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 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 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 in New Orleans, Louisiana to guide app adaptation with STI prevention features and tailoring for the local context. METHODS Four FGDs were conducted with 24 BMSM taking PrEP. We grouped themes into four categories: STI prevention, app preferences, impressions of the app prototype, and adaptations. Participants desired STI prevention strategies and suggested prevention methods to implement through the app. They emphasized the need for an app to offer relevant features and be easy-to-use. Participants thought the current app was useful and generally liked the existing features. They had suggestions for modifications for STI prevention, such as the ability to track and comment on sexual encounters, and for tailoring to the local context, such as depictions of iconic sights from the area. Participants also stressed the importance of ensuring privacy and reducing stigma through the app. RESULTS Four FGDs were conducted with 24 BMSM taking PrEP. Themes are grouped into four categories: STI prevention, app preferences, impressions of the app prototype, and adaptations. Participants desired STI prevention strategies and suggested prevention methods to implement through the app. They emphasized the need for an app to offer relevant features and be easy-to-use. Participants thought the current app was useful and generally liked the existing features. They had suggestions for modifications for STI prevention, such as the ability to track and comment on sexual encounters, and for tailoring to the local context, such as depictions of iconic sights from the area. 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 Black MSM, resulting in a new app modified for the New Orleans context and with STI prevention features. Next steps will assess usage and STI prevention outcomes.
Purpose of Review The purpose of this review is to outline the Virginia Hepatitis Education and Patient Connection. Referral on Release (HEPC-RoR. This program for increasing access to treatment for hepatitis C for those recently released from incarceration, including first-year outcomes, quality improvement practices that were implemented post first year, and second year program data. Using this information, we hope to inform organizations attempting to implement similar programs of potential challenges and corresponding solutions. Alternatively, we hope to share potential program designs for organizations that have identified a need for programs to support linkage to care for those recently released from incarcerated. Recent Findings After analyzing first-year program data, we identified areas for improvement. Based on these findings, the team implemented new processes. After a review of the second-year data, we found significant improvement in clinical data, program workflow, and data quality from the previous year. A change in workflow allowed us to collect additional correct contact data, connect more patients to care and ultimately to cure their hepatitis C. Our database, which was redesigned following year one, provided formatting changes allowing for expedited data extraction and review. The process between facilities also improved, streamlining efforts and alleviating some strain associated with limited staffing. Summary Following the review of first-year HEPC-RoR data, program strengths and weaknesses were identified, and a quality improvement plan was developed to addresses areas of need. Changes included more frequent and varied outreach, follow-ups to community partners for confirmation of appointments and lab results, and a redesigned database for more comprehensive data collection. Second-year program data found significant clinical outcomes, such as an 86.7% linkage to care rate and a 23.5% cure rate, and improved referral and database quality.
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