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Improving Access to Cervical Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118258
Recruitment Status : Unknown
Verified January 2019 by Médecins du Monde.
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : January 31, 2019
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 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.


Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Behavioral: 'Pap smear' arm Behavioral: 'Self-collected vaginal swab for HPV testing + pap smear triage' arm Not Applicable

Detailed Description:

Woman aged 25 to 65 years old met within one of Doctors of the World participating programs will be offered to attend a preventive consultation adressing sexual and reproductive health, and cervical cancer screening. Seven programs are taking part in this study (medical facilities and mobile health programs) in four french cities. Those programs aim to facilitate access to care for people who do not seek or have little access to health services and preventive health measures (lack of health insurance, living far from health services, knowing little about preventive health and how the health system works in France).

These two cervical screening 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.

The inclusion of participants in one or the other study arm will be done through randomization. There will be 11 one-month periods during wich women are invited to perform a self-collected vaginal swab and 11 one-month periods during which women are directly referred to a partner health facility for Pap smear testing. Each one-month period with an invitation to perform a self-collected vaginal swab is followed by a one-month period with direct patient referral for Pap smear testing. The allocation of the starting period has been randomized for each participating program.

Doctors of the World staff who will be offering this preventive health consultation received a specific training adressing sexual and reproductive health topics, cervical screening and counseling approaches. Illustrated tools have been specially developed for this purpose. Professional translators will be sought when needed.

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

The 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* * 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.

('self-collected vaginal swab for HPV-HR testing + Pap smear' triage study arm)

Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Improving Access to Cervical Cancer Screening for Women Living in Precarious Conditions Met Within Doctors of the World Programs
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pap smear
'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.
Behavioral: 'Pap smear' arm

Women are invited to participate in a preventive consultation. Doctor of the World staff provides women with information in their mother tongue and uses visuals adressing cervical cancer, its causes and consequences and ways to prevent it.

This consultation is followed by direct patient referral for Pap smear testing in a partner health facility.


Experimental: Self-collected vaginal swab for HPV testing + pap smear triage

'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.

Behavioral: 'Self-collected vaginal swab for HPV testing + pap smear triage' arm

Women are invited to participate in a preventive consultation. Doctor of the World staff provides women with information in their mother tongue and uses visuals adressing cervical cancer, its causes and consequences and ways to prevent it.

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.





Primary Outcome Measures :
  1. Proportion of women with abnormal cytology [ Time Frame: 4 months after the inclusion ]
    Comparison of the proportion of women with abnormal cytology in each study arm


Secondary Outcome Measures :
  1. Proportion of women who completed cervical screening [ Time Frame: 4 months after the inclusion ]
    Comparison of the proportion of women who completed cervical screening in each study arm

  2. Proportion of women who acquired a specific set of knowledge about cervical cancer before and after the preventive consultation [ Time Frame: At baseline (before and after the preventive consultation) ]
    Comparison of the proportion of women who acquired a specific set of knowledge before and after the preventive consultation, using the same five-item questionnaire

  3. Social determinants of completing cervical screening [ Time Frame: At baseline ]
    Comparisons of medical, socio-demographical and educational characteristics of women who completed screening with that of women who did not.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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)

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


Locations
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France
Médecins du Monde
Paris, Ile De France, France, 75 018
Sponsors and Collaborators
Médecins du Monde
National Cancer Institute, France
Investigators
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Principal Investigator: Philippe de Botton Médecins du Monde
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Responsible Party: Médecins du Monde
ClinicalTrials.gov Identifier: NCT03118258    
Other Study ID Numbers: 2016-A01597-44
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases