Tag: Clinical trial

Background: Rates of opioid use disorder (OUD) have increased among women over the past 2 decades. Medication treatment for opioid use disorder (MOUD) is effective but underused. Gender-specific treatments for women have been associated with improved substance use outcomes. However, these treatments have not specifically targeted women’s engagement in MOUD, and the impact of existing gender-specific treatments is restricted by in-person delivery. Objective: The aim of this study was to develop a digital intervention to feasibly deliver gender-specific care that addresses the individualized needs of women with OUD to increase engagement in MOUD. Methods: A mixed methods, user-centered design approach was used to inform the development of a digital intervention. In phase 1, qualitative interviews were conducted with women with lived experience of OUD (n=20) and providers who treat women with OUD (n=8). Interviews were recorded, transcribed, and coded for themes. In addition, a larger sample of treatment providers (n=55) completed an online survey to further inform the content of the digital intervention. Phase 2 consisted of designing, beta-testing (n=5), and refining the intervention. Results: The age of women with lived experience ranged from 21 to 59 (mean 38.5, SD 9.4) years; 63% (5/8) of providers interviewed were female participants. The qualitative interview data from women with lived experience and providers were grouped into 6 thematic categories: 3 treatment-related (1) barriers to treatment, (2) facilitators to successful recovery, and (3) important issues to address in treatment, and 3 technology-related (4) positives of using technology as part of treatment, (5) suggested technology features, and (6) barriers to using technology. Across the treatment-related categories, several themes touched on women-specific factors including family responsibilities, abusive partners, stigma, and motivation for treatment (eg, pregnancy). The technology-related categories provided information for designing the features of the intervention, as well as revealing barriers to technology use, which could be helpful in developing implementation strategies. Provider survey participants were primarily female participants (40/55, 73%), with a mean age of 42.5 (SD 12.5) years. Survey data provided additional information on barriers to treatment and suggested technology features. Based on these data and preliminary work, the intervention was created. Minor edits to content and visual design were made in the beta-testing phase. The final version includes a web-based component with 6 topic modules and a mobile component. Topics in the web-based component are presented through infographics, text, videos, and interactive questions. The mobile component includes daily motivational messages, skills practice activities (2/wk), weekly check-ins, and resources (always available). Conclusions: Important themes and suggested features from women with lived experience and providers were incorporated into a digital intervention for women with OUD. Data on feasibility, satisfaction, and engagement with the intervention are currently being collected in phase 3, a pilot randomized controlled trial.
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