Allison Vorderstrasse

Background: Persons living with HIV have an increased risk of cardiovascular and metabolic diseases compared with HIV-seronegative individuals. Objective: This study aims to assess the feasibility and acceptability of a virtual environment (VE) for cardiovascular disease and metabolic disease prevention education among men living with HIV through a pilot waitlist-control randomized trial. Methods: In phase 1, we conducted interviews and VE beta testing with 25 individuals. In phase 2, reported here, we conducted a waitlist-controlled trial using permuted block randomization. Participants were allocated to either the VE intervention (n=40) or the waitlist control arm (n=38). The primary outcomes were feasibility (defined by recruitment and retention metrics) and acceptability (defined by levels of engagement) of the VE. We also examined preliminary effect sizes across several cardiovascular health–related indicators. Results: Participants had a mean age of 41.8 (SD 10.4) years and had been living with HIV for a mean of 15.9 (SD 9.7) years. Of the 56 total participants, 35 (63%) were Black and 15 (27%) were Hispanic. A total of 14 out of 31 (45%) of participants with baseline data in the intervention arm engaged with the VE, with an average session duration of 110 minutes. The most highly engaged content modules were nutrition (146 engagements), oral health (138 engagements), fitness tips and videos (82 engagements), and relaxation techniques (75 engagements). Retention was 48 out of 78 (61%) at the final assessment, which, to our knowledge, is higher than the typical retention rates reported in remote digital health and behavioral intervention research. Preliminary efficacy analyses of changes at 3 and 6 months revealed medium effect sizes favoring the intervention for key nutritional outcomes (vegetable consumption: d=0.59-0.66; whole grain intake: d=0.41-0.46) and vigorous physical activity (d=0.38-0.57). Small-to-medium effect sizes were observed for fast food reduction (d=0.37 at 6 months), total physical activity (d=0.37 at 6 months), depressive symptoms (d=0.22 at 3 months), and HIV illness perceptions, including Timeline Acute/Chronic subscale score (d=0.44 at 3 months), Illness Coherence (d=0.33 at 3 months), and Emotional Representations (d=0.23-0.33). Conclusions: The LEARN (LEveraging A viRtual eNvironment to enhance prevention of HIV-related comorbidities) study demonstrated the feasibility and acceptability of a VE designed for cardiovascular and metabolic disease prevention education among persons living with HIV. High engagement with specific educational content and favorable retention rates highlight the promise of this innovative approach. Preliminary effect sizes suggested positive trends in cardiovascular health indicators and mental well-being, indicating the potential for additional benefits associated with the intervention. These findings support progression to a fully powered randomized controlled trial. Subsequent funding has been awarded based on this work to expand the research in LEARN2. We will integrate lessons learned from this study and focus on HIV-related conditions with shared risk factors to enhance the intervention’s impact. By addressing HIV-related conditions with interrelated risk factors, we aim to provide a more comprehensive intervention to improve the overall health and well-being of individuals living with HIV. Trial Registration: ClinicalTrials.gov NCT05242952; https://clinicaltrials.gov/ct2/show/NCT05242952 International Registered Report Identifier (IRRID): RR2-10.2196/38348

BACKGROUND Persons living with HIV have an increased risk of cardiovascular and metabolic diseases compared with HIV-seronegative individuals. OBJECTIVE This study aims to assess the feasibility and acceptability of a virtual environment (VE) for cardiovascular disease and metabolic disease prevention education among men living with HIV through a pilot waitlist-control randomized trial. METHODS In phase 1, we conducted interviews and VE beta testing with 25 individuals. In phase 2, reported here, we conducted a waitlist-controlled trial using permuted block randomization. Participants were allocated to either the VE intervention (n=40) or the waitlist control arm (n=38). The primary outcomes were feasibility (defined by recruitment and retention metrics) and acceptability (defined by levels of engagement) of the VE. We also examined preliminary effect sizes across several cardiovascular health–related indicators. RESULTS Participants had a mean age of 41.8 (SD 10.4) years and had been living with HIV for a mean of 15.9 (SD 9.7) years. Of the 56 total participants, 35 (63%) were Black and 15 (27%) were Hispanic. A total of 14 out of 31 (45%) of participants with baseline data in the intervention arm engaged with the VE, with an average session duration of 110 minutes. The most highly engaged content modules were nutrition (146 engagements), oral health (138 engagements), fitness tips and videos (82 engagements), and relaxation techniques (75 engagements). Retention was 48 out of 78 (61%) at the final assessment, which, to our knowledge, is higher than the typical retention rates reported in remote digital health and behavioral intervention research. Preliminary efficacy analyses of changes at 3 and 6 months revealed medium effect sizes favoring the intervention for key nutritional outcomes (vegetable consumption: d=0.59-0.66; whole grain intake: d=0.41-0.46) and vigorous physical activity (d=0.38-0.57). Small-to-medium effect sizes were observed for fast food reduction (d=0.37 at 6 months), total physical activity (d=0.37 at 6 months), depressive symptoms (d=0.22 at 3 months), and HIV illness perceptions, including Timeline Acute/Chronic subscale score (d=0.44 at 3 months), Illness Coherence (d=0.33 at 3 months), and Emotional Representations (d=0.23-0.33). CONCLUSIONS The LEARN (LEveraging A viRtual eNvironment to enhance prevention of HIV-related comorbidities) study demonstrated the feasibility and acceptability of a VE designed for cardiovascular and metabolic disease prevention education among persons living with HIV. High engagement with specific educational content and favorable retention rates highlight the promise of this innovative approach. Preliminary effect sizes suggested positive trends in cardiovascular health indicators and mental well-being, indicating the potential for additional benefits associated with the intervention. These findings support progression to a fully powered randomized controlled trial. Subsequent funding has been awarded based on this work to expand the research in LEARN2. We will integrate lessons learned from this study and focus on HIV-related conditions with shared risk factors to enhance the intervention’s impact. By addressing HIV-related conditions with interrelated risk factors, we aim to provide a more comprehensive intervention to improve the overall health and well-being of individuals living with HIV. CLINICALTRIAL ClinicalTrials.gov NCT05242952; https://clinicaltrials.gov/ct2/show/NCT05242952 INTERNATIONAL REGISTERED REPORT RR2-10.2196/38348

Background: In clinical settings, counseling patients on physical activity starts by assessing patients’ current physical activity levels. Self-report measures of PA are generally easy to administer; however, they may be too long to be convenient and are known to correlate poorly with objective measures of physical activity. Objective: To assess the concurrent validity of a self-report three-question physical activity vital sign with objective Fitbit step counts and the distance walked during a 6-min walk test. Methods: This pilot study tested a best practice advisory embedded in the Epic electronic health record, which was designed to prompt providers in a preventive cardiology clinic to counsel patients reporting low levels of physical activity. Patients were invited to participate in the remote patient monitoring phase to assess the change in their physical activity by wearing a Fitbit for 12 weeks and completing a 6-min walk test at baseline and 12 weeks. This analysis used the cross-sectional data collected in this phase. Pearson correlations were conducted between self-reported physical activity, Fitbit step counts, and the distance walked during the 6-min walk—a measure associated with current physical activity levels. Kappa coefficients were calculated to assess agreement between self-reported physical activity and step counts. Results: Participants who enrolled in the Fitbit monitoring were approximately 50% female, with the majority identified as White non-Hispanic adults. Their most common cardiovascular risk factor was hypertension. The self-reported physical activity vital signs were significantly associated with step counts at baseline and 12 weeks but were not associated with the distance during the 6-min walk test. However, the distance walked was significantly associated with step counts at baseline and 12 weeks. The Kappa results demonstrate a poor level of agreement between two categories (meeting or not meeting current physical activity guidelines) of self-report physical activity vitals and the objective Fitbit step counts. Discussion: There were moderate correlations between the self-reported physical activity vital signs and the Fitbit step counts, but there was lack of agreement when they were categorized. Further validation of this physical activity vital sign is warranted.

Background: Multiple behavior change interventions have gained traction in the behavioral health space. Yet, previous studies on health coaching (HC) focused on testing its effect on stages of change for individual health behaviors. Objective: The purpose of this study was to examine the effects of HC on stages of change across multiple health behavior domains among patients at high risk of coronary heart disease and type 2 diabetes. Methods: This secondary analysis of a randomized clinical trial included 200 primary care patients (mean age of 47.7 years, 49.0% women, 60.5% Whites) who completed transtheoretical model-based questionnaires related to weight reduction, exercise, healthier eating, and stress management. Multigroup latent transition analysis was used to compare the stage of change distributions and transitions over time between HC and controls at baseline, midpoint of the intervention (3 months), and postintervention (6 months). Results: Three distinct categories of behavior change were identified (“Contemplation,” “Preparation to Action,” and “Action”), and membership in these categories changed over time as a function of intervention exposure. Both groups exhibited positive transitions through stages of change from baseline to 3 months. Pronounced intervention effects emerged from 3 to 6 months, revealing larger differences in transition probabilities between the groups. In particular, HC increased patients' likelihood of transitioning from “Contemplation” to both “Preparation for Action” and “Action,” as well as from “Preparation for Action” to “Action.” The control group remained stagnant during the same period. Conclusions: Although HC produces changes across multiple behavioral domains, it was most effective for patients who were reluctant or ambivalent about changing their behaviors.

Background: Sexual minority men with HIV are at an increased risk of cardiovascular disease (CVD) and have been underrepresented in behavioral research and clinical trials. Objective: This study aims to explore perceptions of HIV-related comorbidities and assess the interest in and usability of a virtual environment for CVD prevention education in Black and Latinx sexual minority men with HIV. Methods: This is a 3-phase pilot behavioral randomized controlled trial. We report on formative phases 1 and 2 that informed virtual environment content and features using qualitative interviews, usability testing, and beta testing with a total of 25 individuals. In phase 1, a total of 15 participants completed interviews exploring HIV-related illnesses of concern that would be used to tailor the virtual environment. In phase 2, usability testing and beta testing were conducted with 10 participants to assess interest, features, and content. Results: In phase 1, we found that CVD risk factors included high blood pressure, myocardial infarction, stroke, and diabetes. Cancer (prostate, colon, and others) was a common concern, as were mental health conditions. In phase 2, all participants completed the 12-item usability checklist with favorable feedback within 30 to 60 minutes. Beta-testing interviews suggested (1) mixed perceptions of health and HIV, (2) high risk for comorbid conditions, (3) virtual environment features were promising, and (4) the need for diverse avatar representations. Conclusions: We identified several comorbid conditions of concern, and findings carry significant implications for mitigating barriers to preventive health screenings, given the shared risk factors between HIV and related comorbidities. Highly rated aspects of the virtual environment were anonymity; meeting others with HIV who identify as gay or bisexual; validating lesbian, gay, bisexual, transgender, queer, and others (LGBTQ+) images and content; and accessibility to CVD prevention education. Critical end-user feedback from beta testing suggested more options for avatar customization in skin, hair, and body representation. Our next phase will test the virtual environment as a new approach to advancing cardiovascular health equity in ethnic and racial sexual minority men with HIV. Trial Registration: ClinicalTrials.gov NCT04061915; https://clinicaltrials.gov/study/NCT05242952 International Registered Report Identifier (IRRID): RR2-10.2196/38348

BACKGROUND Sexual minority men with HIV are at an increased risk of cardiovascular disease (CVD) and have been underrepresented in behavioral research and clinical trials. OBJECTIVE This study aims to explore perceptions of HIV-related comorbidities and assess the interest in and usability of a virtual environment for CVD prevention education in Black and Latinx sexual minority men with HIV. METHODS This is a 3-phase pilot behavioral randomized controlled trial. We report on formative phases 1 and 2 that informed virtual environment content and features using qualitative interviews, usability testing, and beta testing with a total of 25 individuals. In phase 1, a total of 15 participants completed interviews exploring HIV-related illnesses of concern that would be used to tailor the virtual environment. In phase 2, usability testing and beta testing were conducted with 10 participants to assess interest, features, and content. RESULTS In phase 1, we found that CVD risk factors included high blood pressure, myocardial infarction, stroke, and diabetes. Cancer (prostate, colon, and others) was a common concern, as were mental health conditions. In phase 2, all participants completed the 12-item usability checklist with favorable feedback within 30 to 60 minutes. Beta-testing interviews suggested (1) mixed perceptions of health and HIV, (2) high risk for comorbid conditions, (3) virtual environment features were promising, and (4) the need for diverse avatar representations. CONCLUSIONS We identified several comorbid conditions of concern, and findings carry significant implications for mitigating barriers to preventive health screenings, given the shared risk factors between HIV and related comorbidities. Highly rated aspects of the virtual environment were anonymity; meeting others with HIV who identify as gay or bisexual; validating lesbian, gay, bisexual, transgender, queer, and others (LGBTQ+) images and content; and accessibility to CVD prevention education. Critical end-user feedback from beta testing suggested more options for avatar customization in skin, hair, and body representation. Our next phase will test the virtual environment as a new approach to advancing cardiovascular health equity in ethnic and racial sexual minority men with HIV. CLINICALTRIAL ClinicalTrials.gov NCT04061915; https://clinicaltrials.gov/study/NCT05242952 INTERNATIONAL REGISTERED REPORT RR2-10.2196/38348

Background: Currently, only about half of U.S. adults achieve current physical activity guidelines. Routine physical activity is not regularly assessed, nor are patients routinely counseled by their healthcare provider on achieving recommended levels. The three-question physical activity vital sign (PAVS) was developed to assess physical activity duration and intensity and identify adults not meeting physical activity guidelines. Clinical decision support provided via a best practice advisory in an electronic health record (EHR) system can be triggered as a prompt, reminding healthcare providers to implement the best practice intervention when appropriate. Remote patient monitoring of physical activity can provide objective data in the EHR. Objectives: This study aimed to evaluate the feasibility and clinical utility of embedding the PAVS and a triggered best practice advisor into the EHR in an ambulatory preventive cardiology practice setting to alert providers to patients reporting low physical activity and prompt healthcare providers to counsel these patients as needed. Methods: Three components based in the EHR were integrated for the purpose of this study: Patients completed the PAVS through their electronic patient portal prior to an office visit, a best practice advisory was created to prompt providers to counsel patients who reported low levels of physical activity, and remote patient monitoring via Fitbit synced to the EHR provided objective physical activity data. The intervention was pilot-tested in the Epic EHR for 1 year (July 1, 2021 to June 30, 2022). Qualitative feedback on the intervention from both providers and patients was obtained at the completion of the study. Results: Monthly assessments of the use of the PAVS and best practice advisory and remote patient monitoring were completed. Patients’ completion of the PAVS varied from 35% to 48% per month. The best practice advisory was signed by providers between 2% and 65% and was acknowledged by 2%–22% per month. The majority (58%) of patients were able to sync a Fitbit device to their EHR for remote monitoring. Discussion: Although uptake of each component needs improvement, this pilot demonstrated the feasibility of incorporating a physical activity promotion intervention into the EHR. Qualitative feedback provided guidance for future implementation.

Background: No studies have explored the internal structure of the 10-item Perceived Stress Scale in patients with high cardiovascular and diabetes risk. Objective: We scrutinized the dimensionality of the scale in this patient group using exploratory graph analysis, a technique within the developing field of network psychometrics. Methods: Analyses were conducted on 200 primary care patients. A bootstrap version of exploratory graph analysis assessed the stability of the dimensions based on structural consistency, item stability, and network loadings. Results: Exploratory graph analysis revealed a 2-dimensional structure; structural consistency of the first dimension was high (0.863), whereas that for the second was low (0.667). Items belonging to the latter dimension did not cluster consistently with each other (ie, low item stability) and were not strongly associated with any particular dimension (ie, weak network loadings). Conclusion: Exploratory graph analysis offers unique outputs, making it easy to assess the dimensional integrity of scales. Further research is warranted regarding the second dimension of the Perceived Stress Scale.

Background: Given the importance of self-management in type 2 diabetes mellitus (T2DM), a major aspect of health is providing diabetes self-management education and support. Known barriers include access, availability, and the lack of follow through on referral to education programs. Virtual education and support have increased in use over the last few years. Objective: The purpose of the Diabetes Learning in a Virtual Environment (LIVE) study was to compare the effects of the LIVE intervention (educational 3D world) to a diabetes self-management education and support control website on diet and physical activity behaviors and behavioral and metabolic outcomes in adults with T2DM over 12 months. Methods: The LIVE study was a 52-week multisite randomized controlled trial with longitudinal repeated measures. Participants were randomized to LIVE (n=102) or a control website (n=109). Both contained the same educational materials, but the virtual environment was synchronous and interactive, whereas the control was a flat website. Data were collected at baseline and 3, 6, and 12 months using surveys and clinical, laboratory, and Fitbit measures. Descriptive statistics included baseline characteristics and demographics. The effects of the intervention were initially examined by comparing the means and SDs of the outcomes across the 4 time points between study arms, followed by multilevel modeling on trajectories of the outcomes over the 12 months. Results: This trial included 211 participants who consented. The mean age was 58.85 (SD 10.1) years, and a majority were White (127/211, 60.2%), non-Hispanic (198/211, 93.8%), married (107/190, 56.3%), and female (125/211, 59.2%). Mean hemoglobin A1c (HbA1c) level at baseline was 7.64% (SD 1.79%) and mean BMI was 33.51 (SD 7.25). We examined weight loss status versus randomized group, where data with no weight change were eliminated, and the LIVE group experienced significantly more weight loss than the control group (P=.04). There were no significant differences between groups in changes in physical activity and dietary outcomes (all P>.05), but each group showed an increase in physical activity. Both groups experienced a decrease in mean HbA1c level, systolic and diastolic blood pressure, cholesterol, and triglycerides over the course of 12 months of study participation, including those participants whose baseline HbA1c level was 8.6% or higher. Conclusions: This study confirmed that there were minor positive changes on glycemic targets in both groups over the 12-month study period; however, the majority of the participants began with optimal HbA1c levels. We did find clinically relevant metabolic changes in those who began with an HbA1c level >8.6% in both groups. This study provided a variety of resources to our participants in both study groups, and we conclude that a toolkit with a variety of services would be helpful to improving self-care in the future for persons with T2DM. Trial Registration: ClinicalTrials.gov NCT02040038; https://clinicaltrials.gov/ct2/show/NCT02040038