Trial Outcomes & Findings for HPV Self-Sampling in Somali Women (Isbaar Project) (NCT NCT05453006)

Last Updated: 2025-07-10

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

3367 participants

Primary outcome timeframe

Up to one-year (time-to-event) to initiate screening in each of the pre and post implementation periods.

Results posted on

2025-07-10

Participant Flow

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.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	1948 3	1419 37
Overall Study COMPLETED	1948 3	1419 37
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HPV Self-Sampling in Somali Women (Isbaar Project)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=1948 Participants 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.	Control n=1419 Participants 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.	Total n=3367 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1948 Participants n=5 Participants	1419 Participants n=7 Participants	3367 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1948 Participants n=5 Participants	1419 Participants n=7 Participants	3367 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1904 Participants n=5 Participants	1171 Participants n=7 Participants	3075 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	38 Participants n=5 Participants	241 Participants n=7 Participants	279 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to one-year (time-to-event) to initiate screening in each of the pre and post implementation periods.

Outcome measures

Outcome measures
Measure	Intervention & Control Arm Participants n=3367 Participants 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. Women in the 3 intervention clinics will be offered 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. Women in the 37 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.	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.
Difference-in-difference Comparison	1.8 Hazard ratio Interval 1.41 to 2.32	—

PRIMARY outcome

Timeframe: Up to one-year (time-to-event) to initiate screening in the pre-implementation period.

Population: Patients 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.

Outcome measures

Outcome measures
Measure	Intervention & Control Arm Participants n=987 Participants 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. Women in the 3 intervention clinics will be offered 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. Women in the 37 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.	Control n=758 Participants 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.
Pre-implementation Period Cervical Cancer Screening Completion	170 Participants who completed screening	482 Participants who completed screening

PRIMARY outcome

Timeframe: Up to one-year (time-to-event) to initiate screening in the post implementation period.

Population: Patients 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.

Outcome measures

Outcome measures
Measure	Intervention & Control Arm Participants n=961 Participants 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. Women in the 3 intervention clinics will be offered 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. Women in the 37 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.	Control n=661 Participants 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.
Post-implementation Period Cervical Cancer Screening Completion.	303 Participants who completed screening	436 Participants who completed screening

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christina Bliss Barsness

University of Minnesota

Phone: 612-625-7179

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place