PrEP & Soccer: A Program for Pharmacy Chains to Increase PrEP Awareness and Access Among Men
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Self-report attendance at first PrEP appointment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
PrEP & Soccer Intervention
Pharmacies assigned to "PrEP & Soccer" group will receive personalized PrEP navigation support from the PrEP Navigator.
干预措施: PrEP & Soccer PrEP Navigation (Behavioral)
Standard of care (CVS standard health information)
Pharmacies assigned to the control group will receive a brochure describing services offered by CVS Health and the MinuteClinic.
干预措施: CVS Health brochure (Behavioral)
结局指标
主要结局
Self-report attendance at first PrEP appointment
时间窗: Baseline, 3 months, and 6 months
Attendance at the first scheduled PrEP (pre-exposure prophylaxis) appointment will be assessed using self-report responses at baseline, 3 months, and 6 months. Participants will respond to the question: "Did you attend your first scheduled PrEP appointment?" with binary options (Yes/No). This will be measured by the percentage of participants responding "Yes" at each time point and will evaluate engagement with PrEP services over time.
Self-report attendance at first PrEP appointment
时间窗: Baseline, 3 months, and 6 months
Attendance at the first scheduled PrEP (pre-exposure prophylaxis) appointment will be assessed using self-report responses at baseline, 3 months, and 6 months. Participants will respond to the question: "Did you attend your first scheduled PrEP appointment?" with binary options (Yes/No). This will be measured by the percentage of participants responding "Yes" at each time point and will evaluate engagement with PrEP services over time.
次要结局
- Percentage of correct PrEP questions, measured by participant survey responses(Baseline, 3 months, and 6 months.)
- PrEP Cascade Questionnaire, measured by participant survey responses(Baseline, 3 months, and 6 months)
- PrEP Cascade Questionnaire, measured by participant survey responses(Baseline, 3 months, and 6 months)
- Percentage of correct PrEP questions, measured by participant survey responses(Baseline, 3 months, and 6 months.)
研究者
Mariano Juan Kanamori Nishimura
Professor
University of Miami