<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/NCT03835832</url>
  </required_header>
  <id_info>
    <org_study_id>HIV-NAT 260</org_study_id>
    <nct_id>NCT03835832</nct_id>
  </id_info>
  <brief_title>Self-Assessment Tuberculin Skin Test</brief_title>
  <acronym>ISAT</acronym>
  <official_title>Innovation of Self-Assessment Tuberculin Skin Test for Latent TB Screening in HIV Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The HIV Netherlands Australia Thailand Research Collaboration</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taksin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The HIV Netherlands Australia Thailand Research Collaboration</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>
      The research team/investigator/nurse/professional health care workers will teach the&#xD;
      participants how to read the results for TST test. The investigator will compare the reading&#xD;
      results done by the participants to the results read by the nurses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cross-sectional study of HIV-infected patients from 2 HIV clinics in Bangkok:&#xD;
      HIV-NAT, Thai Red Cross AIDS Research Centre and Taksin Hospital. Research&#xD;
      team/investigator/nurse/professional health care workers will assess whether the reading of&#xD;
      TST test between the participants and the nurses are the same or not. The investigator and&#xD;
      team believe that the readings of the TST tests between the participants and the nurses will&#xD;
      be the same. If the investigator and team hypothesis is correct, then this will lessen the&#xD;
      workload of the nurses and reduce the number of times the participants have to come to the&#xD;
      clinic to see the nurses and the doctors. This is a pilot study to test this innovative&#xD;
      method to teach the participants to read the TST results by themselves. If this technique is&#xD;
      successful, then the investigator and team can expand the method to other hospitals in&#xD;
      Thailand as well as in the region.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2019</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>self-assessment versus nurse reading</measure>
    <time_frame>6 months</time_frame>
    <description>this study will assess the sensitivity of this new innovative method for reading TST</description>
  </primary_outcome>
  <primary_outcome>
    <measure>self-assessment versus nurse reading</measure>
    <time_frame>6 months</time_frame>
    <description>this study will assess the specificity of this new innovative method for reading TST</description>
  </primary_outcome>
  <primary_outcome>
    <measure>self-assessment versus nurse reading</measure>
    <time_frame>6 months</time_frame>
    <description>this study will assess the positive predictive value (PPV) of this new innovative method for reading TST</description>
  </primary_outcome>
  <primary_outcome>
    <measure>self-assessment versus nurse reading</measure>
    <time_frame>6 months</time_frame>
    <description>this study will assess the negative predictive value (NPV) of this new innovative method for reading TST</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>In house questionnaire to assess the patients' satisfaction of reading TST by themselves</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of patients' satisfaction in self- assessment TST by using questionnaires</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">215</enrollment>
  <condition>Tuberculin Skin Test</condition>
  <arm_group>
    <arm_group_label>HIV-infected participants who receive TST test</arm_group_label>
    <description>0.1 ml of tuberculin purified protein derivative will be intra-dermally inoculated on the forearm of the HIV-infected participants. They will learn how to interpret the results of the TST test. When they return to the clinic, the nurse will also interpret the results of the TST test. The results from the participants will be compared to the nurses' interpretation. We will assess the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the innovative method.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The participants do not receive any intervention for this study</intervention_name>
    <description>The participants do not receive any intervention for this study</description>
    <arm_group_label>HIV-infected participants who receive TST test</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        HIV-infected adults with documented HIV diagnosis who do not have any signs or symptoms of&#xD;
        active TB.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Documented HIV-1 infection&#xD;
&#xD;
          2. Aged ≥18 years old&#xD;
&#xD;
          3. No sign and symptom of active TB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Refuse to read TST by themselves&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sivaporn Gatechompol, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HIV-NAT, Thai Red Cross - AIDS Research Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HIV-NAT, Thai Red Cross AIDS Research Centre</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taksin Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10600</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tuberculin skin test</keyword>
  <keyword>latent TB infection</keyword>
  <keyword>HIV/TB co-infected participants</keyword>
  <keyword>Sensitivity</keyword>
  <keyword>Specificity</keyword>
  <keyword>positive predictive value (PPV)</keyword>
  <keyword>negative predictive value (NPV)</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/NCT03835832
org study id: HIV-NAT 260
nct id: NCT03835832
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research team/investigator/nurse/professional health care workers will teach the
      participants how to read the results for TST test. The investigator will compare the reading
      results done by the participants to the results read by the nurses.
This is a cross-sectional study of HIV-infected patients from 2 HIV clinics in Bangkok:
      HIV-NAT, Thai Red Cross AIDS Research Centre and Taksin Hospital. Research
      team/investigator/nurse/professional health care workers will assess whether the reading of
      TST test between the participants and the nurses are the same or not. The investigator and
      team believe that the readings of the TST tests between the participants and the nurses will
      be the same. If the investigator and team hypothesis is correct, then this will lessen the
      workload of the nurses and reduce the number of times the participants have to come to the
      clinic to see the nurses and the doctors. This is a pilot study to test this innovative
      method to teach the participants to read the TST results by themselves. If this technique is
      successful, then the investigator and team can expand the method to other hospitals in
      Thailand as well as in the region.
observational model: Other
time perspective: Cross-Sectional
measure: self-assessment versus nurse reading
time frame: 6 months
description: this study will assess the sensitivity of this new innovative method for reading TST
measure: self-assessment versus nurse reading
time frame: 6 months
description: this study will assess the specificity of this new innovative method for reading TST
measure: self-assessment versus nurse reading
time frame: 6 months
description: this study will assess the positive predictive value (PPV) of this new innovative method for reading TST
measure: self-assessment versus nurse reading
time frame: 6 months
description: this study will assess the negative predictive value (NPV) of this new innovative method for reading TST
measure: In house questionnaire to assess the patients' satisfaction of reading TST by themselves
time frame: 6 months
description: Evaluation of patients' satisfaction in self- assessment TST by using questionnaires
arm group label: HIV-infected participants who receive TST test
description: 0.1 ml of tuberculin purified protein derivative will be intra-dermally inoculated on the forearm of the HIV-infected participants. They will learn how to interpret the results of the TST test. When they return to the clinic, the nurse will also interpret the results of the TST test. The results from the participants will be compared to the nurses' interpretation. We will assess the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the innovative method.
intervention type: Other
intervention name: The participants do not receive any intervention for this study
description: The participants do not receive any intervention for this study
arm group label: HIV-infected participants who receive TST test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sivaporn Gatechompol, MD
role: Principal Investigator
affiliation: HIV-NAT, Thai Red Cross - AIDS Research Centre
facility: 
facility: 
country: Thailand
responsible party type: Sponsor