Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03118258
Status:
UNKNOWN
Last Update Posted:
2019-01-31
First Post:
2017-03-30
Brief Title:
Improving Access to Cervical Cancer Screening
Sponsor:
Médecins du Monde
Organization:
Médecins du Monde
Study Overview
Official Title:
Improving Access to Cervical Cancer Screening for Women Living in Precarious Conditions Met Within Doctors of the World Programs
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None