The LEARN Study for CVD Prevention (LEARN)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Gaming in a virtual environment

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Orange, Connecticut, United States, 06477
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Intervention Group; Participants will enter an online game and learn about how to prevent cardiovascular and metabolic conditions.	Behavioral: Gaming 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.
Other: Waitlist Control Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline through Month 6
Acceptability of Virtual Environment- Engagement	Acceptability was evaluated through engagement with the VE measured via platform metadata and logfile analysis.	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.	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.	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.	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.	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.	6-month intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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?"	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?"	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?"	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?"	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?"	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?"	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?"	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.	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.	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.	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.	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.	Baseline and Month 6

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: S. Raquel Ramos, PhD, MBA, MSN, FNP-BC, Yale University School of Nursing

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Virtual Reality; Comorbidity; Sexual and Gender Minorities; HIV Infections; Cardiovascular Health
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Behavior; Sexual Behavior; HIV Infections; Cardiovascular Diseases; Coitus
• Other Study ID Numbers: 2000031403; 1K01HL145580-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No