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Improving Access to Cervical Cancer Screening

Primary Purpose

Uterine Cervical Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
'Pap smear' arm
'Self-collected vaginal swab for HPV testing + pap smear triage' arm
Sponsored by
Médecins du Monde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Uterine Cervical Neoplasms focused on measuring Vaginal HPV self-sampling, Pap test smear, cervical cancer screening, deprivation, sexual and reproductive health, Precariousness

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Médecins du Monde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pap smear

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

Arm 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.

'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.

Outcomes

Primary Outcome Measures

Proportion of women with abnormal cytology
Comparison of the proportion of women with abnormal cytology in each study arm

Secondary Outcome Measures

Proportion of women who completed cervical screening
Comparison of the proportion of women who completed cervical screening in each study arm
Proportion of women who acquired a specific set of knowledge about cervical cancer 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
Social determinants of completing cervical screening
Comparisons of medical, socio-demographical and educational characteristics of women who completed screening with that of women who did not.

Full Information

First Posted
March 30, 2017
Last Updated
January 29, 2019
Sponsor
Médecins du Monde
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT03118258
Brief Title
Improving Access to Cervical Cancer Screening
Official Title
Improving Access to Cervical Cancer Screening for Women Living in Precarious Conditions Met Within Doctors of the World Programs
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Médecins du Monde
Collaborators
National Cancer Institute, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm) 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.
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: Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms
Keywords
Vaginal HPV self-sampling, Pap test smear, cervical cancer screening, deprivation, sexual and reproductive health, Precariousness

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The two strategies consist of a preventive consultation followed by: Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm) 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)
Allocation
Randomized
Enrollment
1258 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pap smear
Arm Type
Experimental
Arm 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.
Arm Title
Self-collected vaginal swab for HPV testing + pap smear triage
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
'Pap smear' arm
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
'Self-collected vaginal swab for HPV testing + pap smear triage' arm
Intervention Description
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 Measure Information:
Title
Proportion of women with abnormal cytology
Description
Comparison of the proportion of women with abnormal cytology in each study arm
Time Frame
4 months after the inclusion
Secondary Outcome Measure Information:
Title
Proportion of women who completed cervical screening
Description
Comparison of the proportion of women who completed cervical screening in each study arm
Time Frame
4 months after the inclusion
Title
Proportion of women who acquired a specific set of knowledge about cervical cancer before and after the preventive consultation
Description
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
Time Frame
At baseline (before and after the preventive consultation)
Title
Social determinants of completing cervical screening
Description
Comparisons of medical, socio-demographical and educational characteristics of women who completed screening with that of women who did not.
Time Frame
At baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe de Botton
Organizational Affiliation
Médecins du Monde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Médecins du Monde
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75 018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34039341
Citation
Reques 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.
Results Reference
derived

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Improving Access to Cervical Cancer Screening

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