Jennifer S. Smith

Implementing self-collection for primary human papillomavirus testing: Perspectives on implications for federally qualified health center patient populations

Background: Primary testing for high-risk human papillomavirus (HPV) via self-collection can increase cervical cancer screening rates. In the United States, federally qualified health center (FQHC) patients often have low incomes, lack health insurance, are medically underserved, and are screened less than the national average. Implementation of HPV self-collection can increase cervical cancer screenings among FQHCs. Objectives: To assess the potential impact of implementing HPV self-collection with FQHC patients by considering perspectives of frontline clinical and administrative staff and leadership to identify patient-focused implementation considerations. Design: This qualitative study utilized focus groups and key informant interviews, and transcripts were analyzed using a coding-based thematic analysis. Emergent themes regarding self-collection implementation perspectives were mapped onto Consolidated Framework for Implementation Research constructs to identify potential facilitators and barriers to implementation for FQHC patient populations. Methods: Participants from six FQHCs in North Carolina were identified. Forty-five clinical and administrative staff participated in focus groups. One chief executive officer, senior level administrator, chief medical officer, and clinical data manager from each FQHC ( N  = 24) were interviewed one-on-one. Coding-based thematic analysis was applied to focus group and interview transcripts to uncover emerging themes. Results: Interviewees indicated that HPV self-collection can be advantageous to patients who do not routinely visit the clinic due to socioeconomic and cultural barriers. Programs must consider these barriers and patient literacy to ensure proper self-collection utilization. For example, FQHC patients may benefit from illustrated instructions for proper self-collection procedures. Conclusion: Tailoring an HPV self-collection implementation to FQHC patient populations may be an important strategy for increasing screening.

Evidence from Europe on implementation, participation and performance of self-collection for cervical cancer screening

Cervical cancer screening programs reduce the number of cervical cancer cases and deaths, but the success of any screening program is dependent on high participant uptake and coverage and many European countries are observing declining cervical cancer screening coverage to below national targets. Self-collection of vaginal samples for human papillomavirus testing, also termed self-sampling, is one strategy which is being introduced to try to increase screening coverage by removing barriers to participation and it has attracted growing interest and support globally. Informed by peer-reviewed and gray literature, this narrative review starts with a case study from the Netherlands and outlines the self-collection landscape in Europe within the themes of program implementation and relative test performance. It highlights some of the current evidence gaps needed to inform policy decisions on the use of self-collection within screening programs.

Extended Human Papillomavirus Genotyping to Predict Progression to High-Grade Cervical Precancer: A Prospective Cohort Study in the Southeastern United States

Abstract Background: High-risk human papillomavirus (hrHPV) testing is utilized in primary cervical cancer screening, generally along with cytology, to triage abnormalities to colposcopy. Most screening-based hrHPV testing involves pooled detection of any hrHPV or of HPV16/18. Cervical neoplasia progression risks based on extended hrHPV genotyping—particularly non-16/18 hrHPV types—are not well characterized. HPV genotype-specific incidence of high-grade cervical intraepithelial neoplasia or more severe (CIN2+) following an abnormal screening result was examined. Methods: We assessed a US-based prospective, multiracial, clinical cohort of 343 colposcopy patients with normal histology (n = 226) or CIN1 (n = 117). Baseline cervical samples underwent HPV DNA genotyping, and participants were followed up to 5 years. Genotype-specific CIN2+ incidence rates (IR) were estimated with accelerated failure time models. Five-year CIN2+ risks were estimated nonparametrically for hierarchical hrHPV risk groups (HPV16; else HPV18/45; else HPV31/33/35/52/58; else HPV39/51/56/59/68). Results: At enrollment, median participant age was 30.1 years; most (63%) were hrHPV-positive. Over follow-up, 24 participants progressed to CIN2+ (7.0%). CIN2+ IR among hrHPV-positive participants was 3.4/1,000 person-months. CIN2+ IRs were highest for HPV16 (8.3), HPV33 (7.8), and HPV58 (4.9). Five-year CIN2+ risk was higher for HPV16 (0.34) compared with HPV18/45 (0.12), HPV31/33/35/52/58 (0.12), and HPV39/51/56/59/68 (0.16) (P = 0.05). Conclusions: Non-16/18 hrHPV types are associated with differential CIN2+ progression rates. HPV16, 33, and 58 exhibited the highest rates over 5 years. HPV risk groups warrant further investigation in diverse US populations. Impact: These novel data assessing extended HPV genotyping in a diverse clinical cohort can inform future directions to improve screening practices in the general population.

Cost-effectiveness of Human Papillomavirus Self-collection Intervention on Cervical Cancer Screening Uptake among Underscreened U.S. Persons with a Cervix

Abstract Background: We evaluate the cost-effectiveness of human papillomavirus (HPV) self-collection (followed by scheduling assistance for those who were HPV+ or inconclusive) compared with scheduling assistance only and usual care among underscreened persons with a cervix (PWAC). Methods: A decision tree analysis was used to estimate the incremental cost-effectiveness ratios (ICER), or the cost per additional PWAC screened, from the Medicaid/state and clinic perspectives. A hypothetical cohort represented 90,807 low-income, underscreened individuals. Costs and health outcomes were derived from the MyBodyMyTest-3 randomized trial except the usual care health outcomes were derived from literature. We performed probabilistic sensitivity analyses (PSA) to evaluate model uncertainty. Results: Screening uptake was highest in the self-collection alternative (n = 65,721), followed by the scheduling assistance alternative (n = 34,003) and usual care (n = 18,161). The self-collection alternative costs less and was more effective than the scheduling assistance alternative from the Medicaid/state perspective. Comparing the self-collection alternative with usual care, the ICERs were $284 per additional PWAC screened from the Medicaid/state perspective and $298 per additional PWAC screened from the clinic perspective. PSAs demonstrated that the self-collection alternative was cost-effective compared with usual care at a willingness-to-pay threshold of $300 per additional PWAC screened in 66% of simulations from the Medicaid/state perspective and 58% of simulations from the clinic perspective. Conclusions: Compared with usual care and scheduling assistance, mailing HPV self-collection kits to underscreened individuals appears to be cost-effective in increasing screening uptake. Impact: This is the first analysis to demonstrate the cost-effectiveness of mailed self-collection in the United States.