Cardiovascular Disease Prevention Education Using a Virtual Environment in Sexual-Minority Men of Color With HIV: Protocol for a Sequential, Mixed Method, Waitlist Randomized Controlled Trial

Background It is estimated that 70% of all deaths each year in the United States are due to chronic conditions. Cardiovascular disease (CVD), a chronic condition, is the leading cause of death in ethnic and racial minority males. It has been identified as the second most common cause of death in persons with HIV. By the year 2030, it is estimated that 78% of persons with HIV will be diagnosed with CVD. Objective We propose the first technology-based virtual environment intervention to address behavioral, modifiable risk factors associated with cardiovascular and metabolic comorbidities in sexual-minority men of color with HIV. Methods This study will be guided using social cognitive theory and the Technology Acceptance Model. A sequential, mixed method, waitlist controlled randomized control feasibility trial will be conducted. Aim 1 is to qualitatively explore perceptions of cardiovascular risk in 15 participants. Aim 2 is to conduct a waitlist controlled comparison to test if a virtual environment is feasible and acceptable for CVD prevention, based on web-based, self-assessed, behavioral, and psychosocial outcomes in 80 sexual-minority men of color with HIV. Results The study was approved by the New York University Institutional Review Board in 2019, University of Texas Health Science Center at Houston in 2020, and by the Yale University Institutional Review Board in February 2022. As of April 2022, aim 1 data collection is 87% completed. We expect to complete data collection for aim 1 by April 30, 2022. Recruitment for aim 2 will begin mid-May 2022. Conclusions This study will be the first online virtual environment intervention for CVD prevention in sexual-minority men of color with HIV. We anticipate that the intervention will be beneficial for CVD prevention education and building peer social supports, resulting in change or modification over time in risk behaviors for CVD. Trial Registration ClinicalTrials.gov NCT05242952; https://clinicaltrials.gov/ct2/show/NCT05242952 International Registered Report Identifier (IRRID) PRR1-10.2196/38348


Candidate: Strengths
• Dr. Ramos is a tenure-track Assistant Professor in the Rory Meyers College of Nursing at New York University.She is well qualified for this K award.Her doctorate was completed at Columbia University and her postdoctoral fellowship at Yale. • She has experience both in cardiovascular diseases and in HIV as a cardiovascular registered nurse in the cardiac intermediate care and intensive care units and in the cardiac catheterization lab and as a research nurse for the Howard Brown Health Center MACS as well as the Midwest AIDS Training and Education Center's (MATEC) Minority AIDS Initiative.• She has been successful in obtaining a couple of small grants: An administrative supplement to a parent R01, and pilot funding through the Center for Interdisciplinary Research on AIDS at Yale University.• She has a good publication record that includes 5 peer-reviewed articles, 4 of them as first author.She has also presented 14 abstracts and has served as an ad-hoc for 3 peer-reviewed journals.

Weaknesses
• The breakdown of career training details into two tables is somewhat confusing.

Research Plan: Strengths
• The proposed research aligns with the goals and compelling questions of NHLBI -chronic disease prevention and treatment more specifically in HIV and the potential use of virtual learning technology to this field.
• The proposed research is innovative in its use of the virtual environment to provide easy access to health information.• The research proposes to prevent HIV-related CVD comorbidities in African American and Latino MSM by using gamification of self-management or health behaviors in the VE.Gamification may provide benefit in self-management by allowing anonymity and providing a safe zone; facilitate social networking with other participants and with health educators.• In response to the previous grant review, a wait-list control design has been incorporated.
• Also, in response to the previous grant review, a section on managing missing data and ensuring credibility of qualitative data has been added to the Data Analysis Section.• In aim 1, Dr. Ramos will utilize qualitative interviews to explore perceptions of HIV related comorbidity concerns; then in aim 2 phase one, she will beta test the VE prior to deployment in the proposed clinical feasibility trial and in phase 2 utilize the Learning in Virtual Environments (LIVE) platform to conduct a wait-list control feasibility clinical trial with 80 adult, minority MSM living with HIV and at-risk for HIV related comorbidities.

Weaknesses
• The population to be studied are restricted to MSM and excludes women.While MSM are at high risk for HIV, the restriction to this specific group could be argued more effectively (such as potential differences in their perspective on CVD risk compared women).• Different ethnic groups are likely to have different concerns regarding CVD risk.The reason for lumping blacks and Latinos, particularly without regard to the breakdown between these two ethnic groups in the 15 individuals to be recruited in aim 1 may be a not be ideal.• For specific aim 1, while it would be valuable to assess the participants views on what is important, it is not clear to this reviewer why the 'most salient illnesses' to be included in the VE intervention should be based on participants' perception of what is important rather than documented research of what intervention is likely to be most beneficial in reducing the risk of CVD in this population.• Figure 1 seems to be missing.
• For aim 2, critical information is missing as to how often and for how long the participants will be expected to log-on; how often will a health care provider hold group sessions?• Self-report survey measures are planned at baseline, 3 months and 6 months.Particularly for assessment of knowledge base regarding CVD risk, it is questioned whether frequent administration particularly in a control group will lead to improvement due to a practice effect.

Mentor(s), Co
Two primary mentors are listed.Dr.Vorderstrasse is Associate Professor and Director of the Florence S. Downs PhD Program in Nursing Research & Theory.Importantly she is an MPI of a NHLBI R01 assessing the utility of virtual environments in diabetes self-management and support.She is an excellent choice for a primary mentor.•Theco-mentorDr. Kershaw is Professor and Chair of Social and Behavioral Sciences at Yale University School of Public Health, and Director of the Interdisciplinary Methods Core at the Center for Interdisciplinary Research on AIDS at Yale University.Dr.Kershaw is an excellent of a mentor in various implementation science technology, complex designs and advanced analytic techniques.•Thecollaborators and consultants are each likely to bring resources to enhance Dr. Ramos' K proposal -Dr.Gwadz, Professor and Associate Dean for Research in NY University for expertise on recruitment of people living with HIV and respondent driven sampling; Dr. Cleland as a collaborator in the planning and analysis of data and Dr. Johnson as a health informatician with interdisciplinary training in health informatics, application of the VE for self-management of chronic illness and data visualization.•Dr.Ramos has submitted a manuscript with her mentors Drs.Vorderstrasse, Melkus and Kershaw demonstrating a track record of working together.Weaknesses • The co-primary mentor Dr. Harmony Reynolds is Associate Professor of Medicine at NYU School of Medicine and Associate Director of the Cardiovascular Clinical Research Center at Langone Health.While likely to provide excellent mentoring in the general area of cardiovascular disease, concern is raised that based on Dr. Reynold's letter of support and the biosketch, Dr. Reynold's expertise does not seem to involve a focus on cardiovascular disease prevention, the focus of Dr. Ramos' K proposal.•Inaddition,as this proposal seeks to utilize behavioral intervention specifically in HIV-infected individuals, it is likely that HIV-related behaviors impacting CVD risk (need for full virologic suppression, role of protease inhibitors in dyslipidemia; more recently the potential role of integrase inhibitors in heavy weight gain and depression) may come up as topics of concern.While understanding that Dr. Ramos has previous experience in HIV, it may be a weakness that no mentor who would be able to advise on these aspects are listed.There is evidence of institutional commitment to the candidate in the form of 3 year departmental start-up package valued at over six figures and a commitment by the college of 75% protected time.Weaknesses• None noted.
choice 5. Environment and Institutional Commitment to the Candidate: Strengths • The environment is excellent.• • For NIH-Defined Phase III trials, Plans for valid design and analysis: • Inclusion/Exclusion of Children under 18: Excluding ages <18; justified scientifically Training in the Responsible Conduct of Research: Acceptable