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

NARecruitingINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

April 15, 2024

Primary Completion Date

September 30, 2024

Study Completion Date

November 30, 2024

Conditions
Papillomavirus InfectionsEarly Detection of CancerCervix CancerSelf-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.

Trial Locations (2)

4050-109

RECRUITING

Unidade de Saúde Familiar Cedofeita, Porto

4250-113

RECRUITING

Unidade de Saúde Familiar Prelada, Porto

All Listed Sponsors
collaborator

Unidade de Saúde Familiar de Garcia de Orta, Porto

UNKNOWN

collaborator

Unidade de Saúde Familiar da Prelada, Porto

UNKNOWN

collaborator

Unidade de Saúde Familiar de Cedofeita, Porto

UNKNOWN

collaborator

Instituto Portugues de Oncologia, Francisco Gentil, Porto

OTHER

lead

Universidade do Porto

OTHER

NCT06371118 - HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme | Biotech Hunter | Biotech Hunter