NCT03038724

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable hiv-infections

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2015

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

January 30, 2017

Last Update Submit

January 30, 2017

Conditions

HIV Infections

Keywords

HIV testing

Outcome Measures

Primary Outcomes (1)

  • Patient acceptance of rapid HIV testing in the ED

    Patient acceptance of rapid HIV testing when offered by electronic questionnaire

    4 months

Secondary Outcomes (1)

  • HIV testing rate after cross-screening strategy

    4 months

Other Outcomes (1)

  • Ease of use of electronic questionnaire

    4 months

Study Arms (2)

Targeted testing

OTHER

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

Non-targeted screening

OTHER

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

Interventions

Rapid HIV testDIAGNOSTIC_TEST
Also known as: INSTI
Non-targeted screeningTargeted testing

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29513659DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
The study investigator will not know which arm each patient is assigned to.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomised, single-blind study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Physician

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 1, 2017

Study Start

August 11, 2015

Primary Completion

November 28, 2015

Study Completion

December 15, 2015

Last Updated

February 1, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share