Background: Gaps remain in achieving retention in care and durable HIV viral load suppression for people with HIV in Washington, DC (hereafter DC). Although people with HIV seeking care in DC have access to a range of supportive services, innovative strategies are needed to enhance patient engagement in this setting. Mobile health (mHealth) interventions have shown promise in reaching previously underengaged groups and improving HIV-related outcomes in various settings. Objective: This study will evaluate the implementation and effectiveness of a clinic-deployed, multifeature mHealth intervention called PositiveLinks (PL) among people with HIV enrolled in the DC Cohort, a longitudinal cohort of people with HIV receiving care in DC. A cluster randomized controlled trial will be conducted using a hybrid effectiveness-implementation design and will compare HIV-related outcomes between clinics randomized to PL versus usual care. Methods: The study aims are threefold: (1) We will perform a formative evaluation of PL in the context of DC Cohort clinics to test the feasibility, acceptability, and usability of PL and tailor the platform for use in this context. (2) We will conduct a cluster randomized controlled trial with 12 DC Cohort clinics randomized to PL or usual care (n=6 [50%] per arm) and measure the effectiveness of PL by the primary outcomes of patient visit constancy, retention in care, and HIV viral load suppression. We aim to enroll a total of 482 participants from DC Cohort clinic sites, specifically including people with HIV who show evidence of inconsistent retention in care or lack of viral suppression. (3) We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to measure implementation success and identify site, patient, provider, and system factors associated with successful implementation. Evaluation activities will occur pre-, mid-, and postimplementation. Results: Formative data collection was completed between April 2021 and January 2022. Preliminary mHealth platform modifications have been performed, and the first round of user testing has been completed. A preimplementation evaluation was performed to identify relevant implementation outcomes and design a suite of instruments to guide data collection for evaluation of PL implementation throughout the trial period. Instruments include those already developed to support DC Cohort Study activities and PL implementation in other cohorts, which required modification for use in the study, as well as novel instruments designed to complete data collection, as guided by the CFIR and RE-AIM frameworks. Conclusions: Formative and preimplementation evaluations will be completed in spring 2022 when the trial is planned to launch. Specifically, comprehensive formative data analysis will be completed following data collection, coding, preliminary review, and synthesis. Corresponding platform modifications are ready for beta testing within the DC Cohort. Finalization of the platform for use in the trial will follow beta testing. Trial Registration: ClinicalTrials.gov NCT04998019; https://clinicaltrials.gov/ct2/show/NCT04998019
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 designing/planning hybrid 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 implementation evaluation 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 tools and assessed provider readiness for implementation with the Organizational Readiness to Implement Change (ORIC) tool. Results: We specified DHI and implementation strategy toward planning measurement of DHI and broader program reach and adoption. Mapping of implementation strategy steps to the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework prompted considerations for how to capture understudied aspects of each dimensions: denominators and demographic representativeness within reach/adoption, and provider/organization-level adaptations, dose, and fidelity within the implementation dimension. Our process also prompted creation of tools to obtain detailed determinants across domains and constructs of the Consolidated Framework for Implementation Research (CFIR) within a large sample at multiple timepoints. Some aspects of real-world PositiveLinks implementation were not reflected within the planned hybrid trial (e.g. RAs selected as de facto site implementation leads) or were modified to preserve internal validity of effectiveness measurement (e.g. ‘Community of Practice’). Providers and RAs (n=17) at intervention sites self-reported high baseline usage of digital tools to communicate with patients. Readiness assessment revealed high median total ORIC scores (48; IQR: 45-54), with RAs scoring higher than physicians (52.5 vs 48.0). Conclusions: Key takeaways, challenges and opportunities arose in planning the implementation evaluation within a hybrid DHI trial among a cohort population. Prospective trial planning must balance generalizability of implementation processes to ‘real world’ conditions with rigorous procedures to measure intervention effectiveness. Rapid, scalable tools require further study to enable evaluations within large multi-site hybrid studies. Clinical Trial: ClinicalTrials.gov NCT04998019; https://clinicaltrials.gov/study/NCT04998019