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ANCHORS: UH3

  • Status
    Accepting Candidates
  • Age
    18 Years - 30 Years
  • Sexes
    Male
  • Healthy Volunteers
    Accepts Healthy Volunteers
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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

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  2. Step
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