Reengineering Cervical Cancer Screening for the 21st Century: Joint Action for a Novel Up-to-date and Sustainable Screening Program

Summary

Cervical cancer screening (CCS) is important to prevent and control cervical cancer (CC). In Portugal, CCS starts with the assessment of the presence of Human Papillomavirus (HPV) in cervical-vaginal samples, collected by a health professional. However, self-sampling (self-collection of vaginal samples by the participants in CCS), is being considered in several settings, aiming to improve participation in CCS, while also exploring its potential to reduce costs.

The goal of this study is to learn how self-sampling could be introduced in the CCS program in Portugal, by testing different strategies to combine the self-collection of samples with the collection of samples by a health professional, which is currently the standard of care.

Researchers will conduct a study comparing the following ways of conducting CCS:

* Sample collection by health professionals - SOC;
* Self-sampling - SS;
* Asking the participants if they prefer to collect their own samples, or to have the samples collected by a health professional, and then proceed as they prefer - CHOICE.

After assessing the adherence to CCS in each of the groups define above, the participants will be given the possibility to participate through a method different from the initially proposed or chosen, as follows:

* SOC will be complemented with invitation for SS;
* SS will be complemented with invitation for the SOC;
* CHOICE participants will be invited again to CHOICE, being given a new opportunity to choose how they prefer to be screened.

This study design allows for comparisons between these groups, to understand how using these strategies alone and complementarily works, and also for comparisons within each group, to understand how one strategy being used on the top of the previous may contribute to increase adherence to screening. The researchers will additionally collect information of the adherence to CCS in the year before the study is conducted, to be used as an additional benchmark.

For a better understanding on the potential barriers and facilitators to incorporating self-sampling in the CCS program, this study will also comprise interviews with the health professionals involved in the study, as well as with females eligible for screening who had been invited to participate.

Depending on the results of HPV testing and complementary cytological evaluations, participants may be referred for further assessment, according to the standard of care in the Portuguese National Health Service. This study will address the possibility of improving the yielding of the referral for further assessment, by testing, in parallel to the current standard of care, a method that is expected to contribute to reducing the number of referrals of false-positives.

Therefore, this study is expected to provide evidence based on different methods of assessment, showing the extent to which SS may contribute to improve adherence do CCS, and testing new methods that may reduce the referral of false-positives for further assessment.

Conditions

• Cervical Cancer Screening

Interventions

OTHER

Invitation of all participants to CCS according to the standard of care (active comparator)

Invitation of all participants to CCS according to the standard of care

OTHER

Invitation of all participants to CCS through self-sampling

A self-sampling kit mailed to the participants, with a prepaid envelope for returning them after sample collection. Participants may also return the kits by depositing them in a container that will be available in their Health Care Center. The invitation for CCS through self-sampling is accompanied by written instructions, SMS reminders and navigation support (dedicated telephone line, WhatsApp, website)

OTHER

Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of care

In a telephone contact, prompted by an SMS, participants will be given the opportunity to schedule CCS according to the standard of care or to ask for a self-sampling kit to be mailed to them. Depending on their choice, the procedure will be similar to what is described for arm SOC or for arm SS, as applicable

OTHER

Invitation of all participants to CCS according to the standard of care, followed by invitation of those non-adherent to CCS through self-sampling

Participants not adhering to CCS after the first invitation (SOC) will be additionally invited for CCS screening through self-sampling (as in SS)

OTHER

Invitation of all participants to CCS through self-sampling, followed by invitation of those non-adherent to CCS according to the standard of care

Participants not adhering to CCS after the first invitation for self-sampling (SS) will be additionally invited for CCS screening according to the standard of care (as in SOC)

OTHER

Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of care; this mode of invitation is repeated when participants do not adhere to the first invitation

Participants not adhering to CCS after a first invitation for screening through a method of their choice (CHOICE) will be invited again, also being given the opportunity to choose between the standard of care or self-sampling (as in the first CHOICE invitation). Depending on the participants' choice, the procedure will be similar to what is described for arm SOC or for arm SS, as applicable, both in the first and in the second CHOICE invitations

Sponsors & Collaborators

• Instituto Portugues de Oncologia, Francisco Gentil, Porto

  collaborator OTHER

• Universidade do Porto

  collaborator OTHER

• Unidade Local de Saude de Gaia e Espinho EPE

  collaborator OTHER

• Instituto de Saude Publica da Universidade do Porto

  lead OTHER

Principal Investigators

• Nuno Lunet, PhD · Universidade do Porto

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

69 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-10

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• Portugal

Study Locations