ANCHORS Alcohol & Sexual Health Study: UH3 Project

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

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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• University of Florida

  lead OTHER

Principal Investigators

• Robert L. Cook, PhD · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-12

Primary Completion

2025-12-31

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States

Study Locations