Testing self-sampling for cervical cancer screening in Portugal
Compares self-collected and clinic-collected samples to see how women take part in cervical screening.
Plain-language title generated from the registry record
Registry title: Reengineering Cervical Cancer Screening for the 21st Century: Joint Action for a Novel Up-to-date and Sustainable Screening Program
Key facts
- Where
- Vila Nova de Gaia, PortugalSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 69 years old?
Source: NCT06915610, who can take part
Where in Portugal
- Unidade Local de Saúde Gaia e EspinhoVila Nova de Gaia, PortugalNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto de Saude Publica da Universidade do Porto
- Trial code
- NCT06915610
- Record updated
- 23 April 2025
- Original description
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.Read full original descriptionShow less
Reengineering Cervical Cancer Screening for the 21st Century: Joint Action for a Novel Up-to-date and Sustainable Screening Program
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.
Inclusion: Females fulfilling the eligibility criteria for CCS, as defined by the current guidelines for the organized screening program in Portugal.
Exclusion: Not having a Portuguese mobile phone number or a Portuguese address available in the clinical/administrative records of the primary healthcare units; Any of the exclusion criteria for CCS, as defined by the current guidelines for the organized screening program in Portugal.