ANCHORS Alcohol & Sexual Health Study: UH3 Project

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Поведенческое Initial Web Survey
  Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
• Поведенческое Interactive Voice Response (IVR) monitoring
  Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking
• Поведенческое 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.
• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Change in quantity of drinks per week [Срок оценки: Baseline up to 1 and 6-month follow-up]
• Change in peak drinking quantity [Срок оценки: Baseline up to 1 and 6-month follow-up]
• PrEP levels in blood at end of intervention period [Срок оценки: 1-month follow-up]
• PrEP levels in blood at the end of the follow-up period [Срок оценки: 6-month follow-up]
• PrEP prescription fill with supporting documentation in the intervention period [Срок оценки: during the 1-month intervention period]
• PrEP prescription fills with supporting documentation during the follow-up period [Срок оценки: the 6-month follow-up period]

Вторичные конечные точки (4)

• Reduced alcohol use as a reason for adherence to PrEP [Срок оценки: Baseline up to 1 and 6-month follow-up]
• Change in perceived risk of HIV as a reason for adherence to PrEP [Срок оценки: Baseline up to 1 and 6-month follow-up]
• Change in sexual risk behavior as a reason for adherence to PrEP [Срок оценки: Baseline up to 1 and 6-month follow-up]
• Increased motivation for behavior change as a reason for adherence to PrEP [Срок оценки: Baseline up to 1 and 6-month follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Florida — Gainesville

Идентификаторы

NCT: NCT04331704 · IRB201902818-N · UH3AA026214 · OCR31862 · F31AA028751

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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