Effect of a mobile cervical cancer screening unit on screening completeness among women living with HIV in a semi-rural area of Cameroon: protocol for a stepped-wedge cluster-randomised trial (OptiTri-EM study) (Preprint)

BACKGROUND Cervical cancer (CC) remains a leading cause of cancer-related deaths among women in Sub-Saharan Africa, especially women living with HIV (WLWH). Effective prevention strategies do exist, but implementation remains insufficient, particularly in remote areas where women face substantial barriers along the CC screening cascade. There is an urgent need of implementation research to identify effective screening strategies adapted to local contexts. OBJECTIVE This study aims to evaluate the implementation of a “mobile unit” and compare its effectiveness versus a “centralised” approach in delivering CC screening among WLWH in primary health units in Cameroon. METHODS This is a stepped-wedge cluster-randomised trial following a type 2 hybrid design, with a dual focus on intervention effectiveness and implementation outcomes. The primary effectiveness outcome is completion of all screening steps within 120 days. The implementation outcomes include the acceptability, adoption, feasibility and sustainability of the intervention. The study will be conducted in 6 HIV clinics in the Western region of Cameroon over eight periods of ten weeks. Each clinic will begin by implementing the centralised CC screening strategy (standard of care) where samples are processed in a reference laboratory and HPV-positive women referred to a regional hospital for triage and treatment. The clinics will be switched at a random point in time to the intervention screening strategy where testing, triage and treatment are provided on-site by a mobile unit. Mixed methods will be used to assess the screening implementation and document the experience of the women. RESULTS This study is funded by the Initiative and the ANRS-MIE. The trial has received approval from the National Ethics Committee of Cameroon, the IARC Ethics Committee, and the French Data Protection Authority. It is registered on the ClinicalTrials.gov website (NCT07181278). As of manuscript submission, the baseline formative research has been completed, implementation strategies have been co-designed, and recruitments are underway. Dissemination in civil society and among decision-makers will be through workshops and policy briefs. CONCLUSIONS This study aims to inform decision-makers about one of the possible screening strategies and thereby contribute to eliminating CC. Its hybrid design allows for a comprehensive evaluation of the implementation processes and outcomes, alongside the effectiveness outcomes. CLINICALTRIAL ClinicalTrial.gov NCT07181278