mHealth Service Linkage for Young Adults Impacted by the Criminal Legal System (LYNX)
2026年5月13日 更新者：Emily Dauria、University of Pittsburgh
Technology Enhanced Substance Use and HIV Service Navigation for Justice-Involved Young Adults
This study is designed to test Project LYNX, a program designed to help young adults (ages 18-29) with recent criminal legal system involvement can find and get connected to substance use and HIV-prevention services in the community. The program combines support from a trained peer navigator with easy-to-use digital tools.
The study will:
- Adapt an existing navigator program by adding new digital (eHealth) tools that were co-developed with young adults. These tools will help navigators refer participants to the right health services.
- Refine and test the updated program to make sure it works well and is easy to use.
- Evaluate whether the program is feasible, acceptable, and helpful in linking young adults to substance use treatment and HIV-prevention services.
The overall goal is to create a practical, user-friendly system that supports young adults find and get connected to services for substance use and HIV prevention that they need.
研究概览
研究类型
介入性
注册 (估计的)
50
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。
学习联系方式
- 姓名：Emily Dauria, PhD, MPH
- 电话号码：412-383-0732
- 邮箱：efd16@pitt.edu
研究联系人备份
- 姓名：Sheridan Sweet, MPH
- 电话号码：(412) 613-8817
- 邮箱：SHS406@pitt.edu
学习地点
-
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15206
- University of Pittsburgh, School of Public Health
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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
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Self-report recent criminal legal involvement (past year);
- Self-identify as HIV-negative
- Endorse behaviors in the past 6 months indicating consideration of PrEP per the Center for Disease Control and Prevention's (CDC) risk indices
- Meet the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tools' criteria for identifying the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) substance use disorder
- Are conversant in English.
Exclusion Criteria:
- Being on PrEP
- Cognitive delays that would interfere with consent or participation
- Inability to provide contact information for >2 locator individuals
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Standard of Care
Standard of care will involve young adults (18 to 29 years) impacted by the criminal legal system engaging in and connecting with HIV and substance use services in healthcare systems via warm referral to services in the community.
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Standard of care will involve young adults (18 to 29 years) impacted by the criminal legal system engaging in and connecting with HIV and substance use services in healthcare systems via warm referral to services in the community.
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实验性的：LYNX Intervention
Project LYNX is a new program designed to help young adults involved in the criminal legal system (ages 18-29) get connected to substance use treatment and HIV-prevention services.
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LYNX is an mHealth enhanced, adapted navigator program designed to refer and link young adults (18 to 29 years) impacted by the criminal legal system to services related to substance use and HIV.
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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 |
|---|---|---|
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Linkage to substance use services
大体时间：Time Frame: 4 month post-enrollment
|
Substance use service linkage will be attendance at a substance use service appointment via self-report via the question: " Did you attend your first appointment with your substance use treatment provider?"
Yes or No.
We will report the number of participants that answered with each response option.
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Time Frame: 4 month post-enrollment
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Linkage to PrEP Services
大体时间：Time Frame: 4 month post-enrollment
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Pre-exposure Prophylaxis linkage will be self-reported engagement in PrEP related services in the last month via the question " Have you received any PrEP-related services in the past [month/3 months]?" Yes or No.
We will report the number of participants that answered with each response option.
|
Time Frame: 4 month post-enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PrEP Referral
大体时间：Time Frame: 4 month post-enrollment
|
PrEP referral be reported via self-report via the question: "Has your navigator offered to connect you to PrEP services?"
Yes or No.
We will report the number of participants that answered with each response option.
|
Time Frame: 4 month post-enrollment
|
|
Time to PrEP Linkage
大体时间：Time Frame: 4 month post-enrollment
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Time to linkage will be reported by the LYNX navigator based on the date they referred the participant to PrEP services and the date they recorded the participant first attended a PrEP related appointment.
We will report the average number of days between the date of referral and first appointment attendance.
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Time Frame: 4 month post-enrollment
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Receipt of PrEP Prescription
大体时间：Time Frame: 4 month post-enrollment
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Receipt of a PrEP prescription will be identified via self-report via the question "Have you received a prescription for PrEP?".
Yes or No.
We will report the number of participants that answered with each response option.
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Time Frame: 4 month post-enrollment
|
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Fill of PrEP Prescription
大体时间：Time Frame: 4 month post-enrollment
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Fill of a PrEP prescription will be identified via self-report via the question: "Have you filled your PrEP prescription?"
Yes or No.
We will report the number of participants that answered with each response option.
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Time Frame: 4 month post-enrollment
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PrEP Initiation
大体时间：Time Frame: 4 month post-enrollment
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PrEP initiation will be identified via self-report via the question: "Have you started to take PrEP?" Yes or No .
We will report the number of participants that answered with each response option.
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Time Frame: 4 month post-enrollment
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PrEP Adherence
大体时间：Time Frame: 4-month post-enrollment
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PrEP adherence will be identified via self-report via the question: "In the past 30 days, rate your ability to take your PrEP medications as prescribed?"
Very often, Somewhat often, Often, Not very often, Never.
We will report the number of participants that answered with each response option.
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Time Frame: 4-month post-enrollment
|
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PrEP Persistence
大体时间：Time Frame: 4-month post-enrollment
|
PrEP persistence will be identified through self-report via the question: "Have you stopped taking PrEP?: Yes or No.
We will report the number of participants that answered with each response option.
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Time Frame: 4-month post-enrollment
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Accepted Substance Use Service Referral
大体时间：Time Frame: 4 month post-enrollment
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Accepted substance use treatment referral will be reported via self-report via the question: "Has your navigator offered to connect you to substance use services?"
Yes or No.
We will report the number of participants that answered with each response option.
|
Time Frame: 4 month post-enrollment
|
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Time to Substance Use Linkage
大体时间：Time Frame: 4 month post-enrollment
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Time to linkage will be reported by the LYNX navigator based on the date they referred the participant to substance use services and the date they recorded the participant first attended a substance use related appointment.
We will report the average number of days between the date of referral and first appointment attendance.
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Time Frame: 4 month post-enrollment
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Navigation Satisfaction Tool
大体时间：Time Frame: 4-month post-enrollment
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The Navigation Satisfaction Tool (NAVSAT) includes twelve items that address client satisfaction with navigation services (e.g., How satisfied are you with the navigator's ability to listen and understand your concerns?
How satisfied are you with the frequency of contact with the navigator?).
Items are rated on a Likert scale from 1 (extremely dissatisfied / extremely unhelpful) to 7 (satisfied/ extremely satisfied).
A total item score is calculated.
Higher scores reflect greater navigator satisfaction.
We will report the mean and the standard deviation for the NAVSAT score.
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Time Frame: 4-month post-enrollment
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Client Intervention Satisfaction
大体时间：Baseline, 1-month post enrollment, 3-months post-enrollment
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The Study Participant Feedback Questionnaire (SPFQ) comprises 23-questions and is split into three brief, validated questionnaires capturing trial experience at baseline, mid-point, and end of the study.
The majority of items use a 5-point Likert satisfaction response scale.
Some questions use a yes/no scale.
The SPFQ is not designed to produce a single composite score.
Responses will be analyzed item by item and reported as frequency distributions for each individual question, by response.
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Baseline, 1-month post enrollment, 3-months post-enrollment
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Perceived Navigator Similarity
大体时间：Time Frame: 4-month post-enrollment
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The Perceived Navigator Similarity scale consists of 10 items - 5 related to personal similarity and 5 related to ethnic similarity.
Patients respond to each item using a 6-point Likert scale ranging from 0 (very different) to 5 (very similar).
We will calculate a total score by summing all items, with higher scores indicating greater perceived similarity.
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Time Frame: 4-month post-enrollment
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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：Emily Dauria, PhD, MPH、University of Pittsburgh
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。
有用的网址
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 (估计的)
2026年7月1日
初级完成 (估计的)
2026年8月30日
研究完成 (估计的)
2027年2月1日
研究注册日期
首次提交
2026年5月13日
首先提交符合 QC 标准的
2026年5月13日
首次发布 (实际的)
2026年5月20日
研究记录更新
最后更新发布 (实际的)
2026年5月20日
上次提交的符合 QC 标准的更新
2026年5月13日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- STUDY22020053 (Aim 3)
- 5R34DA057891-03 (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)？
不
IPD 计划说明
No individual participant data will be shared.
Results will be published by the investigators in academic journals.
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
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.