Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)

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 (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.

Detailed Description
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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: 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. To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults, including: Metabolic abnormalities and risk factors for cardiovascular disease, including glucose and lipid metabolism, blood pressure, and body composition. 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. Reproductive health, fertility, and pregnancy outcomes including mother-to-child transmission of HIV. To define the impact of perinatal HIV infection, its concomitant risk factors and ART on long-term neurocognitive and behavioral health outcomes, including: Mental health and neurocognitive functioning. Health care behaviors, including adherence to ART, participation in health care services, and transition to adult clinical care. Risk behaviors, including sexual behavior and substance use. Independent living skills, and vocational and education achievement necessary for successful transition to adult functioning and quality of life.

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

Conditions
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HIV/AIDS

Participation Criteria
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Eligibility Criteria
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Perinatally HIV-Infected Cohort 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 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 Exclusion Criteria: 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

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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Accepts Healthy Volunteers

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. | |
| Uninfected Cohort<br>Perinatally HIV-exposed but uninfected participant at or beyond their 18th birthday at enrollment. May have horizontally-acquired HIV infection. | |

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 and laboratory assessments and central laboratory testing. | Annually for 6 years | 
| Metabolic abnormalities | 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. | Annually for 6 years | 
| Sexually transmitted infections (STI) | STI testing and chart review conducted annually. | Annually for 6 years | 
| Pregnancies | Data collected annually through online surveys and chart abstraction. | Annually for 6 years | 
| Mental health problems | Assessed at annually through the Patient Health Questionnaire (PHQ-9)) and General Anxiety Disorder-7 (GAD-7) | Annually for 6 years | 
| ART adherence | Data collected annually through an online survey. | Annually for 6 years | 
| Prevalence of risk behaviors including risky sexual behavior and licit and illicit substance use | Participants will complete an annual online survey. | Annually for 6 years | 
| Transition to adult functioning | Every year participants will complete an online survey to collect data on educational attainment, employment, independent living and quality of life. | Every 3 years for 6 years | 
| Hearing dysfunction | Assessed through the NIH Toolbox and a questionnaire to be completed at Entry, Year 3 and Year 6 visits. | Every 3 years for 6 years | 
| Language development | The Clinical Evaluation of Language Fundamentals (CELF) IV assessment will be completed at the Entry or Year 3 visit. | Once, at the Entry or Year 3 visit | 
| End-organ disease | 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. | Annually for 6 years | 
| Mortality | 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. | Annually for 6 years | 
| Risk factors for cardiovascular disease | 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. | Annually for 6 years | 
| Cervical HPV-associated pre-cancers and cancers (among female participants) | Data collected through annual chart review. | Annually for 6 years | 
| Cognitive impairment | Assessed at Entry, Years 3, 6, 9, and 12 visits through the NIH Toolbox. | Every 3 years for 6 years | 
| Maternal-to-child HIV transmission | Data collected through annual chart review. | 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