Case example of a jail-based cancer prevention clinical trial: Social determinants of health framework, novel experimental design, and retention strategies to facilitate long-term follow-up of clinical trial participants

Abstract

Clinical trials conducted with incarcerated populations are rare. We present a case example of one such jail-based cancer prevention clinical trial to demonstrate the importance of including a theory-driven approach to intervention framing, novel experimental designs to boost access to low-risk trials, and retention strategies for long-term follow-up of hard-to-reach populations. As such we offer a social determinant of health framework to ensure cancer prevention research is conducted through the lenses of health promotion and health equity. Deviations from the gold-standard randomized control design, transparent systematic allotment, and street-based outreach retention strategies contribute to the feasibility of conducting clinical trials in carceral settings and after people leave jail. Best practices presented can be used in design and conduct of future clinical trials with criminal legal system-involved populations.

Trends in publication and levels of social determinants of health reporting in Journal of Clinical and Translational Science from 2017 to 2023

“…Initial research has begun to establish the link between social risk factors and the results of clinical trials, suggesting that these factors may compromise trial efficacy [ 13 , 14 ]. However, the evidence for these assertions remains limited primarily due to the inconsistent capture and reporting of SDoH in research studies [ 11 , 15 – 17 ] Furthermore, scoping reviews have consistently indicated a significant gap in reporting social determinants, such as race, ethnicity, and demographic characteristics within the clinical and translational research literature [ 3 , 9 , 16 , 18 ].…”