<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/NCT04491539</url>
  </required_header>
  <id_info>
    <org_study_id>526497</org_study_id>
    <nct_id>NCT04491539</nct_id>
  </id_info>
  <brief_title>Adapting the Finding Respect and Ending Stigma Around HIV (FRESH) Intervention for the Dominican Republic</brief_title>
  <official_title>Adapting the Finding Respect and Ending Stigma Around HIV (FRESH) Intervention for the Dominican Republic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida State University</source>
  <oversight_info>
    <has_dmc>Yes</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 research has the potential to make important contributions toward HIV and intersectional&#xD;
      stigma reduction across the Spanish-speaking Caribbean. It will do so by adapting and testing&#xD;
      a patient-provider, clinic-based intersectional stigma-reduction intervention -- Finding&#xD;
      Respect and Ending Stigma around HIV (FRESH) -- for the Dominican Republic. Preliminary&#xD;
      results from this R21 study (e.g. workshop satisfaction, stigma outcomes, HIV continuum of&#xD;
      care outcomes, etc.) will inform the development of an investigator-initiated R01 proposal to&#xD;
      conduct a full scale stepped wedge cluster randomized controlled trial of the adapted FRESH&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study addresses the high level of stigma against people living with HIV (PLWH),&#xD;
      particularly gender and sexual minorities, that is embedded in the Dominican Republic's HIV&#xD;
      treatment system through the adaptation and testing of a patient-provider intervention --&#xD;
      Finding Respect and Ending Stigma around HIV (FRESH). The Dominican Republic is a high&#xD;
      priority setting with an increasing need for HIV stigma reduction studies. The Caribbean&#xD;
      holds the second highest regional burden of HIV in the world, yet receives insufficient&#xD;
      HIV-related stigma research funding. The Dominican Republic is 1 of 5 countries that accounts&#xD;
      for over 95% of all Caribbean HIV infections; it also has a significant concentrated HIV&#xD;
      epidemic, a deeply conservative society in which PLWH are stigmatized, and an exceptionally&#xD;
      low national viral load suppression rate. To accomplish this pilot study, three Specific Aims&#xD;
      are proposed. Aim 1 is to explore sources, characteristics, and consequences of HIV-related&#xD;
      and intersectional stigmas experienced in healthcare settings by MSM and transgender women to&#xD;
      inform the adaptation of FRESH. To accomplish Aim 1, we will conduct qualitative in-depth&#xD;
      interviews with healthcare workers who provide HIV care, focus groups with MSM, and in-depth&#xD;
      interviews with transgender women. Aim 2 is to adapt FRESH to address stigmas experienced by&#xD;
      MSM and transgender women in the Dominican Republic. We will apply the Aim 1 findings using&#xD;
      the ADAPT-ITT framework to systematically adapt FRESH, an intervention that has been employed&#xD;
      to reduce stigma in healthcare settings in Africa and the United States. Through an iterative&#xD;
      process, each revision of FRESH will be shared with both PLWH and healthcare workers to&#xD;
      solicit and incorporate their feedback about each version of the adapted intervention. Aim 3&#xD;
      will pilot-test the adapted intervention to obtain estimates of its ability to reduce&#xD;
      stigmatizing attitudes and behaviors from HWs and experiences of stigma reported by sexual&#xD;
      and gender minorities (SGM) and non-SGM clients living with HIV (primary); while exploring if&#xD;
      FRESH has the potential to influence clinic-level HIV cascade outcomes.. By adapting and&#xD;
      testing the FRESH intervention for the Spanish-speaking Caribbean, FRESH could become a&#xD;
      validated, multi-region HIV and intersectional stigma reduction intervention designed&#xD;
      specifically for healthcare settings in high-stigma, culturally conservative,&#xD;
      resource-constrained communities; such a scientific development would be a significant&#xD;
      contribution to HIV stigma reduction efforts in the Caribbean and globally.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 28, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Pilot stepped wedged cluster randomized controlled trial.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stigma and Discrimination in Health Care Facilities</measure>
    <time_frame>Year 2</time_frame>
    <description>This will be assessed via participant observation in clinical settings; there is no standardized scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HIV Knowledge Scale (HIV-KQ-19)</measure>
    <time_frame>Year 2</time_frame>
    <description>Includes 18 T/F questions to be collected from providers and patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berger HIV Stigma Sclae</measure>
    <time_frame>Year 2</time_frame>
    <description>40-item instrument with sub-scales on empathy, enacted stigma, and disclosure concerns</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV Continuum of Care Outcomes</measure>
    <time_frame>Years 1-2</time_frame>
    <description>Aggregated cascade data by clinic from the Ministry of Health. This includes rates of viral suppression, those on antiretroviral therapies, and number of newly diagnosed patients licing with HIV per clinic.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">92</enrollment>
  <condition>Hiv</condition>
  <arm_group>
    <arm_group_label>Adaptation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Site will inform the adaptation of the FRESH intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>First Receipt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Site will received the adapted FRESH intervention first.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Second Receipt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Site will received the adapted FRESH intervention second.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Finding Respect and Ending Stigma around HIV (FRESH)</intervention_name>
    <description>The Finding Respect and Ending Stigma around HIV (FRESH) intervention is theoretically informed by Social Cognitive Theory (SCT) and Interpersonal Contact theory (ICT) and was specifically designed for delivery in high-stigma settings, such as Dominican Republic. FRESH was originally developed in Africa to address HIV-related stigma, and later was adapted to address intersectional stigmas experienced by sexual and gender minorities (SGM) living with HIV in the United States Deep South. To our knowledge, FRESH will be the first intervention to address intersectional stigmas experienced by men who have sex with men, transgender women, and people living with HIV in clinical settings in the Spanish-speaking Caribbean.</description>
    <arm_group_label>First Receipt</arm_group_label>
    <arm_group_label>Second Receipt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for health worker participants:&#xD;
&#xD;
          -  Minimally 18 years and 0 months of age&#xD;
&#xD;
          -  Works at one of the three study sites&#xD;
&#xD;
          -  Interacts with people living with HIV&#xD;
&#xD;
          -  Spanish speaking&#xD;
&#xD;
          -  Can read Spanish text&#xD;
&#xD;
          -  Able and willing to provide informed consent&#xD;
&#xD;
        Inclusion Criteria for people living with HIV participants:&#xD;
&#xD;
          -  Minimally 16 years and 0 months of age&#xD;
&#xD;
          -  Is HIV-positive&#xD;
&#xD;
          -  Spanish speaking&#xD;
&#xD;
          -  Receives treatment at one of the three study sites&#xD;
&#xD;
          -  Identifies as an SGM&#xD;
&#xD;
          -  Able and willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Does not meet inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama at Birmingham (UAB)</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>January 10, 2023</last_update_submitted>
  <last_update_submitted_qc>January 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Henna Budhwani</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Stigma</keyword>
  <keyword>Intervention</keyword>
  <keyword>HIV</keyword>
  <keyword>Dominican Republic</keyword>
  <keyword>Spanish</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All data gathered during the proposed study will be available to all participating investigators and institutions. This includes the University of Alabama at Birmingham (UAB), Universidad Iberoamericana (UNIBE), and the Caribbean Vulnerable Communities Coalition (CVC).</ipd_description>
  </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/NCT04491539
org study id: 526497
nct id: NCT04491539
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research has the potential to make important contributions toward HIV and intersectional
      stigma reduction across the Spanish-speaking Caribbean. It will do so by adapting and testing
      a patient-provider, clinic-based intersectional stigma-reduction intervention -- Finding
      Respect and Ending Stigma around HIV (FRESH) -- for the Dominican Republic. Preliminary
      results from this R21 study (e.g. workshop satisfaction, stigma outcomes, HIV continuum of
      care outcomes, etc.) will inform the development of an investigator-initiated R01 proposal to
      conduct a full scale stepped wedge cluster randomized controlled trial of the adapted FRESH
      intervention.
The proposed study addresses the high level of stigma against people living with HIV (PLWH),
      particularly gender and sexual minorities, that is embedded in the Dominican Republic's HIV
      treatment system through the adaptation and testing of a patient-provider intervention --
      Finding Respect and Ending Stigma around HIV (FRESH). The Dominican Republic is a high
      priority setting with an increasing need for HIV stigma reduction studies. The Caribbean
      holds the second highest regional burden of HIV in the world, yet receives insufficient
      HIV-related stigma research funding. The Dominican Republic is 1 of 5 countries that accounts
      for over 95% of all Caribbean HIV infections; it also has a significant concentrated HIV
      epidemic, a deeply conservative society in which PLWH are stigmatized, and an exceptionally
      low national viral load suppression rate. To accomplish this pilot study, three Specific Aims
      are proposed. Aim 1 is to explore sources, characteristics, and consequences of HIV-related
      and intersectional stigmas experienced in healthcare settings by MSM and transgender women to
      inform the adaptation of FRESH. To accomplish Aim 1, we will conduct qualitative in-depth
      interviews with healthcare workers who provide HIV care, focus groups with MSM, and in-depth
      interviews with transgender women. Aim 2 is to adapt FRESH to address stigmas experienced by
      MSM and transgender women in the Dominican Republic. We will apply the Aim 1 findings using
      the ADAPT-ITT framework to systematically adapt FRESH, an intervention that has been employed
      to reduce stigma in healthcare settings in Africa and the United States. Through an iterative
      process, each revision of FRESH will be shared with both PLWH and healthcare workers to
      solicit and incorporate their feedback about each version of the adapted intervention. Aim 3
      will pilot-test the adapted intervention to obtain estimates of its ability to reduce
      stigmatizing attitudes and behaviors from HWs and experiences of stigma reported by sexual
      and gender minorities (SGM) and non-SGM clients living with HIV (primary); while exploring if
      FRESH has the potential to influence clinic-level HIV cascade outcomes.. By adapting and
      testing the FRESH intervention for the Spanish-speaking Caribbean, FRESH could become a
      validated, multi-region HIV and intersectional stigma reduction intervention designed
      specifically for healthcare settings in high-stigma, culturally conservative,
      resource-constrained communities; such a scientific development would be a significant
      contribution to HIV stigma reduction efforts in the Caribbean and globally.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Pilot stepped wedged cluster randomized controlled trial.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Stigma and Discrimination in Health Care Facilities
time frame: Year 2
description: This will be assessed via participant observation in clinical settings; there is no standardized scale.
measure: HIV Knowledge Scale (HIV-KQ-19)
time frame: Year 2
description: Includes 18 T/F questions to be collected from providers and patients
measure: Berger HIV Stigma Sclae
time frame: Year 2
description: 40-item instrument with sub-scales on empathy, enacted stigma, and disclosure concerns
measure: HIV Continuum of Care Outcomes
time frame: Years 1-2
description: Aggregated cascade data by clinic from the Ministry of Health. This includes rates of viral suppression, those on antiretroviral therapies, and number of newly diagnosed patients licing with HIV per clinic.
arm group label: Adaptation
arm group type: No Intervention
description: Site will inform the adaptation of the FRESH intervention.
arm group label: First Receipt
arm group type: Experimental
description: Site will received the adapted FRESH intervention first.
arm group label: Second Receipt
arm group type: Experimental
description: Site will received the adapted FRESH intervention second.
intervention type: Behavioral
intervention name: Finding Respect and Ending Stigma around HIV (FRESH)
description: The Finding Respect and Ending Stigma around HIV (FRESH) intervention is theoretically informed by Social Cognitive Theory (SCT) and Interpersonal Contact theory (ICT) and was specifically designed for delivery in high-stigma settings, such as Dominican Republic. FRESH was originally developed in Africa to address HIV-related stigma, and later was adapted to address intersectional stigmas experienced by sexual and gender minorities (SGM) living with HIV in the United States Deep South. To our knowledge, FRESH will be the first intervention to address intersectional stigmas experienced by men who have sex with men, transgender women, and people living with HIV in clinical settings in the Spanish-speaking Caribbean.
arm group label: First Receipt
arm group label: Second Receipt
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Henna Budhwani
investigator title: Professor
sharing ipd: No
ipd description: All data gathered during the proposed study will be available to all participating investigators and institutions. This includes the University of Alabama at Birmingham (UAB), Universidad Iberoamericana (UNIBE), and the Caribbean Vulnerable Communities Coalition (CVC).