In Canada, at-risk populations are disproportionately impacted by sexually transmitted blood-borne infections (STBBIs). These populations include men who have sex with men; Indigenous, immigrant, and refugee populations; and people who inject drugs, among others [-]. The standard of care with regard to STBBI diagnostics entails laboratory-based testing, sometimes requiring invasive specimen collection, and providing results at a subsequent clinic visit several days later based on geographical location. Location and availability of tests impact the turnaround time to obtain test results, which affects timely counseling and initiation of treatment and care [,].
Challenges in STBBI Diagnostics and Care for At-Risk PopulationsFollowing the COVID-19 pandemic and the provision of self-tests that led to an improved understanding of testing and screening services, at-risk populations desire convenient and timely access to health care services for STBBIs, including demands for rapid testing, confirmation, counselling, and initiation of treatment in 1 to 2 visits, if possible []. However, the current status quo, with health care worker shortages and demands on professional time, limits patient access to sought services, namely due to the lack of dedicated family physicians, translating to many missed opportunities in STBBI screening [-].
In addition, marginalization of at-risk underserved populations, together with stigma, discrimination, and systemic racism, impacts health care seeking and timely screening for these important STBBIs despite availability of testing, further perpetuating health care inequity [].
In parallel, in current times, in the context of acute health care professional shortages nationwide, populations demand the use of innovative patient-centered strategies that improve efficiency and costs of service delivery [-]. Mobile, rapid, connected digital screening programs fill health service delivery gaps in STBBI care, including efficient service delivery, data documentation, and linkage arrangement when screened using point-of-care (POC) technology-based services [].
Innovative Strategies for Improving STBBI Care
As mentioned in the Lancet Commission on Diagnostics, digitization can improve access to screening and linkage and retention pathways for underserved populations []. Together with increasing access to timely diagnostics, the commission has called for an investment in the training of health care professionals using innovative solutions. The proposed solution is an investment to fill gaps in training, data documentation, communication, and linkages using POC technologies that will improve service delivery. To reach global targets, evidence to support the use of innovative and smarter connected screening solutions across different contexts and populations is much needed, for example, a study in a high-income context [].
Since 2009, our laboratory has been at the forefront of creating digital process innovations in this space of POC diagnostics. We have developed screening digital solutions for HIV and hepatitis C virus (HCV) self-testing, multiplexed screening for STBBIs, COVID-19 self-testing, and sexual and reproductive health services. Innovative digital strategies can not only improve rapid STBBI screening and linkage of testers but also help in training, counselling, and data management by health care workers while optimizing the screening pathway. Digital strategies also address the gaps in data and increase efficiency by streamlining workflows thus enabling task shifting, all while providing data to guide health care service delivery [].
The AideSmart! app- and platform-based solution integrated with multiplexed POC technologies, called the AideSmart! multiplexed strategy, is designed for health aides (frontline health care workers) and is one such unique solution.
The AideSmart! strategy was first pilot-tested in India in 2018 in pregnant women in a Grand Challenges Canada–funded study. In that study, the strategy was deemed successful in detecting 239 new infections or conditions (HIV, hepatitis B or C, and syphilis) and helped in reducing vertical transmission to infants []. While the pilot study showed the effectiveness of the AideSmart! strategy in rural India, a middle-income country, we wished to examine its feasibility in Canada, a high-income country with vastly different at-risk subpopulations with varying prevalence of STBBIs.
In this Canadian Institutes of Health Research–funded study, we adapted the innovative solution to meet the needs of Canadian vulnerable populations (people who inject drugs; sexually transmitted disease [STD] clinic attendees; lesbian, gay, bisexual, transgender, and queer individuals; and refugee and immigrant populations). We localized the digital platform into French, tailored the content to align with Canadian guidelines, and integrated the newest versions of multiplexed assays to offer a biomarker-based strategy to populations.
With a focus on global portability and uptake and the aim of introducing scalable solutions that address data and service delivery gaps using POC technologies for STBBI screening, counselling, and linkage to care, we sought to evaluate AideSmart! within a high-income setting using multiplexed strategies that are slowly changing the landscape of delivery of STBBI diagnostics at the POC across global settings.
In this cross-sectional study, our primary aim was to evaluate the feasibility, preference, and acceptability of the AideSmart! strategy among at-risk populations in Canada. Our secondary aim was to estimate the accuracy of the 2 investigational rapid multiplexed devices and demonstrate their impact on detection of new infections.
Ethical ConsiderationsEthics approval was obtained from the Research Institute of the McGill University Health Centre (2020-6048) and from the Horizon Health Network Research Ethics Board at the Saint John Regional Hospital (2020-2963). An informed consent form (ICF) was presented to each participant before study entry in their preferred language (English or French). The ICF described the ability to withdraw consent or opt out during the study in the event that participants no longer wished to continue the study. Participants received financial compensation during the study of CAD $25 (US $18.51) for completing visits 1 and 2; an extra CAD $10 (US $7.41) was provided if a third visit was required and completed.
Furthermore, to ensure data privacy and security, all data recorded on the AideSmart! app were encrypted (3-layer encoded) and protected on a secure Health Insurance Portability and Accountability Act (HIPAA)–compliant server. A keyed access to the server was provided to the principal investigator of the study. A study ID was created to store data. It contained a site-specific code and a randomly generated participant ID. No names were revealed to the data analysts and the staff conducting the study at any point of the study. This anonymized, deidentified data protection process guaranteed participant confidentiality and has been successfully deployed in our national and global studies. The master list that linked names with study IDs was available only to the clinicians responsible for patient care and was safeguarded for the entire duration of the study.
Study PopulationEligible recruited participants were adults with unknown serostatus for HIV, HCV, and syphilis, including but not limited to (1) people who inject drugs, (2) men who have sex with men, and (3) immigrant populations, in Quebec and New Brunswick. Individuals in treatment for any coinfection or with any urgent medical condition requiring hospitalization were excluded.
Participants were recruited from 2 community-based service delivery sites in Quebec and New Brunswick: RÉZO, Montreal, Quebec (May 2021 to February 2022), and the Centre for Research, Education, and Clinical Care of At-Risk Populations (RECAP), Saint John, New Brunswick (March 2021 to August 2022). Convenience sampling was deployed.
Recruitment was managed by the community-based organizations. Social media platforms (Facebook and Grindr) were used to spread the word about the study. Posters were placed in community clinics to increase awareness of the study, and flyers and handouts were printed that explained the purpose of the study (approved by the Research Ethics Board) and shared with clinic attendees and in local magazines. Health care staff participated in community outreach events in the area to increase word of mouth regarding the study, leveraging their existing community-based networks. Enrolled participants were offered to partake in a “refer a friend” program to invite additional persons to participate. Existing relationships with communities were thus leveraged to increase recruitment.
RÉZO is a community organization active since 1991 that offers gay and bisexual cis- and transgender men various free health and wellness promotion programs. RÉZO provides HIV or HCV and STBBI prevention and testing [].
RECAP is a community-based harm reduction clinic dedicated to improving prevention, diagnosis, and treatment of HCV in at-risk populations, many with substance use disorders. This nonprofit organization, active since 2014, provides opioid agonist therapy, harm reduction counseling, safe supplies, and clinic- and outreach-based screening for STBBIs, among other services [].
AideSmart! STBBI Rapid Multiplexed Screening StrategyThe user-friendly AideSmart! app’s main page directs health aides to several tabs offering training on multiplexed tests, counselling, and recommendations for all STBBIs for both health care workers and testers. The Overview tab is shown in , which presents the overall aim of the AideSmart! app and participant eligibility for study inclusion. The app also provides education and screening and testing information related to rapid multiplexed tests and arranges for communication with patients and health care providers while arranging for rapid linkage to confirmatory testing, treatment, and clinical care. As shown in , the AideSmart! app was designed to streamline and simplify STBBI diagnostic care, document and store digital data, and link participants to care, all while maintaining high patient engagement and communication with various stakeholders at all times. The app- or web-based strategy is open access, portable, and customizable to both technologies: multiplexed platforms and rapid biomarker-based multiplexed assays. It is currently being adapted and tested using multiplexed molecular platforms in an India-Canada Centre for Innovative Multidisciplinary Partnerships to Accelerate Community Transformation and Sustainability–funded study in India.
The AideSmart! platform and app solution (open access, McGill University; copyright Report of Invention 16126, 2016) was integrated with 2 investigational lateral flow assays: Multiplo Rapid Treponema pallidum Antibody Test (MedMira Inc) and Dual Path Platform HIV-syphilis assay (Chembio Diagnostic Systems, Inc) []. Of note, the Chembio test for HIV or syphilis was operated using a quantitative reader that removed ambiguity associated with a visual test result interpretation, whereas the MedMira test relied on visual interpretation of test results.
In this study, these tests were used to independently evaluate accuracy and evaluate some prototypes of the rapid tests. Both rapid index tests required health care professional–collected finger stick blood–based samples. Confirmatory testing was performed using both the local laboratory and dried blood spot (DBS) tests as reference standard tests on each participant. Local laboratory testing per standardized algorithms () was conducted in Quebec and New Brunswick. DBS specimens were sent for analysis at the National Laboratory for HIV Reference Services in Winnipeg, Manitoba.
The AideSmart! app-based program connected stakeholders throughout the study. The digital app-based platform detailed study procedures, training on rapid testing procedures, pretest and posttest combined counseling for STBBIs, clinical care and coordination for those who receive a positive test result, treatment, and follow-up. For counseling and treatment, Canada-specific guidelines for STBBIs were included in the app-based program to provide targeted information to participants [].
HIV
Geenius HIV 1/2 test (Quebec) or Architect HIV 1/2 Ag/Ab Combo assay (New Brunswick)If reactive: confirmatory p24 enzyme immunoassay (EIA)If reactive: specimen sent to the National Microbiology Laboratory for final analysis/confirmationSyphilis
Enzyme immunoassay (EIA)If reactive: Rapid plasma regain (RPR) testIf needed, Treponema pallidum particle agglutination (TP-PA) and INNO-LIA testsHCV
Anti-HCV screenIf reactive: qualitative RNA testIf reactive, viral load measuredNote: If either test yielded non-reactive results but the test was conducted in the window period following suspected HCV exposure, follow-up test was recommended three months laterStudy Procedures and InterventionWe recruited throughout the COVID-19 pandemic, and communication was facilitated through SMS text messages and calls enabled by our AideSmart! app strategy.
At visit 1, following an explanation of the study objectives and study procedures by the health care professionals, consenting participants were enrolled in the study. Using the AideSmart! innovation, health care professionals conducted pretest counseling aiming to educate participants regarding STBBIs, rapid and laboratory-based testing methods, and posttest linkage and treatment options for each STBBI.
Participants had the opportunity to ask questions as needed. Next, rapid MedMira and Chembio tests were performed per manufacturer instructions. As both MedMira and Chembio were considered investigational devices (not approved in Canada yet), test results were declared following receipt of local laboratory test results, although turnaround time to obtain rapid test results was recorded in real time. Health care professionals documented deidentified data on participants’ demographics, risk profile, and rapid test results.
Between visits 1 and 2, health care professionals and participants communicated using participants’ preferred method of communication. Health care professionals sent SMS text message reminders to confirm the date and time of the follow-up appointment, also allowing for sufficient time for confirmatory test results to be expedited from local laboratories. All participants returned for a second visit, during which both positive and negative test results were declared in a posttest counseling or harm reduction session aided by the AideSmart! app. Health care professionals documented rapid and confirmatory test completion and preference data. Participants with nonreactive test results were encouraged to seek repeat testing should future exposure be expected. In case of one or more reactive result or results, linkage to treatment was arranged, either in-house or at a nearby clinic.
For follow-up and retention in visit 3, health care professionals coordinated another visit for those who received a positive test result.
FeasibilityFeasibility was computed using the metric completion rate, defined as the number of participants who successfully completed the procedure that consisted of pretest counselling and testing (visit 1) and posttest counselling and linkage to treatment initiation (visit 2; numerator) divided by the total number of participants who consented to take part at baseline (denominator).
The primary end point was used for sample size calculation. On the basis of our previous evaluations, with an assumed completion rate of 70%, a sample size of 323 was deemed sufficient with 95% level of confidence and 5% precision [].
Acceptability was defined as the number of participants who consented to the strategy (numerator) over the number of eligible participants who were approached (denominator).
PreferencePreference was defined as the number of participants who indicated a preference for a patient-reported outcome (including preference of timing to receive test results and retest preference) divided by the number of participants who consented to take part in the study (denominator). Satisfaction of POC and conventional testing was further recorded categorically (very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied).
Health Care Provider PerspectivesHealth care professional feedback was collected to gain perspective regarding their views on multiplexed rapid testing. The following questions were asked: “What do you think about multiplex tests?” “Do you think they will have a future in Canada?” “If approved, do you think they will be useful for populations they serve?” “Is it helpful for people to know if they test negative?”
ImpactImpact was defined as the number of newly diagnosed infections (numerator) relative to the number of patients who consented and were screened (denominator).
Impact was also recorded using the metric that captures turnaround time, defined as the mean time recorded in minutes or days for test results to be obtained so as to inform the next step in the screening pathway.
Diagnostic AccuracyDiagnostic accuracy performance metrics (sensitivity, specificity, and 95% CIs) for each pathogen were tabulated for index tests (Chembio and MedMira) separately and compared to both reference standard tests (local laboratory algorithms and DBS).
Participants’ sociodemographic profiles were tabulated.
Outcome data (feasibility, acceptability, preference, and impact) were calculated in proportions with 95% CIs. All analyses were performed in Stata (version 10; StataCorp) [] and R (version 4.1.3; R Foundation for Statistical Computing) [].
In total, we recruited 401 participants (n=237, 59.1% from RÉZO and n=164, 40.9% from RECAP).
Overall, 71.6% (282/394) of participants were men, 21.6% (85/394) were women, and 6.9% (27/394) identified as another gender. In terms of ethnicity, 5.6% (22/394) self-reported being Indigenous individuals, 5.8% (23/394) self-reported being Asian or Mediterranean individuals, 9.6% (38/394) self-reported being Latin American or Caribbean individuals, 5.3% (21/394) self-reported being African individuals, and 73.6% (290/394) self-reported being White individuals.
Most participants (165/394, 41.6%) were young (aged 18-34 years), 59.4% (234/394) were doing part-time work or were unemployed, and 65.5% (258/394) earned <CAD $2000 (US $1480.26) per month.
Although 86% (339/394) of the participants had completed high school or advanced degrees, nearly half (172/394, 43.7%) of the participants were unemployed ().
In the previous year, with respect to past testing history, nearly half of the participants had been tested for HIV (184/392, 46.9%), HCV (185/392, 47.2%), and syphilis (172/391, 43.9%). A subset of participants (169/385, 43.9%) reported a previous STD, the most common being chlamydia (72/169, 42.6%), syphilis (48/169, 28.4%), and gonorrhea (47/169, 27.8%).
Regarding risk profile, while most (288/394, 73.1%) reported being sexually active, many (247/394, 62.7%) reported no stable partners. Approximately half (159/379, 42%) reported 2 to 5 sexual partners in the previous 6 months, and half (167/370, 45.1%) reported occasional condom use. Approximately half had never been diagnosed with a previous STD (204/385, 53%), had never injected recreational drugs (250/392, 63.8%), or were not alcohol users (206/393, 52.4%). Among people who injected drugs, most (83/139, 59.7%) had shared needles in the past.
Men presented with a riskier baseline status. Of the 60 participants with at least 6 recent sexual partners, 47 (78%) were men, whereas 13 (22%) were women or identified as another gender. Moreover, a higher proportion of men (122/272, 44.9%) reported a previous STD compared to women and those who identified as another gender (38/112, 33.9%).
In addition, the 43.9% (169/385) of participants who had a previous STD presented with riskier baseline sexual behaviors. For instance, 20.7% (35/169), 49.1% (83/169), and 20.7% (35/169) reported always, sometimes, and never using a condom, respectively. Moreover, 73.4% (124/169) had 0 to 5 recent sexual partners, and 24.9% (42/169) had ≥6 partners. Conversely, participants with no previous recorded STDs (216/385, 56.1%) had less risky behaviors, including a higher rate of protected sex (67/216, 31%) and up to 5 recent sexual partners (191/216, 88.4%). However, participants with a previous STD seemed more aware of this riskier behavior, as indicated by higher previous testing rates (14%-19% vs 7%-8%).
Table 1. Demographics and medical history of recruited study populations to the AideSmart! cross-sectional multiplexed rapid sexually transmitted blood-borne infection screening study in Canada (N=394).CriteriaParticipants, n (%)Age (y)aSTD: sexually transmitted disease.
bPatients may have reported >1 previous STD.
cHCV: hepatitis C virus.
FeasibilityAll participants approached (401/401, 100%) accepted the AideSmart! strategy. Completion of AideSmart! over 2 visits was 76.1% (305/401).
The mean turnaround time to receive multiplexed rapid test results was <15 minutes (mean 13.9, SD 2.1 min for Chembio and mean 13.5, SD 2.3 min for MedMira). In comparison, mean turnaround time for local laboratory test results ranged from 4 days to 3 weeks (HIV p24, mean 4.4, SD 3.0 days; HCV RNA, mean 9.0, SD 6.2 days; HIV RNA, mean 11.2, SD 5.1 days; T pallidum particle agglutination, mean 12.4, SD 6.5 days; DBS, mean 24.2, SD 5.8 days).
PreferenceNearly all participants (243/247, 98.4%) reported high or very high satisfaction with the rapid testing and counseling through the AideSmart! strategy versus 95.8% (226/236) who reported satisfaction with the conventional laboratory-based strategy. Participants reported comparable fear, pain, and discomfort between the rapid and conventional strategies ().
Preference to obtain same-day test results using rapid testing was expressed by 56.6% (141/249) of the participants. Preference for follow-up through various digital health supports varied—the most popular response was app-based secure messaging (84/250, 33.6%), followed by face-to-face visits (60/250, 24%), phone calls (39/250, 15.6%), and SMS text messaging (34/250, 13.6%); 13.2% (33/250) had no preference. As a result, unsurprisingly, 93.6% (234/250) of the participants reported that they would recommend rapid testing to friends.
Table 2. Acceptability, feasibility, and preference results of the AideSmart! cross-sectional multiplexed rapid sexually transmitted blood-borne infection screening study in Canada (2021-2022).CriteriaParticipants, n (%)Acceptability (n=401)aMean score for point-of-care: 1.6 (SD 1.0); conventional: 1.6 (SD 1.0).
bMean score for point-of-care: 1.4 (SD 0.6); conventional: 1.4 (SD 0.6).
cMean score for point-of-care: 1.3 (SD 0.6); conventional: 1.3 (SD 0.7).
Health Care Provider PerspectivesHealth care professionals were questioned, and their perspectives were tabulated qualitatively (). Across all queries, favorable responses were conveyed. For instance, health care professionals deemed multiplexed tests to be user-friendly and accurate when compared to reference standard tests. The overall perspective was that they would add value in Canada if implemented in routine care in community settings, although it was noted that acquiring a proper patient medical history was important to identify new infections. The rapid multiplexed test use was considered useful whether the test result was negative or positive; a negative status provided multiple benefits as patients’ anxiety would diminish and the result would serve as a baseline for subsequent testing.
Textbox 2. Health care provider perspective of multiplexed tests in the context of the AideSmart! cross-sectional multiplexed rapid sexually transmitted blood-borne infection screening study in Canada (2021-2022).What do you think about multiplexed tests?
“I really like the multiplex tests. They are super user friendly and I think they have immense potential for providing comprehensive screening to vulnerable populations.”“They should always be paired with such a positive blood test.”“I enjoy using multiplex tests, they are simple to use and provide quick results. I also have found that the results have been consistent with bloodwork results, or dried blood spots.”Do you think they will have a future in Canada?
“I think they have huge potential in Canada. I can see them being used in the community setting to provide on the spot screening.”“Yes, but it’s important to be careful for customers with one of the diagnoses already known.”“I believe that they will have a future in Canada, our clinic has been using point of care testing for HCV screening before the multiplex study, and I believe the multiplex tests are an improvement as we can test for two/three bloodborne pathogens as opposed to one.”“It will take some time to get approved.”If approved, do you think they will be useful for the populations they serve?
“In the population I work with it can be challenging to collect bloodwork, and patients are hesitant to have it done. With the multiplex test it requires minimal blood, and is noninvasive, which makes the patients more likely to participate.”“If approved the multiplex test will be useful in our population, as it is important for patients to have results on site.”Is it helpful for people to know if they test negative?
“This is the reason why they take the test; people want to know if they are not contagious.”“It provides relief and ease of mind to the patient. Furthermore, it serves as a baseline for rescreening.”“I think knowing a negative status is just as important as knowing a positive status.”ImpactWith respect to new infections, 29 new infections (n=27, 93% HCV; n=1, 3% HIV; and n=1, 3% syphilis) were detected using the AideSmart! multiplexed strategy in at-risk populations. Of the 29 new infections, 8 (28%) spontaneously cleared and required no further follow-up. Among the remaining 21 infected participants, 12 (57%) received follow-up treatment and care in visit 3, a total of 2 (10%) died, 4 (19%) were incarcerated, and 3 (14%) were completely lost to follow-up. Furthermore, 94.7% (380/401) of the participants did not require a visit 3 follow-up (participants who tested negative for all 3 pathogens, 372/380, 97.9%; and those who tested positive for HCV but the virus spontaneously cleared and they required no treatment, 8/380, 2.1%).
While the study recruitment occurred during the COVID-19 pandemic, with this strategy, we were able to track 99.3% (398/401) of the participants throughout the study. The pandemic-induced restrictions made it difficult for us to keep participants in care; despite the attempts made by the staff to retain these patients, loss to follow-up was inevitable.
Of note, 38% (11/29) of participants who tested positive had had a previous STD, and 38% (11/29) reported never using condoms at baseline. Interestingly, with the exception of 14% (4/29) of the participants, who were not comfortable disclosing their past sexual history, all individuals with new infections (25/29, 86%) had 0 to 5 recent sexual partners, thereby indicating that even persons with stable or few partners are at risk of contracting a sexually transmitted infection (STI). Moreover, most participants with new infections were unemployed (22/29, 76%), identified as a man (21/29, 72%), and aged ≥35 years (20/29, 69%).
Diagnostic AccuracyThe diagnostic accuracy of both rapid tests is presented in and , compared to reference standard tests through local laboratory assays in and DBS in .
For HIV, both MedMira and Chembio reported a high sensitivity and specificity (>98%) when compared to local laboratory tests as a reference standard. With DBS as a reference standard alone, the sensitivity of the MedMira test for HIV was 93.8% (95% CI 69.8%-99.8%).
For HCV, the MedMira test was the sole rapid test that detected HCV antibodies; it reported a high sensitivity at 91.2% (95% CI 84.3%-95.7%) and a high specificity at >99% (95% CI 97.5%-99.9%).
For syphilis, against local laboratory tests, for both rapid tests, specificity was high (>99%). However, the sensitivity of the Chembio test varied (relative to local laboratory tests: 86.8%, 95% CI 71.9%-95.6%; relative to DBS: 80%, 95% CI 64.4%-91%). MedMira’s sensitivity varied as well (relative to local laboratory tests: 57.9%, 95% CI 40.8%-73.7%; relative to DBS: 55%, 95% CI 38.5%-70.7%). This statement holds true while comparing test results between the rapid tests and both reference standard tests.
Table 3. Diagnostic accuracy of the Chembio and MedMira point-of-care (POC) tests in comparison to local laboratory tests in the AideSmart! cross-sectional multiplexed rapid sexually transmitted blood-borne infection screening study in Canada (2021-2022).POC testSensitivity, % (95% CI)Specificity, % (95% CI)HIVaNot applicable.
Table 4. Diagnostic accuracy of the Chembio and MedMira point-of-care (POC) tests in comparison to dried blood spot tests in the AideSmart! cross-sectional multiplexed rapid sexually transmitted blood-borne infection screening study in Canada (2021-2022).POC testSensitivity, % (95% CI)Specificity, % (95% CI)HIVaNot applicable.
In this study, we report high acceptability (401/401, 100%), satisfaction (393/401, 98%), and feasibility (305/401, 76.1%) for the AideSmart! multiplexed strategy. Participants preferred multiplexed rapid testing (148/249, 59.4%) over conventional laboratory-based testing, primarily due to its ability to provide a test result (negative or positive) in a shorter turnaround time.
Study findings demonstrate the strategy’s relevance for Canadian at-risk populations, as illustrated by the importance of obtaining a negative test result in at-risk populations and its overall impact in detecting new infections. With respect to impact, at the RECAP site, we detected most new infections (26/29, 90%), all of which were HCV, whereas at RÉZO, we detected 3 new infections (n=1, 33% HIV; n=1, 33% HCV; and n=1, 33% syphilis). Furthermore, all participants obtained laboratory-confirmed test results, were engaged throughout the process, stayed in communication with health care aides regarding their test results, and were counselled in time. Furthermore, treatment decisions were expedited in 3 visits for participants who tested positive. Most participants (377/401, 94%) did not require treatment as many infections spontaneously resolved. Although many participants who required follow-up (12/21, 57%) were linked and retained in care in visit 3, due to COVID-19 restrictions and repeat lockdowns, tracking 43% (9/21) of the participants was difficult. However, we were notified that 22% (2/9) died and 44% (4/9) were incarcerated. Despite the best efforts of our staff, 33% (3/9) left the province or were lost to follow-up. Overall, using this digital strategy, 99.3% (398/401) of our participants were tracked throughout the pandemic.
To the health care providers, knowledge of serostatus for STBBIs with rapid tests allowed for planning of screening and confirmatory testing and counselling for these participants at a time during the pandemic when services were interrupted for many STBBIs. This positive impact can be further enhanced by a rapid turnaround time of 15 minutes (once approved and implemented) for preliminary test results, as opposed to a waiting time of 4 to 24 days to obtain laboratory-based confirmatory results. The long waiting time carries the possibility of losing at-risk populations.
Health care providers underscored the importance of declaring both positive and negative test results using multiplexed rapid test results. Indeed, as the study population comprised at-risk individuals, the knowledge of one’s negative status is crucial for infection control. Although false positive results are troublesome, false negative results can lead to more devastating outcomes when used for screening, including a false sense of security and higher likelihood o
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