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BACKGROUND Achieving HIV viral suppression and retention in HIV care continue to be challenging for people with HIV (PWH) in the Washington, D.C. area. The PositiveLinks (PL) mobile application has been associated with an increase in retention in care and in viral load suppression rates among rural and suburban people. However, PL has not been tailored or tested for the unique needs of urban PWH. OBJECTIVE To conduct and analysis formative work to tailor a mHealth application for people living with HIV and their clinic providers in the District of Columbia. METHODS We conducted a three-part formative study to guide tailoring of PL for patients in the D.C. Cohort, a longitudinal cohort of over 11,800 PWH receiving care from HIV clinics in Washington, D.C. Studies included in-depth interviews with providers (n=28) at D.C. Cohort study clinics, focus groups with PWH enrolled in the D.C. Cohort (n=32), and a focus group with members of the D.C. Planning Commission on Health and HIV (COHAH) (n=35). Qualitative analysis used a constant comparison iterative approach. Emerging themes were identified and grouped together to inform an adaptation of the PL platform tailored for patients and providers in the D.C. Cohort. RESULTS Emerging themes for patient, D.C. Cohort clinic providers, and COHAH providers included: population needs and concerns, facilitators and barriers of engagement and viral suppression, technology use, anticipated benefits and questions/concerns, and suggestions. D.C. Cohort clinic and COHAH providers had an additional theme, clinic processes. Themes from all groups were reviewed and discussed with the D.C. Cohort study site principal investigators (site PIs). After reviewing the data, site PIs selected core PositiveLinks app features including: daily medication adherence, mood and stress Check-ins, Resources, FAQs, and the Community board. Additionally, PIs wanted both English and Spanish versions depending on site. Two additional app features (Messaging and Documents) were selected as optional for each clinical site. Three features (Labs, Appointments, and Telehealth) were not included for PL in the DC Cohort. CONCLUSIONS Patient and provider perspectives of the PL app had some overlap, but some themes were unique to the view of providers and patients, respectively. Beta testing of the app with DC Cohort-selected features was conducted (August 2022). This formative work prepared investigators and sites for a cluster randomized trial of PL efficacy. Randomization of the clinics to PositiveLinks or Usual Care was completed in August 2022 and the RCT launched in December 2022. CLINICALTRIAL https://clinicaltrials.gov/ct2/show/NCT04998019 INTERNATIONAL REGISTERED REPORT RR2-10.2196/37748

BACKGROUND Sexual health disparities exist for Black men who have sex with men (BMSM) in New Orleans, Louisiana. Rates of sexually transmitted infections (STIs) are high for both BMSM and those taking HIV pre-exposure prophylaxis (PrEP). OBJECTIVE In this study, we introduced an existing PrEP adherence app to new potential users—BMSM engaged in PrEP care in New Orleans—to guide app adaptation with STI prevention features and tailoring for the local context. METHODS Using a user-centered design, we conducted 4 focus group discussions (FGDs), with interim app adaptations from December 2020 to March 2021. During the FGDs, a video of the app, app website, and mock-ups were shown to participants. We asked about facilitators of and barriers to STI prevention in general, current app use, impressions of the existing app, new app features to potentially facilitate STI prevention, and how the app should be tailored for BMSM. We used applied qualitative thematic analysis to identify themes and needs of the population. RESULTS Overall, 4 FGDs were conducted with 24 BMSM taking PrEP. We grouped themes into 4 categories: STI prevention, current app use and preferences, preexisting features and impressions of the prep’d app, and new features and modifications for BMSM. Participants noted concern about STIs and shared that anxiety about some STIs was higher than that for others; some participants shared that since the emergence of PrEP, little thought is given to STIs. However, participants desired STI prevention strategies and suggested prevention methods to implement through the app, including access to resources, educational content, and sex diaries to follow their sexual activity. When discussing app preferences, they emphasized the need for an app to offer relevant features and be easy to use and expressed that some notifications were important to keep users engaged but that they should be limited to avoid notification fatigue. Participants thought that the current app was useful and generally liked the existing features, including the ability to communicate with providers, staff, and each other through the community forum. They had suggestions for modifications for STI prevention, such as the ability to comment on sexual encounters, and for tailoring to the local context, such as depictions of iconic sights from the area. Mental health emerged as an important need to be addressed through the app during discussion of almost all features. Participants also stressed the importance of ensuring privacy and reducing stigma through the app. CONCLUSIONS A PrEP adherence app was iteratively adapted with feedback from BMSM, resulting in a new app modified for the New Orleans context and with STI prevention features. Participants gave the app a new name, PCheck, to be more discreet. Next steps will assess PCheck use and STI prevention outcomes.

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. CLINICALTRIAL ClinicalTrials.gov NCT04998019; https://clinicaltrials.gov/ct2/show/NCT04998019 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/37748

Background Sexual health disparities exist for Black men who have sex with men (BMSM) in New Orleans, Louisiana. Rates of sexually transmitted infections (STIs) are high for both BMSM and those taking HIV pre-exposure prophylaxis (PrEP). Objective In this study, we introduced an existing PrEP adherence app to new potential users—BMSM engaged in PrEP care in New Orleans—to guide app adaptation with STI prevention features and tailoring for the local context. Methods Using a user-centered design, we conducted 4 focus group discussions (FGDs), with interim app adaptations from December 2020 to March 2021. During the FGDs, a video of the app, app website, and mock-ups were shown to participants. We asked about facilitators of and barriers to STI prevention in general, current app use, impressions of the existing app, new app features to potentially facilitate STI prevention, and how the app should be tailored for BMSM. We used applied qualitative thematic analysis to identify themes and needs of the population. Results Overall, 4 FGDs were conducted with 24 BMSM taking PrEP. We grouped themes into 4 categories: STI prevention, current app use and preferences, preexisting features and impressions of the prep’d app, and new features and modifications for BMSM. Participants noted concern about STIs and shared that anxiety about some STIs was higher than that for others; some participants shared that since the emergence of PrEP, little thought is given to STIs. However, participants desired STI prevention strategies and suggested prevention methods to implement through the app, including access to resources, educational content, and sex diaries to follow their sexual activity. When discussing app preferences, they emphasized the need for an app to offer relevant features and be easy to use and expressed that some notifications were important to keep users engaged but that they should be limited to avoid notification fatigue. Participants thought that the current app was useful and generally liked the existing features, including the ability to communicate with providers, staff, and each other through the community forum. They had suggestions for modifications for STI prevention, such as the ability to comment on sexual encounters, and for tailoring to the local context, such as depictions of iconic sights from the area. Mental health emerged as an important need to be addressed through the app during discussion of almost all features. Participants also stressed the importance of ensuring privacy and reducing stigma through the app. Conclusions A PrEP adherence app was iteratively adapted with feedback from BMSM, resulting in a new app modified for the New Orleans context and with STI prevention features. Participants gave the app a new name, PCheck, to be more discreet. Next steps will assess PCheck use and STI prevention outcomes.

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 International Registered Report Identifier (IRRID) PRR1-10.2196/37748

BACKGROUND Linkage to and retention in HIV care are challenging, especially in the Southeastern United States. The rise in mobile phone app use and the potential for an app to deliver just in time messaging provides a new opportunity to improve linkage and retention among people living with HIV (PLWH). OBJECTIVE This study aimed to develop an app to engage, link, and retain people in care. We evaluated the acceptability, feasibility, and impact of the app among users. METHODS App development was informed by principles of chronic disease self-management and formative interviews with PLWH. Once developed, the app was distributed among participants, and usability feedback was incorporated in subsequent iterations. We interviewed app users after 3 weeks to identify usability issues, need for training on the phone or app, and to assess acceptability. We tracked and analyzed usage of app features for the cohort over 2 years. RESULTS A total of 77 participants used the app during the pilot study. The query response rate for the first 2 years was 47.7%. Query response declined at a rate of 0.67% per month. The community message board was the most popular feature, and 77.9% (60/77) of users posted on the board at least once during the 2 years. CONCLUSIONS The PositiveLinks app was feasible and acceptable among nonurban PLWH. High participation on the community message board suggests that social support from peers is important for people recently diagnosed with or returning to care for HIV.