Engineering an Online STI Prevention Program: CSE2
3 de julho de 2019 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
- Comportamental: Benefícios percebidos sozinhos
- Comportamental: Normas injuntivas e autoeficácia
- Comportamental: Normas descritivas sozinhas
- Comportamental: Normas descritivas e autoeficácia
- Comportamental: Normas descritivas e benefícios percebidos
- Comportamental: Expectativas sozinhas
- Comportamental: Expectativas e autoeficácia
- Comportamental: Expectativas e normas injuntivas
- Comportamental: Expectativas, normas injuntivas, benefícios, eficácia
- Comportamental: Expectativas e normas descritivas
- Comportamental: Expectativas, normas descritivas e injuntivas
- Comportamental: Knowledge Alone
- Comportamental: Self-efficacy alone
- Comportamental: Benefits and self-efficacy
- Comportamental: Injunctive norms alone
- Comportamental: Injunctive norms and benefits
- Comportamental: Injunctive norms, benefits, self-efficacy
- Comportamental: Descriptive norms, benefits, self-efficacy
- Comportamental: Descriptive norms and injunctive norms
- Comportamental: Descriptive and injunctive norms, self-efficacy
- Comportamental: Descriptive and injunctive norms, and benefits
- Comportamental: Descriptive & injunctive norms, benefits, efficacy
- Comportamental: Expectancies and perceived benefits
- Comportamental: Expectancies, benefits, self-efficacy
- Comportamental: Expectancies, injunctive norms, self-efficacy
- Comportamental: Expectancies, injunctive norms, and benefits
- Comportamental: Expectancies, descriptive norms, & self-efficacy
- Comportamental: Expectancies, descriptive norms, benefits
- Comportamental: Expectancies, descriptive norms, benefits, efficacy
- Comportamental: Expectancies, descriptive & injunctive norms, efficacy
- Comportamental: Expectancies, descriptive & injunctive norms, benefits
- Comportamental: Expectancies, descriptive & injunctive, benefits, efficacy
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
2946
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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California
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Fresno, California, Estados Unidos, 93740
- Fresno State University
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58108
- North Dakota State University
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Tennessee
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Murfreesboro, Tennessee, Estados Unidos, 37132
- Middle Tennessee State University
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Texas
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College Station, Texas, Estados Unidos, 77843
- Texas A&M University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 30 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Conhecimento sozinho
Os participantes terão acesso ao módulo de conhecimento por um período de até 3 semanas.
|
Increase knowledge relate d STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing & treatment services.
|
|
Experimental: Autoeficácia sozinha
Os participantes terão acesso ao módulo de conhecimento mais o módulo de autoeficácia por um período de até 3 semanas.
|
Increase self-efficacy to us e protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Normas injuntivas sozinhas
Os participantes terão acesso ao módulo de conhecimento mais o módulo de normas injuntivas por um período de até 3 semanas.
|
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
|
|
Experimental: Normas descritivas e autoeficácia
Os participantes terão acesso ao módulo de conhecimento mais as normas descritivas e os módulos de autoeficácia por um período de até 3 semanas.
|
Corrigir percepções errôneas da prevalência de comportamentos sexuais de risco induzidos pelo álcool, uso/uso indevido de álcool e comportamentos sexuais de risco e aumentar a autoeficácia para usar estratégias comportamentais protetoras (por exemplo, habilidades de negociação de preservativos) para reduzir o sexo desprotegido.
|
|
Experimental: Normas descritivas e benefícios percebidos
Os participantes terão acesso ao módulo de conhecimento mais os módulos de normas descritivas e benefícios percebidos por um período de até 3 semanas.
|
Corrija as percepções errôneas da prevalência de comportamentos sexuais de risco induzidos pelo álcool, uso/uso indevido de álcool e comportamentos sexuais de risco e aumente os benefícios percebidos para usar estratégias comportamentais protetoras para reduzir as consequências negativas do envolvimento em comportamentos sexuais sob a influência do álcool.
|
|
Experimental: Normas descritivas e normas injuntivas
Os participantes terão acesso ao módulo de conhecimento mais os módulos de normas descritivas e normas injuntivas por um período de até 3 semanas.
|
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.
|
|
Experimental: Expectativas sozinhas
Os participantes terão acesso ao módulo de conhecimento mais o módulo de expectativas por um período de até 3 semanas.
|
Diminua a expectativa de que o álcool é necessário para ter um bom encontro sexual.
|
|
Experimental: Expectativas e autoeficácia
Os participantes terão acesso ao módulo de conhecimento mais os módulos de expectativas e autoeficácia por um período de até 3 semanas.
|
Diminuir a expectativa de que o álcool é necessário para ter um bom encontro sexual e aumentar a autoeficácia para usar estratégias comportamentais protetoras (por exemplo, habilidades de negociação de preservativos) para reduzir o sexo desprotegido.
|
|
Experimental: Expectativas e benefícios percebidos
Os participantes terão acesso ao módulo de conhecimento mais os módulos de expectativas e benefícios percebidos por um período de até 3 semanas.
|
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.
|
|
Experimental: Expectativas e normas injuntivas
Os participantes terão acesso ao módulo de conhecimento mais os módulos de expectativas e normas injuntivas por um período de até 3 semanas.
|
Diminuir a expectativa de que o álcool é necessário para ter um bom encontro sexual e corrigir percepções errôneas em relação à aprovação do uso indevido de álcool e tomada de risco sexual.
|
|
Experimental: Expectativas, normas injuntivas e benefícios
Os participantes terão acesso ao módulo de conhecimento mais os módulos de expectativas, normas injuntivas e benefícios percebidos por um período de até 3 semanas.
|
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.
|
|
Experimental: Expectativas, normas injuntivas, benefícios, eficácia
Os participantes terão acesso ao módulo de conhecimento mais os módulos de expectativas, normas injuntivas, benefícios percebidos e autoeficácia por um período de até 3 semanas.
|
Diminuir a expectativa de que o álcool é necessário para ter um bom encontro sexual; corrigir equívocos sobre a aprovação do uso indevido de álcool e tomada de risco sexual; aumentar os benefícios percebidos para usar estratégias comportamentais protetoras para reduzir as consequências negativas do envolvimento em comportamentos sexuais sob a influência do álcool; e aumentar a autoeficácia para usar estratégias comportamentais protetoras (por exemplo, habilidades de negociação de preservativos) para reduzir o sexo desprotegido.
|
|
Experimental: Expectativas e normas descritivas
Os participantes terão acesso ao módulo de conhecimento mais os módulos de expectativas e normas descritivas por um período de até 3 semanas.
|
Diminuir a expectativa de que o álcool é necessário para ter um bom encontro sexual e corrigir percepções errôneas da prevalência de comportamentos sexuais de risco induzidos pelo álcool, uso/abuso de álcool e comportamentos sexuais de risco.
|
|
Experimental: 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**
|
Aumentar os benefícios percebidos para usar estratégias comportamentais protetoras para reduzir as consequências negativas do envolvimento em comportamentos sexuais sob a influência do álcool.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
Corrija percepções errôneas sobre a aprovação do uso indevido de álcool e risco sexual e aumente a autoeficácia para usar estratégias comportamentais protetoras (por exemplo, habilidades de negociação de preservativos) para reduzir o sexo desprotegido.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: Descriptive norms alone
Participants will have access to the knowledge module plus the descriptive norms modules for a period up to 3 weeks.
|
Corrija as percepções errôneas da prevalência de comportamentos sexuais de risco induzidos pelo álcool, uso/abuso de álcool e comportamentos sexuais de risco.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
Diminuir a expectativa de que o álcool é necessário para ter um bom encontro sexual; corrigir percepções errôneas da prevalência de comportamentos sexuais de risco induzidos pelo álcool, uso/abuso de álcool e comportamentos sexuais de risco; e corrigir equívocos em relação à aprovação do uso indevido de álcool e tomada de risco sexual.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Binge drinking behavior collected via an online questionnaire.
Prazo: 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.
|
|
Unprotected sex behavior at most recent sex collected via an online questionnaire.
Prazo: 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.
|
|
Penetrative sex at most recent hookup collected via an online questionnaire.
Prazo: 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.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
18 de setembro de 2017
Conclusão Primária (Real)
31 de dezembro de 2017
Conclusão do estudo (Real)
31 de dezembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
17 de janeiro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de janeiro de 2018
Primeira postagem (Real)
24 de janeiro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de julho de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de julho de 2019
Última verificação
1 de julho de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R01AA022931-2
- R01AA022931 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Benefícios percebidos sozinhos
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