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Clinical Trials/NCT04870723
NCT04870723
Completed
Not Applicable

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

University of Toronto3 sites in 3 countries853 target enrollmentMarch 1, 2021
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
University of Toronto
Enrollment
853
Locations
3
Primary Endpoint
Change in depressive symptoms
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
May 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter A. Newman

Professor

University of Toronto

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)

Outcomes

Primary Outcomes

Change in depressive symptoms

Time Frame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

Frequency of depressed mood and anhedonia (Patient Health Questionnaire 2 \[PHQ-2\], minimum score = 0, maximum score = 6; higher score = worse outcome)

Change in COVID-19 knowledge

Time Frame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

COVID-19 transmission knowledge (index of 8 items, minimum score = 0 - maximum score = 8, higher score = greater knowledge/better outcome, based on CDC, 2020 \[June 30\])

Change in COVID-19 protective behaviors

Time Frame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

Mask wearing, physical distancing, handwashing (index of 9 items, minimum score = 0 - maximum score = 18, higher score = better outcome; based on CDC, 2020 \[July 31\])

Change in anxiety symptoms

Time Frame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

Frequency of anxiety symptoms (Generalized Anxiety Disorder 2 \[GAD-2\], minimum score = 0, maximum score = 6; higher score = worse outcome)

Secondary Outcomes

  • Change in loneliness/social isolation(Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey)

Study Sites (3)

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