Theoretically Informed Behavioral Intervention

Trial Title: Theoretically Informed Behavioral Intervention

NCT ID: NCT06580184

Condition: HIV, CVD, Metabolic Diseases

Conditions: Official terms:
Metabolic Diseases

Conditions: Keywords:
Syndemic; HIV; CVD; HTN; Diabetes Mellitus; Cancer Virtual Reality; Sexual Minorities

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Participant)

Intervention:

Intervention type: Behavioral
Intervention name: LEARN 2 Platform
Description: 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.
Arm group label: LEARN 2 Platform
Arm group label: Waitlist Control

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.

Criteria for eligibility:
Criteria:
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.

Gender: Male

Gender based: Yes

Minimum age: 25 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Yale University

Address:
City: Orange
Zip: 06477
Country: United States

Start date: September 2024

Completion date: June 30, 2029

Lead sponsor:
Agency: Yale University
Agency class: Other

Source: Yale University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06580184