Clinical trial NCT05242952: The LEARN Study for CVD Prevention
Official title: LEveraging A viRtual eNvironment (LEARN) to Enhance Prevention of HIV-related Comorbidities in At-risk Minority MSM
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Comorbidity
Cardiovascular Diseases
Sexual and Gender Minorities
HIV Infections
Virtual Reality
Cardiovascular Health
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-02-16
Enrollment: 80
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability/Feasibility {change over 3 timepoints}
timeFrame: Baseline and Month 3 & 6
Secondary outcomes:
measure: Cardiovascular health {change over 3 timepoints}
timeFrame: Baseline and Month 3 & 6
measure: Physical Activity {change over 3 timepoints}
timeFrame: Baseline and Month 3 & 6
measure: Tobacco and E-cigarette use {change over 3 timepoints}
timeFrame: Baseline and Month 3 & 6
measure: Food consumption {change over 3 timepoints}
timeFrame: Baseline and Month 3 & 6
measure: Psychosocial wellbeing {change over 3 timepoints}
timeFrame: Baseline and Month 3 & 6
measure: Illness Perceptions {change over 3 timepoints}
timeFrame: Baseline and Month 3 & 6
Other outcomes:
Locations:
city: Orange
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University School of Nursing
name: S. Raquel Ramos, PhD, MBA, MSN, FNP-BC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: 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.