ANCHORS Alcohol & Sexual Health Study: UH3 Project

Launched by UNIVERSITY OF FLORIDA · Mar 31, 2020

Keywords

ClinConnect Summary

The ANCHORS Alcohol & Sexual Health Study is looking to understand how education about alcohol and sexual health can help young adult men prevent problems related to drinking and reduce the risk of HIV and other sexually transmitted infections (STIs). In this study, 80 men will complete a survey and then receive one of two types of educational information. They will take a daily medication called PrEP for HIV prevention and participate in a short, 5-minute phone assessment every day for 30 days to track their alcohol use, sexual behavior, and PrEP adherence. After a month, the researchers will follow up with participants again at 6 months to see how they are doing.

To be eligible for this study, participants need to be men who can read and write in English, have consumed five or more alcoholic drinks in a day at least once in the past month, and have had unprotected sex with another man in that same timeframe. They must also be HIV-negative and willing to take the PrEP medication. It’s important to know that individuals with a history of serious alcohol withdrawal symptoms, current injection drug use, or certain medical conditions cannot participate. This study does not use a placebo, meaning all participants will receive the active medication.

Gender

MALE

Eligibility 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