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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,200
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.
A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix.
Adama and Geda Health Center
Ādama, Ethiopia
RECRUITINGSensitivity and specificity of VIA and VIA/VILI as triage test
All HPV pos women will have a cervical biopsy taken
Time frame: 12 weeks
Prevalence of STI other than HPV
Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis
Time frame: 8 weeks
Vaginal Microbiota composition
Assessed in HPV high risk pos women at initiation, who persist and who clear their infection
Time frame: 24 months
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