HPV Self-Collection Program

There are 2 parts of this project; (i) the implementation of a self-collection program at clinics/FQHCs (which is a quality improvement project) and (ii) the study/research portion (which is implementation science).

(i) The investigators will develop protocols and educational materials for an HPV-self-collection program that is conducted in a healthcare setting and/or in patients' homes. These materials will inform individuals about HPV, cervical cancer, and other HPV-related cancers. They will also instruct individuals how to use a self-collection kit. The research team will adapt existing clinical protocol implementation documents for self-collection programs (e.g., colorectal screening, HIV screening, etc.) from available resources and our previous work and collaborations. Implementation protocol and workflows will be created to meet the needs of the individual clinics, and designed for adaptability for other clinics and scalability to other additional and larger health systems.

Self-collection Implementation. Our clinic partners will implement new protocols for cervical cancer screening and follow-up for positive screening results, as developed in earlier stages of the study and as quality improvement. A new option for screening-self-collection-will be offered to eligible patients as an in-clinic option (e.g., collection in the exam room, restroom, mobile clinic) as well as an at-home option. These options will be offered alongside (or after) a recommendation for the patient to receive a Pap test (a.k.a., Pap smear). Patients who test positive for HPV will be followed up with by the clinics to schedule an appointment where they can discuss the next steps with their healthcare provider.

This research will not test the effectiveness of the tools or assay on detecting HPV. Clinics plan for participants to use the Copan swab to self-collect a sample and this will be a dry collection; the specimen will not need to be suspended in a medium or other substance. Clinics will send specimens to an external laboratory that has already validated the assay of self-collected specimens with the Copan swab. The lab's procedures are consistent with regulations for lab developed tests (LDTs). Considering recent FDA approval for a couple of devices used for self-collection in the healthcare setting, clinics may adopt these approved devices for the current study.

Medical records review will not currently be done for research purposes, only for recruitment and/or reviewing study eligibility.

(ii) The investigators will identify and assess the current patient-level barriers and facilitators to HPV self-collection and/or regular, in-clinic HPV screening. Staff at our partner clinics will review their records to identify eligible patients. They will share a de-identified data set (with the exception of the patients' residential zip code, county, date of clinic visits, and medical record number) with our research team. The research team will use the zip codes and county information to code each patient's rurality status and other area-based measures. After coding for rurality, the research team will remove and/or destroy zip codes from our data set(s). Each participant will receive a unique identifier and our team will only store medical record numbers and clinic visit dates in a separate file with a link to the unique identifiers. This study will store this file on a server with security protocols the University deems acceptable for PHI. The file will be accessed by the minimum study personnel necessary.

Additionally, the research team will survey patients who participate in the program at 2 points to assess patient-level barriers to HPV self-collection and understand confusion, ease, and fidelity of both the self-collection process and instructions. Patients will be recruited as described in the recruitment section of this application. Participants will be consented using a questionnaire cover letter, a consenting process for which the researchers request documentation of consent be waived. The research team will collect respondents' names in order to link their data across the 2 surveys. At a future point, this study will seek approval for a medical records review during which the investigators will link some information from their medical records to these survey data.

After its implementation, this research will (1) survey healthcare team members; (2) interview healthcare team members; (3) conduct a records review of patient-level data to assess screening choices, completion, results, and follow up; and (4) conduct analysis of the workflow to evaluate the effectiveness of the self-collection protocol. The research team will evaluate the HPV self-collection program at the clinic- and organization-levels for program effectiveness, reach, barriers and facilitators to adoption, implementation, and maintenance. Finally, the research team will conduct a data synthesis to capitalize on the richness of the mixed methods approach.