CompletedNot Applicable

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

Canada, India, Thailand853 participantsStarted 2021-03-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in COVID-19 knowledge

Timeframe: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

Change in COVID-19 protective behaviors

Timeframe: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

Change in depressive symptoms

Timeframe: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

Change in anxiety symptoms

Timeframe: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

Trial details

NCT IDNCT04870723

SponsorUniversity of Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-15

View on ClinicalTrials.gov More Covid19 trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in COVID-19 knowledge

Timeframe: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

Change in COVID-19 protective behaviors

Timeframe: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

Change in depressive symptoms

Timeframe: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

Change in anxiety symptoms

Timeframe: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey