ANCHORS Alcohol & Sexual Health Study: UH3 Project

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT04331704
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 30 Years
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 12, 2021
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Change in quantity of drinks per week [ Time Frame: Baseline up to 1 and 6-month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611
Robert L. Cook, PhD
[email protected]
352-273-5869
Robert L. Cook, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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