<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03279185</url>
  </required_header>
  <id_info>
    <org_study_id>PH400</org_study_id>
    <secondary_id>PH400</secondary_id>
    <nct_id>NCT03279185</nct_id>
  </id_info>
  <brief_title>Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite</brief_title>
  <acronym>AMP Up Lite</acronym>
  <official_title>Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite (AMP Up Lite)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>NIH Office of AIDS Research (OAR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Harvard School of Public Health (HSPH)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective cohort study designed to define the impact of HIV infection and&#xD;
      antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition&#xD;
      to adulthood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective cohort study designed to define the impact of HIV infection and&#xD;
      antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition&#xD;
      to adulthood.&#xD;
&#xD;
      The primary objectives of this study are:&#xD;
&#xD;
        1. To identify infectious and non-infectious complications of HIV disease and toxicities&#xD;
           resulting from long-term ART, including disease progression, immune suppression, viral&#xD;
           resistance, end-organ disease, and mortality.&#xD;
&#xD;
        2. To define the impact of HIV infection and ART on the long-term clinical outcomes of&#xD;
           young adults with perinatal HIV.&#xD;
&#xD;
        3. To define the impact of perinatal HIV infection and ART on long-term mental and&#xD;
           behavioral health outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>HIV Disease Progression</measure>
    <time_frame>Annually for 6 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic Anomalies</measure>
    <time_frame>Annually for 6 years</time_frame>
    <description>Data will be collected by chart review, physical assessments, and laboratory evaluations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sexually Transmitted Infections</measure>
    <time_frame>Annually for 6 years</time_frame>
    <description>Data collected through chart abstraction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reproductive Health</measure>
    <time_frame>Annually for 6 years</time_frame>
    <description>Data collected through an online surveys and chart abstraction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental Health</measure>
    <time_frame>Annually for 6 years.</time_frame>
    <description>Data collected through an online survey and chart abstraction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ART Adherence</measure>
    <time_frame>Annually for 6 years</time_frame>
    <description>Data collected through an online survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risk Behaviors (Sexual and Substance Use)</measure>
    <time_frame>Annually for 6 years</time_frame>
    <description>Data collected through an online survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transition to Adult Functioning</measure>
    <time_frame>Annually for 6 years.</time_frame>
    <description>Data collected through an online survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hearing Dysfunction</measure>
    <time_frame>Annually for 6 years.</time_frame>
    <description>Data collected through an online survey and chart abstraction.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Infected Cohort</arm_group_label>
    <description>Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, plasma, peripheral blood mononuclear cells (PBMCs)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Perinatally HIV-infected (PHIV+) young adults 18 years of age or older at the time of&#xD;
        enrollment born to HIV-infected mothers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Perinatal HIV infection as documented in the medical record;&#xD;
&#xD;
          -  At or beyond their 18th birthday at the time of informed consent with no upper age&#xD;
             limit;&#xD;
&#xD;
          -  Willingness to provide access to existing medical records; and&#xD;
&#xD;
          -  Willingness to participate and provide legal consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prisoner status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paige L Williams</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard School of Public Health (HSPH)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katherine Tassiopoulos, DSc, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>Harvard School of Public Health (HSPH)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Russell B Van Dyke, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Tulane University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liz Salomon, EdM</last_name>
    <phone>6174324567</phone>
    <email>lsalomon@hsph.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariam Davtyan, MPH</last_name>
      <phone>323-865-1566</phone>
      <email>mdavtyan@usc.edu</email>
    </contact>
    <investigator>
      <last_name>Toinette Frederick, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>David Geffen School of Medicine at UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michele Carter, RN</last_name>
      <phone>301-206-6369</phone>
      <email>mfcarter@mednet.ucla.edu</email>
    </contact>
    <investigator>
      <last_name>Jaime Deville, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bridget Wynn, MPH</last_name>
      <phone>404-616-2213</phone>
      <email>bridget.wynn@emory.edu</email>
    </contact>
    <investigator>
      <last_name>Rana Chakraborty, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rush University Cook County Hospital Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maureen McNichols, RN</last_name>
      <phone>312-572-4541</phone>
      <email>maureen_e_mcnichols@rush.edu</email>
    </contact>
    <investigator>
      <last_name>Mariam Aziz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thuy Anderson, RN</last_name>
      <phone>443-287-8942</phone>
      <email>tander34@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Allison Agwu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Debra McLaud, RN</last_name>
      <phone>617-414-5813</phone>
      <email>debra.mclaud@bmc.org</email>
    </contact>
    <investigator>
      <last_name>Stephen Pelton, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra Deygoo, MS, CCRP</last_name>
      <phone>212-263-5680</phone>
      <email>nagamah.deygoo@nyumc.org</email>
    </contact>
    <investigator>
      <last_name>Mona Rigaud, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>SUNY Stony Brook</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>17794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin Infanzon</last_name>
      <phone>631-444-8832</phone>
      <email>erin.infanzon@stonybrookmedicine.edu</email>
    </contact>
    <investigator>
      <last_name>Sharon Nachman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amanda Robson, BS</last_name>
      <phone>206-884-1535</phone>
      <email>amanda.robson@seattlechildrens.org</email>
    </contact>
    <investigator>
      <last_name>Ann Melvin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.phacsstudy.org</url>
    <description>Pediatric HIV/AIDS Cohort Study</description>
  </link>
  <reference>
    <citation>Tassiopoulos K, Huo Y, Patel K, Kacanek D, Allison S, Siminski S, Nichols SL, Mellins CA; Pediatric HIV/AIDS Cohort Study (PHACS). Healthcare Transition Outcomes Among Young Adults With Perinatally Acquired Human Immunodeficiency Virus Infection in the United States. Clin Infect Dis. 2020 Jun 24;71(1):133-141. doi: 10.1093/cid/ciz747.</citation>
    <PMID>31584617</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>August 26, 2022</last_update_submitted>
  <last_update_submitted_qc>August 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard School of Public Health (HSPH)</investigator_affiliation>
    <investigator_full_name>Paige Williams</investigator_full_name>
    <investigator_title>Senior Lecturer on Biostatistics</investigator_title>
  </responsible_party>
  <keyword>HIV/AIDS, perinatal HIV infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03279185
org study id: PH400
secondary id: PH400
nct id: NCT03279185
lead sponsor: 
collaborator: 
collaborator: 
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: HIV Disease Progression
time frame: Annually for 6 years
description: 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.
measure: Metabolic Anomalies
time frame: Annually for 6 years
description: Data will be collected by chart review, physical assessments, and laboratory evaluations.
measure: Sexually Transmitted Infections
time frame: Annually for 6 years
description: Data collected through chart abstraction.
measure: Reproductive Health
time frame: Annually for 6 years
description: Data collected through an online surveys and chart abstraction.
measure: Mental Health
time frame: Annually for 6 years.
description: Data collected through an online survey and chart abstraction.
measure: ART Adherence
time frame: Annually for 6 years
description: Data collected through an online survey.
measure: Risk Behaviors (Sexual and Substance Use)
time frame: Annually for 6 years
description: Data collected through an online survey.
measure: Transition to Adult Functioning
time frame: Annually for 6 years.
description: Data collected through an online survey.
measure: Hearing Dysfunction
time frame: Annually for 6 years.
description: Data collected through an online survey and chart abstraction.
arm group label: Infected Cohort
description: Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.
Serum, plasma, peripheral blood mononuclear cells (PBMCs)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paige L Williams
role: Principal Investigator
affiliation: Harvard School of Public Health (HSPH)
last name: Katherine Tassiopoulos, DSc, MPH
role: Study Chair
affiliation: Harvard School of Public Health (HSPH)
last name: Russell B Van Dyke, MD
role: Study Chair
affiliation: Tulane University School of Medicine
last name: Liz Salomon, EdM
phone: 6174324567
email: lsalomon@hsph.harvard.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.phacsstudy.org
description: Pediatric HIV/AIDS Cohort Study
citation: Tassiopoulos K, Huo Y, Patel K, Kacanek D, Allison S, Siminski S, Nichols SL, Mellins CA; Pediatric HIV/AIDS Cohort Study (PHACS). Healthcare Transition Outcomes Among Young Adults With Perinatally Acquired Human Immunodeficiency Virus Infection in the United States. Clin Infect Dis. 2020 Jun 24;71(1):133-141. doi: 10.1093/cid/ciz747.
PMID: 31584617
responsible party type: Principal Investigator
investigator affiliation: Harvard School of Public Health (HSPH)
investigator full name: Paige Williams
investigator title: Senior Lecturer on Biostatistics
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections