Skip to main content
Update Location

My Location

Update your location to show providers, locations, and services closest to you.

Enter a zip code
Or
Select a campus/region
(352) 733-0111

ANCHORS: UH3

  • Status
    Accepting Candidates
  • Age
    18 Years - 30 Years
  • Sexes
    Male
  • Healthy Volunteers
    Accepts Healthy Volunteers
I'm interested
Share this study
Facebook
Twitter
LinkedIn

Objective

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.

Details

Full study title Advancing New Computer-based Health Outreach Regarding Sexual behavior (ANCHORS) Study: UH3 Project
Protocol number OCR31862
ClinicalTrials.gov ID NCT04331704
Phase Phase 4

Eligibility

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

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Robert Cook
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.