HIV InfectionsPETTSEQNCT03038724
Randomised Study Comparing Two HIV Screening Strategies
A study testing Rapid HIV test in people with HIV Infections, run by University of Lausanne Hospitals.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Rapid HIV test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2015to 15 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 and ≤ 75 years old
- Patients admitted to an ED examination cubicle within the preceding 12 hours
Who cannot join
- 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
About this study
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)
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Rapid HIV test
- Keywords
- HIV testing
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid HIV testDiagnostic test
Also called INSTI
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Rapid HIV test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient acceptance of rapid HIV testing in the ED
Patient acceptance of rapid HIV testing when offered by electronic questionnaire
Measured: 4 months
Secondary outcomes (1)
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start11 Aug 2015
- Primary completion28 Nov 2015
- Study completion15 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, single-blind study
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Hugli, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038724
- Sponsor's protocol ID
- CHUV
- Acronym
- PETTSEQ
- Status last verified
- Jan 2017
- First submitted
- 30 Jan 2017
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29513659
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03038724
- Acronym / sponsor ID
- PETTSEQ / CHUV
- Conditions
- HIV Infections
- Keywords
- HIV testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 11 Aug 2015 (actual)
- Primary completion
- 28 Nov 2015 (actual)
- Study completion
- 15 Dec 2015 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Randomised, single-blind study
| Arm | Type | Receives |
|---|---|---|
| Targeted testing | Other | Diagnostic Test: Rapid HIV testPatients 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 |
| Non-targeted screening | Other | Diagnostic Test: Rapid HIV testPatients offered a brief information on HIV and HIV testing and are then offered rapid (fingerprick) HIV testing without completing an HIV risk factor assessment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 18 and ≤ 75 years old
- Patients admitted to an ED examination cubicle within the preceding 12 hours
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid HIV testAlso: INSTI | Diagnostic test | Non-targeted screening, Targeted testing |
Primary outcome
Patient acceptance of rapid HIV testing in the ED
Time frame: 4 months
Patient acceptance of rapid HIV testing when offered by electronic questionnaire
1 secondary outcome
HIV testing rate after cross-screening strategy
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Derived from this study: PubMed 29513659Gillet 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.
- Individual participant dataSharing planned: No
Related trials for HIV Infections
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
Lymphoproliferative Disorder, HHV-8
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
Enrolling by invitation
ORCHID: An Online Intervention for Persons With HIV (Miami)
HIV/AIDS, HPV Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid HIV test in people with HIV Infections, run by University of Lausanne Hospitals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient acceptance of rapid HIV testing in the ED (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03038724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017; AzTrials last refreshed its copy on 2 Nov 2026.