Effectiveness of an eHealth intervention for reducing psychological distress and increasing COVID-19 knowledge and protective behaviors among racialized sexual and gender minority adults: A quasi-experimental study (#SafeHandsSafeHearts).

PURPOSE: Sexual and gender minority and racialized populations experienced heightened vulnerability during the Covid-19 pandemic. Marginalization due to structural homophobia, transphobia and racism, and resulting adverse social determinants of health that contribute to health disparities among these populations, were exacerbated by the Covid-19 pandemic and public health measures to control it. We developed and tested a tailored online intervention (#SafeHandsSafeHearts) to support racialized lesbian, gay, bisexual, transgender, queer, and other persons outside of heteronormative and cisgender identities (LGBTQ+) in Toronto, Canada during the pandemic. METHODS: We used a quasi-experimental pre-test post-test design to evaluate the effectiveness of a 3-session, peer-delivered eHealth intervention in reducing psychological distress and increasing Covid-19 knowledge and protective behaviors. Individuals ≥18-years-old, resident in Toronto, and self-identified as sexual or gender minority were recruited online. Depressive and anxiety symptoms, and Covid-19 knowledge and protective behaviors were assessed at baseline, 2-weeks postintervention, and 2-months follow-up. We used generalized estimating equations and zero-truncated Poisson models to evaluate the effectiveness of the intervention on the four primary outcomes. RESULTS: From March to November 2021, 202 participants (median age, 27 years [Interquartile range: 23-32]) were enrolled in #SafeHandsSafeHearts. Over half (54.5%, n = 110) identified as cisgender lesbian or bisexual women or women who have sex with women, 26.2% (n = 53) cisgender gay or bisexual men or men who have sex with men, and 19.3% (n = 39) transgender or nonbinary individuals. The majority (75.7%, n = 143) were Black and other racialized individuals. The intervention led to statistically significant reductions in the prevalence of clinically significant depressive (25.4% reduction, p < .01) and anxiety symptoms (16.6% reduction, p < .05), and increases in Covid-19 protective behaviors (4.9% increase, p < .05), from baseline to postintervention. CONCLUSION: We demonstrated the effectiveness of a brief, peer-delivered eHealth intervention for racialized LGBTQ+ communities in reducing psychological distress and increasing protective behaviors amid the Covid-19 pandemic. Implementation through community-based organizations by trained peer counselors supports feasibility, acceptability, and the importance of engaging racialized LGBTQ+ communities in pandemic response preparedness. This trial is registered with ClinicalTrials.gov, number NCT04870723.

Dissemination of the Women-Centred HIV Care Model: A Multimodal Process and Evaluation.

BACKGROUND: Using data from a national cohort study and focus groups, the Women-Centred HIV Care (WCHC) Model was developed to inform care delivery for women living with HIV. METHODS: Through an evidence-based, integrated knowledge translation approach, we developed 2 toolkits based on the WCHC Model for service providers and women living with HIV in English and French (Canada's national languages). To disseminate, we distributed printed advertising materials, hosted 3 national webinars and conducted 2 virtual capacity-building training series. RESULTS: A total of 315 individuals attended the webinars, and the average WCHC knowledge increased by 29% (SD 4.3%). In total, 131 service providers engaged in 22 virtual capacity-building training sessions with 21 clinical cases discussed. Learners self-reported increased confidence in 15/15 abilities, including the ability to provide WCHC. As of December 2023, the toolkits were downloaded 7766 times. CONCLUSIONS: We successfully developed WCHC toolkits and shared them with diverse clinical and community audiences through various dissemination methods.

A study on creating and sharing a toolkit for healthcare providers and women living with HIVWhy was the study done?:The research team created the Women-Centred HIV Care (WCHC) model to help healthcare providers deliver personalised and thorough care to women living with HIV in Canada. This study aimed to develop a practical toolkit based on the model. The goal was to share this toolkit with women and their providers in various ways to get feedback on its usefulness and to understand the best methods for sharing tools in the future.What did the researchers do?:Through an in-depth, collaborative process, English and French WCHC toolkits were developed by a large and diverse team of women and providers. Various methods including printed materials, national webinars and virtual trainings were used to share the toolkits across Canada. The team assessed the toolkit's reception by using surveys, focus groups and tracking toolkit downloads and webpage views.What did the researchers find?:The study found positive results, including a 29% increase in WCHC knowledge for 315 webinar participants and enhanced confidence in 15 abilities for 131 service providers during virtual training. The toolkits were downloaded 7766 times, indicating broad interest. Usability testing showed that the toolkits were easy to use and helpful. Attendees of the webinars and virtual trainings indicated they were likely to use the toolkit and recommend it to others.What do the findings mean?:Overall, the WCHC toolkits offer valuable guidance to women living with HIV and their providers. The study improved providers' knowledge and confidence in delivering WCHC, especially during the virtual training sessions that focused on applying this knowledge to real clinical cases. During months when the toolkit was shared through printed materials, webinars and virtual training, more people visited the toolkit webpage. The study highlighted the importance of involving those who will use healthcare tools from the beginning and using many ways to share these tools to reach more people.

A Manifesto for transformative action on HIV among Black communities in Canada.

Black communities bear a hugely disproportionate share of Canada's HIV epidemic. Black persons annually represent up to one quarter of new diagnoses, while in contrast, diagnoses have been falling among white Canadians for the past two decades. There has been a notable lack of urgency and serious debate about why the trend persists and what to do about it. For too long, public institutions have reproduced hegemonic white supremacy and profoundly mischaracterized Black life. Consequently, Black communities suffer policies and programs that buttress systemic anti-Black racism, socio-economically disenfranchise Black communities, and in the process marginalize knowledgeable, experienced, and creative Black stakeholders. The Interim Committee on HIV among Black Canadian Communities (ICHBCC) is a group of Black researchers, service providers, and community advocates who came together in early 2022 to interject urgency to the HIV crisis facing Black communities. Specifically, the ICHBCC advocates for self-determined community leadership of research, policies, and programs, backed by access to appropriate resources, to change the trajectory of HIV among Black Canadian communities. In this article, we introduce the wider community to the Black HIV Manifesto that we developed in 2022.

RéSUMé: Les communautés noires constituent une part très disproportionnée de l'épidémie de VIH du Canada. Les personnes noires représentent annuellement jusqu'au quart des nouveaux diagnostics, tandis que les diagnostics diminuent chez les Canadiennes et les Canadiens de race blanche depuis 20 ans. Il y a une absence notable d'urgence et de débat sérieux sur la raison de la persistance de ces tendances et sur ce qu'il faudrait y faire. Pendant trop longtemps, les institutions publiques ont reproduit l'hégémonie de la suprématie blanche et extrêmement mal caractérisé les vies noires. Par conséquent, les communautés noires souffrent de politiques et de programmes qui soutiennent le racisme anti-Noirs systémique, privent les communautés noires de leurs droits socioéconomiques et marginalisent ainsi les connaissances, l'expérience et la créativité des parties prenantes noires. Le comité intérimaire sur le VIH dans les communautés noires du Canada (ICHBCC) est un groupe de chercheurs et de chercheuses, de prestataires de services et de porte-parole communautaires de race noire qui se sont regroupés au début de 2022 pour mettre l'accent sur le caractère urgent de la crise du VIH dans les communautés noires. Plus précisément, l'ICHBCC plaide en faveur d'un leadership communautaire autodéterminé de la recherche, des politiques et des programmes, appuyé par un accès aux ressources nécessaires, pour changer la trajectoire du VIH dans les communautés noires du Canada. Dans cet article, nous présentons à l'ensemble de la communauté le « manifeste noir sur le VIH ¼ que nous avons élaboré en 2022.

Activism and immigrant women's mental health and wellbeing: Building Canadian service provider capacity in the settlement and mental health sectors.

In this qualitative community-based research, we explore service providers' use of activism-based resources and the supports they need to use activism as a tool to promote the mental health and wellbeing of racialized immigrant women. 19 service providers working in settlement and mental health services in the Greater Toronto Area, Canada, participated in one of three focus groups. We analyzed the data using a postcolonial feminist lens. Service providers' understandings of activism, strategies for promoting client mental health and wellbeing, and organizational barriers shaping their practice emerged as relevant. We offer recommendations for building activism-based resources, programs and services that include collaborations with racialized immigrant women communities and action at the organizational level to support service provider practice.

HIV care cascade for women living with HIV in the Greater Toronto Area versus the rest of Ontario and Canada.

BACKGROUND: The Greater Toronto Area (GTA) is home to 39% of Canada's population living with HIV. To identify gaps in access and engagement in care and treatment, we assessed the care cascade of women living with HIV (WLWH) in the GTA versus the rest of Ontario and Canada (in this case: Quebec and British Columbia). METHODS: We analyzed 2013-2015 self-reported baseline data from the Canadian HIV Women's Sexual and Reproductive Health Cohort Study for six care cascade stages: linked to care, retained in care, initiated antiretroviral therapy (ART), currently on ART, ART adherence (≥90%), and undetectable (<50 copies/mL). Multivariable logistic regression was used to reveal associations with being undetectable. RESULTS: Comparing the GTA to the rest of Ontario and Canada, respectively: 96%, 98%, 100% were linked to care; 92%, 94%, 98% retained in care; 72%, 89%, 96% initiated ART; 67%, 81%, 90% were currently using ART; 53%, 66%, 77% were adherent; 59%, 69%, 81% were undetectable. Factors associated with viral suppression in the multivariable model included: living outside of the GTA (Ontario: aOR = 1.72, 95% CI: 1.09-2.72; Canada: aOR = 2.42, 95% CI: 1.62-3.62), non-Canadian citizenship (landed immigrant/permanent resident: aOR = 3.23, 95% CI: 1.66-6.26; refugee/protected person/other status: aOR = 4.77, 95% CI: 1.96-11.64), completed high school (aOR = 1.77, 95% CI: 1.15-2.73), stable housing (aOR = 2.13, 95% CI: 1.33-3.39), income of ≥$20,000 (aOR = 1.52, 95% CI: 1.00-2.31), HIV diagnosis <6 years (6-14 years: aOR = 1.75, 95% CI: 1.16-2.63; >14 years: aOR = 1.87, 95% CI: 1.19-2.96), and higher resilience (aOR = 1.02, 95% CI: 1.00-1.04). CONCLUSION: WLWH living in the GTA had lower rates of viral suppression compared to the rest of Ontario and Canada even after adjustment of age, ethnicity, and HIV diagnosis duration. High-impact programming for WLWH in the GTA to improve HIV outcomes are greatly needed.

Black Canadians' Exposure to Everyday Racism: Implications for Health System Access and Health Promotion among Urban Black Communities.

This study explores the social determinants of Black Canadians' exposure to everyday racism, its relationship to health system access, and implications for health promotion. We used data from the A/C Study survey on HIV transmission and prevention among Black Canadians. We implemented the survey (N = 1360) in 2018-2019 in Toronto and Ottawa-two large cities that together account for 42% of Canada's Black population-among self-identified Black residents aged 15-64 years, who were born in sub-Sahara Africa or the Caribbean or had a parent who was born in those regions. Participants reported racist encounters in the preceding 12 months using the Everyday Discrimination Scale. We assessed the socio-demographic correlates of racist experiences and the impact of racism on health system access using multivariable generalised linear models. Sixty percent of participants reported experiencing racism in the preceding 12 months. Based on the adjusted odds ratios, participants were more likely to experience racism if they were older, employed, Canadian-born, had higher levels of education, self-identified as LGBTQ + and reported generally moderate access to basic needs and adequate housing; and less likely to experience racism if they lived in Ottawa, self-identified as female or reported higher levels of social capital. Visiting a healthcare provider or facility, and difficulty accessing healthcare were associated with racist experiences. Racist experiences diminished the likelihood of being tested for HIV. Racist experiences were widespread, especially among those with higher levels of social wellbeing or greater exposure to Canadian institutions. Study participants also associated racist experiences with the healthcare system.

Willingness of Older Canadians with HIV to Participate in HIV Cure Research Near and After the End of Life: A Mixed-Method Study.

HIV cure research requires interrogating latent HIV reservoirs in deep tissues, which necessitates autopsies to avoid risks to participants. An HIV autopsy biobank would facilitate this research, but such research raises ethical issues and requires participant engagement. This study explores the willingness to participate in HIV cure research at the end of life. Participants include Canadians with HIV [people with HIV (PWHIV)] aged 55 years or older. Following a mixed-method study design, all participants completed a phone or online survey, and a subset of participants participated in in-depth phone or videoconference interviews. We produced descriptive statistics of quantitative data and a thematic analysis of qualitative data. Barriers and facilitators were categorized under domains of the Theoretical Domains Framework. From April 2020 to August 2021, 37 participants completed the survey (mean age = 69.9 years old; mean duration of HIV infection = 28.5 years), including 15 interviewed participants. About three quarters of participants indicated being willing to participate in hypothetical medical studies toward the end of life (n = 30; 81.1%), in HIV biobanking (n = 30; 81.1%), and in a research autopsy (n = 28; 75.7%) to advance HIV cure research, mainly for altruistic benefits. The main perceived risks had to do with physical pain and confidentiality. Barriers and facilitators were distributed across five domains: social/professional role and identity, environmental context and resources, social influences, beliefs about consequences, and capabilities. Participants wanted more information about study objectives and procedures, possible accommodations with their last will, and rationale for studies or financial interests funding studies. Our results indicate that older PWHIV would be willing to participate in HIV cure research toward the end of life, HIV biobanking, and research autopsy. However, a dialogue should be initiated to inform participants thoroughly about HIV cure studies, address concerns, and accommodate their needs and preferences. Additional work is required, likely through increased community engagement, to address educational needs.

Community perspectives on addressing and responding to HIV-testing, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) among African, Caribbean and Black (ACB) people in Ontario, Canada.

BACKGROUND: The African, Caribbean, and Black (ACB) population of Ontario, Canada is comprised of individuals with diverse ethnic, cultural and linguistic backgrounds and experiences; some of whom have resided in Canada for many generations, and others who have migrated in recent decades. Even though the ACB population represents less than 3.5% of the Canadian population, this group accounts for 21.7% of all new HIV infections. It is well-documented that ACB populations, compared to the general population, experience multi-level barriers to accessing appropriate and responsive HIV services. In this paper, we present qualitative findings on the ACB population's experiences with HIV-testing, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) and obtain their perspectives on how to improve access. METHODS: We conducted twelve Focus Group Discussions (FGDs), within a two-day World Café event and used socio-ecological framework and community-based participatory research (CBPR) approaches to guide this work. We meaningfully engaged ACB community members in discussions to identify barriers and facilitators to HIV testing, PEP and PrEP and how these may be addressed. The FGDs were transcribed verbatim and thematic analysis guided data interpretation. Credibility of data was established through data validation strategies such as external audit and peer-debriefing. RESULTS: Our analyses revealed multi-level barriers that explain why ACB community members do not access HIV testing, PEP and PrEP. Fear, health beliefs, stigma and lack of information, were among the most frequently cited individual- and community-level barriers to care. Health system barriers included lack of provider awareness, issues related to cultural sensitivity and confidentiality, cost, and racism in the health care system. Participants identified multi-level strategies to address the HIV needs including community-based educational, health system and innovative inter-sectoral strategies. CONCLUSION: CBPR, co-led by community members, is an important strategy for identifying the multi-level individual, interpersonal, community, institutional and structural factors that increase HIV vulnerability in ACB communities, notably anti-Black systemic racism. Study findings suggest the need for targeted community-based strategies and strategies aimed at reducing health system barriers to testing and care.

Immune parameters of HIV susceptibility in the female genital tract before and after penile-vaginal sex.

Background: In women, most HIV infections are acquired through penile-vaginal sex. Inflammation in the female genital tract (FGT) increases the risk of HIV acquisition and transmission, likely through recruitment of HIV target cells and disruption of epithelial barrier integrity. Although sex may have important immune and epithelial effects, the impact of receptive penile-vaginal sex on the immune correlates of HIV susceptibility in the female genital tract is not well described. Methods: STI-free heterosexual couples were recruited to the Sex, Couples and Science (SECS) Study, with the serial collection of cervical secretions (CVS), endocervical cytobrushes, blood and semen before and up to 72 h after either condomless (n = 29) or condom-protected (n = 8) penile-vaginal sex. Immune cells were characterized by flow cytometry, and immune factors including cytokines and soluble E-cadherin (sE-cad; a marker of epithelial disruption) were quantified by multiplex immunoassay. Co-primary endpoints were defined as levels of IP-10 and IL-1α, cytokines previously associated with increased HIV susceptibility. Results: Here we show that cervicovaginal levels of vaginal IP-10, sE-cad and several other cytokines increase rapidly after sex, regardless of condom use. The proportion of endocervical HIV target cells, including Th17 cells, activated T cells, and activated or mature dendritic cells (DCs) also increase, particularly after condomless sex. Although most of these immune changes resolve within 72 h, increases in activated cervical CD4 + T cells and Tcm persist beyond this time. Conclusions: Penile-vaginal sex induces multiple genital immune changes that may enhance HIV susceptibility during the 72 h post-sex window that is critical for virus acquisition. This has important implications for the mucosal immunopathogenesis of HIV transmission.

Key recommendations for developing a national action plan to advance the sexual and reproductive health and rights of women living with HIV in Canada.

Action on the World Health Organization Consolidated guideline on sexual and reproductive health and rights of women living with HIV requires evidence-based, equity-oriented, and regionally specific strategies centred on priorities of women living with HIV. Through community-academic partnership, we identified recommendations for developing a national action plan focused on enabling environments that shape sexual and reproductive health and rights by, with, and for women living with HIV in Canada. Between 2017 and 2019, leading Canadian women's HIV community, research, and clinical organizations partnered with the World Health Organization to convene a webinar series to describe the World Health Organization Consolidated guideline, define sexual and reproductive health and rights priorities in Canada, disseminate Canadian research and best practices in sexual and reproductive health and rights, and demonstrate the importance of community-academic partnerships and meaningful engagement of women living with HIV. Four webinar topics were pursued: (1) Trauma and Violence-Aware Care/Practice; (2) Supporting Safer HIV Disclosure; (3) Reproductive Health, Rights, and Justice; and (4) Resilience, Self-efficacy, and Peer Support. Subsequent in-person (2018) and online (2018-2021) consultation with > 130 key stakeholders further clarified priorities. Consultations yielded five cross-cutting key recommendations:1. Meaningfully engage women living with HIV across research, policy, and practice aimed at advancing sexual and reproductive health and rights by, with, and for all women.2. Centre Indigenous women's priorities, voices, and perspectives.3. Use language that is actively de-stigmatizing, inclusive, and reflective of women's strengths and experiences.4. Strengthen Knowledge Translation efforts to support access to and uptake of contemporary sexual and reproductive health and rights information for all stakeholders.5. Catalyse reciprocal relationships between evidence and action such that action is guided by research evidence, and research is guided by what is needed for effective action.Topic-specific sexual and reproductive health and rights recommendations were also identified. Guided by community engagement, recommendations for a national action plan on sexual and reproductive health and rights encourage Canada to enact global leadership by creating enabling environments for the health and healthcare of women living with HIV. Implementation is being pursued through consultations with provincial and national government representatives and policy-makers.

Prevalence and correlates of sexual concerns and associated distress among women living with HIV in Canada.

OBJECTIVES: We assessed the prevalence and correlates of sexual concerns and associated distress among women living with HIV in Canada. METHODS: We analyzed cross-sectional survey data from the Canadian HIV Women's Sexual and Reproductive Health Cohort Study (2017-2018). Self-identified women living with HIV were asked about sexual concerns post-HIV diagnosis and associated distress (none, mild, moderate, severe). Five areas of concern were assessed, including difficulties related to sexual self-esteem, sexual function, relationships, and emotional and behavioral aspects of sex. Logistic regression analyses identified correlates of reporting any sexual concerns and severe distress about these concerns. RESULTS: Of 906 participants (median age 48, Q1-Q3 = 41-55), 596 (65.8%) reported sexual concerns post-HIV diagnosis. We found a high prevalence of concerns related to relationships (43.3%), sexual self-esteem (49.4%), and emotional aspects of sex (45.4%), relative to sexual functioning (38.4%) and behavioral aspects (33.7%). Of those with sexual concerns, 36.7% reported severe distress. Reports of severe distress were the highest for relationship difficulties (32.5%), relative to other areas of concern (21.4%-22.8%). In adjusted analyses, women reporting sexual dissatisfaction and high HIV-related stigma had significantly higher odds of reporting sexual concerns. Conversely, those reporting higher resilience, better mental health, African, Caribbean, and Black identity, and sex as somewhat unimportant, not at all important, or neutral to their lives had lower adjusted odds. Factors associated with severe distress about sexual concerns included older age, body dissatisfaction, sexual dissatisfaction, and high HIV-related stigma, while better mental health and getting support from someone living with HIV were protective. While 84.4% of women had discussed with a provider how viral load impacts transmission risk, only 40.6% had conversations about sexual wellbeing. CONCLUSION: More attention to women's sexual wellbeing within social and relational contexts is critical to ensure the sexual rights of women living with HIV are upheld.

Insertive condom-protected and condomless vaginal sex both have a profound impact on the penile immune correlates of HIV susceptibility.

The penis is the primary site of HIV acquisition in heterosexual men. Elevated penile inflammatory cytokines increase sexual acquisition risk, and topically applied cytokines enhance foreskin HIV susceptibility in an explant model. However, the impact of penile-vaginal sex on these immune parameters is undefined. Heterosexual couples were recruited to the Sex, Couples and Science (SECS) Study, with the collection of penile swabs, semen, cervico-vaginal secretions, and blood after a period of abstinence, and repeated sampling up to 72 hours after either condomless (n = 30) or condom-protected (n = 8) penile-vaginal sex. Soluble immune parameters were quantified by multiplex immunoassay. Co-primary immune endpoints were penile levels of IL-8 and MIG, cytokines previously linked to penile HIV acquisition. One hour after sex there were dramatic increases in penile IL-8 and MIG levels, regardless of condom use, with a gradual return to baseline by 72 hours; similar patterns were observed for other chemoattractant chemokines. Penile cytokine changes were similar in circumcised and uncircumcised men, and repeated measures ANOVA and ANCOVA models demonstrated that the degree of change after condomless sex was explained by cytokine levels in their partners' cervico-vaginal secretions. This may have important implications for the biology of penile HIV acquisition.

A cross-sectional investigation of HIV prevalence and risk factors among African, Caribbean and Black people in Ontario: The A/C Study.

Background: The human immunodeficiency virus (HIV) epidemic has disproportionately affected African, Caribbean and Black (ACB) communities in Canada. We investigated the prevalence and factors associated with HIV infection among ACB people in Ontario. Methods: A cross-sectional survey of first- and second-generation ACB people aged 15-64 years in Toronto and Ottawa (Ontario, Canada). We collected sociodemographic information, self-reported HIV status and offered dried blood spot (DBS) testing to determine the prevalence of HIV infection. Factors associated with HIV infection were investigated using regression models. Results: A total of 1,380 people were interviewed and 834 (60.4%) tested for HIV. The HIV prevalence was 7.5% overall (95% confidence interval [CI] 7.1-8.0) and 6.6% (95% CI 6.1-7.1) in the adult population (15-49 years). Higher age (adjusted odds ratio [aOR] 2.8; 95% CI 2.77-2.82), birth outside of Canada (aOR 4.7; 95% CI 1.50-14.71), French language (aOR 9.83; 95% CI 5.19-18.61), unemployment (aOR 1.85; 95% CI 1.62-2.11), part-time employment (aOR 4.64; 95% CI 4.32-4.99), substance use during sex (aOR 1.66; 95% CI 1.47-1.88) and homosexual (aOR 19.68; 95% CI 7.64-50.71) and bisexual orientation (aOR 2.82; 95% CI 1.19-6.65) were associated with a positive HIV test. Those with a high school (aOR 0.01; 95% CI 0.01-0.02), college (aOR 0.00; 95% CI 0.00-0.01) or university education (aOR 0.00; 95% CI 0.00-0.01), more adequate housing (aOR 0.85; 95% CI 0.82-0.88), a higher social capital score (aOR 0.61; 95% CI 0.49-0.74) and a history of sexually transmitted infections (aOR 0.40; 95% CI 0.18-0.91) were less likely to have a positive HIV test. Conclusion: Human immunodeficiency virus infection is linked to sociodemographic, socioeconomic, and behavioural factors among ACB people in Ontario.

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

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.

Development of the Canadian Women-Centred HIV Care Model Using the Knowledge-to-Action Framework.

In Canada, women make up 25% of the prevalent HIV cases and represent an important population of those living with HIV, as a high proportion are racialized and systemically marginalized; furthermore, many have unmet healthcare needs. Using the knowledge-to-action framework as an implementation science methodology, we developed the "Women-Centred HIV Care" (WCHC) Model to address the needs of women living with HIV. The WCHC Model is depicted in the shape of a house with trauma- and violence-aware care as the "foundation". Person-centred care with attention with attention to social determinants of health and family make up the "first" floor. Women's health (including sexual and reproductive health and rights) and mental and addiction health care are integrated with HIV care, forming the "second" floor. Peer support, leadership, and capacity building make up the "roof". To address the priorities of women living with HIV in all their diversity and across their life course, the WCHC Model should be flexible in its delivery (e.g., single provider, interdisciplinary clinic or multiple providers) and implementation settings (e.g., urban, rural).

Examining HIV-related stigma among African, Caribbean, and Black church congregants from the Black PRAISE study in Ontario, Canada.

HIV-related stigma impedes adoption and implementation of effective HIV prevention and treatment strategies. It may also exacerbate racial/ethnic HIV disparities. Given high levels of religious observance within African, Caribbean, and Black (ACB) communities and the social capital that faith-based organizations hold, these entities may be promising venues for stigma-remediation and effective partners in community-based, HIV-focused programing. However, more research is needed to understand HIV-related stigma in these institutions. This study examines HIV-related stigma among six ACB churches in Ontario, Canada. Surveys were distributed to ACB attendees (N = 316) and linear regressions determined relationships between HIV-related stigma and stigma subdomains with demographics, greater disagreement with same-sex relationships, HIV knowledge, and religiosity. Greater disagreement with same-sex relationships was the only variable associated with the HIV-related stigma scale and all of its subscales. Age, gender, HIV knowledge, religiosity, contact with persons living with HIV, and length of time in Canada were associated with varying aspects of HIV-related stigma. Findings can inform the development of HIV-related stigma interventions and the characteristics of individuals these efforts should target to achieve maximum impact.

Love, Judgement and HIV: Congregants' Perspectives on an Intervention for Black Churches to Promote Critical Awareness of HIV Affecting Black Canadians.

We assess participants' experience of Black Pastors Raising Awareness and Insight of Stigma through Engagement (Black PRAISE), an intervention for Black churches to promote critical awareness of HIV affecting Black Canadian communities. We used a community-based participatory approach to implement Black PRAISE among six churches in the Greater Toronto Area and Ottawa, in October-November 2016. For the intervention, congregants received a booklet with validated HIV-related information, attended a sermon on compassion and justice, viewed a short film on HIV-related stigma, and completed baseline and follow-up surveys to evaluate the effectiveness of the intervention. We then conducted in-depth interviews with 18 pastors and congregants from the six churches to explore how they experienced the intervention. Three major themes emerged from an iterative exploration of the thematic content of the interviews: the beneficial impact of the intervention; reconciling the moral and theological issues of their faith with the social reality of HIV and stigma; and perspectives on future stigma reduction efforts. Participants spoke approvingly about Black PRAISE and supported stigma reduction but acknowledged uncertainties about their capacity to actualise their commitment. The main overarching lessons from Black PRAISE are as follows: first, our results support a community-based participatory approach to productively engaging Black congregations in stigma reduction and health promotion; second, promising or successful interventions incorporate multiple components to promote critical awareness about the specific health issue for Black life and wellbeing; and third, interventions are more likely to succeed if they support critical reflection on the underlying conceptual issues, implicit assumptions and belief systems among the professional and lay stakeholders.

Black PRAISE: engaging Black congregations to strengthen critical awareness of HIV affecting Black Canadian communities.

In Canada, HIV disproportionately affects Black communities. Though Black faith leaders play an influential role engaging Black communities around social care and social justice, their response to HIV has been somewhat muted. Black PRAISE is a novel intervention for Black churches to strengthen congregants' critical awareness of HIV affecting Black communities. A multi-stakeholder team developed and tested the intervention in 2016 - 17 among six churches in the province of Ontario, where more than half of Black Canadians reside, using a community-based participatory approach. Specifically, the intervention aimed to strengthen how congregants understand HIV among Black communities and reduce their level of stigma toward people living with HIV. We addressed critical awareness among the participating congregations through (i) disseminating a booklet with validated information that promoted critical health literacy related to HIV; (ii) enabling pastors to deliver a sermon on love, compassion and social justice; and (iii) developing and screening a short film that featured Black Canadians discussing their experiences of HIV-related stigma. We assessed changes in knowledge and stigma by surveying congregants (N = 173) at baseline and two follow-ups using validated instruments and other measures. Through Black PRAISE, congregants significantly increased their HIV-related knowledge; moreover, exposure to all the intervention components was associated with a significantly reduced level of stigma. A likely strategic outcome of Black PRAISE is that churches are empowered to help strengthen Black people's community-based response to HIV and join efforts to eliminate the structural conditions that increase Black people's vulnerability to HIV.

Social, Clinical, and Behavioral Determinants of HIV Infection and HIV Testing among Black Men in Toronto, Ontario: A Classification and Regression Tree Analysis.

Black men bear a disproportionate burden of HIV infection. These HIV inequities are influenced by intersecting social, clinical, and behavioral factors. The purpose of this analysis was to determine the combinations of factors that were most predictive of HIV infection and HIV testing among black men in Toronto. Classification and regression tree analysis was applied to secondary data collected from black men (N = 460) in Toronto, 82% of whom only had sex with women and 18% whom had sex with men at least once. For HIV infection, 10 subgroups were identified and characterized by number of lifetime male partners, age, syphilis history, and perceived stigma. Number of lifetime male partners was the best single predictor of HIV infection. For HIV testing, the analysis identified 8 subgroups characterized by age, condom use, number of sex partners and Chlamydia history. Age (>24 years old) was the best single predictor of HIV testing.