NCT04331704 ANCHORS Alcohol & Sexual Health Study: UH3 Project
| NCT ID | NCT04331704 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Florida |
| Condition | Alcohol Use, Unspecified |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2021-01-12 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 88 participants in total. It began in 2021-01-12 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Robert L. Cook, PhD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT04331704 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 30 Years, studying Alcohol Use, Unspecified. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04331704 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04331704 currently recruiting?
Yes, NCT04331704 is actively recruiting participants. Contact the research team at cookrl@ufl.edu for enrollment information.
Where is the NCT04331704 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT04331704 clinical trial?
NCT04331704 is sponsored by University of Florida. The principal investigator is Robert L. Cook, PhD at University of Florida. The trial plans to enroll 88 participants.