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Engineering an Online STI Prevention Program: RCT

Primary Purpose

Alcohol Consumption, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
itMatters
itMatters and itMatters Sexual Violence Prevention
itMatters Well-being and itMatters Sexual Violence Prevention
itMatters Well-being
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Consumption focused on measuring Multiphase optimization strategy (MOST), College students

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fresno State University
  • University of North Carolina - Greensboro
  • North Dakota State University
  • Middle Tennessee State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

itMatters

itMatters and itMatters Sexual Violence Prevention

itMatters Well-being and itMatters Sexual Violence Prevention

itMatters Well-being

Arm Description

Participants will have access to content focused on general knowledge and injunctive and descriptive norms for a period up to 3 weeks.

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.

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.

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.

Outcomes

Primary Outcome Measures

Unprotected behavior at most recent vaginal or anal sex collected via online questionnaire
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.
Penetrative sex at most recent hookup collected via online questionnaire
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.
Attitudes about sexual violence
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

Injunctive norms about the intersection of alcohol and sex
This scale consists of 5 items reflecting the average perceived approval of the alcohol and sex behaviors, ranging from strongly disapprove to strongly approve.
Descriptive norms about the intersection of alcohol and sex
This scale consists of 5 items reflecting the average perceived prevalence of the alcohol and sex behaviors.

Full Information

First Posted
September 17, 2019
Last Updated
March 13, 2020
Sponsor
Penn State University
Collaborators
University of North Carolina, Greensboro
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1. Study Identification

Unique Protocol Identification Number
NCT04095065
Brief Title
Engineering an Online STI Prevention Program: RCT
Official Title
The Intersection of Alcohol and Sex: Engineering an Online STI Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
University of North Carolina, Greensboro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Sexually Transmitted Diseases
Keywords
Multiphase optimization strategy (MOST), College students

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3098 (Actual)

8. Arms, Groups, and Interventions

Arm Title
itMatters
Arm Type
Experimental
Arm Description
Participants will have access to content focused on general knowledge and injunctive and descriptive norms for a period up to 3 weeks.
Arm Title
itMatters and itMatters Sexual Violence Prevention
Arm Type
Experimental
Arm Description
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.
Arm Title
itMatters Well-being and itMatters Sexual Violence Prevention
Arm Type
Experimental
Arm Description
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.
Arm Title
itMatters Well-being
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
itMatters
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
itMatters and itMatters Sexual Violence Prevention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
itMatters Well-being and itMatters Sexual Violence Prevention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
itMatters Well-being
Intervention Description
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 Measure Information:
Title
Unprotected behavior at most recent vaginal or anal sex collected via online questionnaire
Description
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.
Time Frame
Condom use will be assessed 60 days post-intervention.
Title
Penetrative sex at most recent hookup collected via online questionnaire
Description
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.
Time Frame
This measure will be assessed 60 days post-intervention
Title
Attitudes about sexual violence
Description
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.
Time Frame
This measure will be assessed 60 days post-intervention.
Secondary Outcome Measure Information:
Title
Injunctive norms about the intersection of alcohol and sex
Description
This scale consists of 5 items reflecting the average perceived approval of the alcohol and sex behaviors, ranging from strongly disapprove to strongly approve.
Time Frame
This measure will be assessed 60 days post-intervention.
Title
Descriptive norms about the intersection of alcohol and sex
Description
This scale consists of 5 items reflecting the average perceived prevalence of the alcohol and sex behaviors.
Time Frame
This measure will be assessed 60 days post-intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda M Collins, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fresno State University
City
Fresno
State/Province
California
ZIP/Postal Code
93740
Country
United States
Facility Name
University of North Carolina - Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27412
Country
United States
Facility Name
North Dakota State University
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58108
Country
United States
Facility Name
Middle Tennessee State University
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33704366
Citation
Tanner AE, Guastaferro KM, Rulison KL, Wyrick DL, Milroy JJ, Bhandari S, Thorpe S, Ware S, Miller AM, Collins LM. A Hybrid Evaluation-Optimization Trial to Evaluate an Intervention Targeting the Intersection of Alcohol and Sex in College Students and Simultaneously Test an Additional Component Aimed at Preventing Sexual Violence. Ann Behav Med. 2021 Nov 18;55(12):1184-1187. doi: 10.1093/abm/kaab003.
Results Reference
derived

Learn more about this trial

Engineering an Online STI Prevention Program: RCT

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