Optimizing Cervical Cancer Screening Modalities

NCT03281135 | Unknown DMC

• 1 other identifier: 058/17/SPH
• Study Type: interventional
• Target: 1,760
• Locations: 0 countries
• Sites: N/A

Brief 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

Cervical Cancer

Keywords

Cervical cancer screening; Adherance; HPV typing; HDSS; Ethiopia

Outcome Measures

Primary Outcomes (1)

• Adherence to the procedures

  Proportions of women who adhered in the screening and subsequent follow up based on HPV testing using self-sampling versus an offer of attending for a VIA. This will be compared based on: A women who accessed the HPV self sampling at health post and accessed VIA and treated for positive result plus untreated for negative result divided by the eligible women in the arm versus A women who accessed the VIA at health facility and treated for positive result plus untreated for negative result divided by the eligible women in the arm.

  With in 1 year period

Secondary Outcomes (3)

• Number of women that participate in Cervical Cancer Screening in the control (VIA) compared with the number of women that participate in the intervention(Self sampling HPV testing)

  With in 1 year period

• Demographic and socio cultural factors associated with uptake and adherence of two different cervical cancer screening procedures

  With in 1 year period

• HPV genotypes among rural women

  With in 1 year period

Study Arms (2)

HPV testing

OTHER

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.

Other: HPV testing

Standard care: VIA screening

NO INTERVENTION

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.

Interventions

HPV testing OTHER

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.

HPV testing

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 30 and 49

You may not qualify if:

• women with History of hysterectomy or cervical cancer, pregnant women, not meet the eligibility criteria and unable to give consent.

Sponsors & Collaborators

• Addis Ababa University: lead
• Martin-Luther-Universität Halle-Wittenberg: collaborator
• Charite University, Berlin, Germany: collaborator

Related Publications (1)

• Teka 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 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A cluster randomized trial will be conducted in the Health and Demographic Surveillance Site (HDSS) of Addis Ababa University, School of Public Health which is located in Butajira district. The study population consists of women aged 30-49 who are found among the catchment population of ten Kebele's(Smallest Administrative Unit). Each Kebele will have 2 or more clusters based on the community health workers structure and size. A total of 22 clusters will then be randomized in to two arms. A total of 1760 women will be grouped in to 22 clusters, each comprises 80 women.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 13, 2017
• Study Start: January 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 13, 2017

Record last verified: 2017-09