An interventional study of LEARN 2 Platform in HIV, CVD and Metabolic Disease, sponsored by Yale University. Not yet recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Yale University · Not applicable, Interventional, and Prevention
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 men ages 18 and older living with HIV. The main question[s] are:
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:
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. The principal questions this study aims to address are:
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:
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.
997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.
This study's planned enrollment of 164 is above the median of 48 across 670 interventional studies indexed under Metabolic Diseases.
Browse Metabolic Diseases studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Self-identify as:
Exclusion Criteria:
- medical history of serious complications such as heart attack, stroke, cognitive impairment, or cancer.
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.
Behavioral: LEARN 2 Platform
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.
Behavioral: LEARN 2 Platform
The LEARN 2 Platform will provide tailored prevention education of HIV-comorbidities with shared risk factors. Participants will navigate LEARN 2 and access targeted health content.
Quality of Life scale
29-item scale from the PROMIS® Profile 29 for adults. The quality- of-life questions include physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain intensity over the past 7 days. Each question, except for the pain intensity question, is measured on a 5-point scale.
Time frame: Baseline, 3 and 6 months
Diet
1-item that has participants rate how healthy one's eating was that day and has been validated in EMA studies
Time frame: Months 1, 3, and 5
Physical Activity
3 items that assess the number of minutes of light, moderate, and heavy physical activity and has been validated in EMA studies.
Time frame: Months 1, 3, and 5
Sleep Quality
1-item that assesses the quality of sleep for the previous night from 1(poor) to 8(extremely rested) and has been validated in EMA
Time frame: Months 1, 3, and 5
Health Care Utilization
assesses perceived health needs, whether they have a plan to deal with those needs, and whether they saw a health care provider about those needs
Time frame: Months 1, 3, and 5
Physical Relationship Health
4-items that assess whether participants were intimate and type of activity
Time frame: Months 1, 3, and 5
Smoking
2-items used in EMA studies that assessed whether the participant smoked and how many cigarettes
Time frame: Months 1, 3, and 5
Social Support
3-item scale that assesses the among of emotional, informational, and tangible support received from their social network
Time frame: Months 1, 3, and 5
Coping
7-item scale where participants rate whether they used 7 different coping strategies which has been validated in EMA studies.
Time frame: Months 1, 3, and 5
Social Cohesion
7-item scale that measures decree of cohesion within a person's neighborhood or community.
Time frame: Months 1, 3, and 5
Plan to share: No
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Yale University