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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

The trial investigates cervical cancer screening in rural areas of the Mifi Health District in Cameroon, focusing on women aged 30-49 years (or 25-49 if HIV-positive). Cervical cancer causes a high number of deaths worldwide, especially in low- and middle-income countries due to low screening rates. The World Health Organization aims to eliminate cervical cancer as a public health issue by increasing screening coverage to 70%, but this target remains unmet in Cameroon, particularly in rural communities. This research evaluates whether involving community members in co-developing screening strategies can improve cervical cancer screening uptake compared to a traditional hospital-based approach. Two approaches are assessed: community co-produced action (CCA) and a standard hospital-based strategy. In the intervention group, participatory workshops with community members are held to create locally adapted HPV-based screening strategies, including awareness campaigns, collaboration with community health workers, and facilitation of access to screening and follow-up. The control group uses a standard method where trained community health workers invite women to the district hospital for screening. Both groups offer free HPV testing, triage by visual inspection or genotyping for HPV-positive women, and treatment if needed. Participants are followed for one year after implementation of the screening strategies. Researchers measure the number of women completing cervical cancer screening, including HPV testing within 12 months and triage within 6 months if HPV-positive. The study collects data on screening coverage in each health area, aiming to understand if community involvement increases screening rates. The trial includes monitoring of screening participation, follow-up procedures, and treatment outcomes to evaluate the effectiveness of the interventions in rural Cameroon.

Age: 25Years - 49YearsFEMALEPhase Not Applicable
1 location
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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.

Age: 25Years - 49YearsFEMALEPhase Not Applicable
2 locations
O

Actively Recruiting

Cervical cancer is a major cause of death among women living with HIV in areas with limited resources. Effective screening and prevention methods exist, involving multiple steps like HPV testing, visual inspection, and treatment when needed. This research evaluates two different ways to provide cervical cancer screening to women living with HIV: a centralized approach at well-equipped centers and a decentralized approach using a mobile team visiting usual patient care locations. The study also includes sub-studies on urinary HPV testing, identifying women needing treatment, and risks after treatment. The study compares the centralized strategy, where samples are sent to a reference lab and positive women visit a center for triage and treatment, with the decentralized strategy, where a mobile team performs HPV testing and immediate triage with treatment at health centers. The mobile team includes midwives and a lab technician using a Genexpert platform for point-of-care HPV testing. The trial is organized into six periods of 10 weeks each, with sites switching from centralized to decentralized screening. The main goal is to measure screening completeness within 120 days after enrollment. Participants are women living with HIV aged 25 to 49 who are eligible for cervical cancer screening and receiving or starting antiretroviral treatment. They will provide vaginal self-samples and may undergo triage and treatment if HPV positive. The study monitors the success, reach, and acceptability of each screening approach from both patients' and healthcare workers' perspectives. Outcomes include screening completeness, performance of different HPV testing methods, and treatment effectiveness. The total participation time involves evaluation during the screening process and follow-up within 120 days after enrollment.

Age: 25Years - 49YearsFEMALEPhase Not Applicable
6 locations
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