The LEARN Study for CVD Prevention

Cardiovascular Diseases Clinical Trial

— LEARN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05242952
• Other study ID #: 2000031403
• Secondary ID: 1K01HL145580-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Yale University	Orange	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiovascular health {change over 3 timepoints}	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
Secondary	Physical Activity {change over 3 timepoints}	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
Secondary	Tobacco and E-cigarette use {change over 3 timepoints}	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
Secondary	Food consumption {change over 3 timepoints}	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
Secondary	Psychosocial wellbeing {change over 3 timepoints}	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
Secondary	Illness Perceptions {change over 3 timepoints}	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