The EMERGE Project: Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Messages in Young Adults
2019年4月10日 更新者：Johns Hopkins Bloomberg School of Public Health
The Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project: Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Messages in Homeless Young Adults
As part of the development of the Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the feasibility of assessing economic and sexual risk behaviors using text messages.
The team will enroll approximately 20 young adults, aged 18 to 24, who are African-American, homeless, out-of-school, and un/under-employed.
Participants will complete a text-messaged survey each week for 5 weeks.
The study team will collect information about the number of participants who respond to the weekly survey, the number of questions to which they respond in each survey, and the number of hours from sending a survey to participants to receiving their response.
As an exploratory aim, participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.
The study team will obtain qualitative feedback from participants regarding text messages they most and least liked.
The survey is not designed to evaluate the effectiveness of the text message intervention.
研究概览
详细说明
As part of the development of the Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the feasibility of assessing economic and sexual risk behaviors using text messages.
The study team will enroll approximately 20 young adults, aged 18 to 24, who are African-American, homeless, out-of-school, and un/under-employed.
Participants will complete a text-messaged survey each week for 5 weeks.
The study team will collect information about the number of participants who respond to the weekly survey, the number of questions to which they respond in each survey, and the number of hours from sending a survey to participants to receiving their response.
As an exploratory aim, participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.
The study team will obtain qualitative feedback from participants regarding text messages they most and least liked.
The survey is not designed to evaluate the effectiveness of the text message intervention.
The single-group study is anticipated to start in August 2017.
研究类型
介入性
注册 (实际的)
17
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Maryland
-
Baltimore、Maryland、美国、21205
- Johns Hopkins Bloomberg School of Public Health
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 24年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Individuals will be included in the study if, at the time of enrollment, they are:
- African American
- Aged 18-24
- Living in Baltimore City
- Experiencing homelessness in the past 12 months
- Employed fewer than 10 hours per week
- Not enrolled in school
- Ownership of a mobile phone with text-messaging capacity
- Reporting at least one episode of unprotected sex in prior 6 months or one other personal or sexual partner HIV risk factor within prior 6 months (STI diagnosis, sex while high or drunk, sex exchange, illicit drug use, alcohol dependence).
Exclusion Criteria:
- Aged 17 or younger.
- Older than 24 years
- Unwilling to provide consent for study participation
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Survey and informational text messages
Text-message survey and informational text messages
|
Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors.
Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Who Respond to the Survey in Week 1
大体时间：Week 1
|
Number of enrolled participants who respond to the survey in Week 1. Measure type 'number' was used for small sample size and as described in the original registration protocol.
|
Week 1
|
|
Mean Number of Questions to Which Participant Respond in Each Survey in Week 1
大体时间：Week 1
|
Mean number of questions to which enrolled participant respond in each survey in Week 1.
|
Week 1
|
|
Mean Number of Hours From Sending a Survey to Participants to Receiving Their Response in Week 1
大体时间：Week 1
|
Mean number of hours from sending a survey to enrolled participants to receiving their response in Week 1.
|
Week 1
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Larissa Jennings, PhD MHS、Johns Hopkins Bloomberg School of Public Health
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年7月7日
初级完成 (实际的)
2017年9月19日
研究完成 (实际的)
2017年9月19日
研究注册日期
首次提交
2017年7月25日
首先提交符合 QC 标准的
2017年7月31日
首次发布 (实际的)
2017年8月3日
研究记录更新
最后更新发布 (实际的)
2019年4月12日
上次提交的符合 QC 标准的更新
2019年4月10日
最后验证
2019年4月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB0007563
- K01MH107310 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
All de-identified IPD that underlie results in a publication will be shared.
IPD 共享时间框架
De-identified individual patient data (IPD) that under results in a publication will become available 12 months after publication and will be available for 24 months.
IPD 共享访问标准
Sponsor approval for data sharing will be sought.
Only bona fide research groups are eligible to access data as evidenced via curriculum vitae (CV) and the involvement of a qualified statistician or qualitative research scientist.
Data access requests should be made via email application to the principal investigator detailing the specific requirements and the proposed research and publication plan.
Data access requests will be reviewed against specific criteria by the data custodians.
Decisions about requests will be made promptly and no more than 3 months after receipt of request.
IPD 共享支持信息类型
- 研究协议
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Text-message survey and informational text messages的临床试验
-
Thomas Jefferson University完全的