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临床试验/NCT03766165
NCT03766165已完成不适用

The Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project: Feasibility Trial of an Enhanced Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys

研究概览

简要总结

The study team will conduct a two-group study to examine the feasibility of implementing an enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll approximately 40 young adults. Participants will be randomly assigned to one of two groups. The first group ("control") will receive text messages with information on job openings. The second group ("intervention") will receive text messages with information on job openings plus HIV prevention and business educational sessions, mentored apprenticeship, a start-up grant (provided in 6 payments), and HIV behavioral economics text messages.

详细描述

The study team will conduct a two-group study to examine the feasibility of implementing an enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll approximately 40 young adults, aged 18 to 24, who are African-American, homeless, out-of-school, unemployed or under-employed, report unprotected/unsafe sex, and have access to a cell phone. Participants will be randomly assigned to one of two groups. The first group ("control") will receive text messages with information on job openings. The second group ("intervention") will receive text messages with information on job openings plus HIV prevention and business educational sessions, mentored apprenticeship, a start-up grant (provided in 6 payments), and HIV behavioral economics text messages. Data will be collected for 26 weeks (week 1 to week 26). Participants will undergo a baseline in-person interview at the time of enrollment (week 1) and be randomized to a group after completing a 3-week run-in period (week 1 to week 3). Each group will receive the assigned activities for 20 weeks (week 4 to week 23). An endline in-person interview will be conducted in and around week 26, respectively. Participants will also complete a weekly text message survey from enrollment (week 1) to the end of the study (week 26). The study team will collect feasibility information pertaining to two primary outcomes: (i) the proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys at week 26 and (ii) the proportion of participants in the intervention group who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) at week 23. As secondary outcomes, the study team will collect feasibility information about the proportion of all participants who receive one or more informational text messages each week, the proportion of all participants who respond to a text message survey each week, the proportion of intervention participants who attend an educational session each week, the proportion of intervention participants who receive one or more mentor contacts each week, and the proportion of intervention participants who spend one or more grant payments each week. The study team will also examine the completion and variation in behavioral outcomes pertaining to the proportion of participants in each group who report one or more unprotected/unsafe sex acts in the last week and last month, the proportion of participants in each group who report one or more safer sex acts in the last week and last month, the proportion of participants in each group who report one or more HIV prevention care-seeking or information-seeking acts in the last week and last month, and the proportion of participants in each group who report one or more paid hours of work in the last week and last month. The study is anticipated to start in December 2018.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys

时间窗: Measured at week 26

Proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys (description)

Proportion of Intervention Participants Who Have Completed 70% or More of Intervention Activities (i.e., Text Message Receipt, Session Attendance, Grant Spending, and Mentor Contact)

时间窗: Measured at week 23

Proportion of intervention participants who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) (description)

次要结局

  • Proportion of Intervention Participants Who Attend an Educational Session(Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23)
  • Proportion of Intervention Participants Who Receive One or More Mentor Contacts(Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23)
  • Proportion of All Participants Who Receive One or More Informational Text Messages(Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23)
  • Proportion of All Participants Who Respond to the Text Message Survey(Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26)
  • Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Week(Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26)
  • Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month(Measured at week 1 and 26)
  • Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Week(Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26)
  • Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month(Measured at week 1 and 26)
  • Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Week(Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26)
  • Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month(Measured weekly at week 1 and 26)
  • Proportion of Intervention Participants Who Spend One or More Grant Payments(Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23)
  • Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Week(Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26)
  • Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month(Measured at week 1 and 26)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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