Clinical trial NCT03279185: Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite
Official title: Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite (AMP Up Lite)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV/AIDS
Keywords: HIV/AIDS, perinatal HIV infection
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Drug Abuse (NIDA)
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: NIH Office of AIDS Research (OAR)
name: National Institute of Mental Health (NIMH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: National Institute of Dental and Craniofacial Research (NIDCR)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-09-12
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HIV Disease Progression
timeFrame: Annually for 6 years
measure: Metabolic Anomalies
timeFrame: Annually for 6 years
measure: Sexually Transmitted Infections
timeFrame: Annually for 6 years
measure: Reproductive Health
timeFrame: Annually for 6 years
measure: Mental Health
timeFrame: Annually for 6 years.
measure: ART Adherence
timeFrame: Annually for 6 years
measure: Risk Behaviors (Sexual and Substance Use)
timeFrame: Annually for 6 years
measure: Transition to Adult Functioning
timeFrame: Annually for 6 years.
measure: Hearing Dysfunction
timeFrame: Annually for 6 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Rush University Cook County Hospital Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook
state: New York
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Paige L Williams
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Katherine Tassiopoulos, DSc, MPH
role: STUDY_CHAIR
affiliation: Tulane University School of Medicine
name: Russell B Van Dyke, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.