Karen S. Ingersoll

Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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.

BACKGROUND Despite increasing smartphone penetration globally, personalized mobile health (mHealth) care interventions remain largely untapped for support of people with tuberculosis (TB). An evidence-based multi-feature smartphone platform for HIV care tailored and widely implemented in the US may enhance treatment quality and completion in the Kilimanjaro context. OBJECTIVE We aimed to evaluate contextual determinants of mHealth implementation in the Kilimanjaro region to ensure feasibility, acceptability, and effective adaptation of the platform for TB care within Kilimanjaro. METHODS We conducted semi-structured in-depth interviews at Kilimanjaro Christian Medical Centre (KCMC) and Kibong’oto Infectious Diseases Hospital (KIDH) with people with TB (PWTB) (aged 18+ with drug-susceptible/-resistant TB, with/without HIV, and > 1 month on treatment) and providers/staff (e.g. clinicians, community health workers, laboratory staff). Interview guides were designed using Bury’s Framework for Chronic Illness and the Consolidated Framework for Implementation Research (CFIR), along with an overview of an existing smartphone-based program called PositiveLinks. RESULTS We conducted 14 interviews with PWTB and 11 provider/staff interviews. Several unmet TB treatment needs emerged along with suggestions for platform adaptation and implementation strategies. Findings suggest high personal smartphone access among providers/staff (100%), less so for PWTB interviewed (36%). High provider digital literacy/capability and usage was noted, with smartphone apps routinely used for TB care delivery independent of electronic health systems. PWTB primarily used mobile phones for communication (calls) with clinic providers and staff for care coordination (e.g. reminders). Internet access and stability remain a barrier in rural clinics, along with personal cost of data bundles for both stakeholder groups. Key assets identified within the inner setting of KCMC and KIDH include existing provider/staff commitment to treatment support outside of clinic visits, and a robust infrastructure of community outreach for support of adherence and retention for PWTB. CONCLUSIONS Real-world considerations for the context suggest implementation of provider-facing smartphone interventions would be highly feasible and acceptable with appropriate consideration of personal cost associated with usage among stakeholders. Patient-facing or bi-directional 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.

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 or planning hybrid DHI studies is limited. Objective: 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. Methods: 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. 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 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). 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 multisite hybrid studies.

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 tools and assessed provider readiness for implementation with the Organizational Readiness to Implement Change (ORIC) tool. RESULTS Specification of components of the DHI and implementation strategy identified relevant platform usage data and necessary implementer actions, toward planning measurement of program reach and adoption. A priori mapping of implementation strategy steps to the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework identified how data would be collected for each step/corresponding outcome measure. The multi-site cohort study provided infrastructure for prospective, scaled implementation research, with site research assistants (RAs) coordinating implementation. Existing cohort study tools (periodic site assessments, patient consent logs) were adapted for this evaluation to capture representativeness and reach/adoption ‘denominators.’ New survey instruments allowed for framework-guided evaluation of provider adaptations, dose, and fidelity to planned implementation across more participants and 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 Challenges and opportunities arose in planning the implementation evaluation within a hybrid trial among a cohort population. Prospective hybrid 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. CLINICALTRIAL NCT04998019 INTERNATIONAL REGISTERED REPORT RR2-10.2196/37748

Background: Binge drinking, which is linked to various immediate and long-term negative outcomes, is highly prevalent among US college students. Behavioral interventions delivered via mobile phones have a strong potential to help decrease the hazardous effects of binge drinking by promoting safer drinking behaviors. Objective: This study aims to evaluate the preliminary efficacy of bhoos, a novel smartphone app designed to promote safer drinking behaviors among US college students. The app offers on-demand educational content about safer alcohol use, provides dynamic feedback as users log their alcohol consumption, and includes an interactive drink tracker that estimates blood alcohol content in real time. Methods: The bhoos app was tested in 2 independent pre-post studies each lasting 4 weeks, among US college students aged 18‐35 years. The primary outcome in both trials was students’ self-reported confidence in using protective behavioral strategies related to drinking, with self-reported frequency of alcohol consumption over the past month examined as a secondary outcome. Results: In study 1, bhoos was associated with increased confidence in using protective behavioral strategies. Students also endorsed the high usability of the app and reported acceptable levels of engagement. Study 2 replicated findings of increased confidence in using protective behavioral strategies, and demonstrated a reduction in the self-reported frequency of alcohol consumption. Conclusions: Bhoos is a personalized, accessible, and highly scalable digital intervention with a strong potential to effectively address alcohol-related behaviors on college campuses.

Background: Young adults living with HIV are less likely to engage in care and achieve viral suppression, compared to other age groups. Young adults living with HIV also have a high degree of self-efficacy and willingness to adopt novel care modalities, including mobile health (mHealth) interventions. Interventions to increase care engagement could aid young adults living with HIV in overcoming structural and social barriers and leveraging youth assets to improve their health outcomes. Objective: The objective of the paper was to use an assets-based framework, positive youth development, and human-centered design principles to adapt an existing mHealth intervention, PositiveLinks (PL), to support care engagement for 18‐ to 29-year-olds with HIV. Methods: We conducted a formative evaluation including semistructured interviews with 14 young adults with HIV and focus groups with 26 stakeholders (providers, nurses, case managers, and clinic staff). Interviews covered barriers to care, provider communication, and concerns or suggestions about mHealth interventions. The research team used thematic analysis to review interview transcripts. In the second phase, human-centered design processes informed adaptation of the existing PL platform using data from real-time use suggestions of 3 young adults with HIV. Throughout the formative evaluation and adaptation, a Youth Advisory Board (YAB) provided input. Results: Young adults with HIV and stakeholders identified common elements of an mHealth intervention that would support care engagement including: the convenience of addressing needs through the app, online support groups to support interconnection, short videos or live chats with other young adults with HIV or providers, appointment and medication reminders, and medical information from a trustworthy source. Stakeholders also mentioned the need for youth empowerment. Concerns included worries about confidentiality, unintentional disclosures of status, urgent content in an unmoderated forum, and the impersonality of online platforms. Design suggestions from young adults with HIV included suggestions on appearance, new formatting for usability of the online support group, and prioritization of local content. Based on the feedback received, iterative changes were made to transform PL into Positive Links for Youth (PL4Y). Final votes on adaptations were made by the YAB. The overall appearance of the platform was changed, including logo, color, and font. The online support group was divided into 3 channels which support hashtags and content searches. The “Resources” and “Frequently Asked Questions” sections were condensed and revised to prioritize South Texas–specific content. Conclusions: Our assets-based framework supported young adults with HIV and stakeholder input in the transformation of an mHealth intervention to meet the needs of 18- to 29-year-olds in South Texas. The human-centered design approach allowed young adults with HIV to suggest specific changes to the intervention’s design to support usability and acceptability. This adapted version, PL4Y, is now ready for pilot testing in the final phase of this implementation science project.

By consistently taking medication, people with HIV (PWH) can attain viral suppression, improving their health and reducing transmission risk. PositiveLinks (PL) is a clinic-deployed mobile platform designed to improve engagement in care for PWH by enabling them to track their medications, connect with peers, and communicate with providers. This project investigated the experience of PL users who had recent periods of viral non-suppression to understand how these high-risk episodes can be predicted and prevented. Fifteen participants completed mental health measures and in-depth interviews. Two members of the study team independently coded interview transcripts and resolved any discrepancies. The codebook was developed iteratively until thematic saturation and intercoder reliability were achieved. Participants revealed mental health and substance use concerns. Frequent stressors highlighted were relationship challenges, financial difficulties, and unstable living situations. Relationship challenges were a common barrier to care, along with competing priorities, transportation and finances. In contrast, positive relationships, motivation, positive interactions with clinic staff, and social programs facilitated regaining viral suppression. Participants highlighted the importance of strong patient-provider relationships and social support in overcoming barriers to care. We identified factors that impact medication adherence, which will inform efforts to mitigate and prevent viral non-suppression and thus improve health outcomes.

In HIV care, a strong rapport between patient and provider is essential for strengthening trust, enhancing therapy adherence, and ultimately leading to improved health outcomes. As the adoption of digital interactions in HIV care via mobile health (mHealth) tools is emerging, maintaining rapport in these asynchronous text-based communications becomes a critical yet challenging task. In this paper, we analyze 1,740 messages from an mHealth platform, categorized by experienced clinicians as either ‘rapport-building’ or ‘information-only.’ We utilize linguistic analysis to uncover key attributes of rapport-building communication. This led to a set of machine learning (ML) models and Large Language Models (LLMs) capable of classifying these communication styles. Further, we propose the application of LLMs not only to identify but also to actively rewrite ‘information only’ messages into versions that enhance rapport building without compromising information integrity. Our research demonstrates potential advancements in HIV mHealth communication by integrating linguistic analysis with language models, leading to more effective patient-provider interactions.

Background: Cancer caregivers are more likely to report clinically significant symptoms of insomnia than patients with cancer and the general population, yet research has been limited regarding cognitive-behavioral therapy for insomnia (CBT-I) among this population. Methods: To better understand cancer caregivers' engagement with and benefit from CBT-I, cancer caregivers were enrolled in a nonrandomized pilot feasibility trial of an evidence-based Internet-delivered insomnia program. Thirteen caregivers completed mixed-methods assessments before receiving the insomnia program and after the nine-week intervention period. Results: Compared with the five caregivers who did not complete any intervention Cores, the eight caregivers who completed at least one of the intervention Cores tended to report more sleep impairment (insomnia symptom severity; minutes of sleep onset latency and wake after sleep onset), less physical and emotional strain from caregiving, and less maladaptive sleep beliefs at the baseline assessment. These caregivers who used the program also showed large improvements in their insomnia symptoms. Caregivers' qualitative feedback about their experience with the program identified potential areas that might be modified to improve caregivers' engagement with and benefit from Internet-delivered insomnia programs. Conclusions: Findings suggest that family cancer caregivers can use and benefit from a fully automated Internet-delivered CBT-I program, even without caregiving-specific tailoring. Further rigorous research is needed to better understand whether and how program modifications may allow more caregivers to initiate and engage with this program.