The LEARN Study for CVD Prevention (LEARN)

July 25, 2025 updated by: Yale University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Acceptability/Feasibility {change over 3 timepoints}
Time Frame: Baseline and Month 3 & 6
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity {change over 3 timepoints}
Time Frame: Baseline and Month 3 & 6
International Physical Activity Questionnaire - Short Form will assess intensity of physical activity and sitting time using a 7-item, open-ended measure. Cronbach's alpha 0.80.
Baseline and Month 3 & 6
Tobacco and E-cigarette use {change over 3 timepoints}
Time Frame: Baseline and Month 3 & 6
BRFSS - self report measure questions that pertain to Tobacco use and E-cigarette use (7 questions). kappa statistic 0.81-0.92.
Baseline and Month 3 & 6
Food consumption {change over 3 timepoints}
Time Frame: Baseline and Month 3 & 6
Food Frequency Questionnaire - Reports how frequently individuals consume foods in 16 categories. Multifactor Screener has demonstrated correlations of 0.5-0.8 with estimated true intake.
Baseline and Month 3 & 6
Cardiovascular health {change over 3 timepoints}
Time Frame: Baseline and Month 3 & 6
Life's Simple 7, based on 7 modifiable health behaviors, provides scores (range, 0 to 14) based on smoking, diet, physical activity, body mass index, blood pressure, total cholesterol, and fasting glucose. This study will only measure 4 out of the 7: smoking, diet, physical activity, and BMI.
Baseline and Month 3 & 6
Psychosocial wellbeing {change over 3 timepoints}
Time Frame: Baseline and Month 3 & 6
Patient Health Questionnaire-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety.
Baseline and Month 3 & 6
Illness Perceptions {change over 3 timepoints}
Time Frame: Baseline and Month 3 & 6
The Revised Illness Perception Questionnaire measures illness perceptions about hypertension and type 2 diabetes on a 5-point Likert scale ("strongly disagree" to "strongly agree").
Baseline and Month 3 & 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 28, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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