Theoretically Informed Behavioral Intervention
- Conditions
- HIV, CVD, Metabolic Diseases
- Interventions
- Behavioral: LEARN 2 Platform
- Registration Number
- NCT06580184
- Lead Sponsor
- Yale University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 220
Self-identify as:
- a racial or ethnic minority
- non-heterosexual
- living with HIV
- English speaking
- Access to a device compatible with LEARN 2
- medical history of serious complications such as heart attack, stroke, cognitive impairment, or cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LEARN 2 Platform LEARN 2 Platform 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. Waitlist Control 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.
- Primary Outcome Measures
Name Time Method Quality of Life scale Baseline, 3 and 6 months 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.
- Secondary Outcome Measures
Name Time Method Diet Months 1, 3, and 5 1-item that has participants rate how healthy one's eating was that day and has been validated in EMA studies
Physical Activity Months 1, 3, and 5 3 items that assess the number of minutes of light, moderate, and heavy physical activity and has been validated in EMA studies.
Sleep Quality Months 1, 3, and 5 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
Health Care Utilization Months 1, 3, and 5 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
Sexual Health Months 1, 3, and 5 4-items that assess whether participants had sex, type of sexual activity, and whether a condom was used
Smoking Months 1, 3, and 5 2-items used in EMA studies that assessed whether the participant smoked and how many cigarettes
Social Support Months 1, 3, and 5 3-item scale that assesses the among of emotional, informational, and tangible support received from their social network
Coping Months 1, 3, and 5 7-item scale where participants rate whether they used 7 different coping strategies which has been validated in EMA studies.
LGBT Community Integration Months 1, 3, and 5 6-item measure designed to assess lesbian, gay, and bisexual (LGB) individual\'s active concealment of their sexual minority status. Averaging the six study items produces the overall SOCS score.
Trial Locations
- Locations (1)
Yale University
🇺🇸Orange, Connecticut, United States