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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth for Covid-19 prevention and support | Behavioral | 3-session online peer-counseling intervention based on motivational interviewing and psychoeducation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Self-identified as LGBT+
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Health in Women's Hands | Toronto | Ontario | M5B1J3 | Canada | ||
| Humsafar Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Prentice-Hall. | ||
| 22201237 | 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. | |
| 32221514 |
| Label | URL |
|---|---|
| CDC, 2020. How to Protect Yourself \& Others | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D005791 | Patient Care |
Not provided
Not provided
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| Mumbai |
| Maharashtra |
| 110065 |
| India |
| Institute of HIV Research and Innovation | Bangkok | 10500 | Thailand |
| 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. |
| 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 |
| 32033868 | 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. |
| 20024766 | 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. |
| 29199843 | 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. |
| 20015347 | 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. |
| 32333185 | 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. |
| 30335780 | 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. |
| 22080273 | 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. |
| 23174462 | 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. |
| 27054341 | 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. |
| 23488505 | 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. |
| 15905741 | 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. |
| 33539330 | 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. |
| 23397183 | 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. |
| 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 |
| 22385872 | 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. |
| Background | Miller, W.R., & Rollnick, S. (2002). Motivational interviewing: preparing people for change (2nd ed). Guilford Press. |
| 22890780 | 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. |
| Background | National Statistical Office and United Nations Children's Fund. (2016). Thailand multiple indicator cluster survey 2015-2016, final report. NSO and UNICEF, Thailand. |
| 32297875 | 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. |
| 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 |
| 33637577 | 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. |
| 21563163 | 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. |
| 33004348 | 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. |
| 38701074 | Derived | 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. |
| 34726610 | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |