NCT06145854进行中（未招募）不适用
Real World Clinical Outcomes in Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP: An Observational, Multisite Prospective 2 Year Study in the Southern U.S.
Midway Specialty Care Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Describe the percent of cisgender females persistent on CAB-LA over 44 weeks.
研究概览
简要总结
Oral PrEP regimens (FTC/TDF have been the mainstay of HIV prevention however patients now have more options for HIV prevention. In addition to oral PrEP regimens, the FDA approved the use of long acting Cabotegravir (CAB-LA) as the first long-acting medication for HIV prevention. This study will evaluate real world clinical outcomes of cisgender female patients who start CAB-LA for PrEP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cisgender females, ages 18 years and older
- •Negative HIV test at baseline
- •Negative Pregnancy test at baseline
- •Weigh at least 35 kilograms
- •Already Prescribed CAB-LA (Apretude)
排除标准
- •Transgender females or males
- •Cisgender males
- •Cisgender female who is actively breastfeeding
- •Severe hepatotoxicity
- •Evidence of Hepatitis B Infection
- •History or presence of allergies to cabotegravir or its components
研究组 & 干预措施
Cisgender Females
干预措施: Cabotegravir Injection [Apretude] (Drug)
结局指标
主要结局
Describe the percent of cisgender females persistent on CAB-LA over 44 weeks.
时间窗: 44 Weeks
次要结局
- Describe satisfaction of cisgender female patients while being on CAB-LA through weeks 20, 44 and 92 with the use of satisfaction surveys(Weeks 20, 44 and 92)
- Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females with substance use and/or unstable housing.(Weeks 20, 44 and 92)
- Describe incidence of bacterial STIs through weeks 20, 44 and 92(Weeks 20, 44 and 92)
- Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females(Weeks 20, 44 and 92)
- Describe percentage of cisgender female patients with HIV prevention failure while on CAB-LA, with detection of HIV, at weeks 20, 44 and 92.(Weeks 20, 44 and 92)
- Describe percentage of cisgender female patients with weight gain > 10% from baseline on CAB-LA at weeks 20, 44 and 92(Weeks 20, 44 and 92)
研究者
Emmanuelle Allseits
Physician
Midway Specialty Care Center
研究点 (1)
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