<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/NCT01719965</url>
  </required_header>
  <id_info>
    <org_study_id>CTSG1201</org_study_id>
    <nct_id>NCT01719965</nct_id>
  </id_info>
  <brief_title>Evaluation of Tak Community Advisory Board</brief_title>
  <official_title>Evaluation of the Tak Province Community Ethics Community Advisory Board: Interviews and Focus Group Discussions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A popular form of community engagement is for the researchers to interact with a Community&#xD;
      Advisory Board. The Shoklo Malaria Research Unit has been working on the Thai-Burmese border&#xD;
      for many years and has been informally engaging with the community for its healthcare and&#xD;
      research initiatives, especially in the area of ethics and consent. In January 2009,&#xD;
      community engagement was formalised with the establishment of the Tak Province Border&#xD;
      Community Ethics Advisory Board (T-CAB). The T-CAB is the first of its kind as the&#xD;
      investigators have not come across any set up of similar nature involving mobile and unstable&#xD;
      populations residing along a porous border.&#xD;
&#xD;
      Three years on, SMRU questions if the T-CAB has been &quot;successful&quot; and if the current T-CAB&#xD;
      model is the best model for this community. In order to evaluate the T-CAB, first an&#xD;
      evaluation tool has to be developed as there are no off-the-shelf evaluation tools for CABs,&#xD;
      then the evaluation will be carried out.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Background&#xD;
&#xD;
      Research on the Thai-Myanmar border&#xD;
&#xD;
      Since 1986, the Shoklo Malaria Research Unit (SMRU) has provided basic healthcare and carried&#xD;
      out research aimed at reducing the impact of multi-drug resistant malaria and other&#xD;
      infectious diseases in the area on the border between Thailand and Myanmar. SMRU's main area&#xD;
      of interest is in malaria, with special interest in children and pregnant women - the groups&#xD;
      most at risk from malaria - and it has combined this research with the operation of antenatal&#xD;
      clinics along the border. SMRU currently runs multiple free clinics for the Karen and Burman&#xD;
      border population that would otherwise lack access to health care. The most distant clinic is&#xD;
      about 120 km from the SMRU office in Mae Sot. Carrying out research and providing care along&#xD;
      the border presents a range of unique practical and ethical challenges. This in part because&#xD;
      the people who live near the border are mostly migrants or refugees from elsewhere in Myanmar&#xD;
      who have, since the 1980s, moved to the border area to escape economic hardship and sometimes&#xD;
      conflict and persecution. There are currently thought to be two million migrants from Myanmar&#xD;
      living in Thailand (about 150 000 in refugee camps) and a further million 'internally&#xD;
      displaced' people living near the border inside Myanmar, although numbers are difficult to&#xD;
      verify. The vast majority of these people, who come from a very diverse range of different&#xD;
      ethnic, religious, political and language groups, live in insecure, unsafe conditions and&#xD;
      face a number of serious health difficulties.&#xD;
&#xD;
      Until 1995, SMRU focused its activities primarily in the refugee camps in the border area and&#xD;
      a strong collaboration was established with non-govermental organisations (NGOs) to control&#xD;
      malaria in the refugee population through the operation of &quot;the Malaria Task Force&quot; (MTF).&#xD;
      This was largely successful and malaria is now a minor problem within the camps. As a&#xD;
      consequence, whilst SMRU remains responsible for antenatal and obstetric care and the&#xD;
      treatment of malaria patients in refugee camps such as Mae La, since 1995 it has increasingly&#xD;
      extended its activities to reach out to the wider displaced populations who have little&#xD;
      alternative access to malaria diagnosis and treatment or antenatal care. This is done in&#xD;
      collaboration with the Thai Ministry of Public Health (MOPH) and in close collaboration with&#xD;
      the district hospitals and the Tak provincial health authorities. In 2001-2003 the Tak&#xD;
      Malaria Initiative, supported by the Bill &amp; Melinda Gates Foundation deployed the malaria&#xD;
      control strategy developed by SMRU in the refugee camps to all 200 affected villages in the&#xD;
      province's border districts with substantial success. When the funding from the Gates&#xD;
      Foundation came to an end, the MOPH took over the program.&#xD;
&#xD;
      The border between Thailand and Myanmar is at the forefront of the global fight against&#xD;
      malaria because it is on the frontline in the battle against the development and spread of&#xD;
      resistance to anti-malarial drugs. Malaria parasites found here are some of the most&#xD;
      drug-resistant on earth and their expansion and spread is a very real global threat (research&#xD;
      has already demonstrated that the most drug-resistant malaria parasites found in Africa&#xD;
      originated in South East Asia) . This is particularly urgent and important in the populations&#xD;
      living along the border because there is published evidence that the malaria parasites may&#xD;
      become tolerant even to the most advanced artemisinin combination therapies (ACTs) now at the&#xD;
      forefront of global malaria treatment.&#xD;
&#xD;
      Rationale for the establishment of the community advisory board&#xD;
&#xD;
      There is widespread agreement on the need for community engagement in clinical research,&#xD;
      particularly where the research involves minority groups and other vulnerable populations.&#xD;
      However there has been little research on the effectiveness and challenges associated with&#xD;
      different forms of engagement, and little or no evidence base on which to base engagement&#xD;
      strategies.&#xD;
&#xD;
      A popular form of community engagement is for the researchers to interact with a Community&#xD;
      Advisory Board. The Shoklo Malaria Research Unit has been working on the Thai-Burmese border&#xD;
      for many years and has been informally engaging with the community for its healthcare and&#xD;
      research initiatives, especially in the area of ethics and consent. In January 2009,&#xD;
      community engagement was formalised with the establishment of the Tak Province Border&#xD;
      Community Ethics Advisory Board (T-CAB). The T-CAB is the first of its kind as the&#xD;
      investigators have not come across any set up of similar nature involving mobile and unstable&#xD;
      populations residing along a porous border.&#xD;
&#xD;
      At the time of its establishment, the T-CAB had three main goals. The first of these was&#xD;
      that, after a period of training - about diseases such as malaria and the nature and goals of&#xD;
      research - it's members would be able to advise on whether a study is acceptable to and&#xD;
      perceived as beneficial by, the communities in the region. The second was that, the T-CAB&#xD;
      would play a key role in advising researchers on the ethical and operational aspects of&#xD;
      proposed studies such as: informed consent procedures, fair compensation, risks and benefits,&#xD;
      how to protect the confidentiality of research subjects, and so on. The third, aim was that&#xD;
      the T-CAB would act as a 'bridge' between the communities and researchers. It would on the&#xD;
      one hand, provide communities with an opportunity to express views on proposed research and&#xD;
      to influence and direct research aims, and on the other, provide a means by which the&#xD;
      researchers might feedback the results of the research to the community.&#xD;
&#xD;
      Three years on, SMRU questions if the T-CAB has been &quot;successful&quot; and if the current T-CAB&#xD;
      model is the best model for this community. In order to evaluate the T-CAB, first an&#xD;
      evaluation tool has to be developed as there are no off-the-shelf evaluation tools for CABs,&#xD;
      then the evaluation will be carried out.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative Assessment of Community Advisory Board. A summary of opinions raised in interviews.</measure>
    <time_frame>90 Minutes</time_frame>
    <description>Individual interviews and Focus Group Discussions. This is an observational study and the outcomes will be the comments the investigators receive from participants. The investigators will bring these views together and highlight general views and any particular points of note or problems identified by participants.</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Community Members</condition>
  <arm_group>
    <arm_group_label>Health Workers</arm_group_label>
    <description>Worked in SMRU for at least 6 months&#xD;
Clinic assistants, medics or home visitors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Researchers</arm_group_label>
    <description>Worked in SMRU for at least 6 months&#xD;
Physician or scientist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAB members</arm_group_label>
    <description>- Member of the CAB for at least 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community members</arm_group_label>
    <description>- Lived in the border area (area served by SMRU or Mae Sot) for at least 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Research subjects</arm_group_label>
    <description>- Participants who are currently enrolled in an SMRU study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interviews and Focus Group Discussions</intervention_name>
    <arm_group_label>CAB members</arm_group_label>
    <arm_group_label>Community members</arm_group_label>
    <arm_group_label>Health Workers</arm_group_label>
    <arm_group_label>Research subjects</arm_group_label>
    <arm_group_label>Researchers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Community members who work in Tak Province, Thailand.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A. Health workers&#xD;
&#xD;
          -  Worked in SMRU for at least 6 months&#xD;
&#xD;
          -  Clinic assistants, medics or home visitors&#xD;
&#xD;
        B. Researchers&#xD;
&#xD;
          -  Worked in SMRU for at least 6 months&#xD;
&#xD;
          -  Physician or scientist&#xD;
&#xD;
        C. CAB members&#xD;
&#xD;
        - Member of the CAB for at least 3 months&#xD;
&#xD;
        D. Community members - Lived in the border area (area served by SMRU or Mae Sot) for at&#xD;
        least 6 months&#xD;
&#xD;
        E. Research subjects&#xD;
&#xD;
        - Participants who are currently enrolled in an SMRU study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shoklo Malaria Research Unit</name>
      <address>
        <city>Mae Sot</city>
        <state>Tak</state>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>September 6, 2018</last_update_submitted>
  <last_update_submitted_qc>September 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Community Advisory Board</keyword>
  <keyword>Focus Group Discussion</keyword>
  <keyword>Interview</keyword>
  <keyword>Community Engagement</keyword>
  <keyword>Thailand</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/NCT01719965
org study id: CTSG1201
nct id: NCT01719965
lead sponsor: 
has dmc: No
A popular form of community engagement is for the researchers to interact with a Community
      Advisory Board. The Shoklo Malaria Research Unit has been working on the Thai-Burmese border
      for many years and has been informally engaging with the community for its healthcare and
      research initiatives, especially in the area of ethics and consent. In January 2009,
      community engagement was formalised with the establishment of the Tak Province Border
      Community Ethics Advisory Board (T-CAB). The T-CAB is the first of its kind as the
      investigators have not come across any set up of similar nature involving mobile and unstable
      populations residing along a porous border.

      Three years on, SMRU questions if the T-CAB has been "successful" and if the current T-CAB
      model is the best model for this community. In order to evaluate the T-CAB, first an
      evaluation tool has to be developed as there are no off-the-shelf evaluation tools for CABs,
      then the evaluation will be carried out.
1. Background

      Research on the Thai-Myanmar border

      Since 1986, the Shoklo Malaria Research Unit (SMRU) has provided basic healthcare and carried
      out research aimed at reducing the impact of multi-drug resistant malaria and other
      infectious diseases in the area on the border between Thailand and Myanmar. SMRU's main area
      of interest is in malaria, with special interest in children and pregnant women - the groups
      most at risk from malaria - and it has combined this research with the operation of antenatal
      clinics along the border. SMRU currently runs multiple free clinics for the Karen and Burman
      border population that would otherwise lack access to health care. The most distant clinic is
      about 120 km from the SMRU office in Mae Sot. Carrying out research and providing care along
      the border presents a range of unique practical and ethical challenges. This in part because
      the people who live near the border are mostly migrants or refugees from elsewhere in Myanmar
      who have, since the 1980s, moved to the border area to escape economic hardship and sometimes
      conflict and persecution. There are currently thought to be two million migrants from Myanmar
      living in Thailand (about 150 000 in refugee camps) and a further million 'internally
      displaced' people living near the border inside Myanmar, although numbers are difficult to
      verify. The vast majority of these people, who come from a very diverse range of different
      ethnic, religious, political and language groups, live in insecure, unsafe conditions and
      face a number of serious health difficulties.

      Until 1995, SMRU focused its activities primarily in the refugee camps in the border area and
      a strong collaboration was established with non-govermental organisations (NGOs) to control
      malaria in the refugee population through the operation of "the Malaria Task Force" (MTF).
      This was largely successful and malaria is now a minor problem within the camps. As a
      consequence, whilst SMRU remains responsible for antenatal and obstetric care and the
      treatment of malaria patients in refugee camps such as Mae La, since 1995 it has increasingly
      extended its activities to reach out to the wider displaced populations who have little
      alternative access to malaria diagnosis and treatment or antenatal care. This is done in
      collaboration with the Thai Ministry of Public Health (MOPH) and in close collaboration with
      the district hospitals and the Tak provincial health authorities. In 2001-2003 the Tak
      Malaria Initiative, supported by the Bill & Melinda Gates Foundation deployed the malaria
      control strategy developed by SMRU in the refugee camps to all 200 affected villages in the
      province's border districts with substantial success. When the funding from the Gates
      Foundation came to an end, the MOPH took over the program.

      The border between Thailand and Myanmar is at the forefront of the global fight against
      malaria because it is on the frontline in the battle against the development and spread of
      resistance to anti-malarial drugs. Malaria parasites found here are some of the most
      drug-resistant on earth and their expansion and spread is a very real global threat (research
      has already demonstrated that the most drug-resistant malaria parasites found in Africa
      originated in South East Asia) . This is particularly urgent and important in the populations
      living along the border because there is published evidence that the malaria parasites may
      become tolerant even to the most advanced artemisinin combination therapies (ACTs) now at the
      forefront of global malaria treatment.

      Rationale for the establishment of the community advisory board

      There is widespread agreement on the need for community engagement in clinical research,
      particularly where the research involves minority groups and other vulnerable populations.
      However there has been little research on the effectiveness and challenges associated with
      different forms of engagement, and little or no evidence base on which to base engagement
      strategies.

      A popular form of community engagement is for the researchers to interact with a Community
      Advisory Board. The Shoklo Malaria Research Unit has been working on the Thai-Burmese border
      for many years and has been informally engaging with the community for its healthcare and
      research initiatives, especially in the area of ethics and consent. In January 2009,
      community engagement was formalised with the establishment of the Tak Province Border
      Community Ethics Advisory Board (T-CAB). The T-CAB is the first of its kind as the
      investigators have not come across any set up of similar nature involving mobile and unstable
      populations residing along a porous border.

      At the time of its establishment, the T-CAB had three main goals. The first of these was
      that, after a period of training - about diseases such as malaria and the nature and goals of
      research - it's members would be able to advise on whether a study is acceptable to and
      perceived as beneficial by, the communities in the region. The second was that, the T-CAB
      would play a key role in advising researchers on the ethical and operational aspects of
      proposed studies such as: informed consent procedures, fair compensation, risks and benefits,
      how to protect the confidentiality of research subjects, and so on. The third, aim was that
      the T-CAB would act as a 'bridge' between the communities and researchers. It would on the
      one hand, provide communities with an opportunity to express views on proposed research and
      to influence and direct research aims, and on the other, provide a means by which the
      researchers might feedback the results of the research to the community.

      Three years on, SMRU questions if the T-CAB has been "successful" and if the current T-CAB
      model is the best model for this community. In order to evaluate the T-CAB, first an
      evaluation tool has to be developed as there are no off-the-shelf evaluation tools for CABs,
      then the evaluation will be carried out.
observational model: Cohort
time perspective: Prospective
measure: Qualitative Assessment of Community Advisory Board. A summary of opinions raised in interviews.
time frame: 90 Minutes
description: Individual interviews and Focus Group Discussions. This is an observational study and the outcomes will be the comments the investigators receive from participants. The investigators will bring these views together and highlight general views and any particular points of note or problems identified by participants.
arm group label: Health Workers
description: Worked in SMRU for at least 6 months
Clinic assistants, medics or home visitors
arm group label: Researchers
description: Worked in SMRU for at least 6 months
Physician or scientist
arm group label: CAB members
description: - Member of the CAB for at least 3 months
arm group label: Community members
description: - Lived in the border area (area served by SMRU or Mae Sot) for at least 6 months
arm group label: Research subjects
description: - Participants who are currently enrolled in an SMRU study
intervention type: Other
intervention name: Interviews and Focus Group Discussions
arm group label: CAB members
arm group label: Community members
arm group label: Health Workers
arm group label: Research subjects
arm group label: Researchers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Thailand
responsible party type: Sponsor