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Engineering an Online STI Prevention Program: RCT

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ClinicalTrials.gov Identifier: NCT04095065
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
University of North Carolina, Greensboro
Information provided by (Responsible Party):
Linda Collins, Penn State University

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.

Condition or disease Intervention/treatment Phase
Alcohol Consumption Sexually Transmitted Diseases Behavioral: itMatters Behavioral: itMatters and itMatters Sexual Violence Prevention Behavioral: itMatters Well-being and itMatters Sexual Violence Prevention Behavioral: itMatters Well-being Not Applicable

Detailed Description:
As part of the MOST approach, the investigators have conducted two optimization trials (NCT02897804 and NCT 03408743) to identify the optimized intervention. The current study is the randomized controlled trial of the optimized intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13281 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Intersection of Alcohol and Sex: Engineering an Online STI Prevention Program
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: itMatters
Participants will have access to content focused on general knowledge and injunctive and descriptive norms for a period up to 3 weeks.
Behavioral: itMatters
Increase knowledge related to STIs, STI risk, alcohol impairment, condom use, alcohol use behavior tracking skill, testing & treatment knowledge. Correct misperceptions regarding approval (injunctive norms) and prevalence (descriptive norms) of alcohol misuse & sexual risk taking.

Experimental: itMatters and itMatters Sexual Violence Prevention
Participants will have access to content focused on general knowledge and injunctive and descriptive norms related to alcohol use and sex. Additionally, participants will have access to content focused on sexual violence including basic information and bystander intervention. This content will be available for a period up to 3 weeks.
Behavioral: itMatters and itMatters Sexual Violence Prevention
Increase knowledge related to STIs, STI risk, alcohol impairment, condom use, alcohol use behavior tracking skill, testing & treatment knowledge. Correct misperceptions regarding approval (injunctive norms) and prevalence (descriptive norms) of alcohol misuse & sexual risk taking. Additionally, increased knowledge related to sexual violence (prevalence, key definitions, individual rights and responsibilities, laws) and increased knowledge, efficacy, and intentions to use bystander behaviors during moments of sexual violence.

Experimental: itMatters Well-being and itMatters Sexual Violence Prevention
Participants will have access to content focused on basic information related to sleep wellness and time management. In Addition, participants will have access to content focused on sexual violence including basic information and bystander intervention. This content will be available for a period up to 3 weeks.
Behavioral: itMatters Well-being and itMatters Sexual Violence Prevention
Increase knowledge related to sleep, including biological effects of sleep and sleep hygiene. Increase knowledge related to time management, including important definitions, sleep management strategies, and effective time management routines. Additionally, increased knowledge related to sexual violence (prevalence, key definitions, individual rights and responsibilities, laws) and increase knowledge, efficacy, and intentions to use bystander behaviors during moments of sexual violence.

Experimental: itMatters Well-being
Participants will have access to content focused on basic information related to sleep wellness and time management. This content will be available for a period up to 3 weeks.
Behavioral: itMatters Well-being
Increase knowledge related to sleep, including biological effects of sleep and sleep hygiene. Increase knowledge related to time management, including important definitions, sleep management strategies, and effective time management routines.




Primary Outcome Measures :
  1. Unprotected behavior at most recent vaginal or anal sex collected via online questionnaire [ Time Frame: Condom use will be assessed 60 days post-intervention. ]
    Two items ask whether or not a condom was used for vaginal or anal sex, for those who indicated recently having vaginal or anal sex. The variables will be reported as prevalence of this behavior and likely used as a dichotomous variable (unprotected/protected) in regression analyses.

  2. Penetrative sex at most recent hookup collected via online questionnaire [ Time Frame: This measure will be assessed 60 days post-intervention ]
    This item asks whether or not the most recent hookup included vaginal or anal sex. This will be reported as prevalence of the behavior and likely used as a dichotomous variable in regression analyses.

  3. Attitudes about sexual violence [ Time Frame: This measure will be assessed 60 days post-intervention. ]
    Four items ask about perceptions of sexual violence, including language, consent, pressure, and inappropriate touching. The scale will reflect the average perceptions of sexual violence attitudes.


Secondary Outcome Measures :
  1. Injunctive norms about the intersection of alcohol and sex [ Time Frame: This measure will be assessed 60 days post-intervention. ]
    This scale consists of 5 items reflecting the average perceived approval of the alcohol and sex behaviors, ranging from strongly disapprove to strongly approve.

  2. Descriptive norms about the intersection of alcohol and sex [ Time Frame: This measure will be assessed 60 days post-intervention. ]
    This scale consists of 5 items reflecting the average perceived prevalence of the alcohol and sex behaviors.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095065


Contacts
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Contact: Jeffrey J Milroy, DrPH 336-256-8686 jmilroy@uncg.edu

Locations
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United States, California
Fresno State University Recruiting
Fresno, California, United States, 93740
Contact: Kathy Yarmo    559-278-6739    kyarmo@csufresno.edu   
United States, North Carolina
University of North Carolina - Greensboro Recruiting
Greensboro, North Carolina, United States, 27412
Contact: Kim Sexton-Lewter, PhD    336-334-3072    knsexton@uncg.edu   
United States, North Dakota
North Dakota State University Recruiting
Fargo, North Dakota, United States, 58108
Contact: Emily Hegg    701-231-8560    emily.hegg@ndsu.edu   
Contact: Kelsey Keimig    7012315733    kelsey.a.keimig@ndsu.edu   
United States, Tennessee
Middle Tennessee State University Recruiting
Murfreesboro, Tennessee, United States, 37132
Contact: Lisa Schrader    615-494-8704    lisa.schrader@mtsu.edu   
Sponsors and Collaborators
Penn State University
University of North Carolina, Greensboro
Investigators
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Principal Investigator: Linda M Collins, PhD Penn State University

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Responsible Party: Linda Collins, Distinguished Professor, Department of Human Development and Family Studies, Penn State University
ClinicalTrials.gov Identifier: NCT04095065     History of Changes
Other Study ID Numbers: R01AA02931-3
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linda Collins, Penn State University:
Multiphase optimization strategy (MOST)
College students
Additional relevant MeSH terms:
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Virus Diseases
Ethanol
Sexually Transmitted Diseases
Alcohol Drinking
Infection
Genital Diseases, Male
Genital Diseases, Female
Drinking Behavior
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs