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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 850

Contacts and Locations

• Study Contact: Name: Liz Salomon, EdM; Phone Number: 617-432-6762; Email: lsalomon@hsph.harvard.edu

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936
    • Recruiting
    • San Juan Research Hospital
    • Principal Investigator: Nicolas Rosario, MD
• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California San Diego
      • Principal Investigator: Stephen Spector, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Denver Health Sciences Center
      • Principal Investigator: Elizabeth McFarland, MD
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Recruiting
      • Children's Diagnostic and Treatment Center
      • Principal Investigator: Lisa Gaye Robinson, MD
    • Miami, Florida, United States, 33316
      • Recruiting
      • University of Miami
      • Principal Investigator: Gwendolyn Scott, MD
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Recruiting
      • Ann and Robert H. Lurie Children's Hospital
      • Principal Investigator: Ellen Chadwick, MD
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Tulane University Health Sciences Center
      • Principal Investigator: Margarita Silio, MD
      • Principal Investigator: Russel Van Dyke, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Children's Hospital Boston
      • Principal Investigator: Sandra Burchett, MD
  • New Jersey
    • Newark, New Jersey, United States, 07101
      • Recruiting
      • Rutgers - New Jersey Medical School
      • Principal Investigator: Arry Dieudonne, MD
  • New York
    • Bronx, New York, United States, 10461
      • Recruiting
      • Jacobi Medical Center
      • Principal Investigator: Andrew Wiznia, MD
    • Bronx, New York, United States, 10457
      • Recruiting
      • Bronx Lebanon Hospital Center
      • Principal Investigator: Murli Purswani, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • Recruiting
      • St. Christopher's Hospital for Children
      • Principal Investigator: Janet Chen, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Principal Investigator: Katherine Knapp, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Principal Investigator: Mary Paul, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Young adults 18 years of age or older at the time of enrollment with or without perinatal HIV-infection.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Infected Cohort; Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.
Uninfected Cohort; 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?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Sexually transmitted infections (STI)	STI testing and chart review conducted annually.	Annually for 6 years

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH); National Heart, Lung, and Blood Institute (NHLBI); National Institute of Neurological Disorders and Stroke (NINDS); National Institute of Dental and Craniofacial Research (NIDCR); NIH Office of AIDS Research (OAR); National Institute on Deafness and Other Communication Disorders (NIDCD); Tulane University School of Medicine
• Investigators: Principal Investigator: Russell Van Dyke, MD, Tulane University School of Medicine; Principal Investigator: Katherine Tassiopoulos, DSc, MPH, Harvard School of Public Health (HSPH); Principal Investigator: Paige L Williams, Harvard School of Public Health (HSPH)

Publications and helpful links

General Publications

• Moscicki AB, Karalius B, Tassiopoulos K, Yao TJ, Jacobson DL, Patel K, Purswani M, Seage GR; Pediatric HIV/AIDS Cohort Study. Human Papillomavirus Antibody Levels and Quadrivalent Vaccine Clinical Effectiveness in Perinatally Human Immunodeficiency Virus-infected and Exposed, Uninfected Youth. Clin Infect Dis. 2019 Sep 13;69(7):1183-1191. doi: 10.1093/cid/ciy1040.
• Torre P 3rd, Russell JS, Smith R, Hoffman HJ, Lee S, Williams PL, Yao TJ; Pediatric HIV/AIDS Cohort Study (PHACS). Words-in-Noise Test Performance in Young Adults Perinatally HIV Infected and Exposed, Uninfected. Am J Audiol. 2020 Mar 5;29(1):68-78. doi: 10.1044/2019_AJA-19-00042. Epub 2020 Jan 31.
• Patel K, Karalius B, Powis K, Kacanek D, Berman C, Moscicki AB, Paul M, Tassiopoulos K, Seage GR 3rd; HIV/AIDS Cohort Study (PHACS). Trends in post-partum viral load among women living with perinatal HIV infection in the USA: a prospective cohort study. Lancet HIV. 2020 Mar;7(3):e184-e192. doi: 10.1016/S2352-3018(19)30339-X. Epub 2019 Dec 20.
• Tassiopoulos K, Huo Y, Patel K, Kacanek D, Allison S, Siminski S, Nichols SL, Mellins CA; Pediatric HIV/AIDS Cohort Study (PHACS). Healthcare Transition Outcomes Among Young Adults With Perinatally Acquired Human Immunodeficiency Virus Infection in the United States. Clin Infect Dis. 2020 Jun 24;71(1):133-141. doi: 10.1093/cid/ciz747.
• Berman CA, Kacanek D, Nichamin M, Wilson D, Davtyan M, Salomon L, Patel K, Reznick M, Tassiopoulos K, Lee S, Bauermeister J, Paul M, Aldape T, Seage Iii GR. Using Social Media and Technology to Communicate in Pediatric HIV Research: Qualitative Study With Young Adults Living With or Exposed to Perinatal HIV. JMIR Pediatr Parent. 2020 Jun 23;3(1):e20712. doi: 10.2196/20712.
• Cantos K, Franke MF, Tassiopoulos K, Williams PL, Moscicki AB, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Inconsistent Sexual Behavior Reporting Among Youth Affected by Perinatal HIV Exposure in the United States. AIDS Behav. 2021 Oct;25(10):3398-3412. doi: 10.1007/s10461-021-03268-y. Epub 2021 Apr 24.
• Tassiopoulos K, Patel K, Alperen J, Kacanek D, Ellis A, Berman C, Allison SM, Hazra R, Barr E, Cantos K, Siminski S, Massagli M, Bauermeister J, Siddiqui DQ, Puga A, Van Dyke R, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Following young people with perinatal HIV infection from adolescence into adulthood: the protocol for PHACS AMP Up, a prospective cohort study. BMJ Open. 2016 Jun 9;6(6):e011396. doi: 10.1136/bmjopen-2016-011396.
• Williams PL, Jesson J. Growth and pubertal development in HIV-infected adolescents. Curr Opin HIV AIDS. 2018 May;13(3):179-186. doi: 10.1097/COH.0000000000000450.
• Innes S, Patel K. Noncommunicable diseases in adolescents with perinatally acquired HIV-1 infection in high-income and low-income settings. Curr Opin HIV AIDS. 2018 May;13(3):187-195. doi: 10.1097/COH.0000000000000458.
• Goodenough CJ, Patel K, Van Dyke RB; Pediatric HIV/AIDS Cohort Study (PHACS). Is There a Higher Risk of Mother-to-child Transmission of HIV Among Pregnant Women With Perinatal HIV Infection? Pediatr Infect Dis J. 2018 Dec;37(12):1267-1270. doi: 10.1097/INF.0000000000002084.
• Wilkinson JD, Williams PL, Yu W, Colan SD, Mendez A, Zachariah JPV, Van Dyke RB, Shearer WT, Margossian RE, Lipshultz SE; Pediatric HIV/AIDS Cohort Study (PHACS). Cardiac and inflammatory biomarkers in perinatally HIV-infected and HIV-exposed uninfected children. AIDS. 2018 Jun 19;32(10):1267-1277. doi: 10.1097/QAD.0000000000001810.
• Alperen J, Davidson J, Siminski S, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Utility of the National Death Index in Identifying Deaths in a Clinic-Based, Multisite Cohort: The Experience of the Pediatric HIV/AIDS Cohort Study. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):e37-e39. doi: 10.1097/QAI.0000000000001763. No abstract available.
• Kacanek D, Huo Y, Malee K, Mellins CA, Smith R, Garvie PA, Tassiopoulos K, Lee S, Berman CA, Paul M, Puga A, Allison S; Pediatric HIV/AIDS Cohort Study. Nonadherence and unsuppressed viral load across adolescence among US youth with perinatally acquired HIV. AIDS. 2019 Oct 1;33(12):1923-1934. doi: 10.1097/QAD.0000000000002301.
• Yildirim C, Garvie PA, Chernoff M, Wilkins ML, Patton ED, Williams PL, Nichols SL; Memory and Executive Functioning Study of the Pediatric HIV/AIDS Cohort Study. The Role of Pharmacy Refill Measures in Assessing Adherence and Predicting HIV Disease Markers in Youth with Perinatally-Acquired HIV (PHIV). AIDS Behav. 2019 Aug;23(8):2109-2120. doi: 10.1007/s10461-019-02468-x.
• Patel K, Seage GR 3rd, Burchett SK, Hazra R, Van Dyke RB; Pediatric HIV/AIDS Cohort Study. Disparities in HIV Viral Suppression Among Adolescents and Young Adults by Perinatal Infection. Am J Public Health. 2019 Jul;109(7):e9. doi: 10.2105/AJPH.2019.305108. No abstract available.
• Smith R, Huo Y, Tassiopoulos K, Rutstein R, Kapetanovic S, Mellins C, Kacanek D, Malee K; Pediatric HIV/AIDS Cohort Study (PHACS). Mental Health Diagnoses, Symptoms, and Service Utilization in US Youth with Perinatal HIV Infection or HIV Exposure. AIDS Patient Care STDS. 2019 Jan;33(1):1-13. doi: 10.1089/apc.2018.0096.
• Lemon TL, Tassiopoulos K, Tsai AC, Cantos K, Escudero D, Quinn MK, Kacanek D, Berman C, Salomon L, Nichols S, Chadwick EG, Seage GR 3rd, Williams PL; Pediatric HIV/AIDS Cohort Study (PHACS). Health Insurance Coverage, Clinical Outcomes, and Health-Related Quality of Life Among Youth Born to Women Living With HIV. J Acquir Immune Defic Syndr. 2023 Jan 1;92(1):6-16. doi: 10.1097/QAI.0000000000003100.
• Sirois PA, Huo Y, Nozyce ML, Garvie PA, Harris LL, Malee K, McEvoy R, Mellins CA, Nichols SL, Smith R, Tassiopoulos K; Pediatric HIV/AIDS Cohort Study. Ageing with HIV: a longitudinal study of markers of resilience in young adults with perinatal exposure to HIV, with or without perinatally acquired HIV. J Int AIDS Soc. 2022 Sep;25 Suppl 4(Suppl 4):e25982. doi: 10.1002/jia2.25982.
• Torre P 3rd, Zhang ZJ, Hoffman HJ, Frederick T, Purswani M, Williams PL, Yao TJ; Pediatric HIV/AIDS Cohort Study (PHACS). Auditory Function in the Pediatric HIV/AIDS Cohort Study Adolescent Master Protocol Up Young Adults: A Pilot Study. J Acquir Immune Defic Syndr. 2023 Apr 1;92(4):340-347. doi: 10.1097/QAI.0000000000003145.
• Tassiopoulos K, Huo Y, Kacanek D, Malee K, Nichols S, Mellins CA, Kohlhoff S, Van Dyke RB; Pediatric HIV/AIDS Cohort Study. Association of Perceived Social Support with Viral Suppression Among Young Adults with Perinatally-Acquired HIV in the US-based Pediatric HIV/AIDS Cohort Study (PHACS). Clin Epidemiol. 2023 May 9;15:601-611. doi: 10.2147/CLEP.S403570. eCollection 2023.

Helpful Links

• Pediatric HIV/AIDS Cohort Study

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 17, 2014
• First Posted (Estimated): April 22, 2014

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: HIV/AIDS, perinatal HIV infection
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: HD052102 - PH300; PH300 (Other Identifier: PHACS Protocol Number)