Clinical trial · Interventional
Improving Access to Cervical Cancer Screening
Improving Access to Cervical Cancer Screening for Women Living in Precarious Conditions Met Within Doctors of the World Programs
- 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)
Every year, in France, 3 000 women are diagnosed with cervical cancer, and 1 000 die each year. Recent studies highlighted regional, social and economical inequalities with respect to cervical cancer incidence. In France, the pap-smear test is currently the reference test in order to screen for cervical cancer and neoplasia (CIN). Screening and treatment reduced the incidence and the mortality due to cervical cancer by half in the two last decades. That said, many women are still not reached by prevention programs, especially women living in precarious conditions. In 2013, Doctors of the World France estimated that almost 70% of women aged 25 to 65 years old visiting its medical facilities had never had of a pap-smear test. The main study objectives are : Primary objective To compare the proportion of individuals with abnormal cytology across two screening strategies in order to determine which strategy detects a greater proportion of individuals with abnormal cytology. These two strategies consist of a preventive consultation followed by: 1. Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm) 2. An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive\* ('self-collected vaginal swab for HPV-HR testing + Pap smear triage' study arm) \*A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason. First of secondary objectives: To evaluate the proportion of individuals who completed cervical cancer screening in each study arm in order to determine which strategy resulted in greater screening participation. The above clarification of the study objectives and the related changes in the study protocole have been approved by the Comité de Protection des Personnes Ile de France IV.
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 |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 'Pap smear' arm | Behavioral | — | UNRESOLVED |
| 'Self-collected vaginal swab for HPV testing + pap smear triage' arm | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pap smear
- description
- 'Pap smear' arm: women are invited to participate in a preventive consultation. This consultation is followed by direct patient referral for Pap smear testing in a partner health facility.
- interventionNames
- Behavioral: 'Pap smear' arm
- type
- EXPERIMENTAL
- label
- Self-collected vaginal swab for HPV testing + pap smear triage
- description
- 'Self-collected vaginal swab for HPV testing + pap smear triage' arm : women are invited to participate in a preventive consultation. This consultation is followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive. A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.
- interventionNames
- Behavioral: 'Self-collected vaginal swab for HPV testing + pap smear triage' arm
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Women between 25 and 65 years old * Met within Doctors of the World programs Exclusion Criteria: * History of total hysterectomy (= ablation of uterus and cervix) * Never had sexual intercourse * Last pap smear test made during the three last years (ou first pap smear test during the last year)
References
Publications (1)
- DERIVEDReques L, Rolland C, Lallemand A, Lahmidi N, Aranda-Fernandez E, Lazzarino A, Bottero J, Hamers F, Bergeron C, Haguenoer K, Launoy G, Luhmann N. Comparison of cervical cancer screening by self-sampling papillomavirus test versus pap-smear in underprivileged women in France. BMC Womens Health. 2021 May 26;21(1):221. doi: 10.1186/s12905-021-01356-8. PMID 34039341