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Randomised Study Comparing Two HIV Screening Strategies (PETTSEQ)

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ClinicalTrials.gov Identifier: NCT03038724
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Olivier Hugli, University of Lausanne Hospitals

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE February 1, 2017
Last Update Posted Date February 1, 2017
Actual Study Start Date  ICMJE August 11, 2015
Actual Primary Completion Date November 28, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
Patient acceptance of rapid HIV testing in the ED [ Time Frame: 4 months ]
Patient acceptance of rapid HIV testing when offered by electronic questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
HIV testing rate after cross-screening strategy [ Time Frame: 4 months ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2017)
Ease of use of electronic questionnaire [ Time Frame: 4 months ]
Degree of assistance required by patients when they use the electronic tablet
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Randomised Study Comparing Two HIV Screening Strategies
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised, single-blind study
Masking: Double (Care Provider, Investigator)
Masking Description:
The study investigator will not know which arm each patient is assigned to.
Primary Purpose: Screening
Condition  ICMJE HIV Infections
Intervention  ICMJE Diagnostic Test: Rapid HIV test
Other Name: INSTI
Study Arms  ICMJE
  • Targeted testing
    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
    Intervention: Diagnostic Test: Rapid HIV test
  • Non-targeted screening
    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: Diagnostic Test: Rapid HIV test
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2017)
160
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 15, 2015
Actual Primary Completion Date November 28, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03038724
Other Study ID Numbers  ICMJE CHUV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Olivier Hugli, University of Lausanne Hospitals
Study Sponsor  ICMJE University of Lausanne Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Lausanne Hospitals
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP