Expanding uptake of cervical cancer screening: Feasibility and acceptability of menstrual blood-based HPV DNA testing for cervical cancer screening.

Abstract

e17513 Background: Low uptake of cervical cancer screening remains a significant public health challenge. Delayed diagnosis due to low screening rates results in the detection at later stages, when treatment options are limited and outcomes are poorer. This study aimed to evaluate the feasibility and acceptability of high-risk human papillomavirus (hr-HPV) DNA testing from menstrual blood (MB) with a collection strip, as a potentially more accessible screening strategy. Methods: One hundred eleven healthy women aged 30-50 years, without prior cervical cancer screening, were recruited. Participants collected MB samples using a simple adhesive strip applied to their menstrual pad. Each strip comprised a top layer of perforated thin film plastic, a bottom layer of adhesive thin film plastic, and three discs of absorbing material positioned between these layers. Comprehensive instructions with video demonstrations and pictorial guides, were provided to facilitate sample collection. All samples were analyzed for hr-HPV at the laboratory participating in the study. Results: Seventy-seven women successfully collected and submitted MB samples, all of which were found evaluable. High-risk HPV DNA testing was performed with IVD approved real-time PCR kit on all MB samples, and six samples were positive for hr-HPV DNA. These positive results were subsequently confirmed through conventional cervical smears. Notably, a 100% concordance was observed between hr-HPV DNA detection in MB samples and direct cervical sampling, regardless of the positivity status. From the group of women tested negative for hr-HPV in MB samples, ten women agreed to undergo cervical testing. All ten cervical samples were negative for intraepithelial lesions on histopathological examination and also negative for hr-HPV by real-time PCR, further supporting the accuracy of MB-based hr-HPV testing. Participant feedback recorded with nine-point questionnaire, consistently highlighted high levels of acceptance and preference for this novel MB sampling method. Responses were also recorded from women who refused to participate in the study. More than 90% women found strip-based MB collection safe and hygienic. The ease of sample collection, perceived privacy, and reduced invasiveness were consistently cited as key advantages. Conclusions: This study provides strong evidence for the feasibility and acceptability of hr-HPV DNA testing from menstrual blood as a promising alternative for cervical cancer screening. The non-invasive nature of MB sampling, coupled with its high concordance with conventional methods and the favorable perception of the sampling method by most women, suggests that this approach has the potential to significantly improve screening uptake and ultimately reduce the burden of cervical cancer.