The LEARN Study for CVD Prevention

NCT05242952 | Completed Results

• 2 other identifiers: 20000314031K01HL145580-01A1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Diseases

Keywords

Comorbidity; Cardiovascular Diseases; Sexual and Gender Minorities; HIV Infections; Virtual Reality; Cardiovascular Health

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (15)

• Change in Body Mass Index (BMI)

  Baseline and Month 3 & 6

• Change in Physical Activity

  Baseline and Month 3

• Change in Physical Activity

  Baseline and Month 6

• Tobacco and E-cigarette Use- Question 1

  Baseline

• Tobacco and E-cigarette Use- Question 2

  Baseline

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

Participants will enter an online game and learn about how to prevent cardiovascular and metabolic conditions.

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.

Behavioral: Gaming in a virtual environment

Interventions

Gaming in a virtual environment BEHAVIORAL

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.

Immediate Intervention Group; Waitlist Control Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: assigned male sex at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• myocardial infarction (MI)
• congestive heart failure (CHF)
• coronary artery bypass graft (CABG)
• cerebral vascular accident (CVA)
• cognitive impairment

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Yale University

Orange, Connecticut, 06477, United States

Location

Related Publications (5)

• 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.

  PMID: 38924481 BACKGROUND

• 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.

  PMID: 31343963 BACKGROUND

• 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.

  PMID: 33481464 BACKGROUND

• 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.

  PMID: 35579928 BACKGROUND

• 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.

  PMID: 42154285 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Coitus; HIV Infections

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

1. Sample limited to men with HIV, which may affect generalizability to other populations and chronic conditions. 2. Technical challenges with aging platform (freezing, audio problems, installation difficulties) likely constrained engagement. 3. Retention and engagement diminished over time; future iterations should develop new platform with strategies to maintain participation. 4. Exploratory nature of secondary outcomes means findings were not powered to detect significant changes.

Results Point of Contact

• Title: S. Raquel Ramos, PhD, MBA, MSN, FNYAM, FAHA, FAAN
• Organization: Yale University, School of Nursing

raquel.ramos@yale.edu

203-737-2339

Study Officials

• S. Raquel Ramos, PhD, MBA, MSN, FNP-BC

  Yale University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: February 16, 2022
• Study Start: May 10, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 16, 2026
• Results First Posted: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)