protocolSection identificationModule nctId: NCT06371118, orgStudyIdInfo id: PI 20210032, briefTitle: HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme, acronym: HERSELF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Universidade do Porto, class: OTHER, collaborators name: Unidade de Saúde Familiar de Garcia de Orta, Porto, collaborators name: Unidade de Saúde Familiar da Prelada, Porto, collaborators name: Unidade de Saúde Familiar de Cedofeita, Porto, collaborators name: Instituto Portugues de Oncologia, Francisco Gentil, Porto, descriptionModule briefSummary: This study aims to test the effectiveness and cost-effectiveness of two different strategies of home-delivered HPV self-sampling, in comparison to the standard of care strategy, to increase adherence to cervical cancer screening.An experimental and population-based study will be implemented at three primary healthcare centers located in the Western Porto region: Cedofeita, Garcia de Orta, and Prelada. Eligible women will be randomized into a control group or an intervention group. The control group will correspond to the standard of care (invitation to screening in a clinical setting). The intervention group will be randomized into two subgroups: 1) a "directly mailed" group that will receive a self-sampling kit at their home addresses by post; 2) an "opt-in" group that will receive an invitation at home asking if they want to receive a self-sampling kit, with a pre-paid envelope to return the answer to this question. Women who answer "yes" will receive the self-sampling kit at their home addresses by post.Self-sampling samples will be subjected to HPV genotyping. In parallel, high-risk HPV positive women will be called in by their family doctors to undergo screening in a clinical setting so that they can continue their clinical follow-up in the conventional pathway., conditionsModule conditions: Papillomavirus Infections, conditions: Early Detection of Cancer, conditions: Cervix Cancer, conditions: Self-Examination, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Directly mailed self-sampling kit to collect a vaginal sample, interventions name: Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure, interventions name: Standard of care - screening in a clinical setting, outcomesModule primaryOutcomes measure: Adherence to conventional screening in control group, primaryOutcomes measure: Adherence to HPV self-sampling in intervention 1 (directly mailed) group, primaryOutcomes measure: Adherence to HPV self-sampling in intervention 2 (opt-in) group, primaryOutcomes measure: Adherence proportion to HPV self-sampling in intervention 1 (directly mailed) group VS Adherence proportion to conventional screening in control group, primaryOutcomes measure: Adherence proportion to HPV self-sampling in intervention 2 (opt-in) group VS Adherence proportion to conventional screening in control group, secondaryOutcomes measure: Adherence to first follow-up step in control group, secondaryOutcomes measure: Adherence to first follow-up step in intervention 1 (directly mailed) group, secondaryOutcomes measure: Adherence to first follow-up step in intervention 2 (opt-in) group, secondaryOutcomes measure: Adherence to first follow-up step in control group among women referred for follow-up, secondaryOutcomes measure: Adherence to first follow-up step in intervention 1 (directly mailed) group among women referred for folow-up, secondaryOutcomes measure: Adherence to first follow-up step in intervention 2 (opt-in) group among women referred for folow-up, secondaryOutcomes measure: Adherence to colposcopy in control group, secondaryOutcomes measure: Adherence to colposcopy in intervention 1 (directly mailed) group, secondaryOutcomes measure: Adherence to colposcopy in intervention 2 (opt-in) group, secondaryOutcomes measure: Adherence to colposcopy in control group among women referred for colposcopy, secondaryOutcomes measure: Adherence to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy, secondaryOutcomes measure: Adherence to colposcopy in intervention 2 (opn-in) group among women referred for colposcopy, secondaryOutcomes measure: Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 1 (directly mailed) group, secondaryOutcomes measure: Timelapse (in days) between the invitation to receive a self-sampling kit and the return of the opt-in answer, in intervention 2 (opt-in) group, secondaryOutcomes measure: Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 2 (opt-in) group, secondaryOutcomes measure: Adherence proportion to first follow-up step in intervention 1 (directly mailed) group VS Adherence proportion to first follow-up step in control group, secondaryOutcomes measure: Adherence proportion to first follow-up step in intervention 2 (opt-in) group VS Adherence proportion to first follow-up step in control group, secondaryOutcomes measure: Adherence proportion to first follow-up step in intervention 1 (directly mailed) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up, secondaryOutcomes measure: Adherence proportion to first follow-up step in intervention 2 (opt-in) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up, secondaryOutcomes measure: Adherence proportion to colposcopy in intervention 1 (directly mailed) group VS Adherence proportion to colposcopy in control group, secondaryOutcomes measure: Adherence proportion to colposcopy in intervention 2 (opt-in) group VS Adherence proportion to colposcopy in control group, secondaryOutcomes measure: Adherence proportion to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy, secondaryOutcomes measure: Adherence proportion to colposcopy in intervention 2 (opt-in) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy, secondaryOutcomes measure: Proportion of HR-HPV positivity in control group, secondaryOutcomes measure: Proportion of HR-HPV positivity in intervention 1 (directly mailed) group, secondaryOutcomes measure: Proportion of HR-HPV positivity in intervention 2 (opt-in) group, secondaryOutcomes measure: Proportion of HR-HPV positivity in control group among women who adhered to conventional screening, secondaryOutcomes measure: Proportion of HR-HPV positivity in intervention 1 (directly mailed) group among women who returned the self-sample, secondaryOutcomes measure: Proportion of HR-HPV positivity in intervention 2 (opt-in) group among women who returned the self-sample, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in control group, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in control group among women who adhered to conventional screening, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group among women who returned the self-sample, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group among women who returned the self-sample, secondaryOutcomes measure: Positive predictive value of self-sampling for the detection of HR-HPV, using clinician-sampling results as gold standard, secondaryOutcomes measure: Sensitivity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Specificity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Positive likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Negative likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Accuracy of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Sensitivity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Specificity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Positive likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Negative likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Accuracy of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Sensitivity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Specificity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Positive likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Negative likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Accuracy of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, eligibilityModule sex: FEMALE, minimumAge: 26 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False