Covid19COVID-19NCT04870723
#SafeHandsSafeHearts: An eHealth Intervention for COVID-19 Prevention and Support
A study testing eHealth for Covid-19 prevention and support in people with Covid19, run by University of Toronto at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- eHealth for Covid-19 prevention and support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 853 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Mar 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Located outside of Greater Toronto and Hamilton Area (Canada), Mumbai/Thane (India) or Bangkok metropolitan area (Thailand)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- eHealth for Covid-19 prevention and support
- 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
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth for Covid-19 prevention and supportBehavioural
3-session online peer-counseling intervention based on motivational interviewing and psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Immediate | Experimental | 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. Receives: Behavioral: eHealth for Covid-19 prevention and support |
| Waitlist | Other | 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. Receives: Behavioral: eHealth for Covid-19 prevention and support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])
Measured: 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])
Measured: 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)
Measured: 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)
Measured: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
Secondary outcomes (1)
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)
Measured: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Mar 2021
- Primary completion15 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 853 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter A. Newman, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870723
- Sponsor's protocol ID
- 39769
- Acronym
- COVID-19
- Status last verified
- Nov 2023
- First submitted
- 23 Apr 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Prentice-Hall.
Berg RC, Ross MW, Tikkanen R. The effectiveness of MI4MSM: how useful is motivational interviewing as an HIV risk prevention program for men who have sex with men? A systematic review. AIDS Educ Prev. 2011 Dec;23(6):533-49. doi: 10.1521/aeap.2011.23.6.533.
PubMed 22201237Betsch C. How behavioural science data helps mitigate the COVID-19 crisis. Nat Hum Behav. 2020 May;4(5):438. doi: 10.1038/s41562-020-0866-1.
PubMed 32221514Canadian Institutes of Health Research (CIHR). (2020). Why sex and gender need to be considered in COVID-19 research. https://cihr-irsc.gc.ca/e/51939.html
Chakrapani V, Kaur M, Tsai AC, Newman PA, Kumar R. The impact of a syndemic theory-based intervention on HIV transmission risk behaviour among men who have sex with men in India: Pretest-posttest non-equivalent comparison group trial. Soc Sci Med. 2022 Feb;295:112817. doi: 10.1016/j.socscimed.2020.112817. Epub 2020 Jan 27.
PubMed 32033868Chiasson MA, Shaw FS, Humberstone M, Hirshfield S, Hartel D. Increased HIV disclosure three months after an online video intervention for men who have sex with men (MSM). AIDS Care. 2009 Sep;21(9):1081-9. doi: 10.1080/09540120902730013.
PubMed 20024766DiClemente CC, Corno CM, Graydon MM, Wiprovnick AE, Knoblach DJ. Motivational interviewing, enhancement, and brief interventions over the last decade: A review of reviews of efficacy and effectiveness. Psychol Addict Behav. 2017 Dec;31(8):862-887. doi: 10.1037/adb0000318.
PubMed 29199843Donker T, Griffiths KM, Cuijpers P, Christensen H. Psychoeducation for depression, anxiety and psychological distress: a meta-analysis. BMC Med. 2009 Dec 16;7:79. doi: 10.1186/1741-7015-7-79.
PubMed 20015347Eaton LA, Kalichman SC. Social and behavioral health responses to COVID-19: lessons learned from four decades of an HIV pandemic. J Behav Med. 2020 Jun;43(3):341-345. doi: 10.1007/s10865-020-00157-y. Epub 2020 Apr 25.
PubMed 32333185Frost H, Campbell P, Maxwell M, O'Carroll RE, Dombrowski SU, Williams B, Cheyne H, Coles E, Pollock A. Effectiveness of Motivational Interviewing on adult behaviour change in health and social care settings: A systematic review of reviews. PLoS One. 2018 Oct 18;13(10):e0204890. doi: 10.1371/journal.pone.0204890. eCollection 2018.
PubMed 30335780Gorgos LM, Marrazzo JM. Sexually transmitted infections among women who have sex with women. Clin Infect Dis. 2011 Dec;53 Suppl 3:S84-91. doi: 10.1093/cid/cir697.
PubMed 22080273Guse K, Levine D, Martins S, Lira A, Gaarde J, Westmorland W, Gilliam M. Interventions using new digital media to improve adolescent sexual health: a systematic review. J Adolesc Health. 2012 Dec;51(6):535-43. doi: 10.1016/j.jadohealth.2012.03.014. Epub 2012 May 5.
PubMed 23174462Hart TA, Stratton N, Coleman TA, Wilson HA, Simpson SH, Julien RE, Hoe D, Leahy B, Maxwell J, Adam BD. A Pilot Trial of a Sexual Health Counseling Intervention for HIV-Positive Gay and Bisexual Men Who Report Anal Sex without Condoms. PLoS One. 2016 Apr 7;11(4):e0152762. doi: 10.1371/journal.pone.0152762. eCollection 2016.
PubMed 27054341Hatzenbuehler ML, Phelan JC, Link BG. Stigma as a fundamental cause of population health inequalities. Am J Public Health. 2013 May;103(5):813-21. doi: 10.2105/AJPH.2012.301069. Epub 2013 Mar 14.
PubMed 23488505Herbst JH, Sherba RT, Crepaz N, Deluca JB, Zohrabyan L, Stall RD, Lyles CM; HIV/AIDS Prevention Research Synthesis Team. A meta-analytic review of HIV behavioral interventions for reducing sexual risk behavior of men who have sex with men. J Acquir Immune Defic Syndr. 2005 Jun 1;39(2):228-41.
PubMed 15905741
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04870723
- Acronym / sponsor ID
- COVID-19 / 39769
- Conditions
- Covid19
- Keywords
- COVID-19, Protective behaviors, LGBT populations, Racialized populations, Social determinants of health, Randomized controlled trial, Psychoeducation, Motivational-interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 853 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | Experimental | Behavioral: eHealth for Covid-19 prevention and supportBehavioral: 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. |
| Waitlist | Other | Behavioral: eHealth for Covid-19 prevention and supportBehavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Located outside of Greater Toronto and Hamilton Area (Canada), Mumbai/Thane (India) or Bangkok metropolitan area (Thailand)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth for Covid-19 prevention and support3-session online peer-counseling intervention based on motivational interviewing and psychoeducation | Behavioural | Immediate, Waitlist |
Primary 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 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 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)
1 secondary outcome
Change in loneliness/social isolation
Time frame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- BackgroundBandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Prentice-Hall.
- Background: PubMed 22201237Berg RC, Ross MW, Tikkanen R. The effectiveness of MI4MSM: how useful is motivational interviewing as an HIV risk prevention program for men who have sex with men? A systematic review. AIDS Educ Prev. 2011 Dec;23(6):533-49. doi: 10.1521/aeap.2011.23.6.533.
- Background: PubMed 32221514Betsch C. How behavioural science data helps mitigate the COVID-19 crisis. Nat Hum Behav. 2020 May;4(5):438. doi: 10.1038/s41562-020-0866-1.
- BackgroundCanadian Institutes of Health Research (CIHR). (2020). Why sex and gender need to be considered in COVID-19 research. https://cihr-irsc.gc.ca/e/51939.html
- Background: PubMed 32033868Chakrapani V, Kaur M, Tsai AC, Newman PA, Kumar R. The impact of a syndemic theory-based intervention on HIV transmission risk behaviour among men who have sex with men in India: Pretest-posttest non-equivalent comparison group trial. Soc Sci Med. 2022 Feb;295:112817. doi: 10.1016/j.socscimed.2020.112817. Epub 2020 Jan 27.
- Background: PubMed 20024766Chiasson MA, Shaw FS, Humberstone M, Hirshfield S, Hartel D. Increased HIV disclosure three months after an online video intervention for men who have sex with men (MSM). AIDS Care. 2009 Sep;21(9):1081-9. doi: 10.1080/09540120902730013.
- Background: PubMed 29199843DiClemente CC, Corno CM, Graydon MM, Wiprovnick AE, Knoblach DJ. Motivational interviewing, enhancement, and brief interventions over the last decade: A review of reviews of efficacy and effectiveness. Psychol Addict Behav. 2017 Dec;31(8):862-887. doi: 10.1037/adb0000318.
- Background: PubMed 20015347Donker T, Griffiths KM, Cuijpers P, Christensen H. Psychoeducation for depression, anxiety and psychological distress: a meta-analysis. BMC Med. 2009 Dec 16;7:79. doi: 10.1186/1741-7015-7-79.
- Background: PubMed 32333185Eaton LA, Kalichman SC. Social and behavioral health responses to COVID-19: lessons learned from four decades of an HIV pandemic. J Behav Med. 2020 Jun;43(3):341-345. doi: 10.1007/s10865-020-00157-y. Epub 2020 Apr 25.
- Background: PubMed 30335780Frost H, Campbell P, Maxwell M, O'Carroll RE, Dombrowski SU, Williams B, Cheyne H, Coles E, Pollock A. Effectiveness of Motivational Interviewing on adult behaviour change in health and social care settings: A systematic review of reviews. PLoS One. 2018 Oct 18;13(10):e0204890. doi: 10.1371/journal.pone.0204890. eCollection 2018.
- Background: PubMed 22080273Gorgos LM, Marrazzo JM. Sexually transmitted infections among women who have sex with women. Clin Infect Dis. 2011 Dec;53 Suppl 3:S84-91. doi: 10.1093/cid/cir697.
- Background: PubMed 23174462Guse K, Levine D, Martins S, Lira A, Gaarde J, Westmorland W, Gilliam M. Interventions using new digital media to improve adolescent sexual health: a systematic review. J Adolesc Health. 2012 Dec;51(6):535-43. doi: 10.1016/j.jadohealth.2012.03.014. Epub 2012 May 5.
- CDC, 2020. How to Protect Yourself \& OthersLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth for Covid-19 prevention and support in people with Covid19, run by University of Toronto at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, India, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in COVID-19 knowledge (time frame: Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04870723, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.