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) (Preprint)

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 (i.e., LGBT+). Owing to adverse social determinants of health, including pervasive HIV and sexual stigma, harassment, violence, barriers in access to healthcare, 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 expectable excess burden of COVID-19 and public health-recommended protective measures. OBJECTIVE We will conduct 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 roll-out in the other contexts. The primary outcomes are COVID-19 knowledge (index based on U.S. CDC items), protective behaviors (index based on WHO and U.S. CDC guidelines), depression (PHQ-2) and anxiety (GAD-2). Secondary outcomes include loneliness, COVID-19 stress, and intended care-seeking. We will enroll N = 310 participants in each city, age 18 years and older, one-third cisgender gay, bisexual and other men who have sex with men, one-third cisgender lesbian, bisexual and other women who have sex with women, and one-third transfeminine, transmasculine and gender nonbinary people. Participants will be equally stratified in the immediate intervention and waitlist control group. 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 has 3 sessions delivered weekly over three 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 study protocol was registered with ClinicalTrials.gov (NCT04870723). The trials started recruitment as of August 1, 2021, and all RCT data collection will likely be completed by December 31, 2021. CONCLUSIONS The SafeHandsSafeHearts RCT will provide evidence about the effectiveness of a brief, peer-delivered e-Health 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. CLINICALTRIAL NIH U.S. National Library of Medicine, ClinicalTrials.gov: NCT04870723; https://clinicaltrials.gov/ct2/show/NCT04870723