Theoretically Informed Behavioral Intervention

Yale University

Status: Begins enrollment this month

Conditions: HIV, CVD, Metabolic Diseases

Treatments: Behavioral: LEARN 2 Platform

Study type: Interventional

Funder types: Other

Identifiers

NCT06580184

1R01MD019956-01 (Other Grant/Funding Number)

2000033508

Details and patient eligibility

About

The goal of this waitlist control clinical trial is to learn if the tailored LEARN 2 platform can prevent HIV-related comorbidities with shared risk factors in diverse sexual minority men ages 25 and older living with HIV. The main question[s] are:

1. Can the virtual environment improve quality of life among these participants?
2. Does the LEARN 2 platform effectively serve as prevention education for HIV comorbidity shared risk factors?

Researchers will compare participants receiving the LEARN2 virtual environment intervention to those in a waitlist control group to see if the intervention leads to improvements in quality of life and reductions in risk factors.

Participants will be asked to:

1. Engage with the virtual environment weekly.
2. Participate in virtual live health educator sessions.
3. Complete daily assessments of personal health behaviors through Ecological Momentary Assessment.

Full description

The goal of this waitlist control clinical trial is to determine the efficacy of the tailored LEARN 2 platform in preventing HIV-related comorbidities characterized by shared risk factors among diverse sexual minority men ages 25 and older living with HIV. The principal questions this study aims to address are:

1. Can engagement with the virtual environment enhance the quality of life for participants specifically in diverse sexual minority men?
2. Is the LEARN 2 platform effective in providing prevention education of shared risk factors associated with HIV comorbidities?

To evaluate these objectives, the investigators will conduct comparisons between participants allocated to the LEARN 2 virtual environment intervention and those assigned to a waitlist control group. This design will facilitate the assessment of whether participation in the LEARN 2 intervention correlates with significant improvements in quality of life metrics (behavioral and psychosocial) and a reduction in associated health risk factors.

Participants will be instructed to:

1. Engage with the virtual environment on a weekly basis, exploring tailored health content designed to address their specific needs.
2. Attend virtual live sessions with health educators, where they will receive real-time education on health issues relevant to their condition and associated lifestyle factors using the American Heart Association's Life's Essential 8 as a behavioral prevention framework.
3. Complete daily assessments of their personal health behaviors using Ecological Momentary Assessment (EMA), capturing real-time data on behavioral trends that may influence their health outcomes.

This systematic approach aims to generate comprehensive data on the impact of the LEARN 2 intervention on both quality of life and the modulation of health-related behaviors among these at-risk populations.

Enrollment: 220 estimated patients

Sex: Male

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Self-identify as:

• a racial or ethnic minority
• non-heterosexual
• living with HIV
• English speaking
• Access to a device compatible with LEARN 2

Exclusion criteria

• medical history of serious complications such as heart attack, stroke, cognitive impairment, or cancer.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

LEARN 2 Platform

Experimental group

Description:

The intervention arm in this study involves participants engaging with the LEARN2 virtual environment, designed to provide tailored prevention education for HIV-related comorbidities with shared risk factors. Participants will navigate a virtual platform focused on health education related to body systems, utilizing customizable avatars for anonymity and comfort.

Treatment:

Behavioral: LEARN 2 Platform

Waitlist Control

Active Comparator group

Description:

The waitlist control group will not have immediate access to the LEARN2 intervention but will receive a welcome packet with information on how to contact the study team and the date they will gain access to the intervention after a waiting period. This design helps to ensure that all participants eventually receive the intervention while allowing researchers to assess the efficacy of the LEARN2 platform.

Treatment:

Behavioral: LEARN 2 Platform