Introduction
The development of innovative, evidence-based health care digital interventions for substance use disorders (SUD) often lack the invaluable experiences of people with lived and living experience (PWLE) with SUD to inform their development. The exclusion of PWLE in informing interventions and policies, from both a prevention and treatment standpoint, highlights a significant gap (Taha et al. Reference Taha, Wood, Sondagar, Helis, Payer and Hernandez-Basurto2025).
Key themes have emerged regarding the challenges and opportunities of incorporating PWLE’s perspectives in the design and testing of digital tools, particularly for those with comorbid mental health disorders. Ensuring high levels of participation may translate to greater empowerment and autonomy for PWLE in managing their multimorbidity. Similarly, emphasizing culturally sensitive and geographically specific approaches to digital health innovation requires adherence to ethical principles that protect PWLE (Wells et al. Reference Wells, Thelwell and Giacco2024).
Addressing these gaps is fundamental to upholding ethical principles of inclusion, autonomy, respect, sensitivity, and compassion. Special attention to culturally and trauma-informed inclusionary practices plays an active role in shaping solutions that meet the needs of PWLE (Lowery Reference Lowery2024). Although there is growing momentum to involve PWLE in developing technological responses for substance use prevention and treatment in the context of multimorbidity, meaningful gaps remain in incorporating their voices into decision-making as part of this collaborative process (Taha et al. Reference Taha, Wood, Sondagar, Helis, Payer and Hernandez-Basurto2025).
Dimension and intersection of multimorbidity
People living with SUD often face multiple, complex health and social care needs. Socioeconomic marginalization- presenting as poverty, housing insecurity and structural violence- contributes to the development of SUD and acts as a barrier to accessing treatment, increasing the risk of return to use. Individuals at this intersection of SUD and socioeconomic challenges often experience both physical and mental health comorbidities, yet struggle to access the comprehensive care they require (Delcher et al. Reference Delcher, Harris, Anthony, Stoops, Thompson and Quesinberry2022).
Person-centered care lies at the core of developing effective innovations to support individuals with multiple, complex needs. This approach necessitates collaboration with patients, caregivers, and families, while manifesting partnerships among providers and community groups to identify what is most valuable to the people receiving care. This includes outlining optimal guidelines and guidance, setting meaningful goals, and developing effective tools and resources for self-management (Watson et al. Reference Watson, Estenson, Eden, Gerstein, Carney, Dotson, Milnes and Bierman2024). Person-centered care solutions must reflect the priorities of PWLE (Sanz et al. Reference Sanz, Acha and García2021). This is in alignment with the World Health Organization’s (WHO) Global Strategy on Integrated People-Centred Health Services 2016–2026, which emphasizes co-design and inclusivity (World Health Organization 2016).
Principles and practices for meaningful involvement of people with lived and living experience
Principles
The integration of PWLE into the development of digital interventions for SUD prevention and treatment represents a shift from traditional, academia-type approaches toward novelty. There is value in the engagement of PWLE that includes ethical considerations of those most affected by the tools being developed, as well as help in the improvement of usability and effectiveness when interventions are informed by experiential knowledge (Costanza-Chock Reference Costanza-Chock2020; Volkow Reference Volkow2024). Design Justice is a prominent framework emphasizing the principles that are most impacted by design outcomes and should be central to the design process itself (Costanza-Chock Reference Costanza-Chock2020). Similarly, participatory models like Arnstein’s Ladder of Participation conceptualize a continuum of engagement, ranging from “non-participation to full citizen power” (Arnstein Reference Arnstein1969).
There are many strategies used to support the meaningful involvement of PWLE, with one approach being the use of co-design workshops, generating ideas and tool prototypes in the earlier stages of development (Chang et al. Reference Chang, Shephard-Lewis and Thomas2020; Just Transition Platform Working Groups Action 7: Guidelines to Engage with People Living in Vulnerable Situations 2023). In addition to early-stage involvement, PWLE can also contribute through advisory and governance roles, offering input across various phases of development and evaluation. This form of participation is supported by international frameworks, such as the European Union’s guidelines for engaging people in vulnerable situations and recent recommendations from the National Institute on Drug Abuse (Just Transition Platform Working Groups Action 7: Guidelines to Engage with People Living in Vulnerable Situations 2023; NIDA 2022; Volkow Reference Volkow2024). Community-led monitoring and feedback systems play a central role in sustaining accountability and relevance in technology-based health innovations; for example, the International Network of People who Use Drugs (INPUD) and the International Network of Women who use Drugs (INWUD), in collaboration with the United Nations Office of Drugs and Crime HIV/AIDS Section and Koalisi Satu Hati, a community advocacy group in Indonesia developed the On the A-Gender: Community Monitoring Tool for Gender-Responsive Harm Reduction Services for Women who use Drugs as a tool for women who use drugs to assess the quality of harm reduction services, specifically with respect to gender responsiveness, cultural appropriateness, and inclusivity (Chang et al. Reference Chang, Shephard-Lewis and Thomas2020).
Practices
When these approaches are used in practice, involving PWLE may guide more relevant and user-friendly needs of the people they are meant to support. This is especially important for marginalized communities that have been overlooked or underserved in traditional healthcare systems.
PWLE often struggle with multiple other comorbidities, specifically those associated with mental health. With this in mind, the introduction of digital interventions into practice must be designed with the understanding of potential comorbidities, offering specific, integrated behavioral strategies and trauma-informed approaches. People with dual diagnosis are uniquely positioned to guide usability, engagement and integration of digital innovations, with effectiveness hinging on their participation (Sugarman et al. Reference Sugarman, Campbell, Iles and Greenfield2017).
Challenges in integrating people with lived and living experience
Despite increased recognition of the value of PWLE in digital innovation, several challenges complicate efforts to involve them meaningfully in the development and implementation stages. A key barrier is funding mechanisms that are often rigid, short-term, or incompatible with participatory approaches. Traditional funding models may prioritize commercial scalability and rapid financial returns over community engagement, making it difficult to center PWLE in the design process. Reconfiguring funding criteria to specifically value community participation and lived experience leadership would help address these gaps and support more sustainable innovation. An important addition to address these challenges is dedicated funding streams to strengthen community organizations’ willingness and ambition to partner in digital innovations. By incorporating these priorities into grant review criteria, it would transform engagement from being a potential option to a structural requirement.
Access to technology poses a significant limitation as many PWLE face barriers to stable internet access, reliable devices, and digital literacy. Closely linked to digital access is the economic barrier created by income inequality as individuals from low- and middle-income countries (LMIC) are less likely to own smartphones, computers, or wearable devices, and may not be able to afford the associated costs of data plans or digital services, which may limit their ability to engage with technological tools, participate in their development, or benefit from their use (Sapanel et al. Reference Sapanel, Cloutier, Tremblay, Bourcet, Koerber, Lariviere, Tadeo and Ho2025; Wang et al. Reference Wang, Liu and Lan2023).
Regulatory frameworks and data protection requirements also create challenges. Strict privacy laws, while essential to protect personal data, can make it difficult to involve PWLE in co-design. Frameworks such as the European Union’s General Data Protection Regulation (GDPR), Canada’s Personal Information Protection and Electronic Documents Act (PIPEDA), and the United States’ Health Insurance Portability and Accountability Act (HIPAA) impose important compliance demands (DLA PIPER 2025). Navigating these requires technical expertise and institutional capacity that many community-led initiatives may not have. Conversely, in regions where comprehensive privacy protections are absent, the lack of legal safeguards can create additional difficulties.
Examples of community-informed digital innovations
Several technology-driven solutions show how PWLE have already contributed to tool development for substance use prevention and treatment. The Brave App, a virtual overdose detection and response platform specifically developed with and for PWLE, enables connection with a remote support individual, allowing for real-time monitoring and potential emergency intervention. Its design prioritizes anonymity, safety, and ease of access – key priorities identified through direct engagement with PWLE throughout development (Brave Overdose Detection System n.d.). reSET-O, developed by Pear Therapeutics in the U.S, is an FDA-authorized prescription digital therapeutic, which is used as an adjunct to outpatient treatment for opioid use disorder, representing a growing class of digital therapeutics that must consider human-centered design principles within regulatory frameworks (Palazzo et al. Reference Palazzo, Dorsey, Mogk, Beatty, King, Stefanik-Guizlo, Key, Matson, Shea, Caldeiro, McWethy, Wong, Idu and Glass2024).
My Recovery Plan, a Canadian platform, supports individuals in building personalized recovery strategies whilst being shaped by feedback from PWLE, including peer support elements, and goal-setting functions (My Recovery Plan, n.d.). The broader Canadian policy context, supported by guidelines like PIPEDA, emphasizes equanimity and integrity (DLA PIPER 2025).
Conclusion and future directions
Policy frameworks have increasingly acknowledged the value of involving PWLE with multimorbidity; for example, in the United States, the National Institute on Drug Abuse (NIDA) has guidance encouraging more robust community engagement in addiction science. This includes efforts to involve PWLE not only as participants in research, but also as contributors to design and implementation. In the United States, NIDA’s recent communications describe a commitment to expanding the role of meaningful engagement, emphasizing diversity of perspectives, and integration of insights from affected communities in shaping digital health initiatives (NIDA 2022; Volkow Reference Volkow2024). Similarly, the European Union has provided specific strategies for engaging people living in vulnerable situations (Just Transition Platform Working Groups Action 7: Guidelines to Engage with People Living in Vulnerable Situations 2023). These guidelines emphasize cultural inclusivity, equity, and long-term partnership, and advocate for embedding community engagement across multiple levels of policy implementation.
Future directions include building on these existing frameworks to strengthen collaboration, ensure sustainable funding for participatory practices, and support organizational development within communities. Exchange of models in an international context, such as the work of INPUD in global harm reduction monitoring, may liaise culturally responsive approaches to creative therapeutics (Chang et al. Reference Chang, Shephard-Lewis and Thomas2020). While SUD treatment and prevention initiatives advance rapidly, participatory frameworks, co-design practices, and supportive policy environments ensure PWLE are shaping the direction of digital health. Community-led design, regulatory clarity, global collaboration, and investment remain paramount to innovation.
Acknowledgements
This paper would not have been possible without the encouragement and support from Professor Alexander Baldacchino from University of St. Andrews School of Medicine.
Author contributions
All authors contributed to the conception, drafting, revising, and finalizing of the manuscript.
Funding statement
This research received no specific grant from any funding agency, commercial or not-for-profit sectors.
Competing interests
The authors confirm they have no conflict of interest to declare.
Ethical standards
The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committee on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008.
