Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia
NCT ID: NCT05125380
Last Updated: 2023-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1200 participants
INTERVENTIONAL
2021-12-01
2024-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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1- Triage arm for HPV pos women
HPV positive women
VIA (Visual Inspection with Acetic acid)
A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix.
2- Triage arm for HPV pos women
HPV positive women
VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)
A triage test that involved a gynaecological exam that applies acetic acid and then Lugol's iodine on the surface of the external os of the cervix.
Interventions
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VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)
A triage test that involved a gynaecological exam that applies acetic acid and then Lugol's iodine on the surface of the external os of the cervix.
VIA (Visual Inspection with Acetic acid)
A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Addis Ababa University
OTHER
Armauer Hansen Research Institute, Ethiopia
OTHER
Adama Hospital Medical College, Ethiopia
UNKNOWN
Lund University
OTHER
Responsible Party
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Principal Investigators
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Adane Mihret, PhD
Role: PRINCIPAL_INVESTIGATOR
Armauer Hansen Research Institute
Locations
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Adama and Geda Health Center
Ādama, , Ethiopia
Countries
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Central Contacts
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Facility Contacts
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References
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Mekuria 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.
Mekuria 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.
Other Identifiers
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FBKS 2019-6
Identifier Type: -
Identifier Source: org_study_id
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