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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS

Detailed Description

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:

1. 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.
2. To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults with perinatal HIV.
3. To define the impact of perinatal HIV infection and ART on long-term mental and behavioral health outcomes.

• Study Type: Observational
• Enrollment (Actual): 334

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90095
      • David Geffen School of Medicine at UCLA
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Cook County Hospital Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine
    • Stony Brook, New York, United States, 17794
      • SUNY Stony Brook
  • Washington
    • Seattle, Washington, United States, 98101
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Perinatally HIV-infected (PHIV+) young adults 18 years of age or older at the time of enrollment born to HIV-infected mothers.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Infected Cohort - closed to accrual; Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.

What is the study measuring?

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.

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)
• Investigators: Study Chair: Katherine Tassiopoulos, DSc, MPH, Harvard School of Public Health (HSPH); Study Chair: Russell B Van Dyke, MD, Tulane University School of Medicine; Principal Investigator: Paige L Williams, Harvard School of Public Health (HSPH)

Publications and helpful links

General Publications

• 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.
• Olivero R, Williams PL, Sawyer G, Yee LM, Patel K, Hernandez-Diaz S, Powis K, Paul M, Chadwick EG; Pediatric HIV/AIDS Cohort Study and the HOPE study. Birth outcomes following bictegravir exposure during pregnancy. AIDS. 2025 Mar 15;39(4):381-386. doi: 10.1097/QAD.0000000000004041. Epub 2024 Oct 14.

Helpful Links

• Pediatric HIV/AIDS Cohort Study

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: HIV/AIDS, perinatal HIV infection
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 1P01HD103133 - PH400; PH400 (Other Identifier: PHACS Protocol Number); 1P01HD103133 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No