HPV Self-Sampling in Somali Women (Isbaar Project)

NCT05453006 | Completed Results

• 1 other identifier: FMCH-2019-27849
• Study Type: interventional
• Target: 3,367
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Papillomavirus Infection; Uterine Diseases; Uterine Cervical Disease

Keywords

DNA virus infections; virus diseases; infections; tumor virus infections; papilloma; uterine diseases; uterine cervical diseases; Somali women; primary care; cancer screening

Outcome Measures

Primary Outcomes (3)

• 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: 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.

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

Study Arms (2)

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.

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.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as a Somali woman
• between ages of 30-65
• eligible for cervical cancer screening

You may not qualify if:

• Ineligible for cervical cancer screening, including having a history of cervical cancer or a hysterectomy without intact cervix

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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. 2025 Dec 18. doi: 10.1007/s11606-025-10080-0. Online ahead of print.

  PMID: 41410863 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections; Uterine Diseases; Uterine Cervical Diseases; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Papilloma

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Christina Bliss Barsness
• Organization: University of Minnesota

blis0015@umn.edu

612-625-7179

Study Officials

• Rebekah Pratt, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Rachel Winer, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid Type 2 effectiveness-implementation study; difference-in-difference methods to compare between-period changes in 3 intervention and Fairview non-intervention clinics.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 12, 2022
• Study Start: February 20, 2023
• Primary Completion: May 19, 2024
• Study Completion: May 19, 2025
• Last Updated: July 10, 2025
• Results First Posted: July 10, 2025

Record last verified: 2025-07

Locations

US (1)