Clinical trial · Interventional
Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia
Evaluation of an Human Papillomavirus (HPV) Based Screening Algorithm for Low and Middle Income Countries, by Self-sampling in Ethiopia
- 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)
The overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC). Specific aims are the following: * To evaluate the algorithm using Visual Inspection with Acetic acid (VIA) and VIA together with Lugol's Iodine (VILI) as triage and to use HPV self-sample to follow up those treated and those with persisting HPV. * To evaluate the prevalence of Chlamydia trachomatis, Neisseria gonorrhoeae and other STIs in the cohort. * To determine immune response profiles in high-risk HPV-positive women who cleared, persisted, or developed Cervical Intraepithelial Neoplasia 2/3 (CIN). * To assess how specific cervicovaginal microbiota compositions are associated with HPV infection, cervical dysplasia, and cancer
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 |
| Human Papilloma Virus | — | UNRESOLVED | — |
| Microbiota | — | UNRESOLVED | — |
| STI | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VIA (Visual Inspection with Acetic acid) | Diagnostic Test | — | UNRESOLVED |
| VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1- Triage arm for HPV pos women
- description
- HPV positive women
- interventionNames
- Diagnostic Test: VIA (Visual Inspection with Acetic acid)
- type
- EXPERIMENTAL
- label
- 2- Triage arm for HPV pos women
- description
- HPV positive women
- interventionNames
- Diagnostic Test: VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)
Primary outcomes (1)
- measure
- Sensitivity and specificity of VIA and VIA/VILI as triage test
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Can give consent, Age above 18 Exclusion Criteria: * Women who have undergone hysterectomy
References
Publications (3)
- DERIVEDMekuria S, Assiged N, Biazin H, Borgfeldt C, Abebe T, Mihret A, Forslund O, Jerkeman M. Assessing the feasibility of HPV screening for cervical cancer in pregnant women in Ethiopia. Sci Rep. 2025 Aug 28;15(1):31771. doi: 10.1038/s41598-025-15957-y. PMID 40877387
- DERIVEDKebede HB, Mekuria S, Asegid N, Forslund O, Borgfeldt C, Jerkeman M, Mihret A, Abebe T. High-risk human papillomavirus genotypes in previously unscreened reproductive-age women in Ethiopia: A community-based cohort study. Int J Cancer. 2025 May 15;156(10):1995-2009. doi: 10.1002/ijc.35335. Epub 2025 Feb 14. PMID 39950735
- DERIVEDMekuria SF, Biazin H, Abebe T, Borgfeldt C, Assegid N, Mihret A, Obsi Nemomsa R, Forslund O, Jerkeman M. Comparing visual inspection with acetic acid, with and without Lugol's Iodine for triage of HPV self-sample positive women in Ethiopia: a randomized controlled trial. Int J Gynecol Cancer. 2024 Nov 4;34(11):1691-1697. doi: 10.1136/ijgc-2024-005694. PMID 39362749