ANCHORS Alcohol & Sexual Health Study: UH3 Project
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-30
SponsorUniversity of Florida
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- PrEP acronym (pre-exposure prophylaxis)
- Initial Web Survey
- Interactive Voice Response (IVR) monitoring
- Educational material on alcohol and sexual health behavior
- Interactive Voice Response (IVR) assessment with personalized information
- Personalized information based on web-based survey responses & standardized information
Treatment groups
88 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Florida
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov