<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/NCT02257658</url>
  </required_header>
  <id_info>
    <org_study_id>PHS 398/2590</org_study_id>
    <nct_id>NCT02257658</nct_id>
  </id_info>
  <brief_title>Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM</brief_title>
  <acronym>DPMSM</acronym>
  <official_title>Doxycycline Prophylaxis or Incentive Payments to Reduce Incident Syphilis Among HIV- Infected Men Who Have Sex With Men Who Continue to Engage in High Risk Sex: A Randomized, Controlled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Los Angeles LGBT Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Los Angeles LGBT Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study will investigate the feasibility of conducting a large, randomized trial&#xD;
      comparing a structural intervention to contingency management to reduce incident syphilis&#xD;
      infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have&#xD;
      had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive&#xD;
      either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free.&#xD;
      The investigators will : 1) measure adherence to study visits in both arms; 2) measure&#xD;
      adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study&#xD;
      participants and 4) to the extent possible in a small pilot study of short duration, compare&#xD;
      effectiveness of doxycycline with that of a monetary incentive for remaining STI free.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Measure changes in the incidence of Syphilis, Gonorrhea and Chlamydia at 12 weeks, 24 weeks, 26 weeks and 48 weeks in the Doxycycline Arm and Contingency Management Arms</measure>
    <time_frame>12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure adherence to study visits in the Doxycycline and Contingency Management Arms at Weeks 12, 24, 36 and 48</measure>
    <time_frame>12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure adherence to daily Doxycycline Use using Blood Samples in the Doxycycline Arm at Weeks 12, 24 and 36</measure>
    <time_frame>12 Weeks, 24 Weeks and 36 Weeks</time_frame>
    <description>At Weeks 12, 24 and 36, blood samples were drawn from participants in the Doxycycline arm and sent to a lab to measure doxycyline levels in each participant in the Doxycyline Arm. The purpose of this outcome is to determine if individuals in the Doxycycline Arm are consistently adhering to the daily regimen of the drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure changes in self-report sexual risk behaviors (e.g., condom use, drug use and number of partners) in the Doxycycline and Contingency Management Arms at Weeks 12, 24 and 36</measure>
    <time_frame>12 Weeks, 24 Weeks and 36 Weeks</time_frame>
    <description>Prior to having labs drawn, participants in both the Doxycycline and Contingency Management Arms were asked about their risk behaviors in the past three months including: meth use, condom use with casual partners, condom use with regular partners, condom use with a main partner, number of casual sexual partners and number of regular sexual partners.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Syphilis</condition>
  <arm_group>
    <arm_group_label>Doxycycline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the doxycycyline arm will receive Doxycycline, oral, 100 mg, once daily for 36 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Incentive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in the incentive arm will receive escalating payments for remaining STI free at Weeks 12, 24 and 36.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxycycyline</intervention_name>
    <arm_group_label>Doxycycline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Incentive</intervention_name>
    <arm_group_label>Incentive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infected MSM or transgender women who have sex with men&#xD;
&#xD;
          -  At least two documented and adequately treated episodes of syphilis since HIV&#xD;
             diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had a known allergy or intolerance to doxycycline&#xD;
&#xD;
          -  Abused alcohol or other substances which in the opinion of the investigators would&#xD;
             jeopardize adherence to study procedures&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey D Klausner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <reference>
    <citation>Celum CL. Sexually transmitted infections and HIV: epidemiology and interventions. Top HIV Med. 2010 Oct-Nov;18(4):138-42.</citation>
    <PMID>21107013</PMID>
  </reference>
  <reference>
    <citation>Goh BT. Syphilis in adults. Sex Transm Infect. 2005 Dec;81(6):448-52. doi: 10.1136/sti.2005.015875.</citation>
    <PMID>16326843</PMID>
  </reference>
  <reference>
    <citation>Lynn WA, Lightman S. Syphilis and HIV: a dangerous combination. Lancet Infect Dis. 2004 Jul;4(7):456-66. doi: 10.1016/S1473-3099(04)01061-8.</citation>
    <PMID>15219556</PMID>
  </reference>
  <reference>
    <citation>Centers for Disease Control and Prevention (CDC). Outbreak of syphilis among men who have sex with men--Southern California, 2000. MMWR Morb Mortal Wkly Rep. 2001 Feb 23;50(7):117-20.</citation>
    <PMID>11393490</PMID>
  </reference>
  <reference>
    <citation>Horberg MA, Ranatunga DK, Quesenberry CP, Klein DB, Silverberg MJ. Syphilis epidemiology and clinical outcomes in HIV-infected and HIV-uninfected patients in Kaiser Permanente Northern California. Sex Transm Dis. 2010 Jan;37(1):53-8. doi: 10.1097/OLQ.0b013e3181b6f0cc.</citation>
    <PMID>19734820</PMID>
  </reference>
  <reference>
    <citation>Marcus JL, Katz KA, Bernstein KT, Nieri G, Philip SS. Syphilis testing behavior following diagnosis with early syphilis among men who have sex with men--San Francisco, 2005-2008. Sex Transm Dis. 2011 Jan;38(1):24-9. doi: 10.1097/OLQ.0b013e3181ea170b.</citation>
    <PMID>20679965</PMID>
  </reference>
  <reference>
    <citation>Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect. 1999 Feb;75(1):3-17. doi: 10.1136/sti.75.1.3.</citation>
    <PMID>10448335</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 3, 2014</last_update_submitted>
  <last_update_submitted_qc>October 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Los Angeles LGBT Center</investigator_affiliation>
    <investigator_full_name>Matthew Beymer</investigator_full_name>
    <investigator_title>Epidemiologist, Health and Mental Health Services</investigator_title>
  </responsible_party>
  <keyword>Men who have Sex with Men</keyword>
  <keyword>HIV-positive</keyword>
  <keyword>Syphilis</keyword>
  <keyword>Contingency Management</keyword>
  <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/NCT02257658
org study id: PHS 398/2590
nct id: NCT02257658
lead sponsor: 
collaborator: 
has dmc: No
This pilot study will investigate the feasibility of conducting a large, randomized trial
      comparing a structural intervention to contingency management to reduce incident syphilis
      infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have
      had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive
      either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free.
      The investigators will : 1) measure adherence to study visits in both arms; 2) measure
      adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study
      participants and 4) to the extent possible in a small pilot study of short duration, compare
      effectiveness of doxycycline with that of a monetary incentive for remaining STI free.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Measure changes in the incidence of Syphilis, Gonorrhea and Chlamydia at 12 weeks, 24 weeks, 26 weeks and 48 weeks in the Doxycycline Arm and Contingency Management Arms
time frame: 12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks
measure: Measure adherence to study visits in the Doxycycline and Contingency Management Arms at Weeks 12, 24, 36 and 48
time frame: 12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks
measure: Measure adherence to daily Doxycycline Use using Blood Samples in the Doxycycline Arm at Weeks 12, 24 and 36
time frame: 12 Weeks, 24 Weeks and 36 Weeks
description: At Weeks 12, 24 and 36, blood samples were drawn from participants in the Doxycycline arm and sent to a lab to measure doxycyline levels in each participant in the Doxycyline Arm. The purpose of this outcome is to determine if individuals in the Doxycycline Arm are consistently adhering to the daily regimen of the drug.
measure: Measure changes in self-report sexual risk behaviors (e.g., condom use, drug use and number of partners) in the Doxycycline and Contingency Management Arms at Weeks 12, 24 and 36
time frame: 12 Weeks, 24 Weeks and 36 Weeks
description: Prior to having labs drawn, participants in both the Doxycycline and Contingency Management Arms were asked about their risk behaviors in the past three months including: meth use, condom use with casual partners, condom use with regular partners, condom use with a main partner, number of casual sexual partners and number of regular sexual partners.
arm group label: Doxycycline
arm group type: Experimental
description: Subjects in the doxycycyline arm will receive Doxycycline, oral, 100 mg, once daily for 36 weeks.
arm group label: Incentive
arm group type: Active Comparator
description: Subjects in the incentive arm will receive escalating payments for remaining STI free at Weeks 12, 24 and 36.
intervention type: Drug
intervention name: Doxycycyline
arm group label: Doxycycline
intervention type: Behavioral
intervention name: Incentive
arm group label: Incentive
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey D Klausner, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
citation: Celum CL. Sexually transmitted infections and HIV: epidemiology and interventions. Top HIV Med. 2010 Oct-Nov;18(4):138-42.
PMID: 21107013
citation: Goh BT. Syphilis in adults. Sex Transm Infect. 2005 Dec;81(6):448-52. doi: 10.1136/sti.2005.015875.
PMID: 16326843
citation: Lynn WA, Lightman S. Syphilis and HIV: a dangerous combination. Lancet Infect Dis. 2004 Jul;4(7):456-66. doi: 10.1016/S1473-3099(04)01061-8.
PMID: 15219556
citation: Centers for Disease Control and Prevention (CDC). Outbreak of syphilis among men who have sex with men--Southern California, 2000. MMWR Morb Mortal Wkly Rep. 2001 Feb 23;50(7):117-20.
PMID: 11393490
citation: Horberg MA, Ranatunga DK, Quesenberry CP, Klein DB, Silverberg MJ. Syphilis epidemiology and clinical outcomes in HIV-infected and HIV-uninfected patients in Kaiser Permanente Northern California. Sex Transm Dis. 2010 Jan;37(1):53-8. doi: 10.1097/OLQ.0b013e3181b6f0cc.
PMID: 19734820
citation: Marcus JL, Katz KA, Bernstein KT, Nieri G, Philip SS. Syphilis testing behavior following diagnosis with early syphilis among men who have sex with men--San Francisco, 2005-2008. Sex Transm Dis. 2011 Jan;38(1):24-9. doi: 10.1097/OLQ.0b013e3181ea170b.
PMID: 20679965
citation: Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect. 1999 Feb;75(1):3-17. doi: 10.1136/sti.75.1.3.
PMID: 10448335
responsible party type: Principal Investigator
investigator affiliation: Los Angeles LGBT Center
investigator full name: Matthew Beymer
investigator title: Epidemiologist, Health and Mental Health Services
mesh term: Syphilis