Actively Recruiting

Phase 4
Age: 18Years - 30Years
MALE
Healthy Volunteers
NCT04331704

ANCHORS Alcohol & Sexual Health Study: UH3 Project

Led by University of Florida · Updated on 2025-07-10

88

Participants Needed

1

Research Sites

285 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

80 young adult men will complete an initial survey and receive 1 of 2 types of alcohol and sexual health education and information to encourage prevention of alcohol-related problems, HIV and other sexually transmitted infections (STIs). Participants will then take pre-exposure prophylaxis (PrEP) for HIV prevention and complete a daily 5-minute, telephone-based interactive voice response (IVR) assessment of alcohol/substance use, sexual behavior and PrEP taking for 30 days. Medication will all be active PrEP. There is no placebo control in this study. Follow-up will occur after 30-days and 6-months later.

CONDITIONS

Official Title

ANCHORS Alcohol & Sexual Health Study: UH3 Project

Who Can Participate

Age: 18Years - 30Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

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 PrEP or willing to take PrEP
Not Eligible

You will not qualify if you...

  • History of serious alcohol withdrawal symptoms or treatment
  • Self-reported injection drug use
  • Moderate or severe current substance use disorder besides alcohol and nicotine
  • Serious psychiatric symptoms
  • Use of medications that interfere with PrEP
  • Active hepatitis B infection
  • Serious or life-threatening medical conditions
  • Inadequate liver, blood, or pancreatic function based on lab tests
  • Currently taking injectable PrEP

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Florida

Gainesville, Florida, United States, 32611

Actively Recruiting

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Research Team

R

Robert L. Cook, PhD

CONTACT

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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