NCT04331704

ANCHORS Alcohol & Sexual Health Study: UH3 Project

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: Male
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-01-12
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2020-04-02
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study