Engineering an Online STI Prevention Program

January 8, 2019 updated by: Linda Collins, Penn State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3997

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93740
        • Fresno State University
    • Illinois
      • Carbondale, Illinois, United States, 62901
        • Southern Illinois University
    • North Carolina
      • Greensboro, North Carolina, United States, 27411
        • North Carolina A&T State University
    • North Dakota
      • Fargo, North Dakota, United States, 58108-6050
        • North Dakota State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Knowledge alone
Participants will have access to the knowledge module for a period up to 3 weeks.
Behavioral: Knowledge alone
Increase knowledge related STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing & treatment services.
Experimental: Self-efficacy alone
Participants will have access to the knowledge module plus the self-efficacy module for a period up to 3 weeks.
Behavioral: Self-efficacy alone
Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Perceived benefits alone
Participants will have access to the knowledge module plus the perceived benefits module for a period up to 3 weeks.
Behavioral: Perceived benefits alone
Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Benefits and self-efficacy
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
Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Injunctive norms alone
Participants will have access to the knowledge module plus the injunctive norms module for a period up to 3 weeks.
Behavioral: Injunctive norms
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
Experimental: Injunctive norms and 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.
Behavioral: Injunctive norms and self-efficacy
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Injunctive norms and perceived benefits
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
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Injunctive norms, perceived 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.
Behavioral: Injunctive norms, perceived benefits, and self-efficacy
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Descriptive norms alone
Participants will have access to the knowledge module plus the descriptive norms module for a period up to 3 weeks.
Behavioral: Descriptive norms alone
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
Experimental: Descriptive norms and self-efficacy
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
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Descriptive norms and perceived benefits
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
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Descriptive norms,perceived benefits,self-efficacy
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
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Descriptive norms and injunctive norms
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
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
Experimental: Descriptive norms, injunctive norms,self-efficacy
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
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Descriptive and injunctive norms, 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.
Behavioral: Descriptive and injunctive norms, benefits
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Descriptive and 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.
Behavioral: Descriptive and injunctive norms, benefits,efficacy
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Expectancies alone
Participants will have access to the knowledge module plus the expectancies module for a period up to 3 weeks.
Behavioral: Expectancies alone
Decrease the expectation that alcohol is needed to have good sexual encounter.
Experimental: Expectancies and self-efficacy
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
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.
Experimental: Expectancies and perceived benefits
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
Decrease the expectation that alcohol is needed to have good sexual encounter and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Expectancies, perceived 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.
Behavioral: Expectancies, perceived benefits, self-efficacy
Decrease the expectation that alcohol is needed to have good sexual encounter; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Expectancies and injunctive norms
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
Decrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
Experimental: Expectancies, injunctive norms, and 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.
Behavioral: Expectancies, injunctive norms, and self-efficacy
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Expectancies, injunctive norms, and benefits
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
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Expectancies, injunctive norms, benefits, efficacy
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
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.
Experimental: Expectancies and descriptive norms
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
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.
Experimental: Expectancies, descriptive norms, and 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.
Behavioral: Expectancies, descriptive norms, and self-efficacy
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Expectancies, descriptive norms, and 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.
Behavioral: Expectancies, descriptive norms, and benefits
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Expectancies,descriptive norms, benefits, efficacy
Participants will have access to the knowledge module plus the expectancies, descriptive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
Behavioral: Expectancies,descriptive norms, benefits, efficacy
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Expectancies, descriptive and injunctive norms
Participants will have access to the knowledge module plus the expectancies, descriptive norms, and injunctive norms modules for a period up to 3 weeks.
Behavioral: Expectancies, descriptive and injunctive norms
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.
Experimental: Expectancies, descr& injun 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.
Behavioral: Expectancies, descr& injun norms, efficacy
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Expectancies, desc & injun 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.
Behavioral: Expectancies, desc & injun norms, benefits
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Expectancies,desc & injun norms,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.
Behavioral: Expectancies,desc & injun norms,benefits,efficacy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
This measure will be assessed immediately following the 3-week intervention
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.
This measure will be assessed immediately following the 3-week intervention
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.
This measure will be assessed immediately following the 3-week intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Binge drinking behavior collected via an online questionnaire
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of North Carolina, Greensboro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01AA022931 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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