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

Not Applicable

Recruiting

• Conditions: Microbiota; STI; Cervical Cancer; Human Papilloma Virus
• Interventions: Diagnostic Test: VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine); Diagnostic Test: VIA (Visual Inspection with Acetic acid)

• Registration Number: NCT05125380
• Lead Sponsor: Lund University

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, 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-18
• Study Start: 2021-12-01
• Primary Completion: 2023-10-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-03
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

• Can give consent, Age above 18

Exclusion Criteria

• Women who have undergone hysterectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2- Triage arm for HPV pos women	VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)	HPV positive women
1- Triage arm for HPV pos women	VIA (Visual Inspection with Acetic acid)	HPV positive women

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of VIA and VIA/VILI as triage test	12 weeks	All HPV pos women will have a cervical biopsy taken

Secondary Outcome Measures

Name	Time	Method
Vaginal Microbiota composition	24 months	Assessed in HPV high risk pos women at initiation, who persist and who clear their infection
Prevalence of STI other than HPV	8 weeks	Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis

Trial Locations

Locations (1)

Adama and Geda Health Center; 🇪🇹 Ādama, Ethiopia