An interventional study of Women receive invitation letter with HPV self-sampling kit and Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider in Cervical Cancer, sponsored by International Agency for Research on Cancer. Recruiting at 2 sites in France. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by International Agency for Research on Cancer · Not applicable, Interventional, and Screening
A randomized controlled trial comparing three strategies for cervical cancer screening: direct mailing of HPV self-sampling kit ("Outreach" arm), choice between self-sampling or healthcare provider sampling ("Choice" arm), and standard care (control arm) in two French departments.
In France, over 3,000 women are diagnosed annually with cervical cancer and 1,100 die from it, despite organized screening programs. The national screening coverage rate of 59% (2018- 2020) remains well below the European Union's recommended target of 70% and even further from the French Cancer Plan 2014-2019 objective of 80%. This study evaluates two innovative strategies to improve participation rates in two French departments (Marne and Aube). Eligible women aged 30-65 years will be randomized into three arms. The "Outreach" arm receives HPV self-sampling kit directly at home with SMS reminder at 3 months if no participation. The "Choice" arm can choose between ordering a self-sampling kit or visiting a healthcare provider with SMS reminder at 3 months if no participation. The control arm follows standard procedure with self-sampling offered at 12-month reminder. Women with positive HPV self-sampling tests will be followed for triage cytology, with assistance provided for appointments in the "Outreach" arm and reminders at 6 months post-positive result in the "Choice" arm. The study assesses participation rates, triage completion rates, feasibility, acceptability, and cost-effectiveness of these strategies. If successful, findings could inform modifications to the national organized screening program.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →International Agency for Research on Cancer is the lead sponsor of 30 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Women receive invitation letter with HPV self-sampling kit; Direct mailing of HPV self-sampling kit; Women receive HPV self-sampling kit with instructions; SMS reminder at 3 months if no participation; Assistance provided for triage cytology if HPV positive.
Other: Women receive invitation letter with HPV self-sampling kit
Women receive an invitation letter offering a choice between ordering a free self-sampling kit or visiting a healthcare provider. Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation.
Other: Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider
Standard invitation to visit healthcare provider for cervical cancer screening. Standard screening procedure. Follow standard organized screening program procedure. HPV self-sampling offered at 12-month reminder if no participation.
Direct mailing of HPV self-sampling kit. Women receive HPV self-sampling kit with instructions. SMS reminder at 3 months if no participation. Assistance provided for triage cytology if HPV positive.
Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation.
Participation rate in cervical cancer screening
Time frame: 18 months after invitation
Triage cytology completion rate after positive HPV test
Time frame: 6 months after positive result
HPV positivity rate
Time frame: 12 months after invitation
Invalid result rate
Time frame: 18 months
Time from HPV-positive result to completion of cytological triage
Time frame: 18 months
Women's acceptability of HPV self-sampling
Qualitative assessment through semi-structured interviews with 40 women to assess women's acceptability of HPV self-sampling
Time frame: 24 months
Cost-effectiveness of screening strategies
Costs will be estimated using an ingredients approach whereby resources used for the respective interventions (' Outreach ' and ' Choice' strategies) are identified and valued. The analysis will include all costs incurred by the screening program, including invitation materials, self-sampling kits, laboratory testing, result communication, and follow-up coordination. The incremental cost-effectiveness ratios (ICERs) will be calculated as the mean difference in total costs between each intervention arm and the control arm, divided by the mean difference in screening participation rates. Results will be expressed in euros per percentage change in screening participation.
Time frame: 24 months
Plan to share: No
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International Agency for Research on Cancer