NCT04331704 · University of Florida
ANCHORS Alcohol & Sexual Health Study: UH3 Project
What this study is about
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).
View original scientific description
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.
Interventions
DRUG
PrEP acronym (pre-exposure prophylaxis)
A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.
BEHAVIORAL
Initial Web Survey
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
BEHAVIORAL
Interactive Voice Response (IVR) monitoring
Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking
BEHAVIORAL
Educational material on alcohol and sexual health behavior
Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.
BEHAVIORAL
Interactive Voice Response (IVR) assessment with personalized information
Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking with personalized and information based on daily IVR responses
BEHAVIORAL
Personalized information based on web-based survey responses & standardized information
Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.
Primary outcome measures
Change in quantity of drinks per week
Time frame: Baseline up to 1 and 6-month follow-up
Change in self-reported number of alcoholic drinks per week
Change in peak drinking quantity
Time frame: Baseline 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 period
Time frame: 1-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 period
Time frame: 6-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 period
Time frame: during 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 period
Time frame: the 6-month follow-up period
Observation of prescription fills for PrEP with documentation during the follow-up period based on pharmacy documentation
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Gainesville, Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2025 · Source of record for eligibility and locations