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BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/37748.
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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.
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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.
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Introduction: Cannabis sativa has been used for centuries in treating pain. However, the analgesic role of many of its constituents including terpenes is unknown. This research examined the contributions of terpenes (volatile oil) and cannabinoids in cannabis-mediated analgesia in rats. Methods: Animals received intraperitoneal administration of either vehicle, 10.0 or 18.0 mg/kg morphine, or various doses of the extract without terpenes, isolated terpenes, Δ9-tetrahydrocannabinol (THC), or the full extract. Thirty minutes later animals were tested on hotplate and tail-flick tests of thermal nociception. One week later, rats received a second administration of test articles and were tested 30 min later in the abdominal writhing test of inflammatory nociception. Results: In the thermal assays, hotplate and tail-flick latencies for morphine-treated rats were dose dependent and significantly higher than vehicle-treated animals. All the cannabinoid compounds except for the isolated terpenes produced dose-dependent increases in hotplate and tail-flick latencies. In the inflammatory nociceptive assay, animals treated with vehicle and isolated terpenes demonstrated increased abdominal writhing, whereas all the cannabinoid compounds significantly decreased abdominal writhing responses. Conclusions: Overall, THC alone produced robust analgesia equivalent to the full cannabis extract, whereas terpenes alone did not produce analgesia. These data suggest the analgesic activity of cannabis is largely mediated by THC, whereas terpenes alone do not cause alterations in cannabis-mediated analgesia.
