Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite (AMP Up Lite)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 334
- 试验地点
- 9
- 主要终点
- Risk Behaviors (Sexual and Substance Use)
研究概览
简要总结
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition to adulthood.
详细描述
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition to adulthood.
The primary objectives of this study are:
- To identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART, including disease progression, immune suppression, viral resistance, end-organ disease, and mortality.
- To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults with perinatal HIV.
- To define the impact of perinatal HIV infection and ART on long-term mental and behavioral health outcomes.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Perinatal HIV infection as documented in the medical record;
- •At or beyond their 18th birthday at the time of informed consent with no upper age limit;
- •Willingness to provide access to existing medical records; and
- •Willingness to participate and provide legal consent
排除标准
- •Prisoner status
结局指标
主要结局
Risk Behaviors (Sexual and Substance Use)
时间窗: Annually for 6 years
Data collected through an online survey.
Hearing Dysfunction
时间窗: Annually for 6 years.
Data collected through an online survey and chart abstraction.
Mental Health
时间窗: Annually for 6 years.
Data collected through an online survey and chart abstraction.
ART Adherence
时间窗: Annually for 6 years
Data collected through an online survey.
Sexually Transmitted Infections
时间窗: Annually for 6 years
Data collected through chart abstraction.
Reproductive Health
时间窗: Annually for 6 years
Data collected through an online surveys and chart abstraction.
HIV Disease Progression
时间窗: Annually for 6 years
Factors of interest for this outcome include virologic suppression, immune impairment, immune activation, changes in ART, cumulative exposure to specific ART, viral resistance, co-infections, and host genetic polymorphisms. Data will be collected through chart abstraction.
Metabolic Anomalies
时间窗: Annually for 6 years
Data will be collected by chart review, physical assessments, and laboratory evaluations.
Transition to Adult Functioning
时间窗: Annually for 6 years.
Data collected through an online survey.
次要结局
未报告次要终点
研究者
Paige Williams
Senior Lecturer on Biostatistics
Harvard School of Public Health (HSPH)