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

Covid19 Clinical Trial

— COVID-19  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04870723
• Other study ID #: 39769
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2023
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 853
• Est. completion date: May 31, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Behavioral:
• eHealth for Covid-19 prevention and support
3-session online peer-counseling intervention based on motivational interviewing and psychoeducation

Locations

Country	Name	City	State
Canada	Women's Health in Women's Hands	Toronto	Ontario
India	Humsafar Trust	Mumbai	Maharashtra
Thailand	Institute of HIV Research and Innovation	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Countries where clinical trial is conducted

Canada,  India,  Thailand, 

References & Publications (28)

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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. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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])	Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
Primary	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])	Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
Primary	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)	Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey
Primary	Change in anxiety symptoms	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	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)	Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey

External Links

•   CDC, 2020. How to Protect Yourself & Others
•   CDC, 2020. Stop the spread of rumors