集成支持以促进与应用程序一起工作的黑人青少年的准备
青少年讲话研究：整合支持以促进与应用程序一起工作的黑人青少年的准备
This study applies Social Cognitive Theory to develop behavioral interventions promoting PrEP adherence. It seeks to adapt and test the enhanced HMP app for feasibility and acceptability among Black adolescents and young adults (AYAs) and adult supports.
研究概览
详细说明
HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infections, reducing the risk by over 90%. However, adherence among AYAs remains suboptimal, with only 34% maintaining adherence at 48 weeks. Studies suggest that adult support can improve adherence in pediatric HIV treatment, but this approach has not been systematically evaluated for PrEP use in AYAs. Prior research indicates that Black AYAs and their families are open to incorporating adult support for PrEP adherence.
Given the success of mobile health (mHealth) interventions in promoting sexual health, this study aims to enhance the HealthMPowerment (HMP) app-an existing mHealth platform designed for HIV prevention-to facilitate dyadic communication between Black AYAs and trusted adult support persons.
The study addresses the high rates of HIV among Black adolescents and young adults (AYAs) in Alabama, where AYAs (ages 13-24) account for 31% of new HIV diagnoses, with Black gay and bisexual males, transgender individuals, and heterosexual young women being disproportionately affected. Nearly half of new infections occur in rural areas. The U.S. Department of Health and Human Services Ending the HIV Epidemic initiative prioritizes Alabama as a geographic hotspot, emphasizing the need for patient-centered interventions to reduce HIV incidence.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Samantha Hill, MD, MPH
- 电话号码：404-778-1537
- 邮箱：svhill2@emory.edu
研究联系人备份
- 姓名：Stephanie Wallace, MD, MPH
- 电话号码：(205) 638-9345
- 邮箱：stepheni@uab.edu
学习地点
-
-
Alabama
-
Birmingham、Alabama、美国、25294-0111
- University of Alabama
-
接触：
- Stephenie Wallace, MD
- 电话号码：(205) 638-9345
- 邮箱：stepheni@uab.edu
-
副研究员：
- Stephanie Wallace, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
-
African Americans
-
Living in the state of Alabama
-
Have a PrEP indication (e.g. sex with a partner living with HIV, condomless sex, sex with multiple partners, engagement in transactional sex, or at least one sexually transmitted infection in the past 6 months)
-
Support Person:
- >21 years old
- self-reported provision of instrumental, informational, or emotional support for a Black AYA 14-21 years old
Exclusion Criteria:
- HIV positive
- Inability to provide informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 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：AYA group
All enrolled participants (AYAs and support persons) will receive a demonstration of the app including all of its features. All participants will use the app for 6 months. Each dyad of participants will instructed to use the app to communicate with each other and AYAs will be instructed to use the app to keep track of their PrEP. Data from the medication tracker will be collected at 1-, 3-, and 6-months |
A mobile health app designed to facilitate increased PrEP use and adherence among AYAs |
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 |
|---|---|---|
|
Acceptability/Usability
大体时间：1 month, 3 months, and 6 months
|
The study evaluates an app's impact through post-intervention interviews, focusing on user experience, ethical concerns, and future usage intentions. It explores burden, satisfaction, attitudes, and how the app influences communication and adherence. Sekhon's Theoretical Framework of Acceptability will be utilized to measure this outcome. |
1 month, 3 months, and 6 months
|
|
Feasibility: Communication
大体时间：1 month, 3 months, and 6 months
|
Communication between adolescents and young adults (AYA) and support person (i.e., Experience using chat features; Experience using forums). A modified version of Structured Assessment of FEasibility (SAFE) will be utilized to measure this outcome. |
1 month, 3 months, and 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Medication Adherence Tracker
大体时间：1 month, 3 months, and 6 months
|
This will be measured by analyzing the percent of dates with data entered into the medication tracker and correlating that data with reasons why participants did not take their medication (when applicable) |
1 month, 3 months, and 6 months
|
|
Data Usage
大体时间：1 month, 3 months, and 6 months
|
This will be measured by comparing the amount of time (minutes) spent using distinct features of the app (e.g. forums, educational resources, avatars, side effect trackers, chat features) |
1 month, 3 months, and 6 months
|
合作者和调查者
调查人员
- 首席研究员：Samantha Hill, MD, MPH、Emory University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- STUDY00007320
- 7K23MH128128-03 (美国 NIH 拨款/合同)
- 2024P007023 (其他标识符：Emory IRB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Individual participant data that underlie the results in the article, after deidentification (text, tables, figures, and appendices).
IPD 共享时间框架
Beginning 3 months and ending 5 years following article publication
IPD 共享访问标准
Proposals should be directed to svhill2@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are delivered electronically to investigators.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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