PROJECT SUMMARY - PARENT GRANT STUDY
Cervical cancer incidence is increasing dramatically (2.4% per year) in Puerto Rico (PR), with increased
occurrence of regional (1.5% per year) and distant 5.0% per year) stage disease. In addition, a concurrent 2.4%
per year rise in mortality rate also occurred in PR, which reflects that the increase in incidence is real and further
indicates missed screening and/or precancer treatment opportunities. Unfortunately, 80% of cervical cancer
cases diagnosed in PR occur among low-income women covered by Medicaid or Medicare, who also have a
70% greater likelihood of being diagnosed with cervical cancer. Cervical cancer screening uptake continues to
decline in PR, particularly among low-income Medicaid enrollees, mainly seen by government clinics. Barriers
to cervical cancer screening in PR are mainly due to personal (lack of transportation, obesity-related
embarrassment) and environmental (repeated disaster events that hampered screening uptake and made a
recovery slow) factors. The absence of evidence on the effectiveness, cost-effectiveness, and budget impact of
patient navigators has limited its adoption among government clinics in this US territory. Multicomponent
interventions that can address common screening barriers and improve screening participation in clinic-based
settings or avert the need for a clinical-based visit could help improve screening uptake and follow-up care. Our
preliminary work suggests the feasibility and acceptability of HPV self-sampling in PR. We now propose a hybrid
type 1 effectiveness-implementation study using a four-arm multi-site randomized controlled trial (RCT)
conducted within government OBGYN clinics in PR. We will assess the effectiveness of patient reminders plus
patient navigation and HPV self-collection (individually and in combination) compared to patient reminders alone
in increasing cervical cancer screening, timely colposcopy, and cervical precancer treatment (Aim 1). The
secondary aim will evaluate key implementation outcomes, including patient and provider receptivity, reach, level
of implementation and fidelity, and sustainment intentions. We will then develop an open-cohort microsimulation
model to evaluate the population impact, cost-effectiveness, and budget impact of alternative strategies (Aim 2)
to inform their potential applicability at delivery organization, community, and territory levels. This study will
provide much-needed knowledge that is necessary to successfully facilitate the adoption and sustained
integration of optimal strategies that will improve cervical cancer screening participation and reduce magnifying
disparities in Puerto Rico.
