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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05125380
Other study ID # FBKS 2019-6
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date September 2024

Study information

Verified date November 2023
Source Lund University
Contact Selamawit Mekuria, MD
Phone +46720123974
Email selamawit.mekuria@med.lu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date September 2024
Est. primary completion date October 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Can give consent, Age above 18 Exclusion Criteria: - Women who have undergone hysterectomy

Study Design


Intervention

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.
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.

Locations

Country Name City State
Ethiopia Adama and Geda Health Center Adama

Sponsors (4)

Lead Sponsor Collaborator
Lund University Adama Hospital Medical College, Ethiopia, Addis Ababa University, Armauer Hansen Research Institute, Ethiopia

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of VIA and VIA/VILI as triage test All HPV pos women will have a cervical biopsy taken 12 weeks
Secondary Prevalence of STI other than HPV Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis 8 weeks
Secondary Vaginal Microbiota composition Assessed in HPV high risk pos women at initiation, who persist and who clear their infection 24 months
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