Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 818
- 试验地点
- 14
- 主要终点
- End-organ disease
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 (YAPHIV) as they transition into adulthood. A group of of perinatally exposed but uninfected young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.
详细描述
AMP Up aims to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition into adulthood. A group of uninfected perinatally-exposed young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.
The primary objectives of this study are:
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To identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART, including disease progression, immune dysfunction, viral resistance, end-organ disease, and mortality.
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To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults, including:
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Metabolic abnormalities and risk factors for cardiovascular disease, including glucose and lipid metabolism, blood pressure, and body composition.
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Sexually transmitted infections (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis, human papillomavirus (HPV), genital warts and HSV) among males and females, and cervical HPV-associated pre-cancers and cancers and Mycoplasma genitalium and other vaginal microbiota among females.
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Reproductive health, fertility, and pregnancy outcomes including mother-to-child transmission of HIV.
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To define the impact of perinatal HIV infection, its concomitant risk factors and ART on long-term neurocognitive and behavioral health outcomes, including:
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Mental health and neurocognitive functioning.
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Health care behaviors, including adherence to ART, participation in health care services, and transition to adult clinical care.
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Risk behaviors, including sexual behavior and substance use.
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Independent living skills, and vocational and education achievement necessary for successful transition to adult functioning and quality of life.
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
- 是
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
- •Willing to provide access to existing medical records
- •Available medical record documentation since early childhood of:
- •ART exposure history
- •Opportunistic infection prophylaxis exposure history
- •Viral load and CD4+ cell count history
- •Major medical events history
- •Willingness to participate and provide legal written consent
排除标准
- •HIV acquired by other than maternal-child transmission (e.g., blood products, sexual contact, and IV drug use) as documented in the medical record
- •Uninfected Cohort
- •Inclusion Criteria:
- •Absence of perinatal HIV infection as indicated in the medical record; the Perinatally HIV-Exposed Uninfected (PHEU) participant may have horizontally-acquired HIV infection
- •At or beyond their 18th birthday at the time of informed consent with no upper age limit
- •Willingness to participate and provide legal written consent
- •Exclusion Criteria:
- •Have confirmed perinatal HIV infection as documented in the medical record
结局指标
主要结局
End-organ disease
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 and laboratory assessments.
Cervical HPV-associated pre-cancers and cancers (among female participants)
时间窗: Annually for 6 years
Data collected through annual chart review.
Mental health problems
时间窗: Annually for 6 years
Assessed at annually through the Patient Health Questionnaire (PHQ-9)) and General Anxiety Disorder-7 (GAD-7)
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 and laboratory assessments and central laboratory testing.
Metabolic abnormalities
时间窗: Annually for 6 years
Factors of interest include BMI, body composition, systolic and diastolic blood pressure, lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides). Data will be collected by chart review, physical assessments, and laboratory evaluations.
Sexually transmitted infections (STI)
时间窗: Annually for 6 years
STI testing and chart review conducted annually.
Pregnancies
时间窗: Annually for 6 years
Data collected annually through online surveys and chart abstraction.
Transition to adult functioning
时间窗: Every 3 years for 6 years
Every year participants will complete an online survey to collect data on educational attainment, employment, independent living and quality of life.
Mortality
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 and laboratory assessments.
Cognitive impairment
时间窗: Every 3 years for 6 years
Assessed at Entry, Years 3, 6, 9, and 12 visits through the NIH Toolbox.
Maternal-to-child HIV transmission
时间窗: Annually for 6 years
Data collected through annual chart review.
Language development
时间窗: Once, at the Entry or Year 3 visit
The Clinical Evaluation of Language Fundamentals (CELF) IV assessment will be completed at the Entry or Year 3 visit.
ART adherence
时间窗: Annually for 6 years
Data collected annually through an online survey.
Prevalence of risk behaviors including risky sexual behavior and licit and illicit substance use
时间窗: Annually for 6 years
Participants will complete an annual online survey.
Hearing dysfunction
时间窗: Every 3 years for 6 years
Assessed through the NIH Toolbox and a questionnaire to be completed at Entry, Year 3 and Year 6 visits.
Risk factors for cardiovascular disease
时间窗: Annually for 6 years
Factors of interest include BMI, body composition, systolic and diastolic blood pressure, lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) and cumulative cardiometabolic risk. Data will be collected by chart review, physical assessments, and laboratory evaluations.
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)