ANCHORS Alcohol & Sexual Health Study: UH3 Project

NCT04331704 | Recruiting Phase 4 FDA Drug

• 4 other identifiers: IRB201902818-NUH3AA026214OCR31862F31AA028751
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use, Unspecified; Substance Use; Sex Behavior

Outcome Measures

Primary Outcomes (6)

• Change in quantity of drinks per week

  Change in self-reported number of alcoholic drinks per week

  Baseline up to 1 and 6-month follow-up

• Change in peak drinking quantity

  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

  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

  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

  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

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

  the 6-month follow-up period

Secondary Outcomes (4)

• Reduced alcohol use as a reason for 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

  Baseline up to 1 and 6-month follow-up

• Change in sexual risk behavior as a reason for adherence to PrEP

  Baseline up to 1 and 6-month follow-up

• Increased motivation for behavior change as a reason for adherence to PrEP

  Baseline up to 1 and 6-month follow-up

Study Arms (2)

Personalized Information

EXPERIMENTAL

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); Behavioral: Initial Web Survey; Behavioral: Interactive Voice Response (IVR) assessment with personalized information; Behavioral: Personalized information based on web-based survey responses & standardized information

Educational Information

ACTIVE COMPARATOR

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); Behavioral: Initial Web Survey; Behavioral: Interactive Voice Response (IVR) monitoring; Behavioral: Educational material on alcohol and sexual health behavior

Interventions

PrEP acronym (pre-exposure prophylaxis) DRUG

A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.

Also known as: emtricitabine/tenofovir disoproxil fumarate

Educational Information; Personalized Information

Initial Web Survey BEHAVIORAL

Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors

Educational Information; Personalized Information

Interactive Voice Response (IVR) monitoring BEHAVIORAL

Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking

Educational Information

Educational material on alcohol and sexual health behavior BEHAVIORAL

Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.

Educational Information

Interactive Voice Response (IVR) assessment with personalized information BEHAVIORAL

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

Personalized Information

Personalized information based on web-based survey responses & standardized information BEHAVIORAL

Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.

Personalized Information

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: male sex assigned at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participant reports currently taking injectable PrEP

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking; Substance-Related Disorders; Sexual Behavior

Interventions

Pre-Exposure Prophylaxis; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Ethanol; Restraint, Physical

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Alcohols; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Robert L. Cook, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert L. Cook, PhD

CONTACT

(352) 273-5869; cookrl@ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 2, 2020
• Study Start: January 12, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)