Pre-implementation study demonstrates feasibility of co-designed village doctor-delivered HPV self-sampling in rural women, indicating a rapid path to expand organized cervical cancer screening.
Human papillomavirus (HPV) self-sampling can increase screening uptake among women not engaged in clinic-based screening, but evidence remains limited on how implementation strategies can be developed and integrated into routine screening workflows in low-resource rural settings. We aimed to develop and specify implementation strategies for integrating HPV self-sampling into a rural screening system using a rapid stakeholder-engaged application of the Implementation Research Logic Model (IRLM). We conducted a pre-implementation study in two rural counties of China. The existing organized cervical cancer screening program provided clinic-based, clinician-collected screening. The planned intervention was a “mobilization plus self-sampling option”, in which village doctors would offer HPV self-sampling to hard-to-reach women who declined the routine screening. Using the IRLM, we organized determinants, implementation strategies, hypothesized mechanisms, and planned outcomes along a prospective pathway. Stakeholder interviews were guided by the Consolidated Framework for Implementation Research (CFIR). Barriers were matched to candidate strategies through the CFIR-ERIC (Expert Recommendations for Implementing Change) matching tool. In a co-design workshop, stakeholders prioritized strategies by discussion and dot voting, specified them using Proctor’s categories, and linked them to hypothesized mechanisms. Outcomes were organized using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. A pilot pretest checked the intervention delivery workflow and data capture procedures. The study was conducted from March 23 to April 21, 2025, covering 26 activity days and 331.6 person-hours. CFIR-based interviews included 43 stakeholders, 25 of whom joined the co-design workshop. Three major barriers were identified: insufficient legitimacy of village doctor-led mobilization, gaps between initial agreement and correct self-sampling completion, and poor alignment between the self-sampling workflow and existing service responsibilities and incentives. CFIR-ERIC matching generated 46 candidate strategies; nine received at least 60% stakeholder support and were consolidated into four packages: Champion and Opinion Leader Engagement, Stakeholder Coordination, Cascade Training, and Iterative Implementation. In the pilot pretest, six village doctors reached 172 women; 107 (62.2%) agreed and completed self-sampling. Samples met testing standards in 99.1% of cases (106/107), participant information was complete for 95.3% (102/107), and sample transfer was completed for all cases. This study developed four stakeholder-prioritized strategy packages for integrating village doctor-delivered HPV self-sampling into a rural cervical cancer screening system. Guided by the IRLM, the study linked identified implementation barriers, strategy packages, hypothesized mechanisms, and planned outcomes, providing a time-documented example of rapid pre-implementation planning. Although HPV self-sampling can increase cervical cancer screening uptake, less attention has been paid to how implementation strategies are prospectively developed and specified before delivery in low-resource rural settings. This study contributes to implementation science by showing how CFIR-ERIC strategy matching and stakeholder co-design can be combined within a rapid IRLM-guided pre-implementation process to develop and specify implementation strategies during trial preparation. In the context of cervical cancer screening, these findings illustrate how village doctor-delivered HPV self-sampling can be prepared for integration into existing organized rural screening services for hard-to-reach women.
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