HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme

Summary

This study aims to test the effectiveness and cost-effectiveness of two different strategies of home-delivered HPV self-sampling, in comparison to the standard of care strategy, to increase adherence to cervical cancer screening.

An experimental and population-based study will be implemented at three primary healthcare centers located in the Western Porto region: Cedofeita, Garcia de Orta, and Prelada. Eligible women will be randomized into a control group or an intervention group. The control group will correspond to the standard of care (invitation to screening in a clinical setting). The intervention group will be randomized into two subgroups: 1) a "directly mailed" group that will receive a self-sampling kit at their home addresses by post; 2) an "opt-in" group that will receive an invitation at home asking if they want to receive a self-sampling kit, with a pre-paid envelope to return the answer to this question. Women who answer "yes" will receive the self-sampling kit at their home addresses by post.

Self-sampling samples will be subjected to HPV genotyping. In parallel, high-risk HPV positive women will be called in by their family doctors to undergo screening in a clinical setting so that they can continue their clinical follow-up in the conventional pathway.

Conditions

• Papillomavirus Infections
• Early Detection of Cancer
• Cervix Cancer
• Self-Examination

Interventions

DEVICE

Directly mailed self-sampling kit to collect a vaginal sample

The HPV self-sampling test will be sent by post directly to the woman's address. If the woman does not return the sample within 20 days, she will be sent a SMS reminder. The returned samples will be analysed. If high-risk HPV is present, women will be invited to be screened for cervical cancer in a clinical setting by their family doctors. Self-samples in which high-risk HPV is present will also be subjected to HPV DNA methylation test. If an abnormal HPV DNA methylation is detected and the woman has not attended the screening in a clinical setting yet, she will be informed by her family doctor that a new test has indicated the need to attend a medical appointment.

DEVICE

Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure

Women will initially receive an invitation letter in their home addresses to receive the self-sampling kit, as well as a pre-paid envelope to return the answer to this invitation. If the woman does not return the answer within 10 days, she will be sent a SMS reminder. Only those who respond affirmatively to the question will receive the self-sampling kit. The steps that follow will be the same as in intervention 1.

DIAGNOSTIC_TEST

Standard of care - screening in a clinical setting

Corresponds to the standard of care. An invitation to attend the conventional cervical cancer screening (clinician-collected cervical sample for HPV test and reflex cytology) will be sent by post to the woman's address.

Sponsors & Collaborators

• Unidade de Saúde Familiar de Garcia de Orta, Porto

  collaborator UNKNOWN

• Unidade de Saúde Familiar da Prelada, Porto

  collaborator UNKNOWN

• Unidade de Saúde Familiar de Cedofeita, Porto

  collaborator UNKNOWN

• Instituto Portugues de Oncologia, Francisco Gentil, Porto

  collaborator OTHER

• Universidade do Porto

  lead OTHER

Principal Investigators

• Maria Margarida MN Teixeira, MD · Instituto de Saude Publica da Universidade do Porto

• Nuno Lunet, PhD · Instituto de Saude Publica da Universidade do Porto

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

26 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-15

Primary Completion

2024-09-30

Completion

2024-11-30

Countries

• Portugal

Study Locations