<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/NCT04442152</url>
  </required_header>
  <id_info>
    <org_study_id>265A</org_study_id>
    <nct_id>NCT04442152</nct_id>
  </id_info>
  <brief_title>Impact of COVID-19 on Family Dynamics on Bandebereho Study Participants</brief_title>
  <official_title>Phone Survey for Understanding the Impact of COVID-19 on Caregiving and Family Dynamics on Bandebereho Study Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Promundo, United States</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rwanda Men's Resource Center (Rwamrec)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health/Rwanda Biomedical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Promundo, United States</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 proposed study will assess how COVID-19 and the associated 'stay at home' orders are&#xD;
      affecting low-income Rwandan couples' relationships and family dynamics. The study builds on&#xD;
      an existing randomized controlled trial of the Bandebereho fathers/couples intervention&#xD;
      (NCT02694627), which will allow us to assess not only the current conditions in households,&#xD;
      but also whether or how the significant impacts of the intervention are sustained under&#xD;
      extreme stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This proposed study will assess how COVID-19 and the associated 'stay at home' orders are&#xD;
      affecting low-income Rwandan couples' relationships and family dynamics. It will contribute&#xD;
      to documenting whether and how this disruptive moment might be changing or influencing&#xD;
      relationship dynamics, conflict, and the distribution of care-work. We will build on an&#xD;
      existing randomized controlled trial of the Bandebereho fathers/couples intervention, which&#xD;
      will allow us to assess not only the current conditions in households, but also whether or&#xD;
      how the significant impacts of the intervention are sustained under extreme stress. The&#xD;
      Bandebereho fathers/couples intervention was implemented by the Rwanda Men's Resource Center&#xD;
      (RWAMREC) and Promundo-US, in collaboration with the Rwanda Ministry of Health and local&#xD;
      authorities in Karongi, Musanze, Nyaruguru and Rwamagana districts from 2013-2015. Results&#xD;
      from a randomized controlled study of Bandebereho, a gender transformative intervention for&#xD;
      expectant couples originally implemented in 4 districts in 2015, showed positive results&#xD;
      across multiple outcomes after 21 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Actual">September 4, 2020</completion_date>
  <primary_completion_date type="Actual">September 4, 2020</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>
    <intervention_model_description>Note that we are collecting new data from participants previously randomly assigned to intervention and control arms.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gender division of caregiving/domestic tasks</measure>
    <time_frame>~5 years post intervention</time_frame>
    <description>Question about how caregiving is distributed in the wake of Covid-19</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Couple communication</measure>
    <time_frame>~5 years post intervention</time_frame>
    <description>Frequency of couple communication in the wake of Covid-19</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Couple conflict</measure>
    <time_frame>~5 years post intervention</time_frame>
    <description>Frequency of couple quarreling in the wake of Covid-19</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Men's alcohol use</measure>
    <time_frame>~5 years post intervention</time_frame>
    <description>Frequency of men's alcohol use in the wake of Covid-19</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Household economic situation</measure>
    <time_frame>~5 years post intervention</time_frame>
    <description>Changes in household economic situation in the wake of Covid-19</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress and frustration</measure>
    <time_frame>~5 years post intervention</time_frame>
    <description>Feelings of stress and frustration in the wake of Covid-19</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">998</enrollment>
  <condition>Gender Relations</condition>
  <condition>Partner Communication</condition>
  <condition>Division of Carework</condition>
  <condition>Couple Conflict</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See intervention description</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants who were randomized into the control arm were and will be surveyed at the same time point as intervention participants, but did not receive any intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MenCare+/Bandebereho fathers'/couples' group education</intervention_name>
    <description>MenCare+/Bandebereho is a 3 year project to engage men in maternal, newborn and child health (MNCH) and in sexual and reproductive health in Rwanda. A core component of the project is fathers'/couples' group education. The target participants were first-time parents or parents of young children living in 16 rural and semi-urban sectors selected by the implementing partner in collaboration with local authorities. The MenCare+/Bandebereho fathers'/couples' group education engages men in 15 weekly sessions of group discussion, critical reflection and interactive activities led by a trained facilitator using a curriculum developed by RWAMREC and Promundo and approved by the Rwandan Ministry of Health, adapted from the Program P Manual. Men's partners participate in 6-8 sessions. The sessions focus on men's role in MNCH, family planning, sharing household responsibilities, intimate partner violence, conflict resolution, family budgeting, and gender equality.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Program P</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Original inclusion criteria in the original RCT study included, for men: being between the&#xD;
        ages of 21-35, expecting a child or having one or more children under the age of five,&#xD;
        living in a stable partnership, and residing in the study site. For women, the criteria&#xD;
        were simply being the partner of one of the men selected for the study.&#xD;
&#xD;
        Inclusion criteria for this study include previous participation in the RCT, and that the&#xD;
        respondent indicated they or their partner owned a telephone/phone in the 21-month follow&#xD;
        up that was conducted in November/December 2016. Based on data from the 21-month followup,&#xD;
        approximately 80% of respondents reported a cell phone owned by them or their partner.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>26 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kate E Doyle, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Promundo-US</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ruti G Levtov, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Promundo-US</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Felix Sayingoza, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ministry of Health/Rwanda Biomedical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fidele Rutayisire, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rwanda Men's Resource Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shamsi Kazimbaya, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Promundo-US</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rwanda Men's Resource Centre (Rwamrec)</name>
      <address>
        <city>Kigali</city>
        <country>Rwanda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Rwanda</country>
  </location_countries>
  <reference>
    <citation>Doyle K, Levtov RG, Barker G, Bastian GG, Bingenheimer JB, Kazimbaya S, Nzabonimpa A, Pulerwitz J, Sayinzoga F, Sharma V, Shattuck D. Gender-transformative Bandebereho couples' intervention to promote male engagement in reproductive and maternal health and violence prevention in Rwanda: Findings from a randomized controlled trial. PLoS One. 2018 Apr 4;13(4):e0192756. doi: 10.1371/journal.pone.0192756. eCollection 2018.</citation>
    <PMID>29617375</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>March 11, 2022</last_update_submitted>
  <last_update_submitted_qc>March 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gender, caregiving, Covid-19, couple relations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04442152
org study id: 265A
nct id: NCT04442152
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This proposed study will assess how COVID-19 and the associated 'stay at home' orders are
      affecting low-income Rwandan couples' relationships and family dynamics. The study builds on
      an existing randomized controlled trial of the Bandebereho fathers/couples intervention
      (NCT02694627), which will allow us to assess not only the current conditions in households,
      but also whether or how the significant impacts of the intervention are sustained under
      extreme stress.
This proposed study will assess how COVID-19 and the associated 'stay at home' orders are
      affecting low-income Rwandan couples' relationships and family dynamics. It will contribute
      to documenting whether and how this disruptive moment might be changing or influencing
      relationship dynamics, conflict, and the distribution of care-work. We will build on an
      existing randomized controlled trial of the Bandebereho fathers/couples intervention, which
      will allow us to assess not only the current conditions in households, but also whether or
      how the significant impacts of the intervention are sustained under extreme stress. The
      Bandebereho fathers/couples intervention was implemented by the Rwanda Men's Resource Center
      (RWAMREC) and Promundo-US, in collaboration with the Rwanda Ministry of Health and local
      authorities in Karongi, Musanze, Nyaruguru and Rwamagana districts from 2013-2015. Results
      from a randomized controlled study of Bandebereho, a gender transformative intervention for
      expectant couples originally implemented in 4 districts in 2015, showed positive results
      across multiple outcomes after 21 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Note that we are collecting new data from participants previously randomly assigned to intervention and control arms.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Gender division of caregiving/domestic tasks
time frame: ~5 years post intervention
description: Question about how caregiving is distributed in the wake of Covid-19
measure: Couple communication
time frame: ~5 years post intervention
description: Frequency of couple communication in the wake of Covid-19
measure: Couple conflict
time frame: ~5 years post intervention
description: Frequency of couple quarreling in the wake of Covid-19
measure: Men's alcohol use
time frame: ~5 years post intervention
description: Frequency of men's alcohol use in the wake of Covid-19
measure: Household economic situation
time frame: ~5 years post intervention
description: Changes in household economic situation in the wake of Covid-19
measure: Stress and frustration
time frame: ~5 years post intervention
description: Feelings of stress and frustration in the wake of Covid-19
arm group label: Intervention
arm group type: Experimental
description: See intervention description
arm group label: Control
arm group type: No Intervention
description: Participants who were randomized into the control arm were and will be surveyed at the same time point as intervention participants, but did not receive any intervention.
intervention type: Behavioral
intervention name: MenCare+/Bandebereho fathers'/couples' group education
description: MenCare+/Bandebereho is a 3 year project to engage men in maternal, newborn and child health (MNCH) and in sexual and reproductive health in Rwanda. A core component of the project is fathers'/couples' group education. The target participants were first-time parents or parents of young children living in 16 rural and semi-urban sectors selected by the implementing partner in collaboration with local authorities. The MenCare+/Bandebereho fathers'/couples' group education engages men in 15 weekly sessions of group discussion, critical reflection and interactive activities led by a trained facilitator using a curriculum developed by RWAMREC and Promundo and approved by the Rwandan Ministry of Health, adapted from the Program P Manual. Men's partners participate in 6-8 sessions. The sessions focus on men's role in MNCH, family planning, sharing household responsibilities, intimate partner violence, conflict resolution, family budgeting, and gender equality.
arm group label: Intervention
other name: Program P
criteria: 
gender: All
minimum age: 26 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kate E Doyle, MA
role: Principal Investigator
affiliation: Promundo-US
last name: Ruti G Levtov, PhD
role: Principal Investigator
affiliation: Promundo-US
last name: Felix Sayingoza, MD, MSc
role: Principal Investigator
affiliation: Ministry of Health/Rwanda Biomedical Center
last name: Fidele Rutayisire, MA
role: Principal Investigator
affiliation: Rwanda Men's Resource Center
last name: Shamsi Kazimbaya, MA
role: Principal Investigator
affiliation: Promundo-US
facility: 
country: Rwanda
citation: Doyle K, Levtov RG, Barker G, Bastian GG, Bingenheimer JB, Kazimbaya S, Nzabonimpa A, Pulerwitz J, Sayinzoga F, Sharma V, Shattuck D. Gender-transformative Bandebereho couples' intervention to promote male engagement in reproductive and maternal health and violence prevention in Rwanda: Findings from a randomized controlled trial. PLoS One. 2018 Apr 4;13(4):e0192756. doi: 10.1371/journal.pone.0192756. eCollection 2018.
PMID: 29617375
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No