Addressing violence in the context of opioid use disorder care - PROJECT SUMMARY/ABSTRACT Opioid use disorder (OUD), sexual victimization (SV), and posttraumatic stress disorder (PTSD) are significant co-occurring concerns with high morbidity and mortality. SV is often associated with PTSD. SV and PTSD each increase the odds of OUD. In addition, OUD treatment outcomes are worse among those with SV and PTSD. Women with SV are at high risk for IPV and substance use, which further worsen OUD outcomes. Despite the intersection of OUD, SV, and PTSD, individuals with OUD are rarely screened for SV or PTSD, and mental health treatment engagement is low among those with SV. A program for women seeking OUD treatment with a history of SV which integrates screening for SV, brief intervention for the aftereffects of SV (PTSD, IPV, substance use), and facilitates mental health treatment engagement has the potential to enhance OUD treatment outcomes for this vulnerable group. Consistent with the goals of NOT-DA-23-007 (HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence) the objective of this R61/R33 application (RFA-DA-23-053) is to adapt the Safe and Health Experiences (SHE) program for use in OUD care settings (SHE-OUD) and evaluate its feasibility, acceptability, and preliminary efficacy. SHE is a one-session, modular computer-based screening, brief intervention, and referral to treatment program developed for use among women veterans in primary care settings which: (1) screens for lifetime SV and comorbid harms (i.e., PTSD, IPV, substance use); and 2) provides tailored brief intervention focused on increasing mental health treatment use. In the R61 Phase, we will use information from informant interviews (N = 10), focus groups (N = 30), stakeholder interviews (N = 6), and a Research Advisory Board to adapt the program and research protocol. An open trial (N = 20) with a 1-month follow-up will be used to demonstrate the feasibility, safety, acceptability, and utility of SHE-OUD and the research protocol. If the Go/No Go Criteria are met, the team will proceed to the R33 Phase. In the R33 Phase, we will conduct a randomized trial of SHE-OUD (N = 120) with 3- and 6- month follow-up, to examine whether women randomized to SHE-OUD, relative to a control, demonstrate change in the primary outcome of mental health treatment engagement, as well as the secondary outcomes of: 1) PTSD, IPV, and polysubstance use; 2) OUD treatment outcomes (e.g., opioid use, non-fatal overdose, medication adherence, treatment retention); and 3) SV outcomes (e.g., shame, self-blame, revictimization). Putative mediators (i.e., readiness to change) and moderators (i.e., SV recency) will be examined. To prepare for a Hybrid I Efficacy/Implementation trial, we will conduct exit interviews with participants (N = 30), and practitioners (N = 10) to describe implementation factors. This research expected to produce a scalable strategy to promote mental health treatment engagement among women with SV and PTSD in OUD treatment, with the goal of promoting multiple domains of wellbeing and ultimately enhancing OUD outcomes.
