- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03408743
Engineering an Online STI Prevention Program: CSE2
3 juli 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
- Beteende: Enbart upplevda fördelar
- Beteende: Förbudsnormer och self-efficacy
- Beteende: Enbart beskrivande normer
- Beteende: Beskrivande normer och self-efficacy
- Beteende: Beskrivande normer och upplevd nytta
- Beteende: Enbart förväntningar
- Beteende: Förväntningar och self-efficacy
- Beteende: Förväntningar och föreläggandenormer
- Beteende: Förväntningar, föreläggande normer, fördelar, effektivitet
- Beteende: Förväntningar och beskrivande normer
- Beteende: Förväntningar, beskrivande och föreläggande normer
- Beteende: Knowledge Alone
- Beteende: Self-efficacy alone
- Beteende: Benefits and self-efficacy
- Beteende: Injunctive norms alone
- Beteende: Injunctive norms and benefits
- Beteende: Injunctive norms, benefits, self-efficacy
- Beteende: Descriptive norms, benefits, self-efficacy
- Beteende: Descriptive norms and injunctive norms
- Beteende: Descriptive and injunctive norms, self-efficacy
- Beteende: Descriptive and injunctive norms, and benefits
- Beteende: Descriptive & injunctive norms, benefits, efficacy
- Beteende: Expectancies and perceived benefits
- Beteende: Expectancies, benefits, self-efficacy
- Beteende: Expectancies, injunctive norms, self-efficacy
- Beteende: Expectancies, injunctive norms, and benefits
- Beteende: Expectancies, descriptive norms, & self-efficacy
- Beteende: Expectancies, descriptive norms, benefits
- Beteende: Expectancies, descriptive norms, benefits, efficacy
- Beteende: Expectancies, descriptive & injunctive norms, efficacy
- Beteende: Expectancies, descriptive & injunctive norms, benefits
- Beteende: Expectancies, descriptive & injunctive, benefits, efficacy
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
2946
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Fresno, California, Förenta staterna, 93740
- Fresno State University
-
-
North Dakota
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Fargo, North Dakota, Förenta staterna, 58108
- North Dakota State University
-
-
Tennessee
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Murfreesboro, Tennessee, Förenta staterna, 37132
- Middle Tennessee State University
-
-
Texas
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College Station, Texas, Förenta staterna, 77843
- Texas A&M University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 30 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Kunskap ensam
Deltagarna kommer att ha tillgång till kunskapsmodulen under en period på upp till 3 veckor.
|
Increase knowledge relate d STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing & treatment services.
|
Experimentell: Self-efficacy ensam
Deltagarna kommer att ha tillgång till kunskapsmodulen plus self-efficacy-modulen under en period på upp till 3 veckor.
|
Increase self-efficacy to us e protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
Experimentell: Enbart föreläggande normer
Deltagarna kommer att ha tillgång till kunskapsmodulen plus normmodulen under en period på upp till 3 veckor.
|
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
|
Experimentell: Beskrivande normer och self-efficacy
Deltagarna kommer att ha tillgång till kunskapsmodulen plus de beskrivande normerna och self-efficacy-modulerna under en period på upp till 3 veckor.
|
Korrigera felaktiga uppfattningar om förekomsten av alkoholinducerade sexuella riskbeteenden, alkoholanvändning/missbruk och sexuella riskbeteenden och öka själveffektiviteten för att använda skyddande beteendestrategier (t.ex. kondomförhandlingsfärdigheter) för att minska oskyddat sex.
|
Experimentell: Beskrivande normer och upplevd nytta
Deltagarna kommer att ha tillgång till kunskapsmodulen plus modulerna beskrivande normer och upplevda förmåner under en period på upp till 3 veckor.
|
Korrigera felaktiga uppfattningar om förekomsten av alkoholinducerade sexuella riskbeteenden, alkoholanvändning/missbruk och sexuella riskbeteenden och öka upplevda fördelar för att använda skyddande beteendestrategier för att minska de negativa konsekvenserna av att delta i sexuella beteenden under påverkan av alkohol.
|
Experimentell: Beskrivande normer och föreläggande normer
Deltagarna kommer att ha tillgång till kunskapsmodulen plus modulerna beskrivande normer och föreläggande normer under en period på upp till 3 veckor.
|
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.
|
Experimentell: Enbart förväntningar
Deltagarna kommer att ha tillgång till kunskapsmodulen plus förväntansmodulen under en period på upp till 3 veckor.
|
Minska förväntan på att alkohol behövs för att ha ett bra sexuellt möte.
|
Experimentell: Förväntningar och self-efficacy
Deltagarna kommer att ha tillgång till kunskapsmodulen plus modulerna förväntningar och self-efficacy under en period på upp till 3 veckor.
|
Minska förväntningarna på att alkohol behövs för att ha bra sexuella möten och öka själveffektiviteten för att använda skyddande beteendestrategier (t.ex. kondomförhandlingsfärdigheter) för att minska oskyddat sex.
|
Experimentell: Förväntningar och upplevda fördelar
Deltagarna kommer att ha tillgång till kunskapsmodulen plus modulerna förväntningar och upplevda fördelar under en period på upp till 3 veckor.
|
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.
|
Experimentell: Förväntningar och föreläggandenormer
Deltagarna kommer att ha tillgång till kunskapsmodulen plus modulerna förväntningar och föreläggandenormer under en period på upp till 3 veckor.
|
Minska förväntningarna på att alkohol behövs för att ha ett bra sexuellt möte och korrigera missuppfattningar om godkännande av alkoholmissbruk och sexuellt risktagande.
|
Experimentell: Förväntningar, föreläggandenormer och fördelar
Deltagarna kommer att ha tillgång till kunskapsmodulen plus modulerna förväntningar, föreläggandenormer och upplevda förmåner under en period på upp till 3 veckor.
|
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.
|
Experimentell: Förväntningar, föreläggande normer, fördelar, effektivitet
Deltagarna kommer att ha tillgång till kunskapsmodulen plus förväntningar, föreläggandenormer, upplevda fördelar och moduler för self-efficacy under en period på upp till 3 veckor.
|
Minska förväntan på att alkohol behövs för att ha ett bra sexuellt möte; korrigera missuppfattningar om godkännande av alkoholmissbruk och sexuellt risktagande; öka upplevda fördelar med att använda skyddande beteendestrategier för att minska de negativa konsekvenserna av att delta i sexuella beteenden under påverkan av alkohol; och öka själveffektiviteten för att använda skyddande beteendestrategier (t.ex. kondomförhandlingsfärdigheter) för att minska oskyddat sex.
|
Experimentell: Förväntningar och beskrivande normer
Deltagarna kommer att ha tillgång till kunskapsmodulen plus modulerna förväntningar och beskrivande normer under en period på upp till 3 veckor.
|
Minska förväntningarna på att alkohol behövs för att ha ett bra sexuellt möte och korrigera missuppfattningar om förekomsten av alkoholinducerade sexuella riskbeteenden, alkoholanvändning/missbruk och sexuella riskbeteenden.
|
Experimentell: 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**
|
Öka upplevda fördelar med att använda skyddande beteendestrategier för att minska de negativa konsekvenserna av att delta i sexuella beteenden under påverkan av alkohol.
|
Experimentell: 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.
|
Experimentell: 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.
|
Korrigera missuppfattningar om godkännande av alkoholmissbruk och sexuellt risktagande och öka själveffektiviteten för att använda skyddande beteendestrategier (t.ex. kondomförhandlingsfärdigheter) för att minska oskyddat sex.
|
Experimentell: 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.
|
Experimentell: 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.
|
Experimentell: Descriptive norms alone
Participants will have access to the knowledge module plus the descriptive norms modules for a period up to 3 weeks.
|
Korrigera felaktiga uppfattningar om prevalensen av alkoholinducerade sexuella riskbeteenden, alkoholanvändning/missbruk och sexuella riskbeteenden.
|
Experimentell: 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.
|
Experimentell: 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.
|
Experimentell: 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.
|
Experimentell: 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.
|
Experimentell: 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.
|
Experimentell: 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.
|
Experimentell: 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.
|
Experimentell: 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.
|
Experimentell: 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.
|
Experimentell: 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.
|
Minska förväntan på att alkohol behövs för att ha ett bra sexuellt möte; korrigera felaktiga uppfattningar om prevalensen av alkoholinducerade sexuella riskbeteenden, alkoholanvändning/missbruk och sexuella riskbeteenden; och korrigera missuppfattningar om godkännande av alkoholmissbruk och sexuellt risktagande.
|
Experimentell: 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.
|
Experimentell: 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.
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Binge drinking behavior collected via an online questionnaire.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 september 2017
Primärt slutförande (Faktisk)
31 december 2017
Avslutad studie (Faktisk)
31 december 2017
Studieregistreringsdatum
Först inskickad
17 januari 2018
Först inskickad som uppfyllde QC-kriterierna
17 januari 2018
Första postat (Faktisk)
24 januari 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 juli 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 juli 2019
Senast verifierad
1 juli 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R01AA022931-2
- R01AA022931 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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