Theoretically Informed Behavioral Intervention to Prevent HIV-related Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Quality of Life scale
研究概览
简要总结
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:
- Can the virtual environment improve quality of life among these participants?
- 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:
- Engage with the virtual environment weekly.
- Participate in virtual live health educator sessions.
- Complete daily assessments of personal health behaviors through Ecological Momentary Assessment.
详细描述
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:
- Can engagement with the virtual environment enhance the quality of life for participants?
- 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:
- Engage with the virtual environment on a weekly basis, exploring tailored health content designed to address their specific needs.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Self-identify as:
- •living with HIV
- •English speaking
- •Access to a device compatible with LEARN 2
排除标准
- •- medical history of serious complications such as heart attack, stroke, cognitive impairment, or cancer.
研究组 & 干预措施
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.
干预措施: LEARN 2 Platform (Behavioral)
Waitlist Control
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.
干预措施: LEARN 2 Platform (Behavioral)
结局指标
主要结局
Quality of Life scale
时间窗: 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.
次要结局
- Diet(Months 1, 3, and 5)
- Physical Activity(Months 1, 3, and 5)
- Sleep Quality(Months 1, 3, and 5)
- Health Care Utilization(Months 1, 3, and 5)
- Smoking(Months 1, 3, and 5)
- Social Support(Months 1, 3, and 5)
- Coping(Months 1, 3, and 5)
- Social Cohesion(Months 1, 3, and 5)
- Diet(Months 1, 3, and 5)
- Physical Activity(Months 1, 3, and 5)
- Sleep Quality(Months 1, 3, and 5)
- Health Care Utilization(Months 1, 3, and 5)
- Physical Relationship Health(Months 1, 3, and 5)
- Smoking(Months 1, 3, and 5)
- Social Support(Months 1, 3, and 5)
- Coping(Months 1, 3, and 5)
- Social Cohesion(Months 1, 3, and 5)