Clinical trial NCT03118258: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Cervical Neoplasms
Keywords: Vaginal HPV self-sampling
Pap test smear
cervical cancer screening
deprivation
sexual and reproductive health
Precariousness
Lead sponsor: Médecins du Monde
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2017-04-18
Enrollment: 1258
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 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\* \* 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)
Primary purpose: SCREENING

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.

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.

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)

Primary outcomes:
measure: Proportion of women with abnormal cytology
timeFrame: 4 months after the inclusion
Secondary outcomes:
measure: Proportion of women who completed cervical screening
timeFrame: 4 months after the inclusion
measure: Proportion of women who acquired a specific set of knowledge about cervical cancer before and after the preventive consultation
timeFrame: At baseline (before and after the preventive consultation)
measure: Social determinants of completing cervical screening
timeFrame: At baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Médecins du Monde
state: Ile De France
Study officials:
affiliation: Médecins du Monde
name: Philippe de Botton
role: PRINCIPAL_INVESTIGATOR
References:
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.