<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/NCT03254628</url>
  </required_header>
  <id_info>
    <org_study_id>AID-OAA-A-13-00012</org_study_id>
    <nct_id>NCT03254628</nct_id>
  </id_info>
  <brief_title>Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation</brief_title>
  <official_title>Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jhpiego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Jhpiego</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>
      The study aims are to evaluate the impact of supportive follow-up strategies for a novel&#xD;
      twinned training and capacity-sustaining program among frontline health workers (providers)&#xD;
      attending facility-based births in remote and district level health facilities in Uganda. The&#xD;
      program is designed to improve provider competencies, provider performance and health&#xD;
      outcomes among women giving birth and newborns.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will take place in Uganda at Health Centers (level II, III and IV) and District&#xD;
      Hospitals, to reach 'frontline' health providers who attend births. This study will take&#xD;
      place in districts meeting study criteria in two regions to demonstrate ability to implement&#xD;
      in different geographic settings and potential for scale up. It is a quasi-experimental&#xD;
      design with three study arms/groups that receive different levels or intensities and&#xD;
      modalities of the program intervention.&#xD;
&#xD;
      Briefly, the same simulator-based training will be provided in all three study arms. After&#xD;
      the training, a simulator will be left in the health facility, and providers will be&#xD;
      encouraged to practice with it regularly. In two of the study arms, specific health workers&#xD;
      will be recruited to support the intervention by encouraging their colleagues to practice&#xD;
      with the simulator. In one study arm, the practice will be further reinforced through mobile&#xD;
      phone-based support. Following is a more detailed description of each of the three&#xD;
      components.&#xD;
&#xD;
      Component 1 (Training): Training is composed of two separate training interventions. First,&#xD;
      in each study facility, Ugandan master trainers (district trainers) will conduct a single&#xD;
      day, simulator-driven training on PPH prevention and treatment; all providers who attend&#xD;
      births will be invited to participate. Eight weeks later, in each facility, the same trainers&#xD;
      will conduct a one-day, simulator-driven training for prevention and management of asphyxia&#xD;
      in the newborn. After each one-day training, simulators will be left at the facility for&#xD;
      practice with a corresponding practice schedule.&#xD;
&#xD;
      Component 2 (Peer-led Practice Sessions): On the day the first training (for PPH), 2 birth&#xD;
      attendants at the facility will be selected to serve as clinical mentors (CM). The CMs will&#xD;
      be trained to encourage their coworkers to participate in 15-minute practice sessions each&#xD;
      week for 8 weeks, in which they will use the simulators to practice the skills learned in the&#xD;
      one-day training. After the newborn asphyxia training occurs, these same CMs will be trained&#xD;
      to support a similar practice schedule for the following 12 weeks - 8 weeks for newborn&#xD;
      asphyxia practice and 4 weeks for combined PPH and asphyxia skills practice.&#xD;
&#xD;
      Component 3 (Mobile phone-based support): CMs will be connected to the district trainer via&#xD;
      mobile phone for weekly phone calls during the practice periods to provide reminders and&#xD;
      support for practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2014</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage</measure>
    <time_frame>Baseline, Midline (6 months), Endline (12 months)</time_frame>
    <description>The change in the percentage of women who received oxytocin in correct dose immediately after vaginal birth in three study arms, as assessed by direct clinical observation, using a standardized checklist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in provider performance on simulator-based assessments</measure>
    <time_frame>Pre-test (before training)- post-test (immediately after training) - midline (6 months)</time_frame>
    <description>The proportion of providers that obtain a passing score on the assessments, based on assessments done by clinical trainers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in differences: change in care of the mother composite score</measure>
    <time_frame>Baseline (before training), Midline (6 months), Endline (12 months)</time_frame>
    <description>A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in differences: change care of the newborn composite score</measure>
    <time_frame>Baseline (before training), Midline (6 months), Endline (12 months)</time_frame>
    <description>A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3440</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <condition>Neonatal Asphyxia</condition>
  <arm_group>
    <arm_group_label>Full - Train/oxy&amp;miso/ B&amp;M/Mentor/Phone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Partial - Train/oxy &amp; miso/ B&amp;M/Mentor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison - Train/oxy &amp; miso/ B&amp;M</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask,.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Helping Mothers Survive - Bleeding After Birth training</intervention_name>
    <description>One-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage.</description>
    <arm_group_label>Comparison - Train/oxy &amp; miso/ B&amp;M</arm_group_label>
    <arm_group_label>Full - Train/oxy&amp;miso/ B&amp;M/Mentor/Phone</arm_group_label>
    <arm_group_label>Partial - Train/oxy &amp; miso/ B&amp;M/Mentor</arm_group_label>
    <other_name>HMS BAB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Helping Babies Breathe</intervention_name>
    <description>One-day training in neonatal asphyxia management; this includes routine care for the newborn, such as drying and stimulation immediately after birth, and resuscitation of asphyxiated newborns using a bag &amp; mask device.</description>
    <arm_group_label>Comparison - Train/oxy &amp; miso/ B&amp;M</arm_group_label>
    <arm_group_label>Full - Train/oxy&amp;miso/ B&amp;M/Mentor/Phone</arm_group_label>
    <arm_group_label>Partial - Train/oxy &amp; miso/ B&amp;M/Mentor</arm_group_label>
    <other_name>HBB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mentor</intervention_name>
    <description>A birth attendant in the facility is designated as a clinical mentor and encouraged to lead simulator-based practice sessions in the facility after training day.</description>
    <arm_group_label>Full - Train/oxy&amp;miso/ B&amp;M/Mentor/Phone</arm_group_label>
    <arm_group_label>Partial - Train/oxy &amp; miso/ B&amp;M/Mentor</arm_group_label>
    <other_name>CM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phone</intervention_name>
    <description>District trainers telephone clinical mentors and encourage them to lead practice sessions.</description>
    <arm_group_label>Full - Train/oxy&amp;miso/ B&amp;M/Mentor/Phone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxytocin and misoprostol</intervention_name>
    <description>This study did not provide uterotonic drugs except in the case of stock out where locally purchased oxytocin and misoprostol were provided only as back up.</description>
    <arm_group_label>Comparison - Train/oxy &amp; miso/ B&amp;M</arm_group_label>
    <arm_group_label>Full - Train/oxy&amp;miso/ B&amp;M/Mentor/Phone</arm_group_label>
    <arm_group_label>Partial - Train/oxy &amp; miso/ B&amp;M/Mentor</arm_group_label>
    <other_name>oxy&amp;miso</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Newborn bag and mask</intervention_name>
    <description>All facilities were supplied with at least 1 bag and mask for newborn resuscitation. This bag and mask was used for training, practice, and clinical care</description>
    <arm_group_label>Comparison - Train/oxy &amp; miso/ B&amp;M</arm_group_label>
    <arm_group_label>Full - Train/oxy&amp;miso/ B&amp;M/Mentor/Phone</arm_group_label>
    <arm_group_label>Partial - Train/oxy &amp; miso/ B&amp;M/Mentor</arm_group_label>
    <other_name>B&amp;M</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For Providers: Health providers who attend births in participating health facility and&#xD;
             consent to be assessed at the time of enrollment and at several points in time over&#xD;
             two years.&#xD;
&#xD;
          -  For Clinical mentors: being an experienced skilled birth attendant and likely to&#xD;
             remain at the facility during the study period&#xD;
&#xD;
        For Women in Labor and Delivery and Newborns: Women in any stage of labor in participating&#xD;
        facility who consent to observation of their delivery and care of their newborn (or consent&#xD;
        from the next of kin if the woman is incapacitated and not able to provide consent)&#xD;
&#xD;
        Facility In-charges and Stakeholders: Facility in-charges at sampled health facilities;&#xD;
        stakeholders identified by Jhpiego senior managers as being influential in maternal and&#xD;
        newborn health policy decisions in Uganda.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Providers: has &lt;1 year of experience, and has plans to be transferred to another&#xD;
             facility or leave the facility soon&#xD;
&#xD;
          -  Other types of participants: none&#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>Cherrie Evans, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jhpiego</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Asphyxia Neonatorum</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Asphyxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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>December 20, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03254628/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</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>February 4, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03254628/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03254628
org study id: AID-OAA-A-13-00012
nct id: NCT03254628
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims are to evaluate the impact of supportive follow-up strategies for a novel
      twinned training and capacity-sustaining program among frontline health workers (providers)
      attending facility-based births in remote and district level health facilities in Uganda. The
      program is designed to improve provider competencies, provider performance and health
      outcomes among women giving birth and newborns.
This study will take place in Uganda at Health Centers (level II, III and IV) and District
      Hospitals, to reach 'frontline' health providers who attend births. This study will take
      place in districts meeting study criteria in two regions to demonstrate ability to implement
      in different geographic settings and potential for scale up. It is a quasi-experimental
      design with three study arms/groups that receive different levels or intensities and
      modalities of the program intervention.

      Briefly, the same simulator-based training will be provided in all three study arms. After
      the training, a simulator will be left in the health facility, and providers will be
      encouraged to practice with it regularly. In two of the study arms, specific health workers
      will be recruited to support the intervention by encouraging their colleagues to practice
      with the simulator. In one study arm, the practice will be further reinforced through mobile
      phone-based support. Following is a more detailed description of each of the three
      components.

      Component 1 (Training): Training is composed of two separate training interventions. First,
      in each study facility, Ugandan master trainers (district trainers) will conduct a single
      day, simulator-driven training on PPH prevention and treatment; all providers who attend
      births will be invited to participate. Eight weeks later, in each facility, the same trainers
      will conduct a one-day, simulator-driven training for prevention and management of asphyxia
      in the newborn. After each one-day training, simulators will be left at the facility for
      practice with a corresponding practice schedule.

      Component 2 (Peer-led Practice Sessions): On the day the first training (for PPH), 2 birth
      attendants at the facility will be selected to serve as clinical mentors (CM). The CMs will
      be trained to encourage their coworkers to participate in 15-minute practice sessions each
      week for 8 weeks, in which they will use the simulators to practice the skills learned in the
      one-day training. After the newborn asphyxia training occurs, these same CMs will be trained
      to support a similar practice schedule for the following 12 weeks - 8 weeks for newborn
      asphyxia practice and 4 weeks for combined PPH and asphyxia skills practice.

      Component 3 (Mobile phone-based support): CMs will be connected to the district trainer via
      mobile phone for weekly phone calls during the practice periods to provide reminders and
      support for practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage
time frame: Baseline, Midline (6 months), Endline (12 months)
description: The change in the percentage of women who received oxytocin in correct dose immediately after vaginal birth in three study arms, as assessed by direct clinical observation, using a standardized checklist.
measure: Change in provider performance on simulator-based assessments
time frame: Pre-test (before training)- post-test (immediately after training) - midline (6 months)
description: The proportion of providers that obtain a passing score on the assessments, based on assessments done by clinical trainers.
measure: Difference in differences: change in care of the mother composite score
time frame: Baseline (before training), Midline (6 months), Endline (12 months)
description: A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.
measure: Difference in differences: change care of the newborn composite score
time frame: Baseline (before training), Midline (6 months), Endline (12 months)
description: A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.
arm group label: Full - Train/oxy&miso/ B&M/Mentor/Phone
arm group type: Experimental
description: Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor.
arm group label: Partial - Train/oxy & miso/ B&M/Mentor
arm group type: Experimental
description: Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice.
arm group label: Comparison - Train/oxy & miso/ B&M
arm group type: Active Comparator
description: Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask,.
intervention type: Other
intervention name: Helping Mothers Survive - Bleeding After Birth training
description: One-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage.
arm group label: Comparison - Train/oxy & miso/ B&M
arm group label: Full - Train/oxy&miso/ B&M/Mentor/Phone
arm group label: Partial - Train/oxy & miso/ B&M/Mentor
other name: HMS BAB
intervention type: Other
intervention name: Helping Babies Breathe
description: One-day training in neonatal asphyxia management; this includes routine care for the newborn, such as drying and stimulation immediately after birth, and resuscitation of asphyxiated newborns using a bag & mask device.
arm group label: Comparison - Train/oxy & miso/ B&M
arm group label: Full - Train/oxy&miso/ B&M/Mentor/Phone
arm group label: Partial - Train/oxy & miso/ B&M/Mentor
other name: HBB
intervention type: Behavioral
intervention name: Mentor
description: A birth attendant in the facility is designated as a clinical mentor and encouraged to lead simulator-based practice sessions in the facility after training day.
arm group label: Full - Train/oxy&miso/ B&M/Mentor/Phone
arm group label: Partial - Train/oxy & miso/ B&M/Mentor
other name: CM
intervention type: Behavioral
intervention name: Phone
description: District trainers telephone clinical mentors and encourage them to lead practice sessions.
arm group label: Full - Train/oxy&miso/ B&M/Mentor/Phone
intervention type: Drug
intervention name: oxytocin and misoprostol
description: This study did not provide uterotonic drugs except in the case of stock out where locally purchased oxytocin and misoprostol were provided only as back up.
arm group label: Comparison - Train/oxy & miso/ B&M
arm group label: Full - Train/oxy&miso/ B&M/Mentor/Phone
arm group label: Partial - Train/oxy & miso/ B&M/Mentor
other name: oxy&miso
intervention type: Device
intervention name: Newborn bag and mask
description: All facilities were supplied with at least 1 bag and mask for newborn resuscitation. This bag and mask was used for training, practice, and clinical care
arm group label: Comparison - Train/oxy & miso/ B&M
arm group label: Full - Train/oxy&miso/ B&M/Mentor/Phone
arm group label: Partial - Train/oxy & miso/ B&M/Mentor
other name: B&M
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Cherrie Evans, DrPH
role: Principal Investigator
affiliation: Jhpiego
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Asphyxia Neonatorum
mesh term: Hemorrhage
mesh term: Asphyxia
mesh term: Misoprostol
mesh term: Oxytocin
sharing ipd: Undecided
provided document: 
provided document: 