Status:
RECRUITING
ANCHORS Alcohol & Sexual Health Study: UH3 Project
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use, Unspecified
Substance Use
Eligibility:
MALE
18-30 years
Phase:
PHASE4
Brief Summary
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 se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04331704
Start Date
January 12 2021
End Date
June 30 2026
Last Update
July 10 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32611