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ANCHORS Alcohol & Sexual Health Study: UH3 Project

Recruiting
18 - 30 years of age
Male
Phase 4

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Overview

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.

Eligibility

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

Study details

Alcohol Use, Unspecified, Substance Use, Sex Behavior

NCT04331704

University of Florida

26 January 2024

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