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      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

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          Abstract

          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

          Related collections

          Most cited references88

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          The PHQ-9: validity of a brief depression severity measure.

          K Kroenke, R L Spitzer, J. Williams (2001)
          While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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            Three approaches to qualitative content analysis.

            Hsiu-Fang Hsieh, Sarah Shannon (2016)
            Content analysis is a widely used qualitative research technique. Rather than being a single method, current applications of content analysis show three distinct approaches: conventional, directed, or summative. All three approaches are used to interpret meaning from the content of text data and, hence, adhere to the naturalistic paradigm. The major differences among the approaches are coding schemes, origins of codes, and threats to trustworthiness. In conventional content analysis, coding categories are derived directly from the text data. With a directed approach, analysis starts with a theory or relevant research findings as guidance for initial codes. A summative content analysis involves counting and comparisons, usually of keywords or content, followed by the interpretation of the underlying context. The authors delineate analytic procedures specific to each approach and techniques addressing trustworthiness with hypothetical examples drawn from the area of end-of-life care.
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              Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology

              Fred D. Davis (1989)
              Article 0 comments Cited 4131 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                S Raquel Ramos:
                ORCID: https://orcid.org/0000-0003-2403-7222
                School of NursingYale University400 West Campus DriveOrange, CT, 06477United States1 203 737 2339raquel.ramos@yale.edu
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: May 2022
                Publication date (Electronic): 17 May 2022
                Volume: 11
                Issue: 5
                Electronic Location Identifier: e38348
                Affiliations
                [1 ] School of Nursing Yale University Orange, CT United States
                [2 ] Department of Social and Behavioral Sciences School of Public Health Yale University New Haven, CT United States
                [3 ] Center for Interdisciplinary Research on AIDS Yale University New Haven, CT United States
                [4 ] The Center for Drug Use and HIV Research New York University New York, NY United States
                [5 ] Cizik School of Nursing University of Texas Houston Houston, TX United States
                [6 ] School of Biomedical Informatics University of Texas Houston Houston, TX United States
                [7 ] Rory Meyers College of Nursing New York University New York, NY United States
                [8 ] Silver School of Social Work New York University New York, NY United States
                [9 ] Department of Medicine Grossman School of Medicine New York University New York, NY United States
                [10 ] NYU Langone Health New York, NY United States
                [11 ] Elaine Marieb College of Nursing University of Massachusetts Amherst Amherst, MA United States
                Author notes
                Corresponding Author: S Raquel Ramos raquel.ramos@ 123456yale.edu
                Author information
                https://orcid.org/0000-0003-2403-7222
                https://orcid.org/0000-0003-3162-3932
                https://orcid.org/0000-0002-5859-4118
                https://orcid.org/0000-0002-3300-1355
                https://orcid.org/0000-0002-2386-9409
                https://orcid.org/0000-0003-0284-0655
                https://orcid.org/0000-0001-8770-1851
                Article
                Publisher ID: v11i5e38348
                DOI: 10.2196/38348
                PMC ID: 9157319
                PubMed ID: 35579928
                SO-VID: d6401efa-a173-4733-8d3d-0dc5d6e6e968
                Copyright © ©S Raquel Ramos, Constance Johnson, Gail Melkus, Trace Kershaw, Marya Gwadz, Harmony Reynolds, Allison Vorderstrasse. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 17.05.2022.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 29 March 2022
                Date revision requested : 1 April 2022
                Date revision received : 4 April 2022
                Date accepted : 12 April 2022
                Categories
                Subject: Protocol
                Subject: Protocol
                Custom metadata
                ext-peer-rev This paper was peer reviewed by the National Heart, Lung, and Blood Institute Special Emphasis Panel - K01 Career Development Programs to Promote Diversity in Health Research (National Institutes of Health, USA). See the Multimedia Appendix for the peer-review report;

                Keywords: virtual environment,behavioral intervention,consumer health informatics,hiv,cardiovascular disease,sexual minority men,prevention education,gamification,health communication
                Data availability:
                Keywords: virtual environment, behavioral intervention, consumer health informatics, hiv, cardiovascular disease, sexual minority men, prevention education, gamification, health communication

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