Development and Piloting of a Just-in-Time, Personalized HIV Prevention Intervention for Youth Experiencing Homelessness (YEH) and Unstable Housing (Study Alias: HIV Prevention Messaging Intervention for YEH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effect on HIV risk as assessed by number of sexual partners
研究概览
简要总结
The purpose of this study is develop and pilot test a personalized HIV intervention with youth experiencing homelessness by creating and field testing prevention messages that address real-time predictors (e.g., sexual urge, use to use drugs, and substance use) of HIV risk behaviors,to evaluate the feasibility and acceptability of the intervention and to evaluate the intervention outcome effects on HIV risk behaviors (e.g., condomless sex, number of sexual partners, pre-exposure prophylaxis(PrEP) awareness, substance use during sex,Intravenous(IV)drug use)
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
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •HIV high risk: IV drug user or sexually active youth (sex in the past 3 months) who reports at least one of the following: condomless sex, concurrent sexual partners within 2 weeks,sex with a partner of unknown HIV status, or a bacterial STI in the last 6 months.
- •Homelessness: staying on the streets or in a place not meant for human habitation, a shelter,hotel/motel, or some place they cannot stay for more than 30 days
排除标准
- •Below 6th grade reading level:determined by the Rapid Estimate of Adult Literacy in Medicine Short Form (REALM)
结局指标
主要结局
Effect on HIV risk as assessed by number of sexual partners
时间窗: 6 weeks
Feasibility as assessed by number of participants who complete the study
时间窗: 6 weeks
Feasibility as assessed by number recruited
时间窗: baseline
Number recruited is number of eligible youth minus number who refuse to participate.
Feasibility as assessed by number of staff hours required
时间窗: 6 weeks
Acceptability as assessed by score on the Mobile App Rating Scale (MARS)
时间窗: 6 weeks
The Mobile App Rating Scale (MARS) consists of 23 items on a 5-point (1-5) scale is designed to score apps on the criteria of engagement, functionality, aesthetics, and information quality (sub-scales). Total score is determined by calculating the mean of each sub-scale and an overall mean score. High mean scores indicate a higher quality app.
Number of participants who complete greater than 80% of the Ecological Momentary Assessments (EMAs)
时间窗: 6 weeks
Acceptability as assessed by score on the System Usability Scale (SUS)
时间窗: 6 weeks
The System Usability Scale (SUS) consists of 10 items on a 5-point (0-4) Likert scale and is designed to assess acceptability of a product. Overall score ranges from 0 to 100, with higher scores indicating greater acceptability.
Feasibility as assessed by number of participants who damage or lose phones
时间窗: 6 weeks
Effect on HIV risk behaviors as assessed by number of participants who use condoms
时间窗: 6 weeks
Number of participants who read greater than 80% of Just-In-Time Adaptive Intervention (JITAI) messages
时间窗: 6 weeks
Effect on HIV risk as assessed by number who use substances before sex
时间窗: 6 weeks
Effect on HIV risk as assessed by number of participants who have pre-exposure prophylaxis (PrEP) interest
时间窗: 6 weeks
Effect on HIV risk as assessed by number of participants who undergo HIV or sexually transmitted infection (STI) testing
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Diane Santa Maria
Associate Professor
The University of Texas Health Science Center, Houston