A complex digital health intervention to support people with HIV: Operationalizing implementation science frameworks and organizational readiness evaluation for a hybrid effectiveness-implementation study (Preprint)

作者：Jacqueline Hodges, Wendy Cohn, Amanda D. Castel, Tabor Flickinger, Ava Lena Waldman, Michelle Hilgart, Olivia Kirby, Sylvia Caldwell, Karen Ingersoll · 年份：2025 · DOI：10.2196/preprints.76327 · 研究领域：Health Policy Implementation Science

BACKGROUND Evaluating implementation of digital health interventions (DHIs) in practice settings is complex, involving diverse users and multistep processes. Proactive planning can ensure implementation determinants and outcomes are captured for hybrid studies, but operational guidance for DHI studies is limited. OBJECTIVE We aimed to proactively define, prioritize and operationalize measurement of implementation outcomes and determinants for a DHI hybrid effectiveness-implementation trial. We describe unique advantages and limitations of planning the trial among a large-scale cohort study population and share results of a pre-trial organizational readiness assessment. METHODS We planned a cluster randomized, type II hybrid effectiveness-implementation trial testing PositiveLinks, a smartphone application for HIV care, compared to usual care (n=6 sites per arm), among HIV outpatient sites in the DC Cohort Longitudinal HIV Study in Washington, DC. We 1) Defined components of the DHI and associated implementation strategy, 2) Selected implementation science frameworks to accomplish evaluation aims, 3) Mapped framework dimensions, domains, and constructs to implementation strategy steps, 4) Modified or created instruments to collect data for implementation outcome measures and determinants and 5) Developed a compatible implementation science data collection and management plan. Provider baseline surveys administered at intervention sites probed usage of digital tool...