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ANCHORS Alcohol & Sexual Health Study: UH3 Project
Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project
Who can join
Ages 18 to 30 · Men · Healthy volunteers welcome
Full 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
About the study
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.
What is being tested
- PrEP acronym (pre-exposure prophylaxis) (drug)
- 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 (behavioral)
Sponsor: University of Florida · Participants: 88 · Started: Jan 12, 2021
Contact the study team
- Robert L. Cook, PhD · Phone: (352) 273-5869
Official record on ClinicalTrials.gov — NCT04331704
Locations in the U.S.
| Florida | University of Florida, Gainesville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.