#SafeHandsSafeHearts: An eHealth Intervention for COVID-19 Prevention and Support
NCT ID: NCT04870723
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
853 participants
INTERVENTIONAL
2021-03-01
2022-05-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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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.
eHealth for Covid-19 prevention and support
3-session online peer-counseling intervention based on motivational interviewing and psychoeducation
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.
eHealth for Covid-19 prevention and support
3-session online peer-counseling intervention based on motivational interviewing and psychoeducation
Interventions
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eHealth for Covid-19 prevention and support
3-session online peer-counseling intervention based on motivational interviewing and psychoeducation
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University of Toronto
OTHER
Responsible Party
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Peter A. Newman
Professor
Locations
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Women's Health in Women's Hands
Toronto, Ontario, Canada
Humsafar Trust
Mumbai, Maharashtra, India
Institute of HIV Research and Innovation
Bangkok, , Thailand
Countries
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References
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Canadian 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
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van Daalen KR, Bajnoczki C, Chowdhury M, Dada S, Khorsand P, Socha A, Lal A, Jung L, Alqodmani L, Torres I, Ouedraogo S, Mahmud AJ, Dhatt R, Phelan A, Rajan D. Symptoms of a broken system: the gender gaps in COVID-19 decision-making. BMJ Glob Health. 2020 Oct;5(10):e003549. doi: 10.1136/bmjgh-2020-003549. No abstract available.
Newman PA, Chakrapani V, Massaquoi N, Williams CC, Tharao W, Tepjan S, Roungprakhon S, Forbes J, Sebastian S, Akkakanjanasupar P, Aden M. Effectiveness of an eHealth intervention for reducing psychological distress and increasing COVID-19 knowledge and protective behaviors among racialized sexual and gender minority adults: A quasi-experimental study (#SafeHandsSafeHearts). PLoS One. 2024 May 3;19(5):e0280710. doi: 10.1371/journal.pone.0280710. eCollection 2024.
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Other Identifiers
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39769
Identifier Type: -
Identifier Source: org_study_id