R01MD018503

Being Safe, Healthy and Positively Empowered (BSHAPE): A technology-based multicomponent intervention to improve outcomes for immigrant women with cumulative exposures to violence - pre- and post-migration exposures to interpersonal violence and inadequate or lack of access to care can have a significant negative impact on immigrant women's health and contribute to health disparities among immigrant women in the US.

Immigrant women with pre- and post-migration or cumulative exposures to interpersonal violence are at high risk for co-occurring mental and physical health problems (e.g., PTSD, HIV/STI) and safety issues such as living in unsafe households or being in unsafe relationships. However, very few women seek help from formal service providers due to factors such as isolation, shame, mistrust of health professionals, or lack of knowledge.

Thus, there is a need for evidence-based digital interventions that address the care needs of immigrant women with cumulative exposures to violence and mental health symptoms and can be accessed outside formal service settings.

A trauma-informed internet and mobile-phone based intervention (Being Safe, Healthy, and Positively Empowered - BSHAPE) was designed to improve outcomes for immigrant women with cumulative exposures to violence and mental health symptoms. The findings from the BSHAPE pilot study found the BSHAPE intervention to be feasible and acceptable. Women who participated in BSHAPE showed improvement in outcomes such as reduced stress, enhanced self-efficacy, improved mental health, and safety-related empowerment.

The proposed study will use a sequential, mixed methods longitudinal design to evaluate the efficacy of BSHAPE in a large-scale trial. In the first phase, the study will further refine BSHAPE to make it more user-friendly, engaging, accessible, and adaptive to immigrant women from diverse backgrounds. For this, the study will use findings from the pilot study and the feedback obtained from women who participated in the BSHAPE pilot trial. The input will be obtained from cultural experts and immigrant women from diverse countries of origin using a qualitative approach.

In the second phase, the study will use a longitudinal randomized controlled trial design to randomize 676 women to the BSHAPE arm (N=338) or the control arm (N=338). The health and safety-related outcomes will be assessed at 3, 6, and 12 months follow-up. It is hypothesized that participation in BSHAPE will lead to improved mental health, reduced stress, enhanced self-care, and improved safety among immigrant women with cumulative exposures to violence. In addition, the study will explore potential mediators and moderators of the intervention effect on key outcomes.

The study will result in an evidence-based digital BSHAPE intervention that will be designed to provide remote support to underserved and marginalized immigrant women with unmet needs for care, particularly those residing in low resource and underserved areas in the US. The intervention also has the potential to be more accessible and acceptable to immigrant women survivors who may not access standard care services due to socio-cultural, economic, transportation, and immigration-related barriers.

The Johns Hopkins University

NOT APPLICABLE

93.307 - Minority Health and Health Disparities Research

National Institute for Minority Health and Health Disparities (NIMHD) [HHS - NIH]

Baltimore, Maryland 212052110 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Required) (PA-20-183)

Amendment Since initial award the total obligations have increased 369% from $695,155 to $3,263,495.