<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/NCT01720641</url>
  </required_header>
  <id_info>
    <org_study_id>K23MH084611</org_study_id>
    <secondary_id>IMP-478-2012</secondary_id>
    <secondary_id>K23MH084611</secondary_id>
    <nct_id>NCT01720641</nct_id>
  </id_info>
  <brief_title>Partner Notification Strategies for MSM in Peru</brief_title>
  <official_title>Partner Notification Strategies for STI Control in Urban 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>
      The goal of the proposed research is to assess new strategies for partner management and&#xD;
      sexually transmitted infection (STI) control to reduce the spread of HIV-1 among men who have&#xD;
      sex with men (MSM) in Latin America. The HIV epidemic in Peru remains concentrated within the&#xD;
      core risk group of MSM. STI infection and re-infection are central to the continuation of the&#xD;
      HIV epidemic among MSM in Peru. Development of improved strategies for partner notification&#xD;
      and treatment will reduce the incidence and prevalence of STIs and ultimately reduce the&#xD;
      incidence of HIV infection in this population. The first phase of this study used qualitative&#xD;
      methods to explore attitudes and practices related to partner notification among MSM in Lima,&#xD;
      Peru. Findings from the qualitative research were used to develop a quantitative survey&#xD;
      instrument to assess partner notification decision-making processes and practices among MSM&#xD;
      in Peru recently diagnosed with HIV or syphilis infection. Data from both quantitative and&#xD;
      qualitative phases of the study have been used to develop a partner notification for MSM in&#xD;
      Peru. Investigators plan to implement and assess the impact of the intervention on rates of&#xD;
      partner notification following a diagnosis of syphilis among MSM in Lima, Peru. The&#xD;
      investigators hypothesize that participants randomized to receive one or more partner&#xD;
      notification tools will report a higher frequency of partner notification.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim: To assess the efficacy of internet- and referral card-based partner&#xD;
      notification tools for the improvement of partner notification outcomes among MSM in Lima,&#xD;
      Peru. As attitudes and behaviors related to partner notification vary within specific&#xD;
      behavioral, social, and clinical contexts, interventions designed to improve partner&#xD;
      notification outcomes must address the same contextual determinants to be effective. Partner&#xD;
      notification tools based on electronic distribution of anonymous notification messages and/or&#xD;
      patient-delivered referral cards are expected to increase notification rates in specific&#xD;
      contexts.&#xD;
&#xD;
      Hypothesis: Provision of partner notification tools based on electronic and printed resources&#xD;
      will improve reported and observed partner notification outcomes by overcoming barriers to&#xD;
      notification including limited contact information, fear of disclosure, stigma, and lack of&#xD;
      informational resources. Notification outcomes and use of notification tools will vary&#xD;
      according to strategies of interpersonal communication reflected in the specific behavioral,&#xD;
      social, and biomedical contexts of the individual, the partnership, and the STI diagnosed.&#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 new syphilis infection will be eligible for enrollment in&#xD;
      the Partner Notification protocol.&#xD;
&#xD;
      I. Recruitment: Participants in the EPT/Partner Notification Screening Protocol who are&#xD;
      diagnosed with syphilis based on physician interpretation of results of RPR assay and&#xD;
      clinical history will be invited by the Study Counselor to participate in the Partner&#xD;
      Notification 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 Partner Notification Intervention&#xD;
      Protocol will be randomized to either the experimental Partner Notification intervention or&#xD;
      the Standard of Care (Partner Notification 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 experimental Partner Notification&#xD;
      intervention will be provided with standard partner notification counseling as well as 5&#xD;
      printed referral cards with information about syphilis infection and a referral sheet for the&#xD;
      Spanish language version of the inSPOT internet-based partner notification service&#xD;
      (www.inspot.org). Referral cards will include printed material informing the recipient that&#xD;
      they may have been exposed to syphilis, and will provide information on syphilis infection,&#xD;
      including local resources for testing and treatment. The inSPOT website is a free&#xD;
      internet-based notification service that offers anonymous automated e-mail partner&#xD;
      notification services following an STI diagnosis. Users of the system select a diagnosis as&#xD;
      well as a standardized notification message which they can personalized with their name and&#xD;
      other messages if they desire. The user then enters the e-mail address(es) of the person(s)&#xD;
      they wish to notify and the system delivers an automated e-mail notification to the person&#xD;
      advising them of their potential exposure to an STI and advising them to seek STI testing.&#xD;
      The notification also includes the address of the inSPOT website which contains additional&#xD;
      information on HIV/STIs, risks for transmission, and resources for testing and treatment.&#xD;
      Participants will be instructed on how to use both tools to assist them in the partner&#xD;
      notification process.&#xD;
&#xD;
      Participants randomized to the control arm will receive standard partner notification&#xD;
      counseling by study staff, without any supplemental notification tools.&#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 1 month&#xD;
      after enrollment and randomization. At the Follow-up evaluation, participants will complete a&#xD;
      brief survey (Partner Notification Follow-up Survey).&#xD;
&#xD;
      VII. Survey: Participants will complete a brief follow-up survey assessing their general&#xD;
      partner notification behavior as well as the actual notification and treatment outcome for&#xD;
      each of their three most recent partners, as well as factors that impeded and/or promoted&#xD;
      partner notification and treatment. Participants will be asked to specify whether each&#xD;
      partner was notified, whether they received antibiotic treatment and/or sought STI testing,&#xD;
      the participant's degree of certainty of the outcomes, and the reasons why each partner was&#xD;
      or was not notified and/or treated.&#xD;
&#xD;
      VIII. 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 syphilis, 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;
      IX. Qualitative Evaluation. A randomly selected subgroup of participants in the Partner&#xD;
      Notification Intervention Protocol will be invited to participate in individual interviews&#xD;
      about the 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 interview and will&#xD;
      receive additional compensation for their participation.&#xD;
&#xD;
      X. Eligibility. A randomly selected subset of participants from the Partner Notification&#xD;
      intervention protocol will be invited to participate in the individual qualitative&#xD;
      interviews. Every fourth participant randomized will be invited to participate in an&#xD;
      individual interview until reaching the projected qualitative study sample of 20 participants&#xD;
      (10 each from the intervention and control arms). Participants will be asked to complete a&#xD;
      separate informed consent document indicating their willingness to participate in a&#xD;
      qualitative interview.&#xD;
&#xD;
      XI. Interview Conduct. Interviews will be conducted in Spanish in a private room by a trained&#xD;
      interviewer. Interviews will be recorded and transcribed verbatim. Participants will be&#xD;
      advised that they can stop the interview at any time and that they will be able to stop the&#xD;
      tape and erase any response during the interview if they desire.&#xD;
&#xD;
      XII. 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; structural access to partner testing and treatment within&#xD;
      local social, cultural, and economic contexts; and the effectiveness of the study's&#xD;
      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 recent partner notification at 14-21 days of follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator-confirmed Partner Notification</measure>
    <time_frame>21 Days</time_frame>
    <description>Participants who report notifying one or more of their three most recent partners will be asked for permission for the investigators to contact one or more of these partners to confirm notification outcomes. Partners who are successfully contacted and confirm prior partner notification will be defined as confirmed notifications.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">370</enrollment>
  <condition>Partner Notification Following STI Diagnosis</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>Internet Notification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardized partner notification counseling and referral to internet-based partner referral website.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Referral Card</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardized partner notification counseling and provision of 5 printed partner referral cards.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Internet and Referral Card</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardized partner notification counseling and referral to internet-based partner referral website and provision of 5 printed partner referral cards.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet</intervention_name>
    <description>Referral and user instructions for Peru section of www.inspot.org partner notification website</description>
    <arm_group_label>Internet Notification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Referral Card</intervention_name>
    <description>5 printed referral cards with information on syphilis signs, symptoms, diagnosis, treatment, and local resources.</description>
    <arm_group_label>Referral Card</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet and Referral Card</intervention_name>
    <description>5 printed referral cards with information on syphilis signs, symptoms, diagnosis, treatment, and local resources; Referral and user instructions for Peru section of www.inspot.org partner notification website.</description>
    <arm_group_label>Internet and Referral Card</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Male or biologically male at birth&#xD;
&#xD;
          3. Sexual contact (oral or anal intercourse) with a male or male-to-female transgender&#xD;
             partner in the past 12 months&#xD;
&#xD;
          4. Diagnosis with syphilis infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Under 18 years of age&#xD;
&#xD;
          2. Unable to understand informed consent procedures&#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>
  <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>MSM</keyword>
  <keyword>Transgender Women</keyword>
  <keyword>Partner Notification</keyword>
  <keyword>Syphilis</keyword>
  <keyword>Peru</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01720641
org study id: K23MH084611
secondary id: IMP-478-2012
secondary id: K23MH084611
nct id: NCT01720641
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The goal of the proposed research is to assess new strategies for partner management and
      sexually transmitted infection (STI) control to reduce the spread of HIV-1 among men who have
      sex with men (MSM) in Latin America. The HIV epidemic in Peru remains concentrated within the
      core risk group of MSM. STI infection and re-infection are central to the continuation of the
      HIV epidemic among MSM in Peru. Development of improved strategies for partner notification
      and treatment will reduce the incidence and prevalence of STIs and ultimately reduce the
      incidence of HIV infection in this population. The first phase of this study used qualitative
      methods to explore attitudes and practices related to partner notification among MSM in Lima,
      Peru. Findings from the qualitative research were used to develop a quantitative survey
      instrument to assess partner notification decision-making processes and practices among MSM
      in Peru recently diagnosed with HIV or syphilis infection. Data from both quantitative and
      qualitative phases of the study have been used to develop a partner notification for MSM in
      Peru. Investigators plan to implement and assess the impact of the intervention on rates of
      partner notification following a diagnosis of syphilis among MSM in Lima, Peru. The
      investigators hypothesize that participants randomized to receive one or more partner
      notification tools will report a higher frequency of partner notification.
Specific Aim: To assess the efficacy of internet- and referral card-based partner
      notification tools for the improvement of partner notification outcomes among MSM in Lima,
      Peru. As attitudes and behaviors related to partner notification vary within specific
      behavioral, social, and clinical contexts, interventions designed to improve partner
      notification outcomes must address the same contextual determinants to be effective. Partner
      notification tools based on electronic distribution of anonymous notification messages and/or
      patient-delivered referral cards are expected to increase notification rates in specific
      contexts.

      Hypothesis: Provision of partner notification tools based on electronic and printed resources
      will improve reported and observed partner notification outcomes by overcoming barriers to
      notification including limited contact information, fear of disclosure, stigma, and lack of
      informational resources. Notification outcomes and use of notification tools will vary
      according to strategies of interpersonal communication reflected in the specific behavioral,
      social, and biomedical contexts of the individual, the partnership, and the STI diagnosed.

      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 new syphilis infection will be eligible for enrollment in
      the Partner Notification protocol.

      I. Recruitment: Participants in the EPT/Partner Notification Screening Protocol who are
      diagnosed with syphilis based on physician interpretation of results of RPR assay and
      clinical history will be invited by the Study Counselor to participate in the Partner
      Notification 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 Partner Notification Intervention
      Protocol will be randomized to either the experimental Partner Notification intervention 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 experimental Partner Notification
      intervention will be provided with standard partner notification counseling as well as 5
      printed referral cards with information about syphilis infection and a referral sheet for the
      Spanish language version of the inSPOT internet-based partner notification service
      (www.inspot.org). Referral cards will include printed material informing the recipient that
      they may have been exposed to syphilis, and will provide information on syphilis infection,
      including local resources for testing and treatment. The inSPOT website is a free
      internet-based notification service that offers anonymous automated e-mail partner
      notification services following an STI diagnosis. Users of the system select a diagnosis as
      well as a standardized notification message which they can personalized with their name and
      other messages if they desire. The user then enters the e-mail address(es) of the person(s)
      they wish to notify and the system delivers an automated e-mail notification to the person
      advising them of their potential exposure to an STI and advising them to seek STI testing.
      The notification also includes the address of the inSPOT website which contains additional
      information on HIV/STIs, risks for transmission, and resources for testing and treatment.
      Participants will be instructed on how to use both tools to assist them in the partner
      notification process.

      Participants randomized to the control arm will receive standard partner notification
      counseling by study staff, without any supplemental notification tools.

      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 1 month
      after enrollment and randomization. At the Follow-up evaluation, participants will complete a
      brief survey (Partner Notification Follow-up Survey).

      VII. Survey: Participants will complete a brief follow-up survey assessing their general
      partner notification behavior as well as the actual notification and treatment outcome for
      each of their three most recent partners, 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 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. 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 syphilis, 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.

      IX. Qualitative Evaluation. A randomly selected subgroup of participants in the Partner
      Notification 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 interview and will
      receive additional compensation for their participation.

      X. Eligibility. A randomly selected subset of participants from the Partner Notification
      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.

      XI. 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.

      XII. 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; 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 recent partner notification at 14-21 days of follow-up.
measure: Investigator-confirmed Partner Notification
time frame: 21 Days
description: Participants who report notifying one or more of their three most recent partners will be asked for permission for the investigators to contact one or more of these partners to confirm notification outcomes. Partners who are successfully contacted and confirm prior partner notification will be defined as confirmed notifications.
arm group label: Control
arm group type: No Intervention
description: Standardized partner notification counseling
arm group label: Internet Notification
arm group type: Experimental
description: Standardized partner notification counseling and referral to internet-based partner referral website.
arm group label: Referral Card
arm group type: Experimental
description: Standardized partner notification counseling and provision of 5 printed partner referral cards.
arm group label: Internet and Referral Card
arm group type: Experimental
description: Standardized partner notification counseling and referral to internet-based partner referral website and provision of 5 printed partner referral cards.
intervention type: Behavioral
intervention name: Internet
description: Referral and user instructions for Peru section of www.inspot.org partner notification website
arm group label: Internet Notification
intervention type: Behavioral
intervention name: Referral Card
description: 5 printed referral cards with information on syphilis signs, symptoms, diagnosis, treatment, and local resources.
arm group label: Referral Card
intervention type: Behavioral
intervention name: Internet and Referral Card
description: 5 printed referral cards with information on syphilis signs, symptoms, diagnosis, treatment, and local resources; Referral and user instructions for Peru section of www.inspot.org partner notification website.
arm group label: Internet and Referral Card
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
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