Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Uterine Cervical Neoplasms

Virus Diseases

Papilloma

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Coagulants

Pharmaceutical Solutions

Vitamins

Acetic Acid

Retinol acetate

Iodine

Lugol's solution

Cadexomer iodine

Vitamin A

Retinol palmitate

Anti-Bacterial Agents

Adjuvants, Immunologic

Immunologic Factors

Protective Agents

Hemostatics

Retinol

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) and VILI (Visual Inspection with Lugol's Iodine)

A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix.

VIA (Visual Inspection with Acetic acid)

Selamawit Mekuria, MD

Mats Jerkeman, MD, PhD

Adamu Meghersa

Adane Mihret, PhD

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

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.

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

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

All HPV pos women will have a cervical biopsy taken

Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis

Assessed in HPV high risk pos women at initiation, who persist and who clear their infection

Addis Ababa University

Armauer Hansen Research Institute, Ethiopia

Adama Hospital Medical College, Ethiopia

Lund University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia	NCT05125380	Cervical Cancer STI Human Papilloma... Microbiota	VIA (Visual Ins... VIA (Visual Ins...	18 Years -	Lund University
Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia	NCT05125380	Cervical Cancer STI Human Papilloma... Microbiota	VIA (Visual Ins... VIA (Visual Ins...	18 Years -	Lund University

Spots Global Cancer Trial Database for via (visual inspection with acetic acid) and vili (visual inspection with lugol's iodine)