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

About this trial
This is an interventional screening trial for HIV Infections focused on measuring HIV testing
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
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
NCT ID
NCT03038724
First Posted
January 30, 2017
Last Updated
January 30, 2017
Sponsor
University of Lausanne Hospitals
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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