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JMIR Res Protoc ; 10(12): e34381, 2021 Dec 10.
Article in English | MEDLINE | ID: covidwho-1496866

ABSTRACT

BACKGROUND: Existing data on COVID-19 disparities among vulnerable populations portend excess risk for lesbian, gay, bisexual, transgender (LGBT) and other persons outside of heteronormative and cisgender identities (ie, LGBT+). Owing to adverse social determinants of health, including pervasive HIV and sexual stigma, harassment, violence, barriers in access to health care, and existing health and mental health disparities, sexual and gender minorities in India and Thailand are at disproportionate risk for SARS-CoV-2 infection and severe disease. Despite global health disparities among LGBT+ populations, there is a lack of coordinated, community-engaged interventions to address the expected excess burden of COVID-19 and public health-recommended protective measures. OBJECTIVE: We will implement a randomized controlled trial (RCT) to evaluate the effectiveness of a brief, peer-delivered eHealth intervention to increase COVID-19 knowledge and public health-recommended protective behaviors, and reduce psychological distress among LGBT+ people residing in Bangkok, Thailand, and Mumbai, India. Subsequent to the RCT, we will conduct exit interviews with purposively sampled subgroups, including those with no intervention effect. METHODS: SafeHandsSafeHearts is a 2-site, parallel waitlist-controlled RCT to test the efficacy of a 3-session, peer counselor-delivered eHealth intervention based on motivational interviewing and psychoeducation. The study methods, online infrastructure, and content were pilot-tested with LGBT+ individuals in Toronto, Canada, before adaptation and rollout in the other contexts. The primary outcomes are COVID-19 knowledge (index based on US Centers for Disease Control and Prevention [CDC] items), protective behaviors (index based on World Health Organization and US CDC guidelines), depression (Patient Health Questionnaire-2), and anxiety (Generalized Anxiety Disorder-2). Secondary outcomes include loneliness, COVID-19 stress, and intended care-seeking. We will enroll 310 participants in each city aged 18 years and older. One-third of the participants will be cisgender gay, bisexual, and other men who have sex with men; one-third will be cisgender lesbian, bisexual, and other women who have sex with women; and one-third will be transfeminine, transmasculine, and gender nonbinary people. Participants will be equally stratified in the immediate intervention and waitlist control groups. Participants are mainly recruited from online social media accounts of community-based partner organizations. They can access the intervention on a computer, tablet, or mobile phone. SafeHandsSafeHearts involves 3 sessions delivered weekly over 3 successive weeks. Exit interviews will be conducted online with 3 subgroups (n=12 per group, n=36 in each city) of purposively selected participants to be informed by RCT outcomes and focal populations of concern. RESULTS: The RCT was funded in 2020. The trials started recruitment as of August 1, 2021, and all RCT data collection will likely be completed by January 31, 2022. CONCLUSIONS: The SafeHandsSafeHearts RCT will provide evidence about the effectiveness of a brief, peer-delivered eHealth intervention developed for LGBT+ populations amid the COVID-19 pandemic. If the intervention proves effective, it will provide a basis for future scale-up in India and Thailand, and other low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT04870723; https://clinicaltrials.gov/ct2/show/NCT04870723. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34381.

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