The LEARN Study for CVD Prevention

Study Overview
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Brief Summary
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The investigator is testing a virtual environment to address prevention of HIV-related comorbidities.

Detailed Description
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The primary aims of this study are to test the feasibility, acceptability and preliminary effects of a VE to address prevention of HIV-related comorbidities. A waitlist control feasibility clinical trial will be conducted. We will assign (N=80) eligible participants and ensure balanced allocation to intervention and control groups over the intervention period. We hypothesize that the VE will be feasible and acceptable to persons living with HIV, and that they will apply their VE learning to real-life situations and health behaviors for prevention of HIV-related comorbidities.

Official Title
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LEveraging A viRtual eNvironment (LEARN) to Enhance Prevention of HIV-related Comorbidities in At-risk Minority MSM

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Gaming in a virtual environment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: identify as an ethnic/racial minority with HIV identify as gay, same-gender-loving, or MSM able to read and understand English access to a computer capable of downloading and running the VE software no medical history of serious cardiovascular or cognitive complications Exclusion Criteria: Anything outside of inclusion parameters, including history of: myocardial infarction (MI) congestive heart failure (CHF) coronary artery bypass graft (CABG) cerebral vascular accident (CVA) cognitive impairment

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention Group<br>Participants will enter an online game and learn about how to prevent cardiovascular and metabolic conditions. | Behavioral: Gaming in a virtual environment<br>* To address the primary outcomes of feasibility and acceptability of the VE, we will capture process data using a computer-based virtual environment and self-report measures using an online survey.<br>|
| Other: Waitlist Control Group<br>Participants will enter an online game at a later date after the immediate intervention group and learn about how to prevent cardiovascular and metabolic conditions. | Behavioral: Gaming in a virtual environment<br>* To address the primary outcomes of feasibility and acceptability of the VE, we will capture process data using a computer-based virtual environment and self-report measures using an online survey.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability/Feasibility {change over 3 timepoints} | Based on Technology Acceptance Model, using the same unit of measure, we will examine Perceived Usefulness (Cronbach's alpha 0.98) and Perceived Ease of Use (Cronbach's alpha 0.94) with an online 7-point Likert scale. | Baseline and Month 3 & 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular health {change over 3 timepoints} | Life's Simple 7, based on 7 modifiable health behaviors, provides scores (range, 0 to 14) based on smoking, diet, physical activity, body mass index, blood pressure, total cholesterol, and fasting glucose. This study will only measure 4 out of the 7: smoking, diet, physical activity, and BMI. | Baseline and Month 3 & 6 | 
| Physical Activity {change over 3 timepoints} | International Physical Activity Questionnaire - Short Form will assess intensity of physical activity and sitting time using a 7-item, open-ended measure. Cronbach's alpha 0.80. | Baseline and Month 3 & 6 | 
| Tobacco and E-cigarette use {change over 3 timepoints} | BRFSS - self report measure questions that pertain to Tobacco use and E-cigarette use (7 questions). kappa statistic 0.81-0.92. | Baseline and Month 3 & 6 | 
| Food consumption {change over 3 timepoints} | Food Frequency Questionnaire - Reports how frequently individuals consume foods in 16 categories. Multifactor Screener has demonstrated correlations of 0.5-0.8 with estimated true intake. | Baseline and Month 3 & 6 | 
| Psychosocial wellbeing {change over 3 timepoints} | Patient Health Questionnaire-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety. | Baseline and Month 3 & 6 | 
| Illness Perceptions {change over 3 timepoints} | The Revised Illness Perception Questionnaire measures illness perceptions about hypertension and type 2 diabetes on a 5-point Likert scale (strongly disagree to strongly agree). | Baseline and Month 3 & 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comorbidity, Cardiovascular Diseases, Sexual and Gender Minorities, HIV Infections, Virtual Reality, Cardiovascular Health