RecruitingPhase 4

ANCHORS Alcohol & Sexual Health Study: UH3 Project

United States88 participantsStarted 2021-01-12

Plain-language 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.

Who can participate

Age range

18 Years – 30 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in quantity of drinks per week

Timeframe: Baseline up to 1 and 6-month follow-up

Change in peak drinking quantity

Timeframe: Baseline up to 1 and 6-month follow-up

PrEP levels in blood at end of intervention period

Timeframe: 1-month follow-up

PrEP levels in blood at the end of the follow-up period

Timeframe: 6-month follow-up

PrEP prescription fill with supporting documentation in the intervention period

Timeframe: during the 1-month intervention period

PrEP prescription fills with supporting documentation during the follow-up period

Timeframe: the 6-month follow-up period

Trial details

NCT IDNCT04331704

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Robert L. Cook, PhD

(352) 273-5869 cookrl@ufl.edu

View on ClinicalTrials.gov More Alcohol Use, Unspecified trials

Plain-language summary

Who can participate

Age range

18 Years – 30 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in quantity of drinks per week

Timeframe: Baseline up to 1 and 6-month follow-up

Change in peak drinking quantity

Timeframe: Baseline up to 1 and 6-month follow-up

PrEP levels in blood at end of intervention period

Timeframe: 1-month follow-up

PrEP levels in blood at the end of the follow-up period

Timeframe: 6-month follow-up

PrEP prescription fill with supporting documentation in the intervention period

Timeframe: during the 1-month intervention period

PrEP prescription fills with supporting documentation during the follow-up period

Timeframe: the 6-month follow-up period