ANCHORS Alcohol & Sexual Health Study: UH3 Project

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Emtricitabine; Ethanol; Tenofovir

Criteria

Inclusion Criteria:

• ability to read and write English

• frequent alcohol consumption

• recent sexual intercourse with another man

• HIV seronegative at medical screening

Exclusion Criteria:

• not in alcohol withdrawal

• urine test negative for drugs of abuse besides cannabis;

• no serious psychiatric symptoms;

• no medications that interfere with PrEP;

• otherwise medically appropriate.