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

NCT02119702 | Completed

• 3 other identifiers: 1P01HD103133 - PH300PH3001P01HD103133
• Study Type: observational
• Target: 818
• Locations: 2 countries
• Sites: 14

Brief Summary

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.

Conditions

HIV/AIDS

Keywords

HIV/AIDS, perinatal HIV infection

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (2)

Infected Cohort - Closed to accrual

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Have confirmed perinatal HIV infection as documented in the medical record

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• NIH Office of AIDS Research (OAR): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Tulane University School of Medicine: collaborator

Study Sites (14)

University of California San Diego

La Jolla, California, 92093, United States

Location

University of Colorado Denver Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Children's Diagnostic and Treatment Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Miami

Miami, Florida, 33316, United States

Location

Ann and Robert H. Lurie Children's Hospital

Chicago, Illinois, 60614, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Rutgers - New Jersey Medical School

Newark, New Jersey, 07101, United States

Location

Bronx Lebanon Hospital Center

The Bronx, New York, 10457, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

San Juan Research Hospital

San Juan, 00936, Puerto Rico

Location

Related Publications (22)

• 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.

  PMID: 27288383 RESULT

• 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.

  PMID: 29432228 RESULT

• 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.

  PMID: 29432231 RESULT

• 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.

  PMID: 29742647 RESULT

• 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.

  PMID: 29596110 RESULT

• 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.

  PMID: 29847477 RESULT

• 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.

  PMID: 31274538 RESULT

• 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.

  PMID: 30927547 RESULT

• 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.

  PMID: 30929147 RESULT

• 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.

  PMID: 31166735 RESULT

• 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.

  PMID: 30601062 RESULT

• 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.

  PMID: 32004075 RESULT

• 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.

  PMID: 31870676 RESULT

• 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.

  PMID: 31584617 RESULT

• 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.

  PMID: 32540839 RESULT

• 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.

  PMID: 33893876 RESULT

• 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.

  PMID: 36176020 RESULT

• 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.

  PMID: 36729663 RESULT

• 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.

  PMID: 36150048 RESULT

• 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.

  PMID: 37193342 RESULT

• Dirajlal-Fargo S, Yu W, Jacobson DL, Mirza A, Geffner ME, Jao J, McComsey GA; Pediatric HIV/AIDS Cohort Study (PHACS). Gut permeability is associated with lower insulin sensitivity in youth with perinatally acquired HIV. AIDS. 2024 Jul 1;38(8):1163-1171. doi: 10.1097/QAD.0000000000003896. Epub 2024 Mar 28.

  PMID: 38564437 RESULT

• Gojanovich GS, Yu W, Zhang ZJ, Jacobson DL, Yao TJ, Jao J, Libutti DE, Geffner ME, Gerschenson M; Pediatric HIV/AIDS Cohort Study. Longitudinal changes in mitochondrial-associated measures and insulin resistance in youth with perinatally-acquired HIV in the U.S. Mitochondrion. 2024 Sep;78:101936. doi: 10.1016/j.mito.2024.101936. Epub 2024 Jul 14.

  PMID: 39009104 RESULT

Related Links

• Pediatric HIV/AIDS Cohort Study

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, peripheral blood mononuclear cells (PBMCs), urine, throat wash/gargle, saliva, and vaginal swabs.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Paige L Williams

  Harvard School of Public Health (HSPH)

  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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer on Biostatistics

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 22, 2014
• Study Start: April 1, 2014
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

PR (1); US (13)