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

NCT06371118 | Recruiting

• 1 other identifier: PI 20210032
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (5)

• Adherence to conventional screening in control group

  Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group

  45 and 90 days after the conventional screening appointment date

• Adherence to HPV self-sampling in intervention 1 (directly mailed) group

  Number of women who returned the self-sample in intervention 1 group divided by the number of women assigned to intervention 1 group

  45 and 90 days after the day the self-sampling kit is sent

• Adherence to HPV self-sampling in intervention 2 (opt-in) group

  Number of women who returned the self-sample in intervention 2 group divided by the number of women assigned to intervention 2 group

  45 and 90 days after the day the self-sampling kit is sent

• Adherence proportion to HPV self-sampling in intervention 1 (directly mailed) group VS Adherence proportion to conventional screening in control group

  The quotient of (Number of women in intervention 1 group who returned the self-sample divided by the women assigned to intervention 1 group) dividided by (Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group).

  45 and 90 days after the day the self-sampling kit is sent or 45 and 90 days after the conventional screening appointment date, as appropriate

• Adherence proportion to HPV self-sampling in intervention 2 (opt-in) group VS Adherence proportion to conventional screening in control group

  The quotient of (Number of women in intervention 2 group who returned the self-sample divided by the women assigned to intervention 2 group) dividided by (Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group).

  45 and 90 days after the day the self-sampling kit is sent or 45 and 90 days after the conventional screening appointment date, as appropriate

Secondary Outcomes (51)

• Adherence to first follow-up step in control group

  45 and 90 days after the colposcopy appointment date

• Adherence to first follow-up step in intervention 1 (directly mailed) group

  45 and 90 days after the clinician-sampling appointment date

• Adherence to first follow-up step in intervention 2 (opt-in) group

  45 and 90 days after the clinician-sampling appointment date

• Adherence to first follow-up step in control group among women referred for follow-up

  45 and 90 days after the colposcopy appointment date

• Adherence to first follow-up step in intervention 1 (directly mailed) group among women referred for folow-up

  45 and 90 days after the clinician-sampling appointment date

Study Arms (3)

Control group

ACTIVE COMPARATOR

An invitation to attend a cervical cancer screening in a clinical setting will be sent by post to the woman's address.

Diagnostic Test: Standard of care - screening in a clinical setting

Intervention 1 (directly mailed group)

EXPERIMENTAL

The HPV self-sampling test will be sent by post directly to the woman's address.

Device: Directly mailed self-sampling kit to collect a vaginal sample

Intervention 2 (opt-in group)

EXPERIMENTAL

The HPV self-sampling test will be sent by post directly to the woman's address after a opt-in procedure.

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

Interventions

Directly mailed self-sampling kit to collect a vaginal sample DEVICE

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.

Also known as: Evalyn Brush

Intervention 1 (directly mailed group)

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

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.

Also known as: Evalyn Brush

Intervention 2 (opt-in group)

Standard of care - screening in a clinical setting DIAGNOSTIC_TEST

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.

Control group

Eligibility Criteria

• Age: 26 Years - 60 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 26 and 60 years old;
• Women eligible for cervical cancer screening whose screening is at least 1 year overdue.

You may not qualify if:

• No mobile phone number available at the National Health Service database;
• Foreign mobile phone number;
• No address available at the National Health Service database;
• Foreign address.

Sponsors & Collaborators

• Universidade do Porto: lead
• Unidade de Saúde Familiar de Garcia de Orta, Porto: collaborator
• Unidade de Saúde Familiar da Prelada, Porto: collaborator
• Unidade de Saúde Familiar de Cedofeita, Porto: collaborator
• Instituto Portugues de Oncologia, Francisco Gentil, Porto: collaborator

Study Sites (2)

Unidade de Saúde Familiar Cedofeita

Porto, 4050-109, Portugal

RECRUITING

Unidade de Saúde Familiar Prelada

Porto, 4250-113, Portugal

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Self-Examination

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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; Health Behavior; Behavior

Study Officials

• Maria Margarida MN Teixeira, MD

  Instituto de Saude Publica da Universidade do Porto

  PRINCIPAL INVESTIGATOR

• Nuno Lunet, PhD

  Instituto de Saude Publica da Universidade do Porto

  STUDY CHAIR

Central Study Contacts

Maria Margarida MN Teixeira, Master

CONTACT

00351933099685; margaridat93@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 17, 2024
• Study Start: April 15, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)