<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/NCT03293875</url>
  </required_header>
  <id_info>
    <org_study_id>1U01MD010657-01</org_study_id>
    <nct_id>NCT03293875</nct_id>
  </id_info>
  <brief_title>Adaptation and Implementation of Project Encuentro in the U.S.-Mexico Border</brief_title>
  <official_title>Adaptation and Implementation of Project Encuentro in the U.S.-Mexico Border</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lehigh University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alliance of Border Collaboratives</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Programa Compañeros</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lehigh University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed project is a research collaboration between the University of Texas at El Paso,&#xD;
      The Alliance for Border Collaboratives and Programa Companeros to adapt, implement, and&#xD;
      evaluate a multi-level community-based HIV prevention intervention (Project Encuentro). The&#xD;
      intervention will target active heroin and crack users and consists of increasing access to&#xD;
      HIV testing via a social network HIV testing component and reducing sexual and drug use risk&#xD;
      via a peer network brief behavioral Intervention. Encuentro also consists of conducting&#xD;
      community awareness meeting to target structural factors affecting HIV risk. The intervention&#xD;
      was developed in an area severely affected by violence and stigma towards drug users, El&#xD;
      Salvador, which makes it particularly suitable for adaptation to meet the needs of drug users&#xD;
      living in the proposed intervention site, the U.S.-Mexico border. The proposed intervention&#xD;
      site also has been severely affected by violence which has curtailed any prior attempts to&#xD;
      reduce the risk drug users' HIV risk. Violence has worsened structural factors which affect&#xD;
      HIV risk such as, increasing police persecution and stigma and reducing access to resources.&#xD;
      In our proposed project, we will engage in formative research to understand the context of&#xD;
      HIV risk of drug users in the border region post violence and adapt the intervention&#xD;
      accordingly. Findings will allow the investigators to tailor intervention components to meet&#xD;
      the needs of drug users in the region. Subsequently, the investigators propose to test&#xD;
      intervention effectiveness and evaluate implementation barriers and facilitators. To&#xD;
      accomplish project aims we will use a mixed qualitative, quantitative approach. The&#xD;
      investigators will begin with a formative phase by conducting in-depth interviews with drug&#xD;
      users (n = 40) living in the region to understand how the context of drug use risk changed as&#xD;
      a result of the violence and will administer a social network survey (n = 200) to&#xD;
      characterize the configuration of risk networks. Findings will yield the necessary&#xD;
      information to culturally adapt the intervention to meet the needs of drug users in the&#xD;
      region and will help the investigators focus recruitment efforts where the riskiest networks&#xD;
      are located. After the intervention is adapted with the help of the community advisory boards&#xD;
      and the community coalitions, the investigators will implement the intervention and will&#xD;
      assess the effectiveness and reach via 6 cross-sectional surveys administered to drug users&#xD;
      (n=1,200). The investigators will assess the process of implementation by conducting&#xD;
      ethnographic field notes of all intervention activities including community engagement and&#xD;
      Community Advisory Board and coalition meetings. The investigators will assess the fidelity&#xD;
      and quality of the intervention. Lastly, the investigators will conduct key informant&#xD;
      interviews with key stakeholders involved in the project and interviews and observations will&#xD;
      be coded to reflect key systems factors related to successful implementation of intervention&#xD;
      components in two intervention sites (El Paso, Texas and Ciudad Juarez, Mexico). Findings&#xD;
      will be highly significant as the investigators will be conducting parallel research on the&#xD;
      effectiveness of interventions shown to be effective in Latino drug users in two very&#xD;
      different contexts: El Salvador and the U.S-Mexico border. Findings will elucidate&#xD;
      implementation challenges and barriers and such information can then be used to assess the&#xD;
      effectiveness of diverse implementation strategies in organizations working to serve the&#xD;
      needs of Latino drug users.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention framework of the proposed Intervention is exerting change at multiple&#xD;
      levels, through community based approaches. At the structural level, the investigators&#xD;
      propose to increase the access to HIV testing of high risk drug users and to create change at&#xD;
      the community level regarding factors that influence the risk of drug users such as stigma&#xD;
      towards drug use and HIV among other topics. At the individual level, the investigators&#xD;
      propose to modify normative beliefs around risky behaviors in a social network and hence,&#xD;
      effecting change in participants by changing normative behavior around safer sexual&#xD;
      encounters, HIV testing, and reduced risk in injection and non-injection drug use. Following,&#xD;
      strategies to be employed in each intervention component are delineated.&#xD;
&#xD;
      Social Network HIV Testing Component. To prepare for the rolling-out of the social network&#xD;
      HIV testing component (during month 6 of year 2), the investigators will convene a two day&#xD;
      training with partner organizations from both sides of the border to train staff on the&#xD;
      social network referral methodology. Research staff will initiate the recruitment of seeds by&#xD;
      recruiting four to six seeds per city. Counselors, at the partner organizations, will begin&#xD;
      by administering a rapid HIV test and provide pre and post-test counseling to seeds.&#xD;
      Counselors, who will be trained in the social network assessment methodology, will then ask&#xD;
      seeds to list other drug users in their social network who they believe are at risk of&#xD;
      contracting HIV. Counselors will then provide participants with 3 coupons to recruit&#xD;
      identified network members for an HIV test. Referred participants who engage in high-risk&#xD;
      behavior will be also provided with 3 coupons to refer their own network members for an HIV&#xD;
      test. Whenever social network HIV testing rates slow, research staff will re-seed in the&#xD;
      communities to begin the recruitment process again. Counselors will make appointments for all&#xD;
      participants who test positive for confirmatory HIV testing at the respective local&#xD;
      governmental health care institutions. A research staff will follow-up with HIV positive&#xD;
      participants to engage them in care. Throughout the duration of the project, monthly meetings&#xD;
      will be convened between research staff involved in the project to ascertain that procedures&#xD;
      are being followed and retrain if the need arises. The social network component of the&#xD;
      intervention will continue until month 12 of year 5.&#xD;
&#xD;
      The Peer Network Intervention. During month 1 of year 4, we will roll-out the peer network&#xD;
      behavioral intervention. Two peer leaders will be selected from each city to deliver the&#xD;
      intervention sessions. Eligibility criteria will be being former drug users, having extensive&#xD;
      contacts, high degree of trust among peers, and motivation and demonstrated ability to work&#xD;
      fixed hours. During month 12 of year 3, training sessions, in collaboration with partner&#xD;
      organization, will be conducted to train peer leaders over the course of two weeks during ten&#xD;
      training sessions lasting 3 hours per session. Peer leaders will be trained in the curriculum&#xD;
      as well as in psychosocial theory as the basis for behavioral interventions, interactive&#xD;
      group management, HIV risk reduction, effective instruction for role-plays, and social&#xD;
      network recruitment methods. Peer leaders will recruit drug users they know who will be&#xD;
      asked, in turn, to recruit other drug users in their networks. If this initial contact is&#xD;
      unable to recruit network members, peer leaders will select other initial contact. Peer&#xD;
      leaders will deliver the intervention to 300 drug users (150 per border city) in cycles&#xD;
      composed of small social networks of 5-6 drug users. Four intervention cycles will be held&#xD;
      per month and will consist of 3 consecutive sessions of 2 hours in duration delivered in the&#xD;
      early afternoon. Peer leaders will be expected to comply with a fixed work schedule of 10&#xD;
      hours per week and will be asked to actively recruit social networks for each intervention&#xD;
      cycle. Although we expect the specific information and roles plays to change based on the&#xD;
      findings of our formative phase and our sessions of acceptability and feasibility with our&#xD;
      CAB and coalition, the peer network intervention will have the following structure. The first&#xD;
      session of the intervention will cover training in social contexts of risk and strategies to&#xD;
      avoid them through role plays, techniques for harm reduction for injection and non-injection&#xD;
      drug use, and available community resources to deal with substance abuse. The second session&#xD;
      will provide information about HIV and Sexually Transmitted Diseases through games, didactic&#xD;
      sessions, and exercises to rank the risk of contracting HIV from various behaviors,&#xD;
      negotiation skills for condom use in situations of high risk such as exchange of sex for&#xD;
      drugs. The third session will consist of training in advocacy and sexual rights and&#xD;
      establishment of a personal and social network risk reduction plan. Ethnographers will be&#xD;
      trained to document the process of delivery such as number of participants per intervention&#xD;
      cycle. Research staff will attend one intervention session per cycle to assess intervention&#xD;
      fidelity. Weekly meetings will be held with peer leaders and research staff to discuss&#xD;
      problems, solutions, and planning of community wide events.&#xD;
&#xD;
      Community-Wide Events. The community coalition in collaboration with the CAB and peer leaders&#xD;
      will be asked to plan and convene educational meetings at the community level with drug and&#xD;
      non-drug users to deliver information on topics such as drug use prevention and treatment,&#xD;
      HIV and risk reduction skills, and other issues affecting the HIV risk of communities such as&#xD;
      persecution of drug users by police, human rights violations, and sexual violence. They will&#xD;
      identify experts on topics identified and invite them as guest speakers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Quasi experimental design repeated time series analysis</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HIV testing rates</measure>
    <time_frame>Every 30 days up to 192 weeks</time_frame>
    <description>rates of number of individuals who get tested on a 30- day period for HIV using a coupon</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sexual risk behaviors (questionnaire)</measure>
    <time_frame>six and twelve months after the roll out of the intervention components</time_frame>
    <description>number of sexual partners (primary and casual), number of instances of unprotected anal, vaginal, oral sex, engagement in sexual relations while using drugs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Injection risk behaviors (questionnaire)</measure>
    <time_frame>six and twelve months after the roll-out of the intervention components</time_frame>
    <description>frequency of injection drug use, frequency of needle sharing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV risk reduction behavioral intentions (questionnaire)</measure>
    <time_frame>six and twelve months after the roll-out of the intervention components</time_frame>
    <description>strength of intentions to reduce HIV risk behaviors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV-related vulnerability beliefs (questionnaire)</measure>
    <time_frame>six and twelve months after the roll-out of the intervention components</time_frame>
    <description>perception of risk of contracting HIV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV risk reduction skills (questionnaire)</measure>
    <time_frame>six and twelve months after the roll-out of the intervention components</time_frame>
    <description>frequency with which participants engaged in HIV preventative behaviors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV risk network (questionnaire)</measure>
    <time_frame>six and twelve months after the roll-out of the intervention components</time_frame>
    <description>the extent to which participant has engaged in conversations with members of the social network about engaging in behaviors to prevent HIV</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1400</enrollment>
  <condition>Risk Behavior</condition>
  <arm_group>
    <arm_group_label>HIV testing promoted by members of the social network</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Research staff will initiate the recruitment of seeds by recruiting four to six seeds per city. Counselors, at the partner organizations, will begin by administering a rapid HIV test and provide pre and post-test counseling to seeds. Counselors, who will be trained in the social network assessment methodology, will then ask seeds to list other drug users in their social network who they believe are at risk of contracting HIV. Counselors will then provide participants with 3 coupons to recruit identified network members for an HIV test. Referred participants who engage in high-risk behavior will be also provided with 3 coupons to refer their own network members for an HIV test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peer network behavioral intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Two peer leaders will be selected from each city to deliver the intervention sessions. Peer leaders will recruit drug users they know who will be asked, in turn, to recruit other drug users in their networks. Peer leaders will deliver the intervention to 300 drug users (150 per border city) in cycles composed of small social networks of 5-6 drug users.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Encuentro</intervention_name>
    <description>a behavioral intervention designed to increase HIV testing rates and reduce behaviors that place individuals who use drugs at risk of contracting HIV</description>
    <arm_group_label>HIV testing promoted by members of the social network</arm_group_label>
    <arm_group_label>Peer network behavioral intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 18 years old&#xD;
&#xD;
          -  having engaged in sexual risk in the last 3 months&#xD;
&#xD;
          -  able to give informed consent&#xD;
&#xD;
          -  reported to have used crack or heroin in the last 30 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18 years of age&#xD;
&#xD;
          -  unable to give informed consent&#xD;
&#xD;
          -  engages in disruptive behavior while participating in the project not using crack or&#xD;
             -heroin in the last month&#xD;
&#xD;
          -  not reporting having engaged in sexual risk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia Lechuga, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lehigh University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rebeca Ramos, MPH</last_name>
    <role>Study Director</role>
    <affiliation>9155842875</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julia Lechuga, PhD</last_name>
    <phone>6107584328</phone>
    <email>jul416@lehigh.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rebeca Ramos, MPH</last_name>
    <phone>9155842875</phone>
    <email>rebeca@utep.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Alliance of Border Collaboratives</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebeca Ramos, MPH</last_name>
      <phone>915-584-2875</phone>
      <email>rebeca@utep.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jose Alvarez, MSW</last_name>
      <phone>9155842875</phone>
      <email>arody_3@msn.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Programa Compañeros</name>
      <address>
        <city>Ciudad Juarez</city>
        <state>Chihuahua</state>
        <zip>32330</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria E Ramos</last_name>
      <phone>526566113792</phone>
      <email>pcompa@prodigy.net.mx</email>
    </contact>
    <contact_backup>
      <last_name>Julian Rojas</last_name>
      <phone>526566113792</phone>
      <email>julianrojaspadilla@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lehigh University</investigator_affiliation>
    <investigator_full_name>Julia Lechuga</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03293875
org study id: 1U01MD010657-01
nct id: NCT03293875
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The proposed project is a research collaboration between the University of Texas at El Paso,
      The Alliance for Border Collaboratives and Programa Companeros to adapt, implement, and
      evaluate a multi-level community-based HIV prevention intervention (Project Encuentro). The
      intervention will target active heroin and crack users and consists of increasing access to
      HIV testing via a social network HIV testing component and reducing sexual and drug use risk
      via a peer network brief behavioral Intervention. Encuentro also consists of conducting
      community awareness meeting to target structural factors affecting HIV risk. The intervention
      was developed in an area severely affected by violence and stigma towards drug users, El
      Salvador, which makes it particularly suitable for adaptation to meet the needs of drug users
      living in the proposed intervention site, the U.S.-Mexico border. The proposed intervention
      site also has been severely affected by violence which has curtailed any prior attempts to
      reduce the risk drug users' HIV risk. Violence has worsened structural factors which affect
      HIV risk such as, increasing police persecution and stigma and reducing access to resources.
      In our proposed project, we will engage in formative research to understand the context of
      HIV risk of drug users in the border region post violence and adapt the intervention
      accordingly. Findings will allow the investigators to tailor intervention components to meet
      the needs of drug users in the region. Subsequently, the investigators propose to test
      intervention effectiveness and evaluate implementation barriers and facilitators. To
      accomplish project aims we will use a mixed qualitative, quantitative approach. The
      investigators will begin with a formative phase by conducting in-depth interviews with drug
      users (n = 40) living in the region to understand how the context of drug use risk changed as
      a result of the violence and will administer a social network survey (n = 200) to
      characterize the configuration of risk networks. Findings will yield the necessary
      information to culturally adapt the intervention to meet the needs of drug users in the
      region and will help the investigators focus recruitment efforts where the riskiest networks
      are located. After the intervention is adapted with the help of the community advisory boards
      and the community coalitions, the investigators will implement the intervention and will
      assess the effectiveness and reach via 6 cross-sectional surveys administered to drug users
      (n=1,200). The investigators will assess the process of implementation by conducting
      ethnographic field notes of all intervention activities including community engagement and
      Community Advisory Board and coalition meetings. The investigators will assess the fidelity
      and quality of the intervention. Lastly, the investigators will conduct key informant
      interviews with key stakeholders involved in the project and interviews and observations will
      be coded to reflect key systems factors related to successful implementation of intervention
      components in two intervention sites (El Paso, Texas and Ciudad Juarez, Mexico). Findings
      will be highly significant as the investigators will be conducting parallel research on the
      effectiveness of interventions shown to be effective in Latino drug users in two very
      different contexts: El Salvador and the U.S-Mexico border. Findings will elucidate
      implementation challenges and barriers and such information can then be used to assess the
      effectiveness of diverse implementation strategies in organizations working to serve the
      needs of Latino drug users.
The intervention framework of the proposed Intervention is exerting change at multiple
      levels, through community based approaches. At the structural level, the investigators
      propose to increase the access to HIV testing of high risk drug users and to create change at
      the community level regarding factors that influence the risk of drug users such as stigma
      towards drug use and HIV among other topics. At the individual level, the investigators
      propose to modify normative beliefs around risky behaviors in a social network and hence,
      effecting change in participants by changing normative behavior around safer sexual
      encounters, HIV testing, and reduced risk in injection and non-injection drug use. Following,
      strategies to be employed in each intervention component are delineated.

      Social Network HIV Testing Component. To prepare for the rolling-out of the social network
      HIV testing component (during month 6 of year 2), the investigators will convene a two day
      training with partner organizations from both sides of the border to train staff on the
      social network referral methodology. Research staff will initiate the recruitment of seeds by
      recruiting four to six seeds per city. Counselors, at the partner organizations, will begin
      by administering a rapid HIV test and provide pre and post-test counseling to seeds.
      Counselors, who will be trained in the social network assessment methodology, will then ask
      seeds to list other drug users in their social network who they believe are at risk of
      contracting HIV. Counselors will then provide participants with 3 coupons to recruit
      identified network members for an HIV test. Referred participants who engage in high-risk
      behavior will be also provided with 3 coupons to refer their own network members for an HIV
      test. Whenever social network HIV testing rates slow, research staff will re-seed in the
      communities to begin the recruitment process again. Counselors will make appointments for all
      participants who test positive for confirmatory HIV testing at the respective local
      governmental health care institutions. A research staff will follow-up with HIV positive
      participants to engage them in care. Throughout the duration of the project, monthly meetings
      will be convened between research staff involved in the project to ascertain that procedures
      are being followed and retrain if the need arises. The social network component of the
      intervention will continue until month 12 of year 5.

      The Peer Network Intervention. During month 1 of year 4, we will roll-out the peer network
      behavioral intervention. Two peer leaders will be selected from each city to deliver the
      intervention sessions. Eligibility criteria will be being former drug users, having extensive
      contacts, high degree of trust among peers, and motivation and demonstrated ability to work
      fixed hours. During month 12 of year 3, training sessions, in collaboration with partner
      organization, will be conducted to train peer leaders over the course of two weeks during ten
      training sessions lasting 3 hours per session. Peer leaders will be trained in the curriculum
      as well as in psychosocial theory as the basis for behavioral interventions, interactive
      group management, HIV risk reduction, effective instruction for role-plays, and social
      network recruitment methods. Peer leaders will recruit drug users they know who will be
      asked, in turn, to recruit other drug users in their networks. If this initial contact is
      unable to recruit network members, peer leaders will select other initial contact. Peer
      leaders will deliver the intervention to 300 drug users (150 per border city) in cycles
      composed of small social networks of 5-6 drug users. Four intervention cycles will be held
      per month and will consist of 3 consecutive sessions of 2 hours in duration delivered in the
      early afternoon. Peer leaders will be expected to comply with a fixed work schedule of 10
      hours per week and will be asked to actively recruit social networks for each intervention
      cycle. Although we expect the specific information and roles plays to change based on the
      findings of our formative phase and our sessions of acceptability and feasibility with our
      CAB and coalition, the peer network intervention will have the following structure. The first
      session of the intervention will cover training in social contexts of risk and strategies to
      avoid them through role plays, techniques for harm reduction for injection and non-injection
      drug use, and available community resources to deal with substance abuse. The second session
      will provide information about HIV and Sexually Transmitted Diseases through games, didactic
      sessions, and exercises to rank the risk of contracting HIV from various behaviors,
      negotiation skills for condom use in situations of high risk such as exchange of sex for
      drugs. The third session will consist of training in advocacy and sexual rights and
      establishment of a personal and social network risk reduction plan. Ethnographers will be
      trained to document the process of delivery such as number of participants per intervention
      cycle. Research staff will attend one intervention session per cycle to assess intervention
      fidelity. Weekly meetings will be held with peer leaders and research staff to discuss
      problems, solutions, and planning of community wide events.

      Community-Wide Events. The community coalition in collaboration with the CAB and peer leaders
      will be asked to plan and convene educational meetings at the community level with drug and
      non-drug users to deliver information on topics such as drug use prevention and treatment,
      HIV and risk reduction skills, and other issues affecting the HIV risk of communities such as
      persecution of drug users by police, human rights violations, and sexual violence. They will
      identify experts on topics identified and invite them as guest speakers.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Quasi experimental design repeated time series analysis
primary purpose: Prevention
masking: None (Open Label)
measure: HIV testing rates
time frame: Every 30 days up to 192 weeks
description: rates of number of individuals who get tested on a 30- day period for HIV using a coupon
measure: Change in Sexual risk behaviors (questionnaire)
time frame: six and twelve months after the roll out of the intervention components
description: number of sexual partners (primary and casual), number of instances of unprotected anal, vaginal, oral sex, engagement in sexual relations while using drugs
measure: Change in Injection risk behaviors (questionnaire)
time frame: six and twelve months after the roll-out of the intervention components
description: frequency of injection drug use, frequency of needle sharing
measure: HIV risk reduction behavioral intentions (questionnaire)
time frame: six and twelve months after the roll-out of the intervention components
description: strength of intentions to reduce HIV risk behaviors
measure: HIV-related vulnerability beliefs (questionnaire)
time frame: six and twelve months after the roll-out of the intervention components
description: perception of risk of contracting HIV
measure: HIV risk reduction skills (questionnaire)
time frame: six and twelve months after the roll-out of the intervention components
description: frequency with which participants engaged in HIV preventative behaviors
measure: HIV risk network (questionnaire)
time frame: six and twelve months after the roll-out of the intervention components
description: the extent to which participant has engaged in conversations with members of the social network about engaging in behaviors to prevent HIV
arm group label: HIV testing promoted by members of the social network
arm group type: Other
description: Research staff will initiate the recruitment of seeds by recruiting four to six seeds per city. Counselors, at the partner organizations, will begin by administering a rapid HIV test and provide pre and post-test counseling to seeds. Counselors, who will be trained in the social network assessment methodology, will then ask seeds to list other drug users in their social network who they believe are at risk of contracting HIV. Counselors will then provide participants with 3 coupons to recruit identified network members for an HIV test. Referred participants who engage in high-risk behavior will be also provided with 3 coupons to refer their own network members for an HIV test.
arm group label: Peer network behavioral intervention
arm group type: Other
description: Two peer leaders will be selected from each city to deliver the intervention sessions. Peer leaders will recruit drug users they know who will be asked, in turn, to recruit other drug users in their networks. Peer leaders will deliver the intervention to 300 drug users (150 per border city) in cycles composed of small social networks of 5-6 drug users.
intervention type: Behavioral
intervention name: Encuentro
description: a behavioral intervention designed to increase HIV testing rates and reduce behaviors that place individuals who use drugs at risk of contracting HIV
arm group label: HIV testing promoted by members of the social network
arm group label: Peer network behavioral intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Julia Lechuga, PhD
role: Principal Investigator
affiliation: Lehigh University
last name: Rebeca Ramos, MPH
role: Study Director
affiliation: 9155842875
last name: Julia Lechuga, PhD
phone: 6107584328
email: jul416@lehigh.edu
last name: Rebeca Ramos, MPH
phone: 9155842875
email: rebeca@utep.edu
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Mexico
country: United States
responsible party type: Principal Investigator
investigator affiliation: Lehigh University
investigator full name: Julia Lechuga
investigator title: Assistant Professor