<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/NCT03263195</url>
  </required_header>
  <id_info>
    <org_study_id>HIV-ZIP</org_study_id>
    <secondary_id>HHSN275201800001I</secondary_id>
    <nct_id>NCT03263195</nct_id>
  </id_info>
  <brief_title>Prospective Cohort Study of HIV and Zika in Infants and Pregnancy</brief_title>
  <acronym>HIV ZIP</acronym>
  <official_title>Prospective Cohort Study of HIV and Zika in Infants and Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Westat</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 of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Westat</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to compare the incidence of Zika virus (ZIKV) infection among&#xD;
      pregnant women with and without Human Immunodeficiency Virus (HIV) infection and to determine&#xD;
      the risk of adverse maternal and child outcomes associated with ZIKV/HIV co-infection across&#xD;
      clinical sites in the continental United States (U.S.), Puerto Rico (P.R.) and Brazil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two-phase prospective international cohort study of pregnant women and their&#xD;
      infants from those pregnancies whose goals are to compare the incidence of ZIKV infection&#xD;
      among pregnant women with and without HIV infection and to determine the risk of adverse&#xD;
      maternal and child outcomes associated with ZIKV/HIV co-infection across clinical sites in&#xD;
      the continental U.S., P.R. and Brazil.&#xD;
&#xD;
      Phase I will enroll pregnant women/infant pairs who are: (1) infected with HIV only; (2)&#xD;
      infected with ZIKV only; (3) infected with HIV and ZIKV; and (4) not infected with HIV or&#xD;
      ZIKV. Phase I will assess the feasibility of enrolling a total of 200 pregnant women/infant&#xD;
      pairs within a year, with a target of 150 HIV-infected women, 50 HIV-uninfected women from&#xD;
      the continental U.S. sites only, and a minimum of 20 who are co-infected with HIV and ZIKV by&#xD;
      the end of pregnancy.&#xD;
&#xD;
      Should the feasibility of Phase I prove successful, Phase II will commence by enrolling up to&#xD;
      1,800 additional pregnant women/infant pairs to the 4 groups described above. The comparison&#xD;
      group of HIV-uninfected pregnant women/infant pairs from P.R and Brazil (ZIKV-infected and&#xD;
      uninfected) will be obtained from data collected in the concurrent International Prospective&#xD;
      Observational Cohort Study of Zika in Infants and Pregnancy (ZIP study).&#xD;
&#xD;
      All HIV-infected and uninfected study participants will be tested for ZIKV. Enrolled women&#xD;
      will be followed throughout their pregnancy and up to six weeks postpartum. Infants born to&#xD;
      enrolled women will be followed for a full year after birth. Thereafter, the infants born to&#xD;
      women at continental U.S. and P.R. sites also implementing the Surveillance Monitoring for&#xD;
      Antiretroviral Therapy (ART) Toxicities (SMARTT) study may be followed up yearly until&#xD;
      adulthood through SMARTT depending on the availability of funds.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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>Enrollment (150 HIV-infected and 50 HIV-uninfected Pregnant Women Within One Year, With a Minimum of 20 of These Women Having HIV/ZIKV Co-infection by Their End of Pregnancy).</measure>
    <time_frame>At the time of delivery of all those enrolled up to 1 year after the first enrollment</time_frame>
    <description>This outcome measured feasibility of enrolling 150 pregnant women living with HIV and 50 pregnant women without HIV, with a minimum of 20 of these women having HIV/ZIKV co-infection by their end of pregnancy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery.</measure>
    <time_frame>Maternal viral load at delivery</time_frame>
    <description>This outcome intended to measure HIV suppression at the time of delivery among women living with HIV with and without ZIKV infection during pregnancy. Note there were no women with ZIKV infection in pregnancy. Viral suppression was defined at different thresholds (&lt;40 copies/mL, &lt;400 copies/mL, &lt;1000 copies/mL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of ZIKV Infection (Among Pregnant Women With HIV Infection Compared to Those Without HIV Infection).</measure>
    <time_frame>Maternal baseline to delivery</time_frame>
    <description>Cumulative incidence of ZIKV infection during pregnancy (among pregnant women with HIV infection compared to those without HIV infection).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Adverse Pregnancy Outcomes (in Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women).</measure>
    <time_frame>At time of delivery</time_frame>
    <description>Adverse pregnancy outcomes included miscarriage, stillbirth and preterm delivery. Note there were no women with ZIKV infection in pregnancy.&#xD;
Miscarriage was defined as fetal demise at &lt;20 weeks of gestation. Stillbirth was defined as fetal demise at ≥20 weeks of gestation. Preterm delivery was defined as delivery at &lt;37 weeks of gestation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Vertical Transmission of HIV and/or ZIKV (in Women Co-infected With HIV and ZIKV and Women Infected With Either HIV or ZIKV Alone).</measure>
    <time_frame>Infant birth to 12 months</time_frame>
    <description>Cumulative incidence of confirmed HIV infection among enrolled infants. Note there were no women with ZIKV infection in pregnancy so therefore no risk of transmission of ZIKV to any infants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Congenital Malformations (Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women).</measure>
    <time_frame>Infant birth, 3 months</time_frame>
    <description>Cumulative incidence of congenital malformations. Note there were no women with ZIKV infection in pregnancy.&#xD;
Observed major congenital malformations included: anhydramnios, cerebral ventriculomegaly, clubfoot (unresolved), Down syndrome, hydrops, hypospadias, patient ductus arteriosus, polydactyly (left foot), Potter syndrome, short stature, syndactyly (left foot, 1st and 2nd toes).&#xD;
Observed minor congenital malformations included: clubfoot (resolved), cryptorchidism (bilateral), dislocated hip, heart defect (patent foramen ovale), heart murmur (unresolved), hemangioma, hip dysplasia, hydrocele, inguinal hernia, head circumference -3 ≤ z-score &lt;-2, persistent ductus arteriosus (resolved), plagiocephaly, restrictive ductus arteriosus, renal pyelectasis, sacral dimple, small perimembranous ventricular septal defect, stenosis of nasolacrimal duct, umbilical hernia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone.</measure>
    <time_frame>Infant birth to 12 months</time_frame>
    <description>Other adverse outcomes included microcephaly, neonatal dealth, central nervous system (CNS) malformation, hydrops, and ocular abnormalities. Note there were no women with ZIKV infection in pregnancy.&#xD;
Microcephaly was defined as head circumference less than a z-score of -3 at birth or 3 month visit.&#xD;
Neonatal death was defined as death within 28 days of life. Observed CNS malformations included: cerebral ventriculomegaly. Ocular abnormalities included both structural and functional ophthalmologic abnormalities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV</measure>
    <time_frame>Infant Birth, 3 months, 6 months, 12 months</time_frame>
    <description>Weight as a measure of growth. Note there were no women with ZIKV infection in pregnancy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV</measure>
    <time_frame>Infant Birth, 3 months, 6 months, 12 months</time_frame>
    <description>Length and head circumference as measures of growth. Note there were no women with ZIKV infection in pregnancy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV</measure>
    <time_frame>Within one month of infant birth, 3 months, 6 months, 12 months</time_frame>
    <description>Audiologic function as assessed by OAE test reported. Note there were no women with ZIKV infection in pregnancy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ophthalmologic Structure and Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV</measure>
    <time_frame>Within one month of infant birth, 12 months;</time_frame>
    <description>Ocular abnormalities included both structural and functional ophthalmologic abnormalities. Note there were no women with ZIKV infection in pregnancy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopment Among Children With or Without in Utero Exposure to HIV and/or ZIKV</measure>
    <time_frame>Infant 3 months, 6 months, 12 months</time_frame>
    <description>Infant neurodevelopment was assessed by either the Bayley III or Ages and Stages Questionnaires- 3rd Edition. Combined results reported. Note there were no women with ZIKV infection in pregnancy.</description>
  </primary_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Actual">395</enrollment>
  <condition>HIV</condition>
  <condition>Zika Virus</condition>
  <condition>Pregnant Women</condition>
  <arm_group>
    <arm_group_label>Women with HIV only</arm_group_label>
    <description>Pregnant women with HIV infection only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women with ZIKV only</arm_group_label>
    <description>Pregnant women with ZIKV infection only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women with HIV and ZIKV</arm_group_label>
    <description>Pregnant women with HIV and ZIKV infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women without HIV or ZIKV</arm_group_label>
    <description>Pregnant women without HIV or ZIKV infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants of women with HIV only</arm_group_label>
    <description>Infants of women with HIV infection during pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants of women with ZIKV only</arm_group_label>
    <description>Infants of women with ZIKV infection during pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants of women with HIV and ZIKV</arm_group_label>
    <description>Infants of women with HIV and ZIKV infection during pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants of women without HIV or ZIKV</arm_group_label>
    <description>Infants of women without HIV or ZIKV infection during pregnancy</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Maternal blood, maternal urine, cord blood, and placenta tissue. Infant blood and infant&#xD;
      urine.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Maternal: HIV infected or uninfected (the latter in the continental U.S only) pregnant&#xD;
        women, ages 15 years and older, residing in a geographic area accessible to a research site&#xD;
        in Brazil, Puerto Rico or the continental U.S., meet the ZIKV infection risk criteria and&#xD;
        are less than 18 weeks GA or any GA if presenting with acute ZIKV-like symptoms and have&#xD;
        confirmed ZIKV infection by positive ZIKV RNA detection at the Screening visit.&#xD;
&#xD;
        Infant: All infants born to women while enrolled in this study if the parent(s)/legal&#xD;
        guardian(s) consents for the infant's participation. Infants may be in one of the following&#xD;
        groups: a) HIV infected only; b) ZIKV infected only; c) HIV and ZIKV infected; or d) HIV&#xD;
        and ZIKV uninfected&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Maternal&#xD;
&#xD;
          -  Provides written informed consent (IC) (or assent and parent(s)/legal guardian(s)&#xD;
             permission, where required per state or country regulations).&#xD;
&#xD;
          -  Age 15 years or older at enrollment.&#xD;
&#xD;
          -  Confirmation of pregnancy by βhCG measurement in blood or urine or fetal ultrasound&#xD;
             (US) heart tones present.&#xD;
&#xD;
          -  Based on pregnancy calculator or fetal US: Confirmation of being at &lt;18 weeks&#xD;
             gestational age (GA) of pregnancy or at any GA if presents with acute ZIKV-like&#xD;
             symptoms (i.e., fever, rash, arthralgia, myalgia, pruritus, headache, eye pain, and&#xD;
             conjunctivitis) and has laboratory-confirmed ZIKV infection by ZIKV RNA detection.&#xD;
&#xD;
          -  Plans on remaining in the area of the current study site or if moving, within an area&#xD;
             of any other study site, for the duration of her and her child's participation.&#xD;
&#xD;
          -  Willingness of parent(s)/legal guardian(s) to provide written consent to enroll the&#xD;
             infant from the current pregnancy once delivered.&#xD;
&#xD;
        Has met one of the following three ZIKV-exposure risk categories:&#xD;
&#xD;
          -  Has resided in for at least three months or traveled within the last three months to a&#xD;
             country or United States (U.S.) territory with active, cautionary, or previously&#xD;
             active or cautionary ZIKV transmission based on the list found at&#xD;
             http://www.cdc.gov/zika/geo/active-countries.html; or&#xD;
&#xD;
          -  Sexual partner has resided in or traveled within the last six months to a country or&#xD;
             U.S. territory with active, cautionary, or previously active or cautionary ZIKV&#xD;
             transmissions, or was diagnosed with ZIKV within the previous six months; or&#xD;
&#xD;
          -  Household member has been diagnosed with ZIKV infection or has traveled since the&#xD;
             woman's last menstrual period (LMP) to a country or U.S. territory with active,&#xD;
             cautionary, or previously active or cautionary ZIKV transmission.&#xD;
&#xD;
               -  For HIV-infected women only: Laboratory evidence or clinical criteria for a&#xD;
                  confirmed case of HIV infection per Centers for Disease Control and Prevention&#xD;
                  (CDC) Surveillance Case Definition for HIV, 2014 (Section 1.1.1 or Section 1.1.2)&#xD;
                  http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm.&#xD;
&#xD;
        Infant&#xD;
&#xD;
          -  Born to an enrolled mother.&#xD;
&#xD;
          -  Parent(s)/legal guardian(s) provided written IC for his or her child to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Maternal:&#xD;
&#xD;
          -  Incarcerated or placed in detention.&#xD;
&#xD;
          -  Enrolled in other clinical research (including other ZIKV research) requiring blood&#xD;
             collection, which in combination with HIV ZIP evaluations would exceed a total blood&#xD;
             draw volume of 50 mL in an eight-week period and/or blood collection would be required&#xD;
             more frequently than two times per week.&#xD;
&#xD;
        Infant:&#xD;
&#xD;
        •Enrolled in other clinical research (including other ZIKV research) requiring blood&#xD;
        collection, which in combination with HIV ZIP evaluations, would exceed three mL per kg in&#xD;
        an eight week period and/or blood collection would be required more frequently than two&#xD;
        times per week.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marisa M. Mussi-Pinhata, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Sao Paolo, Riberao Preto Medical School, Department of Pediatrics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami Pediatric/Prenatal HIV/AIDS</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bronx-Lebanon Hospital Center NICHD CRS</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10457</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine; Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SOM Federal University Minas Gerais Brazil NICHD CRS</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30.130-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Federal dos Servidores do Estado NICHD CRS</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20221-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21941-612</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Geral De Nova Igaucu Brazil NICHD CRS</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>26030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Sao Paulo at Riberaio Preto Brazil</name>
      <address>
        <city>São Paulo</city>
        <zip>14049-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Puerto Rico Pediatrics HIV/AIDS Research Program</name>
      <address>
        <city>San Juan</city>
        <zip>00936-5067</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Juan City Hosp. PR NICHD CRS</name>
      <address>
        <city>San Juan</city>
        <zip>00936</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <results_first_submitted>September 30, 2021</results_first_submitted>
  <results_first_submitted_qc>January 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 14, 2022</results_first_posted>
  <last_update_submitted>January 6, 2022</last_update_submitted>
  <last_update_submitted_qc>January 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Zika Virus</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>MTCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zika Virus Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified participant data will be entered into the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (N-DASH) system.&#xD;
Data from the ZIP study, conducted in Zika-endemic areas, may be merged with HIV ZIP. In most cases, ZIP will have the exact same infant assessments as HIV ZIP.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>No later than one year after the date of acceptance for publication of the main findings from the final dataset.</ipd_time_frame>
    <ipd_access_criteria>A Memorandum of Understanding (MOU) about the extent and nature of the sharing as well as a data use agreement will be executed for all collaborations. The MOU will include an understanding of the control of the use of the data, publication rights and authorship rights, as well as address the human participant's confidentiality issues</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03263195/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Maternal Informed Consent</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03263195/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Infant Informed Consent</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03263195/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Women With HIV Only</title>
          <description>Pregnant women with HIV infection only</description>
        </group>
        <group group_id="P2">
          <title>Women With ZIKV Only</title>
          <description>Pregnant women with ZIKV infection only</description>
        </group>
        <group group_id="P3">
          <title>Women With HIV and ZIKV</title>
          <description>Pregnant women with HIV and ZIKV infection</description>
        </group>
        <group group_id="P4">
          <title>Women Without HIV or ZIKV</title>
          <description>Pregnant women without HIV or ZIKV infection</description>
        </group>
        <group group_id="P5">
          <title>Infants of Women With HIV Only</title>
          <description>Infants of women with HIV infection during pregnancy</description>
        </group>
        <group group_id="P6">
          <title>Infants of Women With ZIKV Only</title>
          <description>Infants of women with ZIKV infection during pregnancy</description>
        </group>
        <group group_id="P7">
          <title>Infants of Women With HIV and ZIKV</title>
          <description>Infants of women with HIV and ZIKV infection during pregnancy</description>
        </group>
        <group group_id="P8">
          <title>Infants of Women Without HIV or ZIKV</title>
          <description>Infants of women without HIV or ZIKV infection during pregnancy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="26"/>
                <participants group_id="P5" count="170"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="168"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="23"/>
                <participants group_id="P5" count="155"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="15"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>At baseline (start of study) pregnant women were enrolled. Baseline characteristics of these women enrolled during pregnancy are therefore presented in this table. Live-born infants of these women were subsequently followed for one year if consent was obtained.</population>
      <group_list>
        <group group_id="B1">
          <title>Women With HIV Only</title>
          <description>Pregnant women with HIV infection only</description>
        </group>
        <group group_id="B2">
          <title>Women With ZIKV Only</title>
          <description>Pregnant women with ZIKV infection only</description>
        </group>
        <group group_id="B3">
          <title>Women With HIV and ZIKV</title>
          <description>Pregnant women with HIV and ZIKV infection</description>
        </group>
        <group group_id="B4">
          <title>Women Without HIV or ZIKV</title>
          <description>Pregnant women without HIV or ZIKV infection</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="174"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
            <count group_id="B4" value="26"/>
            <count group_id="B5" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.2" lower_limit="23.2" upper_limit="32.9"/>
                    <measurement group_id="B4" value="29.2" lower_limit="23.9" upper_limit="32.7"/>
                    <measurement group_id="B5" value="28.3" lower_limit="23.2" upper_limit="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="174"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White (US)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black (US)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian (US)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race (US)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other (US)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not reported (US)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White (Brazil)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black (Brazil)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mulatto (Brazil)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amarela/Yellow (Brazil)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indigenous (Brazil)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed Black (Brazil)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race (Brazil)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Puerto Rico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="164"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational age at enrollment</title>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.5" lower_limit="12.0" upper_limit="16.0"/>
                    <measurement group_id="B4" value="16.0" lower_limit="14.0" upper_limit="17.0"/>
                    <measurement group_id="B5" value="15.0" lower_limit="12.0" upper_limit="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Enrollment (150 HIV-infected and 50 HIV-uninfected Pregnant Women Within One Year, With a Minimum of 20 of These Women Having HIV/ZIKV Co-infection by Their End of Pregnancy).</title>
        <description>This outcome measured feasibility of enrolling 150 pregnant women living with HIV and 50 pregnant women without HIV, with a minimum of 20 of these women having HIV/ZIKV co-infection by their end of pregnancy</description>
        <time_frame>At the time of delivery of all those enrolled up to 1 year after the first enrollment</time_frame>
        <population>While the protocol was successful at enrolling at least 150 women living with HIV, it did not achieve its aim of enrolling 50 women without HIV and there were no ZIKV infections observed during the study period. Total enrollment into the expected arms is presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Women With HIV Only</title>
            <description>Pregnant women with HIV infection only</description>
          </group>
          <group group_id="O2">
            <title>Women With ZIKV Only</title>
            <description>Pregnant women ZIKV infection only</description>
          </group>
          <group group_id="O3">
            <title>Women With HIV and ZIKV</title>
            <description>Pregnant women with HIV and ZIKV infection</description>
          </group>
          <group group_id="O4">
            <title>Women Without HIV or ZIKV</title>
            <description>Pregnant women without HIV or ZIKV infection</description>
          </group>
        </group_list>
        <measure>
          <title>Enrollment (150 HIV-infected and 50 HIV-uninfected Pregnant Women Within One Year, With a Minimum of 20 of These Women Having HIV/ZIKV Co-infection by Their End of Pregnancy).</title>
          <description>This outcome measured feasibility of enrolling 150 pregnant women living with HIV and 50 pregnant women without HIV, with a minimum of 20 of these women having HIV/ZIKV co-infection by their end of pregnancy</description>
          <population>While the protocol was successful at enrolling at least 150 women living with HIV, it did not achieve its aim of enrolling 50 women without HIV and there were no ZIKV infections observed during the study period. Total enrollment into the expected arms is presented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="174"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="174"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery.</title>
        <description>This outcome intended to measure HIV suppression at the time of delivery among women living with HIV with and without ZIKV infection during pregnancy. Note there were no women with ZIKV infection in pregnancy. Viral suppression was defined at different thresholds (&lt;40 copies/mL, &lt;400 copies/mL, &lt;1000 copies/mL).</description>
        <time_frame>Maternal viral load at delivery</time_frame>
        <population>All women with HIV enrolled in HIV ZIP during pregnancy</population>
        <group_list>
          <group group_id="O1">
            <title>Women With HIV Only</title>
            <description>Pregnant women with HIV infection only</description>
          </group>
          <group group_id="O2">
            <title>Women With HIV and ZIKV</title>
            <description>Pregnant women with HIV and ZIKV infection</description>
          </group>
        </group_list>
        <measure>
          <title>Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery.</title>
          <description>This outcome intended to measure HIV suppression at the time of delivery among women living with HIV with and without ZIKV infection during pregnancy. Note there were no women with ZIKV infection in pregnancy. Viral suppression was defined at different thresholds (&lt;40 copies/mL, &lt;400 copies/mL, &lt;1000 copies/mL).</description>
          <population>All women with HIV enrolled in HIV ZIP during pregnancy</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="174"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VL &lt;40 copies/mL</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VL &lt;400 copies/mL</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VL &lt;1000 copies/mL</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of ZIKV Infection (Among Pregnant Women With HIV Infection Compared to Those Without HIV Infection).</title>
        <description>Cumulative incidence of ZIKV infection during pregnancy (among pregnant women with HIV infection compared to those without HIV infection).</description>
        <time_frame>Maternal baseline to delivery</time_frame>
        <population>Women with HIV and women without HIV enrolled in HIV ZIP during pregnancy</population>
        <group_list>
          <group group_id="O1">
            <title>Women With HIV</title>
            <description>Pregnant women with HIV infection</description>
          </group>
          <group group_id="O2">
            <title>Women Without HIV</title>
            <description>Pregnant women without HIV infection</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of ZIKV Infection (Among Pregnant Women With HIV Infection Compared to Those Without HIV Infection).</title>
          <description>Cumulative incidence of ZIKV infection during pregnancy (among pregnant women with HIV infection compared to those without HIV infection).</description>
          <population>Women with HIV and women without HIV enrolled in HIV ZIP during pregnancy</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="174"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Adverse Pregnancy Outcomes (in Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women).</title>
        <description>Adverse pregnancy outcomes included miscarriage, stillbirth and preterm delivery. Note there were no women with ZIKV infection in pregnancy.&#xD;
Miscarriage was defined as fetal demise at &lt;20 weeks of gestation. Stillbirth was defined as fetal demise at ≥20 weeks of gestation. Preterm delivery was defined as delivery at &lt;37 weeks of gestation.</description>
        <time_frame>At time of delivery</time_frame>
        <population>Women enrolled in HIV ZIP during pregnancy&#xD;
Miscarriage was defined as fetal demise &lt;20 weeks of gestation. Stillbirth was defined as fetal demise ≥20 weeks of gestation. Preterm delivery was defined as delivery at &lt;37 weeks of gestation.</population>
        <group_list>
          <group group_id="O1">
            <title>Women With HIV Only</title>
            <description>Pregnant women with HIV infection only</description>
          </group>
          <group group_id="O2">
            <title>Women With ZIKV Only</title>
            <description>Pregnant women with ZIKV infection only</description>
          </group>
          <group group_id="O3">
            <title>Women With HIV and ZIKV</title>
            <description>Pregnant women with HIV and ZIKV infection</description>
          </group>
          <group group_id="O4">
            <title>Women Without HIV or ZIKV</title>
            <description>Pregnant women without HIV or ZIKV infection</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Adverse Pregnancy Outcomes (in Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women).</title>
          <description>Adverse pregnancy outcomes included miscarriage, stillbirth and preterm delivery. Note there were no women with ZIKV infection in pregnancy.&#xD;
Miscarriage was defined as fetal demise at &lt;20 weeks of gestation. Stillbirth was defined as fetal demise at ≥20 weeks of gestation. Preterm delivery was defined as delivery at &lt;37 weeks of gestation.</description>
          <population>Women enrolled in HIV ZIP during pregnancy&#xD;
Miscarriage was defined as fetal demise &lt;20 weeks of gestation. Stillbirth was defined as fetal demise ≥20 weeks of gestation. Preterm delivery was defined as delivery at &lt;37 weeks of gestation.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="174"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Miscarriage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stillbirth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preterm delivery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Vertical Transmission of HIV and/or ZIKV (in Women Co-infected With HIV and ZIKV and Women Infected With Either HIV or ZIKV Alone).</title>
        <description>Cumulative incidence of confirmed HIV infection among enrolled infants. Note there were no women with ZIKV infection in pregnancy so therefore no risk of transmission of ZIKV to any infants.</description>
        <time_frame>Infant birth to 12 months</time_frame>
        <population>Infants enrolled in HIV ZIP who were born to women with HIV or ZIKV infection in pregnancy.</population>
        <group_list>
          <group group_id="O1">
            <title>Infants of Women With HIV Only</title>
            <description>Infants of women with HIV during pregnancy</description>
          </group>
          <group group_id="O2">
            <title>Infants of Women With ZIKV Only</title>
            <description>Infants of women with ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O3">
            <title>Infants of Women With HIV and ZIKV</title>
            <description>Infants of women with HIV and ZIKV infection during pregnancy</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Vertical Transmission of HIV and/or ZIKV (in Women Co-infected With HIV and ZIKV and Women Infected With Either HIV or ZIKV Alone).</title>
          <description>Cumulative incidence of confirmed HIV infection among enrolled infants. Note there were no women with ZIKV infection in pregnancy so therefore no risk of transmission of ZIKV to any infants.</description>
          <population>Infants enrolled in HIV ZIP who were born to women with HIV or ZIKV infection in pregnancy.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Congenital Malformations (Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women).</title>
        <description>Cumulative incidence of congenital malformations. Note there were no women with ZIKV infection in pregnancy.&#xD;
Observed major congenital malformations included: anhydramnios, cerebral ventriculomegaly, clubfoot (unresolved), Down syndrome, hydrops, hypospadias, patient ductus arteriosus, polydactyly (left foot), Potter syndrome, short stature, syndactyly (left foot, 1st and 2nd toes).&#xD;
Observed minor congenital malformations included: clubfoot (resolved), cryptorchidism (bilateral), dislocated hip, heart defect (patent foramen ovale), heart murmur (unresolved), hemangioma, hip dysplasia, hydrocele, inguinal hernia, head circumference -3 ≤ z-score &lt;-2, persistent ductus arteriosus (resolved), plagiocephaly, restrictive ductus arteriosus, renal pyelectasis, sacral dimple, small perimembranous ventricular septal defect, stenosis of nasolacrimal duct, umbilical hernia.</description>
        <time_frame>Infant birth, 3 months</time_frame>
        <population>Infants enrolled in HIV ZIP</population>
        <group_list>
          <group group_id="O1">
            <title>Infants of Women With HIV Only</title>
            <description>Infants of women with HIV infection during pregnancy</description>
          </group>
          <group group_id="O2">
            <title>Infants of Women With ZIKV Only</title>
            <description>Infants of women with ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O3">
            <title>Infants of Women With HIV and ZIKV</title>
            <description>Infants of women with HIV and ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O4">
            <title>Infants of Women Without HIV or ZIKV</title>
            <description>Infants of women without HIV or ZIKV infection during pregnancy</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Congenital Malformations (Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women).</title>
          <description>Cumulative incidence of congenital malformations. Note there were no women with ZIKV infection in pregnancy.&#xD;
Observed major congenital malformations included: anhydramnios, cerebral ventriculomegaly, clubfoot (unresolved), Down syndrome, hydrops, hypospadias, patient ductus arteriosus, polydactyly (left foot), Potter syndrome, short stature, syndactyly (left foot, 1st and 2nd toes).&#xD;
Observed minor congenital malformations included: clubfoot (resolved), cryptorchidism (bilateral), dislocated hip, heart defect (patent foramen ovale), heart murmur (unresolved), hemangioma, hip dysplasia, hydrocele, inguinal hernia, head circumference -3 ≤ z-score &lt;-2, persistent ductus arteriosus (resolved), plagiocephaly, restrictive ductus arteriosus, renal pyelectasis, sacral dimple, small perimembranous ventricular septal defect, stenosis of nasolacrimal duct, umbilical hernia.</description>
          <population>Infants enrolled in HIV ZIP</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Major malformations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minor malformations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone.</title>
        <description>Other adverse outcomes included microcephaly, neonatal dealth, central nervous system (CNS) malformation, hydrops, and ocular abnormalities. Note there were no women with ZIKV infection in pregnancy.&#xD;
Microcephaly was defined as head circumference less than a z-score of -3 at birth or 3 month visit.&#xD;
Neonatal death was defined as death within 28 days of life. Observed CNS malformations included: cerebral ventriculomegaly. Ocular abnormalities included both structural and functional ophthalmologic abnormalities.</description>
        <time_frame>Infant birth to 12 months</time_frame>
        <population>Infants enrolled in HIV ZIP</population>
        <group_list>
          <group group_id="O1">
            <title>Infants of Women With HIV Only</title>
            <description>Infants of women with HIV infection during pregnancy</description>
          </group>
          <group group_id="O2">
            <title>Infants of Women With ZIKV Only</title>
            <description>Infants of women with ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O3">
            <title>Infants of Women With HIV and ZIKV</title>
            <description>Infants of women with HIV and ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O4">
            <title>Infants of Women Without HIV or ZIKV</title>
            <description>Infants of women without HIV or ZIKV infection during pregnancy</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone.</title>
          <description>Other adverse outcomes included microcephaly, neonatal dealth, central nervous system (CNS) malformation, hydrops, and ocular abnormalities. Note there were no women with ZIKV infection in pregnancy.&#xD;
Microcephaly was defined as head circumference less than a z-score of -3 at birth or 3 month visit.&#xD;
Neonatal death was defined as death within 28 days of life. Observed CNS malformations included: cerebral ventriculomegaly. Ocular abnormalities included both structural and functional ophthalmologic abnormalities.</description>
          <population>Infants enrolled in HIV ZIP</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Microcephaly</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neonatal death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CNS malformations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hydrops</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular abnormalities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV</title>
        <description>Weight as a measure of growth. Note there were no women with ZIKV infection in pregnancy.</description>
        <time_frame>Infant Birth, 3 months, 6 months, 12 months</time_frame>
        <population>Infants enrolled in HIV ZIP</population>
        <group_list>
          <group group_id="O1">
            <title>Infants of Women With HIV Only</title>
            <description>Infants of women with HIV infection during pregnancy</description>
          </group>
          <group group_id="O2">
            <title>Infants of Women With ZIKV Only</title>
            <description>Infants of women with ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O3">
            <title>Infants of Women With HIV and ZIKV</title>
            <description>Infants of women with HIV and ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O4">
            <title>Infants of Women Without HIV or ZIKV</title>
            <description>Infants of women without HIV or ZIKV infection during pregnancy</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV</title>
          <description>Weight as a measure of growth. Note there were no women with ZIKV infection in pregnancy.</description>
          <population>Infants enrolled in HIV ZIP</population>
          <units>kg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Weight at birth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" lower_limit="2.8" upper_limit="3.4"/>
                    <measurement group_id="O4" value="3.2" lower_limit="2.9" upper_limit="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight at 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" lower_limit="5.4" upper_limit="6.6"/>
                    <measurement group_id="O4" value="5.7" lower_limit="5.3" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="7.0" upper_limit="8.4"/>
                    <measurement group_id="O4" value="8.2" lower_limit="7.0" upper_limit="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="9.0" upper_limit="10.7"/>
                    <measurement group_id="O4" value="9.8" lower_limit="8.8" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV</title>
        <description>Length and head circumference as measures of growth. Note there were no women with ZIKV infection in pregnancy.</description>
        <time_frame>Infant Birth, 3 months, 6 months, 12 months</time_frame>
        <population>Infants enrolled in HIV ZIP</population>
        <group_list>
          <group group_id="O1">
            <title>Infants of Women With HIV Only</title>
            <description>Infants of women with HIV infection during pregnancy</description>
          </group>
          <group group_id="O2">
            <title>Infants of Women With ZIKV Only</title>
            <description>Infants of women with ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O3">
            <title>Infants of Women With HIV and ZIKV</title>
            <description>Infants of women with HIV and ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O4">
            <title>Infants of Women Without HIV or ZIKV</title>
            <description>Infants of women without HIV or ZIKV infection during pregnancy</description>
          </group>
        </group_list>
        <measure>
          <title>Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV</title>
          <description>Length and head circumference as measures of growth. Note there were no women with ZIKV infection in pregnancy.</description>
          <population>Infants enrolled in HIV ZIP</population>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Length at birth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.2" lower_limit="47.0" upper_limit="50.0"/>
                    <measurement group_id="O4" value="48.3" lower_limit="46.9" upper_limit="52.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length at 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.5" lower_limit="57.0" upper_limit="60.5"/>
                    <measurement group_id="O4" value="59.5" lower_limit="55.8" upper_limit="61.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.0" lower_limit="64.0" upper_limit="67.0"/>
                    <measurement group_id="O4" value="67.0" lower_limit="62.0" upper_limit="69.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="73.0" upper_limit="77.5"/>
                    <measurement group_id="O4" value="74.2" lower_limit="71.5" upper_limit="77.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head circumference at birth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0" lower_limit="33.0" upper_limit="35.0"/>
                    <measurement group_id="O4" value="34.0" lower_limit="33.0" upper_limit="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head circumference at 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0" lower_limit="39.0" upper_limit="41.0"/>
                    <measurement group_id="O4" value="40.3" lower_limit="39.0" upper_limit="41.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head circumference at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.0" lower_limit="42.0" upper_limit="44.0"/>
                    <measurement group_id="O4" value="43.8" lower_limit="43.0" upper_limit="44.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head circumference at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.0" lower_limit="45.0" upper_limit="47.0"/>
                    <measurement group_id="O4" value="46.3" lower_limit="45.5" upper_limit="47.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV</title>
        <description>Audiologic function as assessed by OAE test reported. Note there were no women with ZIKV infection in pregnancy.</description>
        <time_frame>Within one month of infant birth, 3 months, 6 months, 12 months</time_frame>
        <population>Infants enrolled in HIV ZIP</population>
        <group_list>
          <group group_id="O1">
            <title>Infants of Women With HIV Only</title>
            <description>Infants of women with HIV infection during pregnancy</description>
          </group>
          <group group_id="O2">
            <title>Infants of Women With ZIKV Only</title>
            <description>Infants of women with ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O3">
            <title>Infants of Women With HIV and ZIKV</title>
            <description>Infants of women with HIV and ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O4">
            <title>Infants of Women Without HIV or ZIKV</title>
            <description>Infants of women without HIV or ZIKV infection during pregnancy</description>
          </group>
        </group_list>
        <measure>
          <title>Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV</title>
          <description>Audiologic function as assessed by OAE test reported. Note there were no women with ZIKV infection in pregnancy.</description>
          <population>Infants enrolled in HIV ZIP</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Right ear (Birth)</title>
              <category_list>
                <category>
                  <title>Passed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Test result not available</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O4" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right ear (3 months)</title>
              <category_list>
                <category>
                  <title>Passed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Test result not available</title>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right ear (6 months)</title>
              <category_list>
                <category>
                  <title>Passed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Test result not available</title>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right ear (12 months)</title>
              <category_list>
                <category>
                  <title>Passed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Test result not available</title>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left ear (Birth)</title>
              <category_list>
                <category>
                  <title>Passed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Test result not available</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O4" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left ear (3 months)</title>
              <category_list>
                <category>
                  <title>Passed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Test result not available</title>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left ear (6 months)</title>
              <category_list>
                <category>
                  <title>Passed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Test result not available</title>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left ear (12 months)</title>
              <category_list>
                <category>
                  <title>Passed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Test result not available</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ophthalmologic Structure and Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV</title>
        <description>Ocular abnormalities included both structural and functional ophthalmologic abnormalities. Note there were no women with ZIKV infection in pregnancy.</description>
        <time_frame>Within one month of infant birth, 12 months;</time_frame>
        <population>Infants enrolled in HIV ZIP</population>
        <group_list>
          <group group_id="O1">
            <title>Infants of Women With HIV Only</title>
            <description>Infants of women with HIV infection during pregnancy</description>
          </group>
          <group group_id="O2">
            <title>Infants of Women With ZIKV Only</title>
            <description>Infants of women with ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O3">
            <title>Infants of Women With HIV and ZIKV</title>
            <description>Infants of women with HIV and ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O4">
            <title>Infants of Women Without HIV or ZIKV</title>
            <description>Infants of women without HIV or ZIKV infection during pregnancy</description>
          </group>
        </group_list>
        <measure>
          <title>Ophthalmologic Structure and Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV</title>
          <description>Ocular abnormalities included both structural and functional ophthalmologic abnormalities. Note there were no women with ZIKV infection in pregnancy.</description>
          <population>Infants enrolled in HIV ZIP</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Ocular abnormalities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No ocular abnormalities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="152"/>
                    <measurement group_id="O4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Neurodevelopment Among Children With or Without in Utero Exposure to HIV and/or ZIKV</title>
        <description>Infant neurodevelopment was assessed by either the Bayley III or Ages and Stages Questionnaires- 3rd Edition. Combined results reported. Note there were no women with ZIKV infection in pregnancy.</description>
        <time_frame>Infant 3 months, 6 months, 12 months</time_frame>
        <population>Infants enrolled in HIV ZIP</population>
        <group_list>
          <group group_id="O1">
            <title>Infants of Women With HIV Only</title>
            <description>Infants of women with HIV infection during pregnancy</description>
          </group>
          <group group_id="O2">
            <title>Infants of Women With ZIKV Only</title>
            <description>Infants of women with ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O3">
            <title>Infants of Women With HIV and ZIKV</title>
            <description>Infants of women with HIV and ZIKV infection during pregnancy</description>
          </group>
          <group group_id="O4">
            <title>Infants of Women Without HIV or ZIKV</title>
            <description>Infants of women without HIV or ZIKV infection during pregnancy</description>
          </group>
        </group_list>
        <measure>
          <title>Neurodevelopment Among Children With or Without in Utero Exposure to HIV and/or ZIKV</title>
          <description>Infant neurodevelopment was assessed by either the Bayley III or Ages and Stages Questionnaires- 3rd Edition. Combined results reported. Note there were no women with ZIKV infection in pregnancy.</description>
          <population>Infants enrolled in HIV ZIP</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Failed screening test at 3 months</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failed screening test at 6 months</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failed screening test at 12 months</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="134"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through study completion, up to 1 year of follow-up of live-born infant.</time_frame>
      <desc>All-Cause Mortality&#xD;
Serious Adverse Events&#xD;
Other (Not Including Serious) Adverse</desc>
      <group_list>
        <group group_id="E1">
          <title>Women With HIV Only</title>
          <description>Pregnant women with HIV only</description>
        </group>
        <group group_id="E2">
          <title>Women With ZIKV Only</title>
          <description>Pregnant women with ZIKV only</description>
        </group>
        <group group_id="E3">
          <title>Women With HIV and ZIKV</title>
          <description>Pregnant women with HIV and ZIKV</description>
        </group>
        <group group_id="E4">
          <title>Women Without HIV or ZIKV</title>
          <description>Pregnant women without HIV or ZIKV</description>
        </group>
        <group group_id="E5">
          <title>Infants of Women With HIV Only</title>
          <description>Infants of women with HIV infection during pregnancy</description>
        </group>
        <group group_id="E6">
          <title>Infants of Women With ZIKV Only</title>
          <description>Infants of women with ZIKV infection during pregnancy</description>
        </group>
        <group group_id="E7">
          <title>Infants of Women With HIV and ZIKV</title>
          <description>Infants of women with HIV and ZIKV infection during pregnancy</description>
        </group>
        <group group_id="E8">
          <title>Infants of Women Without HIV or ZIKV</title>
          <description>Infants of women without HIV or ZIKV infection during pregnancy</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Marisa Mussi-Pinhata</name_or_title>
      <organization>Department of Pediatrics Ribeirão Preto Medical School</organization>
      <phone>55-16-3602-2807</phone>
      <email>mmmpinha@fmrp.usp.br</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03263195
org study id: HIV-ZIP
secondary id: HHSN275201800001I
nct id: NCT03263195
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the incidence of Zika virus (ZIKV) infection among
      pregnant women with and without Human Immunodeficiency Virus (HIV) infection and to determine
      the risk of adverse maternal and child outcomes associated with ZIKV/HIV co-infection across
      clinical sites in the continental United States (U.S.), Puerto Rico (P.R.) and Brazil.
This is a two-phase prospective international cohort study of pregnant women and their
      infants from those pregnancies whose goals are to compare the incidence of ZIKV infection
      among pregnant women with and without HIV infection and to determine the risk of adverse
      maternal and child outcomes associated with ZIKV/HIV co-infection across clinical sites in
      the continental U.S., P.R. and Brazil.

      Phase I will enroll pregnant women/infant pairs who are: (1) infected with HIV only; (2)
      infected with ZIKV only; (3) infected with HIV and ZIKV; and (4) not infected with HIV or
      ZIKV. Phase I will assess the feasibility of enrolling a total of 200 pregnant women/infant
      pairs within a year, with a target of 150 HIV-infected women, 50 HIV-uninfected women from
      the continental U.S. sites only, and a minimum of 20 who are co-infected with HIV and ZIKV by
      the end of pregnancy.

      Should the feasibility of Phase I prove successful, Phase II will commence by enrolling up to
      1,800 additional pregnant women/infant pairs to the 4 groups described above. The comparison
      group of HIV-uninfected pregnant women/infant pairs from P.R and Brazil (ZIKV-infected and
      uninfected) will be obtained from data collected in the concurrent International Prospective
      Observational Cohort Study of Zika in Infants and Pregnancy (ZIP study).

      All HIV-infected and uninfected study participants will be tested for ZIKV. Enrolled women
      will be followed throughout their pregnancy and up to six weeks postpartum. Infants born to
      enrolled women will be followed for a full year after birth. Thereafter, the infants born to
      women at continental U.S. and P.R. sites also implementing the Surveillance Monitoring for
      Antiretroviral Therapy (ART) Toxicities (SMARTT) study may be followed up yearly until
      adulthood through SMARTT depending on the availability of funds.
observational model: Cohort
time perspective: Prospective
measure: Enrollment (150 HIV-infected and 50 HIV-uninfected Pregnant Women Within One Year, With a Minimum of 20 of These Women Having HIV/ZIKV Co-infection by Their End of Pregnancy).
time frame: At the time of delivery of all those enrolled up to 1 year after the first enrollment
description: This outcome measured feasibility of enrolling 150 pregnant women living with HIV and 50 pregnant women without HIV, with a minimum of 20 of these women having HIV/ZIKV co-infection by their end of pregnancy
measure: Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery.
time frame: Maternal viral load at delivery
description: This outcome intended to measure HIV suppression at the time of delivery among women living with HIV with and without ZIKV infection during pregnancy. Note there were no women with ZIKV infection in pregnancy. Viral suppression was defined at different thresholds (<40 copies/mL, <400 copies/mL, <1000 copies/mL).
measure: Incidence of ZIKV Infection (Among Pregnant Women With HIV Infection Compared to Those Without HIV Infection).
time frame: Maternal baseline to delivery
description: Cumulative incidence of ZIKV infection during pregnancy (among pregnant women with HIV infection compared to those without HIV infection).
measure: Incidence of Adverse Pregnancy Outcomes (in Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women).
time frame: At time of delivery
description: Adverse pregnancy outcomes included miscarriage, stillbirth and preterm delivery. Note there were no women with ZIKV infection in pregnancy.
Miscarriage was defined as fetal demise at <20 weeks of gestation. Stillbirth was defined as fetal demise at ≥20 weeks of gestation. Preterm delivery was defined as delivery at <37 weeks of gestation.
measure: Incidence of Vertical Transmission of HIV and/or ZIKV (in Women Co-infected With HIV and ZIKV and Women Infected With Either HIV or ZIKV Alone).
time frame: Infant birth to 12 months
description: Cumulative incidence of confirmed HIV infection among enrolled infants. Note there were no women with ZIKV infection in pregnancy so therefore no risk of transmission of ZIKV to any infants.
measure: Incidence of Congenital Malformations (Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women).
time frame: Infant birth, 3 months
description: Cumulative incidence of congenital malformations. Note there were no women with ZIKV infection in pregnancy.
Observed major congenital malformations included: anhydramnios, cerebral ventriculomegaly, clubfoot (unresolved), Down syndrome, hydrops, hypospadias, patient ductus arteriosus, polydactyly (left foot), Potter syndrome, short stature, syndactyly (left foot, 1st and 2nd toes).
Observed minor congenital malformations included: clubfoot (resolved), cryptorchidism (bilateral), dislocated hip, heart defect (patent foramen ovale), heart murmur (unresolved), hemangioma, hip dysplasia, hydrocele, inguinal hernia, head circumference -3 ≤ z-score <-2, persistent ductus arteriosus (resolved), plagiocephaly, restrictive ductus arteriosus, renal pyelectasis, sacral dimple, small perimembranous ventricular septal defect, stenosis of nasolacrimal duct, umbilical hernia.
measure: Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone.
time frame: Infant birth to 12 months
description: Other adverse outcomes included microcephaly, neonatal dealth, central nervous system (CNS) malformation, hydrops, and ocular abnormalities. Note there were no women with ZIKV infection in pregnancy.
Microcephaly was defined as head circumference less than a z-score of -3 at birth or 3 month visit.
Neonatal death was defined as death within 28 days of life. Observed CNS malformations included: cerebral ventriculomegaly. Ocular abnormalities included both structural and functional ophthalmologic abnormalities.
measure: Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV
time frame: Infant Birth, 3 months, 6 months, 12 months
description: Weight as a measure of growth. Note there were no women with ZIKV infection in pregnancy.
measure: Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV
time frame: Infant Birth, 3 months, 6 months, 12 months
description: Length and head circumference as measures of growth. Note there were no women with ZIKV infection in pregnancy.
measure: Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV
time frame: Within one month of infant birth, 3 months, 6 months, 12 months
description: Audiologic function as assessed by OAE test reported. Note there were no women with ZIKV infection in pregnancy.
measure: Ophthalmologic Structure and Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV
time frame: Within one month of infant birth, 12 months;
description: Ocular abnormalities included both structural and functional ophthalmologic abnormalities. Note there were no women with ZIKV infection in pregnancy.
measure: Neurodevelopment Among Children With or Without in Utero Exposure to HIV and/or ZIKV
time frame: Infant 3 months, 6 months, 12 months
description: Infant neurodevelopment was assessed by either the Bayley III or Ages and Stages Questionnaires- 3rd Edition. Combined results reported. Note there were no women with ZIKV infection in pregnancy.
arm group label: Women with HIV only
description: Pregnant women with HIV infection only
arm group label: Women with ZIKV only
description: Pregnant women with ZIKV infection only
arm group label: Women with HIV and ZIKV
description: Pregnant women with HIV and ZIKV infection
arm group label: Women without HIV or ZIKV
description: Pregnant women without HIV or ZIKV infection
arm group label: Infants of women with HIV only
description: Infants of women with HIV infection during pregnancy
arm group label: Infants of women with ZIKV only
description: Infants of women with ZIKV infection during pregnancy
arm group label: Infants of women with HIV and ZIKV
description: Infants of women with HIV and ZIKV infection during pregnancy
arm group label: Infants of women without HIV or ZIKV
description: Infants of women without HIV or ZIKV infection during pregnancy
Maternal blood, maternal urine, cord blood, and placenta tissue. Infant blood and infant
      urine.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marisa M. Mussi-Pinhata, MD
role: Study Chair
affiliation: University of Sao Paolo, Riberao Preto Medical School, Department of Pediatrics
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Zika Virus Infection
sharing ipd: Yes
ipd description: De-identified participant data will be entered into the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (N-DASH) system.
Data from the ZIP study, conducted in Zika-endemic areas, may be merged with HIV ZIP. In most cases, ZIP will have the exact same infant assessments as HIV ZIP.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: No later than one year after the date of acceptance for publication of the main findings from the final dataset.
ipd access criteria: A Memorandum of Understanding (MOU) about the extent and nature of the sharing as well as a data use agreement will be executed for all collaborations. The MOU will include an understanding of the control of the use of the data, publication rights and authorship rights, as well as address the human participant's confidentiality issues
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 