Comparative effectiveness of implementation strategies for Accelerating Cervical Cancer Elimination through the integration of Screen-and-treat Services (ACCESS study): protocol for a cluster randomized hybrid type III trial in Nigeria

Despite the increased risk of cervical cancer (CC) among women living with HIV (WLHIV), CC screening and treatment (CCST) rates remain low in Africa. The integration of CCST services into established HIV programs in Africa can improve CC prevention and control. However, the paucity of evidence on effective implementation strategies (IS) has limited the success of integration in many countries. In this study, we seek to identify effective IS to enhance the integration of CCST services into existing HIV programs in Nigeria. Our proposed study has formative and experimental activities across the four phases of the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework. Through an implementation mapping conducted with stakeholders in the exploration phase, we identified a core package of IS (Core) and an enhanced package of IS (Core+) mostly selected from the Expert Recommendations for Implementing Change. In the preparation phase, we refined and tailored the Core and Core+ IS with the implementation resource teams for local appropriateness. In the implementation phase, we will conduct a cluster-randomized hybrid type III trial to assess the comparative effectiveness of Core versus Core+. HIV comprehensive treatment sites (k = 12) will be matched by region and randomized to Core or Core+ in the ratio of 1:1 stratified by region. In the sustainment phase, we will assess the sustainment of CCST at each site. The study outcomes will be assessed using RE-AIM: reach (screening rate), adoption (uptake of IS by study sites), IS fidelity (degree to which the IS occurred according to protocol), clinical intervention fidelity (delivery of CC screening, onsite treatment, and referral according to protocol), clinical effectiveness (posttreatment screen negative), and sustainment (continued integrated CCST service delivery). Additionally, we will descriptively explore potential mechanisms, including organizational readiness, implementation climate, CCST self-efficacy, and implementation intentions. The assessment of IS to increase CCST rates is consistent with the global plan of eliminating CC as a public health threat by 2030. Our study will identify a set of evidence-based IS for low-income settings to integrate evidence-based CCST interventions into routine HIV care in order to improve the health and life expectancy of WLHIV. Prospectively registered on November 7, 2023, at ClinicalTrials.gov no. NCT06128304. https://classic.clinicaltrials.gov/ct2/show/study/NCT06128304