Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite (AMP Up Lite)
|ClinicalTrials.gov Identifier: NCT03279185|
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : July 22, 2019
|Condition or disease|
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:
- 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.
- To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults with perinatal HIV.
- To define the impact of perinatal HIV infection and ART on long-term mental and behavioral health outcomes.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite (AMP Up Lite)|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||October 1, 2023|
|Estimated Study Completion Date :||October 1, 2023|
Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.
- HIV Disease Progression [ Time Frame: 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 [ Time Frame: Annually for 6 years ]Data will be collected by chart review, physical assessments, and laboratory evaluations.
- Sexually Transmitted Infections [ Time Frame: Annually for 6 years ]Data collected through chart abstraction.
- Reproductive Health [ Time Frame: Annually for 6 years ]Data collected through an online surveys and chart abstraction.
- Mental Health [ Time Frame: Annually for 6 years. ]Data collected through an online survey and chart abstraction.
- ART Adherence [ Time Frame: Annually for 6 years ]Data collected through an online survey.
- Risk Behaviors (Sexual and Substance Use) [ Time Frame: Annually for 6 years ]Data collected through an online survey.
- Transition to Adult Functioning [ Time Frame: Annually for 6 years. ]Data collected through an online survey.
- Hearing Dysfunction [ Time Frame: Annually for 6 years. ]Data collected through an online survey and chart abstraction.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279185
|Contact: Liz Salomon, EdMfirstname.lastname@example.org|
|United States, California|
|University of Southern California||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Mariam Davtyan, MPH 323-865-1566 email@example.com|
|Principal Investigator: Toinette Frederick, PhD|
|David Geffen School of Medicine at UCLA||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Michele Carter, RN 301-206-6369 firstname.lastname@example.org|
|Principal Investigator: Jaime Deville, MD|
|United States, Georgia|
|Emory University School of Medicine||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Bridget Wynn, MPH 404-616-2213 email@example.com|
|Principal Investigator: Rana Chakraborty, MD|
|United States, Illinois|
|Rush University Cook County Hospital Chicago||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Maureen McNichols, RN 312-572-4541 firstname.lastname@example.org|
|Principal Investigator: Mariam Aziz, MD|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Thuy Anderson, RN 443-287-8942 email@example.com|
|Principal Investigator: Allison Agwu, MD|
|United States, Massachusetts|
|Boston Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Debra McLaud, RN 617-414-5813 firstname.lastname@example.org|
|Principal Investigator: Stephen Pelton, MD|
|United States, New York|
|New York University School of Medicine||Not yet recruiting|
|New York, New York, United States, 10016|
|Contact: Sandra Deygoo, MS, CCRP 212-263-5680 email@example.com|
|Principal Investigator: William Borkowsky, MD|
|SUNY Stony Brook||Recruiting|
|Stony Brook, New York, United States, 17794|
|Contact: Erin Infanzon 631-444-8832 firstname.lastname@example.org|
|Principal Investigator: Sharon Nachman, MD|
|United States, Washington|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98101|
|Contact: Amanda Robson, BS 206-884-1535 email@example.com|
|Principal Investigator: Ann Melvin, MD|
|Principal Investigator:||George R Seage, ScD, MPH||Harvard School of Public Health|
|Study Chair:||Katherine Tassiopoulos, DSc, MPH||Harvard School of Public Health|
|Study Chair:||Russell B Van Dyke, MD||Tulane University School of Medicine|