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

NCT03279185 | Completed

• 3 other identifiers: 1P01HD103133 - PH400PH4001P01HD103133
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 9

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 as they transition to adulthood.

Conditions

HIV/AIDS

Keywords

HIV/AIDS, perinatal HIV infection

Outcome Measures

Primary Outcomes (9)

• 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.

Study Arms (1)

Infected Cohort - closed to accrual

Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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;
• Willingness to provide access to existing medical records; and
• Willingness to participate and provide legal consent

You may not qualify if:

• Prisoner status

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 Institute of Dental and Craniofacial Research (NIDCR): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (9)

University of Southern California

Los Angeles, California, 90033, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Rush University Cook County Hospital Chicago

Chicago, Illinois, 60612, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

SUNY Stony Brook

Stony Brook, New York, 17794, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98101, United States

Location

Related Publications (2)

• 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

• 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.

  PMID: 39411892 RESULT

Related Links

• Pediatric HIV/AIDS Cohort Study

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, peripheral blood mononuclear cells (PBMCs)

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

• Katherine Tassiopoulos, DSc, MPH

  Harvard School of Public Health (HSPH)

  STUDY CHAIR

• Russell B Van Dyke, MD

  Tulane University School of Medicine

  STUDY CHAIR

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: August 22, 2017
• First Posted: September 12, 2017
• Study Start: November 1, 2017
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

US (9)