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/NCT05973890</url>
    </required_header>
    <id_info>
      <org_study_id>b07</org_study_id>
      <secondary_id>UG3HL151599</secondary_id>
      <nct_id>NCT05973890</nct_id>
    </id_info>
    <brief_title>Community-based Communication for Blood Donation in Ghana</brief_title>
    <acronym>C-CAD</acronym>
    <official_title>Community-based Communication Interventions for Increasing Repeat Donation Among First- Time Blood Donors in Ghana: A Pragmatic Type 1 Effectiveness- Implementation Hybrid Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Minnesota</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Blood Service Ghana</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Ghana, College of Health Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Syracuse University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Liverpool School of Tropical Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Minnesota, Coordinating Centers for Biometric Research</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Minnesota</source>
    <oversight_info>
      <has_dmc>Yes</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>
        A randomized controlled trial to evaluate the effectiveness of the WhatsApp groups or&#xD;
        docudrama compared to a control group (usual engagement with blood services) on repeat blood&#xD;
        donation attempts among first-time blood donors in Ghana. Secondary outcomes will be blood&#xD;
        donor retention, blood donation knowledge, attitudes, beliefs, motivations, intention to&#xD;
        donate, and relatedness as potential mediators of blood donation behavior among first-time&#xD;
        blood donors. The RCT will have three arms: 1. WhatsApp; 2. docudrama; 3. control. Each&#xD;
        participant in the WhatsApp and docudrama arms will receive the intervention for 14 months.&#xD;
        Participants in the control arm will receive standard national blood donation communications&#xD;
        and be followed for 14 months. Actualized blood donation is possible every four months using&#xD;
        NBSG guidelines; consequently, participants may make multiple blood donation attempts. Return&#xD;
        blood donation attempts will be evaluated using the Southern Zonal Blood Center (SZBC)&#xD;
        records (primary outcome) and participant self-report (secondary outcome) at 7 months and 14&#xD;
        months. Secondary measures will be evaluated at baseline, 7 and 14 months from enrollment.&#xD;
        The duration of the RCT will be 26 months allowing for 12 months to achieve enrollment goals&#xD;
        and 14 months of follow-up for the last individual enrolled.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2024</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>parallel 3 arm randomized controlled study with equal allocation</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Repeat donation attempt</measure>
      <time_frame>14 months</time_frame>
      <description>The primary outcome for the RCT will be the number of blood donation attempts</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">882</enrollment>
    <condition>Increase Repeat Blood Donation Attempts Among First-time Donors</condition>
    <arm_group>
      <arm_group_label>WhatsApp</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants assigned to the WhatsApp arm will receive messages, audios, images and videos in a moderated, closed WhatsApp group over a 14-month duration. The messages aim to motivate blood donation, encourage participants to discuss their blood donation experiences, and allow them to share their motivations for donating blood.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>docudrama</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized to this arm will meet three times (Month 2; Month 5 and Month 10), in a group setting, during the intervention. Each group will have a maximum of 20-40 participants. This is a stand-alone activity, which is not associated with a donation event. During each meeting, participants will be asked to watch, in the group setting, an episode of drama, lasting 15 minutes. The docudrama on blood donation will address participant's concerns regarding blood donation and address common donor fears.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>standard of care for repeat blood donation</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>WhatsApp</intervention_name>
      <description>Participants assigned to the WhatsApp arm will receive messages, audios, images and videos in a moderated, closed WhatsApp group over a 14-month duration. The messages aim to motivate blood donation, encourage participants to discuss their blood donation experiences, and allow them to share their motivations for donating blood.</description>
      <arm_group_label>WhatsApp</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>docudrama</intervention_name>
      <description>Participants randomized to this arm will meet three times (Month 2; Month 5 and Month 10), in a group setting, during the intervention. Each group will have a maximum of 20-40 participants. This is a stand-alone activity, which is not associated with a donation event. During each meeting, participants will be asked to watch, in the group setting, an episode of drama, lasting 15 minutes. The docudrama on blood donation will address participant's concerns regarding blood donation and address common donor fears.</description>
      <arm_group_label>docudrama</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least 18 years-old&#xD;
  &#xD;
            -  First-time whole blood donor with the SZBC of the NBSG&#xD;
  &#xD;
            -  Eligible to donate again at the time of eligibility confirmation&#xD;
  &#xD;
            -  Consent to participate&#xD;
  &#xD;
            -  Understands one of English, Twi, or Ga&#xD;
  &#xD;
            -  Have a smart phone&#xD;
  &#xD;
            -  Have, or be willing to sign up for an active WhatsApp account&#xD;
  &#xD;
            -  Be willing to watch a docudrama on blood donation in a group setting&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of more than one lifetime whole blood donation (with any blood center)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Susan E Telke, MS</last_name>
      <phone>6125902697</phone>
      <email>telke001@umn.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The BLOODSAFE project is committed to quickly sharing results and data. Papers will be submitted summarizing the primary results of the BLOODSAFE studies once the analysis is complete. These results will be published in major scientific journals and presented at scientific meetings.</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/NCT05973890
  org study id: b07
  secondary id: UG3HL151599
  nct id: NCT05973890
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A randomized controlled trial to evaluate the effectiveness of the WhatsApp groups or
        docudrama compared to a control group (usual engagement with blood services) on repeat blood
        donation attempts among first-time blood donors in Ghana. Secondary outcomes will be blood
        donor retention, blood donation knowledge, attitudes, beliefs, motivations, intention to
        donate, and relatedness as potential mediators of blood donation behavior among first-time
        blood donors. The RCT will have three arms: 1. WhatsApp; 2. docudrama; 3. control. Each
        participant in the WhatsApp and docudrama arms will receive the intervention for 14 months.
        Participants in the control arm will receive standard national blood donation communications
        and be followed for 14 months. Actualized blood donation is possible every four months using
        NBSG guidelines; consequently, participants may make multiple blood donation attempts. Return
        blood donation attempts will be evaluated using the Southern Zonal Blood Center (SZBC)
        records (primary outcome) and participant self-report (secondary outcome) at 7 months and 14
        months. Secondary measures will be evaluated at baseline, 7 and 14 months from enrollment.
        The duration of the RCT will be 26 months allowing for 12 months to achieve enrollment goals
        and 14 months of follow-up for the last individual enrolled.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: parallel 3 arm randomized controlled study with equal allocation
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Repeat donation attempt
  time frame: 14 months
  description: The primary outcome for the RCT will be the number of blood donation attempts
  arm group label: WhatsApp
  arm group type: Experimental
  description: Participants assigned to the WhatsApp arm will receive messages, audios, images and videos in a moderated, closed WhatsApp group over a 14-month duration. The messages aim to motivate blood donation, encourage participants to discuss their blood donation experiences, and allow them to share their motivations for donating blood.
  arm group label: docudrama
  arm group type: Experimental
  description: Participants randomized to this arm will meet three times (Month 2; Month 5 and Month 10), in a group setting, during the intervention. Each group will have a maximum of 20-40 participants. This is a stand-alone activity, which is not associated with a donation event. During each meeting, participants will be asked to watch, in the group setting, an episode of drama, lasting 15 minutes. The docudrama on blood donation will address participant's concerns regarding blood donation and address common donor fears.
  arm group label: control
  arm group type: No Intervention
  description: standard of care for repeat blood donation
  intervention type: Behavioral
  intervention name: WhatsApp
  description: Participants assigned to the WhatsApp arm will receive messages, audios, images and videos in a moderated, closed WhatsApp group over a 14-month duration. The messages aim to motivate blood donation, encourage participants to discuss their blood donation experiences, and allow them to share their motivations for donating blood.
  arm group label: WhatsApp
  intervention type: Behavioral
  intervention name: docudrama
  description: Participants randomized to this arm will meet three times (Month 2; Month 5 and Month 10), in a group setting, during the intervention. Each group will have a maximum of 20-40 participants. This is a stand-alone activity, which is not associated with a donation event. During each meeting, participants will be asked to watch, in the group setting, an episode of drama, lasting 15 minutes. The docudrama on blood donation will address participant's concerns regarding blood donation and address common donor fears.
  arm group label: docudrama
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Susan E Telke, MS
  phone: 6125902697
  email: telke001@umn.edu
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: The BLOODSAFE project is committed to quickly sharing results and data. Papers will be submitted summarizing the primary results of the BLOODSAFE studies once the analysis is complete. These results will be published in major scientific journals and presented at scientific meetings.