Engineering an Online STI Prevention Program

NCT02897804 | Completed

• 1 other identifier: R01AA022931
• Study Type: interventional
• Target: 3,997
• Locations: 1 country
• Sites: 4

Brief 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, 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.

Conditions

Sexual Behavior; Alcohol Consumption; Sexually Transmitted Diseases

Keywords

multiphase optimization strategy; college students

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  This measure will be assessed immediately following the 3-week intervention

Secondary Outcomes (3)

• Binge drinking behavior collected via an online questionnaire

  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 measure will be assessed 1 month following the completion of the intervention

• Penetrative sex at most recent hookup collected via an online questionnaire

  This measure will be assessed 1 month following the completion of the intervention

Study Arms (32)

Knowledge alone

EXPERIMENTAL

Participants will have access to the knowledge module for a period up to 3 weeks.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Behavioral: Expectancies,desc & injun norms,benefits,efficacy

Interventions

Knowledge alone BEHAVIORAL

Increase knowledge related STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing \& treatment services.

Knowledge alone

Self-efficacy alone BEHAVIORAL

Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.

Self-efficacy alone

Perceived benefits alone BEHAVIORAL

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 alone

Perceived benefits and self-efficacy BEHAVIORAL

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.

Benefits and self-efficacy

Injunctive norms BEHAVIORAL

Correct misperceptions regarding approval of alcohol misuse \& sexual risk taking.

Injunctive norms alone

Injunctive norms and self-efficacy BEHAVIORAL

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 self-efficacy

Injunctive norms and perceived benefits BEHAVIORAL

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 and perceived benefits

Injunctive norms, perceived benefits, and self-efficacy BEHAVIORAL

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.

Injunctive norms, perceived benefits,self-efficacy

Descriptive norms alone BEHAVIORAL

Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.

Descriptive norms alone

Descriptive norms and self-efficacy BEHAVIORAL

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 self-efficacy

Descriptive norms and perceived benefits BEHAVIORAL

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 and perceived benefits

Descriptive norms,perceived benefits,self-efficacy BEHAVIORAL

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 norms,perceived benefits,self-efficacy

Descriptive and injunctive norms BEHAVIORAL

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 and injunctive norms

Descriptive norms, injunctive norms,self-efficacy BEHAVIORAL

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 norms, injunctive norms,self-efficacy

Descriptive and injunctive norms, benefits BEHAVIORAL

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

Descriptive and injunctive norms, benefits,efficacy BEHAVIORAL

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.

Descriptive and injunctive norms, benefits,efficacy

Expectancies alone BEHAVIORAL

Decrease the expectation that alcohol is needed to have good sexual encounter.

Expectancies alone

Expectancies and self-efficacy BEHAVIORAL

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 self-efficacy

Expectancies and Perceived Benefits BEHAVIORAL

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 and perceived benefits

Expectancies, perceived benefits, self-efficacy BEHAVIORAL

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, perceived benefits, self-efficacy

Expectancies and injunctive norms BEHAVIORAL

Decrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions regarding approval of alcohol misuse \& sexual risk taking.

Expectancies and injunctive norms

Expectancies, injunctive norms, and self-efficacy BEHAVIORAL

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, and self-efficacy

Expectancies, injunctive norms, benefits BEHAVIORAL

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, and benefits

Expectancies, injunctive norms, benefits, efficacy BEHAVIORAL

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, injunctive norms, benefits, efficacy

Expectancies and descriptive norms BEHAVIORAL

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 and descriptive norms

Expectancies, descriptive norms, and self-efficacy BEHAVIORAL

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 self-efficacy

Expectancies, descriptive norms, and benefits BEHAVIORAL

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, and benefits

Expectancies,descriptive norms, benefits, efficacy BEHAVIORAL

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 norms, benefits, efficacy

Expectancies, descriptive and injunctive norms BEHAVIORAL

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, descriptive and injunctive norms

Expectancies, descr& injun norms, efficacy BEHAVIORAL

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, descr& injun norms, efficacy

Expectancies, desc & injun norms, benefits BEHAVIORAL

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

Expectancies,desc & injun norms,benefits,efficacy BEHAVIORAL

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.

Expectancies,desc & injun norms,benefits,efficacy

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Currently enrolled at an American college or University.
• A first year student or first-year transfer student.
• years of age or older.
• Have not gone through previous versions of itMatters before

You may not qualify if:

• Not a first year student or transfer student
• Younger than 18 years of age
• Have gone through previous versions of itMatters

Sponsors & Collaborators

• Penn State University: lead
• University of North Carolina, Greensboro: collaborator

Study Sites (4)

Fresno State University

Fresno, California, 93740, United States

Location

Southern Illinois University

Carbondale, Illinois, 62901, United States

Location

North Carolina A&T State University

Greensboro, North Carolina, 27411, United States

Location

North Dakota State University

Fargo, North Dakota, 58108-6050, United States

Location

MeSH Terms

Conditions

Sexual Behavior; Alcohol Drinking; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Behavior; Drinking Behavior; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda M Collins, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of The Methodology Center and Distinguished Professor

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 13, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: June 1, 2017
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)