<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/NCT03761836</url>
  </required_header>
  <id_info>
    <org_study_id>JHSPH IRB 8231</org_study_id>
    <nct_id>NCT03761836</nct_id>
  </id_info>
  <brief_title>Evaluation and Adverse Event Surveillance for Initial Implementation of ShangRing Circumcision in Mozambique</brief_title>
  <official_title>Program Evaluation and Active Adverse Event Surveillance for Initial Implementation of WHO Prequalified ShangRing™ Circumcision in Mozambique</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>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-arm interventional study of 1000 male circumcision procedures using the&#xD;
      ShangRing device. The primary objective of the study is to enhance understanding of the&#xD;
      potential clinical and operational challenges and opportunities that may be associated with&#xD;
      widespread use of ShangRing™ device for circumcision in different settings in Mozambique.&#xD;
      Specific objectives are: 1) To monitor the proportion of men who choose circumcision through&#xD;
      the WHO-prequalified, FDA-approved ShangRing™ device in routine voluntary medical male&#xD;
      circumcision (VMMC) service delivery settings where standard surgical methods of&#xD;
      circumcisions are available; and 2) To ensure safety during initial implementation of the&#xD;
      ShangRing™ device and confirm that adverse event rates are comparable to those found during&#xD;
      implementation in other sub-Saharan countries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-arm interventional study of 1000 male circumcision procedures using the&#xD;
      ShangRing device. The primary objective of the study is to enhance understanding of the&#xD;
      potential clinical and operational challenges and opportunities that may be associated with&#xD;
      widespread use of ShangRing™ device for circumcision in different settings in Mozambique.&#xD;
      Specific objectives are:&#xD;
&#xD;
        1. To monitor the proportion of men who choose circumcision through the WHO-prequalified,&#xD;
           FDA-approved ShangRing™ device in routine voluntary medical male circumcision (VMMC)&#xD;
           service delivery settings where standard surgical methods of circumcisions are&#xD;
           available; and&#xD;
&#xD;
        2. To ensure safety during initial implementation of the ShangRing™ device and confirm that&#xD;
           adverse event rates are comparable to those found during implementation in other&#xD;
           sub-Saharan countries.&#xD;
&#xD;
      Population: 1000 males aged 13 years and above who are seeking male circumcision; 3 clinic&#xD;
      sites&#xD;
&#xD;
      Duration: Approximately 3 months of recruitment, 60 days follow-up per participant; total&#xD;
      duration expected to be approximately 6 months in the field.&#xD;
&#xD;
      Sample size: Cumulative target of 1000 ShangRing™ procedures, based on guidance contained in&#xD;
      the WHO Framework for clinical evaluation of devices for male circumcision. The WHO TAG on&#xD;
      Innovations in Male Circumcision recommends active follow-up of the first 1000 clients when a&#xD;
      new device is introduced into a program or as a new program is implemented.&#xD;
&#xD;
      Data analysis plan: Baseline demographic and behavioral characteristics of ShangRing™ clients&#xD;
      will be summarized using counts and percentages. Association between these variables and&#xD;
      selected outcome variables (e.g. AEs, failure to return for device removal, preference for&#xD;
      Shang Ring) will be examined through cross tabulations and tests of association (e.g. Chi&#xD;
      square statistics).&#xD;
&#xD;
      Data quality assurance: Data quality control efforts will include members of the national&#xD;
      VMMC Technical Working Group, including local ShangRing™ Trainers of Trainers, conducting&#xD;
      scheduled site assessments/monitoring as follows: Prior to the start of the active&#xD;
      surveillance (site initiation) using site assessment checklist; and every month using a VMMC&#xD;
      quality assessment checklist. There will be regular monthly supervision visits to the&#xD;
      facilities to ensure proper record filing and storage of physical forms. Data will be entered&#xD;
      into an electronic system by trained data personnel at the facility level. This data will be&#xD;
      reviewed actively and regularly through the central database on a periodic basis. The PI,&#xD;
      lead local investigator and co-investigators will regularly monitor and evaluate data for&#xD;
      completeness and specifically to monitor for any adverse events that may preclude or&#xD;
      terminate the study early. The electronic system will be monitored regularly and by limited&#xD;
      access of study personnel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding no longer available&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 1, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of ShangRing clients who experience moderate and severe adverse events</measure>
    <time_frame>60 days postoperative</time_frame>
    <description>Circumcision-related adverse events are classified as moderate and severe per standardized protocol definitions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of eligible men who chose ShangRing procedure</measure>
    <time_frame>Preoperative</time_frame>
    <description>ShangRing will be offered as a neutral alternative to conventional surgery or other available methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of ShangRing™ clients who fail to return for device removal on day 7</measure>
    <time_frame>7 days postoperative</time_frame>
    <description>Calculated by site and disaggregated by age group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores on Visual Analog Scale</measure>
    <time_frame>Within 48 hours postoperative</time_frame>
    <description>Peri- and post-operative pain scores as determined by visual analog scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Circumcision, Male</condition>
  <arm_group>
    <arm_group_label>ShangRing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Males aged 13 years and above will undergo circumcision through ShangRing procedure, with regular follow-up visits to evaluate pain, wound healing and incidence of adverse events. The ShangRing will be removed after 7 days, with a last follow-up visit at 60 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ShangRing</intervention_name>
    <description>The ShangRing™ is a device for male circumcision that was invented by Jian Zhong Shang and has been on the Chinese market since 2005. It consists of a sterile device with two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. It currently holds a European Conformity (CE) mark, an EN ISO certificate, and is FDA approved. Clinical data from ShangRing studies in Africa were reviewed by the WHO Technical Advisory Group (TAG) on Innovations in Male Circumcision in January 2013 and were found to meet its clinical requirements. The ShangRing manufacturer was accepted by the WHO Prequalification Programme for Male Circumcision Devices in 2015.</description>
    <arm_group_label>ShangRing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male, 13 years old and above&#xD;
&#xD;
          2. Agrees to return to the facility where circumcision procedure is done for device&#xD;
             removal on day 7 and to have home or off-site visits if deemed necessary by the&#xD;
             ShangRing™ providers&#xD;
&#xD;
          3. Is able and willing to provide a valid physical address of residence and at least one&#xD;
             alternate address (address of employer, school, or friend/relative) for tracing&#xD;
&#xD;
          4. Is able and willing to provide a valid primary phone number and at least one alternate&#xD;
             phone number (phone number of friend/relative) and agrees to be contacted via that&#xD;
             alternate number and person. This will facilitate telephone-based follow-up should he&#xD;
             not return for the scheduled post-removal follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Males below 13 years of age&#xD;
&#xD;
          2. Males for whom the correct fitting size of ShangRing™ Device is not available&#xD;
&#xD;
          3. Anatomical abnormalities including adhesions&#xD;
&#xD;
          4. Cognitive impairment&#xD;
&#xD;
          5. Any health condition (reported or observed) that ShangRing™ providers deem a&#xD;
             contraindication to the procedure. These may include history of diabetes, peripheral&#xD;
             vascular disease, cancer, bleeding disorders, and/or current moderate or severe&#xD;
             infectious illness&#xD;
&#xD;
          6. HIV - positive (although may still undergo surgical circumcision)&#xD;
&#xD;
          7. Anatomical variations and anomalies of genitalia&#xD;
&#xD;
          8. Hypospadias, epispadias, or other urethral anomaly&#xD;
&#xD;
          9. Hydrocele&#xD;
&#xD;
         10. Scrotal hernia&#xD;
&#xD;
         11. Other genital anomaly or disease including infectious or traumatic ulcers&#xD;
&#xD;
         12. Dermatitis of the penis or foreskin&#xD;
&#xD;
         13. Genital warts&#xD;
&#xD;
         14. Urethral discharge&#xD;
&#xD;
         15. Balanitis&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edgar Necochea, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jhpiego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Matola II Health Center</name>
      <address>
        <city>Matola</city>
        <state>Maputo</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>September 17 Health Center</name>
      <address>
        <city>Quelimane</city>
        <state>Zambezia</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infulene Psychiatric Hospital</name>
      <address>
        <city>Maputo</city>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mozambique</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>December 19, 2020</last_update_submitted>
  <last_update_submitted_qc>December 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</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/NCT03761836
org study id: JHSPH IRB 8231
nct id: NCT03761836
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a single-arm interventional study of 1000 male circumcision procedures using the
      ShangRing device. The primary objective of the study is to enhance understanding of the
      potential clinical and operational challenges and opportunities that may be associated with
      widespread use of ShangRing™ device for circumcision in different settings in Mozambique.
      Specific objectives are: 1) To monitor the proportion of men who choose circumcision through
      the WHO-prequalified, FDA-approved ShangRing™ device in routine voluntary medical male
      circumcision (VMMC) service delivery settings where standard surgical methods of
      circumcisions are available; and 2) To ensure safety during initial implementation of the
      ShangRing™ device and confirm that adverse event rates are comparable to those found during
      implementation in other sub-Saharan countries.
This is a single-arm interventional study of 1000 male circumcision procedures using the
      ShangRing device. The primary objective of the study is to enhance understanding of the
      potential clinical and operational challenges and opportunities that may be associated with
      widespread use of ShangRing™ device for circumcision in different settings in Mozambique.
      Specific objectives are:

        1. To monitor the proportion of men who choose circumcision through the WHO-prequalified,
           FDA-approved ShangRing™ device in routine voluntary medical male circumcision (VMMC)
           service delivery settings where standard surgical methods of circumcisions are
           available; and

        2. To ensure safety during initial implementation of the ShangRing™ device and confirm that
           adverse event rates are comparable to those found during implementation in other
           sub-Saharan countries.

      Population: 1000 males aged 13 years and above who are seeking male circumcision; 3 clinic
      sites

      Duration: Approximately 3 months of recruitment, 60 days follow-up per participant; total
      duration expected to be approximately 6 months in the field.

      Sample size: Cumulative target of 1000 ShangRing™ procedures, based on guidance contained in
      the WHO Framework for clinical evaluation of devices for male circumcision. The WHO TAG on
      Innovations in Male Circumcision recommends active follow-up of the first 1000 clients when a
      new device is introduced into a program or as a new program is implemented.

      Data analysis plan: Baseline demographic and behavioral characteristics of ShangRing™ clients
      will be summarized using counts and percentages. Association between these variables and
      selected outcome variables (e.g. AEs, failure to return for device removal, preference for
      Shang Ring) will be examined through cross tabulations and tests of association (e.g. Chi
      square statistics).

      Data quality assurance: Data quality control efforts will include members of the national
      VMMC Technical Working Group, including local ShangRing™ Trainers of Trainers, conducting
      scheduled site assessments/monitoring as follows: Prior to the start of the active
      surveillance (site initiation) using site assessment checklist; and every month using a VMMC
      quality assessment checklist. There will be regular monthly supervision visits to the
      facilities to ensure proper record filing and storage of physical forms. Data will be entered
      into an electronic system by trained data personnel at the facility level. This data will be
      reviewed actively and regularly through the central database on a periodic basis. The PI,
      lead local investigator and co-investigators will regularly monitor and evaluate data for
      completeness and specifically to monitor for any adverse events that may preclude or
      terminate the study early. The electronic system will be monitored regularly and by limited
      access of study personnel.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of ShangRing clients who experience moderate and severe adverse events
time frame: 60 days postoperative
description: Circumcision-related adverse events are classified as moderate and severe per standardized protocol definitions
measure: Proportion of eligible men who chose ShangRing procedure
time frame: Preoperative
description: ShangRing will be offered as a neutral alternative to conventional surgery or other available methods
measure: Proportion of ShangRing™ clients who fail to return for device removal on day 7
time frame: 7 days postoperative
description: Calculated by site and disaggregated by age group
measure: Pain scores on Visual Analog Scale
time frame: Within 48 hours postoperative
description: Peri- and post-operative pain scores as determined by visual analog scale
arm group label: ShangRing
arm group type: Experimental
description: Males aged 13 years and above will undergo circumcision through ShangRing procedure, with regular follow-up visits to evaluate pain, wound healing and incidence of adverse events. The ShangRing will be removed after 7 days, with a last follow-up visit at 60 days.
intervention type: Device
intervention name: ShangRing
description: The ShangRing™ is a device for male circumcision that was invented by Jian Zhong Shang and has been on the Chinese market since 2005. It consists of a sterile device with two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. It currently holds a European Conformity (CE) mark, an EN ISO certificate, and is FDA approved. Clinical data from ShangRing studies in Africa were reviewed by the WHO Technical Advisory Group (TAG) on Innovations in Male Circumcision in January 2013 and were found to meet its clinical requirements. The ShangRing manufacturer was accepted by the WHO Prequalification Programme for Male Circumcision Devices in 2015.
arm group label: ShangRing
criteria: 
gender: Male
minimum age: 13 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Edgar Necochea, MD, MPH
role: Principal Investigator
affiliation: Jhpiego
facility: 
facility: 
facility: 
country: Mozambique
responsible party type: Sponsor
sharing ipd: Undecided