HOme-based self-sampling for cervical cancer prevention education among women living with HIV in Ghana (HOPE-inG): study protocol for a cluster-randomized type 2 hybrid effectiveness implementation trial

BACKGROUND: Women living with HIV (WLWH) are six times more likely to develop cervical cancer (CC) than women without HIV, underscoring the urgent need for early and frequent screening. In Ghana, however, screening uptake among WLWH remains critically low and no national screening program exists. The HOPE (HOme-based self-sampling Prevention Education) toolkit has proven effective in increasing screening uptake. HOPE-inG (HOPE 2.0 in Ghana) aims to adapt the HOPE toolkits and develop implementation support strategies (ISS) to enhance the uptake and sustainment of cervical screening within HIV care services. METHODS: This study will be conducted in four HIV clinics in Ghana's Central Region using a three-phase design. Preparation Phase (Year 1): Use mixed methods, including nominal group techniques with 40-60 stakeholders (WLWH, healthcare providers, policymakers), to prioritize ISS and refine HOPE into HOPE 2.0 or HOPE-inG. Implementation Phase (Years 2-3): Conduct a hybrid type 2 cluster-randomized controlled trial, comparing HOPE 2.0 + ISS (intervention group) versus HOPE 2.0 alone (control group). A total of 1,152 WLWH and 80 health providers will be enrolled. Sustainment Phase (Years 3-5): Evaluate the long-term sustainment of HOPE 2.0 and ISS using quantitative and qualitative methods. Primary outcomes include patient-level screening and treatment uptake (effectiveness) and provider-level implementation metrics (adoption, cost, fidelity, penetration and sustainability). Data sources include surveys, interviews, electronic tracking and fidelity checklists at multiple organizational levels. Cost analyses will employ micro-costing methods, and fidelity will be monitored through structured observations and log sheets. DISCUSSION: HOPE-inG is designed to develop scalable, sustainable strategies for improving cervical screening and care among WLWH in Ghana. By embedding evidence-based screening tools within HIV care services and supporting providers with targeted ISS, this study seeks to bridge critical gaps in cervical cancer prevention. Findings will provide evidence to inform national policy and guide the broader implementation of patient-driven and community-based screening programs in other low-resource settings, ultimately improving health outcomes and reducing disparities for WLWH. TRIAL REGISTRATION: ClinicalTrials.gov NCT06800664. Registered on 29 January 2025.