Clinical trial NCT05243888: Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening
Official title: A Randomised Controlled Trial Assessing the Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Screening Test
Keywords: cervical cancer
screening coverage
cancer screening test
under-screened women
urinary self-sampling
vaginal self-sampling
randomised controlled trial
semi-structured interviews
Lead sponsor: Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
name: Sciensano
name: University Hospital, Angers
name: University of Angers
First posted: 2022-02-17
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomised controlled trial with three arms: a control arm (conventional invitation letter) and two experimental arms (mailing of a urine or vaginal self-sampling kit).
Primary purpose: SCREENING

Brief summary: The cervical cancer screening coverage remains moderate (60%) in France. The aim of the study is to evaluate the efficacy of two experimental invitation strategies (offer of urine or vaginal self-sampling kits) to reach under-screened populations and compare them with the current invitation strategy in rural departments (low medical density and low participation rate) in France.

The study is a randomised controlled trial with three arms: a control arm (conventional invitation letter) and two experimental arms (mailing of a urine or vaginal self-sampling kit). The target population includes women aged 30-65 years, who had no screening test recorded since more than four years and who did not respond to an invitation letter within twelve months before. The primary outcome measure is the participation rate in each arm.

A team of psychologists will also investigate attitudes and experiences by semi-structured/focus-group interviews with voluntary CapU4 participants and with health professionals.

CapU4 will identify effective strategies to reach women not responding to current screening invitations and will generate information about acceptance of self-sampling among women and health professionals.

Detailed description: Research question: does the offer of self-sampling kits result in higher attendance to cervical cancer screening compared to sending invitation letters which recommend women to contact a health professional for taking a cervical specimen?

Systematic reviews indicate that Human Papillomavirus (HPV) testing on vaginal specimens taken by the woman her-self is as accurate to detect cervical precancer as HPV testing of cervical specimens collected by a clinician, under the condition that a validated polymerase chain reaction (PCR)-based HPV assay is used. Similar results are shown from recent studies where HPV testing was performed on first-void urine collected with an appropriate device and transport medium. A recent meta-analysis of randomised trials showed higher response rates when under-screened women receive a self-sampling kit at home compared to traditional invitation or reminder letters. However, the absolute participation rates are highly variable among studies. Whereas qualitative research indicates that women prefer collection of urine rather than a vaginal self-sample, no data are available that the offer of urine kits would result in higher participation among women who do not participate regularly in cervical cancer screening.

Objectives:

* To evaluate the effectiveness of two experimental invitation strategies (urine or vaginal self-sampling) to reach under-screened populations and compare them to the current invitation strategy in rural departments in France.
* To improve the response rate among women aged 30 to 65 years (not screened over a period longer than the recommended screening interval) who did not respond to a conventional prior invitation.

Trial design:

1:1:1 randomised population-based participation trial, with 2 experimental and 1 control arm, with in each arm a 1:1 sub-randomisation with subgroup A receiving a questionnaire and subgroup B receiving no questionnaire.

Eligibility criteria: Inclusion Criteria:

* women aged between 30 and 65 years
* living in the Departments of Mayenne, Vendée and Sarthe (Pays de la Loire, France)
* who have not carried out a screening test (cytology of smear or HPV test) following a letter sent 12 months previously (in 2020 or 2021).

Exclusion Criteria:

* recent cervical sampling (less than three years old)
* women younger than 30 or older than 65 years
* women who have had a hysterectomy
* women with ongoing follow-up for a cervical lesion
* women who are not members or beneficiaries of a social security system.

Primary outcomes:
measure: Rate of participation in each arm (%)
timeFrame: 6 months
Secondary outcomes:
measure: Rate of participation (%)
timeFrame: 6 months
measure: Rate of participation (%) with questionnaire or not
timeFrame: 6 months
measure: Rate of screen test positivity (%)
timeFrame: 24 months
measure: Percentage of women screened positive with adherence to gynecological follow-up
timeFrame: 24 months
measure: Impact of age on the participation (rate of participation %)
timeFrame: 6 months
measure: Impact of age on the adherence to gynecological follow-up (% of women)
timeFrame: 24 months
measure: Impact of reimbursement status on the participation (rate of participation %)
timeFrame: 6 months
measure: Impact of reimbursement status on the adherence to gynecological follow-up (% of women)
timeFrame: 24 months
measure: Impact of geographical area on the participation (rate of participation %)
timeFrame: 6 months
measure: Impact of geographical area on the adherence to gynecological follow-up (% of women)
timeFrame: 24 months
measure: Obstacles and levers emerging from the speech of the women participating in the research (thematic analysis)
timeFrame: 24 months
measure: Obstacles and levers emerging from the speech of the women participating in the research (categorical analysis)
timeFrame: 24 months
measure: Obstacles and levers emerging from the speech of the health professionals participating in the research (thematic analysis)
timeFrame: 24 months
measure: Obstacles and levers emerging from the speech of the health professionals participating in the research (categorical analysis)
timeFrame: 24 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CRCDC Pays de la Loire
Study officials:
References: