ANCHORS Alcohol & Sexual Health Study: UH3 Project

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.

Full Title of Study: “Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2024

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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 Measures

  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

male sex assigned at birth

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Collaborator
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert L. Cook, PhD, Principal Investigator, University of Florida
  • Overall Contact(s)
    • Robert L. Cook, PhD, (352) 273-5869, cookrl@ufl.edu

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