Cervical Cancer ScreeningJANUSNCT06915610
Reengineering Cervical Cancer Screening for the 21st Century: Joint Action for a Novel Up-to-date and Sustainable Screening Program
A study testing Invitation of all participants to CCS through self-sampling in people with Cervical Cancer Screening, run by Instituto de Saude Publica da Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Invitation of all participants to CCS through self-sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,700 participants
- Where
- 1 sitePortugal
- Study dates
- 10 Apr 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females fulfilling the eligibility criteria for CCS, as defined by the current guidelines for the organized screening program in Portugal.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Unidade Local de Saúde Gaia e Espinho
Vila Nova de Gaia, 4434-502
About this study
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.
Read more
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.
Read the detailed description
Vaccination against human papillomavirus (HPV) is highly effective and is expected to reduce substantially the burden of cervical cancer (CC), but cervical cancer screening (CCS) remains necessary for females who were not covered by the vaccination plans, those who remain non-adherent to vaccination, and for early detection of the cervical lesions not prevented by the vaccine. However, the sustainability of CCS programs will be challenged by the expectedly dramatic reduction in frequency of cervical precancerous lesions. A paradigm shift for CCS programs, towards a substantial improvement of efficiency, and ability to reach those more in need of screening, is essential to maintain their cost-effectiveness. We will implement a state-of-the-art approach to population-based CCS, with potential to broaden screening coverage, lower costs and increase efficiency, compared to the current standard of care, by including self-sampling and state-of-the-art molecular methods for triage.
The investigation is based on a pragmatic parallel cluster randomized controlled trial (RCT), including nearly 6,000 participants (2,000 in each arm), implemented at Local Health Unit Gaia e Espinho (ULSGE) in collaboration with the Research Center of Portuguese Institute of Oncology of Porto (CI-IPOP). Family doctors will be randomly allocated to one of the three study arms, and all females from their lists of patients who are eligible for screening, as defined by the current guidelines for the organized screening program, will be invited.
CCS screening will be based on high-risk HPV (HrHPV) testing, according to the Portuguese CCS program. Referral to colposcopy will follow the standard of care (based on HrHPV and liquid based cytology [LBC]), regardless of the strategy used for CCS; females testing non-HPV16/18 HrHPV-positive in self-sampling will undergo a new sample collection by a health professional, so that a LBC evaluation can be performed to support the decision of referral to colposcopy, as defined by the standard of care. Deoxyribonucleic acid (DNA) methylation will be conducted in parallel.
Intention to treat analysis will be the primary strategy of analysis for comparison between the groups, based on crude comparisons, or controlling for confounding through multivariable binary logistic regression, when an imbalance between the distribution of confounders between study arms is observed. Methylation accuracy estimates will be computed with 95% confidence intervals. The cutoffs for each biomarker will be those defined in our previous studies.
The sample size was defined to address the primary objectives that involve the comparison of study arms, with a 1:1:1 allocation ratio, considering a statistical power of 90% and a design effect of 1.1 (assuming an average cluster size of 50 and an intracluster correlation coefficient of 0.002). For a non-inferiority hypothesis, considering an alpha (one-sided) of 5% and assuming an adherence of 50% and a non-inferiority margin of 5%, a sample of 5,700 females is needed.
Family doctors from a total of 10 to 20 primary health care units are expected to be enrolled to achieve the sample size needed, depending on the adherence of the medical doctors and the number of eligible females in their lists of patients.
The study will be initially implemented in 2 to 3 primary health care units, to achieve an expected sample of at least 600 participants, for piloting and adjustment of the overall sample size based on the empirical data on the proportions of adherent females in each arm.
The assessment of the adherence according to the different strategies to incorporate self-sampling in the CCS program will be complemented by a qualitative study to assess barriers and facilitators to the implementation of CCS and adherence to CCS in different formats. This will involve the family doctors who have collaborated in the study and females selected among those invited for screening in the different study arms, based on focus groups and individual semi-structured interviews.
Also, a quantitative assessment of the invited females experiences with CCS within the study and determinants of adherence will be conducted on a subsample including approximately 10% of the invited females, who will be asked to answer a structured questionnaire.
- Conditions
- Cervical Cancer Screening
- Being tested
- Invitation of all participants to CCS according to the standard of care (active comparator), Invitation of all participants to CCS through self-sampling, Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of care, Invitation of all participants to CCS according to the standard of care, followed by invitation of those non-adherent to CCS through self-sampling, Invitation of all participants to CCS through self-sampling, followed by invitation of those non-adherent to CCS according to the standard of care
- Keywords
- Cervical cancer, Human papillomavirus, Self-sampling, DNA methylation
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation of all participants to CCS according to the standard of care (active comparator)Other
Also called SOC
Invitation of all participants to CCS according to the standard of care
Invitation of all participants to CCS through self-samplingOther
Also called SS, Evalyn Brush
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)
Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of careOther
Also called CHOICE
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
Invitation of all participants to CCS according to the standard of care, followed by invitation of those non-adherent to CCS through self-samplingOther
Also called SOC+SS
Participants not adhering to CCS after the first invitation (SOC) will be additionally invited for CCS screening through self-sampling (as in SS)
Invitation of all participants to CCS through self-sampling, followed by invitation of those non-adherent to CCS according to the standard of careOther
Also called SS+SOC
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)
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 invitationOther
Also called CHOICEx2
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
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (followed by self-sampling for the non-adherent) - SOC+SS | Other | CCS screening according to the standard of care (sample collected by a health professional). Participants not adhering will be subsequently invited to perform self-sampling for screening.
When considering only the initial use of the SOC for CCS, this corresponds to arm type "active comparator". When considering the use of the SOC, followed by SS for participants not adhering to CCS according to the SOC, this corresponds to arm type "experimental". Receives: Other: Invitation of all participants to CCS according to the standard of care (active comparator); 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 |
| Self-sampling (followed by the standard of care for the non-adherent) - SS+SOC | Experimental | CCS screening by self-sampling. Participants not adhering will be subsequently invited for screening according to the standard of care (sample collected by a health professional). Receives: Other: Invitation of all participants to CCS through self-sampling; 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 |
| Choice (2x) between CCS through sample collected by health professional and self sampling - CHOICEx2 | Experimental | Participants will be asked for their preference for CCS through sample collected by a health professional or by self-sampling, and will undergo CCS accordingly. Those not adhering will be invited again to choose between one of the two methods of CCS. Receives: Other: Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of care; 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to screening, after the first invitation for CCS in the study
Proportion of invited females, in each arm, who adhere after the first scheduling/invitation (SOC, SS or CHOICE)
Measured: 45 days after first scheduling/invitation
Adherence to CCS, after two invitations for screening in the study
Proportion of invited females, in each arm, who adhere after the second scheduling/invitation (SOC+SS, SS+SOC or CHOICEx2)
Measured: 45 days after first scheduling/invitation or 45 days after the second scheduling/invitation (for those not adhering to the first scheduling/invitation within 45 days)
Performance of DNA methylation markers for high-grade squamous intraepithelial lesions or worse (HSIL+) detection
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of methylation analysis for detection of high-grade squamous intraepithelial lesions or worse (HSIL+), using the cytological triage results and the histological results as gold-standard
Measured: 45 days after cytological or histological results, as applicable
Secondary outcomes (8)
Identification of barriers and facilitators to the implementation and participation in CCS
Perception of medical doctors and females eligible for CCS regarding barriers and facilitators to the implementation and participation in CCS, assessed through qualitative research, based on focus groups and semi-structured interviews
Measured: 90 days after the last invitation for CCS in the study
Proportion of HPV infection, overall and for each genotype tested
Proportion of invited and of adherent females, in each arm, testing positive for HPV infection and for the different genotypes tested, after the first invitation/scheduling (SOC, SS or CHOICE) and after the second scheduling/invitation (SOC+SS, SS+SOC or CHOICEx2)
Measured: 45 days after first scheduling/invitation or 45 days after the second scheduling/invitation (for those not adhering to the first scheduling/invitation within 45 days)
Adherence to follow-up appointments (%), overall and among participants referred for follow-up
Proportion of invited and of HPV-positive (eligible for referral according to the guidelines) females, in each arm, referred for follow-up appointments, after the first invitation/scheduling (SOC, SS or CHOICE) and after the second scheduling/invitation (SOC+SS, SS+SOC or CHOICEx2)
Measured: 45 days after the appointment date
Variation in adherence and HPV test result outcomes between the first and the second invitation for screening
Variation in all adherence and HPV test result outcomes between the first and the second invitation for screening (before-after comparison), in each arm
Measured: 45 days after first scheduling/invitation or 45 days after the second scheduling/invitation (for those not adhering to the first scheduling/invitation within 45 days)
Variation in adherence from the previous year to the study period
Before-after comparison of the proportion of adherence during the study with the proportion of adherence among the patients from each participating medical doctor in the previous year (aggregated data), overall in each arm, and by medical doctor
Measured: 45 days after first scheduling/invitation or 45 days after the second scheduling/invitation (for those not adhering to the first scheduling/invitation within 45 days)
Subgroup analyses of all comparisons of adherence between groups
Stratified analyses of the adherence outcomes, according to age groups, deprivation index of the place of residence, primary health care unit, organization model of the primary healthcare units (USFA, USFB or UCSP) and CCS history
Measured: 45 days after first scheduling/invitation or 45 days after the second scheduling/invitation (for those not adhering to the first scheduling/invitation within 45 days)
Subgroup analyses of DNA methylation accuracy outcomes, according to the adherence to self-sampling and to the standard of care
Stratified analyses of the accuracy outcomes, overall and in each arm
Measured: 45 days after cytological or histological results, as applicable
Characterization of the experience with CCS and determinants of adherence
The experience of females invited to CCS as well as the determinants of adherence will be assessed through an observational design based on a subsample of females invites to the study, quantified using descriptive statistics and crude and adjusted odds ratios
Measured: 120 days after the last invitation for CCS in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start10 Apr 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within each group, participants will be initially invited for CCS though one of the methods under evaluation, and those not adhering will be invited again for CCS through another method. This design will allow for between-group comparisons, both after the first invitation and considering the two invitations, as well as within-group comparisons to assess the extent to which the second (complementary) invitation may contribute to improve participation in CCS. Additionally, data on the participation in CCS in the same settings in the previous years will be retrospectively collected, allowing further ("before-after") comparisons within each group. A qualitative study will be conducted involving medical doctors and females invited for CCS within the study to assess barriers and facilitators to CCS implementation and participation. An observational design nested within the RCT will be used to assess the experience of females invited for CCS, and determinants of adherence.
- Masking
- None (open label)
- Enrolment
- 5,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Saude Publica da Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Portugues de Oncologia, Francisco Gentil, Porto, Universidade do Porto, Unidade Local de Saude de Gaia e Espinho EPE
- Responsible party
- Principal investigator, Nuno Lunet, Instituto de Saude Publica da Universidade do Porto
- Investigators
- Nuno Lunet, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915610
- Sponsor's protocol ID
- MPr-2023-12-15422
- Acronym
- JANUS
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reengineering Cervical Cancer Screening for the 21st Century: Joint Action for a Novel Up-to-date and Sustainable Screening Program
- ClinicalTrials.gov ID
- NCT06915610
- Acronym / sponsor ID
- JANUS / MPr-2023-12-15422
- Conditions
- Cervical Cancer Screening
- Keywords
- Cervical cancer, Human papillomavirus, Self-sampling, DNA methylation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,700 participants (estimated)
- Lead sponsor
- Instituto de Saude Publica da Universidade do PortoUniversity, hospital or other
- Collaborators
- Instituto Portugues de Oncologia, Francisco Gentil, Porto, Universidade do Porto, Unidade Local de Saude de Gaia e Espinho EPE
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vaccination against human papillomavirus (HPV) is highly effective and is expected to reduce substantially the burden of cervical cancer (CC), but cervical cancer screening (CCS) remains necessary for females who were not covered by the vaccination plans, those who remain non-adherent to vaccination, and for early detection of the cervical lesions not prevented by the vaccine. However, the sustainability of CCS programs will be challenged by the expectedly dramatic reduction in frequency of cervical precancerous lesions. A paradigm shift for CCS programs, towards a substantial improvement of efficiency, and ability to reach those more in need of screening, is essential to maintain their cost-effectiveness. We will implement a state-of-the-art approach to population-based CCS, with potential to broaden screening coverage, lower costs and increase efficiency, compared to the current standard of care, by including self-sampling and state-of-the-art molecular methods for triage.
The investigation is based on a pragmatic parallel cluster randomized controlled trial (RCT), including nearly 6,000 participants (2,000 in each arm), implemented at Local Health Unit Gaia e Espinho (ULSGE) in collaboration with the Research Center of Portuguese Institute of Oncology of Porto (CI-IPOP). Family doctors will be randomly allocated to one of the three study arms, and all females from their lists of patients who are eligible for screening, as defined by the current guidelines for the organized screening program, will be invited.
CCS screening will be based on high-risk HPV (HrHPV) testing, according to the Portuguese CCS program. Referral to colposcopy will follow the standard of care (based on HrHPV and liquid based cytology [LBC]), regardless of the strategy used for CCS; females testing non-HPV16/18 HrHPV-positive in self-sampling will undergo a new sample collection by a health professional, so that a LBC evaluation can be performed to support the decision of referral to colposcopy, as defined by the standard of care. Deoxyribonucleic acid (DNA) methylation will be conducted in parallel.
Intention to treat analysis will be the primary strategy of analysis for comparison between the groups, based on crude comparisons, or controlling for confounding through multivariable binary logistic regression, when an imbalance between the distribution of confounders between study arms is observed. Methylation accuracy estimates will be computed with 95% confidence intervals. The cutoffs for each biomarker will be those defined in our previous studies.
The sample size was defined to address the primary objectives that involve the comparison of study arms, with a 1:1:1 allocation ratio, considering a statistical power of 90% and a design effect of 1.1 (assuming an average cluster size of 50 and an intracluster correlation coefficient of 0.002). For a non-inferiority hypothesis, considering an alpha (one-sided) of 5% and assuming an adherence of 50% and a non-inferiority margin of 5%, a sample of 5,700 females is needed.
Family doctors from a total of 10 to 20 primary health care units are expected to be enrolled to achieve the sample size needed, depending on the adherence of the medical doctors and the number of eligible females in their lists of patients.
The study will be initially implemented in 2 to 3 primary health care units, to achieve an expected sample of at least 600 participants, for piloting and adjustment of the overall sample size based on the empirical data on the proportions of adherent females in each arm.
The assessment of the adherence according to the different strategies to incorporate self-sampling in the CCS program will be complemented by a qualitative study to assess barriers and facilitators to the implementation of CCS and adherence to CCS in different formats. This will involve the family doctors who have collaborated in the study and females selected among those invited for screening in the different study arms, based on focus groups and individual semi-structured interviews.
Also, a quantitative assessment of the invited females experiences with CCS within the study and determinants of adherence will be conducted on a subsample including approximately 10% of the invited females, who will be asked to answer a structured questionnaire.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Within each group, participants will be initially invited for CCS though one of the methods under evaluation, and those not adhering will be invited again for CCS through another method. This design will allow for between-group comparisons, both after the first invitation and considering the two invitations, as well as within-group comparisons to assess the extent to which the second (complementary) invitation may contribute to improve participation in CCS. Additionally, data on the participation in CCS in the same settings in the previous years will be retrospectively collected, allowing further ("before-after") comparisons within each group. A qualitative study will be conducted involving medical doctors and females invited for CCS within the study to assess barriers and facilitators to CCS implementation and participation. An observational design nested within the RCT will be used to assess the experience of females invited for CCS, and determinants of adherence.
| Arm | Type | Receives |
|---|---|---|
| Standard of care (followed by self-sampling for the non-adherent) - SOC+SS | Other | Other: Invitation of all participants to CCS according to the standard of care (active comparator), Other: Invitation of all participants to CCS according to the standard of care, followed by invitation of those non-adherent to CCS through self-samplingCCS screening according to the standard of care (sample collected by a health professional). Participants not adhering will be subsequently invited to perform self-sampling for screening. When considering only the initial use of the SOC for CCS, this corresponds to arm type "active comparator". When considering the use of the SOC, followed by SS for participants not adhering to CCS according to the SOC, this corresponds to arm type "experimental". |
| Self-sampling (followed by the standard of care for the non-adherent) - SS+SOC | Experimental | Other: Invitation of all participants to CCS through self-sampling, Other: Invitation of all participants to CCS through self-sampling, followed by invitation of those non-adherent to CCS according to the standard of careCCS screening by self-sampling. Participants not adhering will be subsequently invited for screening according to the standard of care (sample collected by a health professional). |
| Choice (2x) between CCS through sample collected by health professional and self sampling - CHOICEx2 | Experimental | Other: Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of care, 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 invitationParticipants will be asked for their preference for CCS through sample collected by a health professional or by self-sampling, and will undergo CCS accordingly. Those not adhering will be invited again to choose between one of the two methods of CCS. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females fulfilling the eligibility criteria for CCS, as defined by the current guidelines for the organized screening program in Portugal.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invitation of all participants to CCS according to the standard of care (active comparator)Also: SOCInvitation of all participants to CCS according to the standard of care | Other | Standard of care (followed by self-sampling for the non-adherent) - SOC+SS |
| Invitation of all participants to CCS through self-samplingAlso: SS, Evalyn BrushA 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 | Self-sampling (followed by the standard of care for the non-adherent) - SS+SOC |
| Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of careAlso: CHOICEIn 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 | Choice (2x) between CCS through sample collected by health professional and self sampling - CHOICEx2 |
| Invitation of all participants to CCS according to the standard of care, followed by invitation of those non-adherent to CCS through self-samplingAlso: SOC+SSParticipants not adhering to CCS after the first invitation (SOC) will be additionally invited for CCS screening through self-sampling (as in SS) | Other | Standard of care (followed by self-sampling for the non-adherent) - SOC+SS |
| Invitation of all participants to CCS through self-sampling, followed by invitation of those non-adherent to CCS according to the standard of careAlso: SS+SOCParticipants 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 | Self-sampling (followed by the standard of care for the non-adherent) - SS+SOC |
| 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 invitationAlso: CHOICEx2Participants 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 | Other | Choice (2x) between CCS through sample collected by health professional and self sampling - CHOICEx2 |
Primary outcome
Adherence to screening, after the first invitation for CCS in the study
Time frame: 45 days after first scheduling/invitation
Proportion of invited females, in each arm, who adhere after the first scheduling/invitation (SOC, SS or CHOICE)
Adherence to CCS, after two invitations for screening in the study
Time frame: 45 days after first scheduling/invitation or 45 days after the second scheduling/invitation (for those not adhering to the first scheduling/invitation within 45 days)
Proportion of invited females, in each arm, who adhere after the second scheduling/invitation (SOC+SS, SS+SOC or CHOICEx2)
Performance of DNA methylation markers for high-grade squamous intraepithelial lesions or worse (HSIL+) detection
Time frame: 45 days after cytological or histological results, as applicable
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of methylation analysis for detection of high-grade squamous intraepithelial lesions or worse (HSIL+), using the cytological triage results and the histological results as gold-standard
8 secondary outcomes
Identification of barriers and facilitators to the implementation and participation in CCS
Time frame: 90 days after the last invitation for CCS in the study
Proportion of HPV infection, overall and for each genotype tested
Time frame: 45 days after first scheduling/invitation or 45 days after the second scheduling/invitation (for those not adhering to the first scheduling/invitation within 45 days)
Adherence to follow-up appointments (%), overall and among participants referred for follow-up
Time frame: 45 days after the appointment date
Variation in adherence and HPV test result outcomes between the first and the second invitation for screening
Time frame: 45 days after first scheduling/invitation or 45 days after the second scheduling/invitation (for those not adhering to the first scheduling/invitation within 45 days)
Variation in adherence from the previous year to the study period
Time frame: 45 days after first scheduling/invitation or 45 days after the second scheduling/invitation (for those not adhering to the first scheduling/invitation within 45 days)
Subgroup analyses of all comparisons of adherence between groups
Time frame: 45 days after first scheduling/invitation or 45 days after the second scheduling/invitation (for those not adhering to the first scheduling/invitation within 45 days)
Subgroup analyses of DNA methylation accuracy outcomes, according to the adherence to self-sampling and to the standard of care
Time frame: 45 days after cytological or histological results, as applicable
Characterization of the experience with CCS and determinants of adherence
Time frame: 120 days after the last invitation for CCS in the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nuno Lunet, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invitation of all participants to CCS through self-sampling in people with Cervical Cancer Screening, run by Instituto de Saude Publica da Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to screening, after the first invitation for CCS in the study (time frame: 45 days after first scheduling/invitation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.