Sexual BehaviorNCT05620849
Young Adult Education on Alcohol & Health
A study testing Online program in people with Sexual Behavior and Alcohol Drinking, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Alcohol Drinking, Condomless Sex
- What is being tested?
- Online program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Assessed as part of screening procedures
Who cannot join
- Do not want to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Jessica Blayney, PhD, 206-678-5118
About this study
Official title: A Technology-based Intervention for Alcohol-related Sexual Risk Behaviors in Young Women
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.
Read the 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.
- Conditions
- Sexual Behavior, Alcohol Drinking, Condomless Sex
- Being tested
- Online program
- Medical subject headings
- Sexual Behavior, Alcohol Drinking, Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online programBehavioural
The online program is 4 weeks and focused on topics such as alcohol and sexual health
| Study group | Role | What they receive |
|---|---|---|
| Intervention only | Experimental | This group will complete 4 weeks of the brief online program along with 5 weeks of check-in surveys. Receives: Behavioral: Online program |
| Assessment only | No intervention | This group will complete 5 weeks of check-in surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinking before sex (frequency)
Using items from the Sexual Health Questionnaire, the investigators will assess the frequency of drinking before sex.
Measured: 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.
Measured: 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.
Measured: Follow up (1 month, 3 month, 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start15 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jessica Blayney, University of Washington
- Investigators
- Jessica Blayney, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620849
- Sponsor's protocol ID
- STUDY00010940
- Other IDs
- 1K99AA028777-01, 4R00AA028777
- Status last verified
- Dec 2024
- First submitted
- 1 Nov 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-based Intervention for Alcohol-related Sexual Risk Behaviors in Young Women
- ClinicalTrials.gov ID
- NCT05620849
- Acronym / sponsor ID
- STUDY00010940
- Conditions
- Sexual Behavior, Alcohol Drinking, Condomless Sex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention only | Experimental | Behavioral: Online programThis group will complete 4 weeks of the brief online program along with 5 weeks of check-in surveys. |
| Assessment only | No intervention | –This group will complete 5 weeks of check-in surveys. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Assessed as part of screening procedures
Key exclusion criteria (1 listed)
- Do not want to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online programThe online program is 4 weeks and focused on topics such as alcohol and sexual health | Behavioural | Intervention only |
Primary outcome
Drinking before sex (frequency)
Time frame: Follow up (1 month, 3 month, 6 months)
Using items from the Sexual Health Questionnaire, the investigators will assess the frequency of drinking before sex.
Drinking before sex (quantity)
Time frame: Follow up (1 month, 3 month, 6 months)
Using items from the Sexual Health Questionnaire, the investigators will assess the number of drinks consumed before sex.
Condomless sex
Time frame: Follow up (1 month, 3 month, 6 months)
Using items from the Sexual Health Questionnaire, the investigators will assess the frequency of condom use during penetrative sex.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Blayney, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online program in people with Sexual Behavior and Alcohol Drinking, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica A Blayney, PhD (2068192946, jab24@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinking before sex (frequency) (time frame: Follow up (1 month, 3 month, 6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.