PrEP for HBCUs (Study 2) (PrEP for HBCUs)
研究概览
详细说明
The following is only pertaining to study 2, HBCUs. PrEP Smart (study 1) is not included in this record.
The investigators' overall goals are to target (a) pre-exposure prophylaxis (PrEP) uptake by addressing access and acceptability and (b) PrEP adherence among Historically Black Colleges and Universities (HBCU) students.
Aim 1/Study 1. Investigate uptake of PrEP services on HBCU campuses. Making PrEP available on HBCU campuses may address uptake by increasing (a) accessibility by allowing students to gain access to tenofovir disproxil fumarate/emtricitabine (TDF/FTC) without having to leave campus and (b) acceptability by providing trained practitioners and student advocates on campus to educate students on the benefits of PrEP. Aim 1a will target PrEP uptake at HBCUs at the healthcare systems level. The investigators will identify Student health centers (SHC) practitioners on 6 HBCUs (North Carolina Central, St. Augustine's, Fayetteville State University, Shaw, North Carolina A&T, and Bennett College). After a comprehensive SHC needs assessment, the investigators will train practitioners on eligibility for PrEP, pre-initiation counseling, and prescribing in partnership with the North Carolina AIDS Education and Training Center (NC AETC). The investigators will also engage key student organizations on campus and train motivated student advocates for the dissemination of information about PrEP on campus. Aim 1b will target PrEP uptake at the individual level. First, the investigators will collect data on all clinical encounters for PrEP at participating SHCs during the study period. Data will be collected on the basic demographics and risk factors necessitating the initiation of PrEP. The investigators will also collect data on PrEP initiations, as well as the number of prescriptions written in follow up during the period of study. To better understand PrEP behaviors on campus, the investigators will ask students initiated on PrEP to take a brief, anonymous questionnaire on relevant topics including: (1) PrEP awareness, (2) Motivation for initiating PrEP, (3) Perceived stigma of HIV and HIV associated risk factors on campus, and (4) Perceptions of confidentiality regarding seeking PrEP services on campus. The investigators anticipate enrolling approximately 250 students for this portion of the study.
Aim 2/Study 2. Adapt a smartphone-based contingency management (CM) application ("app") intervention designed to improve PrEP adherence. CM is a behavioral intervention that involves the systematic use of reinforcement dependent on the occurrence of a predefined behavior. CM improves adherence to antiretroviral therapy (ART) and post-exposure prophylaxis (PEP), and is currently being developed by the investigative team for PrEP. Since the cost of traditional CM interventions may be prohibitive in practice, the investigators will adapt this intervention using a lower cost reinforcement procedure and therefore improve the scalability of this adherence intervention. In a sample of young men who have sex with men (YMSM) prescribed PrEP (n = 20) over an 8 week period, Aim 2a will assess app interaction to address feasibility, Aim 2b will assess acceptability via self-report quantitative ratings and qualitative interviewing, Aim 2c will assess the validity of daily camera-based medication ingestion assessment via the app to validate medication adherence against blood tests to detect PrEP, and Aim 2d will assess barriers to adherence via app-based daily assessments following missed doses.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27705
- Duke University Medical Center
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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:
- Enrolled as a student in a Historically Black College or University, OR identify as Black/African American
- Male
- Self-report having sex with men in the past 6 months
- 18-30 years of age
- English-speaking
- Currently prescribed PrEP (Truvada) for HIV prevention
- Participant has an Android (using v5.x.x or lollipop) or iOS (v6.0) smartphone
Exclusion Criteria:
- History of a chronic/significant medical or psychiatric condition that will interfere with study participation
- Unable to attend sessions
学习计划
研究是如何设计的?
设计细节
- 主要用途:设备可行性
- 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 |
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实验性的:Smartphone app condition
English-speaking males, between the ages of 18-30, who are enrolled at a HBCU or identify as Black/African American, who are currently prescribed PrEP (Truvada) for HIV Prevention, and owners of either an Android or iOS smartphone, will be asked to use an application on their smart phones called "PrEP Smart".
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English-speaking males, between the ages of 18-30, who are enrolled at a HBCU or identify as Black/African American, who are currently prescribed PrEP (Truvada) for HIV Prevention, and owners of either an Android or iOS smartphone, will be asked to use an application on their smart phones called "PrEP Smart".an
application on their smart phones called "PrEP Smart".
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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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Feasibility as measured by the number of times per day that subjects initiate an interaction with PrEP Smart
大体时间:8 weeks
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As measured by the number of times per day that subjects initiate an interaction with PrEP Smart
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8 weeks
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Feasibility as measured by the number of times per day that subjects respond to a PrEP Smart prompt
大体时间:8 weeks
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As measured by the number of times per day that subjects respond to a PrEP Smart prompt
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8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Acceptability will be assessed during the final laboratory visit with an open ended qualitative interview assessing overall feedback
大体时间:8 weeks
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Will be assessed during the final laboratory visit with an open ended qualitative interview assessing overall feedback.
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8 weeks
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Acceptability will be assessed by feedback specific to each of the six individual PrEP Smart features
大体时间:8 weeks
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Will be assessed by feedback specific to each of the six individual PrEP Smart features.
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8 weeks
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Adherence will be assessed by the number of times that PrEP was taken daily over the 8 week period and the number of times that it was taken outside of a one hour window in which it was prescribed
大体时间:8 weeks
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Will be assessed by the number of times that PrEP was taken daily over the 8 week period and the number of times that it was taken outside of a one hour window in which it was prescribed.
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8 weeks
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合作者和调查者
调查人员
- 首席研究员:John T Mitchell, Ph.D.、Study Principal Investigator
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
- Pro00076107
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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
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.
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