The CAPP 2 Study Protocol: Strengthening the capacity of healthcare providers to reduce the impact of COVID-19 on African, Caribbean, and Black communities in Ontario. (preprint)

Introduction: The COVID-19 pandemic emerged as an unprecedented challenge for healthcare systems across the world disproportionately impacting immigrant and racialized populations. Canadian African, Caribbean, and Black (ACB) communities representing some of the most vulnerable populations in terms of their susceptibility to health risks, receipt of adequate care, and chances of recovery. The COVID-19 ACB Providers Project (CAPP 2) aims to strengthen the ability of health care providers (HCP) to address this community's COVID-19 related healthcare needs. Informed by CAPP 1.0 Project, a mixed-method study which examined COVID-19 pandemic impact on ACB communities in Ontario (Ottawa and Toronto), this second study seeks to develop and implement educational programs on five key areas (modules) to strengthen the capacity of HCPs working with ACB populations. The five modules (topics) include: 1) COVID-19 and its impacts on health, 2) social determinants of health and health inequities, 3) critical health literacy, 4) critical racial literacy, and 5) cultural competence and safety. Methods and analysis: An implementation science approach will guide the development, implementation, and evaluation of the evidence-informed interventions. Intersectionality lens, socio-ecological model (SEM) and community-based participatory research (CBPR) frameworks will inform the research process. To ensure active stakeholder engagement, there will be a Project Advisory Committee comprised of 16 ACB community members, health providers, and partner agency representatives. Five modules will be developed: two virtual simulation games in collaboration with leading simulation experts, and three non-simulation modules. Ethics and dissemination: Ethics approval was granted by the University of Ottawa Research Ethics Board on July 18th, 2023 (H - 01- 23 - 8069). The results of this study will be disseminated in community workshops, an online learning platform, at academic conferences and in peer-reviewed publications.

Effectiveness of an eHealth Intervention for Reducing Psychological Distress and Increasing COVID-19 Knowledge and Protective Behaviors among Ethnoracially Diverse Sexual and Gender Minority Adults: A Quasi-experimental Study (#SafeHandsSafeHearts) (preprint)

Purpose: Lesbian, gay, bisexual, transgender, queer, and other persons outside of heteronormative and cisgender identities (LGBTQ+) and ethnic/racial minority populations are at heightened vulnerability amid the Covid-19 pandemic. Systemic marginalization and resulting adverse social determinants of health contribute to health disparities among these populations that result in more severe consequences due to Covid-19 and the public health measures to control it. We developed and tested a tailored online intervention (#SafeHandsSafeHearts) to support ethnoracially diverse LGBTQ+ individuals in Toronto, Canada amid 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, 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 rage: 23-32]) were enrolled in #SafeHandsSafeHearts. Over half (54%, 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 people of color. The intervention led to statistically significant reductions in the prevalence of clinically significant depressive and anxiety symptoms, and increases in Covid-19 protective behaviors from baseline to postintervention. Conclusion: We demonstrated the effectiveness of a brief, peer-delivered eHealth intervention for ethnoracially diverse LGBTQ+ communities in reducing psychological distress and increasing protective behaviors amid the Covid-19 pandemic. Implementation through community-based health services with trained peer educators supports feasibility, acceptability, and the importance of engaging ethnoracially diverse LGBTQ+ communities in pandemic response preparedness. This trial is registered with ClinicalTrials.gov, number NCT04870723.

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

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.

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

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.