skip to content

Clinical Trials

MainTitle

Randomised Study Comparing Two HIV Screening Strategies (PETTSEQ)

This study has been completed
Sponsor
University of Lausanne Hospitals


Information provided by (Responsible Party)
Olivier Hugli, University of Lausanne Hospitals

ClinicalTrials.gov Identifier
NCT03038724

First received: January 30, 2017
Last updated: January 30, 2017
Last Verified: January 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections

Diagnostic Test : Rapid HIV test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, single-blind study
Masking: Double (Care Provider, Investigator)
Primary Purpose: Screening
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)

Further study details as provided by Olivier Hugli, University of Lausanne Hospitals:

Primary Outcome Measures

  • Patient acceptance of rapid HIV testing in the ED [ Time Frame: 4 months ]
    Patient acceptance of rapid HIV testing when offered by electronic questionnaire
Secondary Outcome Measures:
  • 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
Other Outcome Measures:
  • Ease of use of electronic questionnaire [ Time Frame: 4 months ]
    Degree of assistance required by patients when they use the electronic tablet

Enrollment: 160
Study Start Date: August 11, 2015
Study Completion Date: December 15, 2015
Primary Completion Date: November 28, 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: 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
Diagnostic Test: Rapid HIV test
Other Name: INSTI
Other: 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
Diagnostic Test: Rapid HIV test
Other Name: INSTI

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 75 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03038724

Sponsors and Collaborators

University of Lausanne Hospitals
More Information

More Information


Responsible Party: Olivier Hugli, Head Physician, University of Lausanne Hospitals  
ClinicalTrials.gov Identifier: NCT03038724   History of Changes  
Other Study ID Numbers: CHUV  
Study First Received: January 30, 2017  
Last Updated: January 30, 2017  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Olivier Hugli, University of Lausanne Hospitals:

HIV testing

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.