Investigator
University Of Michigan
Comparison of Human Papillomavirus Genotyping by Research vs. Clinical Assay for Two Self-Collection Devices
Abstract Background: Human papillomavirus (HPV) assays and self-collection devices for HPV detection have evolved. We aim to compare two self-sampling devices against speculum-based testing for HPV genotype agreement and their accuracy for cervical intraepithelial neoplasia grade 2 (CIN2+) disease. Secondarily, we aim to compare two HPV assays for different HPV genotype detection agreement and their accuracy for CIN2+ disease. Methods: Women from colposcopy (N = 97) and primary care (N = 96) were block-randomized to two different self-sampling device groups. Self-sampling and speculum-collected pairs of HPV specimens were analyzed with the research assay. A second speculum-collected specimen provided clinical results using the clinical HPV assay. Agreement (prevalence-based κ) and accuracy (sensitivity/specificity ratios) provided the statistical comparison. Results: The two devices did not differ in their κ agreement scores for overall HPV detection compared with the speculum-collected sample [κ = 0.83 (0.72–0.94) and κ = 0.90 (0.81–0.98), respectively, nonsignificant exact McNemar test results]. The two devices did not differ in accuracy as measured by the relative sensitivity/specificity for overall HPV at the CIN2+ disease threshold [1.0 (0.15–6.77) and 1.19 (0.56–2.54), respectively]. The two assays did not differ in HPV agreement nor assay accuracy for CIN2+ (n = 10). Conclusions: HPV self-sampling devices robustly detected high-risk HPV types for cervical cancer screening when using the research assay to compare them. Both research and clinical HPV assays provide equivalent HPV detection for specific and aggregated HPV types. Impact: This study provides a US-based population to show that self-collection for primary HPV testing is accurate for CIN2+ detection with multiple devices using a validated HPV assay.
Acceptability of Home‐Based Urine Self‐Collection for Cervical Cancer Screening Among Women Receiving Care at the Arab Community Center for Economic and Social Services in Michigan
ABSTRACTBackgroundMichigan's Middle Eastern‐North African (MENA) community is an essential and growing part of the state's population. However, MENA individuals are underrepresented in the research literature due to a lack of recognized demographic categorization. Prior work shows that MENA women face barriers to traditional clinician‐directed cervical cancer screening. This study aims to capture the perspectives of MENA women about home‐based urine cervical cancer screening using HPV kits and to assess whether such methods could positively impact future screening intent.MethodsThrough collaboration with a community partner in southeast Michigan, we recruited MENA women ages 30–65, with 44 completing the study. Participants used urine HPV self‐sampling kits at home and then shared their perspectives through a phone interview. We used an inductive, thematic approach to analyze the interviews, which captured experiences with home‐based self‐sampling, screening preferences, and impact on future screening intent.ResultsParticipants found that urine home‐based self‐sampling was acceptable as a convenient and comfortable way to screen for cervical cancer. Most (80%) preferred self‐sampling over traditional clinician‐directed screening and preferred collecting urine samples at home (73%) rather than in the clinic. Overall, 80% reported that access to urine self‐sampling would positively impact their future screening intent.ConclusionsMENA participants in this study positively received home‐based cervical cancer screening using urine HPV self‐sampling kits. These findings support the clinical implementation of self‐sampling and home‐based cervical cancer screening to increase participation, particularly among those in under‐screened communities.
