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

NCT04870723 | Completed

• 1 other identifier: 39769
• Study Type: interventional
• Target: 853
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Covid19

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Change in loneliness/social isolation

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

Study Arms (2)

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.

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.

Behavioral: eHealth for Covid-19 prevention and support

Interventions

eHealth for Covid-19 prevention and support BEHAVIORAL

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

Immediate; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified as LGBT+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Located outside of Greater Toronto and Hamilton Area (Canada), Mumbai/Thane (India) or Bangkok metropolitan area (Thailand)

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (3)

Women's Health in Women's Hands

Toronto, Ontario, M5B1J3, Canada

Location

Humsafar Trust

Mumbai, Maharashtra, 110065, India

Location

Institute of HIV Research and Innovation

Bangkok, 10500, Thailand

Location

Related Publications (30)

• Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Prentice-Hall.

  BACKGROUND

• 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.

  PMID: 22201237 BACKGROUND

• Betsch 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.

  PMID: 32221514 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32033868 BACKGROUND

• Chiasson 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.

  PMID: 20024766 BACKGROUND

• DiClemente 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.

  PMID: 29199843 BACKGROUND

• Donker 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.

  PMID: 20015347 BACKGROUND

• Eaton 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.

  PMID: 32333185 BACKGROUND

• Frost 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.

  PMID: 30335780 BACKGROUND

• Gorgos 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.

  PMID: 22080273 BACKGROUND

• Guse 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.

  PMID: 23174462 BACKGROUND

• Hart 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.

  PMID: 27054341 BACKGROUND

• Hatzenbuehler 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.

  PMID: 23488505 BACKGROUND

• Herbst 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.

  PMID: 15905741 BACKGROUND

• Heslin KC, Hall JE. Sexual Orientation Disparities in Risk Factors for Adverse COVID-19-Related Outcomes, by Race/Ethnicity - Behavioral Risk Factor Surveillance System, United States, 2017-2019. MMWR Morb Mortal Wkly Rep. 2021 Feb 5;70(5):149-154. doi: 10.15585/mmwr.mm7005a1.

  PMID: 33539330 BACKGROUND

• Higa DH, Crepaz N, Marshall KJ, Kay L, Vosburgh HW, Spikes P, Lyles CM, Purcell DW. A systematic review to identify challenges of demonstrating efficacy of HIV behavioral interventions for gay, bisexual, and other men who have sex with men (MSM). AIDS Behav. 2013 May;17(4):1231-44. doi: 10.1007/s10461-013-0418-z.

  PMID: 23397183 BACKGROUND

• Lukens, E. P., & McFarlane, W. R. (2004). Psychoeducation as evidence-based practice: Considerations for practice, research, and policy. Brief Treatment and Crisis Intervention, 4(1), 205-25. https://doi.org/10.1093/brief-treatment/mhh019

  BACKGROUND

• Markland, D., Ryan, R. M., Tobin V. J., Rollnick, S. (2005). Motivational interviewing and self-determination theory. Journal of Social and Clinical Psychology, 24(6), 811-311. https://doi.org/10.1521/jscp.2005.24.6.811

  BACKGROUND

• Miller WR, Rollnick S. Meeting in the middle: motivational interviewing and self-determination theory. Int J Behav Nutr Phys Act. 2012 Mar 2;9:25. doi: 10.1186/1479-5868-9-25. No abstract available.

  PMID: 22385872 BACKGROUND

• Miller, W.R., & Rollnick, S. (2002). Motivational interviewing: preparing people for change (2nd ed). Guilford Press.

  BACKGROUND

• Naar-King S, Parsons JT, Johnson AM. Motivational interviewing targeting risk reduction for people with HIV: a systematic review. Curr HIV/AIDS Rep. 2012 Dec;9(4):335-43. doi: 10.1007/s11904-012-0132-x.

  PMID: 22890780 BACKGROUND

• National Statistical Office and United Nations Children's Fund. (2016). Thailand multiple indicator cluster survey 2015-2016, final report. NSO and UNICEF, Thailand.

  BACKGROUND

• Patel VV, Rawat S, Dange A, Lelutiu-Weinberger C, Golub SA. An Internet-Based, Peer-Delivered Messaging Intervention for HIV Testing and Condom Use Among Men Who Have Sex With Men in India (CHALO!): Pilot Randomized Comparative Trial. JMIR Public Health Surveill. 2020 Apr 16;6(2):e16494. doi: 10.2196/16494.

  PMID: 32297875 BACKGROUND

• Prokopenko, E, & Kevins, C. (2020). Vulnerabilities related to COVID-19 among LGBTQ2+ Canadians. Statistic Canada. https://www150.statcan.gc.ca/n1/pub/45-28-0001/2020001/article/00075-eng.htm

  BACKGROUND

• Razai MS, Osama T, McKechnie DGJ, Majeed A. Covid-19 vaccine hesitancy among ethnic minority groups. BMJ. 2021 Feb 26;372:n513. doi: 10.1136/bmj.n513. No abstract available.

  PMID: 33637577 BACKGROUND

• Smedslund G, Berg RC, Hammerstrom KT, Steiro A, Leiknes KA, Dahl HM, Karlsen K. Motivational interviewing for substance abuse. Cochrane Database Syst Rev. 2011 May 11;2011(5):CD008063. doi: 10.1002/14651858.CD008063.pub2.

  PMID: 21563163 BACKGROUND

• 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.

  PMID: 33004348 BACKGROUND

• 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.

  PMID: 38701074 DERIVED

• Newman PA, Chakrapani V, Williams C, Massaquoi N, Tepjan S, Roungprakhon S, Akkakanjanasupar P, Logie C, Rawat S. An eHealth Intervention for Promoting COVID-19 Knowledge and Protective Behaviors and Reducing Pandemic Distress Among Sexual and Gender Minorities: Protocol for a Randomized Controlled Trial (#SafeHandsSafeHearts). JMIR Res Protoc. 2021 Dec 10;10(12):e34381. doi: 10.2196/34381.

  PMID: 34726610 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Telemedicine; Palliative Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 3, 2021
• Study Start: March 1, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 31, 2022
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

TH (1); CA (1); IN (1)