers. Female-to-male transmasculine (TM) patients, who identify with a gender different from their female sex assigned at birth, have low uptake of screening for STIs and cervical cancer via Papanicolaou (Pap) tests. Self-collection methods for hr-HPV DNA and STI detection may increase TM patient engagement and reduce disparities in screening rates.
To assess the performance characteristics and acceptability of self-collected frontal/vaginal specimens compared with provider-collected cervical swabs for hr-HPV DNA and other STI detection among TM individuals.
This cross-sectional study enrolled 150 TM participants with a cervix, aged 21-64 years (mean age, 27.5 years), between March 2015 and September 2016. Participants completed a 1-time study visit comprising a self-report survey, self-collected frontal/vaginal hr-HPV DNA and and chlamydia trachomatis (GC/CT) swabs, and provider-collected frontal/vaginal GC/CT and cervical hr-HPV swabs. Participants were randomized to complete either self- or provider collection first to minimize ordering effects. We tested self- and provider-collected samples for 13 hr-HPV DNA types using a DNA hybridization assay; provider-collected cervical sample also underwent cytologic review. The primary outcome variable was the concordance (κ statistic) and performance (sensitivity and specificity) of self- vs provider-collected cervical hr-HPV swabs (gold standard). We conducted a qualitative interview to gather acceptability data of screening methods. We conducted national online focus groups with patients (4 groups, n = 27), providers (2 groups, n = 14), and stakeholders (2 groups, n = 10) to explore potential acceptability of methods in different geographic regions and contexts. Of the 150 participants enrolled, 10 did not complete both the self- and provider-collected specimens, and 9 of the provider samples could not be assayed due to low cellular content, resulting in an analytic sample of n = 131.
Of 131 participants completing both self- and provider-collected hr-HPV tests, we detected 21 cases of hr-HPV by provider cervical swab (gold standard; 16.0% hr-HPV prevalence); 15 of these cases were accurately detected by the self-collected frontal/vaginal swab (71.4% concordance) (κ = 0.75; 95% CI, 0.59-0.92; < .001). Compared with the gold standard, the self-collected frontal/vaginal hr-HPV DNA test demonstrated a sensitivity of 71.4% (95% CI, 0.52-0.91; = .0495) and specificity of 98.2% (95% CI, 0.96-1.00; < .0001). The likelihood ratio of a positive test was 39.29, while the likelihood ratio of a negative test was 0.29. No participants tested positive for chlamydia or gonorrhea via self- or provider swabs. We also detected 1 new case of syphilis and 2 new cases of bacterial vaginosis (a vaginal infection). The aggregated lifetime prevalence (self-reported) of other STIs was 16.0% (n = 24). The self-collected frontal/vaginal hr-HPV swab was highly acceptable to TM individuals; more than 90% endorsed a preference for this method over provider-collected cervical swab. Of online focus group participants, 62.5% preferred the idea of self- over provider collection methods.
Self-collected frontal/vaginal swabs are highly acceptable to test for hr-HPV in TM individuals and have performance characteristics consistent with previous studies in cisgender women whose gender and sex at birth are concordant. This screening method may represent a reasonable, patient-centered alternative for first-line cervical cancer screening in TM patients unwilling or unable to have a cervical Pap or hr-HPV test.
Most sexually active individuals will get HPV at some point in their lives; most HPV infections will clear on their own, particularly for younger individuals (ie, aged 21-29 years). Overscreening and overdiagnosis are therefore concerns for hr-HPV testing as a primary screening approach. Additional research is needed to identify and validate an optimal follow-up algorithm for primary hr-HPV screening, including for younger age groups.
