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The LEARN Study for CVD Prevention

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05242952
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
80
Enrollment
1
Location
2
Arms
23.5
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gaming in a virtual environment
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
LEveraging A viRtual eNvironment (LEARN) to Enhance Prevention of HIV-related Comorbidities in At-risk Minority MSM
Anticipated Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Acceptability/Feasibility {change over 3 timepoints} [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.

Secondary Outcome Measures

  1. Cardiovascular health {change over 3 timepoints} [Baseline and Month 3 & 6]

    Life's Simple 7, based on 4 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.

  2. Physical Activity {change over 3 timepoints} [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.

  3. Tobacco and E-cigarette use {change over 3 timepoints} [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.

  4. Food consumption {change over 3 timepoints} [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale University Orange Connecticut United States 06477

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: S. Raquel Ramos, PhD, MBA, MSN, FNP-BC, Yale University School of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05242952
Other Study ID Numbers:
  • 2000031403
  • 1K01HL145580-01A1
First Posted:
Feb 16, 2022
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yale University
Comorbidity
Cardiovascular Diseases
Sexual and Gender Minorities
HIV Infections
Virtual Reality
Cardiovascular Health
Additional relevant MeSH terms:
Cardiovascular Diseases

Study Results

No Results Posted as of Jul 26, 2022