Cervical Cancer ScreeningNCT07856862
Culturally Adapted Materials to Increase Cervical Cancer Screening Among Polish Women in Iceland
A study testing Culturally adapted cervical cancer screening invitation letter and Standard cervical cancer screening invitation letter in people with Cervical Cancer Screening and Cervical Cancer, run by The Primary Health Care in the Capital Area at 1 site in Iceland.
Trial summary
This study tests whether sending Polish women residing in Iceland a culturally adapted invitation letter - tailored in language and messaging to the target group - increases participation in cervical cancer screening compared with a standard, non-adapted invitation letter. Read more about this study
- Who is it for?
- Ages 23 to 64 years, women only
- Conditions the study is for
- Cervical Cancer Screening, Cervical Cancer, Cervical Cancer (Early Detection)
- What is being tested?
- Culturally adapted cervical cancer screening invitation letter and Standard cervical cancer screening invitation letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteIceland
- Study dates
- Sep 2026to Jan 2028
- 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 23 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals within the target population for the national cervical cancer screening program in Iceland, defined as those registered as female in the population register and aged 23-64 years
- Born in Poland
- Being due to be invited for cervical cancer screening during the study enrolment period, in accordance with the cervical cancer screening guidelines issued by the Directorate of Health.
Who cannot join
- -Individuals who are not eligible for the national cervical cancer screening program in Iceland (non-female, outside the screening age and not due for an invitation (time since last screening attendance)).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iceland1 site
Cancer Screening Coordination Center, Primary Health Care of the Capital Area
Garðabaer, 210
About this study
Official title: Testing of Culturally Adapted Materials to Enhance Participation in Cervical Cancer Screening Among Polish Women Residing in Iceland
This study tests whether sending Polish women residing in Iceland a culturally adapted invitation letter - tailored in language and messaging to the target group - increases participation in cervical cancer screening compared with a standard, non-adapted invitation letter. Eligible women will be randomly assigned to receive one of the two letter types, and screening participation will be tracked over the following months.
Read the detailed description
It has been shown that cervical cancer screening participation remains lower among women with immigrant background, compared to the general population. Translating existing screening materials into the languages of the immigrant groups may not be sufficient to motivate screening participation. However, cultural adaptation of cancer screening materials has been suggested as a potential strategy to facilitate screening attendance.
This study investigates whether a culturally adapted invitation letter increases attendance at cervical cancer screening among Polish women residing in Iceland, compared with the standard invitation letter currently used in the national cervical cancer screening program. The adapted letter was developed in collaboration with a focus group from the target population.
All individuals registered as female in Registers Iceland and aged 23-64 years are eligible for cervical cancer screening in accordance with the national cancer screening guidelines issued by the Directorate of Health. Eligible individuals receive an invitation letter both digitally via the national health portal and by post. All eligible individuals receive digital invitations in Icelandic, English and Polish. Paper invitations are available only in Icelandic. Therefore, the culturally adapted letter will only be sent digitally.
Polish-born women residing in Iceland who are due for routine cervical cancer screening will be randomized 1:1 to receive either the culturally adapted invitation letter or the standard invitation letter.
This trial is intended to generate evidence on whether low-cost intervention, such as the cultural adaptation of existing screening materials, may help reduce disparities in screening uptake.
- Being tested
- Culturally adapted cervical cancer screening invitation letter, Standard cervical cancer screening invitation letter
- Keywords
- Culturally Tailored Intervention, Cervical Cancer Screening, Invitation Letter, Health Communication, Underscreened Populations, Health Disparities
- 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.
Culturally adapted cervical cancer screening invitation letterBehavioural
Participants randomized to the intervention group will receive a screening invitation letter which has been culturally adapted, developed with community input from individuals in the target group. The letter provides information about cervical cancer screening and has been adapted to the language, cultural context, and communication needs of the target population of Polish women residing in Iceland. The adapted letter retains the essential information contained in the standard invitation while modifying its wording and presentation to improve relevance, understanding, and engagement, with the aim of increasing attendance at cervical cancer screening. The letter will be sent once digitally via the electronic health platforms heilsuvera.is and island.is.
Standard cervical cancer screening invitation letterBehavioural
Participants randomized to the control group will receive the standard invitation letter routinely used to invite eligible individuals to cervical cancer screening. The standard letter provides information about the screening programme and instructions for attending screening. The letter will be sent once digitally via the electronic health platforms heilsuvera.is and island.is.
| Study group | Role | What they receive |
|---|---|---|
| Culturally adapted invitation letter | Experimental | Participants in this arm receive a screening invitation letter which has been culturally adapted, developed with community input. Receives: Behavioral: Culturally adapted cervical cancer screening invitation letter |
| Standard cervical cancer screening invitation letter | Active comparator | Participants in this arm receive a standard invitation letter to cervical cancer screening. Receives: Behavioral: Standard cervical cancer screening invitation letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate in the national cervical cancer screening program in Iceland
The primary outcome of this study will be the participation rate in the Icelandic national cervical cancer screening program within 6 months of invitation, defined as a registered cervical sample in the Icelandic Cancer Screening Register. Participation will be coded as a binary variable (yes/no).
Measured: From the date the invitation is sent through 6 months post-invitation.
Secondary outcomes (1)
Participation rate in the national cervical cancer screening program in Iceland
The secondary outcome will be the participation rate in the Icelandic national cervical cancer screening program within 3 months of invitation, defined as a registered cervical sample in the Icelandic Cancer Screening Register. Participation will be coded as a binary variable (yes/no).
Measured: From the date the invitation is sent through 3 months post-invitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Primary Health Care in the Capital Area
- Sponsor type
- Other government
- Collaborators
- The Icelandic Cancer Society
- Responsible party
- Sponsor
- Investigators
- Ágúst Ingi Ágústsson, Cand. Med., Principal investigator, Cancer Screening Coordination Center, Primary Health Care of the Capital Area
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856862
- Sponsor's protocol ID
- PHCI-2026-001
- Other IDs
- 101162959
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 5 Oct 2026
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of Culturally Adapted Materials to Enhance Participation in Cervical Cancer Screening Among Polish Women Residing in Iceland
- ClinicalTrials.gov ID
- NCT07856862
- Acronym / sponsor ID
- PHCI-2026-001
- Keywords
- Culturally Tailored Intervention, Cervical Cancer Screening, Invitation Letter, Health Communication, Underscreened Populations, Health Disparities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The Primary Health Care in the Capital AreaOther government
- Collaborators
- The Icelandic Cancer Society
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 5 Oct 2026 (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.
This study tests whether sending Polish women residing in Iceland a culturally adapted invitation letter - tailored in language and messaging to the target group - increases participation in cervical cancer screening compared with a standard, non-adapted invitation letter. Eligible women will be randomly assigned to receive one of the two letter types, and screening participation will be tracked over the following months.
Detailed description
It has been shown that cervical cancer screening participation remains lower among women with immigrant background, compared to the general population. Translating existing screening materials into the languages of the immigrant groups may not be sufficient to motivate screening participation. However, cultural adaptation of cancer screening materials has been suggested as a potential strategy to facilitate screening attendance.
This study investigates whether a culturally adapted invitation letter increases attendance at cervical cancer screening among Polish women residing in Iceland, compared with the standard invitation letter currently used in the national cervical cancer screening program. The adapted letter was developed in collaboration with a focus group from the target population.
All individuals registered as female in Registers Iceland and aged 23-64 years are eligible for cervical cancer screening in accordance with the national cancer screening guidelines issued by the Directorate of Health. Eligible individuals receive an invitation letter both digitally via the national health portal and by post. All eligible individuals receive digital invitations in Icelandic, English and Polish. Paper invitations are available only in Icelandic. Therefore, the culturally adapted letter will only be sent digitally.
Polish-born women residing in Iceland who are due for routine cervical cancer screening will be randomized 1:1 to receive either the culturally adapted invitation letter or the standard invitation letter.
This trial is intended to generate evidence on whether low-cost intervention, such as the cultural adaptation of existing screening materials, may help reduce disparities in screening uptake.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally adapted invitation letter | Experimental | Behavioral: Culturally adapted cervical cancer screening invitation letterParticipants in this arm receive a screening invitation letter which has been culturally adapted, developed with community input. |
| Standard cervical cancer screening invitation letter | Active comparator | Behavioral: Standard cervical cancer screening invitation letterParticipants in this arm receive a standard invitation letter to cervical cancer screening. |
Who may qualify
- Ages
- 23 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals within the target population for the national cervical cancer screening program in Iceland, defined as those registered as female in the population register and aged 23-64 years
- Born in Poland
- Being due to be invited for cervical cancer screening during the study enrolment period, in accordance with the cervical cancer screening guidelines issued by the Directorate of Health.
Key exclusion criteria (1 listed)
- -Individuals who are not eligible for the national cervical cancer screening program in Iceland (non-female, outside the screening age and not due for an invitation (time since last screening attendance)).
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 |
|---|---|---|
| Culturally adapted cervical cancer screening invitation letterParticipants randomized to the intervention group will receive a screening invitation letter which has been culturally adapted, developed with community input from individuals in the target group. The letter provides information about cervical cancer screening and has been adapted to the language, cultural context, and communication needs of the target population of Polish women residing in Iceland. The adapted letter retains the essential information contained in the standard invitation while modifying its wording and presentation to improve relevance, understanding, and engagement, with the aim of increasing attendance at cervical cancer screening. The letter will be sent once digitally via the electronic health platforms heilsuvera.is and island.is. | Behavioural | Culturally adapted invitation letter |
| Standard cervical cancer screening invitation letterParticipants randomized to the control group will receive the standard invitation letter routinely used to invite eligible individuals to cervical cancer screening. The standard letter provides information about the screening programme and instructions for attending screening. The letter will be sent once digitally via the electronic health platforms heilsuvera.is and island.is. | Behavioural | Standard cervical cancer screening invitation letter |
Primary outcome
Participation rate in the national cervical cancer screening program in Iceland
Time frame: From the date the invitation is sent through 6 months post-invitation.
The primary outcome of this study will be the participation rate in the Icelandic national cervical cancer screening program within 6 months of invitation, defined as a registered cervical sample in the Icelandic Cancer Screening Register. Participation will be coded as a binary variable (yes/no).
1 secondary outcome
Participation rate in the national cervical cancer screening program in Iceland
Time frame: From the date the invitation is sent through 3 months post-invitation.
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 5 Oct 2026.
- 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.
Ágúst Ingi Ágústsson, Cand. Med. principal investigator
Cancer Screening Coordination Center, Primary Health Care of the Capital Area
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally adapted cervical cancer screening invitation letter and Standard cervical cancer screening invitation letter in people with Cervical Cancer Screening and Cervical Cancer, run by The Primary Health Care in the Capital Area at 1 site in Iceland.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Oct 2026. 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 Iceland. 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?
Contact Ásgerður Marteinsdóttir (+3545136700, asgerdur.marteinsdottir@heilsugaeslan.is), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate in the national cervical cancer screening program in Iceland (time frame: From the date the invitation is sent through 6 months post-invitation.). 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 5 Oct 2026.