<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/NCT03774602</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 8902</org_study_id>
    <nct_id>NCT03774602</nct_id>
  </id_info>
  <brief_title>Evaluation of the Maternal and Child Survival Program (MCSP) in Mozambique Using Mixed Methods</brief_title>
  <official_title>Evaluation of the Maternal and Child Survival Program (MCSP) in Mozambique Using Mixed Methods</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jhpiego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Mozambique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Save the Children</agency>
      <agency_class>Other</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>
      This study evaluates changes in knowledge, attitudes, practices and coverage of key&#xD;
      reproductive, maternal, newborn, and child health (RMNCH) areas, including malaria, family&#xD;
      planning (FP), nutrition, water, sanitation and hygiene (WASH), and gender equity among the&#xD;
      population in Nampula and Sofala provinces targeted by the Maternal and Child Survival&#xD;
      Program (MCSP) in Mozambique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific objectives of the study are to:&#xD;
&#xD;
        1. Assess changes in knowledge, attitudes, practices and coverage (KAPC) of high-impact&#xD;
           interventions related to MNCH (antenatal care, delivery, post-partum/natal care, and&#xD;
           sick child care), immunization, family planning and reproductive health, nutrition, WASH&#xD;
           and malaria among mothers and fathers of children age 0-23 months in MCSP supported&#xD;
           areas;&#xD;
&#xD;
        2. Evaluate the effectiveness of male engagement interventions that encourage couples&#xD;
           communication at increasing antenatal care (ANC) attendance, joint birth preparedness&#xD;
           and complication readiness (BPCR) plans, institutional birth, and use of modern FP;&#xD;
&#xD;
        3. Determine the feasibility and acceptability of male engagement interventions on RMNCH&#xD;
           services for clients and providers;&#xD;
&#xD;
        4. Explore how decisions between couples are made and what may influence their decisions&#xD;
           about seeking RMNCH services; and&#xD;
&#xD;
        5. Explore the experiences of women who were referred to a health facility for themselves&#xD;
           or their child for obstetric, newborn or child health complications, and examine the&#xD;
           factors contributing to whether and how those referrals were completed in Nampula&#xD;
           Province.&#xD;
&#xD;
      This study is a final program evaluation that will use a mixed methods approach, including&#xD;
      both quantitative and qualitative data collection.&#xD;
&#xD;
      Quantitative data will be collected through a cross-sectional KAPC household survey of&#xD;
      mothers and fathers of children age 0-23 months, replicating the same KAPC questionnaire that&#xD;
      was conducted at baseline in 2016 in the same geographic areas. Questions were harmonized&#xD;
      with the DHS and MICS where appropriate. Findings from the endline KAPC survey will be&#xD;
      compared to findings from the baseline survey to assess changes over time in the primary&#xD;
      outcomes of interest.&#xD;
&#xD;
      Qualitative data will be collected through focus group discussions (FGDs) and in-depth&#xD;
      interviews (IDIs) with clients (mothers and fathers of children age 0-23 months) and health&#xD;
      providers in MCSP-supported areas. The qualitative component will be conducted to help us&#xD;
      gain a more in-depth understanding of the influence of male engagement interventions on&#xD;
      couples' decision-making and care-seeking related to RMNCH as well as the barriers and&#xD;
      facilitators that affected the experience of identified women who were referred to health&#xD;
      facilities for obstetric or newborn complications. We will explore both client and provider&#xD;
      experiences with gender-equitable male engagement practices, as well as individual client&#xD;
      referral narratives related to obstetric or newborn complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2018</start_date>
  <completion_date type="Actual">December 22, 2018</completion_date>
  <primary_completion_date type="Actual">December 22, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Institutional delivery rate</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of last-born children age 0-23 months who were born in a health facility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of pregnant women who had four or more ANC visits</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of mothers of children age 0-23 months who had four or more antenatal care visits while pregnant with their youngest child</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of children under 2 years of age who received Penta 1 vaccination but did not receive Penta 3 (Drop out rate)</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of children age 12-23 months who received a Penta 1 vaccination but did not receive a Penta 3 vaccination according to or card verified at the time of the survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of mothers who made birth preparations before giving birth</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of mothers of children age 0-23 months who made birth preparations before the birth of their youngest child</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of women who have discussed FP use with her partner</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of women of reproductive age who have discussed with her partner whether to use a FP method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of infants under 6 months of age who are exclusively breastfed</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of infants 0-5 months of age who are fed exclusively with breast milk</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2767</enrollment>
  <condition>Knowledge, Attitudes, Practice</condition>
  <condition>Gender Issues</condition>
  <arm_group>
    <arm_group_label>MCSP package of interventions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MCSP package of interventions for health promotion and provision of RMNCH services</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health promotion and provision of RMNCH services</intervention_name>
    <description>Implementation of quality, high-impact interventions at institutional and community levels to increase access to and utilization of RMNCH services</description>
    <arm_group_label>MCSP package of interventions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (KAPC survey):&#xD;
&#xD;
          -  Women 15 years and older who have had a live birth in the 2 years preceding the survey&#xD;
             and the child is living at the time of the interview&#xD;
&#xD;
          -  Male partners (age 18 and older) of women 15 years and older who have had a live birth&#xD;
             in the 2 years preceding the survey and the child is living at the time of the&#xD;
             interview&#xD;
&#xD;
        Exclusion Criteria (KAPC survey): Women 15-17 years without parent permission to&#xD;
        participate in study&#xD;
&#xD;
        Inclusion Criteria (Referral narrative interviews): Women who: a) delivered in the last 12&#xD;
        months who experienced obstetric complications; b) whose newborn experienced complications&#xD;
        in the last year; c) whose child 0-59 months experienced an illness in the last year&#xD;
&#xD;
        Inclusion Criteria (Provider interviews):&#xD;
&#xD;
          -  Facility managers working in selected primary health care centers&#xD;
&#xD;
          -  Health care workers who provide RMNCH services in MCSP-supported facility in one of&#xD;
             these six areas: ANC, maternity, postnatal care, FP, sick child, or well-child&#xD;
&#xD;
        Exclusion Criteria (Provider interviews): Has been working in the facility for &lt; 6 months&#xD;
&#xD;
        Inclusion Criteria (Male engagement FGDs):&#xD;
&#xD;
          -  Women 18-49 years of age who delivered in the last 12 months&#xD;
&#xD;
          -  Male partner (age 18 and older) of a woman 18-49 years of age who delivered in the&#xD;
             last 12 months&#xD;
&#xD;
          -  Participated in a community dialogue&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Connie Lee, MPH, MIA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jhpiego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Angoche District, Community Setting</name>
      <address>
        <city>Angoche</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meconta District, Community Setting</name>
      <address>
        <city>Meconta</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mecuburi District, Community Setting</name>
      <address>
        <city>Mecuburi</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moma District, Community Setting</name>
      <address>
        <city>Moma</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monapo District, Community Setting</name>
      <address>
        <city>Monapo</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mossuril District, Community Setting</name>
      <address>
        <city>Mossuril</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Saude Ontupaia</name>
      <address>
        <city>Nacala</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Saude Quissinmanjulo</name>
      <address>
        <city>Nacala</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nacala Porto District, Community Setting</name>
      <address>
        <city>Nacala</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erati District, Community Setting</name>
      <address>
        <city>Namapa-erati</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Saude Iapala Sede</name>
      <address>
        <city>Ribaue</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Rural de Ribaue</name>
      <address>
        <city>Ribaue</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ribaue District, Community Setting</name>
      <address>
        <city>Ribaue</city>
        <state>Nampula</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beira City, Community Setting</name>
      <address>
        <city>Beira</city>
        <state>Sofala</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buzi District, Community Setting</name>
      <address>
        <city>Buzi</city>
        <state>Sofala</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Saude Ampara</name>
      <address>
        <city>Buzi</city>
        <state>Sofala</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Saude Bandua</name>
      <address>
        <city>Buzi</city>
        <state>Sofala</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dondo District, Community Setting</name>
      <address>
        <city>Dondo</city>
        <state>Sofala</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Saude Metuchira</name>
      <address>
        <city>Nhamatanda</city>
        <state>Sofala</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Rural de Nhamatanda</name>
      <address>
        <city>Nhamatanda</city>
        <state>Sofala</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nhamatanda District, Community Setting</name>
      <address>
        <city>Nhamatanda</city>
        <state>Sofala</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mozambique</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03774602
org study id: IRB 8902
nct id: NCT03774602
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates changes in knowledge, attitudes, practices and coverage of key
      reproductive, maternal, newborn, and child health (RMNCH) areas, including malaria, family
      planning (FP), nutrition, water, sanitation and hygiene (WASH), and gender equity among the
      population in Nampula and Sofala provinces targeted by the Maternal and Child Survival
      Program (MCSP) in Mozambique.
The specific objectives of the study are to:

        1. Assess changes in knowledge, attitudes, practices and coverage (KAPC) of high-impact
           interventions related to MNCH (antenatal care, delivery, post-partum/natal care, and
           sick child care), immunization, family planning and reproductive health, nutrition, WASH
           and malaria among mothers and fathers of children age 0-23 months in MCSP supported
           areas;

        2. Evaluate the effectiveness of male engagement interventions that encourage couples
           communication at increasing antenatal care (ANC) attendance, joint birth preparedness
           and complication readiness (BPCR) plans, institutional birth, and use of modern FP;

        3. Determine the feasibility and acceptability of male engagement interventions on RMNCH
           services for clients and providers;

        4. Explore how decisions between couples are made and what may influence their decisions
           about seeking RMNCH services; and

        5. Explore the experiences of women who were referred to a health facility for themselves
           or their child for obstetric, newborn or child health complications, and examine the
           factors contributing to whether and how those referrals were completed in Nampula
           Province.

      This study is a final program evaluation that will use a mixed methods approach, including
      both quantitative and qualitative data collection.

      Quantitative data will be collected through a cross-sectional KAPC household survey of
      mothers and fathers of children age 0-23 months, replicating the same KAPC questionnaire that
      was conducted at baseline in 2016 in the same geographic areas. Questions were harmonized
      with the DHS and MICS where appropriate. Findings from the endline KAPC survey will be
      compared to findings from the baseline survey to assess changes over time in the primary
      outcomes of interest.

      Qualitative data will be collected through focus group discussions (FGDs) and in-depth
      interviews (IDIs) with clients (mothers and fathers of children age 0-23 months) and health
      providers in MCSP-supported areas. The qualitative component will be conducted to help us
      gain a more in-depth understanding of the influence of male engagement interventions on
      couples' decision-making and care-seeking related to RMNCH as well as the barriers and
      facilitators that affected the experience of identified women who were referred to health
      facilities for obstetric or newborn complications. We will explore both client and provider
      experiences with gender-equitable male engagement practices, as well as individual client
      referral narratives related to obstetric or newborn complications.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Institutional delivery rate
time frame: 2 years
description: Percentage of last-born children age 0-23 months who were born in a health facility
measure: Percentage of pregnant women who had four or more ANC visits
time frame: 2 years
description: Percentage of mothers of children age 0-23 months who had four or more antenatal care visits while pregnant with their youngest child
measure: Percentage of children under 2 years of age who received Penta 1 vaccination but did not receive Penta 3 (Drop out rate)
time frame: 2 years
description: Percentage of children age 12-23 months who received a Penta 1 vaccination but did not receive a Penta 3 vaccination according to or card verified at the time of the survey
measure: Percentage of mothers who made birth preparations before giving birth
time frame: 2 years
description: Percentage of mothers of children age 0-23 months who made birth preparations before the birth of their youngest child
measure: Percentage of women who have discussed FP use with her partner
time frame: 2 years
description: Percentage of women of reproductive age who have discussed with her partner whether to use a FP method
measure: Percent of infants under 6 months of age who are exclusively breastfed
time frame: 2 years
description: Percentage of infants 0-5 months of age who are fed exclusively with breast milk
arm group label: MCSP package of interventions
arm group type: Experimental
description: MCSP package of interventions for health promotion and provision of RMNCH services
intervention type: Behavioral
intervention name: Health promotion and provision of RMNCH services
description: Implementation of quality, high-impact interventions at institutional and community levels to increase access to and utilization of RMNCH services
arm group label: MCSP package of interventions
criteria: 
gender: All
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Connie Lee, MPH, MIA
role: Principal Investigator
affiliation: Jhpiego
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Mozambique
responsible party type: Sponsor
sharing ipd: Undecided