Table 1 summarizes descriptive statistics. We received a total of 183 responses to the survey, of which 72% were completed in English. Stakeholders from 10 different provinces and territories responded. Quebec and Ontario constituted the majority of stakeholders (37 and 24% respectively) (Fig. 1). Healthcare providers constituted 45% of stakeholders; followed by “other” stakeholders (19%), which included AIDS organizations, community outreach workers, and social workers, among others (Fig. 2).
Analyses by job function (all other stakeholders vs. frontline care providers) with ordinal logistic regression models (Table 2), demonstrated other stakeholders (n = 71) were more likely to respond in favour of self-testing than frontline care providers (n = 112). The proportional odds of selecting “agree” versus “neutral” or “disagree” (likewise, for selecting “agree” or “neutral” versus “disagree”) were 3.82 (95% CI 1.89–7.71, “HIV self-tests are an important approach to testing and should be made available to my clients”), 2.44 (95% CI 1.20–4.98, “investment in self-testing is necessary to help bring undiagnosed individuals into care”), and 2.64 (95% CI 1.39–5.02, “clients will benefit by having access to self-test kits”), comparing other stakeholders to frontline providers.
The majority of the qualitative data was analyzed from the responses to the comments provided alongside the non-open ended questions (23 questions). For the open-ended questions, 42% (77/183) of stakeholders provided responses to the first question (“Do you have any thoughts on what type of research is needed for HIV self-testing in Canada?”) and 40% (73/183) responded to the second question (“Do you have any thoughts on what is needed to approve HIV self-tests for Canadians?”).
Stakeholders generally responded in favour of self-testing, with 64.6% (95% CI 57.3–71.3%, n = 181) agreeing that HIV self-tests are an important approach to testing and should be made available to their clients. 70.7% (95% CI 63.6–76.9%, n = 181) agreed that investment in self-testing will be necessary to help bring undiagnosed individuals into care, and 59.2% of respondents (95% CI 51.8–66.2%, n = 179) felt that clients would benefit by having access to self-testing kits. Stakeholders expressed concerns regarding linking patients to clinical care and counselling. Of respondents, 71.5% (95% CI 64.4–77.7%, n = 179) agreed that before self-test kits are made widely available, self-test instructions must be improved to ensure users understand the need to access clinical care (e.g. confirmatory testing, counselling and treatment).
The following major themes emerged from the qualitative analysis. Where available, these were matched with corresponding quantitative findings.
The Client’s Emotional and Cognitive Characteristics in Handling Test Results: “Fit to Test?”
Respondents highlighted several factors, such as a sufficient level of the client’s understanding of self-testing technologies, HIV and its prognosis, and integrity of the client’s mental health status and coping mechanisms as determinants for a client’s capability to handle a positive self-test result without psychological harm or endangering others, and to engage with counselling and care. We summarized these factors as “fitness to test”. This fitness to test also assumes literacy and understanding of the pros and cons of the testing process and entails proactivity on the part of the self-tester. Underlying many comments seemed to be an analysis of the respondent’s own client population, and in particular their psychological state and coping skills (e.g., insufficient trust and aversion to pre-test counselling and interrogation about one’s sex life) which may deter clients from conventional HIV testing. HIV self-testing may allow clients who experience these feelings/perceptions to access HIV testing anyway, offering an advantage. Others emphasized that the act of self-testing itself can be an indicator for inward (seeking counselling and care) and outward (preventing transmission to future partners) responsibility. One health care provider noted: “The majority of my clients would be able to understand the accuracy of the technology, the implications of having a positive test result, and would have the coping skills to actively seek out the services available (…)” when asked about the importance of self testing and whether it should be made available to clients. For clients considered fit to test by the stakeholder, self-testing can be empowering, by allowing clients to autonomously diagnose their infection and seek treatment. In contrast, in a traditional test setting, this is (partially) outsourced, and responsibility is passed from the client to the healthcare provider, who makes the decision to test.
When asked if self-tests are too difficult for clients to interpret, 50% (95% CI 42.7–57.3%, n = 180) of respondents disagreed, 21.1% (95% CI 15.7–27.8%) of respondents were neutral, and 14.4% (95% CI 10.0–20.4%) agreed. Less than one-third of respondents (28.3%, 95% CI 22.2–35.4%, n = 180) felt that self-tests put too much responsibility on clients (42.2% disagreed, 95% CI 35.1–49.6%; 25% neutral, 95% CI 19.2–31.9%).
The Next Steps: Linkage to Counselling and Care
Ensuring customized counselling and care, for both positive and negative results, was a primary concern of respondents as exemplarily noted by an activist and former physician when asked the type of research which was needed for HIV self-testing in Canada: “I think the link from self-test to counselling is the most important thing!”.
The specifications and suitability of the services offered to clients were perceived to depend on pre-existing knowledge of HIV and self-testing, educational background, cognitive ability, and reading and language skills. Here the difference between accessibility and acceptability was highlighted, as a tester may not consider a service that is existing and accessible acceptable or appropriate for their needs. Stakeholders expressed in their comments that their approval of self-testing depends upon their perception of how likely an HIV self-test will lead to a confirmed diagnosis and linkage to care, as highlighted by a health care manager when asked about the relevance of self-testing and whether to make it available to clients: “This is contingent on patients with positive results having the ability and the means to seek appropriate care.” This comment also highlights the relevance of “fitness to test” for successful linkage to counseling and care. Respondents indicated that improvements to self-test instructions were needed to ensure clients access clinical care, and 70.6% (95% CI 63.4–76.9%, n = 177) of respondents considered phone-based counselling and linkage to care would be a good option while offering supervised or unsupervised self-testing. In addition, 60.1% (95% CI 52.7–67.1%, n = 178) of respondents agreed that clients who self-test false-negatively will be less likely to engage with HIV care. However, respondents generally disagreed that clients self-testing positive will be less likely to engage with HIV care (only 11.7%, 95% CI 7.7–17.3% n = 180, of respondents agreed). One quarter (25%; 95% CI 19.2–31.9, n = 180) of respondents felt that self-tests have the potential to do more harm than good.
Self-Test Characteristics: Quality and Accuracy
Of respondents, 34.4% (95% CI 27.8–41.8%) admitted a deficit in knowledge about self-test’s sensitivity, highlighting a need for awareness and education among stakeholders if self-tests are to be approved and made available in Canada. Quality (accuracy) of self-testing was perceived to be determined by sensitivity and specificity, and the ability to detect HIV during the window period. Respondents didn’t want quality of testing (and counselling) to be compromised for increased testing numbers.
Testing Environment, Test Administration and “Subjective Safety”
Self-tests can be made available in a variety of settings, for example home, office, private spaces in clinics, outreach settings, and pride parades (Fig. 3). Several respondents perceived safety, privacy and confidentiality as key determinants of the quality of the self-testing environment, and a distinction was made between the self-testing environments’ ability to provide these determinants, as compared to traditional test settings. As an example for several responses in the same line, a medical director of a clinical microbiology laboratory noted: “(…) I think this type of testing provides clients with the opportunity to test anonymously in the safety and comfort of their home (…)”. Depending on the location where self-tests are made available (e.g. gay pride parade) respondents could not assume privacy, safety, and confidentiality would be ensured, as highlighted by a stakeholder within an AIDS Service Organization when asked about suitable places for self-testing in this statement: “If available at public venues such as Pride Parade, Pharmacies or Kiosks, steps should be taken to ensure set up is respectful of person’s privacy and confidentiality.” Traditional settings (e.g. clinics, health centres) were understood to provide better quality. According to several respondents, privacy and anonymity are particularly relevant for high risk or vulnerable populations, and for this reason, self-testing was perceived to provide a safe testing experience, reaching more individuals in remote areas. Through qualitative responses, the concept of “subjective safety” was developed: the array of individual factors that ensure a comfortable testing experience.
Privacy concerns were mentioned in relation to technological innovations, such as smartphone applications. 53.7% (95% CI 46.2–61.0%, n = 177) of respondents agreed that clients are concerned about protection of health information and confidentiality with online testing. 42.4% (95% CI 35.2–49.8, n = 177) of respondents felt that clients would be comfortable with using mobile phones to engage with counselling, however 24.9%, (95% CI 19.0–31.8%, n = 177) were unsure whether clients would be comfortable doing so. Many stakeholders (21%) expressed a desire for prompt availability of self-tests in Canada.
Approximately 50% of respondents favoured either free or $0–5 CAD cost if self-testing had to be paid for by the individual. The inverse correlation between accessibility (esp. by marginalised groups) and (higher) cost was widely recognised, as noted by a policy maker when asked about the desired pricing of self-testing:“The higher the price, the more likely that marginalized individuals who are hard to reach will not access it”.
Fifty percent (95% CI 42.7–57.3%, n = 180) of respondents felt that self-testing (as an alternative strategy) poses a challenge to current business models for HIV testing (conventional and anonymous HIV testing and counselling); qualitative responses considered the impact that self-testing might have on general HIV testing budgets and related consequences for the overall availability of testing, should existing budgets not be expanded, as illustrated in this statement by a frontline outreach/education worker in the context of self-testing strategies in Canada: “The province of Ontario is already talking about taking away POC testing from underperforming clinics. If the province puts funding into self-testing, I would imagine that money will come from current testing budgets”. Some respondents expressed concerns about the potential for self-testing to economize HIV testing, as stated by a health care provider in the context of supervised self-testing in settings with high case loads: “We need to be careful not to address issues in resource allocation through compromising quality of care”. Moreover, the costs of self-tests were appraised as a determinant for specific groups to access self-testing, and respondents mentioned the need to consider the costs of pre- and post-test counselling.