<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/NCT03774160</url>
  </required_header>
  <id_info>
    <org_study_id>5R01MH109401-04</org_study_id>
    <nct_id>NCT03774160</nct_id>
  </id_info>
  <brief_title>Community and Systems-level HIV Prevention in Peru</brief_title>
  <official_title>Combination HIV Prevention, Linking Prevention and Care, for Hispanic Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Peruana Cayetano Heredia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project involves adapting 3 new intervention components, and then testing them, in&#xD;
      combination with a multi-level, community-based intervention, to promote HIV prevention and&#xD;
      sexual health among men who have sex with men and transgender women in Lima, Peru. The total&#xD;
      intervention has a community-based intervention and a systems-level intervention at the&#xD;
      hospital where people living with HIV get care and medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mpowerment (MP) is an evidence-based community-level, structural, social and behavioral&#xD;
      intervention for HIV prevention for young men who have sex with men (MSM). MP targets&#xD;
      individual and community empowerment and community mobilization, self-affirmation, sexual&#xD;
      self-knowledge and creation of a supportive and affirming social environment. MP has been&#xD;
      widely used in the U.S. but not in Peru, with the exception of earlier pilot research. In the&#xD;
      earlier research, MP was adapted for the sociocultural issues facing MSM and transgender&#xD;
      (trans) women in Peru, and only focused risk reduction and increasing HIV testing. In&#xD;
      addition to the MP (which is called the community-based intervention), a health systems&#xD;
      component has been added. The health systems includes (1) sensitization of hospital staff&#xD;
      (where people living with HIV obtain their medication) to the issues facing transgender women&#xD;
      and MSM; (2) the use of Navigators, who help MSM and trans women at the hospital navigate the&#xD;
      system of care and remain in care; and (3) a focus on &quot;positive prevention&quot;, in which&#xD;
      providers talk about the positive aspects of maintaining in care and being virally suppressed&#xD;
      instead of only talking about &quot;avoiding death.&quot; There is a 2.5 year implementation of the&#xD;
      intervention, called &quot;Projecto Orgullo Plus&quot; or Project Pride Plus, which involves a&#xD;
      longitudinal cohort of MSM/trans in two large districts of Lima, Peru. Primary outcomes will&#xD;
      be unprotected anal sex and HIV testing. Secondary outcomes will be self-reported visits to&#xD;
      hospital for care and adherence to medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 6, 2017</start_date>
  <completion_date type="Actual">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">January 30, 2021</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Two different districts are being used, one in which the intervention is implemented and the other is a no-intervention comparison site.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>condomless anal sex</measure>
    <time_frame>37 months post-baseline</time_frame>
    <description>condomless anal sex with HIV+ or unknown status partners, assessed via questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HIV testing ever</measure>
    <time_frame>37 months post-baseline</time_frame>
    <description>if have ever tested for HIV</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HIV testing frequency</measure>
    <time_frame>37 months post-baseline</time_frame>
    <description>frequency of HIV testing by report on questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>If enrolled in care</measure>
    <time_frame>37 months post-baseline</time_frame>
    <description>Has the person, after testing HIV+, enroll in care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seeking regular HIV care</measure>
    <time_frame>37 months post-baseline</time_frame>
    <description>If have seen HIV provider recently by report on questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taking medications adherently</measure>
    <time_frame>37 months post-baseline</time_frame>
    <description>If have missed any times of taking HIV medications by report on questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>If virally suppressed</measure>
    <time_frame>37 months post-baseline</time_frame>
    <description>Has the person been told that he/she is virally suppressed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">458</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Generacion Actual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Generacion Actual includes Community-based and a Health Systems Components. This multi-level intervention reaches out to all MSM/trans by mobilizing them to encourage friends to reduce risk behavior and increase HIV testing, and for HIV+ friends, encourage them to link, stay in care, and take medications regularly. The community based component includes a leadership group, community space, community mobilization events, and group sessions to address a variety of psychosocial issues as well as HIV literacy. The Health Systems component includes sensitization of the HIV testing and care staff to working with MSM and trans, Navigators to help MSM/trans to navigate the complex health system; and positive prevention training of providers; all evidence-based approaches.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention is implemented in the comparison arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Generacion Actual</intervention_name>
    <description>See description in arm description.</description>
    <arm_group_label>Generacion Actual</arm_group_label>
    <other_name>Mpowerment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must live in either East Lima District or South Lima District&#xD;
&#xD;
          -  identify as man who has sex with men or transgender woman who has sex with men&#xD;
&#xD;
          -  be between the ages of 18 - 40&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not residing in either East or South District of Lima&#xD;
&#xD;
          -  not MSM or transgender woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan M Kegeles, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cayetano Heredia University</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Peru</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03774160
org study id: 5R01MH109401-04
nct id: NCT03774160
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project involves adapting 3 new intervention components, and then testing them, in
      combination with a multi-level, community-based intervention, to promote HIV prevention and
      sexual health among men who have sex with men and transgender women in Lima, Peru. The total
      intervention has a community-based intervention and a systems-level intervention at the
      hospital where people living with HIV get care and medications.
Mpowerment (MP) is an evidence-based community-level, structural, social and behavioral
      intervention for HIV prevention for young men who have sex with men (MSM). MP targets
      individual and community empowerment and community mobilization, self-affirmation, sexual
      self-knowledge and creation of a supportive and affirming social environment. MP has been
      widely used in the U.S. but not in Peru, with the exception of earlier pilot research. In the
      earlier research, MP was adapted for the sociocultural issues facing MSM and transgender
      (trans) women in Peru, and only focused risk reduction and increasing HIV testing. In
      addition to the MP (which is called the community-based intervention), a health systems
      component has been added. The health systems includes (1) sensitization of hospital staff
      (where people living with HIV obtain their medication) to the issues facing transgender women
      and MSM; (2) the use of Navigators, who help MSM and trans women at the hospital navigate the
      system of care and remain in care; and (3) a focus on "positive prevention", in which
      providers talk about the positive aspects of maintaining in care and being virally suppressed
      instead of only talking about "avoiding death." There is a 2.5 year implementation of the
      intervention, called "Projecto Orgullo Plus" or Project Pride Plus, which involves a
      longitudinal cohort of MSM/trans in two large districts of Lima, Peru. Primary outcomes will
      be unprotected anal sex and HIV testing. Secondary outcomes will be self-reported visits to
      hospital for care and adherence to medications.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Two different districts are being used, one in which the intervention is implemented and the other is a no-intervention comparison site.
primary purpose: Prevention
masking: None (Open Label)
measure: condomless anal sex
time frame: 37 months post-baseline
description: condomless anal sex with HIV+ or unknown status partners, assessed via questionnaire
measure: HIV testing ever
time frame: 37 months post-baseline
description: if have ever tested for HIV
measure: HIV testing frequency
time frame: 37 months post-baseline
description: frequency of HIV testing by report on questionnaire
measure: If enrolled in care
time frame: 37 months post-baseline
description: Has the person, after testing HIV+, enroll in care
measure: Seeking regular HIV care
time frame: 37 months post-baseline
description: If have seen HIV provider recently by report on questionnaire
measure: Taking medications adherently
time frame: 37 months post-baseline
description: If have missed any times of taking HIV medications by report on questionnaire
measure: If virally suppressed
time frame: 37 months post-baseline
description: Has the person been told that he/she is virally suppressed
arm group label: Generacion Actual
arm group type: Experimental
description: Generacion Actual includes Community-based and a Health Systems Components. This multi-level intervention reaches out to all MSM/trans by mobilizing them to encourage friends to reduce risk behavior and increase HIV testing, and for HIV+ friends, encourage them to link, stay in care, and take medications regularly. The community based component includes a leadership group, community space, community mobilization events, and group sessions to address a variety of psychosocial issues as well as HIV literacy. The Health Systems component includes sensitization of the HIV testing and care staff to working with MSM and trans, Navigators to help MSM/trans to navigate the complex health system; and positive prevention training of providers; all evidence-based approaches.
arm group label: Comparison
arm group type: No Intervention
description: No intervention is implemented in the comparison arm.
intervention type: Behavioral
intervention name: Generacion Actual
description: See description in arm description.
arm group label: Generacion Actual
other name: Mpowerment
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan M Kegeles, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: Peru
responsible party type: Sponsor
sharing ipd: No