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

November 27, 2023 updated by: Peter A. Newman, University of Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

853

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B1J3
        • Women's Health in Women's Hands
  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 110065
        • Humsafar Trust
  • Thailand
      • Bangkok, Thailand, 10500
        • Institute of HIV Research and Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate
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
3-session online peer-counseling intervention based on motivational interviewing and psychoeducation
Other: Waitlist

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
3-session online peer-counseling intervention based on motivational interviewing and psychoeducation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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])
Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
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])
Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
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)
Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
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)
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
Time Frame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

May 15, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39769

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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