Promoting Comprehensive Cervical Cancer Prevention and Better Women's Health in Low- and Medium Resource Settings HPV Screening With Triage by HPV Genotyping Versus Visual Inspection With Acetic Acid: a Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Cervical cancer is the leading cause of cancer death among women in sub-Saharan Africa, despite the existence of effective prevention and screening methods. Because vaccination rates against human papillomavirus (causing nearly all cervical cancers) are still insufficient in some low-resource countries, early detection and treatment of cervical lesions at risk of progressing to cancer are crucial components of cervical cancer control. Therefore, it is essential to find the most reliable and appropriate screening strategy in the context of low-resource countries in order to identify women in need of treatment and thus prevent the development of cervical cancer. The objective of our study is to compare two different methods of cervical cancer screening adapted to low-resource settings, in two study centers in Cameroon.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 49
Healthy Volunteers: t
View:

• HIV-negative women aged 30-49 and HIV-positive women aged 25-49 years old

• Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).

Locations
Other Locations
Cameroon
Bafoussam Regional Hospital
NOT_YET_RECRUITING
Bafoussam
Dschang Annex Regional Hospital
RECRUITING
Dschang
Contact Information
Primary
Patrick Petignat, PD
patrick.petignat@hcuge.ch
22 37 24 432
Time Frame
Start Date: 2022-12-06
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 5500
Treatments
Experimental: Triage by genotyping
The study intervention will consist in applying HPV genotyping as a triage method of HPV-positive women for cervical cancer screening. After primary screening with the Xpert HPV test, positive women will be sorted according to two groups of genotypes: group 1 (HPV types 16,18,45, 31, 33, 35, 52 and/or 58 obtained from channels 1, 2 and 3) and group 2 (HPV types 51, 59, 39,56, 66 and/or 68 obtained from channels 4 and 5). Women of group 1 will immediately treated, while those of group 2 will not receive immediate treatment and will be followed-up at 12 months. An exception will be made for participants with lesions suspicious of invasive cancer upon examination, which will be referred for further investigations regardless of the HPV type.
Active_comparator: Triage by visual inspection after application of acetic acid (VIA)
The control arm will consist in triage of HPV-positive women by VIA, as currently recommended by the WHO. Women with a positive VIA will be treated immediately, while VIA-negative women will not be treated and will be followed-up at 12 months.
Sponsors
Collaborators: University Hospital, Geneva, Dschang District Hospital, Cameroon, Bafoussam Regional Hospital, Cameroon, University of Dschang
Leads: Prof. Patrick Petignat

This content was sourced from clinicaltrials.gov