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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

1,400

Participants

Timeline

Start Date

February 4, 2025

Primary Completion Date

February 28, 2027

Study Completion Date

August 31, 2028

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.

Trial Locations (1)

00927

University of Puerto Rico, San Juan

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of Puerto Rico Comprehensive Cancer Center

OTHER