A Call for Youth Voice to Support Engagement in Care for 18- to 29-Year Olds Living with HIV in the US South.

Youth with HIV (YWH) face challenges in achieving viral suppression, particularly in the Southern United States, and welcome novel interventions responsive to community needs. The Theory of Planned Behavior (TPB) describes factors that influence behavior change, and the Positive Youth Development (PYD) supports youth-focused program design. We applied TPB and PYD to explore factors supporting care engagement and challenges for YWH in South Texas. We conducted 14 semi-structured interviews with YWH and 7 focus groups with 26 stakeholders informed by TPB, PYD, and themes from a youth advisory board (YAB). The research team and YAB reviewed emerging themes, and feedback-aided iterative revision of interview guides and codebook. Thematic analysis compared code families by respondent type, TPB, and PYD. All study methods were reviewed by the UT Health San Antonio and University Health Institutional Review Boards. Emerging themes associated with care engagement included: varied reactions to HIV diagnosis from acceptance to fear/grief; financial, insurance, and mental health challenges; history of trauma; high self-efficacy; desire for independence; and desire for engagement with clinic staff from their age group. Stakeholders perceived YWH lifestyle, including partying and substance use, as care barriers. In contrast, YWH viewed "partying" as an unwelcome stereotype, and barriers to care included multiple jobs and family responsibilities. Two key themes captured in PYD but not in TPB were the importance of youth voice in program design and structural barriers to care (e.g., insurance, transportation). Based on these findings, we provide critical and relevant guidance for those seeking to design more effective youth-centered HIV care engagement interventions. By considering the perspectives of YWH in program design and incorporating the PYD framework, stakeholders can better align with YWHs' desire for representation and agency. Our findings provide important and relevant guidance for those seeking to design more effective HIV care engagement interventions for YWH.

Assessing efficacy of a web-based smoking cessation tool - QuitAdvisorMD: Protocol for a practice-based, clustered, randomized control trial.

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.

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

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.

Nothing About Us Without Us: Involving Youth Living With HIV in a Virtual Advisory Board.

PURPOSE: We adapted a traditional community advisory board to the needs of youth living with HIV (YLWH), resulting in a virtual, asynchronous, and anonymous youth advisory board (YAB). The YAB's evolution fostered participation during the adaptation of an HIV care mobile health application. METHODS: YAB members, comprised of YLWH in South Texas, engaged in the mobile application's formative evaluation, adaptation, and pilot implementation. We collected feedback via surveys and interviews, analyzed and integrated responses, tracked participation and YAB adaptations, and performed content analysis. RESULTS: Driven by feedback, the YAB evolved from in-person group meetings to the current iteration. We administered five surveys, and YAB members provided feedback on communication preferences; mobile app elements; privacy and confidentiality; and virtual support groups. DISCUSSION: Our adaptive process highlights three primary drivers of innovation: COVID-19 risk reduction, asynchrony, anonymity. Our success in maintaining YAB engagement suggests the adapted model could be employed to support youth input in other contexts.

Development of an mHealth App to Support the Prevention of Sexually Transmitted Infections Among Black Men Who Have Sex With Men Engaged in Pre-exposure Prophylaxis Care in New Orleans, Louisiana: Qualitative User-Centered Design Study.

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.

Effects of an internet-delivered insomnia intervention for older adults: A secondary analysis on symptoms of depression and anxiety.

OBJECTIVE: To test whether an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program for older adults attenuates symptoms of depression and anxiety. METHODS: Adults aged ≥ 55 with insomnia were randomized to SHUTi-OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness; N = 207) or Patient Education (PE; N = 104). Depression and anxiety were assessed (HADS-D and HADS-A, respectively) at baseline, post-assessment, and 6- and 12-month follow-ups. RESULTS: Multilevel modeling of HADS-D showed a condition by time interaction (F[3,779] = 3.23, p = .02): SHUTi-OASIS participants reported lower symptoms than PE at post-assessment. There was no such interaction effect for HADS-A (F[3,779] = 2.12, p = .10). Generalized linear modeling showed no moderation of effects by baseline symptom severity. CONCLUSIONS: Participants randomized to Internet-delivered CBT-I showed stable depression and anxiety across time, while control participants' depressive symptoms briefly increased. CBT-I may help prevent development or worsening of psychological distress among older adults with insomnia. TRIAL REGISTRATION: [Registered at ClinicalTrials.gov; identifier removed for anonymity].

#BingeDrinking-Using Social Media to Understand College Binge Drinking: Qualitative Study.

BACKGROUND: Hazardous drinking among college students persists, despite ongoing university alcohol education and alcohol intervention programs. College students often post comments or pictures of drinking episodes on social media platforms. OBJECTIVE: This study aimed to understand one university's student attitudes toward alcohol use by examining student posts about drinking on social media platforms and to identify opportunities to reduce alcohol-related harm and inform novel alcohol interventions. METHODS: We analyzed social media posts from 7 social media platforms using qualitative inductive coding based on grounded theory to identify the contexts of student drinking and the attitudes and behaviors of students and peers during drinking episodes. We reviewed publicly available social media posts that referenced alcohol, collaborating with undergraduate students to select their most used platforms and develop locally relevant search terms; all posts in our data set were generated by students associated with a specific university. From the codes, we derived themes about student culture regarding alcohol use. RESULTS: In total, 1151 social media posts were included in this study. These included 809 Twitter tweets, 113 Instagram posts, 100 Greekrank posts, 64 Reddit posts, 34 College Confidential posts, 23 Facebook posts, and 8 YouTube posts. Posts included both implicit and explicit portrayals of alcohol use. Across all types of posts reviewed, positive drinking attitudes were most common, followed by negative and then neutral attitudes, but valence varied by platform. Posts that portrayed drinking positively received positive peer feedback and indicate that drinking is viewed by students as an essential and positive part of university student culture. CONCLUSIONS: Social media provide a real-time picture of students' behavior during their own and others' heavy drinking. Posts portray heavy drinking as a normal part of student culture, reinforced by peers' positive feedback on posts. Interventions for college drinking should help students manage alcohol intake in real time, provide safety information during alcohol use episodes, and raise student awareness of web-based privacy concerns and reputation management. Additional interventions for students, alumni, and parents are needed to address positive attitudes about and traditions of drinking.

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.

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.

Communication between patients, peers, and care providers through a mobile health intervention supporting medication-assisted treatment for opioid use disorder.

INTRODUCTION: Our team developed the HOPE app as a clinic-based platform to support patients receiving medication assisted treatment (MAT) for opioid use disorder. We investigated the app's two communication features: an anonymous community message board (CMB) and secure messaging between patients and their clinic team. METHODS: The HOPE (Heal Overcome Persist Endure) app was piloted with patients and MAT providers. Text from the CMB and messaging were downloaded and de-identified. Content analysis was performed using iteratively developed codebooks with team consensus. RESULTS: The pilot study enrolled 28 participants; 25 were "members" (patients) and 3 were providers (physician, nurse, social worker). Of member-generated CMB posts, 45% described the poster's state of mind, including positive and negative emotions, 47% conveyed support and 8% asked for support. Members' secure messages to the team included 52% medical, 45% app-related, and 8% social topics. Provider's messages contained information exchange (90%) and relationship-building (36%). DISCUSSION: Through the CMB, members shared emotions and social support with their peers. Through secure messaging, members addressed medical and social needs with their care team, used primarily for information exchange but also relationship-building. PRACTICE IMPLICATIONS: The HOPE app addresses communication needs for patients in MAT and can support them in recovery.

Six-month outcomes of the HOPE smartphone application designed to support treatment with medications for opioid use disorder and piloted during an early statewide COVID-19 lockdown.

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.

Think-Aloud Testing of a Novel Safer Drinking App for College Students During COVID-19: Usability Study.

BACKGROUND: Hazardous alcohol consumption, and binge drinking in particular, continues to be common among college students, posing the greatest risk for their health and safety. Despite widespread exposure to evidence-based preventive interventions among US undergraduates, only modest and temporary effects on risky drinking occur. Formative studies have demonstrated that students want a more engaging intervention tool for risky drinking that can be used just in time. OBJECTIVE: The purpose of this study is to test the appeal, relevance, and perceived utility of a draft mobile app for safer student drinking at a public university in Virginia. METHODS: Undergraduate student participants tested the draft mobile app via a web-based prototype that tailors to individual feedback with hot spots that responded to their taps to mimic app functionality. They narrated their impressions, navigation, and comments in a standardized think-aloud procedure. After each round of think-aloud interviews, researchers debriefed the investigators and developers to discuss findings and brainstorm app modifications. RESULTS: Minor changes to the functionality and aesthetics would improve usability of the app (eg, option for light mode in app settings). Student testers recommended tailoring the app to the needs of college students and to aspects of the local university's drinking culture. CONCLUSIONS: Findings from this study will be synthesized with information gained from other formative work to determine the final app features. We will test the app in a pilot randomized trial to assess app use and the impact of the app on college student drinking behavior over several months.

Including partners in discussions of sexual side effects from breast cancer: a qualitative study of survivors, partners, and providers.

PURPOSE: Ensuring there are clear standards for addressing cancer-related sexual side effects is important. Currently, there are differences in two leading sets of clinical guidelines regarding the inclusion of survivors' romantic partners into clinical discussions between survivors and their providers about this issue. To help refine guidelines, we examine breast cancer survivor, partner, and oncology provider perspectives about including partners in discussions about cancer-related sexual side effects in a secondary analysis of a broader qualitative study. METHODS: Partnered female breast cancer survivors (N = 29) completed online surveys, and intimate partners of breast cancer survivors (N = 12) and breast oncology providers (N = 8) completed semi-structured interviews. Themes were derived from thematic content analysis. RESULTS: Among survivors who reported a discussion with their provider, fewer than half indicated their partner had been present, despite most survivors expressing it was - or would have been - helpful to include their partner. Partners also largely indicated being included was or would have been helpful, when welcomed by the survivor. Providers similarly emphasized the importance of survivors' autonomy in deciding whether to discuss sexual concerns in the presence of a partner. CONCLUSIONS: Partners were infrequently included in conversations about cancer-related sexual side effects, even though survivors, partners, and providers alike expressed value in these discussions occurring with the couple together - when that is the survivor's preference. Findings suggest future clinical guidelines should emphasize that incorporating partners into clinical discussions about sexual concerns is important for many breast cancer patients. Soliciting and enacting patients' preferences is essential for truly patient-centered care.

South African university women's perspectives on intimate partner violence: a qualitative study of reactions to a tailored vignette.

Intimate partner violence is an ongoing issue in South Africa, which has the highest rates of violence against women and girls in the world. Intimate partner violence is common in Limpopo, where women, including university students, experience elevated rates of violent crime. This qualitative study was conducted to examine university students' perspectives regarding intimate partner violence among their peers. A culturally tailored vignette was used to prompt reflection from 38 female university students in Limpopo. Audiotaped responses to the vignette were transcribed, coded and analysed using thematic analysis. Four main themes were developed from participants' responses to the vignette: cultural beliefs, the university's role in intimate partner violence, likely outcomes of intimate partner violence, and future interventions. Intimate partner violence was seen as a common problem within the university. Students' responses indicated that cultural beliefs perpetuated violence against women, with women entering and remaining in abusive relationships for financial security or resources such as housing. Students also reported lack of adequate on-campus housing options, limited knowledge of intimate partner violence, and few actions to reduce intimate partner violence, all of which placed then at heightened risk of intimate partner violence.

Pilot Randomized Controlled Trial of Motivational Interviewing with Sexual Minority Male Couples to Reduce Drug Use and Sexual Risk: The Couples Health Project.

A randomized controlled trial evaluated the preliminary efficacy of a dyadically-delivered motivational interviewing (MI) intervention to reduce drug use and sexual risk in a sample of 50 sexual minority (cis)male (SMM) couples. In each couple, at least one partner was aged 18-29; reported drug use and sexual HIV transmission risk; and was HIV-negative. Couples were randomized to either the three-session MI intervention or an attention-matched control, with follow-up surveys completed at 3- and 6-months post-baseline. Between-group differences for all outcomes were non-significant in the overall sample. Subsequent moderation analyses indicated the intervention significantly reduced illicit drug use (excluding marijuana) at 3-month follow-up when either respondents (B = - 1.96; interval rate ratio-IRR 0.02-1.22; p = .001), their partners (B = - 2.60; IRR 0.01-0.64; p = .004), or both (B = - 2.38; IRR 0.01-0.80; p = .001) reported high levels of baseline use. The intervention also reduced condomless anal sex (CAS) with casual partners when both partners reported high frequency baseline CAS (B = - 2.54; IRR 0.01-0.83; p = .047). Findings provide initial evidence of the potential for MI to address drug use and sexual risk-taking among SMM couples at highest risk.Trial Registration ClinicalTrials.gov (NIH U.S. National Library of Medicine) Identifier: #NCT03386110.

Development of Motivational Interviewing Treatment Integrity (MITI) Fidelity Codes Assessing Motivational Interviewing with Couples.

This study evaluated preliminary reliability and validity evidence for novel scores that extend the motivational interviewing treatment integrity (MITI) coding system to assess elements unique to motivational interviewing (MI) with couples. We recruited 20 cismale couples where at least one partner was aged 18-29; reported substance use; and was HIV-negative. Couples were randomized to a three-session MI or attention-matched education control. Four coders rated audio-recordings of initial sessions in both conditions. Novel global scores had high nearly-exact percent agreement (Decreasing Dyadic Ambivalence = 100%; Facilitating Dyadic Functioning = 94%). Consistency for novel behavior counts was good (ICCdyadic reflections = .72) and above minimum thresholds (nearly-exact agreement for Relationship Affirmations = 78%). MI sessions generated novel and established MITI codes that were significantly better than education sessions, providing preliminary evidence of validity. Findings provided initial support for the use of these novel scores in future research evaluating MI-based substance use and HIV risk reduction studies with couples.

Liar! Liar! Identifying eligibility fraud by applicants in digital health research.

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.

PositiveLinks and the COVID-19 Response: Importance of Low-Barrier Messaging for PLWH in Non-urban Virginia in a Crisis.

PositiveLinks (PL) is an evidence-based mobile health intervention promoting engagement in care for people living with HIV. PL offers secure, in-app patient-provider messaging. We investigated messaging during the early COVID-19 pandemic, comparing messages exchanged between 01/13/2020 and 03/01/2020 ("Pre-COVID") to messages exchanged between 03/02/2020 and 04/19/2020 ("early COVID") using Poisson regression. We performed qualitative analysis on a subset of messages exchanged between 02/01/2020 and 03/31/2020. Between "Pre-COVID" and "early COVID" periods, weekly member and provider messaging rates increased significantly. Of the messages analyzed qualitatively, most (53.3%) addressed medical topics, and more than a fifth (21.3%) addressed social issues. COVID-related messages often focused on care coordination and risk information; half of COVID messages contained rapport-building. PL patients ("members") and providers used in-app secure messaging to reach out to one another, identifying needs, organizing receipt of healthcare resources, and strengthening patient-care team relationships. These findings underscore the importance of low-barrier messaging during a crisis.

RESUMEN: PositiveLinks (PL) es una intervención de salud móvil basada en evidencia que promueve la participación en la atención de las personas que viven con el VIH. PL ofrece mensajería segura entre paciente y proveedor dentro de la aplicación. Investigamos la mensajería durante la fase temprana de la pandemia de COVID-19, comparando los mensajes intercambiados entre el 13 de enero y el 1 de marzo del 2020 ("pre-COVID") con los mensajes intercambiados entre el 2 de marzo y el 19 de abril del 2020 ("COVID") usando el modelo de regresión de Poisson. Realizamos un análisis cualitativo de un subconjunto de los mensajes intercambiados entre el 1 de febrero y el 31 de marzo del 2020. Entre los períodos "pre-COVID" y "COVID," los índices semanales de mensajes de los miembros y proveedores aumentaron significativamente. De los mensajes analizados cualitativamente, la mayoría (53.3%) abordó temas médicos y más de una quinta parte (21.3%) abordó temas sociales. Los mensajes relacionados con COVID a menudo se centraron en la coordinación de la atención y la información sobre riesgos; la mitad de los mensajes sobre COVID presentó contenido relacionado con el establecimiento de buenas relaciones. Los pacientes de PL ("miembros") y los proveedores utilizaron la mensajería segura dentro de la aplicación para comunicarse entre sí, identificar necesidades, organizar la recepción de recursos de atención médica, y fortalecer las relaciones entre el equipo de atención y el paciente. Este estudio subraya la importancia de facilitar un fácil acceso a la mensajería durante una crisis.

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

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Adapting an m-Health Intervention for Spanish-Speaking Latinx People Living with HIV in the Nonurban Southern United States.

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.

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

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.