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ANCHORS Alcohol & Sexual Health Study

This study is for young men aged 18-30 who drink alcohol and have unprotected sex with other men. It aims to understand how different educational materials on alcohol and sexual health, combined with taking pre-exposure prophylaxis (PrEP) (a daily tablet of tenofovir disoproxil fumarate and emtricitabine to prevent HIV), affect alcohol use and sexual behaviors. You would complete an initial survey, receive educational materials, take PrEP for 30 days, and answer daily phone-based questions about your alcohol use, sexual health, and PrEP taking. Researchers will measure changes in your weekly and peak drinking, and PrEP levels in your blood. The study is currently unclear on its recruitment status and plans to enroll 88 participants.

Study design
This is an interventional study involving 88 young adult men. There is no placebo control; all participants will receive active PrEP.
What's involved
You will complete an initial web survey, receive educational materials, take PrEP for 30 days, and complete daily 5-minute telephone-based assessments. Follow-up will occur after 30 days and then 6 months later.
Compensation
Not stated in the trial record.
Follow-up
You will have follow-up appointments after 30 days and again at 6 months after the intervention period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04331704

ANCHORS Alcohol & Sexual Health Study: UH3 Project

Recruiting
PHASE4Ages 18–30InterventionalPrevention
University of Florida
~88 participants
Updated 2025-07-10 on ClinicalTrials.gov
What's tested:PrEP acronym (pre-exposure prophylaxis)Initial Web SurveyInteractive Voice Response (IVR) monitoringEducational material on alcohol and sexual health behaviorInteractive Voice Response (IVR) assessment with personalized informationPersonalized information based on web-based survey responses & standardized information

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in quantity of drinks per week
Measured over Baseline up to 1 and 6-month follow-up
+5 more outcomes measured

Conditions

Alcohol Use, Unspecified
Substance Use
Sex Behavior

Explore related trials

Alcohol ConsumptionFinding relating to sexuality and sexual activitySubstance Use

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Robert L. Cook, PhD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Robert L. Cook, PhD
[email protected]
(352) 273-5869
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in quantity of drinks per weekBaseline up to 1 and 6-month follow-up

    Change in self-reported number of alcoholic drinks per week

  • Change in peak drinking quantityBaseline up to 1 and 6-month follow-up

    Change in self-reported number of alcoholic drinks consumed on one's peak drinking day in the past 30 days

  • PrEP levels in blood at end of intervention period1-month follow-up

    Determine whether or not participants have therapeutic levels of PrEP in their blood samples

  • PrEP levels in blood at the end of the follow-up period6-month follow-up

    Determine whether or not participants have therapeutic levels of PrEP in their blood samples

  • PrEP prescription fill with supporting documentation in the intervention periodduring the 1-month intervention period

    Observation of whether or not a participant opts to fill a prescription for PrEP in the intervention period based on pharmacy documentation

  • PrEP prescription fills with supporting documentation during the follow-up periodthe 6-month follow-up period

    Observation of prescription fills for PrEP with documentation during the follow-up period based on pharmacy documentation