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

HIV/AIDS Clinical Trial

— AMP Up Lite  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03279185
• Other study ID #: PH400
• Secondary ID: PH400
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: July 31, 2025

Study information

• Verified date: November 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: Liz Salomon, EdM
• Phone: 6174324567
• Email: lsalomon[@]hsph.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts
United States	Rush University Cook County Hospital Chicago	Chicago	Illinois
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	New York University School of Medicine	New York	New York
United States	Seattle Children's Hospital	Seattle	Washington
United States	SUNY Stony Brook	Stony Brook	New York

Sponsors (11)

Lead Sponsor

Collaborator

Harvard School of Public Health (HSPH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Drug Abuse (NIDA), NIH Office of AIDS Research (OAR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

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

External Links

•   Pediatric HIV/AIDS Cohort Study