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.