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Background: Smoking remains the leading cause of preventable death, yet physicians inconsistently provide best-practices cessation advice to smokers. Point-of-care digital health tools can prompt and assist physicians to provide improved smoking cessation counseling. QuitAdvisorMD is a comprehensive web-based counseling and management digital health tool designed to guide smoking cessation counseling at the point-of-care. The tool enables clinicians to assess patient readiness to change and then deliver stage-appropriate interventions, while also incorporating Motivational Interviewing techniques. We present the research protocol to assess the efficacy of QuitAdvisorMD to change frequency and quality of smoking cessation counseling and its effect on patient quit rates. Methods: A practice-based, clustered, randomized controlled trial will be used to evaluate QuitAdvisorMD. Cluster design will be used where patients are clustered within primary care practices and practices will be randomized to either the intervention (QuitAdvisorMD) or control group. The primary outcome is frequency and quality of clinician initiated smoking cessation counseling. Secondary outcomes include, 1) changes in physician knowledge, skills and perceived self-efficacy in providing appropriate stage-based smoking cessation counseling and 2) patient quit attempts. Analyses will be conducted to determine pre- and post-test individual clinician outcomes and between intervention and control group practices for patient outcomes. Conclusion: Results from this study will provide important insights regarding the ability of an integrated, web-based counseling and management tool (QuitAdvisorMD) to impact both the quality and efficacy of smoking cessation counseling in primary care settings.

BackgroundHIV 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. ObjectiveThis study aimed to inform the tailoring of a mobile health app to the needs of people with HIV and their providers in Washington, DC. MethodsWe 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. ResultsEmerging 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. ConclusionsPatient 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

Abstract Background Morbidity and mortality related to opioid use disorder (OUD) in the U.S. is at an all-time high. Innovative approaches are needed to address gaps in retention in treatment with medications for opioid use disorder (MOUD). Mobile health (mHealth) approaches have shown improvement in engagement in care and associated clinical outcomes for a variety of chronic diseases, but mHealth tools designed specifically to support patients treated with MOUD are limited. Methods Following user-centered development and testing phases, a multi-feature smartphone application called HOPE (Heal. Overcome. Persist. Endure) was piloted in a small cohort of patients receiving MOUD and at high risk of disengagement in care at an office-based opioid treatment (OBOT) clinic in Central Virginia. Outcomes were tracked over a six-month period following patient enrollment. They included retention in care at the OBOT clinic, usage of various features of the application, and self-rated measures of mental health, substance use, treatment and recovery. Results Of the 25 participants in the HOPE pilot study, a majority were retained in care at 6 months (56%). Uptake of bi-directional features including messaging with providers and daily check-ins of mood, stress and medication adherence peaked at one month, and usage persisted through the sixth month. Patients who reported that distance to clinic was a problem at baseline had higher loss to follow up compared to those without distance as a reported barrier (67% vs 23%, p = 0.03). Patients lost to in-person clinic follow up continued to engage with one or more app features, indicating that mHealth approaches may bridge barriers to clinic visit attendance. Participants surveyed at baseline and 6 months (N = 16) scored higher on scales related to overall self-control and self-efficacy related to drug abstinence. Conclusions A pilot study of a novel multi-feature smartphone application to support OUD treatment showed acceptable retention in care and patient usage at 6 months. Further study within a larger population is needed to characterize ‘real world’ uptake and association with outcomes related to retention in care, relapse prevention, and opioid-associated mortality.

BackgroundSexual 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). ObjectiveIn 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. MethodsUsing 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. ResultsOverall, 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. ConclusionsA 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: Latinx people in the United States are disproportionately diagnosed with HIV and are more likely to experience worse HIV-related health outcomes. Although m-health has demonstrated success in improving HIV care, a gap remains in the development of m-health platforms tailored to Latinx populations. Methods: We conducted formative study to guide the adaptation of an evidence-based m-health intervention, PositiveLinks (PL), for Spanish-speaking Latinx people living with HIV (PLWH). Spanish-speaking Latinx PLWH in the nonurban Southern United States completed semistructured interviews and viewed a demo version of the m-health intervention. Qualitative analysis was performed using a grounded theory approach. Emerging themes were identified in four topic areas: (1) prior experiences with technology, (2) desired m-health features, (3) experiences with prototype app, and (4) iteration of prototype. Results: All PLWH who participated (n?=?22) were born outside the continental United States. Participants included 10 men, 10 women, and 2 transgender participants. Mean age was 41.1 years (standard deviation 11.6 years). Participants expressed concerns about privacy, a need for reliable information, and interest in practical m-health features such as appointment and medication reminders. After trialing the Spanish-language PL prototype, participants reported that peer support and positive reinforcement were strong motivators to use the app. The ability to individualize the app to meet one's own needs was also considered important. Conclusion: This formative study provides baseline attitudes about m-health among Latinx PLWH as well as desired m-health features. m-Health interventions are acceptable to Spanish-speaking PLWH and involving the target population in a user-centered formative process led to improvements in app accessibility and usability.

BackgroundGaps 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. ObjectiveThis 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. MethodsThe 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. ResultsFormative 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. ConclusionsFormative 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 RegistrationClinicalTrials.gov NCT04998019; https://clinicaltrials.gov/ct2/show/NCT04998019 International Registered Report Identifier (IRRID)PRR1-10.2196/37748

Online studies enable researchers to recruit large, diverse samples, but the nature of these studies provides an opportunity for applicants to misrepresent themselves to increase the likelihood of meeting eligibility criteria for a trial, particularly those that provide financial incentives. This study describes rates of fraudulent applications to an online intervention trial of an Internet intervention for insomnia among older adults (ages ≥55). Applicants were recruited using traditional (e.g., flyers, health providers), online (e.g., Craigslist, Internet searches), and social media (e.g., Facebook) recruitment methods. Applicants first submitted an interest form that included identifying information (name, date of birth, address). This data was then queried against a national database (TransUnion's TLOxp) to determine the application's verification status. Applications were determined to be verified (i.e., information from interest form matched TLOxp report), potentially fraudulent (i.e., potential discrepancy in provided information on interest form versus TLOxp report), or fraudulent (i.e., confirmed discrepancy). Of 1766 total interest forms received, 125 (7.08%) were determined to be fraudulent. Enrollment attempts that were fraudulent were detected among 12.22% of applicants who reported learning of the study through online, 7.04% through social media, 4.58% through traditional, and 4.27% through other methods. Researchers conducting online trials should take precautions, as applicants may provide fraudulent information to gain access to their studies. Reviewing all applications and verifying the identities and eligibility of participants is critical to the integrity of online research trials.

BACKGROUND:PositiveLinks (PL) is a smartphone-based platform designed in partnership with people living with HIV (PLWH) to improve engagement in care. PL provides daily medication reminders, check-ins about mood and stress, educational resources, a community message board, and an ability to message providers. The objective of this study was to evaluate the impact of up to 24 months of PL use on HIV viral suppression and engagement in care and to examine whether greater PL use was associated with improved outcomes. SETTING:This study occurred between September 2013 and March 2017 at a university-based Ryan White HIV clinic. METHODS:We assessed engagement in care and viral suppression from study baseline to the 6-, 12-, 18- and 24-month follow-up time periods and compared trends among high vs. low PL users. We compared time to viral suppression, proportion of days virally suppressed, and time to engagement in care in patients with high vs. low PL use. RESULTS:127 patients enrolled in PL. Engagement in care and viral suppression improved significantly after 6 months of PL use and remained significantly improved after 24 months. Patients with high PL use were 2.09 (95% CI 0.64-6.88) times more likely to achieve viral suppression and 1.52 (95% CI 0.89-2.57) times more likely to become engaged in care compared to those with low PL use. CONCLUSION:Mobile technology, such as PL, can improve engagement in care and clinical outcomes for PLWH. This study demonstrates long-term acceptability of PL over two years and provides evidence for long-term improvement in engagement in care and viral suppression associated with PL use.

Background: Recruiting a hidden population, such as the population of women at risk for alcohol-exposed pregnancy (AEP) who binge drink and are at risk of an unintended pregnancy, is challenging as this population is not typically seeking help or part of an identifiable group. We sought to identify affordable and efficient methods of recruitment for hidden populations. Methods: Several popular online social media and advertising sites were identified. Cities with high rates of binge drinking among women were targeted. We placed advertisements and study notices using Facebook, Twitter, Craigslist, University postings, and ClinicalTrials.gov. Results: For this study, 75 women at risk for AEP were recruited from across the U.S. within 7 months. Online advertising for study participants on Craigslist resulted in enrollment of the majority 51 (68%) of the study participants. While Craigslist advertising could be tailored to specific locations with high rates of binge drinking among women, there were challenges to using Craigslist. These included automated deletion due to repeated postings and mention of sexual behavior or drinking, requiring increased efforts and resources by the study team. Several strategies were developed to optimize advertising on Craigslist. Approximately 100 h of staff time valued at $2500 was needed over the 7-month recruitment period. Discussion: Despite challenges, the target sample of women at risk for AEP was recruited in the 7 month recruitment period using online advertising methods. We recommend that researchers consider online classified advertisements when recruiting from non-help seeking populations. By taking advantage of national data to target specific risk factors, and by tailoring advertising efforts, it is possible to efficiently and affordably recruit a non-treatment seeking sample.