<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/NCT01711411</url>
  </required_header>
  <id_info>
    <org_study_id>10376</org_study_id>
    <nct_id>NCT01711411</nct_id>
  </id_info>
  <brief_title>Observational Study of Male Circumcision Using PrePex Device</brief_title>
  <official_title>Prospective Observational Study of Male Circumcision Using the PrePex Device in Routine Clinical Settings in Kenya</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>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kenyan MOH, Kenyan Natinal AIDS and STI Control Programme(NASCOP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nyanza Reproductive Health Society</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 study will measure the incidence of moderate and severe adverse events (AEs) associated&#xD;
      with PrePex procedures, including both procedural and post-procedure events, and all&#xD;
      device-related incidents such as dislodgment. To assure complete ascertainment of AEs,&#xD;
      study-specific forms will be used to collect standardized data from the circumcision visit&#xD;
      and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and will&#xD;
      revert to routine practice (two follow-up visits) for the remaining 375 cases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and&#xD;
      other global reproductive health organizations have recognized the protective effect of male&#xD;
      circumcision in HIV acquisition. Male Circumcision (MC) is one of the few biomedical methods&#xD;
      to demonstrate consistent effectiveness as an HIV prevention intervention in randomized&#xD;
      controlled trials: three randomized controlled trials (RCTs) in Kenya, Uganda, and South&#xD;
      Africa reported a protective effect up to 60% of circumcision against HIV infection.&#xD;
      Subsequent studies have confirmed the value and persistence of MC's protection against HIV&#xD;
      infection, and have demonstrated that MC also reduces the acquisition and transmission of&#xD;
      human papillomavirus.&#xD;
&#xD;
      A wide variety of instruments, devices, and techniques are used around the world for male&#xD;
      circumcision. In 2008, WHO, UNAIDS and JHPIEGO released a draft document entitled Manual for&#xD;
      Male Circumcision under Local Anesthesia, which includes step-by-step instructions for&#xD;
      performing adult male circumcision using three different surgical procedures: the&#xD;
      forceps-guided, dorsal slit, and sleeve resection methods. Procedure times for these&#xD;
      techniques are approximately 20-30 minutes excluding anesthesia, involve control of bleeding&#xD;
      and considerable suturing, and can be associated with a variety of complications.&#xD;
&#xD;
      Yet the demand for MC even in non-circumcising communities is substantial when offered at no&#xD;
      cost in a safe setting. Following Kenyan support of one of the key research studies&#xD;
      demonstrating the preventive effectiveness of MC, the Kenyan Ministry of Health (MOH) began a&#xD;
      national voluntary medical male circumcision (VMMC) program in 2008, based on a National&#xD;
      Guidance document. MC activities in Kenya have been centered in Nyanza Province, where the&#xD;
      prevalence of circumcision is about 50% compared to about 90% in the rest of the country.&#xD;
      Based on WHO statistics, Kenya is the African country that has made the most progress in&#xD;
      implementing large-scale MC activities: to date, there have been over 400,000 VMMC procedures&#xD;
      in Kenya.&#xD;
&#xD;
      In the current African setting, only surgical circumcision is available for most adults.&#xD;
      Recently, devices have been developed that have the potential to simplify and shorten both&#xD;
      training time and surgical duration by eliminating the need for suturing and hemostasis as&#xD;
      well as allow for task-shifting to lower level cadres of providers. Small-scale safety&#xD;
      studies, RCTs, and field demonstration cohort studies are required before the safety,&#xD;
      effectiveness, acceptability and feasibility of any device is assured.&#xD;
&#xD;
      This is a prospective observational study of the PrePex male circumcision device, which will&#xD;
      be conducted with the aims of ascertaining important adverse events or unexpected side&#xD;
      effects that may not have been observed in other studies. This study will be conducted within&#xD;
      a routine service delivery system to identify potential issues that must be addressed as MC&#xD;
      services are scaled up in a variety of Kenyan settings. PrePex circumcision procedures will&#xD;
      be offered in VMMC services, part of the minimum package of HIV prevention services&#xD;
      recommended by the Kenyan MOH, including HIV testing and counseling, exclusion of men with&#xD;
      symptomatic sexually transmitted infection (STI) and provision of syndromic treatment as&#xD;
      indicated, provision and promotion of condoms, and counseling on risk-reduction and safer&#xD;
      sex.&#xD;
&#xD;
      This study is a prospective observational study of adult male circumcision procedures with&#xD;
      PrePex in sites in Nyanza Province, Kenya. We will enroll a total of 425 men aged 18 to 49&#xD;
      who seek voluntary medical male circumcision. The first 50 men will undergo intensive&#xD;
      follow-up with multiple follow-up visits, per secondary objective 2 above. The remaining 375&#xD;
      men will be scheduled for two follow-up visits at 7 and 42 days after PrePex placement, per&#xD;
      standard practice in Kenyan MC service delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>The incidence of moderate and severe adverse events (AEs) associated with PrePex procedures, including both procedural and post-procedure events, and all device-related incidents such as dislodgment.</measure>
    <time_frame>42 days</time_frame>
    <description>Number of participants with adverse events as a measure of safety, pain as measured by Visual Analogue Scale (VAS), and life table analysis of time to complete wound healing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of PrePex procedures among Kenyan clients</measure>
    <time_frame>42 days</time_frame>
    <description>Quality of life and satisfaction questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of PrePex procedures among Kenyan male circumcision providers</measure>
    <time_frame>42 days</time_frame>
    <description>MC provider questionnaires assessing ease and duration of procedures, problems encountered during procedures and post-procedure care, and opinions of PrePex compared to the forceps-guided method or other circumcision methods with which the providers are familiar</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of men ineligible for circumcision with PrePex</measure>
    <time_frame>42 days</time_frame>
    <description>Proportion of men presenting for MC who are excluded due to tight foreskin, frank phimosis or other criteria</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of men who do not return for removal at 7 days, and the level of effort needed for their active follow-up as well as their outcomes</measure>
    <time_frame>42 days</time_frame>
    <description>Proportion of men who do not return at 7 days and require active follow-up, as well as outcomes among men who do not return for scheduled removal and efforts required for active follow-up</description>
  </other_outcome>
  <other_outcome>
    <measure>Costs of PrePex training and service delivery</measure>
    <time_frame>42 days</time_frame>
    <description>Costs of training and service delivery including human resources (number and cadre of operators required), and materials and supplies</description>
  </other_outcome>
  <enrollment type="Actual">427</enrollment>
  <condition>HIV</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PrePex device for male circumcision</intervention_name>
    <description>PrePex is a sterile device for adult male circumcision, consisting of an inner ring, elastic ring, placement ring, and verification thread. Proper sizing is facilitated by a sizing accessory. The elastic ring is loaded on to the placement ring, which is then placed at the base of the penis. The inner ring is placed inside the foreskin. The elastic ring is then deployed around the foreskin, clamping the foreskin against the inner ring. PrePex is manufactured by Circ MedTech Limited, is certified CE - Class IIa in the European Union, and has been approved by the U.S. Food and Drug Administration.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men aged 18-49 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Must be aged 18 to 49 years&#xD;
&#xD;
               -  Must be uncircumcised (on examination)&#xD;
&#xD;
               -  Must be in good general health&#xD;
&#xD;
               -  Must agree to voluntary counseling and testing for HIV, or have documentation of&#xD;
                  testing no more than one week before the MC visit&#xD;
&#xD;
               -  Must be HIV-uninfected&#xD;
&#xD;
               -  Must be free of genital ulcerations or other visible signs of STI (on&#xD;
                  examination)&#xD;
&#xD;
               -  Must be able to understand study procedures and the requirements of study&#xD;
                  participation&#xD;
&#xD;
               -  Must agree to return to the healthcare facility for the full schedule of&#xD;
                  follow-up visits after his circumcision or be willing to receive a home visit&#xD;
&#xD;
               -  Must freely consent to participate in the study and sign a written informed&#xD;
                  consent form&#xD;
&#xD;
               -  Must have a cell phone or access to a cell phone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Penis does not fit any of the five PrePex sizes&#xD;
&#xD;
               -  Takes a medication that would be a contraindication for elective surgery, such as&#xD;
                  an anticoagulant or steroid&#xD;
&#xD;
               -  Has known bleeding/clotting disorder (e.g. hemophilia)&#xD;
&#xD;
               -  Has an active genital infection, anatomic abnormality (e.g. phimosis or&#xD;
                  hypospadias) or other disease or condition (e.g. extreme obesity, poorly&#xD;
                  controlled diabetes, sickle cell anemia, AIDS-like signs or symptoms) which in&#xD;
                  the investigator's opinion contraindicates MC or participation in the study&#xD;
&#xD;
               -  Is participating in another longitudinal biomedical research study.&#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>Paul Feldblum, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>FHI 360</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nyanza Reproductive Health Society</name>
      <address>
        <city>Kisumu</city>
        <state>Nyanza</state>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>November 25, 2013</last_update_submitted>
  <last_update_submitted_qc>November 25, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV prevention</keyword>
  <keyword>PrePex</keyword>
  <keyword>voluntary medical male circumcision</keyword>
  <keyword>non-surgical</keyword>
  <keyword>medical device</keyword>
  <keyword>wound healing</keyword>
  <keyword>Kenya</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/NCT01711411
org study id: 10376
nct id: NCT01711411
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The study will measure the incidence of moderate and severe adverse events (AEs) associated
      with PrePex procedures, including both procedural and post-procedure events, and all
      device-related incidents such as dislodgment. To assure complete ascertainment of AEs,
      study-specific forms will be used to collect standardized data from the circumcision visit
      and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and will
      revert to routine practice (two follow-up visits) for the remaining 375 cases.
The World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and
      other global reproductive health organizations have recognized the protective effect of male
      circumcision in HIV acquisition. Male Circumcision (MC) is one of the few biomedical methods
      to demonstrate consistent effectiveness as an HIV prevention intervention in randomized
      controlled trials: three randomized controlled trials (RCTs) in Kenya, Uganda, and South
      Africa reported a protective effect up to 60% of circumcision against HIV infection.
      Subsequent studies have confirmed the value and persistence of MC's protection against HIV
      infection, and have demonstrated that MC also reduces the acquisition and transmission of
      human papillomavirus.

      A wide variety of instruments, devices, and techniques are used around the world for male
      circumcision. In 2008, WHO, UNAIDS and JHPIEGO released a draft document entitled Manual for
      Male Circumcision under Local Anesthesia, which includes step-by-step instructions for
      performing adult male circumcision using three different surgical procedures: the
      forceps-guided, dorsal slit, and sleeve resection methods. Procedure times for these
      techniques are approximately 20-30 minutes excluding anesthesia, involve control of bleeding
      and considerable suturing, and can be associated with a variety of complications.

      Yet the demand for MC even in non-circumcising communities is substantial when offered at no
      cost in a safe setting. Following Kenyan support of one of the key research studies
      demonstrating the preventive effectiveness of MC, the Kenyan Ministry of Health (MOH) began a
      national voluntary medical male circumcision (VMMC) program in 2008, based on a National
      Guidance document. MC activities in Kenya have been centered in Nyanza Province, where the
      prevalence of circumcision is about 50% compared to about 90% in the rest of the country.
      Based on WHO statistics, Kenya is the African country that has made the most progress in
      implementing large-scale MC activities: to date, there have been over 400,000 VMMC procedures
      in Kenya.

      In the current African setting, only surgical circumcision is available for most adults.
      Recently, devices have been developed that have the potential to simplify and shorten both
      training time and surgical duration by eliminating the need for suturing and hemostasis as
      well as allow for task-shifting to lower level cadres of providers. Small-scale safety
      studies, RCTs, and field demonstration cohort studies are required before the safety,
      effectiveness, acceptability and feasibility of any device is assured.

      This is a prospective observational study of the PrePex male circumcision device, which will
      be conducted with the aims of ascertaining important adverse events or unexpected side
      effects that may not have been observed in other studies. This study will be conducted within
      a routine service delivery system to identify potential issues that must be addressed as MC
      services are scaled up in a variety of Kenyan settings. PrePex circumcision procedures will
      be offered in VMMC services, part of the minimum package of HIV prevention services
      recommended by the Kenyan MOH, including HIV testing and counseling, exclusion of men with
      symptomatic sexually transmitted infection (STI) and provision of syndromic treatment as
      indicated, provision and promotion of condoms, and counseling on risk-reduction and safer
      sex.

      This study is a prospective observational study of adult male circumcision procedures with
      PrePex in sites in Nyanza Province, Kenya. We will enroll a total of 425 men aged 18 to 49
      who seek voluntary medical male circumcision. The first 50 men will undergo intensive
      follow-up with multiple follow-up visits, per secondary objective 2 above. The remaining 375
      men will be scheduled for two follow-up visits at 7 and 42 days after PrePex placement, per
      standard practice in Kenyan MC service delivery.
measure: The incidence of moderate and severe adverse events (AEs) associated with PrePex procedures, including both procedural and post-procedure events, and all device-related incidents such as dislodgment.
time frame: 42 days
description: Number of participants with adverse events as a measure of safety, pain as measured by Visual Analogue Scale (VAS), and life table analysis of time to complete wound healing
measure: Acceptability of PrePex procedures among Kenyan clients
time frame: 42 days
description: Quality of life and satisfaction questionnaires
measure: Acceptability of PrePex procedures among Kenyan male circumcision providers
time frame: 42 days
description: MC provider questionnaires assessing ease and duration of procedures, problems encountered during procedures and post-procedure care, and opinions of PrePex compared to the forceps-guided method or other circumcision methods with which the providers are familiar
measure: Proportion of men ineligible for circumcision with PrePex
time frame: 42 days
description: Proportion of men presenting for MC who are excluded due to tight foreskin, frank phimosis or other criteria
measure: Proportion of men who do not return for removal at 7 days, and the level of effort needed for their active follow-up as well as their outcomes
time frame: 42 days
description: Proportion of men who do not return at 7 days and require active follow-up, as well as outcomes among men who do not return for scheduled removal and efforts required for active follow-up
measure: Costs of PrePex training and service delivery
time frame: 42 days
description: Costs of training and service delivery including human resources (number and cadre of operators required), and materials and supplies
intervention type: Device
intervention name: PrePex device for male circumcision
description: PrePex is a sterile device for adult male circumcision, consisting of an inner ring, elastic ring, placement ring, and verification thread. Proper sizing is facilitated by a sizing accessory. The elastic ring is loaded on to the placement ring, which is then placed at the base of the penis. The inner ring is placed inside the foreskin. The elastic ring is then deployed around the foreskin, clamping the foreskin against the inner ring. PrePex is manufactured by Circ MedTech Limited, is certified CE - Class IIa in the European Union, and has been approved by the U.S. Food and Drug Administration.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paul Feldblum, PhD
role: Principal Investigator
affiliation: FHI 360
facility: 
country: Kenya
country: United States
responsible party type: Sponsor