TY - JOUR
T1 - Cardiovascular Disease Prevention Education Using a Virtual Environment in Sexual-Minority Men of Color With HIV
T2 - Protocol for a Sequential, Mixed Method, Waitlist Randomized Controlled Trial
AU - Ramos, S. Raquel
AU - Johnson, Constance
AU - Melkus, Gail
AU - Kershaw, Trace
AU - Gwadz, Marya
AU - Reynolds, Harmony
AU - Vorderstrasse, Allison
N1 - Funding Information:
All procedures performed in studies involving human participants are in accordance with the ethical standards of the institutional and national research committee, the 1964 Helsinki Declaration and its later amendments, or comparable ethical standards. The study was funded by the National Heart, Lung, and Blood Institute (K01HL145580) and approved by the New York University Institutional Review Board in 2019 (IRB-FY2018-2284), the University of Texas Health Science Center at Houston in 2020 (HSC-SN-20-1143), and by the Yale University Institutional Review Board in February 2022 (2000031403). Informed consent has been obtained from all individual participants who have participated thus far. We will obtain informed consent from all individuals who meet the eligibility criteria and want to participate.
Publisher Copyright:
© 2022 The authors.
PY - 2022/5/1
Y1 - 2022/5/1
N2 - 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.
AB - 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.
KW - HIV
KW - behavioral intervention
KW - cardiovascular disease
KW - consumer health informatics
KW - gamification
KW - health communication
KW - prevention education
KW - sexual minority men
KW - virtual environment
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UR - http://www.scopus.com/inward/citedby.url?scp=85130556102&partnerID=8YFLogxK
U2 - 10.2196/38348
DO - 10.2196/38348
M3 - Article
AN - SCOPUS:85130556102
SN - 1929-0748
VL - 11
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 5
M1 - e38348
ER -