PRECIS-2 Can Assess Pragmatic Aspects of Ongoing Cervical Cancer Screening Trials to Generate Implementation Evidence

PRAJAKTA ADSUL
Assistant Professor, University of New Mexico

The growing burden of cervical cancer in low- and middle-income countries (LMIC) has led to the introduction of new screening technologies, i.e. HPV based DNA tests, prompting recent guideline changes both in screening and treatment approaches. Several clinical trials have evaluated novel screening tests; however, limited information can be extracted from these trials to inform the implementation of the screening processes in real-world settings.

ESTAMPA is a multi-centric screening and triage study recruiting 50,000 women aged 30-64 years, in 12 sites from 9 Latin American countries.[1] The goal of the study is to evaluate different triage methods for HPV positive women and the feasibility of country/setting-specific implementation process. Using the Pragmatic Explanatory Continuum Indicator (PRECIS-2) [2] we conducted a facilitated group discussion with the primary coordinating team from the International Agency for Research on Cancer (IARC) and separately with the country specific study teams. In addition, we surveyed study teams (n=107) using previously validated measures [3] to assess acceptability, appropriateness, and feasibility of conducting the screening process in their context.

Overall, the PRECIS-2 tool allowed for a formal approach to assess pragmatic aspects ESTAMPA from the perspectives of the coordinating team that discussed the study with respect to the nine domains (scores in parenthesis) (Eligibility (5); Recruitment (3); Setting (5); Organization (3); Flexibility of delivery (4); Flexibility of intervention (2); Follow-up (4); Primary outcome (4); and Primary analysis (5). We are currently engaging with the country teams to generate a discussion using PRECIS-2 about the implementation of the trials in their settings. Results from the survey conducted on staff teams show overall acceptability at 63%, appropriateness at 80%, and feasibility at 71%.

Although ESTAMPA was not designed as a pragmatic trial, we found that it lies mostly in the pragmatic end of the continuum. The trial was conducted with “future implementation in mind” and followed the IARC model of conducting studies where participating countries were considered as partners in research and the study was implemented keeping in mind existing system characteristics. Using PRECIS-2 can help facilitate discussion surrounding the implementation of interventions and processes. This research can helps contextualize research findings and provide decision making guidance for future implementation of effective HPV cervical cancer screening programs in LMICs.