Actively Recruiting
Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project
Led by University of Florida · Updated on 2025-07-10
88
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating different types of alcohol and sexual health education to help prevent alcohol-related problems, HIV, and other sexually transmitted infections in young adult men. This clinical trial involves men aged 18 to 30 who are at risk due to their drinking and sexual behavior. The study is a phase 4 randomized trial sponsored by the University of Florida, focusing on the effects of education combined with pre-exposure prophylaxis (PrEP) for HIV prevention. Participants will be randomly assigned to receive either personalized information based on their alcohol use and sexual health behaviors or educational material about these topics. All participants will take active PrEP medication daily for up to 30 days. They will also complete daily 5-minute telephone-based interactive voice response (IVR) assessments to report on their alcohol and substance use, sexual behavior, and PrEP adherence. Follow-up assessments will occur at 30 days and again at 6 months after the intervention period. Throughout the study, participants will complete initial web-based surveys, daily phone assessments, and provide blood samples to measure PrEP levels. Researchers will monitor changes in drinking habits, sexual behavior, and adherence to PrEP. The study will track prescriptions filled during the intervention and follow-up periods and assess motivation and reasons for adherence to PrEP. The full participation duration spans 6 months, with evaluations at baseline, 1 month, and 6 months.
CONDITIONS
Brief Title
ANCHORS Alcohol & Sexual Health Study: UH3 Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to read and write English
- Consumed 5 or more drinks in a day at least once in the past 30 days
- Had sexual intercourse with another man without condom use at least once in the past 30 days
- HIV negative at medical screening
- Currently taking or willing to take oral PrEP
You will not qualify if you...
- History of significant alcohol withdrawal symptoms or treatment
- Self-reported injection drug use
- Moderate or severe current substance use disorder other than alcohol or nicotine
- Serious psychiatric symptoms
- Use of medications that interfere with PrEP effectiveness
- Active hepatitis B infection
- Serious or life-threatening medical conditions or inadequate liver, blood, or pancreas function
- Currently taking injectable PrEP
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants complete a web-based questionnaire and receive either personalized or educational information regarding their alcohol use and sexual health behavior. They take a daily tablet of PrEP for up to 30 days and participate in daily phone-based IVR monitoring.
Daily phone-based IVR monitoring and 1 baseline visit
Duration - 6 months
Participants are followed for changes in alcohol use, sexual behavior, and PrEP adherence over 6 months after treatment ends.
1 and 6-month follow-up visits
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
Research Team
R
Robert L. Cook, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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