The Being Safe, Health and Positively Empowered Pilot Randomized Controlled Trial: A Digital Multicomponent Intervention for Immigrant Women With Cumulative Exposures to Violence

Objectives: Pre- and postmigration exposures to violence are significant social determinants of immigrant women’s health, safety, and well-being, with Black immigrant women being at high risk because of many coming from conflict-zone countries. The existing literature does not report the development and testing of a multicomponent digital intervention to address safety and health issues among immigrant women with cumulative exposures to violence. This pilot randomized controlled trial evaluated preliminary efficacy of a multicomponent digital intervention (BSHAPE) to improve health and safety outcomes for immigrant women with cumulative violence exposures, posttraumatic stress disorder and/or depression symptoms, and human immune deficiency virus (HIV) risk behaviors. Method: The intervention was developed based on formative qualitative work and input from women. In the randomized controlled trial, 144 Black immigrant women, average age being 33.6 years, were randomly assigned to either the BSHAPE arm (n = 72) or a control arm (n = 72). Data were collected at four time points over 12 months. A generalized estimating equation analysis was performed to examine group differences in change in outcomes over time. Results: Compared to the control arm, participants in BSHAPE showed significant improvement in multiple outcome measures (e.g., HIV/STI risk). Conclusion: This pilot trial of BSHAPE showed promising results for immigrant women with lifetime exposures to violence, poor mental health, and HIV risk. The study also provided useful information to further improve BSHAPE for a full-scale efficacy trial. The digital BSHAPE can be especially advantageous for violence-affected immigrant women who face numerous barriers to accessing in-person care for their safety and health needs.