<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/NCT03038724</url>
  </required_header>
  <id_info>
    <org_study_id>CHUV</org_study_id>
    <nct_id>NCT03038724</nct_id>
  </id_info>
  <brief_title>Randomised Study Comparing Two HIV Screening Strategies</brief_title>
  <acronym>PETTSEQ</acronym>
  <official_title>Randomised Study Comparing Two HIV Screening Strategies in the Emergency Department Using an Electronic Tablet Questionnaire: The PETTSEQ Study (PErformance of Two Testing Strategies by Electronic Questionnaire)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lausanne Hospitals</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>
      A randomised, single-blind study (the study investigator will not know which arm each patient&#xD;
      is assigned to) conducted to examine the most effective strategy for conducting HIV testing&#xD;
      in the Emergency Department (ED) using an electronic tablet. The study will take place in the&#xD;
      ED at Lausanne University Hospital (LUH) between August and December 2015 in the context of&#xD;
      the Masters project of a medical student studying at the Faculty of Medicine at Lausanne&#xD;
      University.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Switzerland, the national HIV testing recommendations have proposed targeted and&#xD;
      diagnostic HIV testing since 2007. These recommendations list medical conditions and&#xD;
      populations at risk in which HIV testing is indicated. The difficulty with this targeted&#xD;
      approach is that it relies on medical personnel 1) to be aware that the medical conditions&#xD;
      listed have an association with HIV infection and 2) to be able to identify their patients as&#xD;
      coming from at-risk populations. In other countries, notably the United States, France and&#xD;
      the United Kingdom, national HIV testing recommendations propose non-targeted screening&#xD;
      whereby everyone presenting to a medical facility is tested if the HIV seroprevalence in the&#xD;
      catchment population is above a defined threshold (0.1% for the US and France; 0.2% for the&#xD;
      UK). As HIV seroprevalence in Switzerland already exceeds these thresholds, the current study&#xD;
      will be performed to see whether non-targeted HIV testing using electronic tablets is&#xD;
      acceptable and feasible in our Emergency Department (ED).&#xD;
&#xD;
      ED patients will be randomised to a targeted or non-targeted arm after consenting to&#xD;
      participate. Eighty patients will be assigned to each study arm. Participating patients will&#xD;
      be issued with an electronic tablet and invited to follow the instructions on the screen.&#xD;
      Targeted arm patients will be invited to complete a questionnaire on HIV risk factors and, if&#xD;
      one or more risk factors are present, they will be informed that HIV testing is indicated and&#xD;
      will be invited to take a free rapid HIV test. Non-targeted arm patients will be provided&#xD;
      with information about HIV and HIV testing and will then be invited to take a free rapid HIV&#xD;
      test without any questions regarding risk factors. Patients in each arm who are either not&#xD;
      offered (targeted arm) or who decline rapid testing (non-targeted arm) will undergo secondary&#xD;
      cross-screening in which targeted arm patients will be automatically directed by the tablet&#xD;
      to the non-targeted arm information page and non-targeted arm patients will be directed to&#xD;
      the targeted arm questionnaire. The primary endpoint is patient acceptance of HIV testing.&#xD;
      The secondary objective is to examine the effect of cross-screening strategies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2015</start_date>
  <completion_date type="Actual">December 15, 2015</completion_date>
  <primary_completion_date type="Actual">November 28, 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>
    <intervention_model_description>Randomised, single-blind study</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
    <masking_description>The study investigator will not know which arm each patient is assigned to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient acceptance of rapid HIV testing in the ED</measure>
    <time_frame>4 months</time_frame>
    <description>Patient acceptance of rapid HIV testing when offered by electronic questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV testing rate after cross-screening strategy</measure>
    <time_frame>4 months</time_frame>
    <description>HIV testing accepted when patients without risk factors are offered testing or if patients offered testing without risk factor assessment then complete an assessment which shows they have risk factors for HIV acquisition</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ease of use of electronic questionnaire</measure>
    <time_frame>4 months</time_frame>
    <description>Degree of assistance required by patients when they use the electronic tablet</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Targeted testing</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients complete a questionnaire on risk factors for HIV acquisition and are offered rapid (fingerprick) HIV testing if their questionnaire responses indicate they have HIV risk factors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-targeted screening</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients offered a brief information on HIV and HIV testing and are then offered rapid (fingerprick) HIV testing without completing an HIV risk factor assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Rapid HIV test</intervention_name>
    <arm_group_label>Non-targeted screening</arm_group_label>
    <arm_group_label>Targeted testing</arm_group_label>
    <other_name>INSTI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥ 18 and ≤ 75 years old&#xD;
&#xD;
          -  Patients admitted to an ED examination cubicle within the preceding 12 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients clinically unstable (admitted to resus or considered unstable by the treating&#xD;
             ED doctor)&#xD;
&#xD;
          -  Patients transferred from another hospital&#xD;
&#xD;
          -  Patients unable to provide informed consent (for example, through cognitive&#xD;
             impairment, acute alcohol intoxication or intoxication by opiates or other&#xD;
             psycho-active substances, acute psychosis, being hard of hearing or not&#xD;
             French-speaking and with no interpreter)&#xD;
&#xD;
          -  Patients of known HIV+ status&#xD;
&#xD;
          -  Patients who have already been offered HIV screening during their ED visit by the&#xD;
             treating ED doctor prior to enrolment in the study&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>Olivier Hugli</investigator_full_name>
    <investigator_title>Head Physician</investigator_title>
  </responsible_party>
  <keyword>HIV testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03038724
org study id: CHUV
nct id: NCT03038724
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomised, single-blind study (the study investigator will not know which arm each patient
      is assigned to) conducted to examine the most effective strategy for conducting HIV testing
      in the Emergency Department (ED) using an electronic tablet. The study will take place in the
      ED at Lausanne University Hospital (LUH) between August and December 2015 in the context of
      the Masters project of a medical student studying at the Faculty of Medicine at Lausanne
      University.
In Switzerland, the national HIV testing recommendations have proposed targeted and
      diagnostic HIV testing since 2007. These recommendations list medical conditions and
      populations at risk in which HIV testing is indicated. The difficulty with this targeted
      approach is that it relies on medical personnel 1) to be aware that the medical conditions
      listed have an association with HIV infection and 2) to be able to identify their patients as
      coming from at-risk populations. In other countries, notably the United States, France and
      the United Kingdom, national HIV testing recommendations propose non-targeted screening
      whereby everyone presenting to a medical facility is tested if the HIV seroprevalence in the
      catchment population is above a defined threshold (0.1% for the US and France; 0.2% for the
      UK). As HIV seroprevalence in Switzerland already exceeds these thresholds, the current study
      will be performed to see whether non-targeted HIV testing using electronic tablets is
      acceptable and feasible in our Emergency Department (ED).

      ED patients will be randomised to a targeted or non-targeted arm after consenting to
      participate. Eighty patients will be assigned to each study arm. Participating patients will
      be issued with an electronic tablet and invited to follow the instructions on the screen.
      Targeted arm patients will be invited to complete a questionnaire on HIV risk factors and, if
      one or more risk factors are present, they will be informed that HIV testing is indicated and
      will be invited to take a free rapid HIV test. Non-targeted arm patients will be provided
      with information about HIV and HIV testing and will then be invited to take a free rapid HIV
      test without any questions regarding risk factors. Patients in each arm who are either not
      offered (targeted arm) or who decline rapid testing (non-targeted arm) will undergo secondary
      cross-screening in which targeted arm patients will be automatically directed by the tablet
      to the non-targeted arm information page and non-targeted arm patients will be directed to
      the targeted arm questionnaire. The primary endpoint is patient acceptance of HIV testing.
      The secondary objective is to examine the effect of cross-screening strategies.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised, single-blind study
primary purpose: Screening
masking: Double (Care Provider, Investigator)
masking description: The study investigator will not know which arm each patient is assigned to.
measure: Patient acceptance of rapid HIV testing in the ED
time frame: 4 months
description: Patient acceptance of rapid HIV testing when offered by electronic questionnaire
measure: HIV testing rate after cross-screening strategy
time frame: 4 months
description: HIV testing accepted when patients without risk factors are offered testing or if patients offered testing without risk factor assessment then complete an assessment which shows they have risk factors for HIV acquisition
measure: Ease of use of electronic questionnaire
time frame: 4 months
description: Degree of assistance required by patients when they use the electronic tablet
arm group label: Targeted testing
arm group type: Other
description: Patients complete a questionnaire on risk factors for HIV acquisition and are offered rapid (fingerprick) HIV testing if their questionnaire responses indicate they have HIV risk factors
arm group label: Non-targeted screening
arm group type: Other
description: Patients offered a brief information on HIV and HIV testing and are then offered rapid (fingerprick) HIV testing without completing an HIV risk factor assessment
intervention type: Diagnostic Test
intervention name: Rapid HIV test
arm group label: Non-targeted screening
arm group label: Targeted testing
other name: INSTI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: Olivier Hugli
investigator title: Head Physician
mesh term: HIV Infections
sharing ipd: No