Cervical Cancer, Human Papilloma Virus, Microbiota, STI
Conditions
Keywords
LMIC Lowe Middle income country, Screening, Vaginal microbiota
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
Interventions
DIAGNOSTIC_TESTVIA (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.
DIAGNOSTIC_TESTVIA (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.
Sponsors
Addis Ababa University
Armauer Hansen Research Institute, Ethiopia
Adama Hospital Medical College, Ethiopia
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Can give consent, Age above 18
Exclusion criteria
* Women who have undergone hysterectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of VIA and VIA/VILI as triage test | 12 weeks | All HPV pos women will have a cervical biopsy taken |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of STI other than HPV | 8 weeks | Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis |
| Vaginal Microbiota composition | 24 months | Assessed in HPV high risk pos women at initiation, who persist and who clear their infection |
Countries
Ethiopia
Contacts
Primary ContactSelamawit Mekuria, MD
Backup ContactMats Jerkeman, MD, PhD
Outcome results
None listed