A Prospective Field Study to Evaluate the Performance and Acceptance of an Oral Fluid-Based HIV Self-Test in Canada

doi:10.21203/rs.3.rs-4871077/v1

Background: Blood and oral fluid-based HIV self-tests are important for reaching the undiagnosed especially in key populations. The study objectives were to: (1) evaluate the oral fluid-based OraQuick^® HIV Self-Test (HIV-ST) performance compared with laboratory reference testing; (2) document if intended users can correctly perform the HIV-ST; (3) document if intended users can successfully interpret contrived positive, negative, and invalid results; and (4) document if intended users can understand the key messages in the product labeling.

Methods: This cross-sectional study recruited consenting adults who were representative of intended users of HIV self-testing from four community sites in Canadian provinces between June 2022 and January 2024. The results of the observed HIV self-tests were compared with results of the laboratory-based “gold standard” Abbott Alinity HIV Antigen/Antibody Combo test. Usability outcomes for critical and noncritical self-test procedure steps were also determined.

Results: Overall, 951 participants were recruited and consented with 911 available for all analyses. With respect to socio-demographics: 84% of participants were between 18-45 years of age, 73% had at least college education, 48% were cis-male, and 45% were employed; 26% identified as White, 23% as African, Caribbean or Black, 5% as Indigenous [First Nations, Métis or Inuit], 33% as Asian, and 6% as LatinX. Primary performance analysis on the 911 completed HIV-ST revealed a positive percent agreement of 100% (1/1) and a negative percent agreement of 100% (880/880, 95% CI: 99.9-100%) with the comparator method. For usability determination, the average success rate for steps identified as “critical” for successful completion of the test was 94.1%. Approximately 97% of participants found the instructions easy to follow, and 98% of participants indicated that they would use the test again. Of the 465 participants who interpreted the strong positive, weak positive, negative, and invalid contrived results, most participants were able to interpret the results correctly.

Conclusions: Having an oral fluid-based HIV self-test approved in Canada can offer an accurate, acceptable, and less invasive alternative to blood-based HIV self-testing. The addition of an oral-fluid self-test along with the current licensed blood-based HIV self-test could significantly increase HIV testing rates by offering individuals a choice of self-testing devices.

HIV testing

oral fluid-based self-test

accuracy

usability

acceptance

Across Canada, HIV diagnosis rates continue to rise. The Public Health Agency of Canada reported 1,833 new HIV diagnoses in 2022 (24.9% increase since 2021) with the highest rates reported in the Prairie provinces of Saskatchewan and Manitoba [1]. Although Canada has endorsed the Undetectable = Untransmittable (U = U) declaration and the UNAIDS 95-95-95 target (95% diagnosed, 95% of those on treatment and in care, and 95% of those achieving viral suppression by 2030), much still needs to be done to meet those targets [2]. As of the end of 2020 an estimated 62,790 people were living with HIV in Canada. Among these persons, an estimated 90% were diagnosed – indicating that there are over 6,200 individuals living with HIV across the country who remain undiagnosed. Of those diagnosed, 87% were estimated to be on treatment and an estimated 95% of persons on treatment had a suppressed viral load. [3]. Collectively, as of the end of 2020 there were still nearly 17,000 people who have not yet been diagnosed or who are not on antiretroviral therapy in Canada and therefore not engaged in the continuum of HIV care. Individuals missed along the care continuum present an important opportunity for intervention to assure better individual health outcomes and to reduce community transmission of HIV. Recent targeted interventions using finger stick blood-based HIV self-testing to reach the undiagnosed, particularly amongst key and underserved populations, and supporting more people to manage and adhere to treatment, have been shown to be broadly acceptable and effective in reaching the undiagnosed in Canada and linking them to care [4, 17, 35, 36, 37]. These interventions can help Canada move successfully towards ending its HIV epidemic by 2030. Diagnosing HIV is critically important for reaching targets aimed at controlling the HIV epidemic [5].

In 2016, the World Health Organization (WHO) recommended HIV self-testing as an alternative to conventional facility-based testing [6], and in 2024 WHO reported on many countries adopting policies that include HIV self-testing as a vital part of differentiated HIV testing approaches [7]. In many countries, now including Canada since 2020, blood or oral fluid-based self-testing for HIV is an established targeted intervention with the potential to increase the access, uptake and frequency of HIV testing, and could potentially become a high impact, low cost, and empowering alternative for those who may not otherwise test, notably for populations at high risk for HIV infection [8, 9]. In a review on modern diagnostic technologies for HIV, the authors conclude that these novel devices, including blood-based and oral fluid-based HIV self-tests, show promise as they are associated with ease of use, high diagnostic accuracy, rapid detection, and the ability to detect HIV-specific markers [10]. There is a growing body of supporting evidence showing the acceptance and usability of HIV self-testing in various global key/priority populations and groups [11, 12, 13], with similar outcomes obtained for blood-based HIV self-testing within the Canadian population [14].

In Canadian settings, three earlier studies were conducted in Montreal, Quebec with oral fluid HIV self-tests in key populations and populations at low risk of acquiring HIV. In these studies, HIV self-testing using oral fluid was demonstrated to be an acceptable and feasible testing solution, with data on technology innovations that can help increase testing and expedite linkages to care [15, 16]. A survey of Canadian stakeholders demonstrated that HIV self-testing is desired by Canadians, yet operational models and linkage data need to be strengthened [17]. In Canada, the first blood-based HIV self-test was approved by Health Canada on November 3, 2020 with implementation and scale-up continuing across the country through targeted intervention programs [18, 35, 36, 37] [include refs to O’Byrne studies here too]. To assess if favourable outcomes from implementation of an oral fluid HIV self-test similar to those of the blood-based self-test study conducted by Galli et al.[14] can be achieved in Canada, this study aims to provide independent data on the OraQuick® HIV Self-Test (OraSure Technologies Inc., Bethlehem, Pennsylvania, USA) performance, acceptance, and usability in the hands of intended users in Canada.

The study objectives were to:

Evaluate the device performance, i.e. sensitivity and specificity, compared to laboratory reference testing (4th generation HIV antigen/antibody test);

Document if intended users (non-professional “lay users”) can successfully perform the steps to use the OraQuick^® HIV Self-Test, without product familiarization or demonstration (accuracy/usability);

Document if intended users can successfully interpret contrived strong positive, weak positive, negative, and a range of invalid results (test results interpretation); and

Document if intended users can understand the key messages in the labeling (label comprehension).

The design and objectives of this study are aligned with the necessary Health Canada requirements for the evaluation of the performance and effectiveness of the OraQuick® HIV Self-Test. The Health Canada Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care (POC) or for Self-Testing provides performance targets that must be met for clinical sensitivity and specificity: “Evidence that the RDT intended for use at the POC or for Self-Testing has a minimum sensitivity and specificity of ≥ 99% for HIV antibody detection should be provided” [19].

Study Design

The study used a cross-sectional design and recruited consenting adults from six community-based sexual health and medical clinics or health centres across Ontario, Québec, Manitoba and British Columbia between June 2022 and January 2024.

Inclusion criteria

The study was open to English and French-speaking people of the general public aged 18 or older who met the inclusion criteria (i.e., consented to have venous blood drawn and undergo self-testing by an investigational device) and did not meet any of the exclusion criteria (see Appendix A for full list of inclusion and exclusion criteria). No participant was excluded based on race, gender, ethnicity, or sexual orientation. Participants were compensated with $50 CAD at their initial study site enrollment and an additional $25 CAD when they returned for their laboratory testing results.

Study Population and Sample Size

Recruitment occurred during routine clinic visits through the use of brochures, waiting room posters, and word of mouth. Self-reported HIV risk activity for the year prior to the study enrolment was collected for each participant. The target sample size for the study was intended to be a minimum of 900 individuals with unknown HIV status including a minimum of 400 “at-risk” of HIV infection, which are the participant numbers required for HIV self-test prospective studies in the published Health Canada guidelines [19].

Study Protocol

The results of the OraQuick® HIV Self-Test performed and interpreted by intended users were compared with results of licensed laboratory-based Comparator Methods (CM). The CM used for all sites was the 4th generation HIV-1/HIV-2 combination antigen/antibody (Ag/Ab) test (Abbott Alinity HIV Ag/Ab Combo test, Abbott Laboratories, Abbott Park, IIllinois, USA) which is licensed by Health Canada and is in routine use at the central public health laboratories of each of the participating provinces. The Geenius™ HIV 1/2 Confirmatory Assay (Bio-Rad Laboratories, Marnes-la-Coquette, France) was used for positive confirmation where necessary.

After informed consent was obtained, one venous blood sample was collected from each participant for testing at respective provincial central laboratories by the CM. Each participant then started the self-test: they self-collected an oral fluid specimen and performed the OraQuick® HIV Self-Test, including result interpretation, using only the manufacturer’s instructions for use as a guide. Each self-test performance was directly observed by a trained healthcare provider (Observer). The Observer did not tutor or interact with the participant conducting the OraQuick® HIV Self-Test but noted observations about the participant’s test performance. There were 18 items developed, similar to those used in a usability assessment of multiple HIV self-test devices in South Africa [20] to capture usability information including instructions for use, pre-self-test preparation, procedure for self-collecting oral fluid sample, self-test procedure, and follow-up procedures. Of these 18 items, 10 were considered “critical” with respect to correct usability (identified with * in Table 5). The Observer also interpreted the HIV self-test result immediately after the participant and recorded the result separately. Lastly, a sub-set of participants who volunteered were provided the contrived “mock” result devices individually in random order and asked to interpret the results. All survey instruments were developed specifically for this study (see Appendix C for full survey instruments).

The provincial public health laboratories conducted CM testing on serum from venous blood samples collected from study participants and the results were provided back to the sites and subsequently to the central data coordination centre at St. Michael’s Hospital, Toronto. Each central laboratory test result was used for study device performance evaluation of the OraQuick® HIV Self-Test, and study participants were able to return to the clinic site at a later date to receive their laboratory testing results. All clinical care decisions were based solely on the results of the standard of care HIV testing in place at each site.

Electronic Data Capture

All participant data were collected by the study observers through the use of pre-loaded tablets at the study sites and stored using Qualtrics (Qualtrics, Provo, UT, USA; https://www.qualtrics.com), a survey collection tool that encrypts data using Hypertext Transfer Protocol Secure (HTTPS) and enforces HTTP Strict Transport Security (HSTS). Participant data were stored on local encrypted servers in Toronto at St. Michael’s Hospital for further data analysis. Only designated research team members accessed the password-protected data from the Qualtrics servers. The survey data for each participant were coded with a corresponding unique study ID to maintain privacy and confidentiality.

Ethics Approval

This study was approved by respective Research Ethics Boards (REB) for the Ontario, Québec, Manitoba, and British Columbia sites participating in the study: St. Michael’s Hospital REB, University of Toronto REB, Veritas IRB Québec and British Columbia, and University of Manitoba HREB. This study was conducted under a Health Canada approved Investigational Testing Authorization (ITA), application ITA# 336702, issued on 11 May 2022 and is listed in ClinicalTrials.gov ID# NCT05020353.

Data Analysis

All data analysis was conducted using IBM SPSS Statistics version 24. The Primary Efficacy Analysis (performance) includes calculation of positive and negative percent agreement between study participants’ self-interpreted results of the OraQuick® HIV Self-Test versus the 4th generation Abbott Alinity test results. The proportion of study participants’ interpretation of their self-test, which was confirmed by the confirmatory test algorithm, and thereby considered “true” was confirmed following determination of study participant’s data inclusion in either the positive percent agreement (PPA) population or the negative percent agreement (NPA) population. Invalid self-test results and results indicated as “do not know” (n = 29) were excluded from the calculation of PPA and NPA. One additional participant with an “inconclusive” laboratory result was also excluded from the percent agreement calculations.

The overall 95% confidence interval was determined where:

PPA = [TP / (TP + FN)] x 100, where

TP (true positive) is positive self-test in agreement with positive Alinity test, and FN (false negative) is negative self-test discordant with positive Alinity test; and

NPA = [TN / (TN + FP)] x100, where

TN (true negative) is negative self-test in agreement with negative Alinity test, and FP (false positive) is positive self-test discordant with negative Alinity test.

As a secondary analysis, study participants’ self-interpreted results were compared with the self-test results interpreted by the observer.

Study Participants

A total of 951 participants were recruited over the study period. Of these, 40 participants were excluded from all analyses for reasons including failure to provide a venous blood sample or failure to provide a self-test result (see Appendix B for details on excluded participants). Figure 1 illustrates the consort flow diagram for the numbers of participants who proceeded to enrolment, allocation, follow-up and analysis within the study.

Table 1 shows the demographic profile of the 911 participants who were included in the performance analysis. Overall, the sample recruited in British Columbia, Manitoba, Ontario, and Québec had the following socio-demographic characteristics: 84% of the sample was between the ages of 18 and 45 years of age; 50% identified as “Cis-women”, 48% identified as “Cis-men” and (for those who chose “other”: 11 identified as “Non-binary”, 7 indicated Trans woman, 4 indicated “Genderqueer”, 2 indicated Trans man, , and 2 who self-described gender). There were also 7 who indicated that they were “Two Spirit” and 5 participants who indicated that they were pregnant. In terms of ethno-racial composition, approximately 33% identified as “Asian” descent, 26% identified as “White”, 23% as “African/Caribbean/Black”, 5% as “Indigenous”, 6% as “LatinX”, 3% as “Middle East/North African” and the remaining 4% as “other”. In terms of educational achievement, approximately 46% had a University degree or higher, 27% completed College, 25% completed High School, and 2% completed primary school. Approximately 4% indicated having any kind of reading or writing impairment. In the sample, 33% indicated visual impairment. Of the 904 participants who responded to the question on employment, 45% were employed, 29% indicated that they were students, 24% were unemployed, and 3% were retired.

In terms of self-reported medical conditions endorsed by participants, these included: visual impairment (33%), hypertension (16%), diabetes (15%); and recent or existing sexually transmitted diseases (9%); approximately 60% disclosed “other” medical conditions (e.g., mental illness, pre-diabetes, Hepatitis C, asthma, and cancer were the most common). Regarding self-reported HIV status, 47% indicated that their status was unknown or had never been tested, while 53% were negative indicating prior experience with HIV testing.

When evaluating self-reported risk category for HIV, 57% of participants (n=520) reported at least one behaviour characteristic that would be considered “high risk”. In terms of specific self-reported high risk characteristics: 31% identified as having condomless sex with men while 21% had unprotected sex with women. Approximately 19% indicated having multiple sexual partners, 44 participants (5%) indicated having used injection drugs, 17 participants (2%) self-identified as sex workers, and 9 individuals (1%) indicated that their sexual partner was HIV positive.

Primary Efficacy (Performance) Analysis

The primary efficacy analysis on the 911 who completed the OraQuick^® HIV Self-Test revealed a positive percent agreement of 100% (1/1) and a negative percent agreement of 100% (880/880, 95% CI: 99.9-100%) when comparing the valid self-tester results to the Abbott ALINITY (see Table 2 for full comparison of participant and laboratory test results and Table 3 for PPA and NPA calculations). The study encountered one previously undiagnosed participant living with HIV that was confirmed by the Abbott Alinity and Geenius comparator methods. This individual was a Black, Cis-man, new Canadian living in a homeless shelter at the time of the new diagnosis who was subsequently linked to treatment, care and support services. The overall percent agreement between participant and observer for the self-test results was 97.6% (884/906) (see Table 4 for full comparison of participant and observer interpretations of HIV-ST results). The overall “invalid” rate for the HIV Self-Test was 2.2% (n=20) and an additional 1.0% (n=9) of participants indicated they were uncertain (“do not know” or “unsure”) as to how to interpret the results.

Usability Assessment Analysis

A total of 911 participants were available for usability assessment by the study Observers. Across the 18 usability assessment questions in the survey, the average for all expected outcomes was 94.1%. For the 10 items identified as critical the average of expected outcomes was also 94.1% (see Table 5 for full breakdown of usability questions). Just over 83% of participants were able to correctly collect the oral-fluid sample, 5% were observed to incorrectly touch the absorbent pad during the collection procedure and 98% were able to correctly place the test device into the developer vial after sample collection.

Following the oral fluid sample collection, there were two types of procedures carried out as part of the test process: (1) performing the test procedure steps in order (88% did so correctly), and (2) waiting at least 20 minutes before interpreting the results (91% waited the correct time to interpret their results). Approximately 5% (n=46) missed one or more steps and yet continued the process despite this, and only one participant quit the process before the test was completed.

Table 6 shows the results from the self-test questionnaire given to each participant. Regarding the instructions for use, 97% of participants (n=878) found them easy to follow. In terms of device use, 100% of responding participants indicated that they were confident with performing the test on their own, and 99% (n=895) found the device easy to use; 98% of participants (n=882) indicated that they would use the test again and 99% (n=890) would recommend this test to a sexual partner or friend. In terms of where participants would prefer using the self-test, 77% (n=697) indicated that they would do the test at home, while 23% (n=205) indicated that they would prefer to do the test at a clinic.

Mock Test Interpretation Results

A total of 465 participants completed the mock (contrived) test interpretation. The six study sites were provided with 2 panels each, with each panel containing 5 OraQuick^® cartridges with the following contrived results:

Strong positive (control line with highly visible test line)
Weak positive (control line with weak but visible test line)
Negative (control line but no test line)
Invalid (no control line but a highly visible test line)
Invalid (no control line and no test line)

Participants were presented with the contrived results cartridges in singular random order and were asked to interpret the results for each. The contrived results interpretations for the participants who participated in this portion of the study showed varied rates in expected results. For 3 of the 5 contrived results (strong positive, negative and invalid with not control line and no test line), the rate of correct interpretations was >90%. For the “weak positive”, the correct interpretation mean was 70% (range 58-75%) which indicates that the majority of participants were able to see the line despite the weak intensity. The lowest rate of correct interpretations was obtained for the “invalid with a visible test line but no control line”, with a mean of 59% (range 49-80%), indicating that participants had some difficulties in interpreting this type of invalid result. In follow-up analyses, most incorrect interpretations of the weak positive were recorded as negative and for the invalid with no control line but a strongly visible test line most incorrect interpretations were reported as positive. There were no participant socio-demographic characteristics that were broadly associated with incorrect interpretations of the contrived results.

Primary efficacy analysis with 911 participants who completed the HIV self-testing study revealed a single positive participant, for positive percent agreement of 100% (1/1). The negative percent agreement was also 100% (880/880, 95% CI: 99.9–100%) when comparing the valid self-tester results to the Abbott Alinity. The overall specificity, indicated as negative percent agreement of 99.5%, with the lower bound of the 95% CI at 98.6% meets the performance criteria required by Health Canada; however, the single HIV positive encountered in this study would not be adequate to meet device sensitivity requirements.

As shown in Table 4, there was a 97.6% concordance in the self-test results interpretation between the untrained self-test study participants and the trained observers indicating that intended users of the OraQuick® HIV Self-Test are able to interpret their self-test results correctly compared to health care provider interpretations. Most discordant results between observer and participant were in the uncertainty (“do not know/not sure”) response category although the overall number of “do not know/not sure” results reported by participants was low (n = 9). A total of 20 participants (2.2% of sample) interpreted their self-test results as invalid. Of these, 17 were also interpreted as invalid by the Observers. Previous Canadian studies of a blood-based HIV self-test had shown that rates of invalid results with self-testing by intended users can vary according to user experience with HIV testing and other contributing socio-demographic factors, with invalid rates of up to 20% reported [14, 21]. The low rate of invalid results observed in this study indicates that participants had few difficulties with performing the test procedures correctly on their own or seeing a visible control line.

The contrived results interpretations for the 465 participants who volunteered for this portion of the study showed the majority were in concordance with the expected results. There was high concordance as expected with 3 of the 5 contrived results: for the “strong positive”, “negative” and the “invalid, with no control or test line present”. However, results indicated that the “weak positive” and “invalid with a visible test line” can be somewhat more challenging to interpret correctly for some individuals. For the weak positive, it is to be expected that a test line with low intensity may not be consistently visualized. This outcome (70% correct interpretations) is similar to that reported by Majam et al in their study of seven HIV-ST performance, including contrived results, in South Africa [20]. For the invalid with no control line but a strongly visible test line (59% correct interpretations), this is unlikely a concern as in real-life testing situations this would rarely occur since it would usually be an indication of a manufacturing flaw in a particular device which had escaped the rigid quality control measures in place during manufacture. Although demographics such as visual impairment that was reported by 33% of participants in this study were not associated with higher rates of incorrect interpretations of contrived results, some mitigations may be considered to improve the instructions for interpreting the range of self-test results that users may experience, particularly with more challenging results such as a weak positive or invalid result with no control line but a visible test line. These mitigations could include slight revisions to the package insert to provide clearer instructions and/or visual illustrations on the proper interpretation, as well alerting the self-tester that even a faint line intensity is considered valid. Consequently, self-test users should also be instructed to conduct self-testing in a well-lit area.

In general, participants across a broad range of socio-demographics representative of intended users of HIV self-tests expressed a high level of satisfaction with the HIV-ST experience as shown in Table 6, the vast majority of participants (97–99%) found the instructions for use easy to follow, found the self-test device easy to use, would use the OraQuick® HIV Self-Test again, and would recommend its use to a sexual partner or friend. Of interest, approximately 77% of participants indicated a preference for using the self-test in a home environment while 23% would prefer to use the test at a clinic or health care facility, suggesting that both assisted (supervised) and unassisted self-testing strategies could potentially be implemented to maximize “real world” access and uptake.

Overall, acceptance of the OraQuick® HIV Self-Test by intended users in this study was high, and similar to studies that reported that oral fluid-based HIV self-testing is highly acceptable among a variety of populations [22, 23, 24, 25, 26]. Oral fluid remains the most common sample substrate for HIV self-testing globally and oral fluid HIV self-tests are broadly utilized in various distribution strategies [27, 28, 29] whereas data on use of blood-based HIV self-tests remains relatively scarce in comparison [30, 31]. Despite encountering just a single HIV positive individual in this prospective study, the performance, usability, and acceptance of the OraQuick® HIV Self-Test were all at highly acceptable levels which suggests that intended user populations are able to conduct and perform the oral fluid self-tests without increased risks of obtaining erroneous results. However, as shown in Table 5, 17% of participants were observed to have had some difficulties in correct use of the swab for oral fluid collection, indicating that additional instructions might be necessary in some situations.

Limited studies have shown that preferences for oral fluid or blood-based HIV self-testing devices are varied depending on user perceptions of accuracy, sample type integrity and ease of collection of the sample type [32, 33, 34]. However, self-test uptake overall could be enhanced by having both types of HIV self-tests licensed for use in Canada and offering users a choice of methods through implementation testing programs.

Despite the overall favourable outcomes from this study, there were some limitations: the study encountered only a single HIV positive participant, therefore meaningful determination of the device sensitivity for accurate detection of HIV antibodies in the hands of intended users could not be measured; as well, survey responses from participants were voluntary and response rates varied across the individual questions, yielding variable denominators for determining outcomes for study participant socio-demographics and usability analyses.

Implementation of blood-based and oral fluid-based HIV self-testing in the post-COVID 19 era has the potential to substantially increase HIV testing rates, and we found high acceptability of the oral fluid-based OraQuick® HIV Self-Test amongst the diverse sample of participants in the current study. The addition of this oral fluid-based HIV self-test into the Canadian HIV testing landscape, once approved by Health Canada, along with barrier-free access to these self-tests, could present prospective self-testers with an important choice between blood-based and oral fluid HIV self-tests. An approved, accessible oral fluid HIV self-test in Canada can offer an accurate, acceptable, and simple alternative to facility-based HIV testing and to blood-based HIV self-testing for key/priority populations.

HIV: Human Immunodeficiency Virus

CM: Comparator Methods

PPA: Positive Percent Agreement

NPA: Negative Percent Agreement

Ethics Approval and Consent to Participate

This study was approved by respective Research Ethics Boards (REB) for the Ontario, Quebec, British Columbia and Manitoba sites participating in the study: St. Michael’s Hospital REB, University of Toronto REB, Veritas IRB British Columbia and Quebec, and University of Manitoba HREB. This study was conducted under Health Canada approved Investigational Testing Authorization (ITA), application ITA# 336702, issued on 11 May 2022. Informed consent was obtained from all individual participants included in the study. To preserve anonymity, participants read the informed consent form and the study observer signed it, attesting that they received the participant’s verbal consent to participate in the study. This procedure was approved by the REB.

Consent for Publication

Not applicable.

Availability of Data and Materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing Interests

The authors have no competing interests to declare.

Funding

This work was funded by a team grant from the Canadian Institutes of Health Research (FRN 422155).

Authors’ contributions

RAG, JML, KM, DM, AM, WT, NN, AC, MS, RT, AFV, ML, LI, MP, JS, CF, MS, ML, RH, NJ, VT, TM and SBR performed the research. RAG, SBR, JML, DM, AM, and KM, designed the research study. SBR, RAG, JML, KM, AM, and DM analyzed the data. SBR, RAG, and JML wrote the paper. All authors have read and approved the final manuscript.

Acknowledgements

The authors are grateful to all staff of the Hassle Free Clinic, Toronto; Women’s Health in Women’s Hands, Toronto; Maple Leaf Clinic, Toronto, Nine Circles Community Health Centre, Winnipeg; Cool Aid Community Health Centre, Victoria, and Clinique Medicale l’Actuel, Montreal, and especially grateful to the staff who participated as study observers including: Mark Da Silva, Zavare Tengra, Marion Selfridge, Jared Starr, Martin Lepage, Nirubini Jeyarajah Nontobeko P. Nkala, Denese Frans-Joseph, Junic Wokuri, Muna Aden, Tumaini Lyaruu

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Table 1 Participant demographics (n=911)
	n	%
Age groups (n=910)
18-25	307	34%
26-35	302	33%
36-45	158	17%
46-55	73	8%
>55	70	8%
Gender (n=910)
Cis-male	434	48%
Cis-female	450	50%
Other	26	3%
Ethnicity (n=911)
White	235	26%
African/Caribbean/Black	211	23%
Indigenous	46	5%
Middle Eastern/North African	25	3%
East Asian	85	9%
South Asian	222	24%
LatinX	54	6%
Other	33	4%
Sexual Orientation (n=890)
Heterosexual	606	68%
Gay/Lesbian	150	17%
Bisexual	82	9%
Other	52	6%
Education (n=908)
No formal education	0	0%
Primary	20	2%
Secondary	226	25%
College	242	27%
University or higher	420	46%
Employment (n=904)
Employed	405	45%
Student	261	29%
Retired	23	3%
Unemployed	215	24%
Medical Condition (n=143)
Diabetes	21	15%
Hypertension	23	16%
Sexually transmitted infection	13	9%
Other medical condition	86	60%
Reading/Writing Impairment (n=905)
No	866	96%
Yes	39	4%
Visual Impairment (n=905)
No	604	67%
Yes	301	33%
Tested for HIV Before (n=905)
No	422	47%
Yes	479	53%
HIV Status (n=911)
Negative status	485	53%
Unknown status/never tested	426	47%
Self-Reported Risk^* (n=911)
High Risk	520	57%
Low Risk	391	43%
^* "High Risk" contains participants who self-reported one or more risk category

	Table 2 Self-Test Interpretation by the Participant and Compared with Lab Result
				ARCHITECT/Alinity Lab Result
OraQuick Self-Test Result		Negative	Positive		Inconclusive	Total
Negative		880	0		1	881
Positive		0	1		0	1
Don't know/Not sure		9	0		0	9
Invalid/Test did not work		20	0		0	20
Total		909	1		1	911

Table 3 Positive and Negative Percent Agreement with Laboratory Results based on 911 completed HIV Self-Tests
True Positive	1
False Negative	0
True Negative	880
False Positive	0
Inconclusive^a	1
Positive % Agreement	100% [1/1]
Negative % Agreement^b	100% [880/880; 95% CI: 99.9-100]
1 participant whose HIV status was inconclusive based on the results of laboratory testing was not included in the calculations. A total of 29 invalid (n=20) or do not know/not sure (n=9) results were excluded from the calculation of negative percent agreement.

Table 4 Participant and observer interpretations
	Observer Interpretation
Participant Interpretation	Negative	Positive	Don't know/ Not sure	Invalid/Test did not work	Total
Negative	864	4	4	5	877
Positive	0	1	0	0	1
Don't know/Not sure	6	1	2	0	9
Invalid/Test did not work	1	1	0	17	19
Total	871	7	6	22	906^a
a. 5/911 observer results interpretations were not uploaded into the database

Table 5 Observer usability assessment
	Yes		No
	n	%	n	%
Instructions for Use (IFU)
Did the study participant read the instructions for use (IFU)?*	859	95%	47	5%
If yes, were the instructions for use (IFU) read before the test?	701	82%	158	18%
Was the IFU referred to during the test process?	864	95%	42	5%
Test Procedure
Did the study participant remove the contents of the test pack?	901	99%	5	1%
Was the study participant able to find the test tube packet?	905	100%	1	0%
Did the study participant remove the test tube from the packet?*	905	100%	1	0%
Did the study participant remove the cap from the test tube?*	896	99%	10	1%
Did the study participant place the test tube in the holder?*	848	94%	58	6%
Did the study participant have any difficulty with the test tube?	175	19%	731	81%
Was the study participant able to find the test stick packet?	903	100%	3	0%
Did the study participant remove the test stick from the packet?*	902	100%	4	0%
Did the study participant touch the flat pad?*	47	5%	859	95%
Did the study participant collect the sample correctly (1x upper and lower swab)?*	754	83%	152	17%
Did the study participant place the test stick in the test tube correctly?*	889	98%	17	2%
Procedure Check
Did the participant perform any steps out of the order?*	106	12%	800	88%
Did the participant miss any step and continue the process despite a missed or incorrect step?	46	5%	860	95%
Did the participant quit the process at any point?	1	0%	905	100%
Did the study participant wait 20 minutes before reading the results of the test?*	820	91%	86	9%
* Considered "critical" steps

Table 6 Participant usability assessment
	Yes		No
	n	%	n	%
Instructions for Use (IFU)
Did you use the Instructions for Use (IFU) sheet to help you complete the test?	881	98%	22	2%
Were the Instructions for Use (IFU) easy to follow?	878	97%	24	3%
Were the pictures and illustrations in the Instruction for Use (IFU) helpful?	878	97%	24	3%
Device Use
Was the Self-Test easy to use?	895	99%	7	1%
Are you confident you could perform this test on your own?	899	100%	3	0%
Self-Test Experience
Would you use this test again if it were available to you?	882	98%	20	2%
Would you prefer to use this test at home (yes) or get tested at a clinic (no)?	697	77%	205	23%
Would you recommend this test to others? (e.g. a sexual partner, friend)	890	99%	12	1%

No competing interests reported.

A Prospective Field Study to Evaluate the Performance and Acceptance of an Oral Fluid-Based HIV Self-Test in Canada

Status:

Version 1

Abstract

Figures

Background

Methods

Study Design

Inclusion criteria

Study Population and Sample Size

Study Protocol

Electronic Data Capture

Ethics Approval

Data Analysis

Results

Discussion

Conclusions

Abbreviations

Declarations

References

Tables

Additional Declarations

Supplementary Files

Status:

Version 1