The LEARN Study for CVD Prevention

NCT ID: NCT05242952

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2025-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immediate Intervention Group

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

Group Type EXPERIMENTAL

Gaming in a virtual environment

Intervention Type 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.

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.

Group Type OTHER

Gaming in a virtual environment

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Nursing

Locations

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Yale University

Orange, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31343963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33481464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35579928 (View on PubMed)

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.

Reference Type RESULT
PMID: 38924481 (View on PubMed)

Other Identifiers

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1K01HL145580-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000031403

Identifier Type: -

Identifier Source: org_study_id

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