Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580184
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Theoretically Informed Behavioral Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Theoretically Informed Behavioral Intervention to Prevent HIV-related Comorbidities
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions 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
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 Associations Lifes 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
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 Associations Lifes 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None