Contributions to the literature
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The PRESTIS trial is a hybrid type 2 pragmatic randomized controlled trial that will assess the effectiveness of mailed self-sample HPV testing kits to improve cervical cancer screening participation among underscreened patients in a safety net health system, while simultaneously assessing patient navigation as an implementation strategy.
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Upon completion, PRESTIS will provide much-needed insight into the utility of self-sample HPV testing as a means to screen medically underserved women otherwise do not or under-attend for standard of care clinic-based screening.
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Although with methodological trade-offs, hybrid designs can advance knowledge of the clinical effectiveness of mailed self-sample HPV testing while establishing best practices to optimize implementation in real-world settings.
Introduction
Background and rationale
Use of hybrid effectiveness intervention trials to optimize self-sample HPV testing
Methods
Overview of trial
Conceptual framework
Protocol approvals, registration, and reporting guidelines
Study setting
Integration of trial elements into health system
Stakeholder Advisory Board
Eligibility and randomization
Study arms and interventions
Study arm | Interventions/implementation strategiesa | ||
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Telephone recall | Mailed HPV self-sampling kit | Patient navigation | |
Arm 1 (enhanced usual care control) | X | ||
Arm 2 (intervention) | X | X | |
Arm 3 (intervention + implementation strategy | X | X | X |
Timepoint | Study period | |||||
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Enrollment | Post-allocation | |||||
Day 1 | + 2 days | + 3–5 days | + 6 months | + 12 months | + 18 months | |
Enrollment: | ||||||
EMR-based eligibility screen | X | |||||
Telephone-based eligibility screen | X | |||||
Allocation | X | |||||
Interventions: | ||||||
Telephone recall | X | |||||
Mailed HPV self-sampling kit | X | |||||
Patient navigation | X | |||||
Assessments: | ||||||
Socio-demographics | X | |||||
Screening participation | X | |||||
Screening test results | X | |||||
Clinical follow-up | X | |||||
Histology | X | |||||
Treatment | X |
Telephone recall (all arms)
Mailed HPV self-sampling kit (arms 2 and 3)
HPV self-sampling kits
Return of kits
Reminder call
Laboratory testing for HR-HPV using self-sampling kits
Management of test results
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HR-HPV negative. Participants with HR-HPV negative self-test results are informed that no high-risk HPV strains were detected in their sample. They are also informed that because HR-HPV self-sampling is not currently approved for primary screening, they should attend for clinic-based screening within the next 12 months.
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HR-HPV positive (HR-HPV-16, HR-HPV-18/45 negative). Participants who test positive for HR-HPV but test negative for HR-HPV-16 or HR-HPV-18/45 are informed of their results and that additional clinical evaluation is recommended. While on the telephone with the patient, patient navigators are able to directly book appointments for clinic-based evaluation by Pap/HR-HPV co-testing at Harris Health primary care clinic locations.
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HR-HPV-16, HR-HPV-18/45 positive. Women who test positive for HR-HPV-16, HR-HPV-18/45 are informed of their results and that additional clinical evaluation is recommended. Patient navigators contact one of Harris Health's colposcopy clinics to request an appointment for colposcopy.
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Clinically Inadequate Specimen: Women whose samples are deemed clinically inadequate (due to unsatisfactory sampling or kit returned after > 30 days) are informed of the results and that they should attend for clinic-based screening. While on the telephone with the patient, patient navigators are able to directly book appointments for clinic-based screening at Harris Health primary care clinic locations.
Patient navigation (arm 3 only)
Surveys and semi-structured interviews
Microcosting
Outcomes measures
Clinical effectiveness outcomes
Implementation outcomes
Assessment | Assessment method | RE-AIM domain |
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Patient flow through protocol | RCT data | Reach |
Enrollment patterns | Recruitment log | Reach |
Clinical effectiveness | RCT data, intent-to-treat analyses | Effectiveness |
Characteristics of women who complete primary screening, by screening test modality | RCT data, intent-to-treat analyses | Adoption, implementation |
Acceptability | Survey | Adoption, implementation |
Experiences | Survey, in-depth interviews | Implementation |
Fidelity/adaptations | Project notes | Implementation |
Cost-effectiveness | Micro-costing, microsimulation model | Maintenance |