- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03118258
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
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ile De France
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Paris, Ile De France, France, 75 018
- Médecins du Monde
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 months after the inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 months after the inclusion
|
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
|
At baseline (before and after the preventive consultation)
|
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.
|
At baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philippe de Botton, Médecins du Monde
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-A01597-44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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