An eHealth Intervention for Promoting COVID-19 Knowledge and Protective Behaviors and Reducing Pandemic Distress Among Sexual and Gender Minorities: Protocol for a Randomized Controlled Trial (#SafeHandsSafeHearts)

Background Existing data on COVID-19 disparities among vulnerable populations portend excess risk for lesbian, gay, bisexual, transgender (LGBT) and other persons outside of heteronormative and cisgender identities (ie, LGBT+). Owing to adverse social determinants of health, including pervasive HIV and sexual stigma, harassment, violence, barriers in access to health care, and existing health and mental health disparities, sexual and gender minorities in India and Thailand are at disproportionate risk for SARS-CoV-2 infection and severe disease. Despite global health disparities among LGBT+ populations, there is a lack of coordinated, community-engaged interventions to address the expected excess burden of COVID-19 and public health–recommended protective measures. Objective We will implement a randomized controlled trial (RCT) to evaluate the effectiveness of a brief, peer-delivered eHealth intervention to increase COVID-19 knowledge and public health–recommended protective behaviors, and reduce psychological distress among LGBT+ people residing in Bangkok, Thailand, and Mumbai, India. Subsequent to the RCT, we will conduct exit interviews with purposively sampled subgroups, including those with no intervention effect. Methods SafeHandsSafeHearts is a 2-site, parallel waitlist-controlled RCT to test the efficacy of a 3-session, peer counselor–delivered eHealth intervention based on motivational interviewing and psychoeducation. The study methods, online infrastructure, and content were pilot-tested with LGBT+ individuals in Toronto, Canada, before adaptation and rollout in the other contexts. The primary outcomes are COVID-19 knowledge (index based on US Centers for Disease Control and Prevention [CDC] items), protective behaviors (index based on World Health Organization and US CDC guidelines), depression (Patient Health Questionnaire-2), and anxiety (Generalized Anxiety Disorder-2). Secondary outcomes include loneliness, COVID-19 stress, and intended care-seeking. We will enroll 310 participants in each city aged 18 years and older. One-third of the participants will be cisgender gay, bisexual, and other men who have sex with men; one-third will be cisgender lesbian, bisexual, and other women who have sex with women; and one-third will be transfeminine, transmasculine, and gender nonbinary people. Participants will be equally stratified in the immediate intervention and waitlist control groups. Participants are mainly recruited from online social media accounts of community-based partner organizations. They can access the intervention on a computer, tablet, or mobile phone. SafeHandsSafeHearts involves 3 sessions delivered weekly over 3 successive weeks. Exit interviews will be conducted online with 3 subgroups (n=12 per group, n=36 in each city) of purposively selected participants to be informed by RCT outcomes and focal populations of concern. Results The RCT was funded in 2020. The trials started recruitment as of August 1, 2021, and all RCT data collection will likely be completed by January 31, 2022. Conclusions The SafeHandsSafeHearts RCT will provide evidence about the effectiveness of a brief, peer-delivered eHealth intervention developed for LGBT+ populations amid the COVID-19 pandemic. If the intervention proves effective, it will provide a basis for future scale-up in India and Thailand, and other low- and middle-income countries. Trial Registration ClinicalTrials.gov NCT04870723; https://clinicaltrials.gov/ct2/show/NCT04870723 International Registered Report Identifier (IRRID) DERR1-10.2196/34381


Quality of project:
Application responds to a number of the objectives in the call in that it is building on a well-established international network in Canada, India and Thailand and that it focuses the on experiences, needs, and priorities regarding COVID-19 and PHR protective measures among diverse LGBT+ persons. The need to focus on LGBT+ persons as a group who may be a higher risk of COVID-19 exposure and well as how they may experience amplified inequities or consequences due to governmental and societal responses is well justified. This research has a high likelihood of generating knowledge and evidence support COVID-19 public health interventions in Canada, other HIC and LMIC. The RCT is well described, especially for such a short, proposal and appears feasible. My only concern is the brief nature of the intervention and the short period of time before cross-over for the control group may make it challenging to detect a meaningful treatment effect. Sex-and gender-based analysis+ (SGBA+) is central to this proposal and is well integrated through-out.

Quality of Applicants:
The team for this application is impressive and diverse. It is clear that they have been working together effectively and have been able mobilize an existing network in creating this application. The degree of support from governmental organization and CBO is outstanding. I have no concern regarding the ability of the team to carry out the project.

Impact of the Research:
Applicants have demonstrated that they can execute a complex project in a short period of time, and have an existing KT network that will help disseminate findings. Crucially, the research will generate globallyrelevant knowledge in improving COVID-19 response and PHR preventative measures for LGBT+ persons.

Budget:
Overall seems appropriate, but note that travel for the international meeting in Thailand may not be possible.

Quality of project:
a. Extent to which the application responds to the objectives; The application is well aligned with the first objective of this funding opportunity.
b. Extent to which the application responds to one or more of the research areas; The application is fit with the mental health issues related to with indirect consequence of COVID-19 pandemic.
c. Appropriateness of the proposed approach, study design, and populations; This is an RCT with aim of understanding needs and challenges faced by diverse LGBT+ people in LMIC and HIC amid the COVID-19 pandemic and what is the level of COVID-19 knowledge, PHR protective behaviors, and pandemic related psychological distress. Also, to know if a brief, tailored, peer-delivered eHealth intervention will increase COVID-19 knowledge and protective behaviours, and reduce psychological distress among LGBT+ people.
The study is well designed with a strong team of researchers.
The sample size calculation is correct and the statistical analysis section is appropriate. · Sex/gender considerations are well described.

Quality of Applicants:
a. Track record of team members in fields related to the proposed research; The applicants have excellent track records of research in the related fields.
If funded the team is quite capable of conducting the study.

Impact of the Research:
The research topic is well justified for the timely response to the global COVID-19 pandemic and can have a timely impact.

Clinical Trial:
This is multinational RCT and the team seems to be quite capable of networking capacity to conduct this multinational trail. The sample size is large enough to warrant generalizability of the results.

Summary
The investigators proposed to conduct an international multi-site, randomized controlled trial of a brief eHealth intervention to increase COVID-19 knowledge and protective behaviors, and reduce pandemic stress among diverse LGBT+ people.
Strengths 1) Strong investigator team, multinational project, including India, Thailand and Canada.
2) The investigator team has track record in research in LGBT+ populations.
3) Design of the study reasonable.

Weaknesses
Aggressive timeline -we are already in June, and recruitment was supposed to start in May, but it is unclear if the team has adapted their e-Health interventions for HIV for COVID19. There are differences between HIV (primarily sexually/blood and body fluid transmitted) and COVID19 (primarily transmitted by droplets and respiratory route).
Overall A strong team with a strong proposal that will help us understand whether the LGBT+ population is differentially affected by COVID19 and will help in the planning of further pandemic response in multiple countries. a. Extent to which the application responds to the objectives.
The proposed project responses to three objectives of this funding opportunity. First, the objective "to accelerate the availability of high-quality and real-time evidence to support Canada's rapid response to the global pandemic" will be addressed by providing information about the efficacy of interventions (counselling and education) specifically tailored to LGBT+ people. Second, the objective "to enable Canadian engagement and coordination in national and international large-scale trials" will be addressed by leading an international RCT aiming to mitigate impacts of the pandemic on vulnerable groups (i.e., LGBT+ people). Third, the objective "to enhance local, national and international collaborative efforts, including in low-and middle-income countries, to mitigate the rapid spread of COVID-19" will be addressed in this project by providing information on variations in LGBT+ community responses to Covid-19 pandemic and the efficacy of specific preventive interventions.
b. Extent to which the application responds to one or more of the research areas.
The proposed project is relevant to "Social Policy and Public Health Responses" theme. It is currently not known how well the public health responses and policy measures in this pandemic address LGBT+ vulnerabilities, including differential risks by sex and gender. Interventions specifically tailored to LGBT+ will likely enhance health and wellbeing of this vulnerable population.
c. Addresses clear knowledge gap/need and high feasibility.
The proposed project addresses gaps in our knowledge of impact of the pandemic and associated public health measures on vulnerable groups, including LGBT+. It is not known if targeted interventions can help to mitigate some of the effects of Covid-19 pandemic in this population. This is a large project; however, the team seems to be well connected and committed to support the project. This RCT will build on a previously funded project involving LGBT+ population.
d. Appropriateness of the proposed approach, study design, and populations.
The RCT is well designed. Phase 1 will include rapid qualitative research to adapt the eHealth interventions An international multi-site, randomized controlled trial of a brief eHealth intervention to increase COVID-19 knowledge and protective behaviors, and reduce pandemic stress among diverse LGBT+ people (originally for HIV) using a mixed-methods qual-QUANT design. Surveys from Ebola, N1H1, and SARS research will be also used. Phase 2 will include the RCT. Power calculations are provided.
Strengths: 1) Randomization to the immediate intervention group or the waitlist control group (with a crossover to receive the intervention later; July-Sept 2020 vs Oct-Nov 2020). This avoids ethical problems with respect to no-intervention control group.
3) Assessment if intervention effects on public health recommended behaviours are mediated by increases in knowledge, self-efficacy, perceived vulnerability, decreases in conspiracy theories and psychological distress. Weaknesses: this RCT is not blinded, however, this is due to the nature of the intervention that precludes blinding. Other limitations including differential attrition, contamination, and social desirability bias are addressed in the proposal.
e. Quality and appropriateness of the sex-and gender-based analysis+ (SGBA+). SGBA+ refers to the consideration and examination of sex, gender and other identity factors (e.g., age, race, ethnicity, culture, religion, geography, education, disability, income and sexual orientation) at all stages of the research process including planning and implementation of the research project and related activities -See How to integrate sex and gender into research. a. See Appendix A: "Why Sex and Gender Need to be Considered in COVID19 Research" for information specific to this funding opportunity.
Sex, gender will be considered in the proposal as the RCT focusses on LGBT+ people.

Quality of Applicants:
a. Track record of team members in fields related to the proposed research.
The team has an excellent track record of publications. The combined expertise includes prevention and intervention research with LGBT people, medicine, public health, epidemiology, social work, social science, and issues surrounding refugees and minorities.
b. Relevance and value-add of collaborations and partnerships to the research objectives.
International partnership will provide a unique international perspective on the effects of Covid-19 pandemic on LGBT+ community and possible differences in the efficacy of public health interventions. The current SSHHRC Partnership infrastructure includes Thai and Indian sites with HIV and STI trial activities.
c. Ability of the project team to carry out the proposed research, including project governance.
The team is able to carry out the project as intended. Expertise of the team, support from international sites, and the track record of publications is excellent, indicating that the project will be accomplished as planned.
d. Ability of team to quickly mobilize necessary resources, including by leveraging existing networks and /or research programs.
The team is well positioned to mobilize their current resources. International collaborations are established and team has expertise and experience to conduct this project.
e. For research involving Indigenous Peoples, extent to which the overall research team has the necessary knowledge, expertise and experience in Indigenous health research, and complementarity of expertise and synergistic potential to conduct Indigenous health research.
This research does not specifically target Indigenous Peoples.

Impact of the Research:
a. Clear justification for rapid response nature of project including the use of funding to achieve timely