Clinical trial · Interventional
Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women
Attitude of Unscreened Women Face to Different Strategies to Participate in Cervical Cancer Screening by Vaginal Self-sampling : Home-mailed or Invitation to Remove to Their General Practitioner
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Cervix | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group 1 remove self sample kit at gp consulting room or perform pap smear | Behavioral | — | UNRESOLVED |
| Group 2 perform self sample at home or pap smear | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Group 1 remove self sample kit at gp consulting room or perform pap smear : Study coordinators send mail inviting women to remove a kit for vaginal self-sampling at their general practitioner s consulting room. Either a pap smear is perform or, at home, women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus).
- interventionNames
- Behavioral: Group 1 remove self sample kit at gp consulting room or perform pap smear
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Group 2 perform self sample at home or pap smear : Kit for vaginal self-sampling sent at women home. Women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus).
- interventionNames
- Behavioral: Group 2 perform self sample at home or pap smear
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria:
* women from 30 to 65 years old
* women living in french territorial division 37 ("Indre-et-Loire")
* women having a reported general practitioner in french territorial division 37 ("Indre-et-Loire")
Exclusion Criteria:
* pap smear made in the three last yearsReferences
Publications (1)
- RESULTBoyard J, Caille A, Brunet-Houdard S, Sengchanh-Vidal S, Giraudeau B, Marret H, Rolland-Lozachmeur G, Rusch E, Gaudy-Graffin C, Haguenoer K. A Home-Mailed Versus General Practitioner-Delivered Vaginal Self-Sampling Kit for Cervical Cancer Screening: A Cluster Randomized Controlled Trial with a Cost-Effectiveness Analysis. J Womens Health (Larchmt). 2022 Oct;31(10):1472-1480. doi: 10.1089/jwh.2021.0597. Epub 2022 Jul 13. PMID 35834620