<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/NCT02242565</url>
  </required_header>
  <id_info>
    <org_study_id>576424</org_study_id>
    <secondary_id>010-04-14</secondary_id>
    <nct_id>NCT02242565</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia</brief_title>
  <official_title>Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FHI 360</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Zambia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>FHI 360</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to assess the safety, effectiveness and acceptability of&#xD;
      providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision&#xD;
      (VMMC) within routine service delivery in Lusaka, Zambia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years&#xD;
      at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs&#xD;
      Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter,&#xD;
      each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used&#xD;
      every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was&#xD;
      scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing&#xD;
      check visit (day 42 after placement), when they were evaluated for adverse events (AEs),&#xD;
      pain, and healing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.</measure>
    <time_frame>42 days</time_frame>
    <description>To assess the safety of ShangRing procedures when providers choose among 7 adult sizes (reduced-sizes or treatment arm) versus the full range of 14 adult sizes (all-sizes or control arm) during routine service delivery in Lusaka, Zambia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of men who cannot be properly fitted with a ShangRing device</measure>
    <time_frame>42 days</time_frame>
    <description>Assess the effectiveness of ShangRing procedures in the reduced-sizes arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the acceptability of ShangRing procedures among participants and providers</measure>
    <time_frame>42 days</time_frame>
    <description>Participant acceptability (with procedure and cosmetic appearance), pain, and time to return to normal activity after ShangRing circumcision, overall and in each arm.&#xD;
Provider acceptability assessing ease, duration, and complications, and preferences comparing ShangRing with other methods of circumcision, and comparing reduced-sizes with all-sizes provision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of men with complete healing at 42 days</measure>
    <time_frame>Day 42</time_frame>
    <description>Percentage of men with complete healing at 42 days for all study participants, and within each arm of the trial.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Male Circumcision</condition>
  <arm_group>
    <arm_group_label>Control: all-sizes of ShangRing</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All-sizes of ShangRings will be available.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reduced-sizes</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>7 adult sizes of ShangRings will be available</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ShangRing</intervention_name>
    <description>ShangRing device for male circumcision</description>
    <arm_group_label>Control: all-sizes of ShangRing</arm_group_label>
    <arm_group_label>Reduced-sizes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be aged 18 to 49 years;&#xD;
&#xD;
          -  Must be HIV-uninfected per same-day routine voluntary testing at the clinic;&#xD;
&#xD;
          -  Must be uncircumcised (on examination);&#xD;
&#xD;
          -  Must be in good general health, at the discretion of the clinician;&#xD;
&#xD;
          -  Must be free of genital ulcerations or other visible signs of STI (on examination);&#xD;
&#xD;
          -  Must be able to understand study procedures, and agree to abide by them including the&#xD;
             follow-up visit schedule;&#xD;
&#xD;
          -  Must freely consent to participate in the study and sign a written informed consent&#xD;
             form;&#xD;
&#xD;
          -  Must provide full contact information including cell phone number, address, and other&#xD;
             locator information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has an active genital infection upon visual inspection;&#xD;
&#xD;
          -  Has an anatomic abnormality (e.g. phimosis or hypospadias) that contraindicates&#xD;
             ShangRing MMC;&#xD;
&#xD;
          -  Takes a medication that would be a contraindication for elective surgery, such as an&#xD;
             anticoagulant or steroid; or&#xD;
&#xD;
          -  Has a self-reported medical condition that would be a contraindication for elective&#xD;
             surgery, e.g. hemophilia, extreme obesity, poorly controlled diabetes, sickle cell&#xD;
             anemia&#xD;
&#xD;
          -  Has a self-reported allergy or sensitivity to lidocaine or other local&#xD;
&#xD;
          -  Is not available to be circumcised on the same day as screening.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Zulu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Teaching Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Feldblum, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>FHI 360</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chilenje Urban Health Centre</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University Teaching Hospital (UTH)</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <results_reference>
    <citation>Feldblum PJ, Zulu R, Linyama D, Long S, Nonde TJ, Lai JJ, Kashitala J, Veena V, Kasonde P. Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes. J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S30-5. doi: 10.1097/QAI.0000000000001015.</citation>
    <PMID>27331587</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV prevention</keyword>
  <keyword>ShangRing</keyword>
  <keyword>adverse events</keyword>
  <keyword>wound healing</keyword>
  <keyword>voluntary medical male circumcision (VMMC)</keyword>
  <keyword>medical device</keyword>
  <keyword>Zambia</keyword>
  <!-- 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/NCT02242565
org study id: 576424
secondary id: 010-04-14
nct id: NCT02242565
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study was to assess the safety, effectiveness and acceptability of
      providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision
      (VMMC) within routine service delivery in Lusaka, Zambia.
We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years
      at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs
      Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter,
      each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used
      every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was
      scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing
      check visit (day 42 after placement), when they were evaluated for adverse events (AEs),
      pain, and healing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.
time frame: 42 days
description: To assess the safety of ShangRing procedures when providers choose among 7 adult sizes (reduced-sizes or treatment arm) versus the full range of 14 adult sizes (all-sizes or control arm) during routine service delivery in Lusaka, Zambia.
measure: Percentage of men who cannot be properly fitted with a ShangRing device
time frame: 42 days
description: Assess the effectiveness of ShangRing procedures in the reduced-sizes arm.
measure: Evaluate the acceptability of ShangRing procedures among participants and providers
time frame: 42 days
description: Participant acceptability (with procedure and cosmetic appearance), pain, and time to return to normal activity after ShangRing circumcision, overall and in each arm.
Provider acceptability assessing ease, duration, and complications, and preferences comparing ShangRing with other methods of circumcision, and comparing reduced-sizes with all-sizes provision.
measure: Percentage of men with complete healing at 42 days
time frame: Day 42
description: Percentage of men with complete healing at 42 days for all study participants, and within each arm of the trial.
arm group label: Control: all-sizes of ShangRing
arm group type: Other
description: All-sizes of ShangRings will be available.
arm group label: Reduced-sizes
arm group type: Active Comparator
description: 7 adult sizes of ShangRings will be available
intervention type: Device
intervention name: ShangRing
description: ShangRing device for male circumcision
arm group label: Control: all-sizes of ShangRing
arm group label: Reduced-sizes
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Zulu, MD
role: Principal Investigator
affiliation: University Teaching Hospital
last name: Paul Feldblum, PhD
role: Principal Investigator
affiliation: FHI 360
facility: 
facility: 
country: Zambia
citation: Feldblum PJ, Zulu R, Linyama D, Long S, Nonde TJ, Lai JJ, Kashitala J, Veena V, Kasonde P. Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes. J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S30-5. doi: 10.1097/QAI.0000000000001015.
PMID: 27331587
responsible party type: Sponsor