Self-Collection for HPV Testing: Potential Issues Related to Performance Measures and Quality Improvement Among Federally Qualified Health Centers.

CONTEXT: Most incident cases of cervical cancer in the United States are attributable to inadequate screening. Federally qualified health centers (FQHCs) serve a large proportion of women who are low-income, have no insurance, and are underserved-risk factors for insufficient cervical cancer screening. FQHCs must maintain quality measures to preserve their accreditation, address financial reimbursements, and provide quality care. Implementation of human papillomavirus (HPV) self-collection can improve cervical cancer screening coverage within FQHCs. OBJECTIVES: To understand perspectives from clinical personnel on current cervical cancer screening rates at FQHCs in North Carolina and the impact of implementing HPV self-collection among underscreened patients on screening rates and performance measures. DESIGN: The study used focus groups and key informant interviews. Coding-based thematic analysis was applied to both focus group and interview transcripts. Emergent themes regarding perspectives on self-collection implementation were mapped onto Consolidated Framework for Implementation Research (CFIR) constructs to identify future barriers and facilitators to implementation. SETTING: Two FQHCs in North Carolina and a cloud-based videoconferencing platform. PARTICIPANTS: Six FQHCs in North Carolina; 45 clinical and administrative staff from the 6 FQHCs; 1 chief executive officer (n = 6), 1 senior-level administrator (n = 6), 1 chief medical officer (n = 6), and 1 clinical data manager (n = 6) from each FQHC. MAIN OUTCOME MEASURE: Achievement of clinical perspectives. RESULTS: Societal-, practice-, and patient-level factors currently contribute to subpar cervical cancer screening rates. HPV self-collection was expected to improve screening uptake among underscreened women at FQHCs, and thus quality and performance measures, by offering an alternative screening approach for in-clinic or at-home use. Implementation barriers include financial uncertainties and HPV self-collection not yet a Food and Drug Administration-approved test. CONCLUSION: HPV self-collection has potential to improve cervical cancer screening quality and performance measures of FQHCs. For a successful implementation, multilevel factors that are currently affecting low screening uptake need to be addressed. Furthermore, the financial implications of implementation and approval of HPV self-collection as a test for cervical cancer screening quality measures need to be resolved.

Combined oral contraceptive utilization and uterine fibroid incidence: A prospective study in a cohort of African-American women.

Published associations between combined oral contraceptive use and uterine fibroid development have lacked prospective imaging with ultrasound to distinguish between incident and prevalent fibroids. The Study of Environment, Lifestyle, and Fibroids prospectively followed fibroid-free, African-American women (the group with the highest disease burden in the U.S.) to identify incident cases. We examined associations between combined oral contraceptive use and the 40-month cumulative risk of fibroids. History of hormonal contraceptive use was collected via telephone interview at enrollment. Fibroid identification was performed using transvaginal ultrasonography at enrollment, and at 20 and 40-months of follow-up. Inverse probability weights for exposures and censoring were used to construct weighted risk ratios (wRR) and weighted risk different (wRD) estimators which control for differences in fibroid risk factors between exposure groups. In addition, unweighted fully adjusted log-binomial regression models (aRR) were run for comparison. Of the 1,308 participants in the analysis sample, 70% had used combined oral contraceptives and 17% developed fibroids by 40 months. We observed an inverse association between ever use of combined oral contraceptives and cumulative fibroid incidence (wRR: 0.78; 95% Confidence Interval (CI): 0.60, 1.00; wRD: -0.05, 95% CI: -0.11, 0; aRR: 0.76, 95% CI: 0.60, 0.98). Fibroid incidence was greater in participants who started using combined oral contraceptives after age 17 years than among younger initiators, though the restriction to ever-users made this estimate less precise (wRR: 1.25; 95% CI: 0.89, 1.76; wRD: 0.04, 95% CI: -0.02, 0.10). No consistent patterns of fibroid incidence were seen among ever-users for duration of, or years since, last combined oral contraceptives use.

Engagement and factors associated with annual anal human papillomavirus screening among sexual and gender minority individuals.

Objectives: Annual screening with a provider has been recommended for groups at highest risk for anal cancer. Anal self-sampling could help address screening barriers, yet no studies have examined annual engagement with this method. Methods: The Prevent Anal Cancer Self-Swab Study recruited sexual and gender minority individuals 25 years and over who have sex with men in Milwaukee, Wisconsin to participate in an anal cancer screening study. Participants were randomized to a home or clinic arm. Home-based participants were mailed an anal human papillomavirus self-sampling kit at baseline and 12 months, while clinic-based participants were asked to schedule and attend one of five participating clinics at baseline and 12 months. Using Poisson regression, we conducted an intention-to-treat analysis of 240 randomized participants who were invited to screen at both timepoints. Results: 58.8% of participants completed annual (median=370 days) anal screening. When stratified by HIV status, persons living with HIV had a higher proportion of home (71.1%) versus clinic (22.2%) annual screening ( p <0.001). Non-Hispanic Black participants had a higher proportion of home-based annual anal screening engagement (73.1%) compared to annual clinic screening engagement (31.6%) ( p =0.01). Overall, annual screening engagement was significantly higher among participants who had heard of anal cancer from an LGBTQ organization, reported "some" prior anal cancer knowledge, preferred an insertive anal sex position, and reported a prior cancer diagnosis. Annual screening engagement was significantly lower for participants reporting a medical condition. Conclusions: Annual screening engagement among those at disproportionate anal cancer risk was higher in the home arm.

Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi.

BACKGROUND: The World Health Organization recommends human papillomavirus (HPV) testing for primary cervical cancer screening, including among women living with HIV (WLWH). Low-and-middle-income countries account for 85% of the cervical cancer burden globally, yet have limited access to HPV-based screening, largely due to cost. This study aims to compare the performance of a rapid, isothermal amplification HPV assay (ScreenFire) to that of the Xpert HPV assay for the detection of HPV and cervical precancer among WLWH in Malawi. METHODS: We utilized stored self- and provider-collected specimens from a prospective cohort study of WLWH in Malawi from July 2020 to February 2022. Specimens were tested with both Xpert and ScreenFire HPV assays. The overall and within-channel non-hierarchical agreement between ScreenFire and Xpert was determined for both self- and provider-collected specimens. Hierarchical ScreenFire HPV positivity by channel was compared to Xpert for each histological diagnosis-cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared to

Barriers to Cervical Cancer Screening by Sexual Orientation Among Low-Income Women in North Carolina.

We sought to examine cervical cancer screening barriers by sexual orientation among low-income women in North Carolina. The MyBodyMyTest-3 Trial recruited low-income women (< 250% of federal poverty level) aged 25-64 years who were 1+ year overdue for cervical cancer screening. We compared perceptions of cervical cancer screening among those who self-identified as lesbian, gay, bisexual, or queer (LGBQ; n = 70) to straight/heterosexual women (n = 683). For both LGBQ and straight respondents, the greatest barriers to screening were lack of health insurance (63% and 66%) and cost (49% and 50%). LGBQ respondents were more likely than straight respondents to report forgetting to screen (16% vs. 8%, p = .05), transportation barriers (10% vs. 2%, p = .001), and competing mental or physical health problems (39% vs. 27%, p = .10). Addressing access remains important for improving cervical cancer screening among those under-screened. For LGBQ women, additional attention may be needed for reminders, co-occurring health needs, and transportation barriers.

Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi.

Background: The World Health Organization (WHO) recommends human papillomavirus (HPV) testing for primary cervical cancer screening, including among women living with HIV (WLWH). Low-and-middle-income countries (LMICs) account for 85% of the cervical cancer burden globally, yet have limited access to HPV-based screening, largely due to cost. This study aims to compare the performance of a rapid, isothermal amplification HPV assay (ScreenFire) to that of the Xpert HPV assay for the detection of HPV and cervical precancer among WLWH in Malawi. Methods: We utilized stored self- and provider-collected specimens from a prospective cohort study of WLWH in Malawi from July 2020 to February 2022. Specimens were tested with both Xpert and ScreenFire HPV assays. The overall and within-channel non-hierarchical agreement between ScreenFire and Xpert was determined for both self- and provider-collected specimens. Hierarchical ScreenFire HPV positivity by channel was compared to Xpert for each histological diagnosis - cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared to

The influence of home versus clinic anal human papillomavirus sampling on high-resolution anoscopy uptake in the Prevent Anal Cancer Self-Swab Study.

Background Anal cancer disproportionately affects sexual and gender minority individuals living with HIV. High-resolution anoscopy (HRA) is an in-clinic procedure to detect precancerous anal lesions and cancer, yet prospective data on factors associated with HRA attendance are lacking. We examined whether anal HPV sampling at home versus in a clinic impacts HRA uptake and assessed HRA acceptability. Methods Sexual and gender minority individuals were randomised to home-based self-sampling or clinical sampling. All were asked to attend in-clinic HRA 1year later. We regressed HRA attendance on study arm using multivariable Poisson regression and assessed HRA acceptability using χ 2 tests. Results A total of 62.8% of 196 participants who engaged in screening attended HRA. Although not significant (P =0.13), a higher proportion of participants who engaged in clinic-based screening attended HRA (68.5%) compared to home-based participants (57.9%). Overall, HRA uptake was higher among participants with anal cytology history (aRR 1.40, 95% CI 1.07-1.82), and lower among participants preferring a versatile anal sex position versus insertive (aRR 0.70, 95% CI 0.53-0.91), but did not differ by race or HIV serostatus. In the clinic arm, persons living with HIV had lower HRA attendance (42.9%) versus HIV-negative participants (73.3%) (P =0.02) and Black non-Hispanic participants had lower HRA attendance (41.7%) than White non-Hispanic participants (73.1%), (P =0.04). No differences in attendance by race or HIV status were observed in the home arm. Conclusions HRA uptake differed significantly by race and HIV status in the clinic arm but not the home arm.

Experiences of women participating in a human papillomavirus-based screen-triage-and treat strategy for cervical cancer prevention in Malawi.

Objective: To explore the experiences of Malawian women who underwent a human papillomavirus (HPV)-based screen-triage-treat algorithm for cervical cancer (CxCa) prevention. This algorithm included GeneXpert® HPV testing of self-collected vaginal samples, visual inspection with acetic acid (VIA) and colposcopy for HPV-positive women, and thermal ablation of ablation-eligible women. Method: In-depth interviews were conducted with participants of a trial that evaluated the feasibility of a HPV-based screen-triage-treat algorithm among women living with HIV and HIV negative women in Lilongwe, Malawi. Participants were recruited from 3 groups: 1) HPV-negative; 2) HPV-positive/VIA-negative; 3) HPV-positive/VIA-positive and received thermal ablation. Interviews explored baseline knowledge of CxCa and screening, attitudes towards self-collection, and understanding of test results. Content analysis was conducted using NVIVO v12. Results: Thematic saturation was reached at 25 interviews. Advantages of HPV self-collection to participants were convenience of sampling, same-day HPV results and availability of same-day treatment. There was confusion surrounding HPV-positive/VIA-negative results, as some participants still felt treatment was needed. Counseling, and in particular anticipatory guidance, was key in helping participants understand complex screening procedures and results. Overall, participants expressed confidence in the HPV screen-triage-treat strategy. Discussion: HPV testing through self-collected samples is a promising tool to increase CxCa screening coverage. A multi-step screening algorithm utilizing HPV self-testing, VIA triage and thermal ablation treatment requires proper counseling and anticipatory guidance to improve patient understanding. Incorporating thorough counseling in CxCa screening programs can change women's perspectives about screening, build trust in healthcare systems, and influence healthcare seeking behavior towards routine screening and prevention.

Between now and later: a mixed methods study of HPV vaccination delay among Chinese caregivers in urban Chengdu, China.

BACKGROUND: Adolescent girls in China have a low HPV vaccination rate. Although vaccination is recommended by the Chinese health authorities, the cost is not covered by the national immunisation programme. Vaccination delay, among other reasons such as supply shortage and poor affordability, may contribute to low uptake. This sequential mixed methods study aimed to identify potential factors of delayed HPV vaccination among Chinese adolescent girls. METHODS: Quantitative data about the attitudes and perceptions of HPV vaccination were collected from 100 caregivers of 14-18-year-old girls using an online survey in Chengdu, China. The survey data informed a subsequent qualitative study using four focus group discussions. We conducted a descriptive analysis of the survey data and a thematic analysis of the qualitative data. The findings were interpreted using a health behaviour model adapted from the Health Belief Model and the Andersen's Behavioural Model for Health Services Use. RESULTS: A total of 100 caregivers - 85 were mothers and 15 were fathers - participated in the survey; 21 caregivers joined focus group discussions. When asked about their intended course of action if the 9vHPV vaccine was out-of-stock, 74% chose to delay until the 9vHPV vaccine is available while 26% would consider 2vHPV or 4vHPV vaccines or seek alternative ways to procure the vaccine. Qualitative results confirmed that caregivers preferred delaying HPV vaccination for adolescent girls. The intent to delay was influenced by systemic barriers such as supply shortage and individual-level factors such as a preference for the 9vHPV vaccine, safety concerns, inadequate health communication, and the belief that adolescents were unlikely to be sexually active. CONCLUSION: In urban areas, Chinese caregivers' intent to delay vaccination in favour of 9vHPV vaccine over receiving the more accessible options was influenced by a mix of individual and contextual factors. Focussed health communication strategies are needed to accelerate HPV vaccination among adolescents.

The impact of body mass index and physical disability on home-based anal self-sampling.

PURPOSE: Self-sampling is increasingly being used in screening programs, yet no studies to date have examined the impact of bodily characteristics on self-sampling experiences. Our objective was to assess whether body mass index (BMI) and physical disability were associated with anal self-sampling difficulty. METHODS: We recruited sexual minority men (SMM) and trans persons in Milwaukee, Wisconsin to participate in an anal cancer screening study. Between January 2020 and August 2022, 240 participants were randomized to a home (n = 120) or clinic (n = 120) screening arm. Home participants received a mailed at-home anal self-sampling kit and were asked to attend a baseline clinic visit where biometric measurements were collected. Participants were asked to complete a survey about their experience with the kit. This research utilized data from participants who used the at-home kit and completed a baseline clinic visit and post-swab survey (n = 82). We assessed the impact of BMI and physical disability on reported body or swab positioning difficulty. RESULTS: Most participants reported no or little difficulty with body positioning (90.3%) or swab positioning (82.9%). Higher BMI was significantly associated with greater reported difficulty with body positioning (aOR = 1.10, 95% CI 1.003-1.20, p = 0.04) and swab positioning (aOR = 1.11, 95% CI 1.02-1.20, p = 0.01). Although not significant, participants who said body positioning was difficult had 2.79 higher odds of having a physical disability. Specimen adequacy did not differ by BMI category (p = 0.76) or physical disability (p = 0.88). CONCLUSION: Anal self-sampling may be a viable option to reach obese persons who may be more likely to avoid screening due to weight-related barriers.

Acceptability of Anal Human Papillomavirus Home Self-Sampling and Clinician Sampling Among Sexual and Gender Minority Individuals in Milwaukee, Wisconsin: The Prevent Anal Cancer Self-Swab Study.

Purpose: Anal cancer has disproportionately high incidence among sexual minority men. We compared acceptability of home versus clinic human papillomavirus (HPV) anal swabbing. Methods: The Prevent Anal Cancer Self-Swab Study recruited sexual and gender minority individuals in Milwaukee, Wisconsin. Eligible participants were randomized to a home or clinic arm. Home participants received a mailed anal HPV self-sampling kit. Clinic participants attended a clinic appointment where a clinician collected an anal HPV swab. We examined acceptability (overall thoughts, comfort with method, pain, and future willingness to swab) of home versus clinic swabbing using postswab survey responses. Results: A total of 191 individuals completed swabbing and a postswab survey (home = 53.4%, clinic = 46.6%). Mean age was 47 years (range = 25-78). Reported overall thoughts about home (71.6%) and clinic (69.7%) swabbing were mostly positive (p = 0.83). Overall thoughts about the home kit did not differ by participant characteristics, but overall thoughts about clinician swabbing differed by race (p = 0.04) and HIV status (p = 0.002). Nearly all participants (98.4%) reported they were comfortable receiving the kit or getting the swabbing in the clinic, reported little or no pain (98.4%), and reported willingness to undergo swabbing in the future (97.9%). After swabbing, clinic participants reported greater trust that swabbing can give accurate information about anal cancer risk (89.9%) than home participants (69.6%) (p < 0.001), and that swabbing will help them avoid anal cancer (clinic = 79.8%, home = 59.8%) (p = 0.01). Conclusion: Anal swabbing acceptability was high and did not differ between home and clinic. Participants reported high confidence and knowledge using the mailed anal self-sampling kit. Clinical Trial Registration number is NCT03489707.

Concordance of Human Papillomavirus Genotypes in Mailed Home-Based Self-Collected Versus Clinician-Collected Anal Swabs Among Sexual and Gender Minority Individuals.

BACKGROUND: Home-based self-sampling may be a viable option for anal cancer screening among sexual minority men (SMM). Yet limited research has compared home-based self-collected with clinician-collected anal swabs for human papillomavirus (HPV) genotyping. METHODS: The Prevent Anal Cancer Self-Swab Study recruited SMM and transgender persons 25 years and over in Milwaukee, WI to participate in an anal cancer screening study. Participants were randomized to a home or clinic arm. Home-based participants were mailed an anal self-sampling kit to complete and return via postal mail. They were also asked to attend a clinic appointment where a clinician collected an anal swab. Swabs were HPV-genotyped using the SPF 10 -LiPA 25 assay. We analyzed 79 paired self and clinician swabs to determine HPV prevalence, percent agreement, and sensitivity and specificity of the mailed home-based anal self-swab to detect HPV genotypes using the clinician-collected swab as the reference. RESULTS: The median number of days between the home and clinic swab was 19 days (range = 2 to 70). Human papillomavirus was detected in 73.3% of self and 75.0% of clinician anal swabs ( P = 0.99). Prevalence of any HPV, any high-risk HPV, any low-risk HPV, and individual HPV types did not significantly differ between self and clinician anal swabs. Agreement between self and clinician swabs was over 90% for 21 of the 25 HPV genotypes. Mailed home-based self-collected swabs had a sensitivity of 94.1% (95% confidence interval, 82.9-99.0) for detection of high-risk HPV versus clinician-collected sampling. CONCLUSIONS: Mailed home-based self-collected and clinician-collected anal swabs demonstrated high concordance for HPV genotyping.

Epigenome-wide methylation and progression to high-grade cervical intraepithelial neoplasia (CIN2+): a prospective cohort study in the United States.

BACKGROUND: Methylation levels may be associated with and serve as markers to predict risk of progression of precancerous cervical lesions. We conducted an epigenome-wide association study (EWAS) of CpG methylation and progression to high-grade cervical intraepithelial neoplasia (CIN2 +) following an abnormal screening test. METHODS: A prospective US cohort of 289 colposcopy patients with normal or CIN1 enrollment histology was assessed. Baseline cervical sample DNA was analyzed using Illumina HumanMethylation 450K (n = 76) or EPIC 850K (n = 213) arrays. Participants returned at provider-recommended intervals and were followed up to 5 years via medical records. We assessed continuous CpG M values for 9 cervical cancer-associated genes and time-to-progression to CIN2+. We estimated CpG-specific time-to-event ratios (TTER) and hazard ratios using adjusted, interval-censored Weibull accelerated failure time models. We also conducted an exploratory EWAS to identify novel CpGs with false discovery rate (FDR) < 0.05. RESULTS: At enrollment, median age was 29.2 years; 64.0% were high-risk HPV-positive, and 54.3% were non-white. During follow-up (median 24.4 months), 15 participants progressed to CIN2+. Greater methylation levels were associated with a shorter time-to-CIN2+ for CADM1 cg03505501 (TTER = 0.28; 95%CI 0.12, 0.63; FDR = 0.03) and RARB Cluster 1 (TTER = 0.46; 95% CI 0.29, 0.71; FDR = 0.01). There was evidence of similar trends for DAPK1 cg14286732, PAX1 cg07213060, and PAX1 Cluster 1. The EWAS detected 336 novel progression-associated CpGs, including those located in CpG islands associated with genes FGF22, TOX, COL18A1, GPM6A, XAB2, TIMP2, GSPT1, NR4A2, and APBB1IP. CONCLUSIONS: Using prospective time-to-event data, we detected associations between CADM1-, DAPK1-, PAX1-, and RARB-related CpGs and cervical disease progression, and we identified novel progression-associated CpGs. IMPACT: Methylation levels at novel CpG sites may help identify individuals with ≤CIN1 histology at higher risk of progression to CIN2+ and inform risk-based cervical cancer screening guidelines.

Self-Collection for Primary HPV Testing: Perspectives on Implementation From Federally Qualified Health Centers.

INTRODUCTION: Primary testing for high-risk human papillomavirus (HPV) by self-collection could result in higher rates of cervical cancer screening. Federally qualified health centers (FQHCs) in the US serve a large proportion of women who have low income and no health insurance and are medically underserved - risk factors for being insufficiently screened for cervical cancer. Although the implementation of self-collection for HPV testing is not yet widespread, health care entities need to prepare for its eventual approval by the US Food and Drug Administration. We conducted focus groups and interviews among clinical and administrative staff and leadership to gather data on key logistical concerns that must be addressed before implementing self-collection for HPV testing in FQHCs. METHODS: We identified focus group and interview participants from 6 FQHCs in North Carolina. We conducted focus groups with clinical and administrative staff (N = 45) and semistructured interviews with chief executive officers, senior-level administrators, chief medical officers, and clinical data managers (N = 24). Transcripts were coded by using codebooks derived from research questions and notes taken during data collection. Themes emerged on implementation of self-collection for HPV testing. We applied the constructs from the Consolidated Framework for Implementation Research (CFIR) to themes to identify domains of potential barriers and facilitators to implementation. RESULTS: Clinical personnel reported that offering self-collection for HPV testing is acceptable and feasible and can increase cervical cancer screening rates. Uncertainties emerged about accuracy of results, workflow disruptions, financial implications, and effects on clinic quality measures. CONCLUSION: Implementing self-collection for HPV testing was considered feasible and acceptable by participants. However, important health service delivery considerations, including financial implications, must be addressed before integrating self-collection for HPV testing into the standard of care.

Pay-it-forward incentives for hepatitis virus testing in men who have sex with men: a cluster randomized trial.

Pay-it-forward incentives involve having a person receive a free test with community-generated messages and then asking if those who received a free test would like to donate money to support others to receive free testing. Here we undertook a two-arm cluster-randomized trial to evaluate pay-it-forward incentives with active community participation to promote hepatitis B virus (HBV) and hepatitis C virus (HCV) testing among men who have sex with men in China. Men randomized to the pay-it-forward arm received free HBV and HCV testing and were offered a chance to pay-it-forward by donating money to support the testing of another anonymous person. Each participant paid for their HCV and HBV test at 7.7 USD per test in the standard-of-care arm. The primary outcome was the proportion of men who tested for HBV and HCV. Between 28 March and 6 November 2021, 32 groups (10 men per group) of men were randomized to the pay-it-forward (n = 160, 16 clusters) and standard-of-care (n = 162, 16 clusters) arms, respectively. HBV and HCV rapid testing were higher in the pay-it-forward arm (59.4%) than in the standard-of-care arm (25.3%) (proportion difference 35.2%, 95% confidence interval 24.1-46.3%). No adverse events were reported. The community-led pay-it-forward incentives improved HBV and HCV testing among men who have sex with men. Clinical Trial registration: ChiCTR 2100046140.

Acceptability and readiness to promote human papillomavirus vaccination at ages 9-10 years: a feasibility study among North Carolina clinics.

While 9-valent human papillomavirus (HPV) vaccination is approved by the US Food and Drug Administration for use in adolescents as young as age 9, providers typically recommend it at ages 11-12. Studies suggest that recommending HPV vaccination at 9 or 10 years of age could increase up-to-date vaccination by age 13, which could especially benefit rural populations with reduced access to primary health care and lower HPV vaccination coverage than urban areas. This study aimed to assess the feasibility of the age-9 recommendation of HPV vaccination in rural clinics. We conducted in-depth interviews with providers and staff from two primary care clinics in central North Carolina to understand attitudes toward recommending HPV vaccination to 9- and 10-year-olds. All interviewees agreed that HPV vaccination was important for cancer prevention and should be recommended before the onset of sexual activity, agreeing that HPV vaccination could be initiated before age 11 to improve timeliness and completion of the vaccination series. However, opinions were mixed on whether HPV vaccination should be initiated as young as 9 years old. Two key informants recruited from two university-affiliated clinics described their experiences recommending HPV vaccination to 9- and 10-year-olds, including a modified vaccination schedule that promotes HPV vaccination during routine well-child visits, prior to pubertal onset, and alongside other recommended adolescent vaccines. Age-9 recommendation and administration of HPV vaccination is possible with minimal changes to current clinical practices and could increase the convenience and acceptability of HPV vaccination in under-vaccinated settings.

Results from Two HPV-Based Cervical Cancer Screening-Family Planning Integration Models in Malawi: A Cluster Randomized Trial.

We conducted a cluster randomized trial of two models for integrating HPV self-collection into family-planning (FP) services at 16 health facilities in Malawi between March 2020-December 2021. Model 1 involved providing only clinic-based HPV self-collection, whereas Model 2 included both clinic-based and community-based HPV self-collection. An endline household survey was performed in sampled villages and households between October-December 2021 in the catchment areas of the health facilities. We analyzed 7664 surveys from 400 villages. Participants from Model 2 areas were more likely to have ever undergone cervical cancer screening (CCS) than participants from Model 1 areas, after adjusting for district, facility location (urban versus rural), and facility size (hospital versus health center) (adjusted odds ratio = 1.73; 95% CI: 1.29, 2.33). Among participants who had ever undergone CCS, participants from Model 2 were more likely to report having undergone HPV self-collection than participants from Model 1 (50.5% versus 22.8%, p = 0.023). Participants from Model 2 were more likely to be using modern FP (adjusted odds ratio = 1.01; 95% CI: 1.41, 1.98) than Model 1 participants. The integration of FP and HPV self-collection in both the clinic and community increases CCS and modern FP uptake more than integration at the clinic-level alone.

Cervical Cancer Screening Knowledge, Perceptions, and Behaviors in a Multiracial Cohort of Low-Income, Underscreened Women in North Carolina.

Background: Underscreened, low-income, and uninsured or publicly insured women in the United States bear a greater burden of cervical cancer morbidity and mortality and may face unique barriers that preclude screening adherence. Methods: Participants were 710 My Body My Test-3 clinical trial participants who were publicly insured or uninsured with incomes ≤250% of the U.S. Federal Poverty Level, aged 25-64 years, and not up to date on cervical cancer screening as per national guidelines. Using Health Belief Model constructs, we assessed screening-related knowledge, perceptions, and behaviors-overall and stratified by race and ethnicity-and estimated associations with past-year attempted screening using multivariable regression models. Results: Overall, knowledge was low about the human papillomavirus, purpose of a Pap test, and recommended screening interval. Perceived severity of cervical cancer was high (3.63 on a 4-point scale). Black and Latina/Hispanic women were more likely to perceive screening as lowering their risk of cervical cancer than White women. Black women reported lower perceived risk of cervical cancer compared with White women (p = 0.03), but Black women were more likely to have sought screening in the past year (p = 0.01). Having at least three doctor visits in the past year was associated with a screening attempt. Greater perceived risk of cervical cancer, more positive perceptions of screening, and feeling more nervousness about screening were also associated with a screening attempt (all p < 0.05). Conclusions: Addressing knowledge gaps and misconceptions about cervical cancer screening and leveraging positive perceptions of screening may improve screening uptake and adherence among diverse underscreened U.S. women. Clinical Trial Registration Number: NCT02651883.

Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial.

BACKGROUND: Most cervical cancer in the USA occurs in under-screened women. The My Body, My Test-3 (MBMT-3) trial sought to assess the efficacy of mailed human papillomavirus (HPV) self-collection kits with appointment-scheduling assistance to increase uptake of cervical cancer screening among under-screened women from low-income backgrounds compared with scheduling assistance alone. METHODS: MBMT-3 is a phase 3, open-label, two-arm, randomised controlled trial. Participants were recruited from 22 counties in North Carolina state, USA, and we partnered with 21 clinics across these counties. Participants were eligible for inclusion if they were aged 25-64 years, had an intact cervix, were uninsured or enrolled in Medicaid or Medicare, had an income of 250% or less of the US Federal Poverty Level, were living within the catchment area of a trial-associated clinic, and were overdue for screening (ie, Papanicolaou test ≥4 years ago or high-risk HPV test ≥6 years ago). Participants were randomly assigned (2:1) to receive a mailed HPV self-collection kit and assistance for scheduling a free screening appointment (intervention group) or to receive scheduling assistance alone (control group). Randomisation was conducted by county using permuted blocks of nine patients and assignment to group was not masked. Participants in the intervention group were mailed HPV self-collection kits to collect a cervical-vaginal sample and return it by mail for testing. Samples were tested with the Aptima HPV assay (Hologic, San Diego, CA, USA), and participants were informed of high-risk HPV results by telephone call. Trial staff made up to three telephone call attempts to provide scheduling assistance for in-clinic screening for all participants. The primary outcome was cervical cancer screening uptake (ie, attending an in-clinic screening appointment or testing negative for high-risk HPV with a returned self-collected sample) within 6 months of enrolment in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02651883, and has been completed. FINDINGS: Recruitment occurred between April 11, 2016, and Dec 16, 2019. 4256 women contacted the trial to participate, of whom 899 (21%) were eligible for inclusion and 697 (78%) returned consent forms. Of those who consented, 461 (66%) women were randomly assigned to the intervention group and 236 (34%) women were randomly assigned to the control group. We excluded 32 ineligible women post-randomisation, leaving 665 for primary analysis. Screening uptake was higher in the intervention group (317 [72%] of 438) than control group (85 [37%] of 227; risk ratio 1·93, 95% CI 1·62-2·31). Among intervention participants, 341 (78%) of 438 returned a self-collection kit. Three participants reported hurt or injury when using the self-collection kit; no participants withdrew due to adverse effects. INTERPRETATION: Among under-screened women from low-income backgrounds, mailed HPV self-collection kits with scheduling assistance led to greater uptake of cervical cancer screening than scheduling assistance alone. At-home HPV self-collection testing has the potential to increase screening uptake among under-screened women. FUNDING: National Cancer Institute.