Theoretically Informed Behavioral Intervention
NCT Number: NCT06580184
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV, CVD, Metabolic Diseases
Interventions: BEHAVIORAL: LEARN 2 Platform
Sponsor: Yale University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2029-06-30
Locations: Yale University, Orange, Connecticut, 06477, United States

Summary:
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.

Primary Outcome Measures: 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., Baseline, 3 and 6 months
Secondary Outcome Measures: Diet, 1-item that has participants rate how healthy one's eating was that day and has been validated in EMA studies, 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., 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, 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, Months 1, 3, and 5|Sexual Health, 4-items that assess whether participants had sex, type of sexual activity, and whether a condom was used, Months 1, 3, and 5|Smoking, 2-items used in EMA studies that assessed whether the participant smoked and how many cigarettes, 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, 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., Months 1, 3, and 5|LGBT Community Integration, 6-item measure designed to assess lesbian, gay, and bisexual (LGB) individual\&#39;s active concealment of their sexual minority status. Averaging the six study items produces the overall SOCS score., Months 1, 3, and 5