Digital Approaches to Enhancing Community Engagement in Clinical Trials

"[S]trengthening community engagement using a digital approach can enhance equity and improve health outcomes."

Clinical trials encounter challenges such as mistrust in research, low levels of participation, and insufficient uptake of research findings in communities. In response, international organisations like the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organization (WHO) have underlined the importance of community engagement in clinical trials. Digital approaches are increasingly common in clinical trial recruitment, retention, analysis, and dissemination, particularly in light of COVID-19 policies that limited in-person interactions. The purpose of this narrative review is to examine the areas where digital methods have been adopted in clinical trials, and how they have helped enhance community engagement.

To identify relevant papers, a search of PubMed was conducted in June 2021. The results highlight three key areas for digital approaches to deepen community engagement in clinical trials:

1. The use of digital technology for trial processes to decentralise trials by improving representation of participants, generalisability of results, and equity of outcomes - For example:
   • Digital clinical trials have the potential to be more inclusive in terms of the communities that are engaged. A crowdsourcing contest that solicited online submissions in Eswatini saw substantial participation from participants in rural areas by combining online participation with offline promotional methods.
   • Technological implementations allow for capturing data from digital interventions that are not attached to specific clinical settings, reducing the need for participants to travel and thus fostering participation from typically underrepresented groups in clinical trial studies.
   • Digital clinical trials may reduce costs associated with recruitment and retention compared to conventional in-person trial designs and, therefore, costs for participants as well.

   Despite these benefits for community engagement, there are weaknesses associated with digital technologies when implementing trial components or processes. For instance, the persistence of a digital divide excludes certain populations, such as older people, people with disabilities, and financially disadvantaged people, from participating in such digital activities.

2. Digital crowdsourcing to develop trial components - Open calls and hackathons, for example, present opportunities to enhance diversity in representation not just among trial participants, but for community input and engagement processes in the design of clinical trials. To mitigate limited participation from marginalised subgroups as a result of individual and structural barriers, strategies for engagement need to be sensitive to availability and distribution of technology among participants. For example, past crowdsourcing activities in low- and middle-income countries (LMICs) have considered barriers to participation such as internet bandwidth issues and have leveraged asynchronous digital technologies and social media apps, such as Facebook, WhatsApp, and WeChat, to organise and promote crowdsourcing activities.
3. Digital qualitative methods to enhance representation in formative and process evaluation research for clinical trials and to lend greater ecological validity to research findings - For instance, scholars have used teleconferencing software and chat apps such as WhatsApp to conduct both asynchronous and synchronous focus group discussions (FGDs). Traditional participant observation methods have also evolved toward approaches such as cyber-ethnography, as well as participant-led methods like photovoice. Among the advantages of these methods: The anonymous nature of online spaces may increase trust in cyber-ethnography compared to other engagement methods because of the lower risk of self-disclosure and resulting safe space. However, there are several drawbacks of community engagement using digital qualitative methods - e.g., informed consent may be difficult to obtain from participants due to the often unobtrusive and covert nature of cyber-ethnographic approaches.

The paper presents an adapted socio-ecological model that underscores considerations at the individual, interpersonal, organisational, community, and policy levels for digital engagement strategies that clinical trials should consider.

It also offers several recommendations for clinical trials to enhance community engagement in these areas, including: pursuing person-centred strategies at the individual level; being sensitive to digitally mediated interactions at the interpersonal level; ensuring capacity through specialised training or allowing for flexible hybrid models of engagement at the organisational level; attending to community norms and ecologies at the community level; and ensuring availability of resources and alignment with legal and regulatory frameworks at the policy and institutional level.

The authors stress that patient and participant privacy is a key concern with digital approaches to research and community engagement. "As digital approaches to community engagement hold promise in reaching diverse participants who are typically underrepresented in clinical trial research, privacy protections need to shift in tandem with potentially heightened vulnerabilities that such communities face." Regulatory hurdles may also need to be addressed to facilitate community engagement through digital approaches. The authors present some ideas to address these barriers.

Table 2 in the paper provides examples of each digital approach and describes how they enhanced community engagement. The authors conclude that, though a digital divide remains, the research summarised by this narrative review "has demonstrated that digital approaches can enhance equity in clinical trials and be modified in ways that are sensitive to local access to digital technologies..."