The LEARN Study for CVD Prevention
LEARN
LEveraging A viRtual eNvironment (LEARN) to Enhance Prevention of HIV-related Comorbidities in At-risk Minority MSM
2 other identifiers
interventional
78
1 country
1
Brief Summary
The investigator is testing a virtual environment to address prevention of HIV-related comorbidities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
February 16, 2022
CompletedStudy Start
First participant enrolled
May 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedJuly 28, 2025
July 1, 2025
1.9 years
October 28, 2020
July 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acceptability/Feasibility {change over 3 timepoints}
Based on Technology Acceptance Model, using the same unit of measure, we will examine Perceived Usefulness (Cronbach's alpha 0.98) and Perceived Ease of Use (Cronbach's alpha 0.94) with an online 7-point Likert scale.
Baseline and Month 3 & 6
Secondary Outcomes (6)
Cardiovascular health {change over 3 timepoints}
Baseline and Month 3 & 6
Physical Activity {change over 3 timepoints}
Baseline and Month 3 & 6
Tobacco and E-cigarette use {change over 3 timepoints}
Baseline and Month 3 & 6
Food consumption {change over 3 timepoints}
Baseline and Month 3 & 6
Psychosocial wellbeing {change over 3 timepoints}
Baseline and Month 3 & 6
- +1 more secondary outcomes
Study Arms (2)
Immediate Intervention Group
EXPERIMENTALParticipants will enter an online game and learn about how to prevent cardiovascular and metabolic conditions.
Waitlist Control Group
OTHERParticipants will enter an online game at a later date after the immediate intervention group and learn about how to prevent cardiovascular and metabolic conditions.
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Yale University
Orange, Connecticut, 06477, United States
Related Publications (4)
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: 31343963BACKGROUNDRamos 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: 33481464BACKGROUNDRamos 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: 35579928BACKGROUNDRamos 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: 38924481RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
S. Raquel Ramos, PhD, MBA, MSN, FNP-BC
Yale University School of Nursing
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 28, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share