FINISHING HIV: An Ending the HIV Epidemic (EHE) Model for Latinx Integrating One-Stop-Shop Pre-Exposure Prophylaxis (PrEP) Services, a Social Network Support Program and a National Pharmacy Chain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 624
- 试验地点
- 1
- 主要终点
- Number of participants that report using PrEP
研究概览
简要总结
This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.
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
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Being 18 to 54 years of age
- •Being a cis-gender male
- •Self-report one or more of the following behaviors and health conditions in the last 6 months which meet the Centers for Disease Control and Prevention (CDC) clinical guidelines for PrEP eligibility
- •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
- •Self-reported status as HIV negative
- •Willing to be tested for HIV
排除标准
- •Display diminished capacity to consent because of:
- •An inability to provide informed consent (e.g., cognitive impairment)
- •Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to provide informed consent, as assessed by interviewers with Collaborative Institutional Training Initiative (CITI) Human Subjects Research and National Institutes of Health (NIH) Good Clinical Practice training
- •<18 years old or >54 years old
- •Self-reported living with HIV
- •Reactive HIV test (for "Amigx" seeds or "Yo Quiero" control participants)
- •Refusal of HIV test
- •Identifies as Non-Latinx
- •Individuals enrolled in other PrEP initiation interventions
- •Individuals with an active PrEP prescription in the last 6-months (oral or injectable)
研究组 & 干预措施
I want "Yo Quiero" Control Group
Participants will receive the standard of care for up to 15-months
干预措施: Control group-Standard Health Promotion (Other)
Friend "Amigx" Social network intervention
Participant will receive a social network intervention for up to 15-months
干预措施: Social network intervention (Behavioral)
结局指标
主要结局
Number of participants that report using PrEP
时间窗: Up to 12-months
PrEP initiation will be measured by analyzing the number of participants that initiate PrEP divided by the total number of participants
Number of Dried Blood Spot (DBS) tests that report PrEP use
时间窗: Up to 12-months
PrEP initiation will be measured by analyzing the number of DBS tests that report PrEP use divided by the total number of participants
Number of participants that bring a proof of PrEP prescription
时间窗: Up to 12-months
PrEP initiation will be measured by analyzing the number of participants that bring proof of a PrEP prescription divided by the total number of participants
次要结局
- Number of Dried Blood Spot (DBS) tests that report adequate PrEP adherence(Up to 12-months)
- PrEP knowledge measured by PrEP knowledge question(Up to 12-months)
研究者
Mariano Juan Kanamori Nishimura
Associate Professor
University of Miami