Cervical CancerIsbaarNCT05453006
HPV Self-Sampling in Somali Women (Isbaar Project)
A study testing COPAN 552c.80 FLOQSwab in people with Cervical Cancer and Papillomavirus Infection, run by University of Minnesota at 1 site in United States.
Trial summary
This study plans to assess the effect of implementing HPV self-sampling in primary care on uptake of cervical cancer screening in 30-65 year old Somali women who are due for cervical cancer screening. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, Papillomavirus Infection, Uterine Diseases
- What is being tested?
- COPAN 552c.80 FLOQSwab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,367 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 19 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identify as a Somali woman
- between ages of 30-65
- eligible for cervical cancer screening
Who cannot join
- Ineligible for cervical cancer screening, including having a history of cervical cancer or a hysterectomy without intact cervix
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Reducing Cervical Cancer Screening Disparities in Somali Immigrant Women Through a Primary Care-based HPV Self-sampling Intervention
This study plans to assess the effect of implementing HPV self-sampling in primary care on uptake of cervical cancer screening in 30-65 year old Somali women who are due for cervical cancer screening.
- Being tested
- COPAN 552c.80 FLOQSwab
- Keywords
- DNA virus infections, virus diseases, infections, tumor virus infections, papilloma, uterine diseases, uterine cervical diseases, Somali women, primary care, cancer screening
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections, Uterine Diseases, Uterine Cervical Diseases, DNA Virus Infections, Virus Diseases, Infections, Tumor Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPAN 552c.80 FLOQSwabDevice
The study will implement HPV self-sampling as an option for cervical cancer screening alongside usual care for Somali women, and evaluate changes pre and post implementation, compared to Fairview non-intervention clinics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | At the three intervention clinics, clinic providers or staff will offer women the option to perform HPV self-sampling as an alternative to cervical cancer screening by a clinician. Receives: Device: COPAN 552c.80 FLOQSwab |
| Control | No intervention | Control clinics will have passive participation and their only involvement will be that data will be pulled from these clinics. Women in the control clinics will be offered usual care cervical cancer screening by a clinician. The research team will not have any contact with women in the control clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference-in-difference Comparison
Difference-in-difference Cox proportional hazards regression to compare screening completion changes 12-months pre- /post-implementation in intervention versus control clinics, adjusting for age, screening history, and CDC social vulnerability index (SVI).
Measured: Up to one-year (time-to-event) to initiate screening in each of the pre and post implementation periods.
Pre-implementation Period Cervical Cancer Screening Completion
For the pre-implementation period (prior to intervention clinics offering the option to perform HPV self-sampling), the operational definition of screening completion is receiving Pap and/or HPV testing by a clinician.
Measured: Up to one-year (time-to-event) to initiate screening in the pre-implementation period.
Post-implementation Period Cervical Cancer Screening Completion.
For the post-implementation period, the operational definition of screening completion accounts for hybrid options that allow for either HPV self-sampling, or Pap and/or HPV testing by a clinician. We define screening completion as:
- receiving Pap and/or HPV testing by a clinician;
- self-sampling HPV-negative or HPV16/18+; or
- self-sampling positive for other high-risk HPV types (i.e., "HPV+ other") or unsatisfactory and returning for a follow-up Pap test to complete the screening episode. For women with "HPV+ other" or unsatisfactory test results on self-sampling, a follow-up Pap test is required; if the Pap test is not completed within 3 months, the woman will not be considered screened.
Measured: Up to one-year (time-to-event) to initiate screening in the post implementation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start20 Feb 2023
- Primary completion19 May 2024
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid Type 2 effectiveness-implementation study; difference-in-difference methods to compare between-period changes in 3 intervention and Fairview non-intervention clinics.
- Masking
- None (open label)
- Enrolment
- 3,367 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebekah Pratt, PhD, Principal investigator, University of MinnesotaRachel Winer, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453006
- Sponsor's protocol ID
- FMCH-2019-27849
- Acronym
- Isbaar
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2022
- Last updated
- 10 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pratt R, Bliss Barsness C, Lin J, Adan F, Abdi S, Mohamed S, Farah H, Trofholz A, Desai J, Fordyce K, Ghebre R, Ibrahim A, Ramer T, Szpiro A, Weiner BJ, Yohe S, Winer RL. Experience with Cervical Cancer Screening and Views on HPV Self-Sampling Among Somali American Women. J Gen Intern Med. 2026 Jun;41(8):2154-2164. doi: 10.1007/s11606-025-10080-0. Epub 2025 Dec 18.
PubMed 41410863Lin J, Winer RL, Barsness CB, Desai J, Fordyce K, Ghebre R, Ibrahim AM, Mohamed S, Ramer T, Szpiro AA, Weiner BJ, Yohe S, Pratt R. Design of a pragmatic trial integrating human papillomavirus (HPV) self-sampling into primary care to reduce cervical cancer screening disparities in Somali American individuals: The Isbaar project. Contemp Clin Trials. 2025 Jan;148:107754. doi: 10.1016/j.cct.2024.107754. Epub 2024 Nov 17.
PubMed 39561921
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cervical Cancer Screening Disparities in Somali Immigrant Women Through a Primary Care-based HPV Self-sampling Intervention
- ClinicalTrials.gov ID
- NCT05453006
- Acronym / sponsor ID
- Isbaar / FMCH-2019-27849
- Keywords
- DNA virus infections, virus diseases, infections, tumor virus infections, papilloma, uterine diseases, uterine cervical diseases, Somali women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,367 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 19 May 2024 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Posted 10 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to assess the effect of implementing HPV self-sampling in primary care on uptake of cervical cancer screening in 30-65 year old Somali women who are due for cervical cancer screening.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid Type 2 effectiveness-implementation study; difference-in-difference methods to compare between-period changes in 3 intervention and Fairview non-intervention clinics.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: COPAN 552c.80 FLOQSwabAt the three intervention clinics, clinic providers or staff will offer women the option to perform HPV self-sampling as an alternative to cervical cancer screening by a clinician. |
| Control | No intervention | –Control clinics will have passive participation and their only involvement will be that data will be pulled from these clinics. Women in the control clinics will be offered usual care cervical cancer screening by a clinician. The research team will not have any contact with women in the control clinics. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Identify as a Somali woman
- between ages of 30-65
- eligible for cervical cancer screening
Key exclusion criteria (1 listed)
- Ineligible for cervical cancer screening, including having a history of cervical cancer or a hysterectomy without intact cervix
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 |
|---|---|---|
| COPAN 552c.80 FLOQSwabThe study will implement HPV self-sampling as an option for cervical cancer screening alongside usual care for Somali women, and evaluate changes pre and post implementation, compared to Fairview non-intervention clinics. | Device | Intervention |
Primary outcome
Difference-in-difference Comparison
Time frame: Up to one-year (time-to-event) to initiate screening in each of the pre and post implementation periods.
Difference-in-difference Cox proportional hazards regression to compare screening completion changes 12-months pre- /post-implementation in intervention versus control clinics, adjusting for age, screening history, and CDC social vulnerability index (SVI).
Pre-implementation Period Cervical Cancer Screening Completion
Time frame: Up to one-year (time-to-event) to initiate screening in the pre-implementation period.
For the pre-implementation period (prior to intervention clinics offering the option to perform HPV self-sampling), the operational definition of screening completion is receiving Pap and/or HPV testing by a clinician.
Post-implementation Period Cervical Cancer Screening Completion.
Time frame: Up to one-year (time-to-event) to initiate screening in the post implementation period.
For the post-implementation period, the operational definition of screening completion accounts for hybrid options that allow for either HPV self-sampling, or Pap and/or HPV testing by a clinician. We define screening completion as: 1. receiving Pap and/or HPV testing by a clinician; 2. self-sampling HPV-negative or HPV16/18+; or 3. self-sampling positive for other high-risk HPV types (i.e., "HPV+ other") or unsatisfactory and returning for a follow-up Pap test to complete the screening episode. For women with "HPV+ other" or unsatisfactory test results on self-sampling, a follow-up Pap test is required; if the Pap test is not completed within 3 months, the woman will not be considered screened.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41410863Pratt R, Bliss Barsness C, Lin J, Adan F, Abdi S, Mohamed S, Farah H, Trofholz A, Desai J, Fordyce K, Ghebre R, Ibrahim A, Ramer T, Szpiro A, Weiner BJ, Yohe S, Winer RL. Experience with Cervical Cancer Screening and Views on HPV Self-Sampling Among Somali American Women. J Gen Intern Med. 2026 Jun;41(8):2154-2164. doi: 10.1007/s11606-025-10080-0. Epub 2025 Dec 18.
- Derived from this study: PubMed 39561921Lin J, Winer RL, Barsness CB, Desai J, Fordyce K, Ghebre R, Ibrahim AM, Mohamed S, Ramer T, Szpiro AA, Weiner BJ, Yohe S, Pratt R. Design of a pragmatic trial integrating human papillomavirus (HPV) self-sampling into primary care to reduce cervical cancer screening disparities in Somali American individuals: The Isbaar project. Contemp Clin Trials. 2025 Jan;148:107754. doi: 10.1016/j.cct.2024.107754. Epub 2024 Nov 17.
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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. This study is not recruiting at the moment.
Rebekah Pratt, PhD principal investigator
University of Minnesota
Rachel Winer, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPAN 552c.80 FLOQSwab in people with Cervical Cancer and Papillomavirus Infection, run by University of Minnesota at 1 site in United States.
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: finished, as of the sponsor's last update on 10 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference-in-difference Comparison (time frame: Up to one-year (time-to-event) to initiate screening in each of the pre and post implementation periods.). 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?
On the ClinicalTrials.gov record for NCT05453006, which also lists 2 linked publications.
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 10 Jul 2025.