Trials / Unknown
UnknownNCT05125380
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,200 (estimated)
- Sponsor
- Lund University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 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 and then Lugol's iodine on the surface of the external os of the cervix. |
| DIAGNOSTIC_TEST | VIA (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. |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2023-10-28
- Completion
- 2024-09-01
- First posted
- 2021-11-18
- Last updated
- 2023-11-03
Locations
1 site across 1 country: Ethiopia
Source: ClinicalTrials.gov record NCT05125380. Inclusion in this directory is not an endorsement.