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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 or planning hybrid DHI studies is limited. This study 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 pretrial organizational readiness assessment. We planned a cluster-randomized, type II hybrid effectiveness-implementation trial testing PositiveLinks, a smartphone app 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 tool. 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 framework prompted considerations for how to capture understudied aspects of each dimension: denominators and demographic representativeness within reach or adoption, and provider or organization-level adaptations, dose, and fidelity within the implementation dimension. Our process also prompted the creation of tools to obtain detailed determinants across domains and constructs of the Consolidated Framework for Implementation Research within a large sample at multiple time points. Some aspects of real-world PositiveLinks implementation were not reflected within the planned hybrid trial (eg, research assistants selected as de facto site implementation leads) or were modified to preserve internal validity of effectiveness measurement (eg, \"Community of Practice\"). Providers and research assistants (n=17) at intervention sites self-reported high baseline use of digital tools to communicate with patients. Readiness assessment revealed high median (48, IQR 45-54) total Organizational Readiness to Implement Change scores, with research assistants scoring higher than physicians (52.5, IQR 44-55 vs 48.0, IQR 46-49). 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 multisite hybrid studies.

Background Morbidity and mortality related to opioid use disorder (OUD) in the U.S. is at an all-time high. Innovative approaches are needed to address gaps in retention in treatment with medications for opioid use disorder (MOUD). Mobile health (mHealth) approaches have shown improvement in engagement in care and associated clinical outcomes for a variety of chronic diseases, but mHealth tools designed specifically to support patients treated with MOUD are limited. Methods Following user-centered development and testing phases, a multi-feature smartphone application called HOPE (Heal. Overcome. Persist. Endure) was piloted in a small cohort of patients receiving MOUD and at high risk of disengagement in care at an office-based opioid treatment (OBOT) clinic in Central Virginia. Outcomes were tracked over a six-month period following patient enrollment. They included retention in care at the OBOT clinic, usage of various features of the application, and self-rated measures of mental health, substance use, treatment and recovery. Results Of the 25 participants in the HOPE pilot study, a majority were retained in care at 6 months (56%). Uptake of bi-directional features including messaging with providers and daily check-ins of mood, stress and medication adherence peaked at one month, and usage persisted through the sixth month. Patients who reported that distance to clinic was a problem at baseline had higher loss to follow up compared to those without distance as a reported barrier (67% vs 23%, p = 0.03). Patients lost to in-person clinic follow up continued to engage with one or more app features, indicating that mHealth approaches may bridge barriers to clinic visit attendance. Participants surveyed at baseline and 6 months (N = 16) scored higher on scales related to overall self-control and self-efficacy related to drug abstinence. Conclusions A pilot study of a novel multi-feature smartphone application to support OUD treatment showed acceptable retention in care and patient usage at 6 months. Further study within a larger population is needed to characterize ‘real world’ uptake and association with outcomes related to retention in care, relapse prevention, and opioid-associated mortality.

Despite increasing smartphone penetration worldwide, personalized mHealth (mobile health) care interventions remain largely untapped for the support of people with tuberculosis. An evidence-based multifeature smartphone platform for HIV care tailored and widely implemented in the United States may enhance treatment quality and completion in the Kilimanjaro context. We aimed to evaluate contextual determinants of mHealth implementation in the Kilimanjaro region to ensure feasibility, acceptability, and effective adaptation of the platform for tuberculosis care within Kilimanjaro. We conducted semistructured in-depth interviews at Kilimanjaro Christian Medical Centre and Kibong'oto Infectious Diseases Hospital with people with tuberculosis (aged 18+ years with drug-susceptible/-resistant tuberculosis, with or without HIV, and >1 mo on treatment) and providers and staff (eg, clinicians, community health workers, or laboratory staff). Interview guides were designed using Bury's Framework for Chronic Illness and the Consolidated Framework for Implementation Research, along with an overview of an existing smartphone-based program called PositiveLinks. Interviews were analyzed using thematic analysis, and determinants were mapped to behavior change frameworks to develop a mechanistic understanding of P adaptation for the context. We conducted 14 interviews with people with tuberculosis and 11 provider and staff interviews. Several unmet tuberculosis treatment needs emerged, along with suggestions for platform adaptation and implementation strategies. Findings suggest high personal smartphone access among providers and staff (11/11, 100%), less so for people with tuberculosis interviewed (5/14, 36%). High provider digital literacy and capability and usage were noted, with smartphone apps routinely used for tuberculosis care delivery independent of electronic health systems. People with tuberculosis primarily used mobile phones for communication (calls) with clinic providers and staff for care coordination (eg, reminders). Internet access and stability remain major barriers in rural clinics, along with the personal cost of data bundles for both stakeholder groups. Key assets identified within the inner setting of Kilimanjaro Christian Medical Centre and Kibong'oto Infectious Diseases Hospital include existing provider and staff commitment to treatment support outside of clinic visits, and a robust infrastructure of community outreach for support of adherence and retention for people with tuberculosis. Findings suggest a role for broader digital wraparound support beyond adherence monitoring for tuberculosis care in the context. Real-world considerations for the context suggest implementation of provider-facing smartphone interventions was perceived as highly feasible and acceptable, with appropriate consideration of personal cost associated with usage among stakeholders. Patient-facing or bidirectional tools would require modifications to existing mHealth implementation strategies, including more comprehensive assessment of digital literacy and related training, as well as provision of subsidized devices and data bundles.

ObjectivesWe developed and tested a mobile health-based programme to enhance integration of HIV and tuberculosis (TB) care and to promote a patient-centred approach in a region of high coinfection burden. Phases of programme development included planning, stakeholder interviews and platform re-build, testing and iteration.SettingIn Irkutsk, Siberia, HIV/TB coinfection prevalence is high relative to the rest of the Russian Federation.ParticipantsPilot testing occurred for a cohort of 60 people with HIV and TB.ResultsKey steps emerged to ensure the mobile health-based programme could be operational and adequately adapted for the context, including platform language adaptation, optimisation of server management, iteration of platform features, and organisational practice integration. Pilot testing of the platform rebuild yielded favourable patient perceptions of usability and acceptability at 6 months (n=47 surveyed), with 18 of 20 items showing scores above 4 (on a scale from 1 to 5) on average. Development of this mobile health-based programme for integrated care of infections highlighted the importance of several considerations for tailoring these interventions contextually, including language adaptation and technological capacity, but also, importantly, contextualised patient preferences related to privacy and communication with peers and/or providers, existing regional capacity for care coordination of different comorbidities, and infection severity and treatment requirements.ConclusionsOur experience demonstrated that integration of care for TB and HIV can be well served by using multimodal mobile health-based programmes, which can enhance communication and streamline workflow between providers across multiple collaborating institutions and improve continuity between inpatient and outpatient care settings. Further study of programme impact on contextual disease-related stigma and social isolation as well as evaluation of implementation on a broader scale for HIV care is currently under way.Trial registration numberNCT03819374.

Gradenigo’s syndrome (GS) classically involves a triad of ear pain due to acute or chronic otitis media (OM), facial or retro-orbital pain in the distribution of the trigeminal nerve, and an abducens nerve palsy. The simultaneous presentation of all three components has become less common in cases of GS reported in the literature, particularly in the era of antibiotics effective against typical organisms attributed to OM and petrous apicitis. In addition to infectious petrous apicitis arising directly from OM, more recent cases of GS are attributed to the compression of the same traversing cranial nerves in the presence of various expansile petrous apex (PA) lesions, both benign and malignant. We report a case of a 24-year-old male who presented initially with nausea, fever, photophobia, left-sided retro-orbital pain, and headache. He was diagnosed with bacterial meningitis by lumbar puncture and treated with empiric antibiotics, with CSF eventually revealing nontypeable Haemophilus influenzae. Several days into his course, he developed diplopia with leftward gaze. Brain imaging revealed an expansile, erosive PA cholesterol granuloma with associated contiguous dural and leptomeningeal enhancement. The patient improved with antibiotics and eventually underwent surgical intervention. This atypical presentation of GS with a rare complication of meningitis in the setting of a PA granuloma demonstrates the importance of early recognition of this syndrome, as well as consideration of added surgical intervention in patients with pre-existing petrous lesions at potentially higher risk of dangerous complications of GS.

HIV viral suppression and retention in care continue to be challenging goals for people with HIV in Washington, District of Columbia (DC). The PositiveLinks mobile app is associated with increased retention in care and viral load suppression in nonurban settings. The app includes features such as daily medication reminders, mood and stress check-ins, an anonymized community board for peer-to-peer social support, secure messaging to care teams, and resources for general and clinic-specific information, among other features. PositiveLinks has not been tailored or tested for this distinct urban population of people with HIV. This study aimed to inform the tailoring of a mobile health app to the needs of people with HIV and their providers in Washington, DC. We conducted a 3-part formative study to guide the tailoring of PositiveLinks for patients in the DC Cohort, a longitudinal cohort of >12,000 people with HIV receiving care in Washington, DC. The study included in-depth interviews with providers (n=28) at study clinics, focus groups with people with HIV enrolled in the DC Cohort (n=32), and a focus group with members of the DC Regional Planning Commission on Health and HIV (COHAH; n=35). Qualitative analysis used a constant comparison iterative approach; thematic saturation and intercoder agreement were achieved. Emerging themes were identified and grouped to inform an adaptation of PositiveLinks tailored for patients and providers. Emerging themes for patients, clinic providers, and COHAH providers included population needs and concerns, facilitators and barriers to engagement in care and viral suppression, technology use, anticipated benefits, questions and concerns, and suggestions. DC Cohort clinic and COHAH provider interviews generated an additional theme: clinic processes. For patients, the most commonly discussed potential benefits included improved health knowledge and literacy (mentioned n=10 times), self-monitoring (n=7 times), and connection to peers (n=6 times). For providers, the most common anticipated benefits were improved communication with the clinic team (n=21), connection to peers (n=14), and facilitation of self-monitoring (n=11). Following data review, site principal investigators selected core PositiveLinks features, including daily medication adherence, mood and stress check-ins, resources, frequently asked questions, and the community board. Principal investigators wanted English and Spanish versions depending on the site. Two additional app features (messaging and documents) were selected as optional for each clinic site. Overall, 3 features were not deployed as not all participating clinics supported them. Patient and provider perspectives of PositiveLinks had some overlap, but some themes were unique to each group. Beta testing of the tailored app was conducted (August 2022). This formative work prepared the team for a cluster randomized controlled trial of PositiveLinks' efficacy. Randomization of clinics to PositiveLinks or usual care occurred in August 2022, and the randomized controlled trial launched in November 2022. RR2-10.2196/37748.

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. 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. 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. 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. 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. ClinicalTrials.gov NCT04998019; https://clinicaltrials.gov/ct2/show/NCT04998019. PRR1-10.2196/37748.

Highly efficacious direct acting antiviral (DAA) therapy for treatment of Hepatitis C Virus (HCV) infection is largely inaccessible to communities facing a shortage of available specialist providers. Though less demanding than previous interferon regimens, DAA therapy requires patients to adhere to 8–12 weeks of daily treatment, which can be challenging for some patient populations. Duffy Health Center, located on Cape Cod, Massachusetts, provides integrated medical, mental health and case management services to people who are homeless or at risk for homelessness. The goal of this manuscript is to evaluate the outcomes of treatment of HCV infection with a shared medical appointment (SMA) model. The primary outcome was sustained virologic response (SVR-12), or HCV RNA ≤ 15 IU/mL at 12 weeks post-treatment. There were 102 patients recruited, with a total of 104 treatments administered. Over three-fourths of patients who attended one SMA visit (78 of 102) continued in SMA for the duration of treatment. Of these patients opting for SMA, 99% (77 of 78) completed the full treatment course, and 91% (71 of 78) of SMA patients achieved SVR-12. DAA therapy provided by non-specialist providers using the SMA model yielded comparable response rates to those achieved by specialist providers, and has the potential to substantially increase access to HCV treatment for patient populations within high-risk communities.