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A Complex Digital Health Intervention to Support People With HIV: Organizational Readiness Survey Study and
Jacqueline Hodges1, Wendy Cohn2, Amanda Castel3
1Division of Infectious Diseases, Department of Medicine, Duke University, 315 Trent Drive, Durham, NC, 27710, United States, 1 919 681 1309, 1 434 404 4578.
Journal of Medical Internet Research
|January 22, 2026
Summary
Planning hybrid digital health intervention trials requires careful consideration of implementation outcomes and determinants. This study outlines a proactive approach to measuring these factors within a large cohort, highlighting challenges and opportunities for real-world effectiveness.
Area of Science:
- Implementation Science
- Digital Health Interventions
- Health Services Research
Background:
- Evaluating digital health interventions (DHIs) in practice is complex, involving diverse users and processes.
- Operational guidance for designing hybrid DHI studies is limited, despite the need for proactive planning.
- Implementation determinants and outcomes must be captured for hybrid studies.
Purpose of the Study:
- To proactively define, prioritize, and operationalize measurement of implementation outcomes and determinants for a DHI hybrid effectiveness-implementation trial.
- To describe the advantages and limitations of planning implementation evaluation within a large-scale cohort study.
- To share results of a pretrial organizational readiness assessment.
Main Methods:
- A cluster-randomized, type II hybrid effectiveness-implementation trial was planned for the PositiveLinks smartphone app for HIV care.
- Implementation science frameworks (RE-AIM, CFIR) were used to guide measurement of implementation outcomes and determinants.
- Instruments were modified or created to collect data, and a data collection plan was developed.
- Provider surveys assessed digital tool usage and organizational readiness to implement change.
Main Results:
- The study specified DHI and implementation strategy to measure program reach and adoption.
- Mapping to the RE-AIM framework highlighted considerations for capturing reach and implementation dimensions.
- Tools were created to obtain detailed determinants across CFIR domains within a large sample.
- High baseline digital tool use and organizational readiness were reported by providers and research assistants.
Conclusions:
- Planning implementation evaluation within hybrid DHI trials in cohort populations presents unique challenges and opportunities.
- Prospective trial planning must balance generalizability with rigorous effectiveness measurement.
- Rapid, scalable tools are needed for evaluations in large, multisite hybrid studies.
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