About this trial
This project looks to improve the return rate of HPV self-sampling (HPVss) as well as the management of women HPVss positive.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
aged 30-65
did not perform a pap smear in the last 4 years
are living in deprived clusters in the Occitanie region.
did not answer to a first "invitation" letter to perform a clinician-collected HPV testing
Disqualifiers
outside the target age group
had a Pap smear in the past 3 years
had hysterectomy including cervix
are pregnant
Trial design
Parallel
Treatments tested in this trial
Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms
BehavioralNon-compliant women those that have not been screened for more than 4 years and living in the disadvantaged areas will be sent screening reminder letters to perform HPV self-sampling (HPVss) test, with access to decision aid tailored to women with lower education attainment and available via Chatbot platforms. ChatBot will deliver information in a responsive, conversational way via text and spoken language in multiple languages through multiple mobile channels.
Treatment groups
Trial outcomes
Primary outcomes
HPV self-sampling "return" rate
Percent of women recalled who "return" HPVss over 12 months "Return" means: 1) the receipt of the vaginal self-sample at the laboratory; 2) the performance of clinician-collected HPV testing for those who prefer to be screened by a health professional; and 3) Information about a recent screening or a cervical screening exclusion reason.
Proportion of HPVss-positive women "well managed"
Percent of recruited women well managed (Percent of women screened and completing full pathway of HPV screening and treatment over 12 months). "Well managed" is defined as: completed a valid screening test (sample processed successfully to positive or negative result, including recollection of invalid samples) AND * for HPV negative women, woman advised of negative result * for HPV positive women, completed assessment.
Cost and cost-efficacy
Costs will be estimated using an ingredients approach whereby resources used for the respective interventions are identified and valued. The incremental cost-effectiveness ratios (ICERs) will be calculated as the mean difference in total costs between the intervention groups with the mean difference in effects, and expressed as both euros and US dollars per percentage change in screening participation.
Locations
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Sponsors and contacts
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International Agency for Research on Cancer
Lead sponsor
National Cancer Institute, France
Collaborator
Université de Bretagne Occidentale, Brest-France
Collaborator