A Study to Evaluate the Accuracy, Usability, and Acceptance of a Blood-Based HIV Self-Test Performed by Observed Intended Users in Canada

Abstract Introduction: Self-Testing for HIV (“HIVST”) is an emerging targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed especially in priority populations. The study objectives of this study were to (1) evaluate the INSTI HIV-Self-Test (HIV-ST) performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV-ST device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for license purposes.Methods: The study used a cross-sectional design and recruited consenting adults from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV-ST were compared with results of the Abbott Architect HIV Ag/Ab Combo test. Results: Primary efficacy analysis on 678 completed HIV-ST revealed a positive percent agreement of 100% and a negative percent agreement of 99.5% with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5%. Of the 708 participants who took part in the usability study, 92.4% of participants successfully performed the steps determined to be “critical” for successful completion of the test, 96.7% of participants found the instructions easy to follow, and 95% of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive) to 99.3% (for negative).Conclusions: The addition of this very first self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. An approved blood-based HIV self-test in Canada can offer an accurate, acceptable and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions.

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A Study to Evaluate the Accuracy, Usability, and Acceptance of A Blood-Based HIV Self-Test Performed by Observed Intended Users in Canada

10.21203/rs.3.rs-89494/v1 ◽

2020 ◽

Author(s):

Jason Lo Hog Tian ◽

Richard A. Galli ◽

Michelle Sumner-Williams ◽

Kristin McBain ◽

Emal Stanizai ◽

...

Keyword(s):

Hiv Testing ◽

Cross Sectional ◽

Efficacy Analysis ◽

Percent Agreement ◽

Self Testing ◽

Simple Alternative ◽

Self Test ◽

Cross Sectional Design ◽

Priority Populations ◽

Health Canada

Abstract Background: Self-Testing for HIV (“HIVST”) is an emerging targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed especially in priority populations. The study objectives of this study were to (1) evaluate the INSTI HIV-Self-Test (HIV-ST) performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV-ST device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for license purposes.Methods: The study used a cross-sectional design and recruited consenting adults from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV-ST were compared with results of the Abbott Architect HIV Ag/Ab Combo test.Results: Primary efficacy analysis on 678 completed HIV-ST revealed a positive percent agreement of 100% and a negative percent agreement of 99.5% with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5%. Of the 708 participants who took part in the usability study, 92.4% of participants successfully performed the steps determined to be “critical” for successful completion of the test, 96.7% of participants found the instructions easy to follow, and 95% of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive) to 99.3% (for negative).Conclusions: The addition of this very first self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. An approved blood-based HIV self-test in Canada can offer an accurate, acceptable and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions.

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An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada

BMC Public Health ◽

10.1186/s12889-021-11418-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Richard A. Galli ◽

Jason M. Lo Hog Tian ◽

Michelle Sumner-Williams ◽

Kristin McBain ◽

Emal Stanizai ◽

...

Keyword(s):

Hiv Testing ◽

First Nations ◽

Latin American ◽

Race And Ethnicity ◽

Test Performance ◽

Test Procedure ◽

Cross Sectional ◽

Percent Agreement ◽

Self Testing ◽

Self Test

Abstract Background Self testing for HIV is a targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed, especially in priority populations. The objectives of this study were to (1) evaluate the INSTI HIV self-test performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV self-test device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for regulatory approval purposes. Methods The study used a cross-sectional design and recruited consenting adults who were representative of intended users of HIV self-testing from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV self-test were compared with results of the Abbott Architect HIV Ag/Ab Combo test. Usability outcomes for critical (e.g., lancing finger, blood droplet into bottle, shaking bottle four times) and noncritical self-test procedure steps were also determined. Results Overall, 77% (n = 522) of participants were between 18 and 45 years of age, 61% (n = 410) were male, 71% (n = 480) had some college or more education, and 45% (n = 307) were employed; identity for race and ethnicity: Caucasian (44%; n = 296), African, Caribbean or Black (17%; n = 113), Indigenous [First Nations, Métis or Inuit] (14%; n = 95), Asian (16%; n = 106), Latin American (7%; n = 46). Primary performance analysis on 678 completed HIV self-tests revealed a positive percent agreement of 100% (5/5, 95% CI: 43.6–97.0%) and a negative percent agreement of 99.5% (614/617, 95% CI: 98.6–99.8%) with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5% (n = 633). For the 708 participants who took part in the usability study, the average success rate for steps determined to be “critical” for successful completion of the test was 92.4%. 97% (n = 670) of participants found the instructions easy to follow, and 95% (n = 655) of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative, and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive, n = 366) to 99.3% (for negative, n = 401). Conclusions The addition of a regulatory-approved self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. Having a blood-based HIV self-test approved in Canada can offer an accurate, acceptable, and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions.

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Analytical Performance of the Exacto Test HIV Self-Test: A Cross-Sectional Field Study in the Democratic Republic of the Congo

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa554 ◽

2020 ◽

Vol 7 (12) ◽

Author(s):

Serge Tonen-Wolyec ◽

Jérémie Muwonga Masidi ◽

Luc Ferdinand Kamanga Lukusa ◽

Gaetan Nsiku Dikumbwa ◽

Angèle Sarassoro ◽

...

Keyword(s):

Field Study ◽

Democratic Republic ◽

Analytical Performance ◽

Viable Option ◽

Excellent Performance ◽

Cross Sectional ◽

Performance Sensitivity ◽

Self Testing ◽

Republic Of The Congo ◽

Self Test

Abstract The Democratic Republic of the Congo (DRC) has begun implementing HIV self-testing to boost the first “95” of the UNAIDS 95-95-95 targets by 2025. This study aims to assess the performance and usability of the Exacto Test HIV (Biosynex, Strasbourg, France) self-test in the lab and in the field. The Exacto Test HIV self-test demonstrated high virological performance (sensitivity, 99.6%; specificity, 100%) in the lab and in the field in the hand of untrained users (sensitivity, 100%; specificity, 98.9%). Taken together, the excellent performance and usability characteristics of the Exacto Test HIV (Biosynex) self-test make the kit a viable option for HIV self-testing in the DRC.

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Feasibility of Indirect Secondary Distribution of HIV Self-Test Kits via WeChat Among Men Who Have Sex with Men: A National Cross-Sectional Study in China (Preprint)

10.2196/preprints.28508 ◽

2021 ◽

Author(s):

Li Shangcao ◽

Jing Zhang ◽

Xiang Mao ◽

Tianyi Lu ◽

Yangyang Gao ◽

...

Keyword(s):

Social Media ◽

Online Survey ◽

Sexual Partners ◽

Cross Sectional ◽

Self Testing ◽

Hiv Test ◽

Condomless Anal Intercourse ◽

Secondary Distribution ◽

Self Test ◽

Sex With Men

BACKGROUND The use of HIV self-test (HST) kits is commonplace in key sexually active populations. The direct secondary distribution of HST kits (DSDHK) is effective in improving the uptake of HIV self-testing. However, there are concerns about various limitations of DSDHK, including limited geographic location, payment problems, and face-to-face interaction. OBJECTIVE We evaluated the feasibility and characteristics of the indirect secondary distribution of HST kits (ISDHK) via WeChat (distributing HST application links and follow-up HST kits to partners) among men who have sex with men (MSM). METHODS From October 2017 to September 2019, an HIV self-testing (HIVST) recruitment advertisement was disseminated on the WeChat social media platform to invite MSM to apply for HST kits (referred to as “index participants” [Ips]). All of the MSM participants were encouraged to distribute the HST application link to their friends and sexual partners (referred to as “Alters”) through their social networks. All Alters were further encouraged to continue to distribute the HST application link. All participants paid a deposit (USD 7), refundable upon completion of the questionnaire and uploading of the test result via an online survey system. RESULTS 2,263 MSM met the criteria and successfully applied for HST. Of these, 1,816 participants returned their HST test results, including 1,422 (88.3%) IPs and 394 (21.7%) Alters. Compared with the IPs, the Alters practiced more condomless anal intercourse (CAI), a higher proportion of them never previously had an HIV test, and they had a greater willingness to distribute HST kits to sexual partners (all p < 0.05). After controlling for age, education, and income, the Alters had a greater proportion of MSM who had never tested for HIV before (aOR = 1.29, 95% CI 1.00–1.68), were more willing to distribute the HST application link (aOR = 1.71, 95% CI 1.21–2.40), had a lower number of sexual partners (aOR = 0.71, 95% CI 0.57–0.90), and were less likely to search for sexual partners via online means (aOR = 0.78, 95% CI 0.60–1.02). In comparison, the rates of reactive HST results, conducting HIV confirmatory tests, HIV seropositivity, and initiation of HIV antiretroviral therapy (ART) were similar for IPs and Alters. CONCLUSIONS The ISDHK mode of distributing HST application links via social media is feasible among the MSM population. The ISDHK mode should be used to supplement the DSDHK mode in order to enable a greater proportion of the MSM population to know their HIV infection status.

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Acceptability and correlates of HIV self-testing among university students in northern Nigeria

International Journal of STD & AIDS ◽

10.1177/0956462420920136 ◽

2020 ◽

Vol 31 (9) ◽

pp. 820-831

Author(s):

Zubairu Iliyasu ◽

Radeeyah B Kassim ◽

Bilkisu Z Iliyasu ◽

Taiwo G Amole ◽

Nafisa S Nass ◽

...

Keyword(s):

University Students ◽

Cross Sectional Study ◽

Consistent Condom ◽

Consistent Condom Use ◽

Cross Sectional ◽

Logistic Regression Models ◽

Program Of Study ◽

Self Testing ◽

Self Test ◽

Testing And Counseling

Concerns about stigma and confidentiality limit the uptake of HIV testing and counseling (HTC) among young adults. HIV self-testing has been offered as a youth-friendly alternative to conventional HTC. We conducted a cross-sectional study to assess HTC uptake, willingness to self-test, and their predictors among university students ( n = 399) in Kano, Nigeria. Anonymous self-administered questionnaires were provided to participants. Adjusted odd ratios were generated for predictors with logistic regression models. The results showed that only 35.8% ( n = 143) of participants had previous HTC.Most respondents (70.4%, n = 281) were willing to self-test. HTC was associated with year of college (500 Level vs. 100 Level), adjusted odds ratio (AOR, [95% Confidence Interval (CI)] = 0.44 (0.19–0.97), campus residence (off- vs. on-campus, AOR = 0.45; 95%CI: 0.28–0.73), sexual activity in the past six months (AOR = 0.39; 95%CI: 0.24–0.64), willingness to self-test (AOR = 0.38; 95%CI: 0.22–0.66), and consistent condom use (AOR = 4.45; 95%CI: 1.41–14.08). Students who were older (≥ 30 vs. <20 years, AOR = 0.20; 95%CI: 0.05–0.90) and female (AOR = 0.56; 95%CI: 0.32–0.98) were less likely to be willing to self-test, whereas students who were more senior (500 Level vs. 100 Level, AOR = 5.24; 95%CI: 1.85–14.84), enrolled in clinical science programs (vs. agriculture, AOR = 4.92; 95%CI: 1.51–16.05) or belonging to “other” ethnic groups (vs. Hausa–Fulani, AOR = 2.40; 95%CI: 1.11–5.19) were more willing to self-test. Overall HTC uptake was low, but acceptability of self-testing was high. College seniority, age, ethnicity, and program of study were associated with willingness to self-test. Our findings support the feasibility of scaling up HIV self-testing among university students in Nigeria.

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A systematic review of qualitative evidence on factors enabling and deterring uptake of HIV self-testing in Africa

BMC Public Health ◽

10.1186/s12889-019-7685-1 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 13

Author(s):

Bernard Njau ◽

Christopher Covin ◽

Esther Lisasi ◽

Damian Damian ◽

Declare Mushi ◽

...

Keyword(s):

Systematic Review ◽

Hiv Testing ◽

Linkage To Care ◽

Ease Of Use ◽

Sub Saharan Africa ◽

Care Providers ◽

African Countries ◽

Qualitative Evidence ◽

Self Testing ◽

Self Test

Abstract Background More than 40% of adults in Sub-Saharan Africa are unaware of their HIV status. HIV self-testing (HIVST) is a novel approach with a potential to increase uptake of HIV testing and linkage to care for people who test HIV positive. We explored HIV stakeholder’s perceptions about factors that enable or deter the uptake of HIV self-testing and experiences of self-testing of adult users in Africa. Methods This systematic review of qualitative evidence included articles on qualitative studies published or made available between January 1998 to February 2018 on perspectives of key stakeholders, including HIV policymakers, HIV experts, health care providers, and adult men and women (18 years and above) about factors that enable or deter the uptake of HIV self-testing and experiences of self-testing among adult users. We searched CINAHL, MEDLINE in Pubmed, EMBASE, AJOL, PsycINFO, Social Science Citation Index (SSCI), and Web of Science for articles in English on HIVST with qualitative data from different African countries. Results In total, 258 papers were retrieved, and only nine (9) studies conducted in 5 African countries were eligible and included in this synthesis. Perceived facilitators of the uptake of HIVST were autonomy and self-empowerment, privacy, confidentiality, convenience, opportunity to test, including couples HIV testing, and ease of use. The perceived barriers included the cost of buying self-test kits, perceived unreliability of test results, low literacy, fear and anxiety of a positive test result, and potential psychological and social harms. HIV stakeholder’s concerns about HIVST included human right issues, lack of linkage to care, lack of face-to-face counseling, lack of regulatory and quality assurance systems, and quality of self-test kits. Actual HIVST users expressed preference of oral-fluid self-testing because of ease of use, and that it is less invasive and painless compared to finger-stick/whole blood-based HIV tests. Lack of clear instructions on how to use self-test kits, and existing different products of HIVST increases rates of user errors. Conclusions Overcoming factors that may deter HIV testing, and HIVST, in particular, is complex and challenging, but it has important implications for HIV stakeholders, HIVST users, and public health in general. Research is warranted to explore the actual practices related to HIVST among different populations in Africa.

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HIV testing practices and the potential role of HIV self-testing among men who have sex with men in Mexico

International Journal of STD & AIDS ◽

10.1177/0956462416641556 ◽

2016 ◽

Vol 28 (3) ◽

pp. 242-249 ◽

Cited By ~ 9

Author(s):

Catherine E Oldenburg ◽

Katie B Biello ◽

Amaya G Perez-Brumer ◽

Joshua Rosenberger ◽

David S Novak ◽

...

Keyword(s):

Confidence Interval ◽

Hiv Testing ◽

Odds Ratio ◽

Adjusted Odds Ratio ◽

Intention To Use ◽

Self Testing ◽

Hiv Test ◽

Self Test ◽

Testing Practices ◽

Sex With Men

The objective of this study was to characterize HIV testing practices among men who have sex with men in Mexico and intention to use HIV self-testing. In 2012, members of one of the largest social/sexual networking websites for men who have sex with men in Latin America completed an anonymous online survey. This analysis was restricted to HIV-uninfected men who have sex with men residing in Mexico. Multivariable logistic regression models were fit to assess factors associated with HIV testing and intention to use a HIV self-test. Of 4537 respondents, 70.9% reported ever having a HIV test, of whom 75.5% reported testing at least yearly. The majority (94.3%) indicated that they would use a HIV home self-test if it were available. Participants identifying as bisexual less often reported ever HIV testing compared to those identifying as gay/homosexual (adjusted odds ratio = 0.52, 95% confidence interval: 0.44–0.62). Having a physical exam in the past year was associated with increased ever HIV testing (adjusted odds ratio = 4.35, 95% confidence interval: 3.73–5.07), but associated with decreased interest in HIV self-testing (adjusted odds ratio = 0.66, 95% confidence interval: 0.48–0.89). The high intention to use HIV home self-testing supports the use of this method as an acceptable alternative to clinic- or hospital-based HIV testing.

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At-home HIV self-testing during COVID: implementing the GetaKit project in Ottawa

Can J Public Health ◽

10.17269/s41997-021-00505-8 ◽

2021 ◽

Author(s):

Patrick O’Byrne ◽

Alexandra Musten ◽

Lauren Orser ◽

Gauri Inamdar ◽

Marie-Odile Grayson ◽

...

Keyword(s):

Hiv Testing ◽

Scale Up ◽

Vaccine Trial ◽

Hiv Treatment ◽

Baseline Survey ◽

Healthcare Settings ◽

Self Testing ◽

Self Test ◽

The University ◽

Hiv Negative

Abstract Setting In March 2020, COVID-19 shuttered access to many healthcare settings offering HIV testing and there is no licensed HIV self-test in Canada. Intervention A team of nurses at the University of Ottawa and Ottawa Public Health and staff from the Ontario HIV Treatment Network (OHTN) obtained Health Canada’s Special Access approval on April 23, 2020 to distribute bioLytical’s INSTI HIV self-test in Ottawa; we received REB approval on May 15, 2020. As of July 20, 2020, eligible participants (≥18 years old, HIV-negative, not on PrEP, not in an HIV vaccine trial, living in Ottawa, no bleeding disorders) could register via www.GetaKit.ca to order kits. Outcomes In the first 6 weeks, 637 persons completed our eligibility screener; 43.3% (n = 276) were eligible. Of eligible participants, 203 completed a baseline survey and 182 ordered a test. These 203 participants were an average of 31 years old, 72.3% were white, 60.4% were cis-male, and 55% self-identified as gay. Seventy-one percent (n = 144) belonged to a priority group for HIV testing. We have results for 70.9% (n = 129/182) of participants who ordered a kit: none were positive, 104 were negative, 22 were invalid, and 2 “preferred not to say”; 1 participant reported an unreadiness to test. Implications Our results show that HIV self-testing is a pandemic-friendly strategy to help ensure access to sexual health services among persons who are good candidates for HIV testing. It is unsurprising that no one tested positive for HIV thus far, given the 0.08% positivity rate for HIV testing in Ottawa. As such, we advocate for scale-up of HIV self-testing in Canada.

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Prevalence and Factors Associated With HIV Self-testing Uptake Among Men Who Have Sex With Men in Ningbo, China: A Cross-sectional Study

10.21203/rs.3.rs-76060/v1 ◽

2020 ◽

Author(s):

Hang Hong ◽

Hong-bo Shi ◽

Hai-bo Jiang ◽

Hong-jun Dong ◽

Yun-liang Shen

Keyword(s):

Hiv Testing ◽

Cross Sectional Study ◽

Sexual Contact ◽

Categorical Variables ◽

Sectional Study ◽

Cross Sectional ◽

Factors Associated ◽

The Past ◽

Self Testing ◽

Sex With Men

Abstract BackgroundHIV testing and early linkage to care are critical for reducing the risk of HIV transmission. HIV self-testing (HIVST) is an useful tool for increasing HIV testing frequency.This study aimed to investigate HIVST rates among men who have sex with men (MSM), the characteristics of MSM who had HIVST, and factors associated with HIVST uptake among MSM in Ningbo, China. MethodsA cross-sectional study was conducted from April to October 2019 in Ningbo,China. Participants were aged at least 18 years and having had sexual contact with men in the past year. Proportions were used for categorical variables. Adjusted Odds Ratio (AOR) and 95% Confidence Interval (CI) for characteristics associated with HIVST uptake was processed by multiple logistic regression models.ResultsAmong a sample of 699 MSM recruited, 38.2% had reported previous use of an HIV self-test kit. A greater proportion of HIVST Users had a higher frequency of HIV testing(≥2 times: 70.0% versus 41.2%, p<0.001) in the past one year. Factor associated with HIVST uptake was gay apps use(AOR=1.86,CI=1.13-3.05), multiple male sex partners (AOR=1.90,CI=1.29-2.80), frequency of male-male sexual contact ≥1 times per week(AOR=1.86, CI=1.30-2.66), syphilis infection(AOR=5.48, CI=2.53-11.88).ConclusionsFurther HIVST education should be strengthened for school-aged children and teenagers, and free HIVST kits may be provided to low-income high-risk MSM through gay apps and NGOs to achieve the increased HIV testing frequency.

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An Unsupervised Smart App–Optimized HIV Self-Testing Program in Montreal, Canada: Cross-Sectional Study (Preprint)

10.2196/preprints.10258 ◽

2018 ◽

Author(s):

Nitika Pant Pai ◽

Megan Smallwood ◽

Laurence Desjardins ◽

Alexandre Goyette ◽

Krisztian G Birkas ◽

...

Keyword(s):

Rapid Test ◽

Health Impact ◽

Completion Rate ◽

World Health ◽

Health Clinic ◽

Testing Strategy ◽

Cross Sectional ◽

Self Testing ◽

Hiv Test ◽

Self Test

BACKGROUND Although HIV self-testing strategies have been recommended by the World Health Organization, HIV self-tests are not yet approved in Canada. Currently approved HIV self-tests offer toll-free lines that are insufficient for initiating expedited linkages to counseling and care, accurate interpretation, and support during HIV self-testing. We developed an innovative, multilingual software app called HIVSmart! to plug these gaps. OBJECTIVE This study aimed to test our app-optimized oral HIV self-testing strategy for feasibility in men who have sex with men (MSM) who presented to test at a large sexual health clinic (Clinique Médicale L’Actuel) in Montreal. METHODS Between July 2016 and February 2017, we offered a strategy consisting of the OraQuick In-Home HIV Test (an investigational device) and a tablet installed with the HIVSmart! app to study participants, who presented at a private office in the clinic, mimicking an unsupervised home environment. We evaluated the strategy for its feasibility, acceptability, and preference. Using the HIVSmart! app, participants were guided through the self-testing process. We determined feasibility with a metric defined as the completion rate, which consisted of the following 3 steps: (1) self-test conduct; (2) self-test interpretation; and (3) linkages to care. Participants independently performed, interpreted, recorded their self-test and result, engaged in pre- and posttest counseling, and sought linkages to care. Laboratory tests (p24, Western Blot, and RNA), as per country algorithms, were expedited, and linkages based on the rapid test status were arranged. RESULTS Mean age of the 451 participants enrolled was 34 (range, 18-73) years. Of all participants, 97.1% (438/451) completed and submitted the survey through the HIVSmart! app. In total, 84.7% (371/438) of the participants were well educated (beyond high school) and 52.5% (230/438) had been tested within the past 6 months. Of the 451, 11.5% (52/451) were on pre-exposure prophylaxis. Feasibility (completion rate), an average proportion of the 3 steps, was computed to be 96.6% (419/451). The acceptability of the strategy was high at 98.5% (451/458). A majority of the participants (448/451, 99.3%) were found to be self-tested and lab-confirmed negative and were counseled after self- and rapid tests. In total, 0.7% (3/451) of the participants who self-tested positive and were lab-confirmed positive were linked to a physician within the same day. Furthermore, 98.8% (417/422) of the participants found the app to be useful and 94.0% (424/451) were willing to recommend it to a friend or partner. CONCLUSIONS The HIVSmart! app-optimized strategy was feasible, accepted, and preferred by an educated, urban MSM population of Montreal. With the app, participants were able to perform, interpret, store results, and get rapidly linked to care. The HIVSmart!-optimized, self-testing strategy could be adapted and contextualized to many at-risk populations within Canada and worldwide, thereby maximizing its public health impact.

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