HPV Screening With Triage by HPV Genotyping Versus Visual Inspection With Acetic Acid
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
Prof. Patrick Petignat
5,500 participants
Dec 6, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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).
Exclusion Criteria7
- Pregnancy at the time of screening
- Previous hysterectomy
- Known cervical cancer
- Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)
- Conditions that can interfere with visualization of the cervix
- Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure)
- Women who are not able to comply with the study protocol.
Interventions
Genotyping will be obtained by the Xpert system which uses 5 color channels containing primers and probes for the detection of specific genotypes or pooled results as follows: i) HPV 16, ii) HPV 18/45 in pooled result, iii) HPV types 31, 33, 35 52, or 58, in pooled result, iv) HPV types 51 or 59, in pooled result, and v) HPV types 39, 56, 66 or 68 in pooled result.
After application of acetic acid and Lugol's iodine, the cervix will be assessed using simplified "ABCD criteria" (A= acetowhite lesion within the transformation zone, B = spontaneous bleeding or upon slight touch, C (optional) = Lugol-positive coloring of acetowhite lesions, D = diameter \> 5mm of acetowhite lesion).
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05385406