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

Completed

• Conditions: HIV/AIDS

• Registration Number: NCT03279185
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

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 Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Study Start: 2017-11-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk Behaviors (Sexual and Substance Use)	Annually for 6 years	Data collected through an online survey.
Hearing Dysfunction	Annually for 6 years.	Data collected through an online survey and chart abstraction.
Sexually Transmitted Infections	Annually for 6 years	Data collected through chart abstraction.
Reproductive Health	Annually for 6 years	Data collected through an online surveys and chart abstraction.
Mental Health	Annually for 6 years.	Data collected through an online survey and chart abstraction.
ART Adherence	Annually for 6 years	Data collected through an online survey.
HIV Disease Progression	Annually for 6 years	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.
Metabolic Anomalies	Annually for 6 years	Data will be collected by chart review, physical assessments, and laboratory evaluations.
Transition to Adult Functioning	Annually for 6 years.	Data collected through an online survey.

Trial Locations

Locations (9)

University of Southern California; 🇺🇸 Los Angeles, California, United States

David Geffen School of Medicine at UCLA; 🇺🇸 Los Angeles, California, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Rush University Cook County Hospital Chicago; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

New York University School of Medicine; 🇺🇸 New York, New York, United States

SUNY Stony Brook; 🇺🇸 Stony Brook, New York, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States