Clinical trials

Background - The burden of cervical cancer is unequally distributed globally, with over 90% of deaths occurring in low- and middle-income countries (LMICs), mainly due to insufficient uptake of preventive measures such as screening. In 2020, the World Health Organization launched a global initiative for the worldwide elimination of cervical cancer as a public health issue, setting a target of 70% of women screened with a high-performance test. In Cameroon, this target is far from being reached, and rural communities are disproportionately affected by low uptake of screening services. Recently, a new cervical cancer screening program has launched in the Bafoussam Regional Hospital, in the capital of the Mifi Health District, as part of a larger research project. To develop a context-specific strategy improving access to screening for women living in rural areas of the district, the active participation of community members for the co-development and implementation of local strategies for cervical cancer screening may be key to improving population screening coverage. Objective - The aim of this study is to evaluate the use of community co-produced action (CCA) for the development and implementation of HPV-based cervical cancer screening strategies compared to a traditional hospital-based approach in rural areas of the Mifi Health District in Cameroon. Methods - Using a cluster-randomized study design, participatory workshops with community members will be led in 7 rural health areas assigned to the intervention arm, with the aim of codeveloping local strategies for HPV-based cervical cancer screening adapted to the setting. The co-produced strategies may include raising awareness among eligible women (aged 30-49 years, or 25-49 years if HIV-positive), as well as facilitating access to screening tests, results and follow-up. Women living in one of the 7 health areas assigned to the control arm will be invited by community health workers to undergo screening at the Bafoussam Regional Hospital. In both study arms, screened women will be included in the GENOVA study, a cervical cancer screening trial offering free-of- charge HPV testing followed by triage by visual inspection or genotyping for HPV-positive women, and free treatment according to triage results. CCA will be evaluated by assessing its effectiveness for screening uptake. Screening coverage among eligible women will be estimated during one year after implementation of screening strategies in both study arms, based on population statistics provided by the Mifi health district for each health area. Expected results - Developing context-sensitive solutions to cervical cancer screening through a community-based participatory approach in rural areas of the Mifi health district is expected to improve screening participation rate.

Cervical cancer remains a major public health challenge in low- and middle-income countries (LMICs) due to financial and logistical issues. The World Health Organization (WHO) recommendation for cervical cancer screening in LMICs includes Human Papillomavirus (HPV) testing as primary screening followed by visual inspection with acetic acid (VIA) and treatment. However, VIA is a subjective procedure dependent on the healthcare provider's experience. Therefore, an objective approach based on quantitative diagnostic algorithms is desirable to improve performance of VIA. With this objective and in a collaboration between the Gynecology and Obstetrics Department of the Geneva University Hospital (HUG) and the Swiss Institute of Technology (EPFL), our group started the development of an automated smartphone-based image classification device called AVC (for Automatic VIA Classifier). Two-minute videos of the cervix are recorded during VIA and classified using an artificial neural network (ANN) and image processing techniques to differentiate precancer and cancer from non-neoplastic cervical tissue. The result is displayed on the smartphone screen with a delimitation map of the lesions when appropriate. The key feature used for classification is the dynamic of cervical acetowhitening during the 120 second following the application of acetic acid. Precancerous and cancerous cells whiten more rapidly than non-cancerous ones and their whiteness persists stronger overtime. Our aim is to assess the diagnostic performance of the AVC and to compare it with the performance of current triage tests (VIA and cytology). Histopathological examination will serve as reference standard. Participants' and providers' acceptability will also be considered as part of the study. The study will be nested in an ongoing cervical cancer screening program called "3T-approach" (for Test, Triage and Treat) which includes HPV self-sampling for women aged 30 to 49 years, followed by VIA triage and treatment if needed. The AVC will be evaluated in this context. The study's risk category is A according to swiss ethical guidelines. This decision is based on the fact that the planned measures for sampling biological material or collecting personal data entail only minimal risks and burdens.

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.