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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are evaluating a smartphone-based artificial intelligence device called the Automatic VIA Classifier (AVC) to improve cervical cancer screening in women aged 30 to 49 years who test positive for Human Papillomavirus (HPV). Cervical cancer remains a significant challenge in low- and middle-income countries due to financial and logistical barriers. This study aims to assess the diagnostic accuracy of the AVC compared to current triage methods, including visual inspection with acetic acid (VIA) and cytology, using histopathological examination as the reference standard. The AVC test involves recording 120-second videos of the cervix immediately after applying acetic acid during VIA. These videos are taken with a smartphone fixed on a tripod about 15 cm from the cervix. Local midwives perform the test, and the device uses artificial intelligence to analyze the dynamic changes in cervical whitening to distinguish precancerous and cancerous tissue from normal tissue. This study is nested within an ongoing cervical cancer screening program called the "3T-approach," which includes HPV self-sampling, VIA triage, and treatment if necessary. Participants will undergo the AVC test during their screening visits. Researchers will measure the accuracy of the AVC test over two years and compare its performance with current triage methods. The study will also consider participants' and healthcare providers' acceptance of the device. Safety is considered minimal risk, with biological sampling and data collection posing only minor burdens. The total study duration and long-term follow-up are designed to ensure thorough evaluation of the device's diagnostic capabilities.
Actively Recruiting
Healthy Volunteer
Cervical cancer is a major cause of death among women in sub-Saharan Africa, especially where vaccination against human papillomavirus (HPV), the main cause of cervical cancer, is low. This research aims to find the most effective cervical cancer screening method suitable for low-resource settings by comparing two approaches in Cameroon. The goal is to better detect and treat precancerous lesions to prevent cervical cancer. The study focuses on evaluating if triage by HPV genotyping is more efficient than visual inspection with acetic acid (VIA) as recommended by the World Health Organization (WHO). Participants will be screened using primary HPV testing followed by a randomized triage method: either HPV genotyping targeting eight high-risk HPV types or visual inspection with acetic acid and Lugol's iodine using simplified criteria. Women with positive results may receive immediate treatment by thermal ablation. The study is a national multicenter open-label, two-arm randomized controlled trial conducted in two centers. During the study, women will undergo HPV testing and either HPV genotyping or visual inspection to identify those needing treatment. Researchers will assess screening accuracy, overtreatment rates, adverse events, and acceptability of both methods by patients and healthcare providers. Additional goals include education on gynecological health and development of an automated tool to help identify cervical lesions. The main outcome is the ability of each triage method to detect significant precancerous lesions over two years.