<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/NCT03023033</url>
  </required_header>
  <id_info>
    <org_study_id>EG0130</org_study_id>
    <nct_id>NCT03023033</nct_id>
  </id_info>
  <brief_title>Supporting Attendance for Facility Delivery and Infant Health</brief_title>
  <acronym>SAFI</acronym>
  <official_title>Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elizabeth Glaser Pediatric AIDS Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Population Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Tanzania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Elizabeth Glaser Pediatric AIDS Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this proposed intervention study is to increase the proportion of HIV positive&#xD;
      and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed&#xD;
      infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of&#xD;
      HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing&#xD;
      within 8 weeks of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following a formative phase I, we propose in phase II to implement a three-group&#xD;
      cluster-randomized study to test the effectiveness of short message service (SMS) reminders&#xD;
      and notifications, [mobile health or mhealth] (group 1) and the combined effectiveness of SMS&#xD;
      reminders/notifications and cash transfers (group 2) compared to the standard prevention of&#xD;
      mother-to-child transmission (of HIV)/maternal, neonatal and child health, (PMTCT/MNCH)&#xD;
      practices (group 3).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Attendance for Early infant diagnosis (EID) of HIV</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of HIV-exposed infants (HEI) attending for early infant diagnosis of HIV (DBS collected) by 8 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Early identification of HEI at Reproductive and Child Health (RCH) Clinic</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of HEI identified early (48 hours,3 and 7 days) at RCH clinic</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antenatal care (ANC) visits</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of pregnant women attending at least 4 ANC visits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Facility delivery</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of pregnant women delivering in a health facility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post natal care (PNC) visits</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nevirapine (NVP) at delivery</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of HEI given NVP at delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Receipt of EID results</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of HEI who received EID results by 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV infected infants initiated on antiretroviral therapy (ART)</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of HIV infected infants initiated on ART by 12 weeks of age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to EID</measure>
    <time_frame>1 year</time_frame>
    <description>Time (days/weeks) from date of birth to attendance for EID</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to receipt of EID results</measure>
    <time_frame>1 year</time_frame>
    <description>Time (days/weeks) from date of birth to receipt of EID results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to treatment</measure>
    <time_frame>! year</time_frame>
    <description>Time (days/weeks) from date of birth to initiation of ART</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1505</enrollment>
  <condition>HIV</condition>
  <condition>AIDS</condition>
  <arm_group>
    <arm_group_label>Clinic group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinics using SMS health promotion and reminder messages (mhealth messaging)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinic group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinic group 3</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Services provided under the Ministry of Health standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mHealth messaging</intervention_name>
    <description>SMS appointment reminders and health messaging via mobile phones</description>
    <arm_group_label>Clinic group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Transport Payments</intervention_name>
    <description>A payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area</description>
    <arm_group_label>Clinic group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Known or recently diagnosed HIV-positive in ANC or; Tested HIV-negative at ANC&#xD;
&#xD;
          -  Plans to deliver in facility catchment area&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Able and willing to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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_official>
    <last_name>Godfrey Woelk, MCOMMH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Elizabeth Glaser Pediatric AIDS Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elizabeth Glaser Pediatric AIDS Foundation</name>
      <address>
        <city>Dar es Salaam</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>February 27, 2015</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</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 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PMTCT</keyword>
  <keyword>MNCH</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The dataset has been given to the USAID, the study sponsor. There is a plan to made these data publically available from 2018</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>The plan is for the data to become available in 2018</ipd_time_frame>
    <ipd_access_criteria>Access criteria will be defined by USAID</ipd_access_criteria>
  </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/NCT03023033
org study id: EG0130
nct id: NCT03023033
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The goal of this proposed intervention study is to increase the proportion of HIV positive
      and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed
      infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of
      HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing
      within 8 weeks of age.
Following a formative phase I, we propose in phase II to implement a three-group
      cluster-randomized study to test the effectiveness of short message service (SMS) reminders
      and notifications, [mobile health or mhealth] (group 1) and the combined effectiveness of SMS
      reminders/notifications and cash transfers (group 2) compared to the standard prevention of
      mother-to-child transmission (of HIV)/maternal, neonatal and child health, (PMTCT/MNCH)
      practices (group 3).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Attendance for Early infant diagnosis (EID) of HIV
time frame: 1 year
description: Proportion of HIV-exposed infants (HEI) attending for early infant diagnosis of HIV (DBS collected) by 8 weeks
measure: Early identification of HEI at Reproductive and Child Health (RCH) Clinic
time frame: 1 year
description: Proportion of HEI identified early (48 hours,3 and 7 days) at RCH clinic
measure: Antenatal care (ANC) visits
time frame: 1 year
description: Proportion of pregnant women attending at least 4 ANC visits
measure: Facility delivery
time frame: 1 year
description: Proportion of pregnant women delivering in a health facility
measure: Post natal care (PNC) visits
time frame: 1 year
description: Proportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery
measure: Nevirapine (NVP) at delivery
time frame: 1 year
description: Proportion of HEI given NVP at delivery
measure: Receipt of EID results
time frame: 1 year
description: Proportion of HEI who received EID results by 12 weeks
measure: HIV infected infants initiated on antiretroviral therapy (ART)
time frame: 1 year
description: Proportion of HIV infected infants initiated on ART by 12 weeks of age
measure: Time to EID
time frame: 1 year
description: Time (days/weeks) from date of birth to attendance for EID
measure: Time to receipt of EID results
time frame: 1 year
description: Time (days/weeks) from date of birth to receipt of EID results
measure: Time to treatment
time frame: ! year
description: Time (days/weeks) from date of birth to initiation of ART
arm group label: Clinic group 1
arm group type: Experimental
description: Clinics using SMS health promotion and reminder messages (mhealth messaging)
arm group label: Clinic group 2
arm group type: Experimental
description: Clinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments)
arm group label: Clinic group 3
arm group type: No Intervention
description: Services provided under the Ministry of Health standard care
intervention type: Behavioral
intervention name: mHealth messaging
description: SMS appointment reminders and health messaging via mobile phones
arm group label: Clinic group 1
intervention type: Behavioral
intervention name: Transport Payments
description: A payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area
arm group label: Clinic group 2
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Godfrey Woelk, MCOMMH, PhD
role: Principal Investigator
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
facility: 
country: Tanzania
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The dataset has been given to the USAID, the study sponsor. There is a plan to made these data publically available from 2018
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The plan is for the data to become available in 2018
ipd access criteria: Access criteria will be defined by USAID