The Effectiveness, Cost-effectiveness, and Budget Impact of Interventions to Improve the Delivery of Cervical Cancer Screening in Puerto Rico.

Summary

Cervical cancer incidence is increasing dramatically (2.5% per year) in Puerto Rico (PR), with increased occurrence of regional (1.7% per year) and distant (4.7% per year) stage cancer, which reflects a real increase and indicates missed screening 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 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 Human Papillomavirus (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 micro-simulation 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.

Conditions

• Cervical Cancer Screening

Interventions

BEHAVIORAL

Arm 2: Patient Navigator

The patient navigation model used in the study is aligned with the conceptual model for cervical cancer screening proposed by the Population-based Research Optimizing Screening Through Personalized Regimens (PROSPR) consortium. The initial contact, as well as most navigation activities, will occur mostly over the phone. In our study, the roles of the patient navigator (Arms 2 and 4) will include: exploring individual barriers to screening, use of motivational interviewing to educate and encourage patients to perform screening, performing reminder calls, and coordinating of referral and clinical services if needed. Also, providing other services to identify and overcome access barriers encountered during the cancer care process, including linkage to community resources. In arm 4, the patient navigator will also facilitate the explanation of the use of the self-collection kits by study participants.

BEHAVIORAL

HPV self-collection kit

Each HPV testing kit will include an invitation letter, information sheet, one FLOQSwabs552C® and one sealable plastic bag to put the swab. Because home high risk (HR) HPV self-screening is not standard of care in the US, the kit will also include a letter advising women to receive routine Pap tests, regardless of their HR-HPV self-sampling results. Detailed instructions on how to collect the cervical sample and how to mail the kit back to the study site or bring it to the clinical visit (depending on their preference) will be included.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Puerto Rico Comprehensive Cancer Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-04

Primary Completion

2027-02-28

Completion

2028-08-31

Countries

• Puerto Rico

Study Locations