Alcohol and sexual health education for young men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves 80 young adult men who will complete an initial survey and receive one of two types of education on alcohol and sexual health to help prevent alcohol-related issues, HIV, and other STIs. Participants will take pre-exposure prophylaxis (PrEP) for HIV prevention and engage in a daily 5-minute telephone-based interactive voice response (IVR) assessment of their alcohol and substance use, sexual behavior, and PrEP adherence for 30 days. Follow-up assessments will occur at 30 days and again at 6 months to evaluate the effectiveness of the interventions.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Robert L. Cook, PhD — University of Florida
• Study coordinator: Robert L. Cook, PhD
• Email: cookrl@ufl.edu
• Phone: (352) 273-5869

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.