Improving Access to Cervical Cancer Screening

Sponsor

Médecins du Monde (Other)

Overall Status

Unknown status

CT.gov ID

NCT03118258

Collaborator

National Cancer Institute, France (Other)

1,258

Enrollment

Location

Arms

Anticipated Duration (Months)

43.4

Patients Per Site Per Month

Study Details

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.

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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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)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)

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 :

Mar 1, 2017

Actual Primary Completion Date :

Dec 31, 2018

Anticipated Study Completion Date :

Aug 1, 2019

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Proportion of women with abnormal cytology [4 months after the inclusion]
Comparison of the proportion of women with abnormal cytology in each study arm

Secondary Outcome Measures

Proportion of women who completed cervical screening [4 months after the inclusion]
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 [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
Social determinants of completing cervical screening [At baseline]
Comparisons of medical, socio-demographical and educational characteristics of women who completed screening with that of women who did not.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)