NCT05385406

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,500 (estimated)
• Sponsor: Prof. Patrick Petignat · Academic / Other
• Sex: Female
• Age: 25 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

HPV used as a stand-alone test has a limited specificity and positive predictive value and as a consequence, a significant number of HPV-positive women have no cervical precancerous lesions or cancer and receive unnecessary workup and treatment. For this reason, the WHO has recommended visual inspection with acetic acid (VIA/VILI) as a triage test of HPV-positive women to identify women requiring treatment. Nevertheless, VIA is a highly subjective procedure dependent on the health care provider's experience, with diagnostic accuracy varying from setting to setting. Triage by HPV genotyping has recently emerged as an alternative to triage by VIA, with immediate treatment of women with a subset of high-risk HPV genotypes only, thus reducing overtreatment rates. However, to date, the triage of HPV-positive women by VIA versus HPV genotyping has not yet been compared. This project aims to implement primary HPV-based screening in Cameroon followed by an immediate offer for treatment by thermal ablation after randomization for triage by HPV genotyping or VIA. More specifically, we aim to determine if triage by HPV genotyping (with immediate treatment of women with HPV types 16, 18, 45, 31, 33, 35, 52 or 58) allows better targeting of women needing treatment and allocation of resources to women at-risk than triage by VIA, as recommended by the WHO. Primary objective: To identify the most efficient screening strategy for cervical cancer in Cameroon, more specifically to determine whether triage by a pool of eight genotypes (HPV types 16, 18, 45, 31, 33, 35, 52 or 58) is more effective than triage by visual inspection with acetic acid for detection of precancerous lesions. ¨ Secondary objectives: * To determine the overtreatment rate in each screening group (HPV genotyping and VIA/VILI) * To determine the rate of adverse events (e.g. hemorrhage, infection, hospitalization) in each screening group * To determine which participant characteristics may be associated with better prediction of CIN2+ for each screening group * To assess patient and health care provider acceptability of both screening strategies * To create a sustainable structure for the promotion of women health with a priority made in the prevention of cervical cancer West Region of Cameroon * To treat all precancerous or cancerous lesions discovered during the screening * To inform women and their families about gynecological pathologies, including cervical cancer, sexually transmitted diseases (STD) and HIV * To create a database of cervical images for continuous clinical education * To develop an Automated VIA/VILI Classifier (AVC) that can help identify cervical precancerous lesions based on a 2-minute video of the cervix during VIA/VILI * To assess women's, the community's and healthcare providers' acceptability of the AVC test Study Design: National multicentric open-label two-arm randomized controlled trial Qualitative and quantitative studies for participants and health care providers will be included during the study period addressing preferences and attitudes toward the screening process and treatment.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HPV genotyping	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.
DIAGNOSTIC_TEST	Visual inspection after application of acetic acid	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).

Timeline

• Start date: 2022-12-06
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2022-05-23
• Last updated: 2024-05-09

Locations

2 sites across 1 country: Cameroon