Acceptability of Self-sampling for Cervical Cancer Screening

NCT05314907 | Unknown

• 2 other identifiers: PI17/01179PI17/01456
• Study Type: interventional
• Target: 1,614
• Locations: 1 country
• Sites: 3

Brief Summary

Main objectives: 1.1. To evaluate the use of self-sampling for HPV test in regular attendants of cervical cancer screening as a primary sample collection method. 1.2. To assess the impact on the acceptability of an educational intervention. 1.3 Confirm the concordance of HPV detection in the samples collected by the professional and in self-sampling. Project methodology: Randomized, parallel multicenter clinical trial in women aged 30-65 years regularly attending cervical cancer screening residents in the Autonomous Communities of Catalonia and the Canary Islands (Spain). The woman attends the routine screening visit where the health professional collects a sample from the cervical screening. She then offers her the study and if the woman accepts, she offers her the SS as a screening test. The modality of information and practice of the self-sampling is random:

• proportion of women who returned the self-sampling device,
• proportion of women who report wanting to use self-sampling in future screens in the acceptability questionnaire. HPV agreement between collection methods will be calculated using Cohen's Kappa coefficient. Cost-effectiveness analisis will be done on public health system by a mathematical model of the cervical cancer natural history and HPV, adjusted for data in Spain. Self-sampling device uses in this trial is Evalyn Brush from Rovers and the HPV detection is COBAS 4800 from Roche.

Conditions

HPV-Related Cervical Carcinoma; Self-sampling; Cervical Cancer Screening

Keywords

Self-sampling; HPV; Cervical cancer screening; Acceptability; HPV concordance

Outcome Measures

Primary Outcomes (1)

• Self-sampling acceptability for cervical cancer screening

  Acceptability will be compared by study arm and evaluated as 1) proportion of women that return the self-sampling device, 2) proportion of women that return the self-sampling device and respond to favour future screening with self-sampling. This will be evaluated according to the sociodemographic variables of the participants and the results of the acceptability questionnaire that each woman has filled out.

  2 months

Secondary Outcomes (2)

• The cost-effectiveness of cervical Self-Sampling on public health system in Spain

  This is a mathematical and cost analisis. No participants are assessed (time frame 2 years)

• HPV test agreement between self-sampling and clinician-collected samples

  2 months

Study Arms (2)

Training group

ACTIVE COMPARATOR

The Health professional shows the woman how to use the self-sampling device (Evalyn Brush) and then she collects a self-sample at the health centre as a training.

Device: Explanation on how to use self-sampling device and training in the screening visit.

No prior training group

PLACEBO COMPARATOR

The Health professional shows the woman how to use the self-sampling device (Evalyn Brush).

Other: Only explanation on how to use self-sampling device.

Interventions

Explanation on how to use self-sampling device and training in the screening visit. DEVICE

During the screening visit, woman is offered to participate in the study. If she accepts, informed consent is signed, a sociodemographic questionnaire is collected, and a cervical sample is collected for HPV detection by the health professional in the consultation. Then, the professional informs the woman of how to carry out the self-collection using Evalyn Brush and after the woman collects an HPV sample by self-sampling in the same medical center as a trainning. Finally, a new cervibrush (Evalyn brush) is given to the woman for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, woman is requested to return the self-collected sample together with the questionnaire in person to the recruitment centre.

Also known as: Evalyn Brush

Training group

Only explanation on how to use self-sampling device. OTHER

During the screening visit, woman is offered to participate in the study. If she accepts, informed consent is signed, a sociodemographic questionnaire is collected, and a cervical sample is taken for HPV detection by the health professional in the consultation. Then, the professional informs the woman of how to carry out the self-collection using Evalyn. Finally, a Evalyn brush is given to the woman for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, woman is requested to return the self-collected sample together with the questionnaire in person to the recruitment centre.

No prior training group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Cervical cancer screening is only for women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 30 to 65 years (both inclusive) with a adequate prior history of cervical cancer screening (last cytological screening test no more than four years ago).

You may not qualify if:

• Women under 30 years of age.
• Women over 65 years of age.
• Pregnant women.
• Women with hysterectomy.
• Women between 30 and 65 years of age who underwent the last screening test more than four years ago.
• Women between the ages of 30 and 65 who attend for follow-up of some ongoing cervical pathology.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead
• Complejo Hospitalario Universitario Insular Materno Infantil: collaborator
• Institut Català de la Salut: collaborator
• Institut Català d'Oncologia: collaborator

Study Sites (3)

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

ACTIVE NOT RECRUITING

CAP II Cerdanyola-Ripollet - Institut Català de la Salut

Ripollet, Barcelona, 08291, Spain

COMPLETED

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, Canary Islands, 35016, Spain

RECRUITING

Related Publications (2)

• Serrano B, Ibanez R, Robles C, Peremiquel-Trillas P, de Sanjose S, Bruni L. Worldwide use of HPV self-sampling for cervical cancer screening. Prev Med. 2022 Jan;154:106900. doi: 10.1016/j.ypmed.2021.106900. Epub 2021 Nov 30.

  PMID: 34861338 BACKGROUND

• Ibanez R, Roura E, Acera A, Andujar M, Pavon MA, Bruni L, de Sanjose S. HPV self-sampling among cervical cancer screening users in Spain: A randomized clinical trial of on-site training to increase the acceptability. Prev Med. 2023 Aug;173:107571. doi: 10.1016/j.ypmed.2023.107571. Epub 2023 Jun 10.

  PMID: 37308042 DERIVED

Study Officials

• Raquel Ibáñez Pérez, Dra.

  Institut Català d'Oncologia - IDIBELL

  PRINCIPAL INVESTIGATOR

• Silvia de Sanjosé Llongueras, Dra.

  National Cancer Institute (NCI)

  STUDY DIRECTOR

• Amelia Acera, Dra.

  Institut Català de la Salut

  STUDY CHAIR

• Miguel Andujar, Dr.

  Complejo Hospitalario Universitario Insular Materno Infantil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel Ibáñez Pérez, Dra.

CONTACT

932607812; raquelip@iconcologia.net

Laia Bruni Coccoz, Dra.

CONTACT

932607812; lbruni@iconcologia.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: April 7, 2022
• Study Start: November 28, 2018
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)