What Does It Mean to Work? the Politics of Scientific Reform in a Randomized Controlled Trial

Background: What is the goal of a clinical trial? While the answer might be neatly delineated in grants, clinicaltrials.gov, or public facing presentations, complex clinical trials host a diverse array of stakeholders oftentimes with unique political commitments. Accordingly, such stakeholders attach varied and oftentimes competing desires for the fruits of their experimental labor. This becomes especially salient when social services are routed through the criminal-legal context, which creates a hybridized form of care, surveillance, and punishment. Such hybrid forms are known to create tension, particularly when harm reduction actors, who generally reject the criminalization of drug use, are asked to collaborate with criminal-legal actors who increasingly see jails as sites for therapeutic intervention. Study leadership must manage the tension of ensuring success of the experiment while maintaining trust and credibility with actors performing and hosting the intervention. This presentation illustrates how service provision becomes not only reshaped through the clinical trial, but also how researchers negotiate diverse and competing conceptions of “success” endemic to social change.

Method: This ethnographic research project draws upon virtual and in-person participant observation and semi-structured interviews with research staff, administrators, community partners, and frontline clinicians, culminating in over 500 hours of meetings and 40 semi-structured interviews. Evidence from participant observation was collected during six primary activities over a period of 3 years: formal intervention training, internal research team meetings, implementation meetings, and clinical case consultations.

Results: Efforts to provide tailored care were frustrated by the requirements of randomized controlled trial (RCT) standardization and the perceived pressure of meeting the studies’ pre-registered outcomes. Providers felt that necessary activities (e.g., securing housing) would be vital for participant well-being, but not necessarily directly linked to accessing medications, the primary trial outcome. Providing a diverse set of services–varying by site and individual and effectively destabilizing the intervention–could trouble the RCT’s statistical model. Likewise, clinical conceptions of individual change–that it is iterative and, within harm reduction models, “any positive change to reduce harm”–was not reflected in the trajectory of change offered by the RCT (a 12-month timeline, pre-registered and defined outcomes). Additionally, in clinical trials, recruitment and engagement are important metrics of success–yet this often stood in tension for practitioners with the clinical imperative of “meeting people where they are at.” The implementation science team and providers identified structural issues (e.g., charging and criminalizing drug use, police rejection of Naloxone, limited access to legal representation) that would require advocacy outside the strict confines of the study. However, such advocacy, experimentalists feared, could erode researcher-partner site relationships (e.g., jails). Therefore, advocacy was often deferred to “capturing” contextual issues that weren’t part of the intervention per se though integral to achieving study outcomes.

Implications: This presentation illustrates the politics of scientific reform, and how diverse conceptions of social change, whether structural or individual, are negotiated. It attempts to uncover how the RCT, a prominent form of knowledge production in contemporary social work, might supplant, through appeals to scientific rigor, more radical or grassroots attempts at social change.