ANCHORS Alcohol & Sexual Health Study: UH3 Project

July 9, 2025 updated by: University of Florida

Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Robert L. Cook, PhD
  • Phone Number: (352) 273-5869
  • Email: cookrl@ufl.edu

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • University of Florida
        • Contact:
          • Robert L. Cook, PhD
          • Phone Number: 352-273-5869
          • Email: cookrl@ufl.edu
        • Principal Investigator:
          • Robert L. Cook, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Personalized Information
Participants randomized to this condition will complete a web-based questionnaire and then receive personalized information regarding their alcohol use and sexual health behavior. They will complete daily, phone-based IVR monitoring for assessment purposes and receive further personalized information based on their responses.
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.
Other Names:
  • emtricitabine/tenofovir disoproxil fumarate
Behavioral: Initial Web Survey
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
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.
Active Comparator: Educational Information
Participants randomized to this condition will complete a web-based questionnaire and then receive educational material regarding their alcohol use and sexual health behavior. They will complete daily phone-based IVR monitoring for assessment purposes.
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.
Other Names:
  • emtricitabine/tenofovir disoproxil fumarate
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline up to 1 and 6-month follow-up
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
Baseline up to 1 and 6-month follow-up
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
1-month follow-up
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
6-month follow-up
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
during the 1-month intervention period
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
the 6-month follow-up period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reduced alcohol use as a reason for adherence to PrEP
Time Frame: Baseline up to 1 and 6-month follow-up
Test reductions in alcohol use following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP
Baseline up to 1 and 6-month follow-up
Change in perceived risk of HIV as a reason for adherence to PrEP
Time Frame: Baseline up to 1 and 6-month follow-up
Test increase in Perceived Risk of HIV Scale score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP
Baseline up to 1 and 6-month follow-up
Change in sexual risk behavior as a reason for adherence to PrEP
Time Frame: Baseline up to 1 and 6-month follow-up
Test reduction in Risk Assessment Battery score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP
Baseline up to 1 and 6-month follow-up
Increased motivation for behavior change as a reason for adherence to PrEP
Time Frame: Baseline up to 1 and 6-month follow-up
Test increased score on the Contemplation Ladder for motivation to avoid risky sexual health behavior, to take PrEP and to reduce drinking following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP
Baseline up to 1 and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert L. Cook, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201902818-N
  • UH3AA026214 (U.S. NIH Grant/Contract)
  • OCR31862 (Other Identifier: OnCore University of Florida)
  • F31AA028751 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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