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
Conditions
Alcohol Use, UnspecifiedSubstance UseSex Behavior
Locations
University of Florida
Gainesville, Florida 32611
United States