Abstract
BACKGROUND: Women living with HIV (WLWH) face a significantly higher risk of developing cervical cancer (CC) due to immune system suppression, which impairs the body's ability to clear high-risk HPV infections. Despite this increased risk, cervical cancer screening rates remain low among WLWH in Ghana, hindered by financial, logistical, and cultural barriers. Evidence-based interventions, such as HPV self-sampling and the 3R communication model (reframe, reprioritize, and reform) offer promising strategies to improve screening uptake. The primary objective of this study was to evaluate the effectiveness of the Home-based self-sampling for cervical cancer Prevention Education (HOPE) toolkit in increasing CC screening among WLWH in Ghana. Secondary objectives include assessing the feasibility, acceptability, appropriateness and adoptability of the HOPE intervention, as well as identifying key factors that influence its implementation. METHODS: The study will be conducted at the Cape Coast Teaching Hospital (CCTH) in Ghana, using a Hybrid Type 1 effectiveness-implementation randomized controlled trial (RCT) design. A total of 108 WLWH will be randomly assigned to either the HOPE intervention group, which includes HPV self-sampling and 3R messaging, or a control group receiving standard care. Data will be collected through structured surveys, key informant interviews, and focus group discussions. The study will also engage a stakeholder advisory board (SAB) comprising WLWH, healthcare providers and community members to co-develop and adapt the intervention through nominal group technique. DISCUSSION: By leveraging existing healthcare infrastructure and community engagement, this study seeks to provide a scalable, evidence-based approach to improving CC screening among WLWH in Ghana. Findings will inform national strategies for integrating HPV self-sampling and health communication interventions to enhance early detection and reduce cervical cancer-related morbidity and mortality in this high-risk population. TRIAL REGISTRATION: ClinicalTrials.gov NCT06739772. Registered on 18 December 2024.