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

Primary Purpose

Cervical Cancer, STI, Human Papilloma Virus

Status
Recruiting
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)
VIA (Visual Inspection with Acetic acid)
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring LMIC Lowe Middle income country, Screening, Vaginal microbiota

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Can give consent, Age above 18

Exclusion Criteria:

  • Women who have undergone hysterectomy

Sites / Locations

  • Adama and Geda Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1- Triage arm for HPV pos women

2- Triage arm for HPV pos women

Arm Description

HPV positive women

HPV positive women

Outcomes

Primary Outcome Measures

Sensitivity and specificity of VIA and VIA/VILI as triage test
All HPV pos women will have a cervical biopsy taken

Secondary Outcome Measures

Prevalence of STI other than HPV
Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis
Vaginal Microbiota composition
Assessed in HPV high risk pos women at initiation, who persist and who clear their infection

Full Information

First Posted
October 7, 2021
Last Updated
November 15, 2021
Sponsor
Lund University
Collaborators
Addis Ababa University, Armauer Hansen Research Institute, Ethiopia, Adama Hospital Medical College, Ethiopia
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1. Study Identification

Unique Protocol Identification Number
NCT05125380
Brief Title
Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia
Official Title
Evaluation of an Human Papillomavirus (HPV) Based Screening Algorithm for Low and Middle Income Countries, by Self-sampling in Ethiopia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University
Collaborators
Addis Ababa University, Armauer Hansen Research Institute, Ethiopia, Adama Hospital Medical College, Ethiopia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 and Neisseria gonorrhoeae and their effect on the quality of VIA. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, STI, Human Papilloma Virus, Microbiota
Keywords
LMIC Lowe Middle income country, Screening, Vaginal microbiota

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The whole cohort is offered an HPV self-sample. The HPV high risk positive women gets randomised into two arms VIA or VIA/VILI at the triage step.
Masking
Participant
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1- Triage arm for HPV pos women
Arm Type
Active Comparator
Arm Description
HPV positive women
Arm Title
2- Triage arm for HPV pos women
Arm Type
Experimental
Arm Description
HPV positive women
Intervention Type
Diagnostic Test
Intervention Name(s)
VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
VIA (Visual Inspection with Acetic acid)
Intervention Description
A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of VIA and VIA/VILI as triage test
Description
All HPV pos women will have a cervical biopsy taken
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Prevalence of STI other than HPV
Description
Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis
Time Frame
8 weeks
Title
Vaginal Microbiota composition
Description
Assessed in HPV high risk pos women at initiation, who persist and who clear their infection
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Can give consent, Age above 18 Exclusion Criteria: Women who have undergone hysterectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Selamawit Mekuria, MD
Phone
+46720123974
Email
selamawit.mekuria@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Mats Jerkeman, MD, PhD
Phone
+46704973507
Email
mats.jerkeman@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adane Mihret, PhD
Organizational Affiliation
Armauer Hansen Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adama and Geda Health Center
City
Ādama
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adamu Meghersa
Email
adamumeghersa@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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