Sample sociodemographic characteristics and self-HPV assessment.

<p>Sample sociodemographic characteristics and self-HPV assessment.</p

Accuracy of self-collected vaginal dry swabs using the Xpert human papillomavirus assay

<div><p>Background</p><p>Polymerase chain reaction-based Xpert human papillomavirus (HPV) assay is a rapid test that detects high-risk HPV (hrHPV) infection. This point-of-care test is usually performed by collecting a cervical specimen in a vial of PreservCyt® transport medium. We compared HPV test positivity and accuracy between self-collected sample with a dry swab (s-DRY) versus physician-collected cervical sampling using a broom like brush and immediate immersion in PreservCyt (dr-WET).</p><p>Methods</p><p>In this cross-sectional study, we recruited 150 women ≥ 18 years old attending the colposcopy clinic in the University Hospital of Geneva. Each participant first self-collected a vaginal sample using a dry swab and then the physician collected a cervical specimen in PreservCyt. HPV analysis was performed with Xpert. Part of the PreservCyt-collected sample was used for hrHPV detection with the cobas® HPV test. HPV test positivity and performance of the two collection methods was compared.</p><p>Results</p><p>HPV positivity was 49.1% for s-DRY, 41.8% for dr-WET and 46.2% for cobas. Good agreement was found between s-DRY and dr-WET samples (kappa±Standard error (SE) = 0.64±0.09,), particularly for low-grade squamous intraepithelial lesions (LSIL+) (kappa±SE = 0.80±0.17). Excellent agreement was found between the two samples for HPV16 detection in general (kappa±SE = 0.91±0.09) and among LSIL+ lesions (kappa±SE = 1.00±0.17). Sensitivities and specificities were, respectively, 84.2% and 47.1%(s-DRY), 73.1% and 58.7%. (dr-WET) and 77.8% and 45.7% (cobas) for CIN2+ detection. The median delay between sampling and HPV analysis was 7 days for the Xpert HPV assay and 19 days for cobas. There were 36 (24.0%) invalid results among s-DRY samples and 4 (2.7%) among dr-WET (p = 0.001). Invalid results happened due to the long interval between collection and analysis.</p><p>Conclusion</p><p>Self-collected vaginal dry swabs are a valid alternative to collecting cervical samples in PreservCyt solution for HPV testing with the Xpert HPV assay.</p><p>Impact</p><p>HPV self-collection with dry cotton swabs might assist in the implementation of an effective screening strategy in developing countries.</p><p>Trial registration</p><p>International Standard Randomized Controlled Trial Number Registry <a href="https://clinicaltrials.gov/ct2/show/DRKS00000584" target="_blank">ISRCTN83050913</a></p></div

Agreement between s-DRY and dr-WET for Xpert HPV results for all hrHPV and each HPV channel, overall and stratified on disease status, negative cytology, and LSIL or more severe diagnoses (LSIL+).

<p>Agreement between s-DRY and dr-WET for Xpert HPV results for all hrHPV and each HPV channel, overall and stratified on disease status, negative cytology, and LSIL or more severe diagnoses (LSIL+).</p

Impact of an Educational Intervention on Women's Knowledge and Acceptability of Human Papillomavirus Self-Sampling: A Randomized Controlled Trial in Cameroon

<div><p>Objective</p><p>Human papillomavirus (HPV) self-sampling (Self-HPV) may be used as a primary cervical cancer screening method in a low resource setting. Our aim was to evaluate whether an educational intervention would improve women's knowledge and confidence in the Self-HPV method.</p><p>Method</p><p>Women aged between 25 and 65 years old, eligible for cervical cancer screening, were randomly chosen to receive standard information (control group) or standard information followed by educational intervention (interventional group). Standard information included explanations about what the test detects (HPV), the link between HPV and cervical cancer and how to perform HPV self-sampling. The educational intervention consisted of a culturally tailored video about HPV, cervical cancer, Self-HPV and its relevancy as a screening test. All participants completed a questionnaire that assessed sociodemographic data, women's knowledge about cervical cancer and acceptability of Self-HPV.</p><p>Results</p><p>A total of 302 women were enrolled in 4 health care centers in Yaoundé and the surrounding countryside. 301 women (149 in the “control group” and 152 in the “intervention group”) completed the full process and were included into the analysis. Participants who received the educational intervention had a significantly higher knowledge about HPV and cervical cancer than the control group (p<0.05), but no significant difference on Self-HPV acceptability and confidence in the method was noticed between the two groups.</p><p>Conclusion</p><p>Educational intervention promotes an increase in knowledge about HPV and cervical cancer. Further investigation should be conducted to determine if this intervention can be sustained beyond the short term and influences screening behavior.</p><p>Trials Registration</p><p>International Standard Randomised Controlled Trial Number (ISRCTN) Register <a href="http://www.controlled-trials.com/ISRCTN78123709" target="_blank">ISRCTN78123709</a></p></div

Flowchart of study participants.

<p>Abbreviations: dr-WET = physician-collected sample with swab immediately immersed in PreservCyt; s-DRY = Self-vaginal collection with dry swab. ASC-US = Atypical squamous cells of undetermined significance; ASC-H = Atypical squamous cells-cannot rule out high grade; LSIL = Low-grade squamous intraepithelial lesion; HSIL = High-grade squamous intraepithelial lesion; CIN1 = cervical intraepithelial neoplasia grade 1; CIN2 = cervical intraepithelial neoplasia grade 2; CIN3 = cervical intraepithelial neoplasia grade 3; CIN2+ = cervical intraepithelial neoplasia grade 2 or more severe. * Invalid results were excluded in the agreement analysis between dr-WET and s-DRY samples, as well as in the determination of clinical performance, using cobas results and histology (CIN2+), as reference standard.</p

Kaplan–Meier failure estimate showing the proportion of s-DRY and dr-WET invalid tests by length of delay.

<p>Kaplan–Meier failure estimate showing the proportion of s-DRY and dr-WET invalid tests by length of delay.</p

Answers to questionnaire about HPV and cervical cancer, intervention versus control group.

<p>* Chi-square test and **Mann-Whitney-U-test was used to analyze the data.</p><p>** Poor knowledge: 0-2 right answers out of 6 questions, mediocre knowledge: 3–4 right answers out of 6 questions, good knowledge: 5–6 right answers out of 6 questions.</p><p>There were 11 missing answers in the intervention group and 21 missing answers in the control group caused by some women answering only part of the questionnaire. This is why the sum of answers for each item can differ and be less than the total of participants (301 women).</p><p>HPV (human papillomavirus), AIDS (Acquired Immunodeficiency Syndrome).</p><p>Answers to questionnaire about HPV and cervical cancer, intervention versus control group.</p

Study design and flow diagram.

<p>Flow diagram of patients in the study.</p

Willingness to perform HPV self-sampling (intervention vs control).

<p>* <i>Mann-Whitney-U-test was used to analyze the data. p<0.05 was considered as significant.</i></p><p>Willingness to perform HPV self-sampling (intervention vs control).</p

Baseline socio-demographic characteristics of intervention and control participants (n = 301).

<p>*<i>some women speak two or more languages.</i></p><p>Baseline socio-demographic characteristics of intervention and control participants (n = 301).</p