xml: <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/NCT06013787</url>
    </required_header>
    <id_info>
      <org_study_id>0000065203</org_study_id>
      <nct_id>NCT06013787</nct_id>
    </id_info>
    <brief_title>&quot;Nuestras Historias&quot;: Evaluating the Impact of Community-Created Digital Stories on Pre- and Perinatal Health Motivation in the Peruvian Amazon</brief_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Peruana Cayetano Heredia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universidad Peruana Cayetano Heredia</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>
        &quot;Nuestras Historias&quot; curriculum is a tablet-based digital story curriculum that was created&#xD;
        through community-based participatory methods. It uses narrative videos to teach about local&#xD;
        prenatal health issues in the Parinari District of Peru. This study aims to assess the impact&#xD;
        of &quot;Nuestras Historias&quot; on pregnant women and their partners by measuring participants'&#xD;
        changes in prenatal health knowledge, attitudes and behavioral intentions for pregnancy and&#xD;
        birth after exposure to the curriculum. The study uses a cluster-randomized design, in which&#xD;
        communities were match-paired and then randomized for pregnant women/partners to receive the&#xD;
        &quot;Nuestras Historias&quot; curriculum vs. standard prenatal health teaching, delivered by local&#xD;
        community health workers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background and Study Setting:&#xD;
  &#xD;
        Parinari is a district in the Loreto region that has 30 communities with approximately 7264&#xD;
        people. The communities are very dispersed and only accessible by river. Inhabitants of this&#xD;
        district do not have access to running water, electricity or sanitation and the majority live&#xD;
        in poverty. Our study takes place in the 13 communities of Parinari where the Mama River&#xD;
        project operated. Mama River selects community health workers (CHWs) who are able to use&#xD;
        smartphones in these communities and trains them on the use of smartphones to collect&#xD;
        information of new pregnancies, deliveries, alarms signs or deaths of pregnant women or&#xD;
        newborns. CHWs then send this information via mobile phone to local health care providers.&#xD;
        CHWs are also all trained in the delivery of verbal MCH educational messages to pregnant&#xD;
        women, and perform home visits and group visits throughout pregnancies.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        Twelve communities (6 intervention, 6 control) were recruited and after a final evaluation we&#xD;
        excluded two communities, as one had no pregnant women at time of study initiation. The&#xD;
        remaining communities were divided into 5 pairs, where the two within the pair were similar&#xD;
        in terms of overall population, distance from a health center, and number of pregnant women.&#xD;
        One community in each pair was randomly assigned to the intervention group received the Mama&#xD;
        River programming along with the digital story curriculum, and the other community to the&#xD;
        control group, which received only the standard existing program with no digital stories.&#xD;
  &#xD;
        The community agents in the five communities selected for the intervention received training&#xD;
        on how to use and show the digital stories on solar-powered tablets.&#xD;
  &#xD;
        During the recruitment phase, all pregnant women identified by Mama River were recruited into&#xD;
        the trial, with an effort to also recruit their partners. All trial participants signed an&#xD;
        informed consent prior to participating, and then completed the pre-intervention survey&#xD;
        instrument that measured prenatal health knowledge, attitudes, and behavioral intentions for&#xD;
        pregnancy and birth.&#xD;
  &#xD;
        Then, in the intervention communities, the participants received home visits and attended&#xD;
        group meetings with the community agent in which the digital story curriculum was shown and&#xD;
        discussed. In the control communities, participants also received home visits and attended&#xD;
        group meetings, but the community agents carried on their standard of practice without the&#xD;
        digital stories.&#xD;
  &#xD;
        One month after completing the pre-survey, participants completed a post-survey. Those in the&#xD;
        intervention group had a slightly longer survey including a short quantitative questions&#xD;
        regarding their reactions to the digital stories.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 10, 2016</start_date>
    <completion_date type="Actual">April 3, 2018</completion_date>
    <primary_completion_date type="Actual">May 21, 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>
      <intervention_model_description>Cluster-matched randomized trial, by community, with 5 intervention communities and 5 control communities</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Participants were made aware through the informed consent that 1/2 of the communities would be receiving a video intervention. Care providers (community health workers who delivered the video intervention) were trained in it so were not blinded. Outcomes assessor was investigator</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Prenatal Health Knowledge Change</measure>
      <time_frame>Pre and post one month intervention</time_frame>
      <description>Change in understanding of basic prenatal health information covered in curriculum, measured using our study's survey tool, which included knowledge questions from several validated studies and from the Peruvian government's manual for community health agents, total possible score of 45</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prenatal Health Attitude Change</measure>
      <time_frame>Pre and post one month intervention</time_frame>
      <description>Change in attitudes towards local issues associated with pregnancy, measured via our study's survey tool with tailored questions to topics that are covered in the curriculum (adolescent pregnancy, domestic violence), and a previously validated measure on locus of control, total possible score of 8</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Behavioral Intentions</measure>
      <time_frame>Pre and post one month intervention</time_frame>
      <description>Change in reported behavioral intentions for practices during pregnancy and at time of birth, measure via our study's survey tool, with a series of questions about the expected birth plan based on the Peruvian government's community agent guide and some video-specific questions, total possible score of 6</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">26</enrollment>
    <condition>Health Knowledge, Attitudes, Practice</condition>
    <condition>Maternal Behavior</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the communities randomized into the intervention arm, the pregnant women who enrolled in the study received a month long prenatal health education intervention called &quot;Nuestras Historias&quot;, a digital story curriculum. This video-based curriculum was delivered by by community health workers during their normal home visits and group visits.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>In the communities randomized to the control arm, the pregnant women who enrolled in study had normal visits and group visits with community health workers and received standard prenatal health education, but with no video intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>&quot;Nuestras Historias&quot;</intervention_name>
      <description>&quot;Nuestras Historias&quot; is a digital story curriculum that is displayed on a small solar-powered tablet. The curriculum is a collection of 7 digital stories used to discuss health issues during pregnancy that the community identified as important. The digital stories are short videos that combine local photos and local voices sharing real-life narratives about experiences during pregnancy. The videos were made in collaboration with community health workers and local mothers.</description>
      <arm_group_label>Intervention Group</arm_group_label>
      <other_name>A Digital Story Curriculum on Prenatal Health</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All female participants had to be confirmed pregnancies, living permanently within the&#xD;
               selected communities of the Parinari District, and age 18 or older&#xD;
  &#xD;
            -  All male participants had to be partners of women who were confirmed to be pregnant,&#xD;
               living permanently within the selected communities of the Parinari District, and age&#xD;
               18 or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants were excluded if not pregnant, if not living in the correct communities&#xD;
               or likely to travel away within the study time frame, or if did not consent to the&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</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>Neha Limaye, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fellow at UPCH and UW</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Universidad Peruana Cayetano Heredia</name>
        <address>
          <city>Lima</city>
          <country>Peru</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Peru</country>
    </location_countries>
    <verification_date>August 2018</verification_date>
    <study_first_submitted>October 17, 2018</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Community-based participatory research</keyword>
    <keyword>Digital storytelling</keyword>
    <keyword>Maternal child health</keyword>
    <keyword>Community health workers</keyword>
    <keyword>Behavior change communication</keyword>
    <keyword>Low-resource settings</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>At present, all data is securely stored. If study is published, de-identified data will be made available via a secure sharing method.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013787
  org study id: 0000065203
  nct id: NCT06013787
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  "Nuestras Historias" curriculum is a tablet-based digital story curriculum that was created
        through community-based participatory methods. It uses narrative videos to teach about local
        prenatal health issues in the Parinari District of Peru. This study aims to assess the impact
        of "Nuestras Historias" on pregnant women and their partners by measuring participants'
        changes in prenatal health knowledge, attitudes and behavioral intentions for pregnancy and
        birth after exposure to the curriculum. The study uses a cluster-randomized design, in which
        communities were match-paired and then randomized for pregnant women/partners to receive the
        "Nuestras Historias" curriculum vs. standard prenatal health teaching, delivered by local
        community health workers.
  Background and Study Setting:
  
        Parinari is a district in the Loreto region that has 30 communities with approximately 7264
        people. The communities are very dispersed and only accessible by river. Inhabitants of this
        district do not have access to running water, electricity or sanitation and the majority live
        in poverty. Our study takes place in the 13 communities of Parinari where the Mama River
        project operated. Mama River selects community health workers (CHWs) who are able to use
        smartphones in these communities and trains them on the use of smartphones to collect
        information of new pregnancies, deliveries, alarms signs or deaths of pregnant women or
        newborns. CHWs then send this information via mobile phone to local health care providers.
        CHWs are also all trained in the delivery of verbal MCH educational messages to pregnant
        women, and perform home visits and group visits throughout pregnancies.
  
        Methods:
  
        Twelve communities (6 intervention, 6 control) were recruited and after a final evaluation we
        excluded two communities, as one had no pregnant women at time of study initiation. The
        remaining communities were divided into 5 pairs, where the two within the pair were similar
        in terms of overall population, distance from a health center, and number of pregnant women.
        One community in each pair was randomly assigned to the intervention group received the Mama
        River programming along with the digital story curriculum, and the other community to the
        control group, which received only the standard existing program with no digital stories.
  
        The community agents in the five communities selected for the intervention received training
        on how to use and show the digital stories on solar-powered tablets.
  
        During the recruitment phase, all pregnant women identified by Mama River were recruited into
        the trial, with an effort to also recruit their partners. All trial participants signed an
        informed consent prior to participating, and then completed the pre-intervention survey
        instrument that measured prenatal health knowledge, attitudes, and behavioral intentions for
        pregnancy and birth.
  
        Then, in the intervention communities, the participants received home visits and attended
        group meetings with the community agent in which the digital story curriculum was shown and
        discussed. In the control communities, participants also received home visits and attended
        group meetings, but the community agents carried on their standard of practice without the
        digital stories.
  
        One month after completing the pre-survey, participants completed a post-survey. Those in the
        intervention group had a slightly longer survey including a short quantitative questions
        regarding their reactions to the digital stories.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Cluster-matched randomized trial, by community, with 5 intervention communities and 5 control communities
  primary purpose: Prevention
  masking: None (Open Label)
  masking description: Participants were made aware through the informed consent that 1/2 of the communities would be receiving a video intervention. Care providers (community health workers who delivered the video intervention) were trained in it so were not blinded. Outcomes assessor was investigator
  measure: Prenatal Health Knowledge Change
  time frame: Pre and post one month intervention
  description: Change in understanding of basic prenatal health information covered in curriculum, measured using our study's survey tool, which included knowledge questions from several validated studies and from the Peruvian government's manual for community health agents, total possible score of 45
  measure: Prenatal Health Attitude Change
  time frame: Pre and post one month intervention
  description: Change in attitudes towards local issues associated with pregnancy, measured via our study's survey tool with tailored questions to topics that are covered in the curriculum (adolescent pregnancy, domestic violence), and a previously validated measure on locus of control, total possible score of 8
  measure: Change in Behavioral Intentions
  time frame: Pre and post one month intervention
  description: Change in reported behavioral intentions for practices during pregnancy and at time of birth, measure via our study's survey tool, with a series of questions about the expected birth plan based on the Peruvian government's community agent guide and some video-specific questions, total possible score of 6
  arm group label: Intervention Group
  arm group type: Experimental
  description: In the communities randomized into the intervention arm, the pregnant women who enrolled in the study received a month long prenatal health education intervention called "Nuestras Historias", a digital story curriculum. This video-based curriculum was delivered by by community health workers during their normal home visits and group visits.
  arm group label: Control Group
  arm group type: No Intervention
  description: In the communities randomized to the control arm, the pregnant women who enrolled in study had normal visits and group visits with community health workers and received standard prenatal health education, but with no video intervention.
  intervention type: Behavioral
  intervention name: "Nuestras Historias"
  description: "Nuestras Historias" is a digital story curriculum that is displayed on a small solar-powered tablet. The curriculum is a collection of 7 digital stories used to discuss health issues during pregnancy that the community identified as important. The digital stories are short videos that combine local photos and local voices sharing real-life narratives about experiences during pregnancy. The videos were made in collaboration with community health workers and local mothers.
  arm group label: Intervention Group
  other name: A Digital Story Curriculum on Prenatal Health
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Neha Limaye, MD
  role: Principal Investigator
  affiliation: Fellow at UPCH and UW
  facility: 
  country: Peru
  responsible party type: Sponsor
  sharing ipd: Undecided
  ipd description: At present, all data is securely stored. If study is published, de-identified data will be made available via a secure sharing method.