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.
調査の概要
状態
完了
介入・治療
- 行動:メリットだけを実感
- 行動:差し止め規範と自己効力感
- 行動:記述規範のみ
- 行動:記述的規範と自己効力感
- 行動:記述的規範と認識される利点
- 行動:期待だけ
- 行動:期待と自己効力感
- 行動:期待と差し止めの規範
- 行動:期待、差し止めの規範、利益、有効性
- 行動:期待と記述規範
- 行動:期待、記述的および差し止め的規範
- 行動:Knowledge Alone
- 行動:Self-efficacy alone
- 行動:Benefits and self-efficacy
- 行動:Injunctive norms alone
- 行動:Injunctive norms and benefits
- 行動:Injunctive norms, benefits, self-efficacy
- 行動:Descriptive norms, benefits, self-efficacy
- 行動:Descriptive norms and injunctive norms
- 行動:Descriptive and injunctive norms, self-efficacy
- 行動:Descriptive and injunctive norms, and benefits
- 行動:Descriptive & injunctive norms, benefits, efficacy
- 行動:Expectancies and perceived benefits
- 行動:Expectancies, benefits, self-efficacy
- 行動:Expectancies, injunctive norms, self-efficacy
- 行動:Expectancies, injunctive norms, and benefits
- 行動:Expectancies, descriptive norms, & self-efficacy
- 行動:Expectancies, descriptive norms, benefits
- 行動:Expectancies, descriptive norms, benefits, efficacy
- 行動:Expectancies, descriptive & injunctive norms, efficacy
- 行動:Expectancies, descriptive & injunctive norms, benefits
- 行動:Expectancies, descriptive & injunctive, benefits, efficacy
詳細な説明
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.
研究の種類
介入
入学 (実際)
2946
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Fresno、California、アメリカ、93740
- Fresno State University
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North Dakota
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Fargo、North Dakota、アメリカ、58108
- North Dakota State University
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Tennessee
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Murfreesboro、Tennessee、アメリカ、37132
- Middle Tennessee State University
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Texas
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College Station、Texas、アメリカ、77843
- Texas A&M University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~30年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:階乗代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:知識のみ
参加者は、最大 3 週間、ナレッジ モジュールにアクセスできます。
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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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実験的:自己効力感だけ
参加者は、知識モジュールと自己効力感モジュールに最大 3 週間アクセスできます。
|
Increase self-efficacy to us e protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
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実験的:差止命令のみ
参加者は、最大 3 週間、ナレッジ モジュールと差止命令モジュールにアクセスできます。
|
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
|
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実験的:記述的規範と自己効力感
参加者は、知識モジュールに加えて、記述的規範と自己効力感モジュールに最大 3 週間アクセスできます。
|
アルコール誘発性の性的リスク行動、アルコールの使用/誤用、および性的リスク行動の蔓延に関する誤解を正し、自己効力感を高めて保護行動戦略(コンドーム交渉スキルなど)を使用して、無防備なセックスを減らします。
|
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実験的:記述的規範と認識される利点
参加者は、知識モジュールに加えて、記述的規範と認識された利点モジュールに最大 3 週間アクセスできます。
|
アルコール誘発性の性的リスク行動、アルコールの使用/誤用、および性的リスク行動の蔓延に関する誤解を正し、アルコールの影響下での性的行動に従事することの否定的な結果を減らすために保護行動戦略を使用するために認識される利点を増やします。
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実験的:記述的規範と差止的規範
参加者は、ナレッジ モジュールに加えて、記述的規範および差し止め的規範モジュールに最大 3 週間アクセスできます。
|
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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実験的:期待だけ
参加者は、最大 3 週間、ナレッジ モジュールと期待値モジュールにアクセスできます。
|
良好な性的関係を持つためにアルコールが必要であるという期待を減らします。
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実験的:期待と自己効力感
参加者は、ナレッジ モジュールに加えて、期待値と自己効力感モジュールに最大 3 週間アクセスできます。
|
良好な性的関係を持つためにアルコールが必要であるという期待を減らし、自己効力感を高めて保護行動戦略 (コンドーム交渉スキルなど) を使用して、無防備なセックスを減らします。
|
|
実験的:期待と認識される利点
参加者は、ナレッジ モジュールに加えて、最大 3 週間、期待値と認識された利点のモジュールにアクセスできます。
|
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.
|
|
実験的:期待と差し止めの規範
参加者は、最大 3 週間、ナレッジ モジュールに加えて、期待値と差止命令モジュールにアクセスできます。
|
良好な性的出会いを得るためにアルコールが必要であるという期待を減らし、アルコールの誤用や性的な危険を冒すことの承認に関する誤解を正します。
|
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実験的:期待、差し止めの規範、および利益
参加者は、ナレッジ モジュールに加えて、期待値、差止命令の規範、および認識された利点のモジュールに最大 3 週間アクセスできます。
|
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.
|
|
実験的:期待、差し止めの規範、利益、有効性
参加者は、ナレッジ モジュールに加えて、期待値、差止命令の規範、知覚される利点、および自己効力感モジュールに最大 3 週間アクセスできます。
|
良好な性的関係を持つためにアルコールが必要であるという期待を減らします。アルコールの乱用と性的なリスクテイクの承認に関する誤解を正す。アルコールの影響下で性行為を行うことによる悪影響を軽減するために、保護行動戦略を使用することで得られると思われる利益を増やします。保護されていないセックスを減らすために、保護行動戦略(コンドーム交渉スキルなど)を使用する自己効力感を高めます。
|
|
実験的:期待と記述規範
参加者は、知識モジュールに加えて、期待値と記述的規範のモジュールに最大 3 週間アクセスできます。
|
良好な性的出会いを得るためにアルコールが必要であるという期待を減らし、アルコール誘発性の性的リスク行動、アルコールの使用/誤用、および性的リスク行動の蔓延に関する誤解を正す.
|
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実験的: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**
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アルコールの影響下で性行為を行うことの悪影響を減らすために、保護行動戦略を使用することで得られる利益を増やします。
|
|
実験的: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.
|
|
実験的: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.
|
アルコールの乱用や性的な危険を冒すことの承認に関する誤解を正し、自己効力感を高めて保護行動戦略 (コンドーム交渉スキルなど) を使用して、保護されていないセックスを減らします。
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的:Descriptive norms alone
Participants will have access to the knowledge module plus the descriptive norms modules for a period up to 3 weeks.
|
アルコール誘発性の性的リスク行動、アルコールの使用/誤用、および性的リスク行動の蔓延に関する誤解を正す。
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
|
良好な性的関係を持つためにアルコールが必要であるという期待を減らします。アルコール誘発性の性的リスク行動、アルコールの使用/誤用、および性的リスク行動の蔓延に関する誤解を正す。アルコールの乱用と性的なリスクテイクの承認に関する誤解を正す。
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.
時間枠: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.
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This measure will be assessed immediately following the 3-week intervention.
|
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Injunctive norms about the intersection of alcohol and sex collected via an online questionnaire.
時間枠: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.
|
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Expectancies about the intersection of alcohol use and sex collected via an online questionnaire.
時間枠: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.
|
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Perceived benefits about using protective behavioral strategies collected via an online questionnaire.
時間枠: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.
|
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Self-efficacy to use protective behavioral strategies collected via an online questionnaire.
時間枠: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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Binge drinking behavior collected via an online questionnaire.
時間枠: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.
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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.
時間枠: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.
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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.
時間枠:This measure will be assessed 1 month following the completion of the intervention.
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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.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年9月18日
一次修了 (実際)
2017年12月31日
研究の完了 (実際)
2017年12月31日
試験登録日
最初に提出
2018年1月17日
QC基準を満たした最初の提出物
2018年1月17日
最初の投稿 (実際)
2018年1月24日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月5日
QC基準を満たした最後の更新が送信されました
2019年7月3日
最終確認日
2019年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
メリットだけを実感の臨床試験
-
Physician Recommended NutriceuticalsRothman Institute Orthopedicsわからない