Sexual BehaviorNCT02897804
Engineering an Online STI Prevention Program
A study testing Knowledge alone, Self-efficacy alone and Perceived benefits alone in people with Sexual Behavior and Alcohol Consumption, run by Penn State University at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Alcohol Consumption, Sexually Transmitted Diseases
- What is being tested?
- Knowledge alone, Self-efficacy alone and Perceived benefits alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,997 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Not a first year student or transfer student
- Younger than 18 years of age
- Have gone through previous versions of itMatters
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Southern Illinois University
Carbondale, Illinois, 62901
North Dakota State University
Fargo, North Dakota, 58108-6050
Fresno State University
Fresno, California, 93740
North Carolina A&T State University
Greensboro, North Carolina, 27411
About this study
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.
Read the detailed description
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 first (of two) screening experiments.
- Being tested
- Knowledge alone, Self-efficacy alone, Perceived benefits alone, Perceived benefits and self-efficacy, Injunctive norms
- Keywords
- multiphase optimization strategy, college students
- Medical subject headings
- Sexual Behavior, Alcohol Drinking, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge aloneBehavioural
Increase knowledge related STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing \& treatment services.
Self-efficacy aloneBehavioural
Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Perceived benefits aloneBehavioural
Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Perceived benefits and self-efficacyBehavioural
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.
Injunctive normsBehavioural
Correct misperceptions regarding approval of alcohol misuse \& sexual risk taking.
Injunctive norms and self-efficacyBehavioural
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.
Injunctive norms and perceived benefitsBehavioural
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.
Injunctive norms, perceived benefits, and self-efficacyBehavioural
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.
Descriptive norms aloneBehavioural
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
Descriptive norms and self-efficacyBehavioural
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.
Descriptive norms and perceived benefitsBehavioural
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.
Descriptive norms,perceived benefits,self-efficacyBehavioural
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.
Descriptive and injunctive normsBehavioural
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.
Descriptive norms, injunctive norms,self-efficacyBehavioural
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.
Descriptive and injunctive norms, benefitsBehavioural
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.
Descriptive and injunctive norms, benefits,efficacyBehavioural
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.
Expectancies aloneBehavioural
Decrease the expectation that alcohol is needed to have good sexual encounter.
Expectancies and self-efficacyBehavioural
Decrease the expectation that alcohol is needed to have good sexual encounter and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Expectancies and Perceived BenefitsBehavioural
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.
Expectancies, perceived benefits, self-efficacyBehavioural
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.
Expectancies and injunctive normsBehavioural
Decrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions regarding approval of alcohol misuse \& sexual risk taking.
Expectancies, injunctive norms, and self-efficacyBehavioural
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.
Expectancies, injunctive norms, benefitsBehavioural
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.
Expectancies, injunctive norms, benefits, efficacyBehavioural
Decrease the expectation that alcohol is needed to have good sexual encounter; 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.
Expectancies and descriptive normsBehavioural
Decrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
Expectancies, descriptive norms, and self-efficacyBehavioural
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.
Expectancies, descriptive norms, and benefitsBehavioural
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.
Expectancies,descriptive norms, benefits, efficacyBehavioural
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.
Expectancies, descriptive and injunctive normsBehavioural
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 correct misperceptions regarding approval of alcohol misuse \& sexual risk taking.
Expectancies, descr& injun norms, efficacyBehavioural
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.
Expectancies, desc & injun norms, benefitsBehavioural
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.
Expectancies,desc & injun norms,benefits,efficacyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Knowledge alone | Experimental | Participants will have access to the knowledge module for a period up to 3 weeks. Receives: Behavioral: Knowledge alone |
| Self-efficacy alone | Experimental | Participants will have access to the knowledge module plus the self-efficacy module for a period up to 3 weeks. Receives: Behavioral: Self-efficacy alone |
| Perceived benefits alone | Experimental | Participants will have access to the knowledge module plus the perceived benefits module for a period up to 3 weeks. Receives: Behavioral: Perceived benefits alone |
| Benefits and self-efficacy | Experimental | Participants will have access to the knowledge module plus the perceived benefits and self-efficacy modules for a period up to 3 weeks. Receives: Behavioral: Perceived benefits and self-efficacy |
| Injunctive norms alone | Experimental | Participants will have access to the knowledge module plus the injunctive norms module for a period up to 3 weeks. Receives: Behavioral: Injunctive norms |
| Injunctive norms and self-efficacy | Experimental | Participants will have access to the knowledge module plus the injunctive norms and self-efficacy modules for a period up to 3 weeks. Receives: Behavioral: Injunctive norms and self-efficacy |
| Injunctive norms and perceived benefits | Experimental | Participants will have access to the knowledge module plus the injunctive norms and perceived benefits modules for a period up to 3 weeks. Receives: Behavioral: Injunctive norms and perceived benefits |
| Injunctive norms, perceived benefits,self-efficacy | Experimental | 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. Receives: Behavioral: Injunctive norms, perceived benefits, and self-efficacy |
| Descriptive norms alone | Experimental | Participants will have access to the knowledge module plus the descriptive norms module for a period up to 3 weeks. Receives: Behavioral: Descriptive norms alone |
| Descriptive norms and self-efficacy | Experimental | Participants will have access to the knowledge module plus the descriptive norms and self-efficacy modules for a period up to 3 weeks. Receives: Behavioral: Descriptive norms and self-efficacy |
| Descriptive norms and perceived benefits | Experimental | Participants will have access to the knowledge module plus the descriptive norms and perceived benefits modules for a period up to 3 weeks. Receives: Behavioral: Descriptive norms and perceived benefits |
| Descriptive norms,perceived benefits,self-efficacy | Experimental | Participants will have access to the knowledge module plus the descriptive norms module for a period up to 3 weeks. Receives: Behavioral: Descriptive norms,perceived benefits,self-efficacy |
| Descriptive norms and injunctive norms | Experimental | Participants will have access to the knowledge module plus the descriptive norms and injunctive norms modules for a period up to 3 weeks. Receives: Behavioral: Descriptive and injunctive norms |
| Descriptive norms, injunctive norms,self-efficacy | Experimental | Participants will have access to the knowledge module plus the descriptive norms, injunctive norms, and self-efficacy modules for a period up to 3 weeks. Receives: Behavioral: Descriptive norms, injunctive norms,self-efficacy |
| Descriptive and injunctive norms, benefits | Experimental | 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. Receives: Behavioral: Descriptive and injunctive norms, benefits |
| Descriptive and injunctive norms, benefits,efficacy | Experimental | 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. Receives: Behavioral: Descriptive and injunctive norms, benefits,efficacy |
| Expectancies alone | Experimental | Participants will have access to the knowledge module plus the expectancies module for a period up to 3 weeks. Receives: Behavioral: Expectancies alone |
| Expectancies and self-efficacy | Experimental | Participants will have access to the knowledge module plus the expectancies and self-efficacy modules for a period up to 3 weeks. Receives: Behavioral: Expectancies and self-efficacy |
| Expectancies and perceived benefits | Experimental | Participants will have access to the knowledge module plus the expectancies and perceived benefits modules for a period up to 3 weeks. Receives: Behavioral: Expectancies and Perceived Benefits |
| Expectancies, perceived benefits, self-efficacy | Experimental | Participants will have access to the knowledge module plus the expectancies, perceived benefits, and self-efficacy modules for a period up to 3 weeks. Receives: Behavioral: Expectancies, perceived benefits, self-efficacy |
| Expectancies and injunctive norms | Experimental | Participants will have access to the knowledge module plus the expectancies and injunctive norms modules for a period up to 3 weeks. Receives: Behavioral: Expectancies and injunctive norms |
| Expectancies, injunctive norms, and self-efficacy | Experimental | Participants will have access to the knowledge module plus the expectancies, injunctive norms, and self-efficacy modules for a period up to 3 weeks. Receives: Behavioral: Expectancies, injunctive norms, and self-efficacy |
| Expectancies, injunctive norms, and benefits | Experimental | Participants will have access to the knowledge module plus the expectancies, injunctive norms, and perceived benefits modules for a period up to 3 weeks. Receives: Behavioral: Expectancies, injunctive norms, benefits |
| Expectancies, injunctive norms, benefits, efficacy | Experimental | Participants will have access to the knowledge module plus the expectancies, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks. Receives: Behavioral: Expectancies, injunctive norms, benefits, efficacy |
| Expectancies and descriptive norms | Experimental | Participants will have access to the knowledge module plus the expectancies and descriptive norms modules for a period up to 3 weeks. Receives: Behavioral: Expectancies and descriptive norms |
| Expectancies, descriptive norms, and self-efficacy | Experimental | Participants will have access to the knowledge module plus the expectancies, descriptive norms, and self-efficacy modules for a period up to 3 weeks. Receives: Behavioral: Expectancies, descriptive norms, and self-efficacy |
| Expectancies, descriptive norms, and benefits | Experimental | Participants will have access to the knowledge module plus the expectancies, descriptive norms, and perceived benefits modules for a period up to 3 weeks. Receives: Behavioral: Expectancies, descriptive norms, and benefits |
| Expectancies,descriptive norms, benefits, efficacy | Experimental | 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. Receives: Behavioral: Expectancies,descriptive norms, benefits, efficacy |
| Expectancies, descriptive and injunctive norms | Experimental | Participants will have access to the knowledge module plus the expectancies, descriptive norms, and injunctive norms modules for a period up to 3 weeks. Receives: Behavioral: Expectancies, descriptive and injunctive norms |
| Expectancies, descr& injun norms, efficacy | Experimental | 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. Receives: Behavioral: Expectancies, descr& injun norms, efficacy |
| Expectancies, desc & injun norms, benefits | Experimental | 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. Receives: Behavioral: Expectancies, desc & injun norms, benefits |
| Expectancies,desc & injun norms,benefits,efficacy | Experimental | 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. Receives: Behavioral: Expectancies,desc & injun norms,benefits,efficacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.
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.
Measured: 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.
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.
Measured: This measure will be assessed immediately following the 3-week intervention
Expectancies about the intersection of alcohol use and sex collected via an online questionnaire.
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.
Measured: This measure will be assessed immediately following the 3-week intervention
Perceived benefits about using protective behavioral strategies collected via an online questionnaire.
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.
Measured: This measure will be assessed immediately following the 3-week intervention
Self-efficacy to use protective behavioral strategies collected via an online questionnaire.
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.
Measured: This measure will be assessed immediately following the 3-week intervention
Secondary outcomes (3)
Binge drinking behavior collected via an online questionnaire
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.
Measured: 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
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.
Measured: This measure will be assessed 1 month following the completion of the intervention
Penetrative sex at most recent hookup collected via an online questionnaire
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.
Measured: This measure will be assessed 1 month following the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3,997 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Greensboro
- Responsible party
- Principal investigator, Linda Collins, Penn State University
- Investigators
- Linda M Collins, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897804
- Sponsor's protocol ID
- R01AA022931
- Status last verified
- Jan 2019
- First submitted
- 22 Aug 2016
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engineering an Online STI Prevention Program
- ClinicalTrials.gov ID
- NCT02897804
- Acronym / sponsor ID
- R01AA022931
- Keywords
- multiphase optimization strategy, college students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,997 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Greensboro
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 first (of two) screening experiments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 32
| Arm | Type | Receives |
|---|---|---|
| Knowledge alone | Experimental | Behavioral: Knowledge aloneParticipants will have access to the knowledge module for a period up to 3 weeks. |
| Self-efficacy alone | Experimental | Behavioral: Self-efficacy aloneParticipants will have access to the knowledge module plus the self-efficacy module for a period up to 3 weeks. |
| Perceived benefits alone | Experimental | Behavioral: Perceived benefits aloneParticipants will have access to the knowledge module plus the perceived benefits module for a period up to 3 weeks. |
| Benefits and self-efficacy | Experimental | Behavioral: Perceived benefits and self-efficacyParticipants will have access to the knowledge module plus the perceived benefits and self-efficacy modules for a period up to 3 weeks. |
| Injunctive norms alone | Experimental | Behavioral: Injunctive normsParticipants will have access to the knowledge module plus the injunctive norms module for a period up to 3 weeks. |
| Injunctive norms and self-efficacy | Experimental | Behavioral: Injunctive norms and self-efficacyParticipants will have access to the knowledge module plus the injunctive norms and self-efficacy modules for a period up to 3 weeks. |
| Injunctive norms and perceived benefits | Experimental | Behavioral: Injunctive norms and perceived benefitsParticipants will have access to the knowledge module plus the injunctive norms and perceived benefits modules for a period up to 3 weeks. |
| Injunctive norms, perceived benefits,self-efficacy | Experimental | Behavioral: Injunctive norms, perceived benefits, and self-efficacyParticipants will have access to the knowledge module plus the injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks. |
| Descriptive norms alone | Experimental | Behavioral: Descriptive norms aloneParticipants will have access to the knowledge module plus the descriptive norms module for a period up to 3 weeks. |
| Descriptive norms and self-efficacy | Experimental | Behavioral: Descriptive norms and self-efficacyParticipants will have access to the knowledge module plus the descriptive norms and self-efficacy modules for a period up to 3 weeks. |
| Descriptive norms and perceived benefits | Experimental | Behavioral: Descriptive norms and perceived benefitsParticipants will have access to the knowledge module plus the descriptive norms and perceived benefits modules for a period up to 3 weeks. |
| Descriptive norms,perceived benefits,self-efficacy | Experimental | Behavioral: Descriptive norms,perceived benefits,self-efficacyParticipants will have access to the knowledge module plus the descriptive norms module for a period up to 3 weeks. |
| Descriptive norms and injunctive norms | Experimental | Behavioral: Descriptive and injunctive normsParticipants will have access to the knowledge module plus the descriptive norms and injunctive norms modules for a period up to 3 weeks. |
| Descriptive norms, injunctive norms,self-efficacy | Experimental | Behavioral: Descriptive norms, injunctive norms,self-efficacyParticipants will have access to the knowledge module plus the descriptive norms, injunctive norms, and self-efficacy modules for a period up to 3 weeks. |
| Descriptive and injunctive norms, benefits | Experimental | Behavioral: Descriptive and injunctive norms, benefitsParticipants will have access to the knowledge module plus the descriptive norms, injunctive norms, and perceived benefits modules for a period up to 3 weeks. |
| Descriptive and injunctive norms, benefits,efficacy | Experimental | Behavioral: Descriptive and injunctive norms, benefits,efficacyParticipants 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. |
| Expectancies alone | Experimental | Behavioral: Expectancies aloneParticipants will have access to the knowledge module plus the expectancies module for a period up to 3 weeks. |
| Expectancies and self-efficacy | Experimental | Behavioral: Expectancies and self-efficacyParticipants will have access to the knowledge module plus the expectancies and self-efficacy modules for a period up to 3 weeks. |
| Expectancies and perceived benefits | Experimental | Behavioral: Expectancies and Perceived BenefitsParticipants will have access to the knowledge module plus the expectancies and perceived benefits modules for a period up to 3 weeks. |
| Expectancies, perceived benefits, self-efficacy | Experimental | Behavioral: Expectancies, perceived benefits, self-efficacyParticipants will have access to the knowledge module plus the expectancies, perceived benefits, and self-efficacy modules for a period up to 3 weeks. |
| Expectancies and injunctive norms | Experimental | Behavioral: Expectancies and injunctive normsParticipants will have access to the knowledge module plus the expectancies and injunctive norms modules for a period up to 3 weeks. |
| Expectancies, injunctive norms, and self-efficacy | Experimental | Behavioral: Expectancies, injunctive norms, and self-efficacyParticipants will have access to the knowledge module plus the expectancies, injunctive norms, and self-efficacy modules for a period up to 3 weeks. |
| Expectancies, injunctive norms, and benefits | Experimental | Behavioral: Expectancies, injunctive norms, benefitsParticipants will have access to the knowledge module plus the expectancies, injunctive norms, and perceived benefits modules for a period up to 3 weeks. |
| Expectancies, injunctive norms, benefits, efficacy | Experimental | Behavioral: Expectancies, injunctive norms, benefits, efficacyParticipants will have access to the knowledge module plus the expectancies, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks. |
| Expectancies and descriptive norms | Experimental | Behavioral: Expectancies and descriptive normsParticipants will have access to the knowledge module plus the expectancies and descriptive norms modules for a period up to 3 weeks. |
| Expectancies, descriptive norms, and self-efficacy | Experimental | Behavioral: Expectancies, descriptive norms, and self-efficacyParticipants will have access to the knowledge module plus the expectancies, descriptive norms, and self-efficacy modules for a period up to 3 weeks. |
| Expectancies, descriptive norms, and benefits | Experimental | Behavioral: Expectancies, descriptive norms, and benefitsParticipants will have access to the knowledge module plus the expectancies, descriptive norms, and perceived benefits modules for a period up to 3 weeks. |
| Expectancies,descriptive norms, benefits, efficacy | Experimental | Behavioral: Expectancies,descriptive norms, benefits, efficacyParticipants 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. |
| Expectancies, descriptive and injunctive norms | Experimental | Behavioral: Expectancies, descriptive and injunctive normsParticipants will have access to the knowledge module plus the expectancies, descriptive norms, and injunctive norms modules for a period up to 3 weeks. |
| Expectancies, descr& injun norms, efficacy | Experimental | Behavioral: Expectancies, descr& injun norms, efficacyParticipants 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. |
| Expectancies, desc & injun norms, benefits | Experimental | Behavioral: Expectancies, desc & injun norms, benefitsParticipants 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. |
| Expectancies,desc & injun norms,benefits,efficacy | Experimental | Behavioral: Expectancies,desc & injun norms,benefits,efficacyParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Not a first year student or transfer student
- Younger than 18 years of age
- Have gone through previous versions of itMatters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knowledge aloneIncrease knowledge related STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing \& treatment services. | Behavioural | Knowledge alone |
| Self-efficacy aloneIncrease self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex. | Behavioural | Self-efficacy alone |
| Perceived benefits aloneIncrease perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol. | Behavioural | Perceived benefits alone |
| Perceived benefits and self-efficacyIncrease 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. | Behavioural | Benefits and self-efficacy |
| Injunctive normsCorrect misperceptions regarding approval of alcohol misuse \& sexual risk taking. | Behavioural | Injunctive norms alone |
| Injunctive norms and self-efficacyCorrect 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. | Behavioural | Injunctive norms and self-efficacy |
| Injunctive norms and perceived benefitsCorrect 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. | Behavioural | Injunctive norms and perceived benefits |
| Injunctive norms, perceived benefits, and self-efficacyCorrect 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. | Behavioural | Injunctive norms, perceived benefits,self-efficacy |
| Descriptive norms aloneCorrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors. | Behavioural | Descriptive norms alone |
| Descriptive norms and self-efficacyCorrect 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. | Behavioural | Descriptive norms and self-efficacy |
| Descriptive norms and perceived benefitsCorrect 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. | Behavioural | Descriptive norms and perceived benefits |
| Descriptive norms,perceived benefits,self-efficacyCorrect 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. | Behavioural | Descriptive norms,perceived benefits,self-efficacy |
| Descriptive and injunctive normsCorrect 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. | Behavioural | Descriptive norms and injunctive norms |
| Descriptive norms, injunctive norms,self-efficacyCorrect 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. | Behavioural | Descriptive norms, injunctive norms,self-efficacy |
| Descriptive and injunctive norms, benefitsCorrect 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. | Behavioural | Descriptive and injunctive norms, benefits |
| Descriptive and injunctive norms, benefits,efficacyCorrect 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. | Behavioural | Descriptive and injunctive norms, benefits,efficacy |
| Expectancies aloneDecrease the expectation that alcohol is needed to have good sexual encounter. | Behavioural | Expectancies alone |
| Expectancies and self-efficacyDecrease the expectation that alcohol is needed to have good sexual encounter and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex. | Behavioural | Expectancies and self-efficacy |
| Expectancies and Perceived BenefitsDecrease 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. | Behavioural | Expectancies and perceived benefits |
| Expectancies, perceived benefits, self-efficacyDecrease 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. | Behavioural | Expectancies, perceived benefits, self-efficacy |
| Expectancies and injunctive normsDecrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions regarding approval of alcohol misuse \& sexual risk taking. | Behavioural | Expectancies and injunctive norms |
| Expectancies, injunctive norms, and self-efficacyDecrease 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. | Behavioural | Expectancies, injunctive norms, and self-efficacy |
| Expectancies, injunctive norms, benefitsDecrease 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. | Behavioural | Expectancies, injunctive norms, and benefits |
| Expectancies, injunctive norms, benefits, efficacyDecrease the expectation that alcohol is needed to have good sexual encounter; 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. | Behavioural | Expectancies, injunctive norms, benefits, efficacy |
| Expectancies and descriptive normsDecrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors. | Behavioural | Expectancies and descriptive norms |
| Expectancies, descriptive norms, and self-efficacyDecrease 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. | Behavioural | Expectancies, descriptive norms, and self-efficacy |
| Expectancies, descriptive norms, and benefitsDecrease 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. | Behavioural | Expectancies, descriptive norms, and benefits |
| Expectancies,descriptive norms, benefits, efficacyDecrease 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. | Behavioural | Expectancies,descriptive norms, benefits, efficacy |
| Expectancies, descriptive and injunctive normsDecrease 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 correct misperceptions regarding approval of alcohol misuse \& sexual risk taking. | Behavioural | Expectancies, descriptive and injunctive norms |
| Expectancies, descr& injun norms, efficacyDecrease 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. | Behavioural | Expectancies, descr& injun norms, efficacy |
| Expectancies, desc & injun norms, benefitsDecrease 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. | Behavioural | Expectancies, desc & injun norms, benefits |
| Expectancies,desc & injun norms,benefits,efficacyDecrease 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. | Behavioural | Expectancies,desc & injun norms,benefits,efficacy |
Primary outcome
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.
Time frame: 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.
Injunctive norms about the intersection of alcohol and sex collected via an online questionnaire.
Time frame: 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 approval of the alcohol and sex behaviors, ranging from strongly disapprove to strongly approve.
Expectancies about the intersection of alcohol use and sex collected via an online questionnaire.
Time frame: 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.
Perceived benefits about using protective behavioral strategies collected via an online questionnaire.
Time frame: 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.
Self-efficacy to use protective behavioral strategies collected via an online questionnaire.
Time frame: 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.
3 secondary outcomes
Binge drinking behavior collected via an online questionnaire
Time frame: 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
Time frame: This measure will be assessed 1 month following the completion of the intervention
Penetrative sex at most recent hookup collected via an online questionnaire
Time frame: This measure will be assessed 1 month following the completion of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda M Collins, PhD principal investigator
Penn State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge alone, Self-efficacy alone and Perceived benefits alone in people with Sexual Behavior and Alcohol Consumption, run by Penn State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire. (time frame: This measure will be assessed immediately following the 3-week intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.