<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/NCT03773913</url>
  </required_header>
  <id_info>
    <org_study_id>ICBHSS Kozah</org_study_id>
    <nct_id>NCT03773913</nct_id>
  </id_info>
  <brief_title>Integrated Community Based Health Systems Strengthening Preliminary Study in Kozah Togo</brief_title>
  <acronym>ICBHSS-Kozah</acronym>
  <official_title>Integrated Community Based Health Systems Strengthening in Northern Togo: A Preliminary Mixed-Methods Study in Kozah District</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Integrate Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministère de la Santé et de l'Hygiène Publique, Togo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université de Lomé, Faculté des Sciences de la Santé, Togo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>City University of New York, School of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Integrate Health</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 preliminary study aims to inform the design and delivery of the integrated facility and&#xD;
      community-based health systems strengthening (ICBHSS) model in four Kozah District health&#xD;
      facilities over a period of 48 months. Specific aims include: (1) Assess maternal and child&#xD;
      health outcomes and health service utilization rates in the 4 ICBHSS model intervention sites&#xD;
      catchment areas; (2) Identify barriers to and facilitators of access and quality services&#xD;
      related to ICBHSS model; and (3) Assess changes in health care services coverage,&#xD;
      effectiveness, and adoption of ICBHSS model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention: The investigators have adapted an integrated facility and community-based&#xD;
      health systems strengthening (ICBHSS) model to improve primary healthcare services in Togo.&#xD;
      The ICBHSS model includes a bundle of evidence based interventions including (1) community&#xD;
      engagement meetings and feedback; (2) the elimination of facility user fees for children&#xD;
      under five and pregnant women; (3) pro-active community based IMCI using Community Health&#xD;
      Workers (CHWs) with additional services including linkage to family planning and counseling,&#xD;
      HIV testing &amp; referrals; (4) clinical mentoring and enhanced supervision at public sector&#xD;
      facilities; and (5) improved supply chain management and facility structures.&#xD;
&#xD;
      Study: The investigators will conduct a mixed methods assessment, using the RE-AIM framework&#xD;
      to evaluate the impact and implementation of the ICBHSS initiative in Kozah district. It will&#xD;
      include: (1) a repeated cross-sectional study to obtain annual coverage, effectiveness, and&#xD;
      adoption metrics using a population-based household survey as well as (2) qualitative key&#xD;
      informant interviews and focus group discussions conducted at 12 months for each intervention&#xD;
      health facility. The primary outcome will be under 5 year old mortality rate, with secondary&#xD;
      outcomes including under-one mortality rate, maternal mortality rate, as well as maternal and&#xD;
      child health service utilization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Anticipated">August 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Under-five year old mortality rate, annual</measure>
    <time_frame>72 months</time_frame>
    <description>The under-five mortality rate (expressed as a rate per 1,000 live births) is the probability of a child dying in a specified year between birth and 5 years of age.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Under-one year old mortality rate, annual</measure>
    <time_frame>72 months</time_frame>
    <description>The under-one mortality rate (expressed as a rate per 1,000 live births) is the probability of a child dying in a specified year between birth and 1 year of age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal mortality rate, annual</measure>
    <time_frame>72 months</time_frame>
    <description>The maternal mortality rate (expressed as a rate per 100,000 live births) is the probability of a mother dying in a specified year within 42 days of pregnancy termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual proportion of children under age five reported to be febrile in the prior two weeks who received an effective antimalarial treatment within 24 hours of symptom onset.</measure>
    <time_frame>72 months</time_frame>
    <description>The number of febrile children under-five who received an effective antimalarial treatment within 24 hours of symptom onset out of the total number of children under age five reported to be febrile in the prior two weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual proportion of children under age five reported to have a cough in the prior two weeks who received an effective pneumonia treatment within 24 hours of symptom onset.</measure>
    <time_frame>72 months</time_frame>
    <description>The number of children under-five who received an effective pneumonia treatment within 24 hours of symptom onset out of the total number of children under age five reported to have a cough in the prior two weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual proportion of children under age five reported to have diarrhea in the prior two weeks who received an effective treatment for diarrheal disease within 24 hours of symptom onset.</measure>
    <time_frame>72 months</time_frame>
    <description>The number of children under-five who received an effective treatment for diarrheal disease within 24 hours of symptom onset out of the total number of children under age five reported to have diarrhea in the prior two weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal facility based birth delivery incidence rate, annual</measure>
    <time_frame>72 months</time_frame>
    <description>The proportion of women reported to have delivered in a health facility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protocol Adherence by IH community health workers in iCCM and maternal consultations</measure>
    <time_frame>72 months</time_frame>
    <description>The average adherence by IH community health workers to evidence-based protocols for iCCM and maternal consultations as measured by CHW supervisor check-list.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protocol adherence by clinical staff at IH intervention facilities in iCCM and maternal consultations</measure>
    <time_frame>72 months</time_frame>
    <description>The average adherence by public sector clinical staff at IH intervention sites to evidence-based protocols for iCCM and maternal consultations as measured by IH clinical mentor supervision check-list.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Maternal-Child Health Services</condition>
  <condition>Health Service Utilization</condition>
  <arm_group>
    <arm_group_label>Four facilities in Kozah District</arm_group_label>
    <description>Baseline estimated population of 33,412 served by four public sector facilities in Kozah District.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ICBHSS model</intervention_name>
    <description>Bundle of evidence-based interventions that include the following 5 components:&#xD;
Community engagement meetings and feedback;&#xD;
Elimination of public sector facility user fees for children under five and pregnant women;&#xD;
Pro-active community based IMCI using trained, equipped, supervised, and salaried Community Health Workers (CHWs) with additional services including linkage to family planning and counseling, HIV testing &amp; referrals;&#xD;
Clinical mentoring and enhanced supervision by a trained peer coach at public sector facilities;&#xD;
Basic infrastructure improvements and supply chain management training of pharmacy managers</description>
    <arm_group_label>Four facilities in Kozah District</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Females of reproductive age (aged 15-49 years) who reside in a selected household within&#xD;
        the study catchment area.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female of reproductive age (aged 15-49 years)&#xD;
&#xD;
          -  Individuals aged 15-17 years will only be included if they have children and/or are&#xD;
             pregnant&#xD;
&#xD;
          -  Lives in selected household within study catchment area&#xD;
&#xD;
          -  Informed consent is obtained for participants 18-49&#xD;
&#xD;
          -  Waiver of parental permission is obtained for 15-17 year-old participants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin P Fiori Jr., MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Integrate Health; Albert Einstein School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Molly E Lauria, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Integrate Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Molly E Lauria, MPH</last_name>
    <email>mlauria@integratehealth.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kevin P Fiori Jr., MD MPH</last_name>
    <email>kfiori@integratehealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Integrate Health</name>
      <address>
        <city>Kara</city>
        <country>Togo</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Molly E Lauria, MPH</last_name>
      <phone>646-397-0217</phone>
      <email>mlauria@integratehealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Togo</country>
  </location_countries>
  <link>
    <url>http://integratehealth.org/</url>
    <description>Integrate Health</description>
  </link>
  <reference>
    <citation>Fiori K, Schechter J, Dey M, Braganza S, Rhatigan J, Houndenou S, Gbeleou C, Palerbo E, Tchangani E, Lopez A, Bensen E, Hirschhorn LR. Closing the delivery gaps in pediatric HIV care in Togo, West Africa: using the care delivery value chain framework to direct quality improvement. AIDS Care. 2016 Mar;28 Suppl 2(sup2):29-33. doi: 10.1080/09540121.2016.1176678.</citation>
    <PMID>27391996</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>October 11, 2019</last_update_submitted>
  <last_update_submitted_qc>October 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Child Mortality</keyword>
  <keyword>Reproductive, Maternal, Newborn, and Child Health</keyword>
  <keyword>Community Health Workers</keyword>
  <keyword>Implementation Research</keyword>
  <keyword>Preliminary Research</keyword>
  <keyword>Health Systems Strengthening</keyword>
  <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/NCT03773913
org study id: ICBHSS Kozah
nct id: NCT03773913
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This preliminary study aims to inform the design and delivery of the integrated facility and
      community-based health systems strengthening (ICBHSS) model in four Kozah District health
      facilities over a period of 48 months. Specific aims include: (1) Assess maternal and child
      health outcomes and health service utilization rates in the 4 ICBHSS model intervention sites
      catchment areas; (2) Identify barriers to and facilitators of access and quality services
      related to ICBHSS model; and (3) Assess changes in health care services coverage,
      effectiveness, and adoption of ICBHSS model.
Intervention: The investigators have adapted an integrated facility and community-based
      health systems strengthening (ICBHSS) model to improve primary healthcare services in Togo.
      The ICBHSS model includes a bundle of evidence based interventions including (1) community
      engagement meetings and feedback; (2) the elimination of facility user fees for children
      under five and pregnant women; (3) pro-active community based IMCI using Community Health
      Workers (CHWs) with additional services including linkage to family planning and counseling,
      HIV testing & referrals; (4) clinical mentoring and enhanced supervision at public sector
      facilities; and (5) improved supply chain management and facility structures.

      Study: The investigators will conduct a mixed methods assessment, using the RE-AIM framework
      to evaluate the impact and implementation of the ICBHSS initiative in Kozah district. It will
      include: (1) a repeated cross-sectional study to obtain annual coverage, effectiveness, and
      adoption metrics using a population-based household survey as well as (2) qualitative key
      informant interviews and focus group discussions conducted at 12 months for each intervention
      health facility. The primary outcome will be under 5 year old mortality rate, with secondary
      outcomes including under-one mortality rate, maternal mortality rate, as well as maternal and
      child health service utilization.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Under-five year old mortality rate, annual
time frame: 72 months
description: The under-five mortality rate (expressed as a rate per 1,000 live births) is the probability of a child dying in a specified year between birth and 5 years of age.
measure: Under-one year old mortality rate, annual
time frame: 72 months
description: The under-one mortality rate (expressed as a rate per 1,000 live births) is the probability of a child dying in a specified year between birth and 1 year of age.
measure: Maternal mortality rate, annual
time frame: 72 months
description: The maternal mortality rate (expressed as a rate per 100,000 live births) is the probability of a mother dying in a specified year within 42 days of pregnancy termination.
measure: Annual proportion of children under age five reported to be febrile in the prior two weeks who received an effective antimalarial treatment within 24 hours of symptom onset.
time frame: 72 months
description: The number of febrile children under-five who received an effective antimalarial treatment within 24 hours of symptom onset out of the total number of children under age five reported to be febrile in the prior two weeks.
measure: Annual proportion of children under age five reported to have a cough in the prior two weeks who received an effective pneumonia treatment within 24 hours of symptom onset.
time frame: 72 months
description: The number of children under-five who received an effective pneumonia treatment within 24 hours of symptom onset out of the total number of children under age five reported to have a cough in the prior two weeks.
measure: Annual proportion of children under age five reported to have diarrhea in the prior two weeks who received an effective treatment for diarrheal disease within 24 hours of symptom onset.
time frame: 72 months
description: The number of children under-five who received an effective treatment for diarrheal disease within 24 hours of symptom onset out of the total number of children under age five reported to have diarrhea in the prior two weeks.
measure: Maternal facility based birth delivery incidence rate, annual
time frame: 72 months
description: The proportion of women reported to have delivered in a health facility.
measure: Protocol Adherence by IH community health workers in iCCM and maternal consultations
time frame: 72 months
description: The average adherence by IH community health workers to evidence-based protocols for iCCM and maternal consultations as measured by CHW supervisor check-list.
measure: Protocol adherence by clinical staff at IH intervention facilities in iCCM and maternal consultations
time frame: 72 months
description: The average adherence by public sector clinical staff at IH intervention sites to evidence-based protocols for iCCM and maternal consultations as measured by IH clinical mentor supervision check-list.
arm group label: Four facilities in Kozah District
description: Baseline estimated population of 33,412 served by four public sector facilities in Kozah District.
intervention type: Other
intervention name: ICBHSS model
description: Bundle of evidence-based interventions that include the following 5 components:
Community engagement meetings and feedback;
Elimination of public sector facility user fees for children under five and pregnant women;
Pro-active community based IMCI using trained, equipped, supervised, and salaried Community Health Workers (CHWs) with additional services including linkage to family planning and counseling, HIV testing & referrals;
Clinical mentoring and enhanced supervision by a trained peer coach at public sector facilities;
Basic infrastructure improvements and supply chain management training of pharmacy managers
arm group label: Four facilities in Kozah District
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kevin P Fiori Jr., MD MPH
role: Principal Investigator
affiliation: Integrate Health; Albert Einstein School of Medicine
last name: Molly E Lauria, MPH
role: Study Director
affiliation: Integrate Health
last name: Molly E Lauria, MPH
email: mlauria@integratehealth.org
last name: Kevin P Fiori Jr., MD MPH
email: kfiori@integratehealth.org
facility: 
status: Recruiting
contact: 
country: Togo
url: http://integratehealth.org/
description: Integrate Health
citation: Fiori K, Schechter J, Dey M, Braganza S, Rhatigan J, Houndenou S, Gbeleou C, Palerbo E, Tchangani E, Lopez A, Bensen E, Hirschhorn LR. Closing the delivery gaps in pediatric HIV care in Togo, West Africa: using the care delivery value chain framework to direct quality improvement. AIDS Care. 2016 Mar;28 Suppl 2(sup2):29-33. doi: 10.1080/09540121.2016.1176678.
PMID: 27391996
responsible party type: Sponsor
sharing ipd: No