Improving Access to Cervical Cancer Screening

NCT03118258 | Unknown DMC

• 1 other identifier: 2016-A01597-44
• Study Type: interventional
• Target: 1,258
• Locations: 1 country
• Sites: 1

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. 1.Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm)
2. 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.

Conditions

Uterine Cervical Neoplasms

Keywords

Vaginal HPV self-sampling; Pap test smear; cervical cancer screening; deprivation; sexual and reproductive health; Precariousness

Outcome Measures

Primary Outcomes (1)

• Proportion of women with abnormal cytology

  Comparison of the proportion of women with abnormal cytology in each study arm

  4 months after the inclusion

Secondary Outcomes (3)

• Proportion of women who completed cervical screening

  4 months after the inclusion

• 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)

• Social determinants of completing cervical screening

  At baseline

Study Arms (2)

Pap smear

EXPERIMENTAL

'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

Self-collected vaginal swab for HPV testing + pap smear triage

EXPERIMENTAL

'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

Interventions

'Pap smear' arm BEHAVIORAL

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.

Pap smear

'Self-collected vaginal swab for HPV testing + pap smear triage' arm BEHAVIORAL

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.

Self-collected vaginal swab for HPV testing + pap smear triage

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between 25 and 65 years old
• Met within Doctors of the World programs

You may not qualify if:

• 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)

Sponsors & Collaborators

• Médecins du Monde: lead
• National Cancer Institute, France: collaborator

Study Sites (1)

Médecins du Monde

Paris, Île-de-France Region, 75 018, France

Location

Related Publications (1)

• 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.

  PMID: 34039341 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Coitus

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Behavior; Behavior

Study Officials

• Philippe de Botton

  Médecins du Monde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 18, 2017
• Study Start: March 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: August 1, 2019
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)