Universal HIV Screening and Targeted HCV Screening in Emergency Department
Phase: NA
Conditions: Hepatitis C, Hiv
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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Universal HIV Screening and Targeted HCV Screening in 
Emergency Department 
 
NCT03595527 
 
 
The initial version of this protocol was approved in French by the Centre hospitalier de l’Université 
de Montréal institutional review board on March 6th, 2018.  An investigator was added on June 
20th, 2018.  This is a translation of the latest version. 
 
 

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Dépistage universel du VIH et dépistage ciblé du VHC à l’urgence 
 
 
Rational:  
The cascade of care is a widely used concept in HIV.  It is a way of representing 
a patient's progression from diagnosis to disease management.  It is used to 
assess the quality of care provided, to identify barriers that limit patient progress, 
to focus research on these barriers, and to develop public health policies.1,2 The 
advent of effective treatments for HCV has made it possible to transpose the 
concept of the cascade to HCV, thus moving away from a research logic focused 
on optimizing the sustained virological response (SVR) of individuals to a logic of 
access to this virological response for all.1 The two steps in the cascade that are 
most critical for the management of HCV in Quebec, as in other countries, are 
access to the screening test and linkage to the health care system. Problems 
with screening, linkage to the health care system and losses to follow-up 
throughout the cascade are estimated to reduce the effectiveness of treatment by 
up to 75%.3  
 
HCV and HIV screening based on risk factors, according to Quebec and 
Canadian recommendations, does not allow for the identification of all cases.  It 
is estimated that 44% of Canadians infected with HCV and 21% of Quebecers 
infected with HIV are unaware of their status.4,5 In addition, nearly 26% of HCV-
positive patients do not obtain their test results and are therefore not managed 
(loss of follow-up between the test and the results).3 It is therefore important to 
evaluate new models of screening adapted to the Quebec healthcare system. 
 
To address the problem of under-testing for HIV and HCV in the United States, 
the U.S. Preventive Services Task Force recommended universal HIV testing 
among 15-65 year olds in 2012 and HCV testing among individuals born between 
1945 and 1965 in 2013.6,7 Different approaches to providing expanded testing 
have been evaluated. With opt-in, the patients are informed of the availability of 
the test and asked if they want to be tested, whereas with opt-out, the patients 
are informed that they will be tested unless they decline the test.  Several studies 
have demonstrated the acceptability of the latter approach with a higher rate of 
testing than the opt-in option.8,9 One argument cited against the opt-out approach 
is the need for extensive pre-test counseling before testing for HIV. However, a 
recent randomized trial evaluated the impact of pre-test counselling on the 
acquisition of sexually transmitted infections in the six months following 
counselling and showed no benefit in the group that received counselling.10 In 
Quebec, the opt-out approach is currently used for HIV testing of pregnant 
women. 
 
For HIV, a recent study in an urban setting in Ireland using the opt-out approach 
identified a proportion of new diagnoses of 0.8 per 1000 patients.11 In another 

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opt-out study in an emergency department (ED) in Phoenix, Arizona, 22 468 
patients aged 18-64 years were tested for HIV.12 There were 0.28% of new 
diagnoses, of which 23% were in the acute phase of infection, the period when 
the risk of HIV transmission is highest.12 Universal HIV screening would be cost-
effective in clinical settings where the prevalence of undiagnosed HIV infection is 
≥ 0.1%.13 In a study of opt-out HCV screening of baby boomers visiting an 
emergency department in Alabama, 170 new cases were identified out of 1,529 
patients tested (11.1%).14 However, the results of this American study did not 
change our approach in Quebec.     
 
Once diagnosed, in order to be treated, patients must see a physician and 
undergo the various tests and laboratory analyses mentioned above.  The patient 
who engages in this process is considered to be "linked-to-care".  However, 
many patients do not consult or quickly disengage from follow-up.  A US study 
reported that 47% of patients who know their status do not link to the health care 
system.3 The often long delays between diagnosis and clinical management 
contribute to the current loss to follow-up. For example, one Canadian study 
reported delays of 66.3 months from initial diagnosis to referral to a specialty, an 
additional 1.5 months to seeing the specialist, and 6.8 months from initial visit to 
initiation of treatment.15 Another Canadian study reported loss-to-follow-up rates 
of 19% during evaluation, while a Scottish study noted that 16% of patients never 
made it to the first visit and 24% were lost after only one visit.16,17 It is therefore 
important to assess whether expediting management would allow more patients 
to initiate treatment by limiting disengagement from care. 
 
The goal of the first project is to evaluate the feasibility of routine HIV and HCV 
screening using an opt-out approach in the CHUM emergency department and to 
determine the rate of new HIV and HCV diagnoses.  A sub-analysis will focus 
more specifically on HCV in the Quebec equivalent of the baby boomers (1945-
1975), since this is the group that was targeted in the United States.18 We also 
want to evaluate the effectiveness of linkage-to-care for people diagnosed with 
HIV or HCV and the speed with which these people are taken into care and put 
on treatment. 
 
Hypothesis: 
We believe that it is realistic to observe a proportion of new diagnoses greater 
than 1/1000 for HIV and 1/100 for HCV in the CHUM emergency department. 
 
Objectives: 
Primary objectives  
1. 
To determine the prevalence of new HIV and HCV diagnoses among the 
patients visiting the CHUM emergency department 
2. 
To determine the overall prevalence of HIV and HCV (new cases and 
known cases) among the patients visiting the CHUM emergency department 
 
Secondary objectives 

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1. 
To determine the prevalence of new and known HCV cases among the 
"baby boomers" (41-73 years) 
2. 
To determine the proportion of adherence of ED staff to the offer of HIV 
and HCV testing 
3. 
To determine the proportion of patients "opting out" of routine HIV and 
HCV testing in the ED 
4. 
To determine the proportion of patients with a newly positive HIV or HCV 
test in the ED who attended a first appointment at 1 month 
5. 
To determine the proportion who completed certain steps in the HIV and 
HCV care cascades at 1 or 3 months, namely confirmation of diagnosis (HIV and 
HCV: 1 month), liver fibrosis assessment (HCV: 3 months), and treatment 
initiation (HIV: 1 month and HCV: 3 months) 
6. 
To define the organization of services needed to continue screening 
beyond the research project in terms of costs, nursing time, volume of tests and 
communication of results. 
 
Design:  
Cross-sectional study of ED patients with evaluation of the implementation of the 
screening program and prospective follow-up for 3 months of the positive cases. 
 
Method:  
Implementation: Preparatory meetings will be held with CHUM ED managers, 
medical leaders, and nurses to discuss issues associated with routine screening 
and to attempt to find solutions to anticipated barriers in advance. Following 
these discussions, ED triage staff, including day, evening and night staff, will be 
met for training on the importance of screening and the procedure that will be 
followed under this protocol.   
 
Informational Tools:  
Patient announcements  
Information materials will be prepared to announce to CHUM ED patients that 
HIV and/or HCV testing will be performed.  Posters will be put up in the ED and 
an information sheet will be given to patients at the time of registration. 
 
Materials for Nurses:  
The following items will be added to the triage form already in place in the ED: 
"Are you infected with HIV? Are you infected with HCV?", "Unless you decline, 
we will be performing a blood test for HIV (and/or) HCV today."  These questions 
will simultaneously serve as a reminder for staff to offer the test and as a data 
collection form for investigators.   
Pre-printed orders for HIV and HCV testing will also be created with the name 
and license number of one of the investigators.   
 
Laboratory Tests:  
The tests used will be the routine CHUM tests (ARCHITECT HIV Ag/Ab combo 
and ARCHITECT anti-HCV assay). These were chosen over rapid tests because 

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they are less expensive and more sensitive, they are more representative of what 
might be widely available in the event of a provincial rollout of ED screening, and 
there are no licensed rapid tests for HCV in Canada. 
 
Screening:  
At triage, patients will be advised that they will be tested for HIV and/or HCV 
unless they refuse to be tested or are already known to be infected with HIV 
and/or HCV.  If a patient is known to be infected with HIV or HCV, they may be 
tested for the virus whose status is unknown.  The time required to educate the 
patient and obtain answers to questions will be measured for a sample of 
patients after an initial period of staff adjustment. The nurse performing the 
collection will be the same nurse who performs the patient's regular blood work. 
She will use the pre-printed orders for this purpose.  The physician in charge of 
receiving the results will be one of the study investigators.  Patients who do not 
have to have their blood drawn for their health problem will still be offered the 
test. 
 
Results management:  
Patients will be notified that they will receive their test results without specifying 
how.  As opposed to having all patients travel or announcing all results over the 
phone, this strategy is intended to ensure that patients called back for an 
appointment do not spontaneously understand that they are infected with HIV or 
hepatitis C when they are home alone, while limiting the number of patients who 
will have to travel since the vast majority of tests will be negative.   
 
The research nurse will have access to the results of all tests performed via the 
CHUM computer system.  In the event of a positive result (confirmed by the 
Laboratoire de santé publique du Québec (LSPQ) for HIV and by the CHUM 
laboratory +/- the LSPQ as needed for HCV), she will notify one of the 
investigators who will contact the patient in person, if he or she is still present at 
the hospital, or by giving him or her an appointment, if he or she has left.  The 
research nurse will organize a follow-up with one of the CHUM's specialized 
clinic coordinators, taking into account the diagnosis, the type of clientele and the 
person's choice. The time required to reach the patient and plan the liaison with 
the care team as well as the mode of communication used will be noted. If the 
result is negative, the physician will delegate the research nurse to contact the 
patient to give him or her the result, either by telephone or by mail, depending on 
the method of communication available in the hospital file.   
 
Health system linkage:  
The research nurse will check the hospital's computer system to see if the patient 
has been seen in a specialty clinic within one month of the positive test 
announcement.  If not, the research nurse will follow up with the patient by phone 
to see if they have been seen outside the hospital for this new diagnosis.  If after 
three attempts to call, the patient is not reached, they will be considered not 
linked to the health care system. For HIV patients, she will check for confirmatory 

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serology, viral load, and CD4 count and whether treatment has been initiated. 
For HCV, she will verify that RNA testing and, if applicable, genotyping have 
been performed. For chronic HCV patients, she will assess at 3 months whether 
liver fibrosis has been assessed and whether treatment has been prescribed. 
 
Eligibility criteria for the cross-sectional HIV/HCV screening component of the 
study: 
 
Inclusion criteria :  
Individuals between the ages of 18 and 73 years consulting the CHUM 
emergency department regardless of the time of consultation. 
 
Exclusion criteria :  
Persons unable to refuse the test, notably because of their medical condition 
leading them to consult the emergency room.  
If the person's condition improves during the emergency room visit, they may be 
offered screening at that time. 
 
Eligibility criteria for the linkage-to-care of HIV/HCV-infected patients component 
of the study: 
 
Inclusion criteria:  
● Patient who has agreed to HIV or HCV test(s) in the UHC emergency department. 
● Aged 18 years to 73 years 
● Tested positive for HIV and/or HCV 
● Able to consent and sign the information and consent form 
 
 
Outcomes: 
Primary outcomes 
1. Prevalence of unknown HIV or HCV infections in the CHUM emergency 
department during the study period: positive tests / tests performed in unknown 
patients with HIV or HCV 
2. Overall prevalence of HCV and HIV during the study period: (positive tests + 
known positive cases) / (tests performed + known positive cases)  
 
Secondary outcomes 
1. For HCV, among baby boomers (1945-1975 or 43-73 years) 
a. 
Prevalence of new cases (positive tests/tests performed) 
b. 
Overall prevalence (positive tests + known positive cases) / (tests 
performed + known positive cases) 
2. Staff adherence: (tests performed, refused or known positive) / (eligible patients) 
3. Proportion of patient opt-outs: tests refused / (tests performed + tests refused) 
4. Linkage of positive cases to a care team 1 month post-test (definition: attended 
at least one appointment). 
5. Progression through the care cascade at 1 and 3 months: 

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a. HIV and HCV: confirmation of diagnosis and baseline laboratory testing 
at 1 month (HIV: confirmatory serology, viral load and genotyping; HCV: 
qualitative RNA measurement and genotyping) 
b. HCV: liver fibrosis assessment at 3 months. 
c. HIV and HCV: initiation of treatment for HIV at 1 month and HCV at 3 
months. 
6. Organization of services: nursing time to inform the patient, time for results 
management, mode of communication used to announce results, number of 
tests performed per period and associated costs. 
 
Data collection 
The number of eligible patients during the study period will be determined via 
data from the SIURGE system.  Completed triage sheets will identify the number 
of known patients for each virus, the number of refusals, the number of patients 
not approached for the study and basic patient demographics (age, zip code).  
The hospital computer system (OACIS) will be used to obtain the results of 
screening tests (including confirmatory tests performed at the LSPQ as part of an 
initial screening test) for all screened patients as well as management results for 
patients included in the cohort of infected patients (2nd confirmatory serology, 
viral load and genotyping for HIV, qualitative RNA, genotyping and liver fibrosis 
assessment for HCV).  Management and initiation of treatment will be 
determined in OACIS or by follow-up calls 1 and 3 months after diagnosis 
depending on whether the patient has decided to be followed at the CHUM or 
not.  The time required to notify patients of results will be recorded in the 
research nurse's observation sheets, as will the means of communication used to 
reach the patient. Test costs will be extracted from the Répertoire québécois et 
système de mesure des procédures de biologie médicale.19 
 
Statistical Considerations 
Sample size  
The sample size was based on the threshold prevalence of newly diagnosed HIV 
infection that warrants the implementation of a routine HIV testing program 
(1/1000 according to the CDC).  Assuming a prevalence of undiagnosed cases of 
1/1000, a study of 4,000 subjects would yield a 95% confidence interval of 
0.3/1000 to 2.7/1000. For HCV, assuming a prevalence of undiagnosed cases of 
1/100, we will obtain a 95% confidence interval between 0.7 and 1.3%.  In 2014-
2015, 110 420 consultations took place in the CHUM emergency department.20 
Patients were between 18 and 74 years of age in 85% of cases,20 which 
represented 93 857 consultations per year (7821/month). Few studies have 
reported missed opportunities for screening in emergency department opt-out 
situations.  One study reported 49.9% missed opportunities due to either staff 
oversight or patient refusal.11 In other studies, patient refusal rates were in the 
range of 30-35%.8,9 Assuming a proportion of patient refusal and staff oversight 
of 50%, the recruitment period should be a maximum of 2 months. 
 
Analyses  

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Descriptive statistics with 95% confidence intervals will be used to calculate, 
separately for HIV and HCV, the prevalences of new and known cases and the 
proportions of "opt-out" and staff adherence to testing.  The prevalences of new 
and known HCV cases among baby boomers will be calculated in the same way. 
Medians and their confidence intervals will be calculated for the time required to 
inform the patient of the screening and for the time required to announce the 
result. Program costs will be presented in absolute terms and as a cost per newly 
diagnosed case.  Liaison with a specialized team, completion of the initial workup 
and initiation of treatment at one month (HIV) or three months (HCV) will also be 
presented as proportions with their confidence intervals. 
 
 
Ethical and Regulatory Considerations 
Research Ethics Board 
The protocol, forms and regulatory documents will be submitted to and approved 
by the CHUM Research Ethics Committee and Scientific Committee.   
 
Information and consent form  
In an opt-out evaluation context, consent is an issue.  A standard research 
consent form is definitely an opt-in, not an opt-out.  In this context, we will 
consider the initial tests as part of a screening program and not strictly a 
research project. It is the program as a whole that must be evaluated.  These 
considerations and the rationale, in agreement with the ethics committee, exempt 
us from the presentation of a consent form to perform the screening tests. 
Patients will receive a brochure explaining the introduction of the screening 
program, the risks and benefits and their right to refuse the test.  The triage nurse 
will validate with them that they have understood the information and ask them if 
they want to opt out of this screening opportunity. 
 
The second part of the project, linkage-to-care, is more routine.  Patients will be 
met by the research nurse who will present them with the information and 
consent form and explain the steps in the process and ask for their permission to 
collect their data.  Interested patients will sign the information and consent form 
approved by the research ethics board. 
 
Subjects will have the opportunity to discuss the project and ask questions before 
signing the information and consent form. They will also be able to take time to 
reflect if necessary. They will be free to participate or not or to withdraw at any 
time. Care will not be compromised. All procedures related to the research 
project will be initiated following the subject's signature on the information and 
consent form. A signed and dated copy of the information and consent form will 
be given to the subject. 
 
Investigator's responsibilities  
The principal investigator is responsible for the conduct of this project. She will 
ensure that the co-investigators, ED personnel and research staff are trained and 

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competent to perform their duties according to the protocol and objectives of the 
interventions and then according to their delegation of duties in this study.  
 
Study subjects  
Study subjects will receive no monetary compensation for their participation in 
this research project. The investigator or co-investigator reserves the right to 
exclude a patient during this project. The reasons for this withdrawal will be noted 
in the file.  
 
Study changes, follow-up and documentation 
Amendments or changes to the protocol will be submitted to the CHUM 
institutional review board for approval. Deviations will be reported. Compliance 
rules for clinical studies and GCP will be followed. In the context of this project, 
which is a cross-sectional and prospective follow-up study, no adverse events 
are anticipated and will not be noted or reported. 
 
The documents and results of the research will be kept under lock and key in the 
research premises and at the end of the study, they will be kept at Archivex for 
10 years according to CRCHUM procedures.  
 
The information collected from the data collection will be entered on a 
computerized Window Excel file in a specific confidential secured research file 
with limited access. Access will be restricted to delegated research personnel 
according to the signature and task delegation log for this study.  
 
The data may be published in specialized journals or be the subject of scientific 
discussions while maintaining the confidentiality of the participants and therefore 
without any reference to the identity of the subjects. 
 
Stopping the project 
As this is a cross-cutting and prospective project, the principal investigator 
reserves the right to discontinue this project at any time due to various 
considerations and will notify the CHUM institutional review board and the 
participants of the prospective portion of the project. 
 
Team 
Cécile Tremblay, CHUM, Gilles Lambert, Institut national de santé publique du 
Québec (INSPQ), Isabelle Alarie, Université de Sherbrooke, Jean-Guy Baril, 
Clinique médicale du Quartier-Latin, Josée Côté, CHUM, Judith Leblanc, CHUM, 
Claude Fortin, CHUM 
 
Strengths, limitations, expected contributions 
In terms of strengths, the proposed study covers several stages of the care 
cascade, from diagnosis to initiation of treatment.  The target population is easily 
accessible and is the one in which we believe we have the best chance of 
identifying new cases.  While it is true that the overall prevalence would be higher 

                                                                                                                                                                                                                      
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if only people who use drugs were to be screened, this would not likely be the 
case for the prevalence of new cases, as the screening service for people who 
use drugs in Montreal is already well established.  Although similar projects have 
been carried out in the United States, it is important not to make inferences from 
the epidemiological data established there. The different context of care in 
Quebec, including free health care and possibly easier access to screening, may 
have a major impact on the prevalence of new cases that we will establish. 
Expanded screening may not be as cost-effective in Quebec as in the United 
States.  
 
In terms of limitations, it is possible that patients who come to us for reasons that 
do not warrant blood sampling will refuse the test more often than those who 
need it. The former group of patients may be healthier, so there may be a bias 
towards an increase in the observed prevalence. Since the same situation is 
likely to occur in real practice, our results will still be valid. The night-time 
clientele may be different from the daytime clientele.  It is important that nurses 
on different shifts adhere to the protocol in the same way to avoid bias. Training 
will therefore be given to all shifts. Like all serological tests, those used have a 
window period and may miss acute cases, thus reducing the observed 
prevalence of new cases. However, the tests used are those with the shortest 
window period available on the market. Finally, the clientele consulting the 
emergency room varies greatly depending on the geographic location of a 
hospital.  The results obtained at the CHUM may not be generalizable to other 
hospitals and a second multicentre project will be necessary if the initial targets 
are met. This second phase will better establish the prevalence of new cases and 
the cost-effectiveness of screening in EDs serving populations with fewer 
traditional risk factors for HIV or HCV than CHUM. 
 
 
 
References 
 
1. 
Yehia BR, Schranz AJ, Umscheid CA, Lo Re V, 3rd. The treatment 
cascade for chronic hepatitis C virus infection in the United States: a systematic 
review and meta-analysis. PloS one 2014;9:e101554. 
2. 
90-90-90.  An ambitious treatment target to help end the AIDS epidemic. 
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Linas BP, Barter DM, Leff JA, et al. The hepatitis C cascade of care: 
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Trubnikov M, Yan P, Archibald C. Estimation de la prévalence de 
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VIH/sida: Estimations de la prévalence et de l'incidence de l'infection par le VIH 
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les infections 2014. 

                                                                                                                                                                                                                      
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Geren KI, Lovecchio F, Knight J, et al. Identification of acute HIV infection 
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Galbraith JW, Franco RA, Donnelly JP, et al. Unrecognized chronic 
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Répertoire québécois et système de mesure des procédures de biologie 
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