<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/NCT01733927</url>
  </required_header>
  <id_info>
    <org_study_id>DIEECII #3</org_study_id>
    <nct_id>NCT01733927</nct_id>
  </id_info>
  <brief_title>An Evaluation of a Rapid Test for HIV</brief_title>
  <official_title>An Evaluation of an Oral Rapid Test for HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pontificia Universidad Catolica de Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pontificia Universidad Catolica de Chile</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study, conducted in Santiago-Chile, was to:&#xD;
&#xD;
        1. Evaluate the sensitivity and specificity of OraQuick Advance oral rapid test (OQA)when&#xD;
           compared to ELISA;&#xD;
&#xD;
        2. Track the number of people in the study who returned for their ELISA test HIV results;&#xD;
           and&#xD;
&#xD;
        3. Analyze the perception among participants of the use of OQA compared to ELISA testing&#xD;
           for HIV screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human Immunodeficiency Virus /Acquired Immunodeficiency Syndrome (HIV/AIDS) continues to be&#xD;
      one of the most devastating worldwide pandemics. In response to the HIV/AIDS epidemic, the&#xD;
      Joint United Nations Programme on HIV/AIDS in 2010, urged countries to improve access to&#xD;
      HIV/AIDS testing and counseling in an effort to increase the number of people who know their&#xD;
      HIV status, thereby attempting to decrease transmission and increase treatment. Thus, an&#xD;
      effective country response is to increase voluntary testing and counseling, particularly&#xD;
      among at-risk populations. Ensuring patients receive their test results is an essential&#xD;
      component of these efforts.&#xD;
&#xD;
      Chile, since 1991, has seen an increase of notified cases of HIV/ AIDS among certain regions&#xD;
      of the country. The Chilean government offers free screening for HIV using only the ELISA&#xD;
      test. In addition, many Chileans fail to return to receive their test results, as do many&#xD;
      other individuals worldwide. In the United States, the Center for Disease Control reported&#xD;
      that when using the &quot;gold standard of HIV testing&quot; (the ELISA) 30% of people with negative&#xD;
      results and 39% of people with positive results do not return for their test results.&#xD;
&#xD;
      In Western counties, as well as several Latin American countries, the use of rapid testing&#xD;
      technology to identify HIV 1 and 2 has increased the percentage of people who learn their&#xD;
      serological status when compared with those who are tested using the traditional ELISA&#xD;
      method. Neither the rapid test nor ELISA yield a definitive diagnosis, so further&#xD;
      confirmation testing is required using the Western Blot to rule out the possibility of a&#xD;
      false positive result. Nonetheless, by providing quick turn-around, rapid testing helps to&#xD;
      facilitate individuals receiving their initial test results, thereby increasing the their&#xD;
      probability of being quickly referred to appropriate health services for confirmatory testing&#xD;
      and treatment.&#xD;
&#xD;
      Although the Food and Drug Administration (FDA) currently has approved six different rapid&#xD;
      tests for clinical use to detect HIV 1 and 2, the OraQuick Advance Rapid Assessment (OQA) is&#xD;
      the only one that is administered orally.&#xD;
&#xD;
      OQA testing can be conducted in geographical locations where laboratory facilities capable of&#xD;
      performing ELISA assays are unavailable. Thus, HIV screening programs that adopt OQA can&#xD;
      extend their reach far beyond previous locations.&#xD;
&#xD;
      Despite OQA's growing success and popularity in many different settings globally, Chile has&#xD;
      yet to accept OQA or any rapid testing as a viable alternative to ELISA testing. The Chilean&#xD;
      government has delayed approval for the adoption of OQA pending additional evidence among&#xD;
      Chileans that it offers a more advantageous alternative to ELISA testing with equal&#xD;
      specificity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">March 2011</completion_date>
  <primary_completion_date type="Actual">November 2010</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The sensitivity and specificity of a rapid test in oral fluid (OraQuick Advance)compare to the ELISA test for HIV.</measure>
    <time_frame>1 day (Immediately after the participants had taken their ELISA test for HIV or when recruited in case of people living with HIV.)</time_frame>
    <description>OraQuick Advance rapid oral test (OQA) was administered to people living with HIV (PLWH) who were not under Anti-retroviral treatment. The PLWH had a previous positive ELISA test and confirmed diagnose with a Western-blot. People who didn't know their HIV diagnose, and who had come to the clinic for an ELISA test for HIV were also administered OQA test after they had completed their ELISA test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of people who received their result from the ELISA for HIV test, versus the number of people who receives their OQA results.</measure>
    <time_frame>Clinic staff notified patient of their ELISA test results for up to three weeks after their clinic visit.</time_frame>
    <description>Ones the results of the ELISA test came back from the laboratory, the responsible party at the clinic had to notify the patient and the research team about their ELISA for HIV result and if they had been successfully notifying the HIV status. The patient had authorized the clinic staff to disclosure their HIV result to the research team in the consent form when enrolled in the research. This results were compared with the number of people that would have received their result in the same visit (after 20 minutes) if administered OQA instead of the ELISA.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Perceptions among study participants of the use of OQA compared to ELISA testing for HIV screening.</measure>
    <time_frame>Within 3 months after they were administered their OQA test, the participants were either interviewed or participated in a focus group.</time_frame>
    <description>Participants indicated their interest on their consent forms in being contacted at a later date to participate in a focus group or interview to discuss their testing experience and perceptions of both tests.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">497</enrollment>
  <condition>HIV Seropositivity</condition>
  <arm_group>
    <arm_group_label>Rapid testing for HIV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention consisted in administer an oral rapid test for HIV (OQA) to people that also had taken an ELISA test to compare their tests results. Group 1 consisted of 344 participants who did not know their HIV status; Group 2 consisted of 153 participants who were previously confirmed to be HIV positive. The participants were instructed to obtain their own oral fluid sample using the testing devices provide by the OQA rapid test kits. Project team members, certified to interpret OQA results, registered each test outcome on a data form using the same code number that the participant was assigned for the ELISA test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rapid testing for HIV</intervention_name>
    <description>The research team members were trained and certified in administering the OQA testing through the AIDS International Consortium in Philadelphia (WHCI), USA. During the recruitment process, participants were informed about the nature of the test, the length of time for results, and what procedures would be involved in self-administering the OQA test. After providing informed consent, including the release of information for research use, participants demonstrated their ability to properly take an OQA sample using a popsicle stick as a proxy for the testing device.</description>
    <arm_group_label>Rapid testing for HIV</arm_group_label>
    <other_name>OraQuick Advance rapid test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or older&#xD;
&#xD;
          -  Seeking ELISA testing to learn their HIV status (group 1) or&#xD;
&#xD;
          -  Having been confirmed HIV positive through Western Blot testing (Group 2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV positive currently under antiretroviral medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisette P Irarrazabal, PhD ©</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pontificia Universidad Catolica de Chile / University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Nursing, Pontificia Universidad Catolica de Chile</name>
      <address>
        <city>Macul</city>
        <state>Santiago</state>
        <zip>7810000</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 26, 2012</last_update_submitted>
  <last_update_submitted_qc>November 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV screening</keyword>
  <keyword>Rapid test for HIV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Seropositivity</mesh_term>
  </condition_browse>
  <!-- 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/NCT01733927
org study id: DIEECII #3
nct id: NCT01733927
lead sponsor: 
has dmc: No
The purpose of this study, conducted in Santiago-Chile, was to:

        1. Evaluate the sensitivity and specificity of OraQuick Advance oral rapid test (OQA)when
           compared to ELISA;

        2. Track the number of people in the study who returned for their ELISA test HIV results;
           and

        3. Analyze the perception among participants of the use of OQA compared to ELISA testing
           for HIV screening.
Human Immunodeficiency Virus /Acquired Immunodeficiency Syndrome (HIV/AIDS) continues to be
      one of the most devastating worldwide pandemics. In response to the HIV/AIDS epidemic, the
      Joint United Nations Programme on HIV/AIDS in 2010, urged countries to improve access to
      HIV/AIDS testing and counseling in an effort to increase the number of people who know their
      HIV status, thereby attempting to decrease transmission and increase treatment. Thus, an
      effective country response is to increase voluntary testing and counseling, particularly
      among at-risk populations. Ensuring patients receive their test results is an essential
      component of these efforts.

      Chile, since 1991, has seen an increase of notified cases of HIV/ AIDS among certain regions
      of the country. The Chilean government offers free screening for HIV using only the ELISA
      test. In addition, many Chileans fail to return to receive their test results, as do many
      other individuals worldwide. In the United States, the Center for Disease Control reported
      that when using the "gold standard of HIV testing" (the ELISA) 30% of people with negative
      results and 39% of people with positive results do not return for their test results.

      In Western counties, as well as several Latin American countries, the use of rapid testing
      technology to identify HIV 1 and 2 has increased the percentage of people who learn their
      serological status when compared with those who are tested using the traditional ELISA
      method. Neither the rapid test nor ELISA yield a definitive diagnosis, so further
      confirmation testing is required using the Western Blot to rule out the possibility of a
      false positive result. Nonetheless, by providing quick turn-around, rapid testing helps to
      facilitate individuals receiving their initial test results, thereby increasing the their
      probability of being quickly referred to appropriate health services for confirmatory testing
      and treatment.

      Although the Food and Drug Administration (FDA) currently has approved six different rapid
      tests for clinical use to detect HIV 1 and 2, the OraQuick Advance Rapid Assessment (OQA) is
      the only one that is administered orally.

      OQA testing can be conducted in geographical locations where laboratory facilities capable of
      performing ELISA assays are unavailable. Thus, HIV screening programs that adopt OQA can
      extend their reach far beyond previous locations.

      Despite OQA's growing success and popularity in many different settings globally, Chile has
      yet to accept OQA or any rapid testing as a viable alternative to ELISA testing. The Chilean
      government has delayed approval for the adoption of OQA pending additional evidence among
      Chileans that it offers a more advantageous alternative to ELISA testing with equal
      specificity.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: The sensitivity and specificity of a rapid test in oral fluid (OraQuick Advance)compare to the ELISA test for HIV.
time frame: 1 day (Immediately after the participants had taken their ELISA test for HIV or when recruited in case of people living with HIV.)
description: OraQuick Advance rapid oral test (OQA) was administered to people living with HIV (PLWH) who were not under Anti-retroviral treatment. The PLWH had a previous positive ELISA test and confirmed diagnose with a Western-blot. People who didn't know their HIV diagnose, and who had come to the clinic for an ELISA test for HIV were also administered OQA test after they had completed their ELISA test.
measure: The number of people who received their result from the ELISA for HIV test, versus the number of people who receives their OQA results.
time frame: Clinic staff notified patient of their ELISA test results for up to three weeks after their clinic visit.
description: Ones the results of the ELISA test came back from the laboratory, the responsible party at the clinic had to notify the patient and the research team about their ELISA for HIV result and if they had been successfully notifying the HIV status. The patient had authorized the clinic staff to disclosure their HIV result to the research team in the consent form when enrolled in the research. This results were compared with the number of people that would have received their result in the same visit (after 20 minutes) if administered OQA instead of the ELISA.
measure: Perceptions among study participants of the use of OQA compared to ELISA testing for HIV screening.
time frame: Within 3 months after they were administered their OQA test, the participants were either interviewed or participated in a focus group.
description: Participants indicated their interest on their consent forms in being contacted at a later date to participate in a focus group or interview to discuss their testing experience and perceptions of both tests.
arm group label: Rapid testing for HIV
arm group type: Experimental
description: The intervention consisted in administer an oral rapid test for HIV (OQA) to people that also had taken an ELISA test to compare their tests results. Group 1 consisted of 344 participants who did not know their HIV status; Group 2 consisted of 153 participants who were previously confirmed to be HIV positive. The participants were instructed to obtain their own oral fluid sample using the testing devices provide by the OQA rapid test kits. Project team members, certified to interpret OQA results, registered each test outcome on a data form using the same code number that the participant was assigned for the ELISA test.
intervention type: Device
intervention name: Rapid testing for HIV
description: The research team members were trained and certified in administering the OQA testing through the AIDS International Consortium in Philadelphia (WHCI), USA. During the recruitment process, participants were informed about the nature of the test, the length of time for results, and what procedures would be involved in self-administering the OQA test. After providing informed consent, including the release of information for research use, participants demonstrated their ability to properly take an OQA sample using a popsicle stick as a proxy for the testing device.
arm group label: Rapid testing for HIV
other name: OraQuick Advance rapid test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lisette P Irarrazabal, PhD ©
role: Principal Investigator
affiliation: Pontificia Universidad Catolica de Chile / University of Illinois at Chicago
facility: 
country: Chile
responsible party type: Sponsor
mesh term: HIV Seropositivity