scholarly journals Comparison of two invitation-based methods for human papillomavirus (HPV) self-sampling with usual care among un- and under-screened Māori, Pacific and Asian women: study protocol for a randomised controlled community trial to examine the effect of self-sampling on participation in cervical-cancer screening

BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Naomi Brewer ◽  
Karen Bartholomew ◽  
Anna Maxwell ◽  
Jane Grant ◽  
Helen Wihongi ◽  
...  

Abstract Background Māori, Pacific and Asian women in New Zealand have lower cervical-cancer screening rates than European women, and there are persistent inequities in cervical cancer outcomes for Māori and Pacific women. Innovative ways to address access barriers are required. New Zealand is transitioning to screening with human papillomavirus (HPV) DNA testing, which could allow women themselves, rather than a clinician, to take the sample. Internationally, self-sampling has been found to increase screening participation rates. The aim of this open-label community-based randomised controlled trial is to investigate whether self-sampling increases screening participation among un- and under-screened Māori, Pacific and Asian women in New Zealand. Methods/design We aim to invite at least 3550 un- or under-screened (≥5 years overdue) Māori, Pacific and Asian women (1050, 1250, 1250 respectively), aged 30–69 years, for screening. The three study arms are: usual care in which women are invited to attend a clinic for a standard clinician-collected cytology test; clinic-based self-sampling in which women are invited to take a self-sample at their usual general practice; and mail-out self-sampling in which women are mailed a kit and invited to take a self-sample at home. Women will be randomised 3:3:1 to the clinic and mail-out self-sampling groups, and usual care. There is also a nested sub-study in which non-responding women in all allocation groups, when they subsequently present to the clinic for other reasons, are offered clinic or home-kit self-sampling. The primary outcome will be the proportion of women who participate (by taking a self-sample or cytology test). Discussion This trial is the first to evaluate the effectiveness of mailed self-sampling in New Zealand and will be one of the first internationally to evaluate the effectiveness of opportunistic in-clinic invitations for self-sampling. The trial will provide robust evidence on the impact on participation proportions from different invitation approaches for HPV self-sampling in New Zealand un- and under-screened Māori, Pacific and Asian women. Trial registration ANZCTR Identifier: ACTRN12618000367246 (date registered 12/3/2018) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371741&isReview=true; UTN: U1111–1189-0531.

2021 ◽  
Author(s):  
Naomi Brewer ◽  
Karen Bartholomew ◽  
Jane Grant ◽  
Anna Maxwell ◽  
Georgina McPherson ◽  
...  

AbstractBackgroundInternationally, self-sampling for human papillomavirus (HPV) has been shown to increase participation in cervical-cancer screening. In Aotearoa New Zealand, there are long-standing ethnic inequalities in cervical-cancer screening, incidence, and mortality; particularly for indigenous Māori women, as well as Pacific, and Asian women.MethodsWe invited never- and markedly under-screened (≥5 years overdue) 30-69-year-old Māori, Pacific, and Asian women to participate in an open-label, three-arm, community-based, randomised controlled trial, with a nested sub-study. We aimed to assess whether two specific invitation methods for self-sampling improved screening participation over usual care among the least medically served populations. Women were individually randomised 3:3:1 to: clinic-based self-sampling (CLINIC – invited to take a self-sample at their usual general practice); home-based self-sampling (HOME – mailed a kit and invited to take a self- sample at home); and usual care (USUAL – invited to attend a clinic for collection of a standard cytology sample). Neither participants nor research staff could be blinded to the intervention. In a subset of general practices, women who did not participate within three months of invitation were opportunistically invited to take a self-sample, either next time they attended a clinic or by mail.FindingsWe randomised 3,553 women: 1,574 to CLINIC, 1,467 to HOME, and 512 to USUAL. Participation was highest in HOME (14.6% among Māori, 8.8% among Pacific, and 18.5% among Asian) with CLINIC (7.0%, 5.3% and 6.9%, respectively) and USUAL (2.0%, 1.7% and 4.5%, respectively) being lower. In fully adjusted models, participation was statistically significantly more likely in HOME than USUAL: Māori OR=9.7, (95%CI 3.0-31.5); Pacific OR=6.0 (1.8-19.5); and Asian OR=5.1 (2.4-10.9). There were no adverse outcomes reported. After three months, 2,780 non-responding women were invited to participate in a non-randomised, opportunistic, follow-on substudy. After 6 months,192 (6.9%) additional women had taken a self-sample.InterpretationUsing recruitment methods that mimic usual practice, we provide critical evidence that self-sampling increases screening among the groups of women (never and under-screened) who experience the most barriers in Aotearoa New Zealand, although the absolute level of participation through this population approach was modest. Follow-up for most women was routine but a small proportion required intensive support.Trial registrationANZCTR Identifier: ACTRN12618000367246 (date registered 12/3/2018) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371741&isReview=true;UTN:U1111-1189-0531FundingHealth Research Council of New Zealand (HRC 16/405)Protocolhttp://publichealth.massey.ac.nz/assets/Uploads/Study-protocol-V2.1Self-sampling-for-HPV-screening-a-community-trial.pdf


2019 ◽  
Vol 5 (Supplement_1) ◽  
pp. 14-14
Author(s):  
Ruixuan J. Zhang ◽  
Madeline Bach ◽  
Julia Yip ◽  
Athena Lin

PURPOSE Cervical cancer remains the eighth leading cause of cancer mortality among women in Taiwan. Despite availability of a National Health Insurance program with free yearly screenings, Papanicolaou testing and human papillomavirus (HPV) vaccination rates have been historically low in Taiwan. Even in the United States, cervical cancer screening rates for Asian women are significantly lower than other ethnic groups. The goal is to direct future interventions by providing insight on barriers leading to low screening and vaccination rates among Taiwanese and Asian women. METHODS Anonymous surveys without patient identifiers were randomly administered to patients at a traditional Chinese medicine clinic in Hualien City in June 2018. Inclusion criterion was females. No exclusion criteria were defined. Participants provided written consent. Sixty-three completed surveys were received. A χ2 test was used to determine statistical significance (α = 0.05). RESULTS Formal education level correlated with increased knowledge of HPV ( P = .001), its route of transmission ( P = .044), its link to genital cancer ( P = .0024), and HPV vaccination ( P = .0039). Women were more likely to have Papanicolaou smears if they were older than 30 years of age ( P = .0033), visited the gynecologist ( P < .001), or were recommended one by their physicians ( P < .001). Although 57% of respondents knew of the HPV vaccine, only 19% were vaccinated. Among those not vaccinated, most cited reasons included an inability to find a physician providing it (23.5%), safety concerns (16.4%), belief that it encourages sexual behavior (14.5%), and high out-of-pocket expense (9.1%). CONCLUSION Knowledge of HPV does not predict a higher adherence to cervical screening guidelines. Instead, diligent physician recommendations on Papanicolaou smears can elevate adherence rates among patients. Significant contributors to low HPV vaccination rates in rural Taiwan include lack of awareness and access to the vaccine. Our study emphasizes the physician-patient relationship as a means to target vulnerable populations and increase rates of cervical cancer screening and HPV vaccination.


2019 ◽  
Vol 2 (11) ◽  
pp. e1914729 ◽  
Author(s):  
Rachel L. Winer ◽  
John Lin ◽  
Jasmin A. Tiro ◽  
Diana L. Miglioretti ◽  
Tara Beatty ◽  
...  

Author(s):  
Collette Bromhead ◽  
Helen Wihongi ◽  
Susan M. Sherman ◽  
Sue Crengle ◽  
Jane Grant ◽  
...  

In Aotearoa, New Zealand, the majority of cervical cancer cases occur in women who have never been screened or are under-screened. Wāhine Māori, Pacific and Asian women have the lowest rate of cervical screening. Self-sampling for human papillomavirus (HPV-SS) has been shown to increase participation in cervical cancer screening. A whole-of-system approach, driven by evidence in the most effective delivery of HPV-SS, is required to mitigate further widening of the avoidable gap in cervical screening access and outcomes between groups of women in Aotearoa. This single-arm feasibility and acceptability study of HPV self-sampling invited never- and under-screened (≥5 years overdue) 30–69-year-old women from general practices in Auckland, Aotearoa. Eligible women were identified by data matching between the National Cervical Programme (NCSP) Register and practice data. Focus groups were additionally held with eligible wāhine Māori, Asian and Pacific women to co-design new patient information materials. Questionnaires on HPV knowledge and post-test experience were offered to women. Our follow-up protocols included shared decision-making principles, and we committed to follow-up ≥90% of women who tested positive for HPV. Data matching identified 366 eligible never- and under-screened wāhine Māori, Pacific and Asian women in participating practices. We were only able to contact 114 women, and 17, during the discussion, were found to be ineligible. Identifying and contacting women overdue for a cervical screen was resource-intensive, with a high rate of un-contactability despite multiple attempts. We found the best uptake of self-sampling was at focus groups. Of the total 84 HPV-SS tests, there were five positive results (6%), including one participant with HPV18 who was found to have a cervical Adenocarcinoma at colposcopy. In our feasibility study, self-sampling was acceptable and effective at detecting HPV and preventing cervical cancer in under-screened urban wāhine Māori, Pacific and Asian women in Aotearoa. This is the first report of cervical Adenocarcinoma (Grade 1B) as a result of an HPV-18 positive self-sample in Aotearoa. We co-designed new patient information materials taking a health literacy and ethnicity-specific approach. This work provides policy-relevant information to the NCSP on the resources required to implement an effective HPV self-sampling programme to improve equity in national cervical cancer screening.


2021 ◽  
Vol 13 ◽  
pp. 175883592110109
Author(s):  
Binhua Dong ◽  
Huachun Zou ◽  
Xiaodan Mao ◽  
Yingying Su ◽  
Hangjing Gao ◽  
...  

Background: China’s Fujian Cervical Pilot Project (FCPP) transitioned cervical cancer screening from high-risk human papillomavirus (HR-HPV) nongenotyping to genotyping. We investigated the clinical impact of this introduction, comparing performance indicators between HR-HPV genotyping combined with cytology screening (HR-HPV genotyping period) and the previous HR-HPV nongenotyping combined with cytology screening (HR-HPV nongenotyping period). Methods: A retrospective population-based cohort study was performed using data from the FCPP for China. We obtained data for the HR-HPV nongenotyping period from 1 January 2012 to 31 December 2013, and for the HR-HPV genotyping period from 1 January 2014 to 31 December 2016. Propensity score matching was used to match women from the two periods. Multivariable Cox regression was used to assess factors associated with cervical intraepithelial neoplasia of grade 2 or worse (CIN2+). The primary outcome was the incidence of CIN2+ in women aged ⩾25 years. Performance was assessed and included consistency, reach, effectiveness, adoption, implementation and cost. Results: Compared with HR-HPV nongenotyping period, in the HR-HPV genotyping period, more CIN2+ cases were identified at the initial screening (3.06% versus 2.32%; p < 0.001); the rate of colposcopy referral was higher (10.87% versus 6.64%; p < 0.001); and the hazard ratio of CIN2+ diagnosis was 1.64 (95% confidence interval, 1.43–1.88; p < 0.001) after controlling for health insurance status and age. The total costs of the first round of screening (US$66,609 versus US$65,226; p = 0.293) were similar during the two periods. Higher screening coverage (25.95% versus 25.19%; p = 0.007), higher compliance with age recommendations (92.70% versus 91.69%; p = 0.001), lower over-screening (4.92% versus 10.15%; p < 0.001), and reduced unqualified samples (cytology: 1.48% versus 1.73%, p = 0.099; HR-HPV: 0.57% versus 1.34%, p < 0.001) were observed in the HR-HPV genotyping period. Conclusions: Introduction of an HR-HPV genotyping assay in China could detect more CIN2+ lesions at earlier stages and improve programmatic indicators. Evidence suggests that the introduction of HR-HPV genotyping is likely to accelerate the elimination of cervical cancer in China.


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