Background Cervical cancer is caused by HR-HPV infection. Self-collection of genital specimens and HPV DNA testing are methods increasing screening rates. The GYNAUTO-CHAD study compared the acceptability and HPV DNA diagnostic accuracy of clinician-collected endocervical sample with swab (as reference collection) and genital self-collection method with veil (V-Veil-Up Gyn Collection Device, V-Veil-Up Pharma Ltd., Nicosia, Cyprus) in adult women living in N’Djamena, Chad.
Methods Five of the 10 districts of N’Djamena were randomly selected for inclusion. Peer educators contacted women to participate to the survey by coming to the clinic for women’s sexual health ‘La Renaissance Plus’. A clinician performed pelvic examination and endocervical sampling using swab. Genital secretions were also obtained by self-collection using veil. Both clinician- and self-collected specimens were tested for HR-HPV DNA using Anyplex™ II HPV28 genotyping test (Seegene, Seoul, South Korea). Acceptability and accuracy of both collection methods were assessed.
Results 253 women (mean, 35.0 years) were prospectively enrolled. HPV prevalence was 22.9%, including 68.9% of HR-HPV (total HR-HPV prevalence: 15.8%), with unusual HR-HPV genotypes distribution and preponderance (70%) of HR-HPV targeted by Gardasil-9® vaccine. Veil-based genital self-collection showed high acceptability (96%), feasibility and satisfaction. Self-collection by veil was non-inferior to clinician-based collection for HR-HPV DNA testing, with ‘good’ agreement between both methods, high sensitivity (95.0%; 95%CI: 88.3–100.0%) and specificity (88.2%; 95%CI: 83.9–92.6%). Remarkably, the rates of HPV DNA and HR-HPV DNA positivity were significantly higher (1.67- and 1.57- fold, respectively) when using veil-based collection than clinician-collection.
Conclusion These observations highlight the unsuspected high burden of cervical oncogenic HR-HPV infection in Chadian women. Self-collection of genital secretions using the V-Veil-Up Gyn Collection Device constitutes a simple, highly acceptable and powerful tool to collect genital secretions for further molecular testing and screening of oncogenic HR-HPV that could be easily implemented in the national cervical cancer prevention program in Chad.
Disclosure No significant relationships.
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