<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/NCT01720654</url>
  </required_header>
  <id_info>
    <org_study_id>R21MH092232</org_study_id>
    <secondary_id>IMP-478-2012</secondary_id>
    <secondary_id>R21MH092232</secondary_id>
    <nct_id>NCT01720654</nct_id>
  </id_info>
  <brief_title>Expedited Partner Therapy for MSM in Peru</brief_title>
  <official_title>Expedited Partner Therapy as STI Control Among MSM in Peru</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Asociación Civil Impacta Salud y Educación, Peru</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent&#xD;
      gonorrhea and chlamydia infection in heterosexual patients, but has not been evaluated for&#xD;
      use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner&#xD;
      management with heterosexual patients, but note the absence of evidence necessary to make an&#xD;
      equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess&#xD;
      the impact of EPT on partner notification, treatment, and STI re-infection among MSM are&#xD;
      critical to the development of evidence-based partner management guidelines.&#xD;
&#xD;
      Recent data from urban Peru has identified prevalences of rectal and pharyngeal gonorrhea and&#xD;
      chlamydia ranging from 5-20%. The elevated burden of disease among MSM in Peru suggests that&#xD;
      frequent transmission of undiagnosed gonorrhea and chlamydia through MSM sexual networks may&#xD;
      be a factor contributing to the persistently high incidence of HIV infection among MSM in the&#xD;
      region. The investigators propose a pilot evaluation of the effect of EPT on partner&#xD;
      notification and treatment among MSM in Peru diagnosed with gonorrhea or chlamydia at any&#xD;
      anatomic site.&#xD;
&#xD;
      Specific Aim 1: To explore the social norms and structural factors influencing partner&#xD;
      notification and treatment among MSM in Peru.&#xD;
&#xD;
      Specific Aim 2: To determine the effect of EPT on anticipated and actual partner notification&#xD;
      among MSM diagnosed with gonorrhea or chlamydia infection.&#xD;
&#xD;
      Specific Aim 3: To develop preliminary data on rates of gonococcal and chlamydial&#xD;
      re-infection among MSM randomized to receive EPT compared with standard partner notification&#xD;
      counseling.&#xD;
&#xD;
      The proposed study will provide pilot data on the use of EPT with MSM diagnosed with&#xD;
      gonorrhea or chlamydia and form the basis for a subsequent Phase III clinical trial of EPT as&#xD;
      an STI control method among MSM in Latin America.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim 1: To determine the effect of Expedited Partner Therapy (EPT) on anticipated and&#xD;
      actual partner notification among MSM diagnosed with gonorrhea or chlamydia infection.&#xD;
&#xD;
      The investigators believe that provision of EPT will alter the behavioral and social contexts&#xD;
      of STI management in MSM partnerships by coupling the acts of partner treatment and partner&#xD;
      notification. As a result, the investigators hypothesize that MSM provided with EPT will&#xD;
      report higher rates of partner notification and treatment compared with men who receive&#xD;
      standard partner notification counseling. Quantitative analysis of partner notification&#xD;
      outcomes, using the specific examples of participants' five most recent sex partners, will&#xD;
      provide a broad estimate of notification and treatment behaviors within the study population.&#xD;
      Individual in-depth interviews with a diverse sub-set of participants will be used to provide&#xD;
      further interpretive depth regarding the behavioral, social, and structural issues associated&#xD;
      with anticipated and actual partner notification and treatment in specific interpersonal&#xD;
      contexts, and to address logistical issues related to implementation of the intervention and&#xD;
      the accuracy of the study's outcome measures for assessing participants' experiences of&#xD;
      partner management.&#xD;
&#xD;
      Specific Aim 2: To collect preliminary data on rates of gonorrhea and chlamydia re-infection&#xD;
      among MSM randomized to receive EPT compared with standard partner notification counseling.&#xD;
&#xD;
      The investigators anticipate that MSM provided with EPT will have a lower prevalence of&#xD;
      persistent or recurrent urethral, rectal, or pharyngeal gonorrhea and/or chlamydia infection&#xD;
      at the one-month follow-up visit compared with men who receive only standard partner&#xD;
      notification counseling. Due to the exploratory nature of the proposed study, the&#xD;
      investigators have not designed the protocol as an evaluation of the clinical effectiveness&#xD;
      of EPT on STI re-infection among MSM. However, the data collected will provide essential&#xD;
      preliminary information on the behavioral, social, and epidemiologic contexts of partner&#xD;
      management among MSM in Peru needed to design a future clinical trial on the use of EPT as a&#xD;
      network-based strategy for STI control among MSM.&#xD;
&#xD;
      Participants will be selected for participation in the study depending on the findings of the&#xD;
      EPT/Partner Notification Screening Protocol. Participants in the EPT/Partner Notification&#xD;
      Screening Protocol diagnosed with urethritis and/or proctitis, or Gonorrhea and/or Chlamydia&#xD;
      in the urethra, rectum, or oropharynx will be eligible for enrollment in the EPT trial&#xD;
      protocol.&#xD;
&#xD;
      I. Recruitment: Participants in the EPT/Partner Notification Screening Protocol who are&#xD;
      diagnosed by the Study Physician as having clinical urethritis or proctitis, or diagnosed&#xD;
      with laboratory-confirmed Gonorrhea and/or Chlamydia infection will be invited by the Study&#xD;
      Counselor to participate in the EPT Intervention Protocol.&#xD;
&#xD;
      II. Informed Consent: All potential subjects will receive an explanation of the study&#xD;
      procedures and risks and benefits and asked to provide written Informed Consent. Participants&#xD;
      will be given the opportunity to take the Informed Consent Document home for further review&#xD;
      and decide at a later time if they wish to participate in the study.&#xD;
&#xD;
      III. Enrollment: Subjects who consent to participate in the EPT Intervention Protocol will be&#xD;
      randomized to either the Intervention (EPT) or the Standard of Care (Partner Notification&#xD;
      Counseling) arm.&#xD;
&#xD;
      IV Randomization: Eligible subjects who provide consent to participate will be randomly&#xD;
      assigned to intervention or control groups using a random permuted block allocation (block&#xD;
      size=7 in an alternating 4/3 ratio). Computer-generated randomization assignments will be&#xD;
      stored in opaque, sealed envelopes opened at the time of allocation. Randomization&#xD;
      assignments will be recorded and identified by the participant's numeric study code.&#xD;
&#xD;
      V. Intervention Delivery. Participants assigned to the EPT intervention will be provided with&#xD;
      standard partner notification counseling as well as a maximum of 5 EPT packets to distribute&#xD;
      to their recent (within 3 months) sex partners.&#xD;
&#xD;
      EPT packets will contain both Cefixime 400 mg and Azithromycin 1g in pill form, as well as a&#xD;
      card providing information on gonorrhea and chlamydia infections, the risks and benefits of&#xD;
      the antibiotics provided (including allergic reactions), and the importance of testing for&#xD;
      HIV and other STIs.&#xD;
&#xD;
      Participants randomized to the control arm will receive standard partner notification&#xD;
      counseling by study staff.&#xD;
&#xD;
      Following delivery of the intervention, an appointment will be scheduled for participants to&#xD;
      return to the research site in 1 month.&#xD;
&#xD;
      VI. Follow-up Evaluation. All participants will be asked to return to the study site 2-4&#xD;
      weeks after enrollment and randomization. At the Follow-up evaluation, participants will&#xD;
      complete a brief survey and undergo repeat testing for gonorrhea/chlamydia.&#xD;
&#xD;
      VII. Survey: Participants will complete a brief follow-up survey assessing the actual&#xD;
      notification and treatment outcome for all of their recent partners generally and each of&#xD;
      their three most recent partners specifically, as well as factors that impeded and/or&#xD;
      promoted partner notification and treatment. Participants will be asked to specify whether&#xD;
      each partner was notified, whether they received antibiotic treatment and/or sought HIV/STI&#xD;
      testing, the participant's degree of certainty of the outcomes, and the reasons why each&#xD;
      partner was or was not notified and/or treated.&#xD;
&#xD;
      VIII. Specimen Collection: Samples of urine, rectal and pharyngeal swabs will be collected as&#xD;
      follows:&#xD;
&#xD;
      -Physical Examination: The study physician will conduct a brief physical examination and&#xD;
      clinical history to assess for signs or symptoms of STIs, including urethritis, proctitis,&#xD;
      and genital ulcer disease. During the physical examination, the study physician will obtain&#xD;
      swabs of the rectum and oropharynx. While performing the pharyngeal exam, the physician will&#xD;
      use a new Aptima GenProbe collection kit to obtain a swab of the tonsillar pillars. While&#xD;
      performing the rectal examination, the physician will use a new Aptima GenProbe collection&#xD;
      kit to obtain a swab of the anorectal canal. Participants will also be given the option to&#xD;
      self-collect the rectal swab specimen. No urethral swab will be obtained for this study.&#xD;
&#xD;
      Findings from the physical exam and clinical history will be recorded on a Case Report Form&#xD;
      (CRF) and identified by the participant's numeric study code.&#xD;
&#xD;
      -Specimen Collection: Following physical examination, participants will be asked to provide a&#xD;
      urine sample. Participants will also be instructed in how to collect a 20 mL clean,&#xD;
      first-catch urine specimen in a sterile container.&#xD;
&#xD;
      IX. Laboratory Testing: All samples will be tested for the presence of Gonorrhea and&#xD;
      Chlamydia at the U.S. Naval Medical Research Unit Laboratory. Participants will be asked to&#xD;
      return to the study site in 14 days for results of repeat Gonorrhea and Chlamydia testing.&#xD;
      Participants with recurrent or persistent infection will receive a second course of treatment&#xD;
      according to the treatment protocol described above. All participants with recurrent or&#xD;
      persistent infection will receive additional counseling on the importance of partner&#xD;
      notification.&#xD;
&#xD;
      Due to the possibility of fluoroquinolone-resistant gonorrhea infection, participants treated&#xD;
      with Ciprofloxacin will be informed of the high frequency of Ciprofloxacin resistance and&#xD;
      study staff will emphasize with all participants, but with these participants in particular,&#xD;
      the importance of returning to the study site to receive results of their repeat testing/test&#xD;
      of cure.&#xD;
&#xD;
      X. Confirmation of Partner Notification: In order to provide independent confirmation of&#xD;
      participant-reported notification status, study staff will ask participants for permission to&#xD;
      conduct third party partner notification and confirmation of reported notification status.&#xD;
      Participants will be asked for permission to contact their recent partner(s) by telephone or&#xD;
      e-mail to confirm the notification outcome. Subjects will be informed that they are not&#xD;
      obligated to provide contact information for any of their partners. Subjects will also be&#xD;
      informed that if they provide contact information for their partner(s), study staff will&#xD;
      contact the person using the contact information provided and notify the person only that&#xD;
      someone they recently had sex with has been diagnosed with an STI, provide information on&#xD;
      local sites offering free or low cost testing for HIV and STIs, and answer any questions the&#xD;
      partner might have. Subjects will be informed that study staff will not reveal the&#xD;
      participant's name or other identifying information to their partner(s). If the participant&#xD;
      provides contact information for their partner(s), study staff will contact the person and&#xD;
      provide third-party partner notification using an IRB-approved script. After completing the&#xD;
      partner notification process, study staff will ask the partner only if they had previously&#xD;
      been notified by a partner about an STI diagnosis (&quot;Yes/No&quot;). Partners will not be asked for&#xD;
      any additional information.&#xD;
&#xD;
      XI. Qualitative Evaluation. A randomly selected subgroup of participants in the EPT&#xD;
      Intervention Protocol will be invited to participate in individual interviews about the&#xD;
      partner notification process. Each participant will be asked to participate in two&#xD;
      interviews, one following randomization and one following the Follow-up Visit. Participants&#xD;
      will complete a separate informed consent process for the individual interviews and will&#xD;
      receive additional compensation for their participation.&#xD;
&#xD;
      XII. Eligibility. A randomly selected subset of participants from the EPT intervention&#xD;
      protocol will be invited to participate in the individual qualitative interviews. Every&#xD;
      fourth participant randomized will be invited to participate in an individual interview until&#xD;
      reaching the projected qualitative study sample of 20 participants (10 each from the&#xD;
      intervention and control arms). Participants will be asked to complete a separate informed&#xD;
      consent document indicating their willingness to participate in a qualitative interview.&#xD;
&#xD;
      XIII. Interview Conduct. Interviews will be conducted in Spanish in a private room by a&#xD;
      trained interviewer. Interviews will be recorded and transcribed verbatim. Participants will&#xD;
      be advised that they can stop the interview at any time and that they will be able to stop&#xD;
      the tape and erase any response during the interview if they desire.&#xD;
&#xD;
      XIV. Interview Content: Baseline interviews will focus on individual decision-making&#xD;
      processes regarding partner notification in specific partnership contexts with a focus on the&#xD;
      influence of: STI-related stigma and shame; the gender and sexual identity of participants&#xD;
      and their partner(s); perceived power differentials within the partnership(s); patterns of&#xD;
      communication within the partnership(s); and structural access to testing and treatment.&#xD;
&#xD;
      Follow-up interviews will discuss actual notification and treatment outcomes. Follow-up&#xD;
      interviews will emphasize: barriers or catalysts to implementing notification decisions in&#xD;
      specific partnership contexts; the impact of EPT on partner notification practices; practical&#xD;
      and logistical issues related to delivery of EPT; structural access to partner testing and&#xD;
      treatment within local social, cultural, and economic contexts; and the effectiveness of the&#xD;
      study's quantitative outcomes in accurately measuring participants' lived experiences.&#xD;
&#xD;
      Each interview is expected to last approximately 20-30 minutes. Audio recordings and&#xD;
      transcripts of interviews will be identified by the participant's numeric study code and the&#xD;
      date of the interview.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 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>Self-reported Partner Notification</measure>
    <time_frame>21 Days</time_frame>
    <description>Participant self-report of partner notification 14-21 days after randomization</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Gonorrhea</condition>
  <condition>Chlamydia</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standardized partner notification counseling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EPT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardized partner notification counseling and provision of 5 partner treatment (EPT) packets.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EPT</intervention_name>
    <description>Standardized partner notification counseling and provision of 5 partner treatment packets containing: Printed information on signs, symptoms, diagnosis, and treatment of gonorrhea and chlamydia as well as information on local testing/treatment resources; 400 mg Cefixime and 1g Azithromycin.</description>
    <arm_group_label>EPT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Biologically male at birth&#xD;
&#xD;
          2. 18 years of age or older&#xD;
&#xD;
          3. Sexual contact (oral or anal intercourse) with a male or male-to-female transgender&#xD;
             person within the past 12 months.&#xD;
&#xD;
          4. Clinical Urethritis or proctitis OR Laboratory-diagnosed gonorrhea and/or chlamydia in&#xD;
             any anatomic site (urethra, rectum, or oropharynx)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Under 18 years of age&#xD;
&#xD;
          2. Anatomically female at birth&#xD;
&#xD;
          3. Unable to understand study procedures or provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jesse L Clark, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas J Coates, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asociacion Civil Impacta Salud y Educacion</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Peru</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Jesse Clark</investigator_full_name>
    <investigator_title>Assistant Professor-in-Residence</investigator_title>
  </responsible_party>
  <keyword>Expedited Partner Therapy</keyword>
  <keyword>MSM</keyword>
  <keyword>Peru</keyword>
  <keyword>Gonorrhea</keyword>
  <keyword>Chlamydia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlamydia Infections</mesh_term>
    <mesh_term>Gonorrhea</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/NCT01720654
org study id: R21MH092232
secondary id: IMP-478-2012
secondary id: R21MH092232
nct id: NCT01720654
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent
      gonorrhea and chlamydia infection in heterosexual patients, but has not been evaluated for
      use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner
      management with heterosexual patients, but note the absence of evidence necessary to make an
      equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess
      the impact of EPT on partner notification, treatment, and STI re-infection among MSM are
      critical to the development of evidence-based partner management guidelines.

      Recent data from urban Peru has identified prevalences of rectal and pharyngeal gonorrhea and
      chlamydia ranging from 5-20%. The elevated burden of disease among MSM in Peru suggests that
      frequent transmission of undiagnosed gonorrhea and chlamydia through MSM sexual networks may
      be a factor contributing to the persistently high incidence of HIV infection among MSM in the
      region. The investigators propose a pilot evaluation of the effect of EPT on partner
      notification and treatment among MSM in Peru diagnosed with gonorrhea or chlamydia at any
      anatomic site.

      Specific Aim 1: To explore the social norms and structural factors influencing partner
      notification and treatment among MSM in Peru.

      Specific Aim 2: To determine the effect of EPT on anticipated and actual partner notification
      among MSM diagnosed with gonorrhea or chlamydia infection.

      Specific Aim 3: To develop preliminary data on rates of gonococcal and chlamydial
      re-infection among MSM randomized to receive EPT compared with standard partner notification
      counseling.

      The proposed study will provide pilot data on the use of EPT with MSM diagnosed with
      gonorrhea or chlamydia and form the basis for a subsequent Phase III clinical trial of EPT as
      an STI control method among MSM in Latin America.
Specific Aim 1: To determine the effect of Expedited Partner Therapy (EPT) on anticipated and
      actual partner notification among MSM diagnosed with gonorrhea or chlamydia infection.

      The investigators believe that provision of EPT will alter the behavioral and social contexts
      of STI management in MSM partnerships by coupling the acts of partner treatment and partner
      notification. As a result, the investigators hypothesize that MSM provided with EPT will
      report higher rates of partner notification and treatment compared with men who receive
      standard partner notification counseling. Quantitative analysis of partner notification
      outcomes, using the specific examples of participants' five most recent sex partners, will
      provide a broad estimate of notification and treatment behaviors within the study population.
      Individual in-depth interviews with a diverse sub-set of participants will be used to provide
      further interpretive depth regarding the behavioral, social, and structural issues associated
      with anticipated and actual partner notification and treatment in specific interpersonal
      contexts, and to address logistical issues related to implementation of the intervention and
      the accuracy of the study's outcome measures for assessing participants' experiences of
      partner management.

      Specific Aim 2: To collect preliminary data on rates of gonorrhea and chlamydia re-infection
      among MSM randomized to receive EPT compared with standard partner notification counseling.

      The investigators anticipate that MSM provided with EPT will have a lower prevalence of
      persistent or recurrent urethral, rectal, or pharyngeal gonorrhea and/or chlamydia infection
      at the one-month follow-up visit compared with men who receive only standard partner
      notification counseling. Due to the exploratory nature of the proposed study, the
      investigators have not designed the protocol as an evaluation of the clinical effectiveness
      of EPT on STI re-infection among MSM. However, the data collected will provide essential
      preliminary information on the behavioral, social, and epidemiologic contexts of partner
      management among MSM in Peru needed to design a future clinical trial on the use of EPT as a
      network-based strategy for STI control among MSM.

      Participants will be selected for participation in the study depending on the findings of the
      EPT/Partner Notification Screening Protocol. Participants in the EPT/Partner Notification
      Screening Protocol diagnosed with urethritis and/or proctitis, or Gonorrhea and/or Chlamydia
      in the urethra, rectum, or oropharynx will be eligible for enrollment in the EPT trial
      protocol.

      I. Recruitment: Participants in the EPT/Partner Notification Screening Protocol who are
      diagnosed by the Study Physician as having clinical urethritis or proctitis, or diagnosed
      with laboratory-confirmed Gonorrhea and/or Chlamydia infection will be invited by the Study
      Counselor to participate in the EPT Intervention Protocol.

      II. Informed Consent: All potential subjects will receive an explanation of the study
      procedures and risks and benefits and asked to provide written Informed Consent. Participants
      will be given the opportunity to take the Informed Consent Document home for further review
      and decide at a later time if they wish to participate in the study.

      III. Enrollment: Subjects who consent to participate in the EPT Intervention Protocol will be
      randomized to either the Intervention (EPT) or the Standard of Care (Partner Notification
      Counseling) arm.

      IV Randomization: Eligible subjects who provide consent to participate will be randomly
      assigned to intervention or control groups using a random permuted block allocation (block
      size=7 in an alternating 4/3 ratio). Computer-generated randomization assignments will be
      stored in opaque, sealed envelopes opened at the time of allocation. Randomization
      assignments will be recorded and identified by the participant's numeric study code.

      V. Intervention Delivery. Participants assigned to the EPT intervention will be provided with
      standard partner notification counseling as well as a maximum of 5 EPT packets to distribute
      to their recent (within 3 months) sex partners.

      EPT packets will contain both Cefixime 400 mg and Azithromycin 1g in pill form, as well as a
      card providing information on gonorrhea and chlamydia infections, the risks and benefits of
      the antibiotics provided (including allergic reactions), and the importance of testing for
      HIV and other STIs.

      Participants randomized to the control arm will receive standard partner notification
      counseling by study staff.

      Following delivery of the intervention, an appointment will be scheduled for participants to
      return to the research site in 1 month.

      VI. Follow-up Evaluation. All participants will be asked to return to the study site 2-4
      weeks after enrollment and randomization. At the Follow-up evaluation, participants will
      complete a brief survey and undergo repeat testing for gonorrhea/chlamydia.

      VII. Survey: Participants will complete a brief follow-up survey assessing the actual
      notification and treatment outcome for all of their recent partners generally and each of
      their three most recent partners specifically, as well as factors that impeded and/or
      promoted partner notification and treatment. Participants will be asked to specify whether
      each partner was notified, whether they received antibiotic treatment and/or sought HIV/STI
      testing, the participant's degree of certainty of the outcomes, and the reasons why each
      partner was or was not notified and/or treated.

      VIII. Specimen Collection: Samples of urine, rectal and pharyngeal swabs will be collected as
      follows:

      -Physical Examination: The study physician will conduct a brief physical examination and
      clinical history to assess for signs or symptoms of STIs, including urethritis, proctitis,
      and genital ulcer disease. During the physical examination, the study physician will obtain
      swabs of the rectum and oropharynx. While performing the pharyngeal exam, the physician will
      use a new Aptima GenProbe collection kit to obtain a swab of the tonsillar pillars. While
      performing the rectal examination, the physician will use a new Aptima GenProbe collection
      kit to obtain a swab of the anorectal canal. Participants will also be given the option to
      self-collect the rectal swab specimen. No urethral swab will be obtained for this study.

      Findings from the physical exam and clinical history will be recorded on a Case Report Form
      (CRF) and identified by the participant's numeric study code.

      -Specimen Collection: Following physical examination, participants will be asked to provide a
      urine sample. Participants will also be instructed in how to collect a 20 mL clean,
      first-catch urine specimen in a sterile container.

      IX. Laboratory Testing: All samples will be tested for the presence of Gonorrhea and
      Chlamydia at the U.S. Naval Medical Research Unit Laboratory. Participants will be asked to
      return to the study site in 14 days for results of repeat Gonorrhea and Chlamydia testing.
      Participants with recurrent or persistent infection will receive a second course of treatment
      according to the treatment protocol described above. All participants with recurrent or
      persistent infection will receive additional counseling on the importance of partner
      notification.

      Due to the possibility of fluoroquinolone-resistant gonorrhea infection, participants treated
      with Ciprofloxacin will be informed of the high frequency of Ciprofloxacin resistance and
      study staff will emphasize with all participants, but with these participants in particular,
      the importance of returning to the study site to receive results of their repeat testing/test
      of cure.

      X. Confirmation of Partner Notification: In order to provide independent confirmation of
      participant-reported notification status, study staff will ask participants for permission to
      conduct third party partner notification and confirmation of reported notification status.
      Participants will be asked for permission to contact their recent partner(s) by telephone or
      e-mail to confirm the notification outcome. Subjects will be informed that they are not
      obligated to provide contact information for any of their partners. Subjects will also be
      informed that if they provide contact information for their partner(s), study staff will
      contact the person using the contact information provided and notify the person only that
      someone they recently had sex with has been diagnosed with an STI, provide information on
      local sites offering free or low cost testing for HIV and STIs, and answer any questions the
      partner might have. Subjects will be informed that study staff will not reveal the
      participant's name or other identifying information to their partner(s). If the participant
      provides contact information for their partner(s), study staff will contact the person and
      provide third-party partner notification using an IRB-approved script. After completing the
      partner notification process, study staff will ask the partner only if they had previously
      been notified by a partner about an STI diagnosis ("Yes/No"). Partners will not be asked for
      any additional information.

      XI. Qualitative Evaluation. A randomly selected subgroup of participants in the EPT
      Intervention Protocol will be invited to participate in individual interviews about the
      partner notification process. Each participant will be asked to participate in two
      interviews, one following randomization and one following the Follow-up Visit. Participants
      will complete a separate informed consent process for the individual interviews and will
      receive additional compensation for their participation.

      XII. Eligibility. A randomly selected subset of participants from the EPT intervention
      protocol will be invited to participate in the individual qualitative interviews. Every
      fourth participant randomized will be invited to participate in an individual interview until
      reaching the projected qualitative study sample of 20 participants (10 each from the
      intervention and control arms). Participants will be asked to complete a separate informed
      consent document indicating their willingness to participate in a qualitative interview.

      XIII. Interview Conduct. Interviews will be conducted in Spanish in a private room by a
      trained interviewer. Interviews will be recorded and transcribed verbatim. Participants will
      be advised that they can stop the interview at any time and that they will be able to stop
      the tape and erase any response during the interview if they desire.

      XIV. Interview Content: Baseline interviews will focus on individual decision-making
      processes regarding partner notification in specific partnership contexts with a focus on the
      influence of: STI-related stigma and shame; the gender and sexual identity of participants
      and their partner(s); perceived power differentials within the partnership(s); patterns of
      communication within the partnership(s); and structural access to testing and treatment.

      Follow-up interviews will discuss actual notification and treatment outcomes. Follow-up
      interviews will emphasize: barriers or catalysts to implementing notification decisions in
      specific partnership contexts; the impact of EPT on partner notification practices; practical
      and logistical issues related to delivery of EPT; structural access to partner testing and
      treatment within local social, cultural, and economic contexts; and the effectiveness of the
      study's quantitative outcomes in accurately measuring participants' lived experiences.

      Each interview is expected to last approximately 20-30 minutes. Audio recordings and
      transcripts of interviews will be identified by the participant's numeric study code and the
      date of the interview.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Self-reported Partner Notification
time frame: 21 Days
description: Participant self-report of partner notification 14-21 days after randomization
arm group label: Control
arm group type: No Intervention
description: Standardized partner notification counseling.
arm group label: EPT
arm group type: Experimental
description: Standardized partner notification counseling and provision of 5 partner treatment (EPT) packets.
intervention type: Behavioral
intervention name: EPT
description: Standardized partner notification counseling and provision of 5 partner treatment packets containing: Printed information on signs, symptoms, diagnosis, and treatment of gonorrhea and chlamydia as well as information on local testing/treatment resources; 400 mg Cefixime and 1g Azithromycin.
arm group label: EPT
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jesse L Clark, MD, MSc
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Thomas J Coates, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: Peru
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Jesse Clark
investigator title: Assistant Professor-in-Residence
mesh term: Chlamydia Infections
mesh term: Gonorrhea