Uterine Cervical Neoplasms Clinical Trial
Official title:
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:
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.
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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