HPV Self-Sampling in Somali Women

Study Overview
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Brief Summary
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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.

Official Title
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Reducing Cervical Cancer Screening Disparities in Somali Immigrant Women Through a Primary Case-based HPV Self-sampling Intervention

Conditions
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Cervical Cancer, Papillomavirus Infection, Uterine Diseases, Uterine Cervical Disease

Intervention / Treatment
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* Device: COPAN 552c.80 FLOQSwab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Device: COPAN 552c.80 FLOQSwab<br>* 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 intervention clinics.<br>|
| No Intervention: Control<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical cancer screening uptake rate | Our operational definition of screening uptake accounts for hybrid options that allow for either HPV self-sampling, or Pap and/or HPV testing by a clinician. We define screening uptake as follows: a) receiving Pap and/or HPV testing by a clinician; b) completing a self-sampling kit that is negative for all HPV or is HPV16/18+; or c) completing a self-sampling kit that is negative for HPV16/18 but positive for other types (i.e., HPV+ other) or unsatisfactory. | up to one-year (time-to-event) following intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DNA virus infections, virus diseases, infections, tumor virus infections, papilloma, uterine diseases, uterine cervical diseases, Somali women, primary care, cancer screening