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

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ClinicalTrials.gov Identifier: NCT02119702
Recruitment Status : Recruiting
First Posted : April 22, 2014
Last Update Posted : October 26, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Allergy and Infectious Diseases (NIAID)
NIH Office of AIDS Research (OAR)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Tulane University School of Medicine
Information provided by (Responsible Party):
George Seage, Harvard School of Public Health

Tracking Information
First Submitted Date April 10, 2014
First Posted Date April 22, 2014
Last Update Posted Date October 26, 2020
Study Start Date April 2014
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2014)
  • 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 and laboratory assessments.
  • Metabolic abnormalities [ Time Frame: Annually for 6 years ]
    Factors of interest include BMI, body composition, systolic and diastolic blood pressure, lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides). Data will be collected by chart review, physical assessments, and laboratory evaluations.
  • Sexually transmitted infections [ Time Frame: Annually for 6 years ]
    STI testing and chart review conducted annually.
  • Pregnancies [ Time Frame: Annually for 6 years ]
    Data collected annually through online surveys and chart abstraction.
  • Mental health problems [ Time Frame: Every 3 years for 6 years ]
    Assessed at Entry, Year 3, and Year 6 visits through the NIH Toolbox and Center for Epidemiologic Studies Depression Scale (CES-D).
  • ART adherence [ Time Frame: Annually for 6 years ]
    Data collected annually through an online survey.
  • Prevalence of risk behaviors including risky sexual behavior and licit and illicit substance use [ Time Frame: Annually for 6 years ]
    Participants will complete an annual online survey.
  • Transition to adult functioning [ Time Frame: Annually for 6 years ]
    Every year participants will complete an online survey to collect data on educational attainment, employment, independent living and quality of life.
  • Hearing dysfunction [ Time Frame: Every 3 years for 6 years ]
    Assessed through the NIH Toolbox and a questionnaire to be completed at Entry, Year 3 and Year 6 visits.
  • Language development [ Time Frame: Once, at the Entry or Year 3 visit ]
    The Clinical Evaluation of Language Fundamentals (CELF) IV assessment will be completed at the Entry or Year 3 visit.
  • End-organ disease [ 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 and laboratory assessments.
  • Mortality [ 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 and laboratory assessments.
  • Risk factors for cardiovascular disease [ Time Frame: Annually for 6 years ]
    Factors of interest include BMI, body composition, systolic and diastolic blood pressure, lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) and cumulative cardiometabolic risk. Data will be collected by chart review, physical assessments, and laboratory evaluations.
  • Cervical HPV-associated pre-cancers and cancers (among female participants) [ Time Frame: Annually for 6 years ]
    Data collected through annual chart review.
  • Cognitive impairment [ Time Frame: Every 3 years for 6 years ]
    Assessed at Entry, Year 3, and Year 6 visits through the NIH Toolbox.
  • Maternal-to-child HIV transmission [ Time Frame: Annually for 6 years ]
    Data collected through annual chart review.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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 into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) 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 perinatally HIV-exposed, -uninfected (PHEU) 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, 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 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma, serum, peripheral blood monocuclear cells (PBMCs), urine, throat wash/gargle, saliva, and vaginal swabs.
Sampling Method Non-Probability Sample
Study Population HIV-infected and -uninfected young adults 18 years of age or older at the time of enrollment born to HIV-infected mothers.
Condition HIV/AIDS
Intervention Not Provided
Study Groups/Cohorts
  • Infected Cohort
    Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment, engaged in care with ART treatment history available.
  • Uninfected Cohort
    Perinatally HIV-exposed, perinatally-uninfected participant at or beyond their 18th birthday at enrollment. Must have been previously or currently enrolled in PHACS AMP or PHACS SMARTT, and may have horizontally-acquired HIV infection.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 17, 2014)
850
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
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
  • Engaged in medical care and medical records are available
  • At least one of the following is true:

    • Previously or currently enrolled in PHACS AMP, or
    • Previously enrolled in any of the studies included on the list of approved studies for enrollment into AMP Up, or
    • 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

Perinatally HIV-Exposed, -Uninfected Cohort

Inclusion Criteria:

  • Perinatally HIV-exposed, perinatally-uninfected as indicated in the medical record; the 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
  • At least one of the following is true:

    • Previously or currently enrolled in PHACS AMP, or
    • Previously or currently enrolled in PHACS SMARTT
  • Willingness to participate and provide legal written consent

Exclusion Criteria:

  • Have confirmed perinatal HIV infection as documented in the medical record
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Liz Salomon, EdM 617-432-6762 lsalomon@hsph.harvard.edu
Listed Location Countries Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02119702
Other Study ID Numbers HD052102 - PH300
PH300 ( Other Identifier: PHACS Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party George Seage, Harvard School of Public Health
Study Sponsor Harvard School of Public Health
Collaborators
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • NIH Office of AIDS Research (OAR)
  • National Institute of Mental Health (NIMH)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Tulane University School of Medicine
Investigators
Principal Investigator: George R Seage III, ScD, MPH Harvard School of Public Health
Principal Investigator: Russell Van Dyke, MD Tulane University School of Medicine
PRS Account Harvard School of Public Health
Verification Date October 2020