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NCT Number: NCT04331704

ANCHORS Alcohol & Sexual Health Study: UH3 Project

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.

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Key information

Conditions

Alcohol Use, Unspecified Alcohol Drinking Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Sex Behavior Sexual Behavior Substance Use Substance-Related Disorders

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Location status: Recruiting

Location contact

Robert L. Cook, PhD

CONTACT

[email protected]

352-273-5869

Robert L. Cook, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: emtricitabine/tenofovir disoproxil fumarate

Initial Web Survey

Behavioral

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

Interactive Voice Response (IVR) monitoring

Behavioral

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

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.

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 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.

Primary outcomes

  1. Change in quantity of drinks per week

    Time frame: Baseline up to 1 and 6-month follow-up

    Change in self-reported number of alcoholic drinks per week

  2. Change in peak drinking quantity

    Time frame: Baseline up to 1 and 6-month follow-up

    Change in self-reported number of alcoholic drinks consumed on one's peak drinking day in the past 30 days

  3. PrEP levels in blood at end of intervention period

    Time frame: 1-month follow-up

    Determine whether or not participants have therapeutic levels of PrEP in their blood samples

  4. PrEP levels in blood at the end of the follow-up period

    Time frame: 6-month follow-up

    Determine whether or not participants have therapeutic levels of PrEP in their blood samples

  5. PrEP prescription fill with supporting documentation in the intervention period

    Time frame: during the 1-month intervention period

    Observation of whether or not a participant opts to fill a prescription for PrEP in the intervention period based on pharmacy documentation

  6. PrEP prescription fills with supporting documentation during the follow-up period

    Time frame: the 6-month follow-up period

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

Secondary outcomes

  1. Reduced alcohol use as a reason for adherence to PrEP

    Time frame: Baseline up to 1 and 6-month follow-up

    Test reductions in alcohol use following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

  2. Change in perceived risk of HIV as a reason for adherence to PrEP

    Time frame: Baseline up to 1 and 6-month follow-up

    Test increase in Perceived Risk of HIV Scale score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

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

    Time frame: Baseline up to 1 and 6-month follow-up

    Test reduction in Risk Assessment Battery score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

  4. Increased motivation for behavior change as a reason for adherence to PrEP

    Time frame: Baseline up to 1 and 6-month follow-up

    Test increased score on the Contemplation Ladder for motivation to avoid risky sexual health behavior, to take PrEP and to reduce drinking following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

Study contacts

Contact information is provided by the study sponsor or research team.

Robert L. Cook, PhD

CONTACT

[email protected]

(352) 273-5869

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 2, 2020
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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