Methods: We provide an overview of the development and adaptation of a hybrid type-1 Effectiveness and Implementation randomized controlled trial (RCT) that will evaluate an m-Health syndemic intervention (PrEP for WINGS) and aims to increase PrEP initiation among women in CSPs in New York City who report hazardous drinking. The proposed RCT will be conducted with 300 women in CSPs.
Results: We describe how we adapted PrEP 4 WINGS, which addresses PrEP, IPV, and alcohol use into an integrated m-health application for women in CSPs. Adaptation strategies include;PRISM/RE-AIM(S) framework with a health equity lens to guide engaging community consultants (persons with lived experience); creating a Community Advisory Board, and key stakeholders; generating real-world challenges; and situations from community consultants to develop the intervention material to address barriers and improve engagement, skills-building, and initiation of PrEP, IPV and alcohol risk content.
Conclusions: To the best of our knowledge, this will be the first RCT testing the effect of an integrated evidence-based SBIRT for IPV and hazardous drinking with a decision aid for PrEP. Eligible women will be randomly assigned to receive either (1) PrEP for WIGNGS or (2) PrEP alone. Both conditions include the same evidence-based PrEP decision-making aid single session with peer navigation and will be delivered by Fortune Society, a community-based organization that serves women in CSPs. This study provides opportunities for implementing a self-paced mHealth intervention in real-world CSP settings.