ANCHORS Alcohol & Sexual Health Study: UH3 Project

Description

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

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Study Overview

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Study Details

Study overview

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.

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

ANCHORS Alcohol & Sexual Health Study: UH3 Project

Condition
Alcohol Use, Unspecified
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Gainesville, Florida, United States, 32611

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 30 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Florida,

Robert L. Cook, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

2024-08-31