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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
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexual Behavior

Eligibility Criteria

18 Years - 24 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
November 1, 2022
Last Updated
September 15, 2023
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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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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