JMIR Publications

ABSTRACT

Background:

The French organized population-based cervical cancer screening (CCS) programme shifted from a cytology-based to a human papillomavirus (HPV)-based screening strategy in August 2020. HPV testing is offered every 5 years, starting at age 30 years. In the new programme, women are invited to have the HPV test at a gynaecologist’s, primary care physician’s, or midwife’s office, a private clinic or health centre, family planning centre, or hospital. HPV self-sampling (HPVss) was also made available as an additional approach. However, French studies reported that less than 20% of non-compliant women performed vaginal self-sampling when a kit was sent to their home. Women with lower income and educational levels participate less in CCS. Lack of information about the disease and the benefits of CCS was reported as one of the major barriers among non-compliant women. This barrier could be addressed by overcoming disparities in HPV- and CC-related knowledge and perceptions about CCS.

Objective:

The main objective of this study is to assess the effectiveness of a chatbot-based decision aid to improve women’s participation in the HPVss detection-based CCS care pathway.

Methods:

AppDate-You is a two-arm cluster randomized controlled trial (cRCT) nested within the French organized CCS programme. Eligible women are those aged 30–65 years who have not been screened for CC for more than 4 years and live in the disadvantaged clusters in the Occitanie Region, France. Thirty-two clusters will be allocated to the intervention and control arms, 16 in each arm (approximately 4000 women). Eligible women living in randomly selected disadvantaged clusters will be identified using the Regional Cancer Screening Coordinating Centre of Occitanie (CRCDC-OC) database. Women in the experimental group will receive screening reminder letters and HPVss kits, combined with access to a chatbot-based decision aid tailored to women with lower educational attainment. Women in the control group will receive the reminder letters and HPVss kits (standard of care). The CRCDC-OC database will be used to check the progress of the trial and assess the impact of the intervention. The trial has two primary outcomes: 1) the proportion of screening participation within 12 months among women recalled for CCS, and 2) the proportion of HPVss-positive women who are “well-managed” as stipulated in the French guidelines.

Results:

The AppDate-You study group is currently preparing and developing the chatbot-based decision aid (intervention). The cRCT will be conducted once the decision aid has been completed and validated. Recruitment of women is expected to begin in January 2023.

Conclusions:

This study is the first to evaluate the impact of a chatbot-based decision aid to promote the CCS programme and increase its performance. The study results will inform policy-makers and health professionals as well as the research community. Clinical Trial: The study was registered on clinicaltrials.gov: NCT05286034, on March 18, 2022.