Clinical trial · Interventional
HPV Self-Sampling in Somali Women (Isbaar Project)
Reducing Cervical Cancer Screening Disparities in Somali Immigrant Women Through a Primary Care-based HPV Self-sampling Intervention
NCT05453006CI-TRIAL-00091982IsbaarcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Papillomavirus Infection | — | UNRESOLVED | — |
| Uterine Cervical Disease | — | UNRESOLVED | — |
| Uterine Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| COPAN 552c.80 FLOQSwab | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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.
- interventionNames
- Device: COPAN 552c.80 FLOQSwab
- type
- NO_INTERVENTION
- label
- Control
- description
- 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.
Primary outcomes (3)
- measure
- Difference-in-difference Comparison
- timeFrame
- Up to one-year (time-to-event) to initiate screening in each of the pre and post implementation periods.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDPratt 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. PMID 41410863
- DERIVEDLin 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. PMID 39561921