LEveraging A viRtual eNvironment (LEARN) to Enhance Prevention of HIV-related Comorbidities in At-risk Minority MSM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Feasibility of Virtual Environment Intervention
研究概览
简要总结
The investigator is testing a virtual environment (VE) to address prevention of HIV-related comorbidities.
详细描述
The primary aims of this study are to test the feasibility, acceptability and preliminary effects of a VE to address prevention of HIV-related comorbidities. A waitlist control feasibility clinical trial will be conducted. We will assign (N=80) eligible participants and ensure balanced allocation to intervention and control groups over the intervention period. We hypothesize that the VE will be feasible and acceptable to persons living with HIV, and that they will apply their VE learning to real-life situations and health behaviors for prevention of HIV-related comorbidities.
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
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •identify as an ethnic/racial minority with HIV
- •identify as gay, same-gender-loving, or MSM
- •able to read and understand English
- •access to a computer capable of downloading and running the VE software
- •no medical history of serious cardiovascular or cognitive complications
排除标准
- •Anything outside of inclusion parameters, including history of:
- •myocardial infarction (MI)
- •congestive heart failure (CHF)
- •coronary artery bypass graft (CABG)
- •cerebral vascular accident (CVA)
- •cognitive impairment
研究组 & 干预措施
Immediate Intervention Group
Participants will enter an online game and learn about how to prevent cardiovascular and metabolic conditions.
干预措施: Gaming in a virtual environment (Behavioral)
Waitlist Control Group
Participants will enter an online game at a later date after the immediate intervention group and learn about how to prevent cardiovascular and metabolic conditions.
干预措施: Gaming in a virtual environment (Behavioral)
结局指标
主要结局
Feasibility of Virtual Environment Intervention
时间窗: Baseline through Month 6
Feasibility was operationalized through recruitment metrics (proportion of individuals who enrolled from those initially contacted) and retention metrics (percentage of participants who completed 3-month and 6-month follow-up assessments from baseline analysis sample).
Acceptability of Virtual Environment- Engagement
时间窗: 6-month intervention period
Acceptability was evaluated through engagement with the VE measured via platform metadata and logfile analysis.
Acceptability of Virtual Environment- Total Sessions
时间窗: 6-month intervention period
Acceptability was evaluated through total sessions logged in the VE measured via platform metadata and logfile analysis.
Acceptability of Virtual Environment- Mean Session Duration
时间窗: 6-month intervention period
Acceptability was evaluated through mean session duration in the VE in minutes measured via platform metadata and logfile analysis.
Acceptability of Virtual Environment- Total Educational Quests Accessed
时间窗: 6-month intervention period
Acceptability was evaluated through the total number of distinct educational quests accessed in the VE measured via platform metadata and logfile analysis.
Acceptability of Virtual Environment- Percent VE District Visits
时间窗: 6-month intervention period
Acceptability was evaluated through the percentage of visits for each of the districts within the VE measured via platform metadata and logfile analysis.
Acceptability of Virtual Environment- Total Engagements Per Module
时间窗: 6-month intervention period
Acceptability was evaluated through total number of engagements per module in the VE measured via platform metadata and logfile analysis.
次要结局
- Change in Body Mass Index (BMI)(Baseline and Month 3 & 6)
- Change in Physical Activity(Baseline and Month 3)
- Change in Physical Activity(Baseline and Month 6)
- Tobacco and E-cigarette Use- Question 1(Baseline)
- Tobacco and E-cigarette Use- Question 2(Baseline)
- Tobacco and E-cigarette Use- Question 3(Baseline)
- Tobacco and E-cigarette Use- Question 4(Baseline)
- Tobacco and E-cigarette Use- Question 5(Baseline)
- Tobacco and E-cigarette Use- Question 6(Baseline)
- Tobacco and E-cigarette Use- Question 7(Baseline)
- Change in Nutrition Intake(Baseline and Month 3)
- Change in Nutrition Intake(Baseline and Month 6)
- Change in Psychosocial Wellbeing(Baseline and Month 3 & 6)
- Change in Revised Illness Perceptions Questionnaire(Baseline and Month 3)
- Change in Revised Illness Perceptions Questionnaire(Baseline and Month 6)