<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/NCT03276338</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00012292</org_study_id>
    <secondary_id>5R01MH087339-04</secondary_id>
    <nct_id>NCT03276338</nct_id>
  </id_info>
  <brief_title>Using CBPR to Reduce HIV Risk Among Immigrant Latino MSM</brief_title>
  <acronym>HOLA</acronym>
  <official_title>Using CBPR to Reduce HIV Risk Among Immigrant Latino MSM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The intervention is based on social cognitive theory and theory of empowerment education and&#xD;
      was developed using community-based participatory research (CBPR). This study is a result of&#xD;
      a long-term community-university partnership that has used and will continue to use CBPR&#xD;
      throughout all phases of research. A total of 21 Latino MSM in rural NC have been screened&#xD;
      and recruited to serve as LHAs. The CBPR partnership selected LHAs based on qualities of&#xD;
      natural helpers and informal leaders and having existing social networks of other Latino MSM.&#xD;
      Eight members of each LHA's social network have been screened and recruited to participate as&#xD;
      well. The LHAs, coupled with their social networks, have been randomized to intervention or&#xD;
      delayed-intervention groups. LHAs (n=11) in the intervention group were trained and serve as&#xD;
      LHAs within their social networks in Year 2. Delayed-intervention LHAs (n=10) receive the&#xD;
      same LHA training and serve as LHAs within their social networks in Year 3. Quantitative&#xD;
      assessment data is collected from each LHA (n=21) and the 8 members of his social network&#xD;
      (n=189) longitudinally at: (1) baseline, (2) immediate post-intervention, and (3) 12-month&#xD;
      follow-up. This is an &quot;intent-to-treat&quot; study, in which participant data are analyzed based&#xD;
      on their randomization group.&#xD;
&#xD;
      The investigators hypothesize that participants in the HIV prevention intervention, relative&#xD;
      to those in the delayed intervention comparison group, will demonstrate (1) increased&#xD;
      self-reported use of condoms during sexual intercourse and (2) increased self-reported HIV&#xD;
      testing.&#xD;
&#xD;
      The results and products from this study will be disseminated to inform public health&#xD;
      practice, research, and policy. Results and products will include: (1) a Spanish-language&#xD;
      intervention that is: culturally congruent and gender-specific; designed to reduce HIV risk&#xD;
      among Latino MSM; and ready for dissemination and adaptation; (2) a deeper understanding of&#xD;
      HIV risk and intervention among Latino MSM; and (3) insight into a CBPR process that includes&#xD;
      community members, organizational representatives, and academic researchers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goals of this study are to refine, implement, and evaluate a culturally relevant&#xD;
      intervention designed to reduce the disproportionate HIV burden borne by Latino men who have&#xD;
      sex with men (MSM) in the United States (US). This application is the culmination of ongoing&#xD;
      research from an established partnership and was developed using community-based&#xD;
      participatory research (CBPR). The proposed research refines an intervention that was&#xD;
      developed, implemented, and evaluated using CBPR and was found effective in increasing condom&#xD;
      use and HIV testing among heterosexual immigrant Latino men.1 Our CBPR partnership will&#xD;
      refine the intervention based on findings from an R21 formative CBPR study among Latino MSM&#xD;
      in rural North Carolina (NC) as well as ongoing insights provided by members of the&#xD;
      partnership. CBPR will continue to be used to enhance the quality and validity of this&#xD;
      research, continuing to equitably involve community members, organizational representatives,&#xD;
      and academic researchers in all phases of the research. Together, the partners have developed&#xD;
      the following specific aims for this proposal:&#xD;
&#xD;
      Aim 1: Refine a culturally relevant HIV prevention intervention designed to increase condom&#xD;
      use and HIV testing among adult Latino MSM.&#xD;
&#xD;
      Aim 2: Implement and evaluate the effectiveness of the intervention by comparing Latino MSM&#xD;
      in the intervention to those in the delayed-intervention comparison, using a study design&#xD;
      recommended by members of the CBPR partnership.&#xD;
&#xD;
      The Specific Aims will be met by applying principles of CBPR to:&#xD;
&#xD;
        1. Refine the HoMBReS intervention, which has been found effective in increasing condom use&#xD;
           and HIV testing among heterosexual Latino men, while retaining the integrity of&#xD;
           intervention themes, concepts, and approaches;&#xD;
&#xD;
        2. Recruit and enroll adult male Latino lay health advisors (LHAs; total n=20) who&#xD;
           represent 20 distinct social networks of Latino MSM within central NC;&#xD;
&#xD;
        3. Recruit and enroll 12 members from the social network of each of the 20 LHAs for a total&#xD;
           of n=240 social network members;&#xD;
&#xD;
        4. Randomize the 20 LHAs, coupled with their social networks, into intervention and&#xD;
           delayed-intervention comparison groups;&#xD;
&#xD;
        5. Train and support the LHAs in 2 waves (intervention and delayed-intervention) to serve&#xD;
           as health advisors, opinion leaders, and community advocates;&#xD;
&#xD;
        6. Evaluate the impact of the intervention by comparing rates of change in condom use and&#xD;
           HIV testing from baseline to immediate post-intervention between those in the&#xD;
           intervention group (10 LHAs; 120 social network members) and their peers in the&#xD;
           delayed-intervention group (10 LHAs; 120 social network members), who will not have been&#xD;
           exposed to the intervention, using an interviewer-administered assessment;&#xD;
&#xD;
        7. Evaluate the sustainability of intervention by comparing rates of change in condom use&#xD;
           and HIV testing from immediate post-intervention to a 12-month follow-up using data from&#xD;
           both the intervention and delayed-intervention groups who will all have been exposed to&#xD;
           the intervention; and&#xD;
&#xD;
        8. Interpret and disseminate findings to community members, other key stakeholders, and&#xD;
           policy leaders at the local, regional, and national levels.&#xD;
&#xD;
      This study will advance the field of HIV prevention research by refining, implementing, and&#xD;
      evaluating an intervention for Latino MSM, who are disproportionately affected by HIV.&#xD;
      Currently, there are few HIV prevention interventions with evidence of efficacy and none&#xD;
      tailored to the unique and growing Latino immigrant communities currently settling in the&#xD;
      southeastern US. Moreover, although LHA interventions are widely promoted, outcome data&#xD;
      supporting LHA interventions as an approach to health promotion and disease prevention are&#xD;
      limited. Our HoMBReS intervention, which was developed, implemented, and evaluated using&#xD;
      CBPR, uses an LHA approach and has evidence of effectiveness.1 The investigators propose to&#xD;
      refine it to fill important gaps in both the science and the practice of HIV prevention. The&#xD;
      results and products from this study will be disseminated to inform public health practice,&#xD;
      research, and policy. Results and products will include: (1) a Spanish-language intervention&#xD;
      that is: culturally relevant and gender-specific; designed to reduce HIV risk among Latino&#xD;
      MSM; and ready for dissemination and adaptation; (2) a deeper understanding of HIV risk and&#xD;
      prevention among Latino MSM; and (3) insight into a research process that includes community&#xD;
      members, organizational representatives, and academic researchers.&#xD;
&#xD;
      Study hypotheses. The investigators hypothesize that compared to participants in the&#xD;
      delayed-intervention group, participants in the intervention group will demonstrate (a)&#xD;
      increased self-reported use of condoms during sexual intercourse; and (b) increased&#xD;
      self-reported HIV testing. The investigators also hypothesize that the sustainability of&#xD;
      intervention will continue through 12-month follow-up (24 months after the Navegantes are&#xD;
      trained).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2011</start_date>
  <completion_date type="Actual">February 28, 2016</completion_date>
  <primary_completion_date type="Actual">June 1, 2015</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in condom use</measure>
    <time_frame>4 months</time_frame>
    <description>Evaluate the amount of condom use at from baseline to 4 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HIV status</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluate the change in HIV status from baseline to 12 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participation in the HOLA intervention designed to prevention HIV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed-intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Delayed intervention with participation in HOLA intervention after follow-up data have been collected</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HOLA</intervention_name>
    <description>To increase condom use and HIV testing</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  self-identify as Latino or Hispanic;&#xD;
&#xD;
          -  be 18 years of age;&#xD;
&#xD;
          -  report MSM behavior since age 18;&#xD;
&#xD;
          -  have some Spanish-language literacy;&#xD;
&#xD;
          -  and provide informed consent.&#xD;
&#xD;
        To be eligible to participate as a social network member of a Navegante, a participant&#xD;
        must:&#xD;
&#xD;
          -  self-identify as Latino or Hispanic;&#xD;
&#xD;
          -  be 18 years of age;&#xD;
&#xD;
          -  report MSM behavior since age 18;&#xD;
&#xD;
          -  and provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having participated in the HoMBReS or HoMBReS-2 interventions, or in the refinement of&#xD;
             the HOLA intervention.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Transgender identity is an inclusion criterion</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Rhodes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>May 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03276338
org study id: IRB00012292
secondary id: 5R01MH087339-04
nct id: NCT03276338
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The intervention is based on social cognitive theory and theory of empowerment education and
      was developed using community-based participatory research (CBPR). This study is a result of
      a long-term community-university partnership that has used and will continue to use CBPR
      throughout all phases of research. A total of 21 Latino MSM in rural NC have been screened
      and recruited to serve as LHAs. The CBPR partnership selected LHAs based on qualities of
      natural helpers and informal leaders and having existing social networks of other Latino MSM.
      Eight members of each LHA's social network have been screened and recruited to participate as
      well. The LHAs, coupled with their social networks, have been randomized to intervention or
      delayed-intervention groups. LHAs (n=11) in the intervention group were trained and serve as
      LHAs within their social networks in Year 2. Delayed-intervention LHAs (n=10) receive the
      same LHA training and serve as LHAs within their social networks in Year 3. Quantitative
      assessment data is collected from each LHA (n=21) and the 8 members of his social network
      (n=189) longitudinally at: (1) baseline, (2) immediate post-intervention, and (3) 12-month
      follow-up. This is an "intent-to-treat" study, in which participant data are analyzed based
      on their randomization group.

      The investigators hypothesize that participants in the HIV prevention intervention, relative
      to those in the delayed intervention comparison group, will demonstrate (1) increased
      self-reported use of condoms during sexual intercourse and (2) increased self-reported HIV
      testing.

      The results and products from this study will be disseminated to inform public health
      practice, research, and policy. Results and products will include: (1) a Spanish-language
      intervention that is: culturally congruent and gender-specific; designed to reduce HIV risk
      among Latino MSM; and ready for dissemination and adaptation; (2) a deeper understanding of
      HIV risk and intervention among Latino MSM; and (3) insight into a CBPR process that includes
      community members, organizational representatives, and academic researchers.
The goals of this study are to refine, implement, and evaluate a culturally relevant
      intervention designed to reduce the disproportionate HIV burden borne by Latino men who have
      sex with men (MSM) in the United States (US). This application is the culmination of ongoing
      research from an established partnership and was developed using community-based
      participatory research (CBPR). The proposed research refines an intervention that was
      developed, implemented, and evaluated using CBPR and was found effective in increasing condom
      use and HIV testing among heterosexual immigrant Latino men.1 Our CBPR partnership will
      refine the intervention based on findings from an R21 formative CBPR study among Latino MSM
      in rural North Carolina (NC) as well as ongoing insights provided by members of the
      partnership. CBPR will continue to be used to enhance the quality and validity of this
      research, continuing to equitably involve community members, organizational representatives,
      and academic researchers in all phases of the research. Together, the partners have developed
      the following specific aims for this proposal:

      Aim 1: Refine a culturally relevant HIV prevention intervention designed to increase condom
      use and HIV testing among adult Latino MSM.

      Aim 2: Implement and evaluate the effectiveness of the intervention by comparing Latino MSM
      in the intervention to those in the delayed-intervention comparison, using a study design
      recommended by members of the CBPR partnership.

      The Specific Aims will be met by applying principles of CBPR to:

        1. Refine the HoMBReS intervention, which has been found effective in increasing condom use
           and HIV testing among heterosexual Latino men, while retaining the integrity of
           intervention themes, concepts, and approaches;

        2. Recruit and enroll adult male Latino lay health advisors (LHAs; total n=20) who
           represent 20 distinct social networks of Latino MSM within central NC;

        3. Recruit and enroll 12 members from the social network of each of the 20 LHAs for a total
           of n=240 social network members;

        4. Randomize the 20 LHAs, coupled with their social networks, into intervention and
           delayed-intervention comparison groups;

        5. Train and support the LHAs in 2 waves (intervention and delayed-intervention) to serve
           as health advisors, opinion leaders, and community advocates;

        6. Evaluate the impact of the intervention by comparing rates of change in condom use and
           HIV testing from baseline to immediate post-intervention between those in the
           intervention group (10 LHAs; 120 social network members) and their peers in the
           delayed-intervention group (10 LHAs; 120 social network members), who will not have been
           exposed to the intervention, using an interviewer-administered assessment;

        7. Evaluate the sustainability of intervention by comparing rates of change in condom use
           and HIV testing from immediate post-intervention to a 12-month follow-up using data from
           both the intervention and delayed-intervention groups who will all have been exposed to
           the intervention; and

        8. Interpret and disseminate findings to community members, other key stakeholders, and
           policy leaders at the local, regional, and national levels.

      This study will advance the field of HIV prevention research by refining, implementing, and
      evaluating an intervention for Latino MSM, who are disproportionately affected by HIV.
      Currently, there are few HIV prevention interventions with evidence of efficacy and none
      tailored to the unique and growing Latino immigrant communities currently settling in the
      southeastern US. Moreover, although LHA interventions are widely promoted, outcome data
      supporting LHA interventions as an approach to health promotion and disease prevention are
      limited. Our HoMBReS intervention, which was developed, implemented, and evaluated using
      CBPR, uses an LHA approach and has evidence of effectiveness.1 The investigators propose to
      refine it to fill important gaps in both the science and the practice of HIV prevention. The
      results and products from this study will be disseminated to inform public health practice,
      research, and policy. Results and products will include: (1) a Spanish-language intervention
      that is: culturally relevant and gender-specific; designed to reduce HIV risk among Latino
      MSM; and ready for dissemination and adaptation; (2) a deeper understanding of HIV risk and
      prevention among Latino MSM; and (3) insight into a research process that includes community
      members, organizational representatives, and academic researchers.

      Study hypotheses. The investigators hypothesize that compared to participants in the
      delayed-intervention group, participants in the intervention group will demonstrate (a)
      increased self-reported use of condoms during sexual intercourse; and (b) increased
      self-reported HIV testing. The investigators also hypothesize that the sustainability of
      intervention will continue through 12-month follow-up (24 months after the Navegantes are
      trained).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Change in condom use
time frame: 4 months
description: Evaluate the amount of condom use at from baseline to 4 months.
measure: Change in HIV status
time frame: 12 months
description: Evaluate the change in HIV status from baseline to 12 months
arm group label: Intervention
arm group type: Experimental
description: Participation in the HOLA intervention designed to prevention HIV
arm group label: Delayed-intervention
arm group type: No Intervention
description: Delayed intervention with participation in HOLA intervention after follow-up data have been collected
intervention type: Behavioral
intervention name: HOLA
description: To increase condom use and HIV testing
arm group label: Intervention
criteria: 
gender: Male
gender based: Yes
gender description: Transgender identity is an inclusion criterion
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Scott Rhodes
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: Undecided