Acceptability of Self-sampling for Cervical Cancer Screening

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:

1. Training group): Educational intervention with self-sampling practice: clinician-led explanation on how to proceed with self-sampling prior to collecting a self-sample at the clinic.
2. No prior trainning group): Same training without practicing self-sampling collection.

Both groups has a standard of care cervical sample collection by a clinician. Women are asked to return a self-sampling specimen one month after the baseline visit together with an acceptability questionnaire on self-sampling use.

Acceptability will be analyzed according to two definitions:

* 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

Interventions

DEVICE

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

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.

OTHER

Only explanation on how to use self-sampling 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 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.

Sponsors & Collaborators

• Complejo Hospitalario Universitario Insular Materno Infantil

  collaborator OTHER

• Institut Català de la Salut

  collaborator OTHER

• Institut Català d'Oncologia

  collaborator OTHER

• Institut d'Investigació Biomèdica de Bellvitge

  lead OTHER

Principal Investigators

• Raquel Ibáñez Pérez, Dra. · Institut Català d'Oncologia - IDIBELL

• Silvia de Sanjosé Llongueras, Dra. · National Cancer Institute (NCI)

• Amelia Acera, Dra. · Institut Català de la Salut

• Miguel Andujar, Dr. · Complejo Hospitalario Universitario Insular Materno Infantil

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-28

Primary Completion

2022-06-30

Completion

2022-06-30

Countries

• Spain

Study Locations