<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/NCT02262390</url>
  </required_header>
  <id_info>
    <org_study_id>ST/0109/14</org_study_id>
    <nct_id>NCT02262390</nct_id>
  </id_info>
  <brief_title>Syphilis Treatment of Partners Trial</brief_title>
  <acronym>STOP</acronym>
  <official_title>Comparison of Different Partner Notification Strategies After Antenatal Syphilis Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Infectious Diseases Institute, Uganda</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Makerere University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      2.1 Primary Study Hypothesis In sub-Saharan Africa, between 2.5-17% of pregnant women are&#xD;
      infected with syphilis [1]. It is estimated that 53-82% of women with untreated syphilis had&#xD;
      adverse outcomes compared to only 10-21% of uninfected women[2]. The investigators and others&#xD;
      have shown that syphilis screening integrated into an HIV antenatal clinic with prevention of&#xD;
      mother to child transmission (PMTCT) is highly accepted with excellent uptake. Unfortunately,&#xD;
      the minority of male partners come in for testing and treatment (1%-27%) which has important&#xD;
      implications for the roll-out of rapid syphilis testing and the inability to detect&#xD;
      reinfection with treponemal antibody test as the test will remain positive despite treatment.&#xD;
      The investigators hypothesize that sending an SMS reminder or a telephone call reminder by a&#xD;
      health care worker will be more effective than a standard notification slip given to women to&#xD;
      bring male partners to antennal clinic for testing and treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Title: Comparison of Different Partner Notification Strategies after Antenatal Syphilis&#xD;
      Screening Short Title: Syphilis Treatment of Partners (STOP) Trial Objectives: Primary For&#xD;
      pregnant women who test rapid syphilis test positive; to compare the proportion of male&#xD;
      partners who report to the clinic for syphilis testing (and treatment) when the women are&#xD;
      given only partner notification slips (standard of care) compared to a notification slip plus&#xD;
      a weekly automated SMS reminder OR a notification slip plus a weekly nurse phone call&#xD;
      reminder.&#xD;
&#xD;
      Secondary&#xD;
&#xD;
        -  To compare the proportion of male partners who test positive for syphilis when they&#xD;
           report to the clinic after receiving notification in the three groups via their pregnant&#xD;
           partners.&#xD;
&#xD;
        -  To compare the proportion of male partners who undergo treatment among the three groups.&#xD;
&#xD;
        -  To explore factors associated with reporting/not reporting after notification.&#xD;
&#xD;
        -  To compare birth outcomes (congenital syphilis, stillbirths, neonatal deaths, preterm or&#xD;
           low birth weight) between the three arms (self-reported by women).&#xD;
&#xD;
        -  To assess time from syphilis point of care (POC) test to treatment in mothers who test&#xD;
           syphilis positive using a rapid treponemal antibody kit.&#xD;
&#xD;
        -  To compare the proportion of women who have a 4-fold decrease in RPR titer by&#xD;
           intervention arm in each arm at post natal visit.&#xD;
&#xD;
      Study Population and sample size: • Pregnant women from 14years and above reporting to&#xD;
      antenatal and subsequently postnatal clinics at the Infectious Disease Institute, Mulago&#xD;
      Hospital (antenatal and STI clinics), and Kasangati Health Center IV in Kampala, Uganda who&#xD;
      screen positive by rapid treponemal antibody test.&#xD;
&#xD;
        -  Male sexual partners to these enrolled syphilis positive pregnant mothers.&#xD;
&#xD;
        -  876participants will be enrolled. Study Design: Individual patient randomized open-label&#xD;
           clinical trial of syphilis partner notification interventions.&#xD;
&#xD;
      Study Duration: Approximately 24 months&#xD;
&#xD;
      Endpoints:&#xD;
&#xD;
      Primary:&#xD;
&#xD;
      1) Proportion of male partners who present at clinic and receive syphilis testing&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        1. Male partners tested (standard vs. intervention in 3 arm randomization)&#xD;
&#xD;
        2. Proportion of male partners who test positive for syphilis when they report to the&#xD;
           clinic after notification.&#xD;
&#xD;
        3. Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo&#xD;
           treatment among the three groups.&#xD;
&#xD;
        4. Factors associated with partners reporting/not reporting after notification.&#xD;
&#xD;
        5. Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional&#xD;
           titer decrease in RPR (by standard vs. intervention arm)&#xD;
&#xD;
        6. Mother reported birth outcomes (by standard vs. intervention arm) Subject Participants:&#xD;
           Pregnant women testing positive for syphilis at the antenatal clinics and their&#xD;
           partners.&#xD;
&#xD;
      Description of Study Design: This is a prospective clinical trial in which pregnant syphilis&#xD;
      positive women (tested by rapid treponemal antibody kit) will be randomized to one of three&#xD;
      arms to notify participants to bring their sexual partners at risk for syphilis for syphilis&#xD;
      screening and treatment. Women will be randomized in a 1:1:1 ratio to one of the following&#xD;
      three strategies: A) To receive a notification slip per the Ministry of Health standard B) to&#xD;
      receive a notification slip plus an SMS reminder or C) to receive a notification slip plus&#xD;
      standardized nurse/clinician initiated phone call.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of male partners who present at clinic and receive syphilis testing</measure>
    <time_frame>2 years</time_frame>
    <description>Proportion of male partners who present at clinic and receive syphilis testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Male partners tested (standard vs. intervention in 3 arm randomization)</measure>
    <time_frame>2 years</time_frame>
    <description>Male partners tested (standard vs. intervention in 3 arm randomization)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of male partners who test positive for syphilis when they report to the clinic after notification.</measure>
    <time_frame>2 years</time_frame>
    <description>Proportion of male partners who test positive for syphilis when they report to the clinic after notification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.</measure>
    <time_frame>2 years</time_frame>
    <description>Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors associated with partners reporting/not reporting after notification.</measure>
    <time_frame>2 years</time_frame>
    <description>Factors associated with partners reporting/not reporting after notification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional titer decrease in RPR (by standard vs. intervention arm)</measure>
    <time_frame>2 years</time_frame>
    <description>Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional titer decrease in RPR (by standard vs. intervention arm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mother reported birth outcomes (by standard vs. intervention arm)</measure>
    <time_frame>2 years</time_frame>
    <description>Mother reported birth outcomes (by standard vs. intervention arm)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">1752</enrollment>
  <condition>Syphilis Infection</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Partner notification slip is given to the pregnant female participant on the day she receives her syphilis test results to give to their sexual partner encouraging them to come to the STI clinic and be screened for syphilis. The partner notification slip will have a code number, but no identifiable features (no names).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMS reminders and notification slip for partner screening</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive weekly SMS reminders to encourage their partners to attend the STI clinic for syphilis testing for up to 8 weeks after initial positive syphilis test for the participant. The participant ID number will be written on both the notification paper which partners should bring in with them and on the SMS reminders.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phone call reminders and notification slip for partner scree</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive weekly phone call reminders to encourage their partners to attend the STI clinic for syphilis testing for up to 8 weeks after initial positive syphilis test for the participant. The participant ID number will be written on both the notification paper which partners should bring in with them and be given to the participant when the nurse calls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Partner Notification Reminders</intervention_name>
    <description>For all 3 arms, the following will be done:&#xD;
All participants will have an antenatal clinic visit every 4 weeks until delivery.&#xD;
All notification slips will be duplicate; one given to the mother and one held in the clinic. The study ID number will be documented on the slip. On partner return the slips will be matched and used to link mothers with male returning partners.&#xD;
Partner participant test result will be linked to the patient using the participant ID number in the lab. Partners will be tested using a rapid treponemal antibody test.</description>
    <arm_group_label>Phone call reminders and notification slip for partner scree</arm_group_label>
    <arm_group_label>SMS reminders and notification slip for partner screening</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Individuals must meet all of the following inclusion criteria in order to be eligible to&#xD;
        participate:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Treponemal antibody rapid positive test&#xD;
&#xD;
          -  Age&gt; 14 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Known sexual partner&#xD;
&#xD;
          -  Access to cell phone and willing and able to use and receive SMS or phone calls In the&#xD;
             Uganda guidelines (section 9.3 Mature and Emancipated Minors), &quot;mature minors are&#xD;
             individuals 14-17 years of age who have drug or alcohol dependency or a sexually&#xD;
             transmitted infection; Mature minors may independently provide informed consent to&#xD;
             participate in research if in the view of the IRC the research is not objectionable to&#xD;
             parents or guardian (established by the IRC with evidence from the community); and b)&#xD;
             The research protocol include clear justification for targeting mature and&#xD;
             emancipated.&quot; This protocol will recruit pregnant women with a sexually transmitted&#xD;
             infection in an intervention with minimal risk and with the potential to prevent&#xD;
             future reinfection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any subjects meeting any of the following exclusion criteria at baseline will be&#xD;
             excluded from study participation:&#xD;
&#xD;
               -  Illiterate and unable to read a text message&#xD;
&#xD;
               -  Inability to use a mobile phone&#xD;
&#xD;
               -  Patients with confirmed neuro syphilis treated with IV Benzyl penicillin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuka C Manabe, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rosalind Parkes-Ratanshi, PhD</last_name>
    <phone>+256312307000</phone>
    <phone_ext>237</phone_ext>
    <email>rratanshi@idi.co.ug</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joshua K Mbazira, CO</last_name>
    <phone>+256312307000</phone>
    <phone_ext>310</phone_ext>
    <email>jmbazira@idi.co.ug</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Infectious Diseases Institute</name>
      <address>
        <city>Kampala</city>
        <zip>256</zip>
        <country>Uganda</country>
      </address>
    </facility>
    <contact>
      <last_name>Rosalind Parkes-Ratanshi, PhD</last_name>
      <phone>+256312307000</phone>
      <phone_ext>237</phone_ext>
      <email>rratanshi@idi.co.ug</email>
    </contact>
    <contact_backup>
      <last_name>Allen M Mukhwana, MBA</last_name>
      <phone>+256312307000</phone>
      <phone_ext>242</phone_ext>
      <email>amukhwana@idi.co.ug</email>
    </contact_backup>
    <investigator>
      <last_name>Edith Nakku-Joloba, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 10, 2014</last_update_submitted>
  <last_update_submitted_qc>October 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makerere University</investigator_affiliation>
    <investigator_full_name>Infectious Diseases Institute</investigator_full_name>
    <investigator_title>Head of Prevention Care &amp; Treatment, IDI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syphilis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02262390
org study id: ST/0109/14
nct id: NCT02262390
lead sponsor: 
collaborator: 
has dmc: No
2.1 Primary Study Hypothesis In sub-Saharan Africa, between 2.5-17% of pregnant women are
      infected with syphilis [1]. It is estimated that 53-82% of women with untreated syphilis had
      adverse outcomes compared to only 10-21% of uninfected women[2]. The investigators and others
      have shown that syphilis screening integrated into an HIV antenatal clinic with prevention of
      mother to child transmission (PMTCT) is highly accepted with excellent uptake. Unfortunately,
      the minority of male partners come in for testing and treatment (1%-27%) which has important
      implications for the roll-out of rapid syphilis testing and the inability to detect
      reinfection with treponemal antibody test as the test will remain positive despite treatment.
      The investigators hypothesize that sending an SMS reminder or a telephone call reminder by a
      health care worker will be more effective than a standard notification slip given to women to
      bring male partners to antennal clinic for testing and treatment.
Title: Comparison of Different Partner Notification Strategies after Antenatal Syphilis
      Screening Short Title: Syphilis Treatment of Partners (STOP) Trial Objectives: Primary For
      pregnant women who test rapid syphilis test positive; to compare the proportion of male
      partners who report to the clinic for syphilis testing (and treatment) when the women are
      given only partner notification slips (standard of care) compared to a notification slip plus
      a weekly automated SMS reminder OR a notification slip plus a weekly nurse phone call
      reminder.

      Secondary

        -  To compare the proportion of male partners who test positive for syphilis when they
           report to the clinic after receiving notification in the three groups via their pregnant
           partners.

        -  To compare the proportion of male partners who undergo treatment among the three groups.

        -  To explore factors associated with reporting/not reporting after notification.

        -  To compare birth outcomes (congenital syphilis, stillbirths, neonatal deaths, preterm or
           low birth weight) between the three arms (self-reported by women).

        -  To assess time from syphilis point of care (POC) test to treatment in mothers who test
           syphilis positive using a rapid treponemal antibody kit.

        -  To compare the proportion of women who have a 4-fold decrease in RPR titer by
           intervention arm in each arm at post natal visit.

      Study Population and sample size: • Pregnant women from 14years and above reporting to
      antenatal and subsequently postnatal clinics at the Infectious Disease Institute, Mulago
      Hospital (antenatal and STI clinics), and Kasangati Health Center IV in Kampala, Uganda who
      screen positive by rapid treponemal antibody test.

        -  Male sexual partners to these enrolled syphilis positive pregnant mothers.

        -  876participants will be enrolled. Study Design: Individual patient randomized open-label
           clinical trial of syphilis partner notification interventions.

      Study Duration: Approximately 24 months

      Endpoints:

      Primary:

      1) Proportion of male partners who present at clinic and receive syphilis testing

      Secondary:

        1. Male partners tested (standard vs. intervention in 3 arm randomization)

        2. Proportion of male partners who test positive for syphilis when they report to the
           clinic after notification.

        3. Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo
           treatment among the three groups.

        4. Factors associated with partners reporting/not reporting after notification.

        5. Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional
           titer decrease in RPR (by standard vs. intervention arm)

        6. Mother reported birth outcomes (by standard vs. intervention arm) Subject Participants:
           Pregnant women testing positive for syphilis at the antenatal clinics and their
           partners.

      Description of Study Design: This is a prospective clinical trial in which pregnant syphilis
      positive women (tested by rapid treponemal antibody kit) will be randomized to one of three
      arms to notify participants to bring their sexual partners at risk for syphilis for syphilis
      screening and treatment. Women will be randomized in a 1:1:1 ratio to one of the following
      three strategies: A) To receive a notification slip per the Ministry of Health standard B) to
      receive a notification slip plus an SMS reminder or C) to receive a notification slip plus
      standardized nurse/clinician initiated phone call.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Proportion of male partners who present at clinic and receive syphilis testing
time frame: 2 years
description: Proportion of male partners who present at clinic and receive syphilis testing
measure: Male partners tested (standard vs. intervention in 3 arm randomization)
time frame: 2 years
description: Male partners tested (standard vs. intervention in 3 arm randomization)
measure: Proportion of male partners who test positive for syphilis when they report to the clinic after notification.
time frame: 2 years
description: Proportion of male partners who test positive for syphilis when they report to the clinic after notification.
measure: Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.
time frame: 2 years
description: Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.
measure: Factors associated with partners reporting/not reporting after notification.
time frame: 2 years
description: Factors associated with partners reporting/not reporting after notification.
measure: Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional titer decrease in RPR (by standard vs. intervention arm)
time frame: 2 years
description: Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional titer decrease in RPR (by standard vs. intervention arm)
measure: Mother reported birth outcomes (by standard vs. intervention arm)
time frame: 2 years
description: Mother reported birth outcomes (by standard vs. intervention arm)
arm group label: Standard of Care
arm group type: Active Comparator
description: Partner notification slip is given to the pregnant female participant on the day she receives her syphilis test results to give to their sexual partner encouraging them to come to the STI clinic and be screened for syphilis. The partner notification slip will have a code number, but no identifiable features (no names).
arm group label: SMS reminders and notification slip for partner screening
arm group type: Active Comparator
description: Participants will receive weekly SMS reminders to encourage their partners to attend the STI clinic for syphilis testing for up to 8 weeks after initial positive syphilis test for the participant. The participant ID number will be written on both the notification paper which partners should bring in with them and on the SMS reminders.
arm group label: Phone call reminders and notification slip for partner scree
arm group type: Active Comparator
description: Participants will receive weekly phone call reminders to encourage their partners to attend the STI clinic for syphilis testing for up to 8 weeks after initial positive syphilis test for the participant. The participant ID number will be written on both the notification paper which partners should bring in with them and be given to the participant when the nurse calls.
intervention type: Procedure
intervention name: Partner Notification Reminders
description: For all 3 arms, the following will be done:
All participants will have an antenatal clinic visit every 4 weeks until delivery.
All notification slips will be duplicate; one given to the mother and one held in the clinic. The study ID number will be documented on the slip. On partner return the slips will be matched and used to link mothers with male returning partners.
Partner participant test result will be linked to the patient using the participant ID number in the lab. Partners will be tested using a rapid treponemal antibody test.
arm group label: Phone call reminders and notification slip for partner scree
arm group label: SMS reminders and notification slip for partner screening
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: No
last name: Yuka C Manabe, MD
role: Study Chair
affiliation: Johns Hopkins University
last name: Rosalind Parkes-Ratanshi, PhD
phone: +256312307000
phone ext: 237
email: rratanshi@idi.co.ug
last name: Joshua K Mbazira, CO
phone: +256312307000
phone ext: 310
email: jmbazira@idi.co.ug
facility: 
contact: 
contact backup: 
investigator: 
country: Uganda
responsible party type: Principal Investigator
investigator affiliation: Makerere University
investigator full name: Infectious Diseases Institute
investigator title: Head of Prevention Care & Treatment, IDI
mesh term: Syphilis