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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Cardiovascular Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Immediate Intervention Group | Experimental | Participants will enter an online game and learn about how to prevent cardiovascular and metabolic conditions. Receives: Behavioral: Gaming in a virtual environment |
| Waitlist Control Group | Other | 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. Receives: Behavioral: Gaming in a virtual environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted16 Feb 2022
- Study start10 May 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- S. Raquel Ramos, PhD, MBA, MSN, FNP-BC, Principal investigator, Yale University School of Nursing
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 38924481Ramos 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 31343963Ramos 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 33481464Ramos 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 35579928Ramos 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEveraging A viRtual eNvironment (LEARN) to Enhance Prevention of HIV-related Comorbidities in At-risk Minority MSM
- ClinicalTrials.gov ID
- NCT05242952
- Acronym / sponsor ID
- LEARN / 2000031403
- Conditions
- Cardiovascular Diseases
- Keywords
- Comorbidity, Cardiovascular Diseases, Sexual and Gender Minorities, HIV Infections, Virtual Reality, Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Posted 16 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Experimental | Behavioral: Gaming in a virtual environmentParticipants will enter an online game and learn about how to prevent cardiovascular and metabolic conditions. |
| Waitlist Control Group | Other | Behavioral: Gaming in a virtual environmentParticipants will enter an online game at a later date after the immediate intervention group and learn about how to prevent cardiovascular and metabolic conditions. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- myocardial infarction (MI)
- congestive heart failure (CHF)
- coronary artery bypass graft (CABG)
- cerebral vascular accident (CVA)
- cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gaming in a virtual environmentTo 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. | Behavioural | Immediate Intervention Group, Waitlist Control Group |
Primary outcome
Feasibility of Virtual Environment Intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6-month intervention period
Acceptability was evaluated through total number of engagements per module in the VE measured via platform metadata and logfile analysis.
15 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline and Month 3 & 6
Change in Physical Activity
Time frame: Baseline and Month 3
Change in Physical Activity
Time frame: Baseline and Month 6
Tobacco and E-cigarette Use- Question 1
Time frame: Baseline
Tobacco and E-cigarette Use- Question 2
Time frame: Baseline
Tobacco and E-cigarette Use- Question 3
Time frame: Baseline
Tobacco and E-cigarette Use- Question 4
Time frame: Baseline
Tobacco and E-cigarette Use- Question 5
Time frame: Baseline
Tobacco and E-cigarette Use- Question 6
Time frame: Baseline
Tobacco and E-cigarette Use- Question 7
Time frame: Baseline
Change in Nutrition Intake
Time frame: Baseline and Month 3
Change in Nutrition Intake
Time frame: Baseline and Month 6
Change in Psychosocial Wellbeing
Time frame: Baseline and Month 3 & 6
Change in Revised Illness Perceptions Questionnaire
Time frame: Baseline and Month 3
Change in Revised Illness Perceptions Questionnaire
Time frame: Baseline and Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38924481Ramos 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.
- Background: PubMed 31343963Ramos 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.
- Background: PubMed 33481464Ramos 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.
- Background: PubMed 35579928Ramos 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.
- Results publication: PubMed 42154285Ramos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Raquel Ramos, PhD, MBA, MSN, FNP-BC principal investigator
Yale University School of Nursing
1 site in 1 country: see every site and its status.
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.