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NCT04331704PHASE4RecruitingAccepts Healthy Volunteers

ANCHORS Alcohol & Sexual Health Study: UH3 Project

University of Florida

Start Date

1/12/2021

Completion Date

6/30/2026

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 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 Criteria

Age Range: 18 years to 30 years

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

Interventions

DRUG

PrEP acronym (pre-exposure prophylaxis)

BEHAVIORAL

Initial Web Survey

BEHAVIORAL

Interactive Voice Response (IVR) monitoring

BEHAVIORAL

Educational material on alcohol and sexual health behavior

BEHAVIORAL

Interactive Voice Response (IVR) assessment with personalized information

BEHAVIORAL

Personalized information based on web-based survey responses & standardized information

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Conditions

Alcohol Use, UnspecifiedSubstance UseSex Behavior

Locations

University of Florida

Gainesville, Florida 32611

United States