Optimizing a community-engaged multi-level group intervention to reduce substance use: an application of the multiphase optimization strategy.

Background: Rates of alcohol and illicit drug use (AIDU) are consistently similar across racial groups (Windsor and Negi, J Addict Dis 28:258-68, 2009; Keyes et al. Soc Sci Med 124:132-41, 2015). Yet AIDU has significantly higher consequences for residents in distressed communities with concentrations of African Americans (DCAA - i.e., localities with high rates of poverty and crime) who also have considerably less access to effective treatment of substance use disorders (SUD). This project is optimizing Community Wise, an innovative multi-level behavioral-health intervention created in partnership with service providers and residents of distressed communities with histories of SUD and incarceration, to reduce health inequalities related to AIDU.

Methods: Grounded in critical consciousness theory, community-based participatory research principles (CBPR), and the multiphase optimization strategy (MOST), this study employs a 2 × 2 × 2 × 2 factorial design to engineer the most efficient, effective, and scalable version of Community Wise that can be delivered for US$250 per person or less. This study is fully powered to detect change in AIDU in a sample of 528 men with a histories of SUD and incarceration, residing in Newark, NJ in the United States. A community collaborative board oversees recruitment using a variety of strategies including indigenous field worker sampling, facility-based sampling, community advertisement through fliers, and street outreach. Participants are randomly assigned to one of 16 conditions that include a combination of the following candidate intervention components: peer or licensed facilitator, group dialogue, personal goal development, and community organizing. All participants receive a core critical-thinking component. Data are collected at baseline plus five post-baseline monthly follow ups. Once the optimized Community Wise intervention is identified, it will be evaluated against an existing standard of care in a future randomized clinical trial.

Discussion: This paper describes the protocol of the first ever study using CBPR and MOST to optimize a substance use intervention targeting a marginalized population. Data from this study will culminate in an optimized Community Wise manual; enhanced methodological strategies to develop multi-component scalable interventions using MOST and CBPR; and a better understanding of the application of critical consciousness theory to the field of health inequalities related to AIDU.

Trial Registration: ClinicalTrials.gov, NCT02951455 . Registered on 1 November 2016.