Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)

NCT ID: NCT02119702

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 818 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2025-05-31

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 (YAPHIV) as they transition into adulthood. A group of of perinatally exposed but uninfected young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.

Detailed Description

AMP Up aims to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition into adulthood. A group of uninfected perinatally-exposed young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.

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 dysfunction, 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, including:

• Metabolic abnormalities and risk factors for cardiovascular disease, including glucose and lipid metabolism, blood pressure, and body composition.
• Sexually transmitted infections (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis, human papillomavirus (HPV), genital warts and HSV) among males and females, and cervical HPV-associated pre-cancers and cancers and Mycoplasma genitalium and other vaginal microbiota among females.
• Reproductive health, fertility, and pregnancy outcomes including mother-to-child transmission of HIV.
• To define the impact of perinatal HIV infection, its concomitant risk factors and ART on long-term neurocognitive and behavioral health outcomes, including:

• Mental health and neurocognitive functioning.
• Health care behaviors, including adherence to ART, participation in health care services, and transition to adult clinical care.
• Risk behaviors, including sexual behavior and substance use.
• Independent living skills, and vocational and education achievement necessary for successful transition to adult functioning and quality of life.

Conditions

HIV/AIDS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infected Cohort - Closed to accrual

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

No interventions assigned to this group

Uninfected Cohort

Perinatally HIV-exposed but uninfected participant at or beyond their 18th birthday at enrollment. May have horizontally-acquired HIV infection.

No interventions assigned to this group

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
• Willing to provide access to existing medical records

• Available medical record documentation since early childhood of:

• ART exposure history
• Opportunistic infection prophylaxis exposure history
• Viral load and CD4+ cell count history
• Major medical events history
• Willingness to participate and provide legal written consent

• Absence of perinatal HIV infection as indicated in the medical record; the Perinatally HIV-Exposed Uninfected (PHEU) participant may have horizontally-acquired HIV infection
• At or beyond their 18th birthday at the time of informed consent with no upper age limit
• Willingness to participate and provide legal written consent

Exclusion Criteria

• HIV acquired by other than maternal-child transmission (e.g., blood products, sexual contact, and IV drug use) as documented in the medical record

Uninfected Cohort

• Have confirmed perinatal HIV infection as documented in the medical record

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

NIH Office of AIDS Research (OAR)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Tulane University School of Medicine

OTHER

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: lead

Responsible Party

Paige Williams

Senior Lecturer on Biostatistics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paige L Williams

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Russell Van Dyke, MD

Role: PRINCIPAL_INVESTIGATOR

Tulane University School of Medicine

Katherine Tassiopoulos, DSc, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

University of California San Diego

La Jolla, California, United States

University of Colorado Denver Health Sciences Center

Aurora, Colorado, United States

Children's Diagnostic and Treatment Center

Fort Lauderdale, Florida, United States

University of Miami

Miami, Florida, United States

Ann and Robert H. Lurie Children's Hospital

Chicago, Illinois, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Children's Hospital Boston

Boston, Massachusetts, United States

Rutgers - New Jersey Medical School

Newark, New Jersey, United States

Bronx Lebanon Hospital Center

The Bronx, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

San Juan Research Hospital

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

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Related Links

http://www.phacsstudy.org

Pediatric HIV/AIDS Cohort Study

Other Identifiers

PH300

Identifier Type: OTHER

Identifier Source: secondary_id

1P01HD103133

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1P01HD103133 - PH300

Identifier Type: -

Identifier Source: org_study_id