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

Cervical Cancer Clinical Trial

Official title:

Evaluation of an Human Papillomavirus (HPV) Based Screening Algorithm for Low and Middle Income Countries, by Self-sampling in Ethiopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05125380
• Other study ID #: FBKS 2019-6
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cervical Cancer
• Human Papilloma Virus
• Microbiota
• Papilloma
• STI
• Uterine Cervical Neoplasms

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