#SafeHandsSafeHearts: An eHealth Intervention for COVID-19 Prevention and Support

Study Overview
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Brief Summary
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This project seeks to test the efficacy of a brief eHealth intervention in an international randomized controlled trial (RCT) to increase COVID-19 knowledge and protective behaviors, and reduce psychological distress among LGBT people. This project involves enrolling racially diverse samples of lesbian, gay, bisexual and transgender people in three cities, randomizing 900 people (stratified among cisengender men, cisgender women, and transgender people) to either the immediate behavioral intervention or the waitlist control condition. Participants will complete a baseline survey, a follow-up survey 2 weeks post-intervention, and a final survey 2 months after the post-intervention survey. Primary outcomes are COVID-19 transmission knowledge, COVID-19 protective behaviors, and psychological distress.

Detailed Description
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Lesbian, gay, bisexual, and transgender (LGBT+) populations are at heightened vulnerability to COVID-19 due to existing health disparities amid adverse social determinants of health (SDOH), rights violations, and social-structural constraints on public health recommended (PHR) protective measures. Yet, public health responses largely do not address LGBT+ vulnerabilities nor do they include LGBT+ communities in pandemic response planning. As there is no manualized intervention for COVID-19 prevention, the investigators will adapt an efficacious eHealth intervention for preventing HIV infection and transmission, the deadliest pandemic of the last century. This study builds on evidence-based eHealth interventions using Motivational Interviewing (MI) and Psychoeducation to increase health knowledge and behaviors, and reduce psychological distress, including interventions with LGBT+ people. MI is a client-centered counseling approach that elicits and strengthens intrinsic motivation for change. Psychoeducation integrates education and counseling to promote mental health. Peer counselors will receive 5 days of online training on COVID-19, PHR behaviors, pandemic stress (anxiety, depression, social isolation), MI-based counselling, psychoeducation, and research ethics. The 3 primary study outcomes are increasing COVID-19 knowledge, PHR protective behaviors, and reducing psychological distress; these are crucial elements of public health approaches to control SARS-CoV-2 transmission. #SafeHandsSafeHearts is a 3-session peer-delivered MI-based brief counselling (45 min-1 hr) with weekly individual sessions. Participants will be recruited online with electronic flyers and social media messages developed with community-based organization (CBO) partners, and distributed through CBO social media accounts and listservs in each of the three study sites (Toronto, Bangkok, Mumbai), and a study website. Participants will be randomized to the immediate intervention group or waitlist control group at a 1:1 ratio, stratified by sex and gender (cisgender men, cisgender women, transgender people), using a computer-generated sequence. All participants will complete a baseline survey, a post-intervention follow-up survey 2 weeks after completing the intervention, and a final survey 2 months after post-intervention survey. NOTE: Due to pandemic-related delays and lockdowns, and Toronto site ethics approvals and opening 6+ months prior to Bangkok and Mumbai sites, the Toronto site was conducted as a pilot intervention, using a pre-test post-test quasi-experimental design, to inform feasibility, acceptability, and implementation of the eHealth intervention, and provide initial outcomes. Bangkok and Mumbai sites remained RCTs. All sites used the prospectively identified study procedures including enrollment criteria, eHealth intervention, and baseline, post-intervention, and 2-month follow-up assessments.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Behavioral: eHealth for Covid-19 prevention and support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Self-identified as LGBT+ Lived in the study locale (city/region) for at least 6 months Plan to remain in the study locale (city/region) for at least 3 months Exclusion Criteria: Located outside of Greater Toronto and Hamilton Area (Canada), Mumbai/Thane (India) or Bangkok metropolitan area (Thailand)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate<br>Behavioral: Motivational interviewing (MI)-based peer counseling: MI-based peer counseling will comprise of 3 weekly 1-hour sessions administered online addressing 1) Covid-19 knowledge; 2) Assessing risk for infection and understanding and practicing public health-recommended protective behaviors (masking, physical distancing, handwashing); and 3) Understanding psychosocial issues and maintaining mental wellness. | Behavioral: eHealth for Covid-19 prevention and support<br>* 3-session online peer-counseling intervention based on motivational interviewing and psychoeducation<br>|
| Other: Waitlist<br>Behavioral: Motivational interviewing (MI)-based peer counseling: After the immediate group completes the intervention, the waitlist group will receive the intervention. MI-based peer counseling will comprise of 3 weekly 1-hour sessions administered online addressing 1) Covid-19 knowledge; 2) Assessing risk for infection and understanding and practicing public health-recommended protective behaviors (masking, physical distancing, handwashing); and 3) Understanding psychosocial issues and maintaining mental wellness. | Behavioral: eHealth for Covid-19 prevention and support<br>* 3-session online peer-counseling intervention based on motivational interviewing and psychoeducation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in COVID-19 knowledge | COVID-19 transmission knowledge (index of 8 items, minimum score = 0 - maximum score = 8, higher score = greater knowledge/better outcome, based on CDC, 2020 [June 30]) | Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey | 
| Change in COVID-19 protective behaviors | Mask wearing, physical distancing, handwashing (index of 9 items, minimum score = 0 - maximum score = 18, higher score = better outcome; based on CDC, 2020 [July 31]) | Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey | 
| Change in depressive symptoms | Frequency of depressed mood and anhedonia (Patient Health Questionnaire 2 [PHQ-2], minimum score = 0, maximum score = 6; higher score = worse outcome) | Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey | 
| Change in anxiety symptoms | Frequency of anxiety symptoms (Generalized Anxiety Disorder 2 [GAD-2], minimum score = 0, maximum score = 6; higher score = worse outcome) | Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in loneliness/social isolation | Frequency of feeling lonely/socially isolated (Three-Item Loneliness Scale, minimum score = 0, maximum score = 6; higher score = worse outcome) | Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Protective behaviors, LGBT populations, Racialized populations, Social determinants of health, Randomized controlled trial, Psychoeducation, Motivational-interviewing, Low- and middle-income countries, Psychological distress