Clinical trial NCT04870723: #SafeHandsSafeHearts: An eHealth Intervention for COVID-19 Prevention and Support
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: 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
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 853
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in COVID-19 knowledge
timeFrame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
measure: Change in COVID-19 protective behaviors
timeFrame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
measure: Change in depressive symptoms
timeFrame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
measure: Change in anxiety symptoms
timeFrame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
Secondary outcomes:
measure: Change in loneliness/social isolation
timeFrame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's Health in Women's Hands
state: Ontario
city: Mumbai
country: India
facility: Humsafar Trust
state: Maharashtra
city: Bangkok
country: Thailand
facility: Institute of HIV Research and Innovation
Study officials:
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