<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/NCT03824067</url>
  </required_header>
  <id_info>
    <org_study_id>EG0170</org_study_id>
    <nct_id>NCT03824067</nct_id>
  </id_info>
  <brief_title>Impact of Point-of-Care EID for HIV-Exposed Infants</brief_title>
  <acronym>POC-EID</acronym>
  <official_title>Evaluation of the Impact of Point-of-Care Early Infant Diagnostic (EID) Testing on Timely Receipt of EID Results and Treatment Initiation in HIV-Exposed Children in Kenya and Zimbabwe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elizabeth Glaser Pediatric AIDS Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UNITAID</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Elizabeth Glaser Pediatric AIDS Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This mixed methods study will utilize a randomized step-wedge design to assess the impact of&#xD;
      point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes&#xD;
      including timely return of results to caregivers and time to initiation on treatment for&#xD;
      HIV-infected infants. Data will be collected through longitudinal clinical follow-up and&#xD;
      medical chart extraction of routine records and lab forms. Feasibility and acceptability data&#xD;
      will be collected through interviews with mothers/caregivers of HIV-exposed infants, and&#xD;
      community focus groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study seeks to evaluate the impact of point of care (POC) early infant HIV diagnosis&#xD;
      (EID) on turn-around time from sample collection until notification of parents/caregivers of&#xD;
      test result, linkage to care, and time to initiation of treatment, and early retention in HIV&#xD;
      care (3-6 months) for those infected.&#xD;
&#xD;
      The study will take place in two countries, Zimbabwe and Kenya, with high HIV prevalence, and&#xD;
      where EGPAF-supported POC EID platforms are being implemented as part of a Unitaid-funded POC&#xD;
      EID project. As part of POC program implementation activities, in each country up to 50&#xD;
      EGPAF-supported sites will implement POC EID platforms. These sites may be prevention of&#xD;
      mother-to-child transmission (PMTCT) of HIV clinics, HIV clinics or multidisciplinary health&#xD;
      facilities. Project sites have been selected as part of the program implementation. In each&#xD;
      country, 18 sites will be randomly selected as study sites for the impact evaluation.&#xD;
&#xD;
      Using a stepped wedge design, the intervention (the POC EID platforms) will be rolled out&#xD;
      sequentially to the study facilities over three randomly-assigned time periods. Quantitative&#xD;
      data will be derived from routine medical and laboratory charts and longitudinal tracking and&#xD;
      follow-up of HIV-infected infants.&#xD;
&#xD;
      Qualitative data on feasibility and acceptability of POC will be derived from in-depth&#xD;
      interviews with mothers/caregivers of HIV-exposed infants at the beginning and end of the&#xD;
      study and community focus group discussions at the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The design of this study is a cluster-randomized stepped wedge trial. This is whereby an intervention is rolled out sequentially to the study facilities over a number of time periods. The order in which the different clusters receive the intervention is determined at random and by the end of random allocation, all facilities will have received the intervention. Testing sites (determined from the list of all project facilities excluding pilot sites) will be randomized regarding timing of POC implementation; sites that serve as &quot;hub&quot; sites and their associated &quot;spoke&quot; sites will be given the same designation. The study will use a mixed method approach in data collection, and a qualitative component will also be conducted, including interviews and focus groups.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of HIV exposed infants (HEI) who have received the 4-6 week EID test result by 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of children for whom a sample was drawn for the 4-6-week indication receiving EID result by 12 weeks, divided by the number of HEI who presented to the clinic and had an indication for 4-6 week EID testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Testing coverage for the 4-6 week indication</measure>
    <time_frame>18 months</time_frame>
    <description>Number of EID samples collected for 4-6 week indication divided by the number of HEI who presented to the clinic and had an indication for 4-6 week EID testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from sample collection for 4-6 week EID test indication to parent's/ caregiver notification</measure>
    <time_frame>18 months</time_frame>
    <description>Date of sample collection to the date that results were given to care giver</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age of patient at test result notification for 4-6 week EID test indication</measure>
    <time_frame>18 months</time_frame>
    <description>HEIs date of birth, date of sample collection and date of result notification to care giver</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from test result received for 4-6 week EID test to initiation of ART, for HIV-infected infants</measure>
    <time_frame>18 months</time_frame>
    <description>Date positive result received at facility to the date the result was communicated to mother and date of ART initiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of HIV positive infants diagnosed during 4-6 week EID testing initiated on ART</measure>
    <time_frame>18 months</time_frame>
    <description>Number of HIV-infected infants initiated on ART after 4-6 week EID test divided by the number of HIV-infected infants identified after 4-6 week EID test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of HIV-infected infants diagnosed at the 4-6 week EID with retention in care at 6 months</measure>
    <time_frame>24 months</time_frame>
    <description>Total number of infants initiated on ART 6 months ago and number of active on ART at 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9539</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Infant Morbidity</condition>
  <condition>Pediatric HIV Infection</condition>
  <condition>Transmission, Perinatal Infection</condition>
  <arm_group>
    <arm_group_label>Standard of Care Early Infant Diagnosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional laboratory based (standard of care - SOC) early infant diagnosis (EID) testing: SOC EID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Point of Care Early Infant Diagnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is Point of Care (POC) early infant diagnosis (EID) testing, where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Point of Care Early Infant Diagnosis</intervention_name>
    <description>HIV testing where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.</description>
    <arm_group_label>Point of Care Early Infant Diagnosis</arm_group_label>
    <other_name>POC EID</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Standard of Care Early Infant Diagnosis</intervention_name>
    <description>Conventional laboratory based EID testing</description>
    <arm_group_label>Standard of Care Early Infant Diagnosis</arm_group_label>
    <other_name>SOC EID</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any infant who receives an EID test, either conventional or POC, for the 4-6 week EID&#xD;
             indication at one of the study sites (which were randomly selected from project sites&#xD;
             in country)&#xD;
&#xD;
          -  HEI under 12 weeks of age or their parents/caregivers&#xD;
&#xD;
          -  Some methods will only include HEI who test positive (medical chart extraction and&#xD;
             longitudinal follow up)&#xD;
&#xD;
          -  Purposively selected caregivers of HEI for in-depth interviews&#xD;
&#xD;
          -  Focus groups with community members will not require participants to have sought&#xD;
             testing for EID&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants not at selected study sites&#xD;
&#xD;
          -  For some methods (medical chart extraction and longitudinal follow-up), HEI who test&#xD;
             negative&#xD;
&#xD;
          -  For qualitative component, excluded if unable to consent due to age, competence, or&#xD;
             inability to speak any of the study languages&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emma Sacks, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>George Washington University School of Public Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Collins Odhiambo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Elizabeth Glaser Pediatric Aids Foundation - Kenya</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Agnes Mahomva, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Elizabeth Glaser Pediatric Aids Foundation - Zimbabwe</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Cohn, MD MPH</last_name>
    <role>Study Director</role>
    <affiliation>Elizabeth Glaser Pediatric AIDS Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elizabeth Glaser Pediatric AIDS Foundation</name>
      <address>
        <city>Nairobi</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elizabeth Glaser Pediatric AIDS Foundation</name>
      <address>
        <city>Harare</city>
        <country>Zimbabwe</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
    <country>Zimbabwe</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV/AIDS</keyword>
  <keyword>Point of Care</keyword>
  <keyword>Early infant diagnosis</keyword>
  <keyword>Health systems</keyword>
  <keyword>Diagnostic tools</keyword>
  <keyword>LMIC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03824067
org study id: EG0170
nct id: NCT03824067
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This mixed methods study will utilize a randomized step-wedge design to assess the impact of
      point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes
      including timely return of results to caregivers and time to initiation on treatment for
      HIV-infected infants. Data will be collected through longitudinal clinical follow-up and
      medical chart extraction of routine records and lab forms. Feasibility and acceptability data
      will be collected through interviews with mothers/caregivers of HIV-exposed infants, and
      community focus groups.
This study seeks to evaluate the impact of point of care (POC) early infant HIV diagnosis
      (EID) on turn-around time from sample collection until notification of parents/caregivers of
      test result, linkage to care, and time to initiation of treatment, and early retention in HIV
      care (3-6 months) for those infected.

      The study will take place in two countries, Zimbabwe and Kenya, with high HIV prevalence, and
      where EGPAF-supported POC EID platforms are being implemented as part of a Unitaid-funded POC
      EID project. As part of POC program implementation activities, in each country up to 50
      EGPAF-supported sites will implement POC EID platforms. These sites may be prevention of
      mother-to-child transmission (PMTCT) of HIV clinics, HIV clinics or multidisciplinary health
      facilities. Project sites have been selected as part of the program implementation. In each
      country, 18 sites will be randomly selected as study sites for the impact evaluation.

      Using a stepped wedge design, the intervention (the POC EID platforms) will be rolled out
      sequentially to the study facilities over three randomly-assigned time periods. Quantitative
      data will be derived from routine medical and laboratory charts and longitudinal tracking and
      follow-up of HIV-infected infants.

      Qualitative data on feasibility and acceptability of POC will be derived from in-depth
      interviews with mothers/caregivers of HIV-exposed infants at the beginning and end of the
      study and community focus group discussions at the end of the study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The design of this study is a cluster-randomized stepped wedge trial. This is whereby an intervention is rolled out sequentially to the study facilities over a number of time periods. The order in which the different clusters receive the intervention is determined at random and by the end of random allocation, all facilities will have received the intervention. Testing sites (determined from the list of all project facilities excluding pilot sites) will be randomized regarding timing of POC implementation; sites that serve as "hub" sites and their associated "spoke" sites will be given the same designation. The study will use a mixed method approach in data collection, and a qualitative component will also be conducted, including interviews and focus groups.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Percentage of HIV exposed infants (HEI) who have received the 4-6 week EID test result by 12 weeks
time frame: 12 weeks
description: The number of children for whom a sample was drawn for the 4-6-week indication receiving EID result by 12 weeks, divided by the number of HEI who presented to the clinic and had an indication for 4-6 week EID testing
measure: Testing coverage for the 4-6 week indication
time frame: 18 months
description: Number of EID samples collected for 4-6 week indication divided by the number of HEI who presented to the clinic and had an indication for 4-6 week EID testing
measure: Time from sample collection for 4-6 week EID test indication to parent's/ caregiver notification
time frame: 18 months
description: Date of sample collection to the date that results were given to care giver
measure: Age of patient at test result notification for 4-6 week EID test indication
time frame: 18 months
description: HEIs date of birth, date of sample collection and date of result notification to care giver
measure: Time from test result received for 4-6 week EID test to initiation of ART, for HIV-infected infants
time frame: 18 months
description: Date positive result received at facility to the date the result was communicated to mother and date of ART initiation
measure: Percentage of HIV positive infants diagnosed during 4-6 week EID testing initiated on ART
time frame: 18 months
description: Number of HIV-infected infants initiated on ART after 4-6 week EID test divided by the number of HIV-infected infants identified after 4-6 week EID test
measure: Number of HIV-infected infants diagnosed at the 4-6 week EID with retention in care at 6 months
time frame: 24 months
description: Total number of infants initiated on ART 6 months ago and number of active on ART at 6 months
arm group label: Standard of Care Early Infant Diagnosis
arm group type: Active Comparator
description: Conventional laboratory based (standard of care - SOC) early infant diagnosis (EID) testing: SOC EID
arm group label: Point of Care Early Infant Diagnosis
arm group type: Experimental
description: The intervention is Point of Care (POC) early infant diagnosis (EID) testing, where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.
intervention type: Diagnostic Test
intervention name: Point of Care Early Infant Diagnosis
description: HIV testing where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.
arm group label: Point of Care Early Infant Diagnosis
other name: POC EID
intervention type: Diagnostic Test
intervention name: Standard of Care Early Infant Diagnosis
description: Conventional laboratory based EID testing
arm group label: Standard of Care Early Infant Diagnosis
other name: SOC EID
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Emma Sacks, PhD
role: Principal Investigator
affiliation: George Washington University School of Public Health
last name: Collins Odhiambo, MD
role: Principal Investigator
affiliation: Elizabeth Glaser Pediatric Aids Foundation - Kenya
last name: Agnes Mahomva, MD
role: Principal Investigator
affiliation: Elizabeth Glaser Pediatric Aids Foundation - Zimbabwe
last name: Jennifer Cohn, MD MPH
role: Study Director
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
facility: 
facility: 
country: Kenya
country: Zimbabwe
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
sharing ipd: No