<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/NCT01684358</url>
  </required_header>
  <id_info>
    <org_study_id>CDC-NCCDPHP-6163</org_study_id>
    <nct_id>NCT01684358</nct_id>
  </id_info>
  <brief_title>A Trial on the Effect of Sino-implant (II) Use on Condom Use Among Women in Kingston, Jamaica</brief_title>
  <acronym>SIS</acronym>
  <official_title>A Randomized Controlled Trial on the Effect of Sino-implant (II) Use on Condom Use Among Women in Kingston, Jamaica</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FHI 360</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Jamaica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of The West Indies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centers for Disease Control and Prevention</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This unblinded, randomized controlled trial (RCT) among women to determine:&#xD;
&#xD;
      1)if unprotected sex as measured prostate-specific antigen (PSA) will be more among women who&#xD;
      receive a contraceptive implant immediately at baseline during three months of follow up&#xD;
      compared to women who receive the implant at the three month follow-up visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This unblinded, randomized controlled trial (RCT) will assess whether the use of a&#xD;
      contraceptive implant leads to more sex unprotected by a condom, as measured by the detection&#xD;
      of a biological marker of exposure to semen in vaginal fluid, among women in Kingston,&#xD;
      Jamaica.&#xD;
&#xD;
      Eligible women will be non-pregnant, not known to be HIV-positive, 18-44 years of age, not&#xD;
      already using a long-acting method of contraception, without contraindications to implant&#xD;
      use, and willing to use the Sino-implant (II). Eligible women will be recruited from the&#xD;
      Comprehensive Health Centre Center of Excellence (CHC) in Kingston, Jamaica and from the&#xD;
      community. Women who give written consent for study participation will be enrolled in the&#xD;
      study and randomized to one of the two study groups: 1) &quot;immediate implant&quot; insertion or 2)&#xD;
      &quot;delayed implant&quot; insertion (i.e., when their study participation ends after three months of&#xD;
      follow up). All participants will receive safer sex counseling, will be supplied with&#xD;
      condoms, and will be administered a baseline questionnaire on demographics, reproductive&#xD;
      history and contraceptive and sexual practices. A study clinician will perform a pelvic&#xD;
      examination during which a double-headed vaginal swab will be collected to be tested for&#xD;
      prostate-specific antigen (PSA), which is a semen biomarker. Participants will be asked to&#xD;
      return for follow-up visits scheduled at 1 and 3 months after enrollment, at which times they&#xD;
      will have another double-headed vaginal swab collected during a pelvic examination for&#xD;
      testing for PSA and will be administered follow-up questionnaires. Participants in the&#xD;
      &quot;delayed implant&quot; group will have the Sino-implant (II) inserted at the 3-month visit if they&#xD;
      still want the device.&#xD;
&#xD;
      Primary objective: To determine whether the frequency of PSA detection during three months of&#xD;
      follow up is higher in the immediate implant group than in the delayed implant group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prostate-specific antigen (PSA)</measure>
    <time_frame>3 months</time_frame>
    <description>Number of women with recent exposure to semen as measured by the detection of prostate-specific antigen (PSA) in vaginal swabs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported exposure to semen</measure>
    <time_frame>3 months</time_frame>
    <description>Number of women reporting recent exposure to semen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>3 months</time_frame>
    <description>Number of women with side effects, including changes in menstrual bleeding patterns, and mean change in body weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Product discontinuation</measure>
    <time_frame>3 months</time_frame>
    <description>Number of women in the immediate implant arm who discontinue implant use during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>3 months</time_frame>
    <description>Number of women in the immediate implant arm who perceive the implant as acceptable</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">414</enrollment>
  <condition>Women Wanting Contraceptive Implant for Pregnancy Prevention</condition>
  <arm_group>
    <arm_group_label>Immediate implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sino-implant (II) inserted at enrollment visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed implant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sino-implant (II) inserted at 3-month follow-up visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sino-implant (II)</intervention_name>
    <description>Sino-implant (II) (Shanghai Dahua Pharmaceutical Co, Ltd.; Shanghai, China), a contraceptive implant with two rods each of which contain 75 mg of levonorgestrel.</description>
    <arm_group_label>Delayed implant</arm_group_label>
    <arm_group_label>Immediate implant</arm_group_label>
    <other_name>Zarin</other_name>
    <other_name>TRUST</other_name>
    <other_name>Femplant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be willing to be randomized to receive the implant at the enrollment visit or in three&#xD;
             months;&#xD;
&#xD;
          -  Be 18-44 years of age;&#xD;
&#xD;
          -  Not known to be HIV-positive;&#xD;
&#xD;
          -  Have a negative pregnancy test at baseline;&#xD;
&#xD;
          -  Not currently using an intrauterine device or system, a contraceptive implant, or&#xD;
             injectable contraception;&#xD;
&#xD;
          -  Not planning to start use an intrauterine contraceptive device or system or injectable&#xD;
             contraception in the next three months;&#xD;
&#xD;
          -  Not have had surgical sterilization or plan to have it in the next three months;&#xD;
&#xD;
          -  Not have medical contraindication to implant use, including lactation within first 6&#xD;
             weeks postpartum, acute deep venous thrombosis or pulmonary embolism, lupus, migraine&#xD;
             with aura, unexplained vaginal bleeding, current or history of breast cancer,severe&#xD;
             cirrhosis, liver tumors, history of stroke, and current or history of ischaemic heart&#xD;
             disease;&#xD;
&#xD;
          -  Be willing to return to the clinic for two follow-up visits over the next three&#xD;
             months; and&#xD;
&#xD;
          -  Be otherwise a good candidate for study participation based on investigator assessment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carole Rattray, DM</last_name>
    <role>Study Chair</role>
    <affiliation>University of West Indies</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth Costenbader, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>FHI 360</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Athena Kourtis, MD, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centers for Disease Control and Prevention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Epidemiology Research Training Unit</name>
      <address>
        <city>Kingston</city>
        <zip>5</zip>
        <country>Jamaica</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jamaica</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>November 4, 2014</last_update_submitted>
  <last_update_submitted_qc>November 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate-specific antigen</keyword>
  <keyword>Contraceptive implant</keyword>
  <keyword>Biological marker</keyword>
  <keyword>Condoms</keyword>
  <keyword>Women</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/NCT01684358
org study id: CDC-NCCDPHP-6163
nct id: NCT01684358
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This unblinded, randomized controlled trial (RCT) among women to determine:

      1)if unprotected sex as measured prostate-specific antigen (PSA) will be more among women who
      receive a contraceptive implant immediately at baseline during three months of follow up
      compared to women who receive the implant at the three month follow-up visit.
This unblinded, randomized controlled trial (RCT) will assess whether the use of a
      contraceptive implant leads to more sex unprotected by a condom, as measured by the detection
      of a biological marker of exposure to semen in vaginal fluid, among women in Kingston,
      Jamaica.

      Eligible women will be non-pregnant, not known to be HIV-positive, 18-44 years of age, not
      already using a long-acting method of contraception, without contraindications to implant
      use, and willing to use the Sino-implant (II). Eligible women will be recruited from the
      Comprehensive Health Centre Center of Excellence (CHC) in Kingston, Jamaica and from the
      community. Women who give written consent for study participation will be enrolled in the
      study and randomized to one of the two study groups: 1) "immediate implant" insertion or 2)
      "delayed implant" insertion (i.e., when their study participation ends after three months of
      follow up). All participants will receive safer sex counseling, will be supplied with
      condoms, and will be administered a baseline questionnaire on demographics, reproductive
      history and contraceptive and sexual practices. A study clinician will perform a pelvic
      examination during which a double-headed vaginal swab will be collected to be tested for
      prostate-specific antigen (PSA), which is a semen biomarker. Participants will be asked to
      return for follow-up visits scheduled at 1 and 3 months after enrollment, at which times they
      will have another double-headed vaginal swab collected during a pelvic examination for
      testing for PSA and will be administered follow-up questionnaires. Participants in the
      "delayed implant" group will have the Sino-implant (II) inserted at the 3-month visit if they
      still want the device.

      Primary objective: To determine whether the frequency of PSA detection during three months of
      follow up is higher in the immediate implant group than in the delayed implant group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Prostate-specific antigen (PSA)
time frame: 3 months
description: Number of women with recent exposure to semen as measured by the detection of prostate-specific antigen (PSA) in vaginal swabs
measure: Self-reported exposure to semen
time frame: 3 months
description: Number of women reporting recent exposure to semen
measure: Side effects
time frame: 3 months
description: Number of women with side effects, including changes in menstrual bleeding patterns, and mean change in body weight
measure: Product discontinuation
time frame: 3 months
description: Number of women in the immediate implant arm who discontinue implant use during the study
measure: Acceptability
time frame: 3 months
description: Number of women in the immediate implant arm who perceive the implant as acceptable
arm group label: Immediate implant
arm group type: Experimental
description: Sino-implant (II) inserted at enrollment visit
arm group label: Delayed implant
arm group type: Active Comparator
description: Sino-implant (II) inserted at 3-month follow-up visit
intervention type: Device
intervention name: Sino-implant (II)
description: Sino-implant (II) (Shanghai Dahua Pharmaceutical Co, Ltd.; Shanghai, China), a contraceptive implant with two rods each of which contain 75 mg of levonorgestrel.
arm group label: Delayed implant
arm group label: Immediate implant
other name: Zarin
other name: TRUST
other name: Femplant
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carole Rattray, DM
role: Study Chair
affiliation: University of West Indies
last name: Elizabeth Costenbader, PhD
role: Principal Investigator
affiliation: FHI 360
last name: Athena Kourtis, MD, PhD, MPH
role: Principal Investigator
affiliation: Centers for Disease Control and Prevention
facility: 
country: Jamaica
responsible party type: Sponsor