Engineering an Online STI Prevention Program: CSE2
2019年7月3日 更新者:Linda Collins、Penn State University
The Intersection of Alcohol and Sex: Engineering an Online STI Prevention Program
The overall objective of the proposed research is to reduce the incidence of sexually transmitted infections (STIs) among college students.
The investigators propose to accomplish this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to develop a highly effective, appealing, economical, and readily scalable internet-delivered behavioral intervention targeting the intersection of alcohol use and sexual risk behavior.
The rate of STIs on college campuses is alarming: one in four college students is diagnosed with an STI at least once during their college experience.
Sexual activity when drinking alcohol is highly prevalent among college students.
Alcohol use is known to contribute to the sexual risk behaviors that are most responsible for the transmission of STIs, namely unprotected sex, contact with numerous partners, and "hook-ups" (casual sexual encounters).
Few interventions have been developed that explicitly target the intersection of alcohol use and sexual risk behaviors, and none have been optimized.
In order to reduce the incidence of STI transmission among this and other high-risk groups, a new approach is needed.
MOST is a comprehensive methodological framework that brings the power of engineering principles to bear on optimization of behavioral interventions.
MOST enables researchers to experimentally test the individual components in an intervention to determine their effectiveness, indicating which components need to be revised and re-tested.
Given the high rates of alcohol use and sex among college students, the college setting provides an ideal opportunity for intervening on alcohol use and sexual risk behaviors.
The proposed study will include a diverse population of college students on 4 campuses which will increase the generalizability of the findings.
The specific aims are to (1) develop and pilot test an initial set of online intervention components targeting the link between alcohol use and sexual risk behaviors, (2) use the MOST approach to build an optimized preventive intervention, and (3) evaluate the effectiveness of the newly optimized preventive intervention using a fully powered randomized controlled trial (RCT).
This work will result in a new, more potent behavioral intervention that will reduce the incidence of STIs among college students in the US, and will lay the groundwork for a new generation of highly effective STI prevention interventions aimed at other subpopulations at risk.
研究概览
地位
完全的
干预/治疗
- 行为的:单独感知的好处
- 行为的:强制性规范和自我效能
- 行为的:仅描述性规范
- 行为的:描述性规范和自我效能
- 行为的:描述性规范和感知利益
- 行为的:仅凭期望
- 行为的:期望和自我效能
- 行为的:期望和强制性规范
- 行为的:期望、强制性规范、益处、功效
- 行为的:期望和描述性规范
- 行为的:期望、描述性和指令性规范
- 行为的:Knowledge Alone
- 行为的:Self-efficacy alone
- 行为的:Benefits and self-efficacy
- 行为的:Injunctive norms alone
- 行为的:Injunctive norms and benefits
- 行为的:Injunctive norms, benefits, self-efficacy
- 行为的:Descriptive norms, benefits, self-efficacy
- 行为的:Descriptive norms and injunctive norms
- 行为的:Descriptive and injunctive norms, self-efficacy
- 行为的:Descriptive and injunctive norms, and benefits
- 行为的:Descriptive & injunctive norms, benefits, efficacy
- 行为的:Expectancies and perceived benefits
- 行为的:Expectancies, benefits, self-efficacy
- 行为的:Expectancies, injunctive norms, self-efficacy
- 行为的:Expectancies, injunctive norms, and benefits
- 行为的:Expectancies, descriptive norms, & self-efficacy
- 行为的:Expectancies, descriptive norms, benefits
- 行为的:Expectancies, descriptive norms, benefits, efficacy
- 行为的:Expectancies, descriptive & injunctive norms, efficacy
- 行为的:Expectancies, descriptive & injunctive norms, benefits
- 行为的:Expectancies, descriptive & injunctive, benefits, efficacy
详细说明
As part of the MOST approach, the investigators will conduct a series of screening experiments to build an optimized intervention.
The current study is the second (of two) screening experiments.
The first screening experiment corresponds to clinicaltrials.gov
ID # NCT02897804.
研究类型
介入性
注册 (实际的)
2946
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
-
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California
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Fresno、California、美国、93740
- Fresno State University
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North Dakota
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Fargo、North Dakota、美国、58108
- North Dakota State University
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Tennessee
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Murfreesboro、Tennessee、美国、37132
- Middle Tennessee State University
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Texas
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College Station、Texas、美国、77843
- Texas A&M University
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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
18年 至 30年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Currently enrolled at an American college or university
- A first-year student or first-year transfer student
- 18 years of age or older
- Have not gone through previous versions of itMatters before
Exclusion Criteria:
- Not a first-year student or transfer student
- Younger than 18 years of age
- Have gone through previous versions of itMatters
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:阶乘赋值
- 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:唯有知识
参与者将有权访问知识模块长达 3 周的时间。
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Increase knowledge relate d STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing & treatment services.
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实验性的:自我效能感
参与者将可以访问知识模块和自我效能模块长达 3 周。
|
Increase self-efficacy to us e protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
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实验性的:仅指令性规范
参与者将可以访问知识模块和强制性规范模块长达 3 周。
|
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
|
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实验性的:描述性规范和自我效能
参与者将可以访问知识模块以及描述性规范和自我效能模块长达 3 周。
|
纠正对酒精引起的性危险行为、酒精使用/滥用和性危险行为流行率的误解,并提高自我效能以使用保护性行为策略(例如,安全套谈判技巧)来减少无保护性行为。
|
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实验性的:描述性规范和感知利益
参与者将可以访问知识模块以及描述性规范和感知收益模块,为期长达 3 周。
|
纠正对酒精引起的性危险行为、酒精使用/滥用和性危险行为流行率的误解,并增加感知的好处,以使用保护性行为策略来减少在酒精影响下进行性行为的负面后果。
|
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实验性的:描述性规范和指令性规范
参与者将可以访问知识模块以及描述性规范和指令性规范模块,为期长达 3 周。
|
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
|
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实验性的:仅凭期望
参与者将可以访问知识模块和期望模块长达 3 周。
|
降低需要酒精才能有良好性接触的期望。
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实验性的:期望和自我效能
参与者将可以使用知识模块以及期望和自我效能模块长达 3 周。
|
降低对需要酒精才能有良好性接触的期望,并提高自我效能以使用保护性行为策略(例如,安全套谈判技巧)来减少无保护性行为。
|
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实验性的:期望和感知的好处
参与者将可以访问知识模块以及预期和感知收益模块,为期长达 3 周。
|
Decrease the expectation that alcohol is needed to have good sexual encounter and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
|
|
实验性的:期望和强制性规范
参与者将可以访问知识模块以及期望和强制性规范模块长达 3 周的时间。
|
降低需要酒精才能有良好性接触的期望,并纠正关于批准酒精滥用和性冒险的错误观念。
|
|
实验性的:期望、强制性规范和收益
参与者将可以访问知识模块以及期望、强制性规范和感知收益模块,为期长达 3 周。
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
|
|
实验性的:期望、强制性规范、益处、功效
参与者将可以访问知识模块以及期望、强制性规范、感知收益和自我效能模块,为期长达 3 周。
|
降低需要酒精才能有良好性接触的期望;纠正关于批准酗酒和性冒险的错误认识;增加感知到的好处,以使用保护性行为策略来减少在酒精影响下进行性行为的负面后果;提高自我效能以使用保护性行为策略(例如安全套谈判技巧)来减少无保护性行为。
|
|
实验性的:期望和描述性规范
参与者将可以访问知识模块以及期望和描述性规范模块长达 3 周的时间。
|
降低对良好性接触需要酒精的期望,并纠正对酒精引起的性危险行为、酒精使用/滥用和性危险行为普遍存在的误解。
|
|
实验性的:Perceived benefits alone
Participants will have access to the knowledge module plus the perceived benefits module for a period up to 3 weeks.
*Also referred to as 'benefits' in other arm descriptions**
|
增加感知到的好处,以使用保护性行为策略来减少在酒精影响下进行性行为的负面后果。
|
|
实验性的:Benefits and self-efficacy
Participants will have access to the knowledge module plus perceived benefits and self-efficacy modules for a period up to 3 weeks.
|
Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
实验性的:Injunctive norms and self-efficacy
Participants will have access to the knowledge module plus injunctive norms and self-efficacy modules for a period up to 3 weeks.
|
纠正关于批准酒精滥用和性冒险行为的误解,并提高自我效能以使用保护性行为策略(例如,安全套谈判技巧)来减少无保护性行为。
|
|
实验性的:Injunctive norms and benefits
Participants will have access to the knowledge module plus injunctive norms and perceived benefits modules for a period up to 3 weeks.
|
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
实验性的:Injunctive norms, benefits, self-efficacy
Participants will have access to the knowledge module plus the injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
实验性的:Descriptive norms alone
Participants will have access to the knowledge module plus the descriptive norms modules for a period up to 3 weeks.
|
纠正对酒精引起的性危险行为、酒精使用/滥用和性危险行为流行率的误解。
|
|
实验性的:Descriptive norms, benefits, self-efficacy
Participants will have access to the knowledge module plus the descriptive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
实验性的:Descriptive and injunctive norms, self-efficacy
Participants will have access to the knowledge module plus the injunctive norms and self-efficacy modules for a period up to 3 weeks.
|
orrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
实验性的:Descriptive and injunctive norms, and benefits
Participants will have access to the knowledge module plus the descriptive norms, injunctive norms, and perceived benefits modules for a period up to 3 weeks.
|
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
|
|
实验性的:Descriptive & injunctive norms, benefits, efficacy
Participants will have access to the knowledge module plus the descriptive norms, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
实验性的:Expectancies, benefits, self-efficacy
Participants will have access to the knowledge module plus the expectancies, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
实验性的:Expectancies, injunctive norms, self-efficacy
Participants will have access to the knowledge module plus the expectancies, injunctive norms, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
实验性的:Expectancies, descriptive norms, self-efficacy
Participants will have access to the knowledge module plus the expectancies, descriptive norms, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
实验性的:Expectancies, descriptive norms, benefits
Participants will have access to the knowledge module plus the expectancies, descriptive norms, and perceived benefits modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
|
|
实验性的:Expectancies, descriptive norms, benefits, efficacy
Participants will have access to the knowledge module plus the expectancies, descriptive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
实验性的:Expectancies, descriptive and injunctive norms
Participants will have access to the knowledge module plus the expectancies , descriptive norms, and injunctive norms modules for a period up to 3 weeks.
|
降低需要酒精才能有良好性接触的期望;纠正对酒精引起的性危险行为、酒精使用/滥用和性危险行为流行率的误解;并纠正关于批准酒精滥用和性冒险行为的误解。
|
|
实验性的:Expectancies, descriptive & injunctive norms, efficacy
Participants will have access to the knowledge module plus the expectancies , descriptive norms, injunctive norms, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
实验性的:Expectancies, descriptive & injunctive norms, benefits
Participants will have access to the knowledge module plus the expectancies, descriptive norms, injunctive norms, and perceived benefits modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
|
|
实验性的:Expectancies, descriptive & injunctive, benefits, efficacy
Participants will have access to the knowledge module plus the expectancies, descriptive norms, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
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 |
|---|---|---|
|
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.
大体时间:This measure will be assessed immediately following the 3-week intervention.
|
This scale consists of 6 items and will be created as a weighted scale score.
Analyses will report the mean and standard deviation and expected mean values from a regression analysis.
The scale will reflect the average perceived prevalence of the alcohol and sex behaviors.
|
This measure will be assessed immediately following the 3-week intervention.
|
|
Injunctive norms about the intersection of alcohol and sex collected via an online questionnaire.
大体时间:his measure will be assessed immediately following the 3-week intervention.
|
This scale consists of 6 items and will be created as a weighted scale score.
Analyses will report the mean and standard deviation and expected mean values from a regression analysis.
The scale will reflect the average perceived approval of the alcohol and sex behaviors, ranging from strongly disapprove to strongly approve.
|
his measure will be assessed immediately following the 3-week intervention.
|
|
Expectancies about the intersection of alcohol use and sex collected via an online questionnaire.
大体时间:This measure will be assessed immediately following the 3-week intervention.
|
This scale consists of 10 items and will be created as a weighted scale score.
Analyses will report the mean and standard deviation and expected mean values from a regression analysis.
The scale will reflect the average number of drinks expected to experience the 10 different outcomes.
|
This measure will be assessed immediately following the 3-week intervention.
|
|
Perceived benefits about using protective behavioral strategies collected via an online questionnaire.
大体时间:This measure will be assessed immediately following the 3-week intervention.
|
This scale consists of 11 items and will be created as a weighted scale score.
Analyses will report the mean and standard deviation and expected mean values from a regression analysis.
The scale will reflect the average likelihood of contracting an STI using the listed behaviors.
|
This measure will be assessed immediately following the 3-week intervention.
|
|
Self-efficacy to use protective behavioral strategies collected via an online questionnaire.
大体时间:This measure will be assessed immediately following the 3-week intervention.
|
This scale consists of 9 items and will be created as a weighted scale score.
Analyses will report the mean and standard deviation and expected mean values from a regression analysis.
The scale will reflect the average level of confidence is using protective behavioral strategies to reduce the risk of contracting and STI, ranging from not at all confident to extremely confident.
|
This measure will be assessed immediately following the 3-week intervention.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Binge drinking behavior collected via an online questionnaire.
大体时间:This measure will be assessed 1 month following the completion of the intervention.
|
This item asks how many times in the past two weeks a male has 5 or more drinks in a 2-hour period (or females 4 or more drinks in a 2-hour period).
This variable will be collapsed into 1 or more times versus other and reported as a prevalence of this behavior and used as a dichotomous outcome in regression analyses.
|
This measure will be assessed 1 month following the completion of the intervention.
|
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Unprotected sex behavior at most recent sex collected via an online questionnaire.
大体时间:This measure will be assessed 1 month following the completion of the intervention.
|
This item asks whether or not a condom was used for oral, anal or vaginal sex.
This variable will be collapsed into a dichotomous variable with unprotected anal or vaginal sex versus other and reported as a prevalence of this behavior and used as a dichotomous outcome in regression analyses.
|
This measure will be assessed 1 month following the completion of the intervention.
|
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Penetrative sex at most recent hookup collected via an online questionnaire.
大体时间:This measure will be assessed 1 month following the completion of the intervention.
|
This item asks whether or not the most recent hookup included vaginal or anal sex.
This variable will be collapsed into a dichotomous variable with penetrative sex versus other and reported as a prevalence of this behavior and used as a dichotomous outcome in regression analyses.
|
This measure will be assessed 1 month following the completion of the intervention.
|
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。
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9月18日
初级完成 (实际的)
2017年12月31日
研究完成 (实际的)
2017年12月31日
研究注册日期
首次提交
2018年1月17日
首先提交符合 QC 标准的
2018年1月17日
首次发布 (实际的)
2018年1月24日
研究记录更新
最后更新发布 (实际的)
2019年7月5日
上次提交的符合 QC 标准的更新
2019年7月3日
最后验证
2019年7月1日
更多信息
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.
单独感知的好处的临床试验
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Physician Recommended NutriceuticalsRothman Institute Orthopedics未知