<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/NCT04480749</url>
  </required_header>
  <id_info>
    <org_study_id>17848</org_study_id>
    <nct_id>NCT04480749</nct_id>
  </id_info>
  <brief_title>Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST)</brief_title>
  <official_title>Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biomedical Research and Training Institute, Zimbabwe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pangaea Zimbabwe Aids Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>London School of Hygiene and Tropical Medicine</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Syphilis infection is a major global health problem, leading to substantial morbidity among&#xD;
      key populations in low- and middle-income countries (LMICs). Men who have sex with men (MSM)&#xD;
      are disproportionately affected by syphilis worldwide. Rates of syphilis diagnoses have been&#xD;
      increasing amongst MSM in many countries in the last decade. A growing evidence base&#xD;
      supporting HIV self-testing shows that self-testing kits based on the same proposed clinical&#xD;
      pathways are feasible and reliable. The proposed study will leverage this body of evidence&#xD;
      and apply it to syphilis self-testing.&#xD;
&#xD;
      This is a pilot study conducted in Zimbabwe. It aims to collect initial data on the&#xD;
      feasability of implementing syphilis self-testing to establish if a large scale-RCT of this&#xD;
      approach would be appropriate and, if so, to inform the design of this trial.&#xD;
&#xD;
      The investigators will recruit 100 MSM in Harare to join the pilot program. Participants will&#xD;
      be recruited through two methods: in-person at MSM community-based organizations that&#xD;
      currently operate HIV self-testing programs and online through banner advertisements that&#xD;
      advertise HIV self-testing.&#xD;
&#xD;
      Study Arms:&#xD;
&#xD;
      Arm 1: One arm of the pilot will receive a free syphilis self-test kit (Intervention Arm) Arm&#xD;
      2: One arm will receive standard free facility-based syphilis testing (Control Arm).&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      In the intervention arm the investigators will provide a treponemal rapid syphilis test kit&#xD;
      to all participants in the intervention arm of the pilot, delivered through MSM community&#xD;
      facilitators. This is similar to existing rapid treponemal test kits that are available at&#xD;
      many clinical facilities. Kits will be accompanied by simplified pictorial instructions on&#xD;
      finger prick blood sample collection. Among participants in the control group, they will&#xD;
      receive a list of local clinics that can provide free syphilis testing.&#xD;
&#xD;
      Data Collection:&#xD;
&#xD;
      For individuals in the intervention am the investigators will aim to obtain confirmation of&#xD;
      test uptake. This will be done using either photographic confirmation sent via encrypted&#xD;
      message on a smartphone, SMS message of a unique code or sending a unique five-digit code&#xD;
      along with their test result to the study coordinator. The investigators will conduct&#xD;
      cross-sectional surveys at baseline and six months later to assess sexual risk behaviours,&#xD;
      HIV and syphilis testing experiences, and self-testing experiences. In addition to the survey&#xD;
      data tool the investigators will conduct in-depth interviews with a small number of&#xD;
      participants to gain additional data about their experience of syphilis self-testing.&#xD;
&#xD;
      The investigators will obtain information on linkage to care from routine clinic&#xD;
      administrative records and by providing study participants with a unique code to be provided&#xD;
      when attending at the facility.&#xD;
&#xD;
      Analysis:&#xD;
&#xD;
      The investigators will used mixed-methods to evaluate our pilot intervention including&#xD;
&#xD;
      The investigators will examine the proportion of individuals who undertake a syphilis test in&#xD;
      the interventional and control arms; among those who receive a test, the proportion of&#xD;
      individuals who receive appropriate post-testing services. The investigators will also&#xD;
      collect qualitative data on attitudes to syphilis self-testing and quantitative data on&#xD;
      syphilis prevalence to inform a subsequent clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 14, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <phase>Phase 4</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Syphilis Tests Undertaken</measure>
    <time_frame>6 months</time_frame>
    <description>The total number of participants undertaking a syphilis test</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Syphilis</condition>
  <arm_group>
    <arm_group_label>Routine Testing</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Among men in the control group, they will receive a list of local clinics that can provide free syphilis testing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the intervention arm we will provide a treponemal rapid syphilis test kit to all individuals in the intervention arm of the pilot, delivered through MSM community facilitators. This is similar to existing rapid treponemal test kits that are available at many clinical facilities. Kits will be accompanied by simplified pictorial instructions on finger prick blood sample collection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Access to Facility based Syphilis Testing</intervention_name>
    <description>List of facilities where syphilis testing can be accessed</description>
    <arm_group_label>Routine Testing</arm_group_label>
    <arm_group_label>Self-Testing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Syphilis Self-Test</intervention_name>
    <description>Rapid Treponemal Test kit</description>
    <arm_group_label>Self-Testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men who have sex with men&#xD;
&#xD;
          -  Able to consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Men who have sex with men</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Harare City Council Health Facilities</name>
      <address>
        <city>Harare</city>
        <state>NIL Return</state>
        <country>Zimbabwe</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zimbabwe</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <results_first_submitted>January 20, 2022</results_first_submitted>
  <results_first_submitted_qc>March 25, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 25, 2022</results_first_posted>
  <last_update_submitted>March 25, 2022</last_update_submitted>
  <last_update_submitted_qc>March 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syphilis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT04480749/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Routine Testing</title>
          <description>Among men in the control group, they will receive a list of local clinics that can provide free syphilis testing.&#xD;
Access to Facility based Syphilis Testing: List of facilities where syphilis testing can be accessed</description>
        </group>
        <group group_id="P2">
          <title>Self-Testing</title>
          <description>In the intervention arm we will provide a treponemal rapid syphilis test kit to all individuals in the intervention arm of the pilot, delivered through MSM community facilitators. This is similar to existing rapid treponemal test kits that are available at many clinical facilities. Kits will be accompanied by simplified pictorial instructions on finger prick blood sample collection.&#xD;
Access to Facility based Syphilis Testing: List of facilities where syphilis testing can be accessed&#xD;
Syphilis Self-Test: Rapid Treponemal Test kit</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Routine Testing</title>
          <description>Among men in the control group, they will receive a list of local clinics that can provide free syphilis testing.&#xD;
Access to Facility based Syphilis Testing: List of facilities where syphilis testing can be accessed</description>
        </group>
        <group group_id="B2">
          <title>Self-Testing</title>
          <description>In the intervention arm we will provide a treponemal rapid syphilis test kit to all individuals in the intervention arm of the pilot, delivered through MSM community facilitators. This is similar to existing rapid treponemal test kits that are available at many clinical facilities. Kits will be accompanied by simplified pictorial instructions on finger prick blood sample collection.&#xD;
Access to Facility based Syphilis Testing: List of facilities where syphilis testing can be accessed&#xD;
Syphilis Self-Test: Rapid Treponemal Test kit</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Zimbabwe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Syphilis Tests Undertaken</title>
        <description>The total number of participants undertaking a syphilis test</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Routine Testing</title>
            <description>Among men in the control group, they will receive a list of local clinics that can provide free syphilis testing.&#xD;
Access to Facility based Syphilis Testing: List of facilities where syphilis testing can be accessed</description>
          </group>
          <group group_id="O2">
            <title>Self-Testing</title>
            <description>In the intervention arm we will provide a treponemal rapid syphilis test kit to all individuals in the intervention arm of the pilot, delivered through MSM community facilitators. This is similar to existing rapid treponemal test kits that are available at many clinical facilities. Kits will be accompanied by simplified pictorial instructions on finger prick blood sample collection.&#xD;
Access to Facility based Syphilis Testing: List of facilities where syphilis testing can be accessed&#xD;
Syphilis Self-Test: Rapid Treponemal Test kit</description>
          </group>
        </group_list>
        <measure>
          <title>Syphilis Tests Undertaken</title>
          <description>The total number of participants undertaking a syphilis test</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Routine Testing</title>
          <description>Among men in the control group, they will receive a list of local clinics that can provide free syphilis testing.&#xD;
Access to Facility based Syphilis Testing: List of facilities where syphilis testing can be accessed</description>
        </group>
        <group group_id="E2">
          <title>Self-Testing</title>
          <description>In the intervention arm we will provide a treponemal rapid syphilis test kit to all individuals in the intervention arm of the pilot, delivered through MSM community facilitators. This is similar to existing rapid treponemal test kits that are available at many clinical facilities. Kits will be accompanied by simplified pictorial instructions on finger prick blood sample collection.&#xD;
Access to Facility based Syphilis Testing: List of facilities where syphilis testing can be accessed&#xD;
Syphilis Self-Test: Rapid Treponemal Test kit</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael Marks</name_or_title>
      <organization>LSHTM</organization>
      <phone>020 7636 8636</phone>
      <email>michael.marks@lshtm.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04480749
org study id: 17848
nct id: NCT04480749
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Syphilis infection is a major global health problem, leading to substantial morbidity among
      key populations in low- and middle-income countries (LMICs). Men who have sex with men (MSM)
      are disproportionately affected by syphilis worldwide. Rates of syphilis diagnoses have been
      increasing amongst MSM in many countries in the last decade. A growing evidence base
      supporting HIV self-testing shows that self-testing kits based on the same proposed clinical
      pathways are feasible and reliable. The proposed study will leverage this body of evidence
      and apply it to syphilis self-testing.

      This is a pilot study conducted in Zimbabwe. It aims to collect initial data on the
      feasability of implementing syphilis self-testing to establish if a large scale-RCT of this
      approach would be appropriate and, if so, to inform the design of this trial.

      The investigators will recruit 100 MSM in Harare to join the pilot program. Participants will
      be recruited through two methods: in-person at MSM community-based organizations that
      currently operate HIV self-testing programs and online through banner advertisements that
      advertise HIV self-testing.

      Study Arms:

      Arm 1: One arm of the pilot will receive a free syphilis self-test kit (Intervention Arm) Arm
      2: One arm will receive standard free facility-based syphilis testing (Control Arm).

      Intervention:

      In the intervention arm the investigators will provide a treponemal rapid syphilis test kit
      to all participants in the intervention arm of the pilot, delivered through MSM community
      facilitators. This is similar to existing rapid treponemal test kits that are available at
      many clinical facilities. Kits will be accompanied by simplified pictorial instructions on
      finger prick blood sample collection. Among participants in the control group, they will
      receive a list of local clinics that can provide free syphilis testing.

      Data Collection:

      For individuals in the intervention am the investigators will aim to obtain confirmation of
      test uptake. This will be done using either photographic confirmation sent via encrypted
      message on a smartphone, SMS message of a unique code or sending a unique five-digit code
      along with their test result to the study coordinator. The investigators will conduct
      cross-sectional surveys at baseline and six months later to assess sexual risk behaviours,
      HIV and syphilis testing experiences, and self-testing experiences. In addition to the survey
      data tool the investigators will conduct in-depth interviews with a small number of
      participants to gain additional data about their experience of syphilis self-testing.

      The investigators will obtain information on linkage to care from routine clinic
      administrative records and by providing study participants with a unique code to be provided
      when attending at the facility.

      Analysis:

      The investigators will used mixed-methods to evaluate our pilot intervention including

      The investigators will examine the proportion of individuals who undertake a syphilis test in
      the interventional and control arms; among those who receive a test, the proportion of
      individuals who receive appropriate post-testing services. The investigators will also
      collect qualitative data on attitudes to syphilis self-testing and quantitative data on
      syphilis prevalence to inform a subsequent clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Syphilis Tests Undertaken
time frame: 6 months
description: The total number of participants undertaking a syphilis test
arm group label: Routine Testing
arm group type: Other
description: Among men in the control group, they will receive a list of local clinics that can provide free syphilis testing.
arm group label: Self-Testing
arm group type: Experimental
description: In the intervention arm we will provide a treponemal rapid syphilis test kit to all individuals in the intervention arm of the pilot, delivered through MSM community facilitators. This is similar to existing rapid treponemal test kits that are available at many clinical facilities. Kits will be accompanied by simplified pictorial instructions on finger prick blood sample collection.
intervention type: Diagnostic Test
intervention name: Access to Facility based Syphilis Testing
description: List of facilities where syphilis testing can be accessed
arm group label: Routine Testing
arm group label: Self-Testing
intervention type: Diagnostic Test
intervention name: Syphilis Self-Test
description: Rapid Treponemal Test kit
arm group label: Self-Testing
criteria: 
gender: Male
gender based: Yes
gender description: Men who have sex with men
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Zimbabwe
responsible party type: Sponsor
mesh term: Syphilis
sharing ipd: Yes
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 