Recruiting

Alcohol & Sexual HealthANCHORS Alcohol & Sexual Health Study: UH3 Project

Sponsor:

University of Florida

Code:

NCT04331704

Conditions

Alcohol Use, Unspecified

Substance Use

Sex Behavior

Eligibility Criteria

Sex: Male

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

PrEP acronym (pre-exposure prophylaxis)

Initial Web Survey

Interactive Voice Response (IVR) monitoring

Educational material on alcohol and sexual health behavior

Interactive Voice Response (IVR) assessment with personalized information

Study Details

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

Study ID

NCT04331704

Start date

Jan 12, 2021

Status verified date

Jul, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Sex: Male

Age: 18 - 30

Healthy Volunteers: Accepted

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 Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Initial Web Survey

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

Interactive Voice Response (IVR) monitoring

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

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.

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

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 measure

Change in quantity of drinks per week [ Time Frame: 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 ]
PrEP levels in blood at end of intervention period [ Time Frame: 1-month follow-up ]
PrEP levels in blood at the end of the follow-up period [ Time Frame: 6-month follow-up ]
PrEP prescription fill with supporting documentation in the intervention period [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Robert L. Cook, PhD

(352) 273-5869 cookrl@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Robert L. Cook, PhD

352-273-5869 cookrl@ufl.edu

Principal Investigator:

Robert L. Cook, PhD

More Information

Sponsor

University of Florida

Last update posted

Jul 10, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-07-10.