<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/NCT03027258</url>
  </required_header>
  <id_info>
    <org_study_id>820085-3</org_study_id>
    <secondary_id>R21TW010252-01</secondary_id>
    <nct_id>NCT03027258</nct_id>
  </id_info>
  <brief_title>Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome</brief_title>
  <acronym>mHealth</acronym>
  <official_title>Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nevada, Las Vegas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fogarty International Center of the National Institute of Health</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nevada, Las Vegas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to adopt sustainable community networks (in this case churches) to&#xD;
      implement an integrated community-based screening that incorporates mobile health technology&#xD;
      (mHealth) to make prenatal test results available at the point-of-delivery to guide medical&#xD;
      management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will develop and test the feasibility, acceptability, and usability of a&#xD;
      mobile health platform that captures results for HIV, Hepatitis B virus (HBV) and sickle cell&#xD;
      genotype obtained from participants during the Healthy Beginning Initiative (HBI) program;&#xD;
      store data in a secure, web-based database; encrypt data on a &quot;smart card&quot; which is given to&#xD;
      participants, and make these data available at the point-of-delivery using a cell-phone&#xD;
      application to read the &quot;smart card&quot;. Data on the web-based database can also be accessed&#xD;
      directly using the cell phone application. Evidence exists that when clinician have maternal&#xD;
      records available at the point of delivery, they are more likely to initiate antiretroviral&#xD;
      prophylaxis for HIV-exposed infants, administer the first dose of hepatitis B vaccine with 24&#xD;
      hours for infants born to women who have positive hepatitis B surface antigen and screen&#xD;
      infants born to mothers with sickle cell trait to allow early identification and initiation&#xD;
      of penicillin prophylaxis for infants who have sickle cell disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reach</measure>
    <time_frame>6 months</time_frame>
    <description>Reach will be calculated as: the proportion of enrolled pregnant women relative to eligible pregnant women in the study catchment area.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness</measure>
    <time_frame>6 months</time_frame>
    <description>Effectiveness will be determined by assessing the impact of the mHealth platform on key outcomes such as screening for HIV, HBV, and sickle cell genotype, and health care utilizations for follow up visits. This will be measured by calculating the percentage of pregnant women that used the &quot;smart card&quot; at the point-of-delivery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adoption</measure>
    <time_frame>6 months</time_frame>
    <description>Adoption rates will be calculated using the proportion of interested health care settings to the total number eligible for participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>6 months</time_frame>
    <description>The proportion of enrolled pregnant women who accept to use the smart card for their health care services</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>HIV</condition>
  <condition>Sickle Cell Disease</condition>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mHealth intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mHealth</intervention_name>
    <description>HBI participants who consent will be enrolled in this study and will have data collected from their community screening stored in a secure, web-based database. The stored data will be encrypted into a Quick Response code embedded in a &quot;smart card.&quot; A unique identification number and participant's blood group type will be on the outside of the card. There will be no names or any other identifiers. Each participating center will identify a dedicated delivery room staff that will be trained to read the contents of the card using the cell phone application as well as enter new data in the participant's profile. When a participant presents at delivery without the card, information can still be obtained from the secure, web-based database and confirmed using the participant's name, date of birth and cell phone number. This information is provided to the clinician to guide management of the infant.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women; 18 years or older enrolled in the Healthy Beginning Initiative&#xD;
&#xD;
          -  One of the three conditions - HIV, Hepatitis B, and Sickle cell trait/disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who do not accept to have their information uploaded on the secure database&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Echezona Ezeanolue, MD, MPH</last_name>
    <phone>7028952687</phone>
    <email>echezona.ezeanolue@unlv.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Semiu O Gbadamosi, MD, MPH</last_name>
    <phone>7028351946</phone>
    <email>semiu.gbadamosi@unlv.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Catholic Caritas Foundation</name>
      <address>
        <city>Makurdi</city>
        <state>Benue</state>
        <country>Nigeria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Olawepo, MD, MSc</last_name>
      <phone>+234-805 564 8788</phone>
      <email>jolawepo@ccfng.org</email>
    </contact>
    <investigator>
      <last_name>Echezona Ezeanolue, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <reference>
    <citation>Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.</citation>
    <PMID>23758933</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>October 13, 2017</last_update_submitted>
  <last_update_submitted_qc>October 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nevada, Las Vegas</investigator_affiliation>
    <investigator_full_name>Echezona Ezeanolue</investigator_full_name>
    <investigator_title>Professor of Public Health and Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Mobile health technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Anemia, Sickle Cell</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/NCT03027258
org study id: 820085-3
secondary id: R21TW010252-01
nct id: NCT03027258
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators propose to adopt sustainable community networks (in this case churches) to
      implement an integrated community-based screening that incorporates mobile health technology
      (mHealth) to make prenatal test results available at the point-of-delivery to guide medical
      management.
The investigators will develop and test the feasibility, acceptability, and usability of a
      mobile health platform that captures results for HIV, Hepatitis B virus (HBV) and sickle cell
      genotype obtained from participants during the Healthy Beginning Initiative (HBI) program;
      store data in a secure, web-based database; encrypt data on a "smart card" which is given to
      participants, and make these data available at the point-of-delivery using a cell-phone
      application to read the "smart card". Data on the web-based database can also be accessed
      directly using the cell phone application. Evidence exists that when clinician have maternal
      records available at the point of delivery, they are more likely to initiate antiretroviral
      prophylaxis for HIV-exposed infants, administer the first dose of hepatitis B vaccine with 24
      hours for infants born to women who have positive hepatitis B surface antigen and screen
      infants born to mothers with sickle cell trait to allow early identification and initiation
      of penicillin prophylaxis for infants who have sickle cell disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Reach
time frame: 6 months
description: Reach will be calculated as: the proportion of enrolled pregnant women relative to eligible pregnant women in the study catchment area.
measure: Effectiveness
time frame: 6 months
description: Effectiveness will be determined by assessing the impact of the mHealth platform on key outcomes such as screening for HIV, HBV, and sickle cell genotype, and health care utilizations for follow up visits. This will be measured by calculating the percentage of pregnant women that used the "smart card" at the point-of-delivery.
measure: Adoption
time frame: 6 months
description: Adoption rates will be calculated using the proportion of interested health care settings to the total number eligible for participation.
measure: Acceptability
time frame: 6 months
description: The proportion of enrolled pregnant women who accept to use the smart card for their health care services
arm group label: Intervention
arm group type: Experimental
description: mHealth intervention
intervention type: Other
intervention name: mHealth
description: HBI participants who consent will be enrolled in this study and will have data collected from their community screening stored in a secure, web-based database. The stored data will be encrypted into a Quick Response code embedded in a "smart card." A unique identification number and participant's blood group type will be on the outside of the card. There will be no names or any other identifiers. Each participating center will identify a dedicated delivery room staff that will be trained to read the contents of the card using the cell phone application as well as enter new data in the participant's profile. When a participant presents at delivery without the card, information can still be obtained from the secure, web-based database and confirmed using the participant's name, date of birth and cell phone number. This information is provided to the clinician to guide management of the infant.
arm group label: Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Echezona Ezeanolue, MD, MPH
phone: 7028952687
email: echezona.ezeanolue@unlv.edu
last name: Semiu O Gbadamosi, MD, MPH
phone: 7028351946
email: semiu.gbadamosi@unlv.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: Nigeria
citation: Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.
PMID: 23758933
responsible party type: Principal Investigator
investigator affiliation: University of Nevada, Las Vegas
investigator full name: Echezona Ezeanolue
investigator title: Professor of Public Health and Pediatrics
mesh term: Hepatitis B
mesh term: Anemia, Sickle Cell
sharing ipd: No