NCT05620849

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

2.3 years

First QC Date

November 1, 2022

Last Update Submit

December 5, 2024

Conditions

Sexual BehaviorAlcohol DrinkingCondomless Sex

Outcome Measures

Primary Outcomes (3)

  • Drinking before sex (frequency)

    Using items from the Sexual Health Questionnaire, the investigators will assess the frequency of drinking before sex.

    Follow up (1 month, 3 month, 6 months)

  • Drinking before sex (quantity)

    Using items from the Sexual Health Questionnaire, the investigators will assess the number of drinks consumed before sex.

    Follow up (1 month, 3 month, 6 months)

  • Condomless sex

    Using items from the Sexual Health Questionnaire, the investigators will assess the frequency of condom use during penetrative sex.

    Follow up (1 month, 3 month, 6 months)

Study Arms (2)

Intervention only

EXPERIMENTAL

This group will complete 4 weeks of the brief online program along with 5 weeks of check-in surveys.

Behavioral: Online program

Assessment only

NO INTERVENTION

This group will complete 5 weeks of check-in surveys.

Interventions

Online programBEHAVIORAL

The online program is 4 weeks and focused on topics such as alcohol and sexual health

Intervention only

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEnrollment is based on female birth sex and female gender identity
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Assessed as part of screening procedures

You may not qualify if:

  • Do not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Sexual BehaviorAlcohol DrinkingUnsafe Sex

Condition Hierarchy (Ancestors)

BehaviorDrinking Behavior

Study Officials

  • Jessica Blayney, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica A Blayney, PhD

CONTACT

2068192946jab24@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 17, 2022

Study Start

September 15, 2023

Primary Completion

December 31, 2025

Study Completion

January 31, 2026

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)