The LEARN Study for CVD Prevention

Yale University

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Gaming in a virtual environment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05242952

1K01HL145580-01A1 (U.S. NIH Grant/Contract)

2000031403

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

78 participants in 2 patient groups

Immediate Intervention Group

Experimental group

Description:

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

Treatment:

Behavioral: Gaming in a virtual environment

Waitlist Control Group

Other group

Description:

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.

Treatment:

Behavioral: Gaming in a virtual environment