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Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia

NCT05125380 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2023-11-03

No results posted yet for this study

Summary

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

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Addis Ababa University

    collaborator OTHER

  • Armauer Hansen Research Institute, Ethiopia

    collaborator OTHER

  • Adama Hospital Medical College, Ethiopia

    collaborator UNKNOWN

  • Lund University

    lead OTHER

Principal Investigators

  • Adane Mihret, PhD · Armauer Hansen Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-10-28
Completion
2024-09-30

Countries

  • Ethiopia

Study Locations

More Related Trials

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 NCT05125380 on ClinicalTrials.gov