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Cardiovascular DiseasesLEARNNCT05242952

The LEARN Study for CVD Prevention

A study testing Gaming in a virtual environment in people with Cardiovascular Diseases, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigator is testing a virtual environment (VE) to address prevention of HIV-related comorbidities. Read more about this study

Who is it for?
Ages 30 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Gaming in a virtual environment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteUnited States
Study dates
10 May 2023to 31 Mar 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yale University

    Orange, Connecticut, 06477

Other trials in United States

About this study

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

The investigator is testing a virtual environment (VE) to address prevention of HIV-related comorbidities.

Read the 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.

Being tested
Gaming in a virtual environment
Keywords
Comorbidity, Cardiovascular Diseases, Sexual and Gender Minorities, HIV Infections, Virtual Reality, Cardiovascular Health
Medical subject headings
Cardiovascular Diseases, Coitus, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gaming in a virtual environmentBehavioural

    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.

Study groups in NCT05242952
Study groupRoleWhat they receive
Immediate Intervention GroupExperimentalParticipants will enter an online game and learn about how to prevent cardiovascular and metabolic conditions.
Receives: Behavioral: Gaming in a virtual environment
Waitlist Control GroupOtherParticipants will enter an online game at a later date after the immediate intervention group and learn about how to prevent cardiovascular and metabolic conditions.
Receives: Behavioral: Gaming in a virtual environment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Virtual Environment Intervention

    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).

    Measured: Baseline through Month 6

  2. Acceptability of Virtual Environment- Engagement

    Acceptability was evaluated through engagement with the VE measured via platform metadata and logfile analysis.

    Measured: 6-month intervention period

  3. Acceptability of Virtual Environment- Total Sessions

    Acceptability was evaluated through total sessions logged in the VE measured via platform metadata and logfile analysis.

    Measured: 6-month intervention period

  4. Acceptability of Virtual Environment- Mean Session Duration

    Acceptability was evaluated through mean session duration in the VE in minutes measured via platform metadata and logfile analysis.

    Measured: 6-month intervention period

  5. Acceptability of Virtual Environment- Total Educational Quests Accessed

    Acceptability was evaluated through the total number of distinct educational quests accessed in the VE measured via platform metadata and logfile analysis.

    Measured: 6-month intervention period

  6. Acceptability of Virtual Environment- Percent VE District Visits

    Acceptability was evaluated through the percentage of visits for each of the districts within the VE measured via platform metadata and logfile analysis.

    Measured: 6-month intervention period

  7. Acceptability of Virtual Environment- Total Engagements Per Module

    Acceptability was evaluated through total number of engagements per module in the VE measured via platform metadata and logfile analysis.

    Measured: 6-month intervention period

Secondary outcomes (15)
  1. Change in Body Mass Index (BMI)

    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.

    Measured: Baseline and Month 3 & 6

  2. Change in Physical Activity

    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

    Measured: Baseline and Month 3

  3. Change in Physical Activity

    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

    Measured: Baseline and Month 6

  4. Tobacco and E-cigarette Use- Question 1

    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?"

    Measured: Baseline

  5. Tobacco and E-cigarette Use- Question 2

    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?"

    Measured: Baseline

  6. Tobacco and E-cigarette Use- Question 3

    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?"

    Measured: Baseline

  7. Tobacco and E-cigarette Use- Question 4

    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?"

    Measured: Baseline

  8. Tobacco and E-cigarette Use- Question 5

    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?"

    Measured: Baseline

  9. Tobacco and E-cigarette Use- Question 6

    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?"

    Measured: Baseline

  10. Tobacco and E-cigarette Use- Question 7

    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?"

    Measured: Baseline

  11. Change in Nutrition Intake

    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.

    Measured: Baseline and Month 3

  12. Change in Nutrition Intake

    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.

    Measured: Baseline and Month 6

  13. Change in Psychosocial Wellbeing

    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.

    Measured: Baseline and Month 3 & 6

  14. Change in Revised Illness Perceptions Questionnaire

    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.

    Measured: Baseline and Month 3

  15. Change in Revised Illness Perceptions Questionnaire

    The Revised Illness Perception Questionnaire was used to assess perceptions about hypertension and diabetes on a 5-point Likert scale ("strongly disagree" to "strongly agree") over 8 dimensions. 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.

    Measured: Baseline and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2022
  2. Study start10 May 2023
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05242952
Sponsor's protocol ID
2000031403
Other IDs
1K01HL145580-01A1
Acronym
LEARN
Status last verified
Jul 2026
First submitted
28 Oct 2020
Last updated
16 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ramos SR, Reynolds H, Johnson C, Melkus G, Kershaw T, Thayer JF, Vorderstrasse A. Perceptions of HIV-Related Comorbidities and Usability of a Virtual Environment for Cardiovascular Disease Prevention Education in Sexual Minority Men With HIV: Formative Phases of a Pilot Randomized Controlled Trial. J Med Internet Res. 2024 Aug 22;26:e57351. doi: 10.2196/57351.

    PubMed 38924481
  • Ramos SR, Warren R, Shedlin M, Melkus G, Kershaw T, Vorderstrasse A. A Framework for Using eHealth Interventions to Overcome Medical Mistrust Among Sexual Minority Men of Color Living with Chronic Conditions. Behav Med. 2019 Apr-Jun;45(2):166-176. doi: 10.1080/08964289.2019.1570074.

    PubMed 31343963
  • Ramos SR, O'Hare OM, Hernandez Colon A, Kaplan Jacobs S, Campbell B, Kershaw T, Vorderstrasse A, Reynolds HR. Purely Behavioral: A Scoping Review of Nonpharmacological Behavioral and Lifestyle Interventions to Prevent Cardiovascular Disease in Persons Living With HIV. J Assoc Nurses AIDS Care. 2021 Sep-Oct 01;32(5):536-547. doi: 10.1097/JNC.0000000000000230.

    PubMed 33481464
  • Ramos SR, Johnson C, Melkus G, Kershaw T, Gwadz M, Reynolds H, Vorderstrasse A. 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. JMIR Res Protoc. 2022 May 17;11(5):e38348. doi: 10.2196/38348.

    PubMed 35579928
  • Ramos SR, Boerger L, Restar AJ, Phadke M, Jeon S, Johnson C, Melkus G, Kershaw T, Reynolds H, Vorderstrasse A. A Web-Based Virtual Environment Behavioral Intervention as Cardiovascular Disease and Metabolic Disease Prevention Education in Persons With HIV: Evaluation of the LEARN Randomized Controlled Trial. J Med Internet Res. 2026 Jun 15;28:e91145. doi: 10.2196/91145.

    PubMed 42154285

Questions about this trial

What is this clinical trial studying?

A study testing Gaming in a virtual environment in people with Cardiovascular Diseases, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Virtual Environment Intervention (time frame: Baseline through Month 6). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05242952, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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