Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite (AMP Up Lite)

Conditions
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HIV/AIDS

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Prisoner status

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infected Cohort<br>Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Disease Progression | 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. | Annually for 6 years | 
| Metabolic Anomalies | Data will be collected by chart review, physical assessments, and laboratory evaluations. | Annually for 6 years | 
| Sexually Transmitted Infections | Data collected through chart abstraction. | Annually for 6 years | 
| Reproductive Health | Data collected through an online surveys and chart abstraction. | Annually for 6 years | 
| Mental Health | Data collected through an online survey and chart abstraction. | Annually for 6 years. | 
| ART Adherence | Data collected through an online survey. | Annually for 6 years | 
| Risk Behaviors (Sexual and Substance Use) | Data collected through an online survey. | Annually for 6 years | 
| Transition to Adult Functioning | Data collected through an online survey. | Annually for 6 years. | 
| Hearing Dysfunction | Data collected through an online survey and chart abstraction. | Annually for 6 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, perinatal HIV infection