Abstract B116: Cervical HPV testing with two home self-collection methods compared to a standard clinical-collection method

Abstract

Abstract Background: The purpose of this randomized trial was to examine the feasibility of using home self-sampling for HPV testing to screen for cervical cancer, as compared to HPV samples obtained by a physician or nurse practitioner during a clinical exam. Methods: Two LSU study sites were used, New Orleans and Shreveport, LA. Stratified, permuted blocks randomization was used to allocate patients to one of two methods of home sampling: a standard tampon inserted and worn for two hours, or an easy-to-use vaginal swab device (HerSwab®). All self- collected and clinical were tested for HPV 16 and 18 subtypes and other high-risk subtypes. Each self-collected sample was compared to the patient's clinical sample using McNemarâ' paired chi-squared test. Tampon and self-collected swab samples were compared using an unpaired chi-squared test. Results: A total of one hundred and seventy-four (174) eligible subjects were recruited. Ninety-five subjects were recruited from Shreveport and 79 from New Orleans. The age of the women subjects ranged from 21 to 69, with a mean age of 47 years. The predominant race was African American, 73%, with 22% white and 5% Asian, mixed race or unknown. Hispanic or Latino ethnicity was reported as 4%. Overall, 66% of home-collected specimens were returned for processing. The percent positive specimens was approximately the same, regardless of specimen source, e.g., clinical (13.5% positive), tampon (14.5% positive) or swab (15% positive). There was no statistical difference between the positive specimen rates of tampon and swab methods. By oversight, 11 clinical specimens were not collected for HPV testing. Six women had a positive self-test, but their clinical test results were not positive. All the clinical samples were sufficient for valid DNA analysis. Only one of the home swab specimens was insufficient, but 15 of the tampon specimens were insufficient. This difference is highly statistically significant, p< 0.0001 by Fisher's exact test. Also, as mentioned above, the return rate was better for the swab method. Fifty-five women answered the satisfaction questionnaire. Participants assigned to the tampon use complained about the procedure verbally to the study nurse, although the formal questionnaire did not reflect this. None reported problems with the swab method. Conclusion: The self-collected HPV specimens were not significantly different from the clinically collected specimens, although the tampon method had more unreturned specimens and significantly more specimens of insufficient quality for testing. Citation Format: Jerry McLarty, Donna Williams, Susan Loyd, Michael Hagensee. Cervical HPV testing with two home self-collection methods compared to a standard clinical-collection method [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr B116.