Clinical trial · Interventional
Optimizing Cervical Cancer Screening Modalities
Optimizing Cervical Cancer Screening Modalities and Identifying the Molecular Epidemiology of Human Papilloma Virus in Ethiopia: A Cluster Randomized Trial
- 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 project aims to optimize cervical cancer screening adherence comparing Arm A (VIA) and Arm B self-sampled Human Papilloma Virus (HPV) testing and determine the molecular epidemiology of HPV, persistence level and identify factors responsible for persistence, and also characterizing the potential dysplasia by biomarkers that describe the disease stage in a population of Ethiopia. A cluster-randomized trial will be used in this study. The total number of ten kebele's(Smallest administrative unit) will be randomly classified in to two arms(VIA and HPV+VIA).Community health workers will be used as a cluster for randomization. Community sensitization and awareness creation will be performed at health facilities and in communities at social, business or religious gatherings, about cervical cancer and its prevention for eligible women in both arms. Women will be educated about cervical cancer and advice for testing at the Hospital offering VIA (arm A). Women will also be instructed to undergo HPV self-sampling at nearby health posts with a vaginal evalyn brush (arm B). All eligible women on each cluster will be included in the study at both arms. Based on the community health workers number and structure study area there will be about 22 clusters with 80 eligible women on each cluster. Brushes will be sent to the Microbiology Laboratory of Department of Microbiology,Immunology and Parasitology,College of Health Sciences, Addis Ababa University, Addis Ababa, where the laboratory service is sated-up . Trained Microbiologists will perform the laboratory analysis at the HPV laboratory. Only women with samples positive for high-risk HPV (hrHPV) will be contacted and informed to go to the Hospital offering VIA. Further tests will also be performed from the brushes at the collaborators' HPV laboratory, Germany to better characterize the dysplesia. The women found positive for VIA or hrHPV+VIA will receive cryo treatment at Butajira Hospital. To evaluate the long-term effect and factors for persistence, all eligible women within the catchment area will be visited after 2 years door to-door and asked for a vaginal self-sample and HPV-genotype test. The impact of intervention, factors associated with HPV infection, persistence, clearance, and adherence to the screening service will be seen.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- HPV testing
- description
- This is an experimental arm for the primary outcome, 'adherence to the procedures'. In this group self sampling will be done using the Evalyn brush for HPV testing.
- interventionNames
- Other: HPV testing
- type
- NO_INTERVENTION
- label
- Standard care: VIA screening
- description
- Control Arm, in which women's are invited to cervical cancer screening as per standard Ethiopian cervical cancer prevention and control guideline. Uptake of screening in this group will be compared with the HPV testing arm group to test for significant differences in adherence.
Primary outcomes (1)
- measure
- Adherence to the procedures
- timeFrame
- With in 1 year period
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged between 30 and 49 Exclusion Criteria: * women with History of hysterectomy or cervical cancer, pregnant women, not meet the eligibility criteria and unable to give consent.
References
Publications (1)
- DERIVEDTeka B, Gizaw M, Firdawoke E, Addissie A, Sisay TA, Schreckenberger C, Skof AS, Thies S, Mihret A, Kantelhardt EJ, Abebe T, Kaufmann AM. A Technical Comparison of Human Papillomavirus Genotyping Assays from a Population-Based Cervical Cancer Screening in South Central Ethiopia. Cancer Manag Res. 2022 Jul 29;14:2253-2263. doi: 10.2147/CMAR.S360712. eCollection 2022. PMID 35937937