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

Study Overview
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Brief Summary
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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

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

Conditions
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Cervical Cancer, STI, Human Papilloma Virus, Microbiota

Intervention / Treatment
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* Diagnostic Test: VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)
* Diagnostic Test: VIA (Visual Inspection with Acetic acid)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Can give consent, Age above 18 Exclusion Criteria: Women who have undergone hysterectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1- Triage arm for HPV pos women<br>HPV positive women | Diagnostic Test: VIA (Visual Inspection with Acetic acid)<br>* A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix.<br>|
| Experimental: 2- Triage arm for HPV pos women<br>HPV positive women | Diagnostic Test: VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of VIA and VIA/VILI as triage test | All HPV pos women will have a cervical biopsy taken | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LMIC Lowe Middle income country, Screening, Vaginal microbiota