PrEP & Soccer: A Program for Pharmacy Chains to Increase PrEP Awareness and Access Among Men

Обзор

This type 3 Hybrid Effectiveness-Implementation study will evaluate PrEP \& Soccer, a multicomponent and multilevel implementation strategy delivered by a pharmacy chain to increase PrEP knowledge and initial PrEP appointment attendance among men. Using mixed methods and implementation science approaches, this parallel cluster randomized controlled study will assess key implementation factors at CVS Health pharmacy locations assigned either to the PrEP \& Soccer intervention or to a general CVS Health service information-only control.

Вмешательства

• Поведенческое PrEP & Soccer PrEP Navigation
  Pharmacies assigned to this group will receive personalized PrEP navigation support provided by a PrEP Navigator following baseline assessment. Sessions may be brief (\~15 minutes) or longer depending on participant needs. The navigator supplies a pamphlet describing PrEP (how it works, payment options), and CVS-provided HIV services; discusses whether PrEP or another HIV prevention strategy is best for the participant; and, if PrEP is selected, provides a referral to a PrEP provider.
• Поведенческое CVS Health brochure
  Standard health information delivered via brochure, no active navigation components. Content includes a brochure describing services offered by CVS Health and the MinuteClinic.

Первичные конечные точки

• Self-report attendance at first PrEP appointment [Срок оценки: Baseline, 3 months, and 6 months]

Вторичные конечные точки (2)

• PrEP Cascade Questionnaire, measured by participant survey responses [Срок оценки: Baseline, 3 months, and 6 months]
• Percentage of correct PrEP questions, measured by participant survey responses [Срок оценки: Baseline, 3 months, and 6 months.]

Критерии участия

Критерии включения

• Provide their informed consent to participate.
• Demonstrate willingness to comply with all study procedures and be available for the study duration.
• Ages 18 to 54 years of age.
• A man.
• Self-report any of the following behaviors and/or health conditions

• Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia)
• Sex with a partner who is living with HIV
• Sex without a condom with two or more partners whose HIV status were unknown
• Injection drug use and sharing injection equipment
• Have been without a PrEP prescription for at least 24 weeks.

Критерии исключения

• Diminished capacity to consent due to:

• Inability to provide informed consent (e.g., cognitive impairment), or
• Presence of severe psychiatric symptoms (e.g., mania, psychosis) that impair the ability to provide informed consent, as assessed by interviewers trained in CITI Human Subjects Research and NIH Good Clinical Practice.
• Younger than 18 or older than 54 years of age.
• A woman.
• Does not self-report any of the following behaviors and/or health conditions

• Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia)
• Sex with a partner who is living with HIV
• Sex without a condom with two or more partners whose HIV status were unknown
• Injection drug use and sharing injection equipment
• Has had an active PrEP prescription within the past 24 weeks.
• Living with HIV (e.g. has received an HIV diagnosis).
• Planning to move outside of Miami-Dade or Broward counties in the next 7 months.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT07263048 · 20250645 · 1R01AI191576-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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