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Randomised Study Comparing Two HIV Screening Strategies (PETTSEQ)

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rapid HIV test
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV Infections focused on measuring HIV testing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients ≥ 18 and ≤ 75 years old
  • Patients admitted to an ED examination cubicle within the preceding 12 hours

Exclusion Criteria:

  • Patients clinically unstable (admitted to resus or considered unstable by the treating ED doctor)
  • Patients transferred from another hospital
  • Patients unable to provide informed consent (for example, through cognitive impairment, acute alcohol intoxication or intoxication by opiates or other psycho-active substances, acute psychosis, being hard of hearing or not French-speaking and with no interpreter)
  • Patients of known HIV+ status
  • Patients who have already been offered HIV screening during their ED visit by the treating ED doctor prior to enrolment in the study
  • Prisoners

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Targeted testing

    Non-targeted screening

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    Patient acceptance of rapid HIV testing in the ED
    Patient acceptance of rapid HIV testing when offered by electronic questionnaire

    Secondary Outcome Measures

    HIV testing rate after cross-screening strategy
    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

    Full Information

    First Posted
    January 30, 2017
    Last Updated
    January 30, 2017
    Sponsor
    University of Lausanne Hospitals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03038724
    Brief Title
    Randomised Study Comparing Two HIV Screening Strategies
    Acronym
    PETTSEQ
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 11, 2015 (Actual)
    Primary Completion Date
    November 28, 2015 (Actual)
    Study Completion Date
    December 15, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Lausanne Hospitals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    HIV testing

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomised, single-blind study
    Masking
    Care ProviderInvestigator
    Masking Description
    The study investigator will not know which arm each patient is assigned to.
    Allocation
    Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Targeted testing
    Arm Type
    Other
    Arm 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 Title
    Non-targeted screening
    Arm Type
    Other
    Arm 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(s)
    Rapid HIV test
    Other Intervention Name(s)
    INSTI
    Primary Outcome Measure Information:
    Title
    Patient acceptance of rapid HIV testing in the ED
    Description
    Patient acceptance of rapid HIV testing when offered by electronic questionnaire
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    HIV testing rate after cross-screening strategy
    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
    Time Frame
    4 months
    Other Pre-specified Outcome Measures:
    Title
    Ease of use of electronic questionnaire
    Description
    Degree of assistance required by patients when they use the electronic tablet
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients ≥ 18 and ≤ 75 years old Patients admitted to an ED examination cubicle within the preceding 12 hours Exclusion Criteria: Patients clinically unstable (admitted to resus or considered unstable by the treating ED doctor) Patients transferred from another hospital Patients unable to provide informed consent (for example, through cognitive impairment, acute alcohol intoxication or intoxication by opiates or other psycho-active substances, acute psychosis, being hard of hearing or not French-speaking and with no interpreter) Patients of known HIV+ status Patients who have already been offered HIV screening during their ED visit by the treating ED doctor prior to enrolment in the study Prisoners

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29513659
    Citation
    Gillet C, Darling KEA, Senn N, Cavassini M, Hugli O. Targeted versus non-targeted HIV testing offered via electronic questionnaire in a Swiss emergency department: A randomized controlled study. PLoS One. 2018 Mar 7;13(3):e0190767. doi: 10.1371/journal.pone.0190767. eCollection 2018.
    Results Reference
    derived

    Learn more about this trial

    Randomised Study Comparing Two HIV Screening Strategies

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