Clinical trial NCT02119702: Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
Official title: Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
Study type: OBSERVATIONAL
Overall status: 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 Heart, Lung, and Blood Institute (NHLBI)
name: National Institute of Dental and Craniofacial Research (NIDCR)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Tulane University School of Medicine
First posted: 2014-04-22
Enrollment: 820
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adults 18 years of age or older at the time of enrollment with or without perinatal HIV-infection.

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.

Eligibility criteria: Perinatally HIV-Infected Cohort

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

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

Inclusion Criteria:

* 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:

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

Primary outcomes:
measure: HIV disease progression
timeFrame: Annually for 6 years
measure: Metabolic abnormalities
timeFrame: Annually for 6 years
measure: Sexually transmitted infections (STI)
timeFrame: Annually for 6 years
measure: Pregnancies
timeFrame: Annually for 6 years
measure: Mental health problems
timeFrame: Annually for 6 years
measure: ART adherence
timeFrame: Annually for 6 years
measure: Prevalence of risk behaviors including risky sexual behavior and licit and illicit substance use
timeFrame: Annually for 6 years
measure: Transition to adult functioning
timeFrame: Every 3 years for 6 years
measure: Hearing dysfunction
timeFrame: Every 3 years for 6 years
measure: Language development
timeFrame: Once, at the Entry or Year 3 visit
measure: End-organ disease
timeFrame: Annually for 6 years
measure: Mortality
timeFrame: Annually for 6 years
measure: Risk factors for cardiovascular disease
timeFrame: Annually for 6 years
measure: Cervical HPV-associated pre-cancers and cancers (among female participants)
timeFrame: Annually for 6 years
measure: Cognitive impairment
timeFrame: Every 3 years for 6 years
measure: Maternal-to-child HIV transmission
timeFrame: Annually for 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Aurora
country: United States
facility: University of Colorado Denver Health Sciences Center
state: Colorado
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Children's Hospital
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Newark
country: United States
facility: Rutgers - New Jersey Medical School
state: New Jersey
city: Bronx
country: United States
facility: Bronx Lebanon Hospital Center
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Juan
country: Puerto Rico
facility: San Juan Research Hospital
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Paige L Williams
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University School of Medicine
name: Russell Van Dyke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Katherine Tassiopoulos, DSc, MPH
role: PRINCIPAL_INVESTIGATOR
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