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ANCHORS Alcohol & Sexual Health Study: UH3 Project

University of Florida · with National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NCT04331704

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–30 · Men only
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
88
US sites recruiting
1
Study start
January 12, 2021
Record last updated
July 10, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: PrEP acronym (pre-exposure prophylaxis); Initial Web Survey; Interactive Voice Response (IVR) monitoring; Educational material on alcohol and sexual health behavior; Interactive Voice Response (IVR) assessment with personalized information; Personalized information based on web-based survey responses & standardized information

Conditions: Alcohol Use, Unspecified; Substance Use; Sex Behavior

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Ability to read and write English
  • Consumption of 5 or more drinks per drinks in a day at least once in the past 30-days
  • Sexual intercourse with another man without condom use at least once in the past 30 days
  • HIV seronegative at medical screening
  • Report currently taking PrEP willingness to take PrEP

Exclusion Criteria

  • History of clinically significant withdrawal from alcohol, defined as any one of the following: a) a lifetime history of seizures, delirium, or hallucinations during alcohol withdrawal; b) a Clinical Institute Withdrawal Assessment scale score > 8; c) a report of drinking to avoid withdrawal symptoms in the past 12 months; or d) a lifetime history of medical treatment for withdrawal.
  • Self report injection drug use
  • DSM-5 criteria for moderate or severe current substance use disorder besides alcohol and nicotine.
  • Serious psychiatric symptoms
  • Use of medications that interfere with PrEP including diuretics, nephrotoxic drugs, non-steroidal anti-inflammatory drugs, antiretroviral drugs or other drugs that may interfere with tenofovir excretion
  • Active hepatitis B infection
  • The following medical exclusions: serious or life-threatening conditions; inadequate biochemical, hepatic, hematologic, or pancreatic function according to laboratory testing
  • Participant reports currently taking injectable PrEP

Recruiting US locations

  • University of Florida

    Gainesville, FL 32611

    Site contact: Robert L. Cook, PhD · 352-273-5869 · cookrl@ufl.edu

Study contacts (from the official record)

  • Robert L. Cook, PhD · (352) 273-5869 · cookrl@ufl.edu
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ANCHORS Alcohol & Sexual Health Study: UH3 Project (NCT04331704) | Bored Studies