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Optimizing Cervical Cancer Screening Modalities

NCT03281135 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1760

Last updated 2017-09-13

No results posted yet for this study

Summary

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

Interventions

OTHER

HPV testing

Clusters randomly allocated to this arm of the study will be sensitized to be showed up in nearby health posts for self sampling with Evalyn brush for HPV testing.

Sponsors & Collaborators

  • Martin-Luther-Universität Halle-Wittenberg

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Addis Ababa University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2019-05-31
Completion
2019-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03281135 on ClinicalTrials.gov