An mHealth Platform for People With HIV Receiving Care in Washington, District of Columbia: Qualitative Analysis of Stakeholder Feedback.

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.

Caldwell S ，Flickinger T ，Hodges J ，Waldman ALD ，Garofalini C ，Cohn W ，Dillingham R ，Castel A ，Ingersoll K ... -  《-》

Evaluation of the Implementation and Effectiveness of a Mobile Health Intervention to Improve Outcomes for People With HIV in the Washington, DC Cohort: Study Protocol for a Cluster Randomized Controlled Trial.

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.

Hodges J ，Caldwell S ，Cohn W ，Flickinger T ，Waldman AL ，Dillingham R ，Castel A ，Ingersoll K ... -  《JMIR Research Protocols》

A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study.

Opioid use disorder (OUD) is a public health crisis with more than 2 million people living with OUD in the United States. Medication-assisted treatment (MAT) is an evidence-based approach for the treatment of OUD that relies on a combination of behavioral therapy and medication. Less than half of those living with OUD are accessing this treatment. Mobile technology can enhance the treatment of chronic diseases in readily accessible and cost-effective ways through self-monitoring and support. The aim of this study is to describe the adaptation of a mobile platform for patients undergoing treatment for OUD and preliminary pilot testing results. Our study was conducted with patient and provider participants at the University of Virginia MAT clinic and was approved by the institutional review board. The formative phase included semistructured interviews to understand the needs of patients with OUD, providers' perspectives, and opportunities for MAT support via a mobile app. A second round of formative interviews used mock-ups of app features to collect feedback on feature function and desirability. Formative participants' input from 16 interviews then informed the development of a functional smartphone app. Patient participants (n=25) and provider participants (n=3) were enrolled in a 6-month pilot study of the completed platform. Patient app use and usability interviews, including a system usability score and open-ended questions, were completed 1 month into the pilot study. Open-ended responses were analyzed for prevalent themes. Formative interviews resulted in the development of a mobile app, named HOPE, which includes both evidence-based and participant-suggested features. The features included daily prompts for monitoring mood, stress, treatment adherence, and substance use; patient tracking of goals, reminders, and triggering or encouraging experiences; informational resources; an anonymous community board to share support with other patients; and secure messaging for communication between patients and providers. All patient participants engaged with at least one app feature during their first month of pilot study participation, and the daily self-monitoring prompts were the most used. Patients and providers reported high levels of system usability (mean 86.9, SD 10.2 and mean 83.3, SD 12.8, respectively). Qualitative analysis of open-ended usability questions highlighted the value of self-monitoring, access to support through the app, and perceived improvement in connection to care and communication for both patient and provider participants. The use of the HOPE program by pilot participants, high usability scoring, and positive perceptions from 1-month interviews indicate successful program development. By engaging with end users and eliciting feedback throughout the development process, we were able to create an app and a web portal that was highly usable and acceptable to study participants. Further work is needed to understand the program's effect on clinical outcomes, patient linkage, and engagement in care.

Waselewski ME ，Flickinger TE ，Canan C ，Harrington W ，Franklin T ，Otero KN ，Huynh J ，Waldman ALD ，Hilgart M ，Ingersoll K ，Ait-Daoud Tiouririne N ，Dillingham RA ... -  《-》

An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research.

Mobile health (mHealth) apps can provide support to people living with a chronic disease by offering resources for communication, self-management, and social support. PositiveLinks (PL) is a clinic-deployed mHealth app designed to improve the health of people with HIV. In a pilot study, PL users experienced considerable improvements in care engagement and viral load suppression. To promote its expansion to other HIV clinics, we developed an implementation strategy consisting of training resources and on-demand program support. The objective of our study was to conduct an interim analysis of the barriers and facilitators to PL implementation at early adopting sites to guide optimization of our implementation strategy. Semistructured interviews with stakeholders at PL expansion sites were conducted. Analysis of interviews identified facilitators and barriers that were mapped to 22 constructs of the Consolidated Framework for Implementation Research (CFIR). The purpose of the analysis was to identify the facilitators and barriers to PL implementation in order to adapt the PL implementation strategy. Four Ryan White HIV clinics were included. Interviews were conducted with one health care provider, two clinic managers, and five individuals who coordinated site PL activities. Ten common facilitators and eight common barriers were identified. Facilitators to PL implementation included PL's fit with patient and clinic needs, PL training resources, and sites' early engagement with their information technology personnel. Most barriers were specific to mHealth, including access to Wi-Fi networks, maintaining patient smartphone access, patient privacy concerns, and lack of clarity on how to obtain approvals for mHealth use. The CFIR is a useful framework for evaluating mHealth interventions. Although PL training resources were viewed favorably, we identified important barriers to PL implementation in a sample of Ryan White clinics. This enabled our team to expand guidance on identifying information technology stakeholders and procuring and managing mobile resources. Ongoing evaluation results continue to inform improvements to the PL implementation strategy, facilitating PL access for future expansion sites.

Cohn WF ，Canan CE ，Knight S ，Waldman AL ，Dillingham R ，Ingersoll K ，Schexnayder J ，Flickinger TE ... -  《JMIR mHealth and uHealth》

Toward understanding the impact of mHealth features for people with HIV: a latent class analysis of PositiveLinks usage.

PositiveLinks (PL) is a multi-feature smartphone-based platform to improve engagement-in-care and viral suppression (VS) among clinic patients living with HIV. Features include medication reminders, mood/stress check-ins, a community board, and secure provider messaging. Our goal was to examine how PL users interact with the app and determine whether usage patterns correlate with clinical outcomes. Patients (N = 83) at a university-based Ryan White clinic enrolled in PL from June 2016 to March 2017 and were followed for up to 12 months. A subset (N = 49) completed interviews after 3 weeks of enrollment to explore their experiences with and opinions of PL. We differentiated PL members based on 6-month usage of app features using latent class analysis. We explored characteristics associated with class membership, compared reported needs and preferences by class, and examined association between class and VS. The sample of 83 PL members fell into four classes. "Maximizers" used all app features frequently (27%); "Check-in Users" tended to interact only with daily queries (22%); "Moderate All-Feature Users" used all features occasionally (33%); and "As-Needed Communicators" interacted with the app minimally (19%). VS improved or remained high among all classes after 6 months. VS remained high at 12 months among Maximizers (baseline and 12-month VS: 100%, 94%), Check-in Users (82%, 100%), and Moderate All-Feature Users (73%, 94%) but not among As-Needed Communicators (69%, 60%). This mixed-methods study identified four classes based on PL usage patterns that were distinct in characteristics and clinical outcomes. Identifying and characterizing mHealth user classes offers opportunities to tailor interventions appropriately based on patient needs and preferences as well as to provide targeted alternative support to achieve clinical goals.

Canan CE ，Flickinger TE ，Waselewski M ，Tabackman A ，Baker L ，Eger S ，Waldman ALD ，Ingersoll K ，Dillingham R ... -  《-》