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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• Can give consent, Age above 18

Locations
Other Locations
Ethiopia
Adama and Geda Health Center
RECRUITING
Ādama
Contact Information
Primary
Selamawit Mekuria, MD
selamawit.mekuria@med.lu.se
+46720123974
Backup
Mats Jerkeman, MD, PhD
mats.jerkeman@med.lu.se
+46704973507
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2024-09
Participants
Target number of participants: 1200
Treatments
Active_comparator: 1- Triage arm for HPV pos women
HPV positive women
Experimental: 2- Triage arm for HPV pos women
HPV positive women
Sponsors
Leads: Lund University
Collaborators: Armauer Hansen Research Institute, Ethiopia, Adama Hospital Medical College, Ethiopia, Addis Ababa University

This content was sourced from clinicaltrials.gov