- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03408743
Engineering an Online STI Prevention Program: CSE2
3 juillet 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
- Comportemental: Bénéfices perçus seuls
- Comportemental: Normes injonctives et auto-efficacité
- Comportemental: Normes descriptives seules
- Comportemental: Normes descriptives et auto-efficacité
- Comportemental: Normes descriptives et avantages perçus
- Comportemental: Les attentes seules
- Comportemental: Attentes et auto-efficacité
- Comportemental: Attentes et normes injonctives
- Comportemental: Attentes, normes injonctives, bénéfices, efficacité
- Comportemental: Attentes et normes descriptives
- Comportemental: Attentes, normes descriptives et injonctives
- Comportemental: Knowledge Alone
- Comportemental: Self-efficacy alone
- Comportemental: Benefits and self-efficacy
- Comportemental: Injunctive norms alone
- Comportemental: Injunctive norms and benefits
- Comportemental: Injunctive norms, benefits, self-efficacy
- Comportemental: Descriptive norms, benefits, self-efficacy
- Comportemental: Descriptive norms and injunctive norms
- Comportemental: Descriptive and injunctive norms, self-efficacy
- Comportemental: Descriptive and injunctive norms, and benefits
- Comportemental: Descriptive & injunctive norms, benefits, efficacy
- Comportemental: Expectancies and perceived benefits
- Comportemental: Expectancies, benefits, self-efficacy
- Comportemental: Expectancies, injunctive norms, self-efficacy
- Comportemental: Expectancies, injunctive norms, and benefits
- Comportemental: Expectancies, descriptive norms, & self-efficacy
- Comportemental: Expectancies, descriptive norms, benefits
- Comportemental: Expectancies, descriptive norms, benefits, efficacy
- Comportemental: Expectancies, descriptive & injunctive norms, efficacy
- Comportemental: Expectancies, descriptive & injunctive norms, benefits
- Comportemental: Expectancies, descriptive & injunctive, benefits, efficacy
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
2946
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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Fresno, California, États-Unis, 93740
- Fresno State University
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North Dakota
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Fargo, North Dakota, États-Unis, 58108
- North Dakota State University
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Tennessee
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Murfreesboro, Tennessee, États-Unis, 37132
- Middle Tennessee State University
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Texas
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College Station, Texas, États-Unis, 77843
- Texas A&M University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 30 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Connaissance seule
Les participants auront accès au module de connaissances pour une période allant jusqu'à 3 semaines.
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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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Expérimental: L'auto-efficacité seule
Les participants auront accès au module de connaissances ainsi qu'au module d'auto-efficacité pour une période allant jusqu'à 3 semaines.
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Increase self-efficacy to us e protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
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Expérimental: Normes injonctives seules
Les participants auront accès au module de connaissances ainsi qu'au module de normes injonctives pour une période allant jusqu'à 3 semaines.
|
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
|
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Expérimental: Normes descriptives et auto-efficacité
Les participants auront accès au module de connaissances ainsi qu'aux modules de normes descriptives et d'auto-efficacité pendant une période allant jusqu'à 3 semaines.
|
Corriger les perceptions erronées de la prévalence des comportements sexuels à risque induits par l'alcool, de la consommation/de l'abus d'alcool et des comportements sexuels à risque et augmenter l'auto-efficacité pour utiliser des stratégies comportementales protectrices (par exemple, les compétences de négociation du préservatif) pour réduire les rapports sexuels non protégés.
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Expérimental: Normes descriptives et avantages perçus
Les participants auront accès au module de connaissances ainsi qu'aux modules sur les normes descriptives et les avantages perçus pendant une période pouvant aller jusqu'à 3 semaines.
|
Corriger les perceptions erronées de la prévalence des comportements sexuels à risque induits par l'alcool, de la consommation/de l'abus d'alcool et des comportements sexuels à risque et augmenter les avantages perçus pour utiliser des stratégies comportementales protectrices afin de réduire les conséquences négatives de l'engagement dans des comportements sexuels sous l'influence de l'alcool.
|
|
Expérimental: Normes descriptives et normes injonctives
Les participants auront accès au module de connaissances ainsi qu'aux modules de normes descriptives et de normes injonctives pendant une période allant jusqu'à 3 semaines.
|
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.
|
|
Expérimental: Les attentes seules
Les participants auront accès au module de connaissances ainsi qu'au module d'attentes pendant une période allant jusqu'à 3 semaines.
|
Diminuez l'attente selon laquelle l'alcool est nécessaire pour avoir une bonne relation sexuelle.
|
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Expérimental: Attentes et auto-efficacité
Les participants auront accès au module de connaissances ainsi qu'aux modules sur les attentes et l'auto-efficacité pendant une période allant jusqu'à 3 semaines.
|
Diminuez l'attente selon laquelle l'alcool est nécessaire pour avoir une bonne relation sexuelle et augmentez l'auto-efficacité pour utiliser des stratégies comportementales protectrices (par exemple, les compétences de négociation du préservatif) pour réduire les rapports sexuels non protégés.
|
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Expérimental: Attentes et avantages perçus
Les participants auront accès au module de connaissances ainsi qu'aux modules sur les attentes et les avantages perçus pendant une période allant jusqu'à 3 semaines.
|
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.
|
|
Expérimental: Attentes et normes injonctives
Les participants auront accès au module de connaissances ainsi qu'aux modules d'attentes et de normes injonctives pendant une période allant jusqu'à 3 semaines.
|
Diminuez l'attente selon laquelle l'alcool est nécessaire pour avoir une bonne relation sexuelle et corrigez les idées fausses concernant l'approbation de l'abus d'alcool et de la prise de risques sexuels.
|
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Expérimental: Attentes, normes injonctives et avantages
Les participants auront accès au module de connaissances ainsi qu'aux modules sur les attentes, les normes injonctives et les avantages perçus pendant une période allant jusqu'à 3 semaines.
|
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.
|
|
Expérimental: Attentes, normes injonctives, bénéfices, efficacité
Les participants auront accès au module de connaissances ainsi qu'aux modules sur les attentes, les normes injonctives, les avantages perçus et l'auto-efficacité pendant une période allant jusqu'à 3 semaines.
|
Diminuer l'attente selon laquelle l'alcool est nécessaire pour avoir une bonne relation sexuelle ; corriger les perceptions erronées concernant l'approbation de l'abus d'alcool et de la prise de risques sexuels ; augmenter les avantages perçus pour utiliser des stratégies comportementales protectrices afin de réduire les conséquences négatives de l'engagement dans des comportements sexuels sous l'influence de l'alcool ; et augmenter l'auto-efficacité pour utiliser des stratégies comportementales protectrices (par exemple, les compétences de négociation du préservatif) pour réduire les rapports sexuels non protégés.
|
|
Expérimental: Attentes et normes descriptives
Les participants auront accès au module de connaissances ainsi qu'aux modules d'attentes et de normes descriptives pendant une période allant jusqu'à 3 semaines.
|
Diminuer l'attente selon laquelle l'alcool est nécessaire pour avoir une bonne relation sexuelle et corriger les perceptions erronées de la prévalence des comportements sexuels à risque induits par l'alcool, de la consommation/abus d'alcool et des comportements sexuels à risque.
|
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Expérimental: 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**
|
Augmenter les avantages perçus pour utiliser des stratégies comportementales protectrices afin de réduire les conséquences négatives de l'engagement dans des comportements sexuels sous l'influence de l'alcool.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Corriger les perceptions erronées concernant l'approbation de l'abus d'alcool et de la prise de risques sexuels et augmenter l'auto-efficacité pour utiliser des stratégies comportementales protectrices (par exemple, les compétences de négociation du préservatif) pour réduire les rapports sexuels non protégés.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: Descriptive norms alone
Participants will have access to the knowledge module plus the descriptive norms modules for a period up to 3 weeks.
|
Corriger les perceptions erronées de la prévalence des comportements sexuels à risque induits par l'alcool, de la consommation/de l'abus d'alcool et des comportements sexuels à risque.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Diminuer l'attente selon laquelle l'alcool est nécessaire pour avoir une bonne relation sexuelle ; corriger les perceptions erronées de la prévalence des comportements sexuels à risque induits par l'alcool, de la consommation/de l'abus d'alcool et des comportements sexuels à risque ; et corriger les perceptions erronées concernant l'approbation de l'abus d'alcool et de la prise de risques sexuels.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Binge drinking behavior collected via an online questionnaire.
Délai: This measure will be assessed 1 month following the completion of the intervention.
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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.
Délai: 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.
Délai: 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.
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This measure will be assessed 1 month following the completion of the intervention.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 septembre 2017
Achèvement primaire (Réel)
31 décembre 2017
Achèvement de l'étude (Réel)
31 décembre 2017
Dates d'inscription aux études
Première soumission
17 janvier 2018
Première soumission répondant aux critères de contrôle qualité
17 janvier 2018
Première publication (Réel)
24 janvier 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 juillet 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juillet 2019
Dernière vérification
1 juillet 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01AA022931-2
- R01AA022931 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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