Cervical Cancer, Papillomavirus Infection, Uterine Cervical Disease, Uterine Diseases
Conditions
Keywords
DNA virus infections, virus diseases, infections, tumor virus infections, papilloma, uterine diseases, uterine cervical diseases, Somali women, primary care, cancer screening
Brief 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.
Interventions
DEVICECOPAN 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.
Sponsors
University of Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Identify as a Somali woman * between ages of 30-65 * eligible for cervical cancer screening
Exclusion criteria
* Ineligible for cervical cancer screening, including having a history of cervical cancer or a hysterectomy without intact cervix
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference-in-difference Comparison | 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 | 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. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,948 |
| 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. | 1,419 |
| Total | 3,367 |
Baseline characteristics
| Characteristic | Total | Intervention | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3367 Participants | 1948 Participants | 1419 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3075 Participants | 1904 Participants | 1171 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 279 Participants | 38 Participants | 241 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 3367 Participants | 1948 Participants | 1419 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,948 | 0 / 1,419 |
| other Total, other adverse events | 0 / 1,948 | 0 / 1,419 |
| serious Total, serious adverse events | 0 / 1,948 | 0 / 1,419 |
Outcome results
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).
Time frame: Up to one-year (time-to-event) to initiate screening in each of the pre and post implementation periods.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention & Control Arm Participants | Difference-in-difference Comparison | 1.8 Hazard ratio |
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: 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.
Time frame: Up to one-year (time-to-event) to initiate screening in the post implementation period.
Population: Patients in the post-implementation period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention & Control Arm Participants | Post-implementation Period Cervical Cancer Screening Completion. | 303 Participants who completed screening |
| Control | Post-implementation Period Cervical Cancer Screening Completion. | 436 Participants who completed screening |
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.
Time frame: Up to one-year (time-to-event) to initiate screening in the pre-implementation period.
Population: Patients in the pre-implementation period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention & Control Arm Participants | Pre-implementation Period Cervical Cancer Screening Completion | 170 Participants who completed screening |
| Control | Pre-implementation Period Cervical Cancer Screening Completion | 482 Participants who completed screening |