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Improve Access to Cervical Cancer Screening

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ClinicalTrials.gov Identifier: NCT03118258
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Médecins du Monde

Brief Summary:

Every year, in France, 3 000 women are diagnosed for cervical cancer, and 1 000 die each year. The incidence of this cancer is very inequal: recent studies found regional, social and economical inequalities.

Currently, in France, the pap-smear test is the reference in prevention for cervical neoplasia (CIN) and cancer screening. Screening and treatment allowed to reduce the incidence and the mortality by cervical cancer by half, since the two last decades. But many women are still not reached by prevention programs, especially precarious women. In 2013, Doctors of the World France evaluated that almost 70% of women aged from 25 to 65 years coming in its medical center had never benefit of a pap-smear test.

The objective of this study is to compare the rate of participation in the pap-smear screening with the proposition of a prevention consultation about sexual and reproductive health associated or not with the proposition of a vaginal Human Papillomavirus (HPV) self-sampling.


Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Behavioral: Arm "Pap test" Behavioral: Arm "HPV self-sampling + Pap test" Not Applicable

Detailed Description:

Every woman aged from 25 to 65 years met in a the Doctors of the World's programs will attend to a prevention consultation about sexual and reproductive health and cervical cancer screening. 8 programs are included at this study: medical centers and mobile programs, in five french cities. Those programs intends to facilitate access to care for people who does not have access for different reasons :no health insurance, living far from health services, doesn't know prevention or health system in France.

After the dedicated consultation, one intervention will be proposed :

  • Either an orientation to health centers partners for a pap smear test (arm "Pap test")
  • Or a vaginal HPV self-sampling on site, and after results an orientation to health centers partners for a pap smear test (arm"HPV self sampling + Pap test")

The inclusion of women in one or the other arm will be done through randomization: 7 periods of one month with a proposition of vaginal HPV self-sampling and 7 periods of one month without vaginal HPV self-sampling. Each period with a proposition of HPV self-sampling will be followed by a period without HPV self-sampling, to prevent the seasonality impact. The first period have been randomized for each program.

To lead this consultation, prevention team members have been trained on how to lead the consultation and specifically how to deal with sexual and reproductive health, cervical cancer screening topics and counseling. Illustrated tools have been specially developed for this purpose. Professional translators will be involved in consultation when needed.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

After the prevention consultation women would be included in one of the two groups :

  • refered to health centers partners for a pap smear test (arm "Pap test")
  • make a vaginal HPV self-sampling, and after that refered to health centers partners for a pap smear ("HPV self sampling + Pap test")
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Improve Access to Cervical Cancer Screening for Deprived and Eligible Women Met in Doctors of the World's Programs
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: "Pap test"
Arm "Pap test": Participation of a prevention consultation and a referral to health centers partners for a pap smear test
Behavioral: Arm "Pap test"
"Arm "Pap test": Woman is invited to participate in a prevention consultation. The health prevention staff informs the woman in her language and with adapted tools on cervical cancer, causes, consequences, ways of prevention. He proposes an appointment in a health center partner, to realise a pap smear test

Experimental: "HPV self-sampling + Pap test"
Arm "HPV self-sampling + Pap test": Participation of a prevention consultation and proposition of vaginal HPV self-sampling and a referral to health centers partners for a pap smear test. HPV test is performed on the sample in a virology laboratory.
Behavioral: Arm "HPV self-sampling + Pap test"
"Arm "HPV self-sampling + Pap test": Woman is invited to participate in a prevention consultation. The health prevention staff informs the woman in her language and with adapted tools on cervical cancer, causes, consequences, ways of prevention. The woman is invited to make a vaginal HPV self-sampling, immediately after the consultation on site or at home if more convenient. She has to come back 10 days after to receive results and to take an appointment in an health center partner, to make a pap smear test




Primary Outcome Measures :
  1. Rate of women achieving cervical cancer screening, in the two arms [ Time Frame: 4 months after the inclusion ]
    Rate of women who have a pap smear test, in the two arms


Secondary Outcome Measures :
  1. Rate of pap-smear tests abnormals [ Time Frame: 4 months after the inclusion ]
    Rate of pap smear test abnormals, in the two arms

  2. Improving women's knowledges about cervical cancer [ Time Frame: At baseline ]
    Comparison between women's knowledges before and after the prevention consultation, by using the same five-point questionnaire

  3. Social determinants of screening [ Time Frame: At baseline ]
    Comparisons of medical, socio-demographical, educational characteristics of reached and unreached women by using a questionnaire



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women between 25 and 65 years old
  • Met by a Doctors of the World program

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118258


Contacts
Contact: Laurence Sophie, Mss +33144921498 sophie.laurence@medecinsdumonde.net
Contact: Lyonnais Elisabeth, Mss +33144921614 elisabeth.lyonnais@medecinsdumonde.net

Locations
France
Médecins du Monde Recruiting
Paris, Ile de France, France, 75 018
Sponsors and Collaborators
Médecins du Monde
National Cancer Institute, France
Investigators
Principal Investigator: Sivignon Françoise, MD Médecins du Monde

Responsible Party: Médecins du Monde
ClinicalTrials.gov Identifier: NCT03118258     History of Changes
Other Study ID Numbers: 2016-A01597-44
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Médecins du Monde:
Vaginal HPV self-sampling
Pap test smear
cervical cancer screening
deprivation
sexual and reproductive health
Precariousness

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female