Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPAN 552c.80 FLOQSwab | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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:
| Up to one-year (time-to-event) to initiate screening in the post implementation period. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rebekah Pratt, PhD | University of Minnesota | Principal Investigator |
| Rachel Winer, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41410863 | Derived | 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. | |
| 39561921 |
Not provided
Not provided
Not provided
Clinics were assigned to study arms; 3 clinics were assigned to the intervention group and 37 clinics to the control group. However, as all data analysis is done at the participant level, we are reflecting participant data in the flow here.
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 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. COPAN 552c.80 FLOQSwab: 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. |
| FG001 | Control | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 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. COPAN 552c.80 FLOQSwab: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | 95% Confidence Interval | Hazard ratio | Up to one-year (time-to-event) to initiate screening in each of the pre and post implementation periods. |
|
12 months (post-implementation period)
The pre-implementation period was observational; all adverse events are assessed in the post-implementation period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 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. COPAN 552c.80 FLOQSwab: 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Bliss Barsness | University of Minnesota | 612-625-7179 | blis0015@umn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2023 | May 16, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 14, 2025 | Apr 24, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D030361 | Papillomavirus Infections |
| D014591 | Uterine Diseases |
| D002577 | Uterine Cervical Diseases |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D010212 | Papilloma |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Hybrid Type 2 effectiveness-implementation study; difference-in-difference methods to compare between-period changes in 3 intervention and Fairview non-intervention clinics.
Not provided
Not provided
Not provided
Not provided
| Lin 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. |
| BG001 | Control | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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. | Patients in the pre-implementation period | Posted | Number | Participants who completed screening | Up to one-year (time-to-event) to initiate screening in the pre-implementation period. |
|
|
|
| Primary | 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:
| Patients in the post-implementation period | Posted | Number | Participants who completed screening | Up to one-year (time-to-event) to initiate screening in the post implementation period. |
|
|
|
| 0 |
| 1,948 |
| 0 |
| 1,948 |
| 0 |
| 1,948 |
| EG001 | Control | 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. | 0 | 1,419 | 0 | 1,419 | 0 | 1,419 |
Not provided
Not provided
| D009369 |
| Neoplasms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018307 | Neoplasms, Squamous Cell |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |