Young Adult Education on Alcohol & Health
Primary Purpose
Sexual Behavior, Alcohol Drinking, Condomless Sex
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online program
Sponsored by
About this trial
This is an interventional prevention trial for Sexual Behavior
Eligibility Criteria
Inclusion Criteria: Assessed as part of screening procedures Exclusion Criteria: Do not want to participate
Sites / Locations
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention only
Assessment only
Arm Description
This group will complete 4 weeks of the brief online program along with 5 weeks of check-in surveys.
This group will complete 5 weeks of check-in surveys.
Outcomes
Primary Outcome Measures
Drinking before sex (frequency)
Using items from the Sexual Health Questionnaire, the investigators will assess the frequency of drinking before sex.
Drinking before sex (quantity)
Using items from the Sexual Health Questionnaire, the investigators will assess the number of drinks consumed before sex.
Condomless sex
Using items from the Sexual Health Questionnaire, the investigators will assess the frequency of condom use during penetrative sex.
Secondary Outcome Measures
Full Information
NCT ID
NCT05620849
First Posted
November 1, 2022
Last Updated
September 15, 2023
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05620849
Brief Title
Young Adult Education on Alcohol & Health
Official Title
A Technology-based Intervention for Alcohol-related Sexual Risk Behaviors in Young Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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 goal of this clinical trial is to test the effectiveness of our brief online program when compared to those who don't complete the program at all.
Detailed Description
A total of 300 participants will complete this 6 month study. The study will include a background survey, 5 week monitoring period where participants either complete the brief online program with check-in surveys or check-in surveys only, and follow-up surveys 1, 3, and 6 months later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Behavior, Alcohol Drinking, Condomless Sex
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention only
Arm Type
Experimental
Arm Description
This group will complete 4 weeks of the brief online program along with 5 weeks of check-in surveys.
Arm Title
Assessment only
Arm Type
No Intervention
Arm Description
This group will complete 5 weeks of check-in surveys.
Intervention Type
Behavioral
Intervention Name(s)
Online program
Intervention Description
The online program is 4 weeks and focused on topics such as alcohol and sexual health
Primary Outcome Measure Information:
Title
Drinking before sex (frequency)
Description
Using items from the Sexual Health Questionnaire, the investigators will assess the frequency of drinking before sex.
Time Frame
Follow up (1 month, 3 month, 6 months)
Title
Drinking before sex (quantity)
Description
Using items from the Sexual Health Questionnaire, the investigators will assess the number of drinks consumed before sex.
Time Frame
Follow up (1 month, 3 month, 6 months)
Title
Condomless sex
Description
Using items from the Sexual Health Questionnaire, the investigators will assess the frequency of condom use during penetrative sex.
Time Frame
Follow up (1 month, 3 month, 6 months)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Enrollment is based on female birth sex and female gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Assessed as part of screening procedures
Exclusion Criteria:
Do not want to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica A Blayney, PhD
Phone
2068192946
Email
jab24@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Blayney, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Blayney, PhD
Phone
206-678-5118
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Young Adult Education on Alcohol & Health
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