Cardiovascular Diseases
Conditions
Keywords
Comorbidity, Cardiovascular Diseases, Sexual and Gender Minorities, HIV Infections, Virtual Reality, Cardiovascular Health
Brief summary
The investigator is testing a virtual environment (VE) to address prevention of HIV-related comorbidities.
Detailed description
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.
Interventions
BEHAVIORALGaming in a virtual environment
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.
Sponsors
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Virtual Environment Intervention | Baseline through Month 6 | Feasibility was operationalized through recruitment metrics (proportion of individuals who enrolled from those initially contacted) and retention metrics (percentage of participants who completed 3-month and 6-month follow-up assessments from baseline analysis sample). |
| Acceptability of Virtual Environment- Engagement | 6-month intervention period | Acceptability was evaluated through engagement with the VE measured via platform metadata and logfile analysis. |
| Acceptability of Virtual Environment- Total Sessions | 6-month intervention period | Acceptability was evaluated through total sessions logged in the VE measured via platform metadata and logfile analysis. |
| Acceptability of Virtual Environment- Mean Session Duration | 6-month intervention period | Acceptability was evaluated through mean session duration in the VE in minutes measured via platform metadata and logfile analysis. |
| Acceptability of Virtual Environment- Total Educational Quests Accessed | 6-month intervention period | Acceptability was evaluated through the total number of distinct educational quests accessed in the VE measured via platform metadata and logfile analysis. |
| Acceptability of Virtual Environment- Percent VE District Visits | 6-month intervention period | Acceptability was evaluated through the percentage of visits for each of the districts within the VE measured via platform metadata and logfile analysis. |
| Acceptability of Virtual Environment- Total Engagements Per Module | 6-month intervention period | Acceptability was evaluated through total number of engagements per module in the VE measured via platform metadata and logfile analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline and Month 3 & 6 | Between group change from baseline in Body Mass Index (BMI) represented as Cohen's d effect size. Effect Size Interpretation: Negligible \< 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70. Positive values are favorable for intervention; negative values are unfavorable for intervention. |
| Change in Physical Activity | Baseline and Month 3 | The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a validated questionnaire that assesses physical activity through self-reported frequency and duration. Walking includes any walking for work, transport, or recreation (3.3 Metabolic Equivalent of Task or METs). Moderate-intensity activity includes activities requiring moderate effort such as carrying light loads or recreational swimming (4.0 METs). Vigorous-intensity activity includes activities requiring hard physical effort such as running or aerobics (8.0 METs). Total physical activity is calculated as MET-minutes per week (MET value × minutes × days). Values are reported as minutes per week or MET-minutes per week, with a minimum of 0 and no fixed maximum. Higher values indicate greater physical activity, which is favorable for cardiovascular health. Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible \< 0.20; Small=0.20-0.39; Medium=0.40-0.69; La |
| Tobacco and E-cigarette Use- Question 1 | Baseline | Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 1: "Have you smoked at least 100 cigarettes in your entire life?" |
| Tobacco and E-cigarette Use- Question 2 | Baseline | Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 2 "Do you now smoke cigarettes every day, some days, or not at all?" |
| Tobacco and E-cigarette Use- Question 3 | Baseline | Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 3: "During the past 12 months, have you stopped smoking for one day or longer because you were trying to quit smoking?" |
| Tobacco and E-cigarette Use- Question 4 | Baseline | Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 4: "How long has it been since you last smoked a cigarette, even one or two puffs?" |
| Tobacco and E-cigarette Use- Question 5 | Baseline | Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 5: "Do you currently use chewing tobacco, snuff, or snus every day, some days, or not at all?" |
| Tobacco and E-cigarette Use- Question 6 | Baseline | Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 6: "Have you ever used an e-cigarette or other electronic "vaping" product, even just one time, in your entire life?" |
| Tobacco and E-cigarette Use- Question 7 | Baseline | Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 7: "Do you now use e-cigarettes or other electronic "vaping" products every day, some days, or not at all?" |
| Change in Nutrition Intake | Baseline and Month 3 | Dietary intake was assessed using the NCI Multifactor Screener, a validated food frequency questionnaire that reports how frequently individuals consume foods in 6 categories. Vegetables, fruit, and whole grains were measured as average daily servings; sweets, red meat, and fast food were measured as weekly servings or meals. Values are self-reported counts with a minimum of 0 and no fixed maximum. Adherence was evaluated against dietary guidelines recommending ≥3 servings of vegetables and ≥2.5 servings of fruit daily. For vegetables, fruit, and whole grains, higher values indicate healthier dietary patterns (favorable). For sweets, red meat, and fast food, lower consumption is favorable for cardiovascular health. Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible \< 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70. Positive values are favorable for intervention; negative values are unfavorable for intervention. |
| Change in Psychosocial Wellbeing | Baseline and Month 3 & 6 | The Patient Health Questionnaire-9 (PHQ-9) is a validated 9-item questionnaire used to screen for depression. Each item is scored 0-3, with total scores ranging from 0 to 27. Severity categories: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). Higher scores indicate greater severity of depressive symptoms (unfavorable). Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible \< 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70. Positive values are favorable for intervention; negative values are unfavorable for intervention. |
| Change in Revised Illness Perceptions Questionnaire | Baseline and Month 3 | Assesses cognitive and emotional representations of illness using 5-point Likert scales (1 = strongly disagree, 5 = strongly agree). Subscale scores are calculated as sum totals with the following ranges: Timeline Acute/Chronic (3-15), Timeline Cyclical (4-20), Consequences (5-25), Personal Control (4-20), Treatment Control (4-20), Illness Coherence (4-20), and Emotional Representations (6-30). Higher scores indicate stronger beliefs in each domain. For Personal Control, Treatment Control, and Illness Coherence, higher scores indicate more adaptive beliefs (favorable). For Consequences and Emotional Representations, higher scores indicate more negative perceptions (unfavorable). Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible \< 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70. Positive values are favorable for intervention; negative values are unfavorable for intervention. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORS. Raquel Ramos, PhD, MBA, MSN, FNP-BC
Yale University School of Nursing
Participant flow
Recruitment details
Participantls were screened via community-based organizations, hospital MyChart messaging campaigns, research center call lists, and an external research listserv of 1,800 individuals. Study was fully remote.
Pre-assignment details
After eligibility screening and informed consent via phone, participants were allocated using permuted-block randomization with varying block sizes to ensure allocation concealment and balanced allocation between intervention and control groups.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.1 years STANDARD_DEVIATION 9.7 |
| Body Mass Index (BMI) Category Missing | 1 Participants |
| Body Mass Index (BMI) Category Normal weight (18.5-24.9) | 10 Participants |
| Body Mass Index (BMI) Category Obese (≥30.0) | 8 Participants |
| Body Mass Index (BMI) Category Overweight (25.0-29.9) | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| History of Hypertension and/or Diabetes No | 42 Participants |
| History of Hypertension and/or Diabetes Yes | 7 Participants |
| PHQ-9 Depression Score | 5.2 score on a scale STANDARD_DEVIATION 5.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 31 Participants |
| Years Living with HIV | 18.1 years STANDARD_DEVIATION 11.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 38 |
| other Total, other adverse events | 0 / 40 | 0 / 38 |
| serious Total, serious adverse events | 0 / 40 | 0 / 38 |
Outcome results
None listed