Proof of Concept Study: Comparability of Microbiome Diversity in Self- and Physician-Collected HPV-Positive and HPV-Negative Cervicovaginal Samples

Recent studies have revealed the impact of human papillomavirus (HPV) infections on the cervicovaginal microbiome; however, few have explored the utility of self-collected specimens (SCS) for microbiome detection, obtained using standardised methods for HPV testing. Here, we present a proof-of-concept analysis utilising Oxford Nanopore sequencing of the 16S rRNA gene in paired samples collected either by the patient using an Evalyn Brush or collected by a physician using liquid-based cytology (LBC). We found no significant differences in the alpha-diversity estimates between the SCS and LBC samples. Similarly, when analysing beta-diversity, we observed a close grouping of paired samples, indicating that both collection methods detected the same microbiome features. The identification of genera and Lactobacillus species in each sample allowed for their classification into community state types (CSTs). Notably, paired samples had the same CST, while HPV-positive and -negative samples belonged to distinct CSTs. As previously described in other studies, HPV-positive samples exhibited heightened bacterial diversity, reduced Lactobacillus abundance, and an increase in genera like Sneathia or Dialister. Altogether, this study showed comparable results between the SCS and LBC samples, underscoring the potential of self-sampling for analysing the microbiome composition in cervicovaginal samples initially collected for HPV testing in the context of cervical cancer screening

Increasing Cervical Cancer Screening Coverage: A randomised, Community-Based Clinical Trial

Altres ajuts: The project received a research grant from the Carlos III Institute of Health, Ministry of Economy and Competitiveness (Spain), awarded on the 2010 call under the Health Strategy Action 2013-16, within the National Research Program oriented to Societal Challenges within the Technical, Scientific and Innovation Research National Plan 2013-16 with reference PI10/01275 co-funded with European Union ERDF funds. Additional support was provided by the European Regional Development Fund (ERDF), public grants from the Carlos III Institute of Health (RTIC RD06/0020/0095 RD12/0036/0056 and CIBERESP) and the Agència de Gestió d'Ajuts Universitaris i de Recerca (grants AGAUR 2014SGR1077 and 2014SGR2016) and the Primary Health Care Unit IDIAP Jordi Gol and the Catalan Institute of Health resolved 07/04/2014.Background. Opportunistic cervical cancer screening can lead to suboptimal screening coverage. Coverage could be increased after a personalised invitation to the target population. We present a community randomized intervention study with three strategies aiming to increase screening coverage.Methods. The CRICERVA study is a community-based clinical trial to improve coverage of population based screening in the Cerdanyola SAP area in Barcelona.A total of 32,858 women residing in the study area, aged 30 to 70 years were evaluated. A total of 15,965 women were identified as having no registration of a cervical cytology in the last 3.5 years within the Public Health data base system. Eligible women were assigned to one of four community randomized intervention groups (IGs): (1) (IG1 N = 4197) personalised invitation letter, (2) (IG2 N =3601) personalised invitation letter + informative leaflet, (3) (IG3 N = 6088) personalised invitation letter + informative leaflet + personalised phone call and (4) (Control N = 2079) based on spontaneous demand of cervical cancer screening as officially recommended. To evaluate screening coverage, we used heterogeneity tests to compare impact of the interventions and mixed logistic regression models to assess the age effect. We refer a ªrescueº visit as the screening visit resulting from the study invitation. Results. Among the 13,886 women in the IGs, 2,862 were evaluated as having an adequate screening history after the initial contact; 4,263 were lost to follow-up and 5,341 were identified as having insufficient screening and thus being eligible for a rescue visit. All intervention strategies significantly increased participation to screening compared to the control group. Coverage after the intervention reached 84.1% while the control group reached 64.8%. The final impact of our study was an increase of 20% in the three IGs and of 9% in the control group (p<0.001). Within the intervention arms, age was an important determinant of rescue visits showing a statistical interaction with the coverage attained in the IGs. Within the intervention groups, final screening coverage was significantly higher in IG3 (84.4%) (p<0.001). However, the differences were more substantial in the age groups 50±59 and those 60+. The highest impact of the IG3 intervention was observed among women 60+ y.o with 32.0% of them being rescued for screening. The lowest impact of the interventions was in younger women.Conclusions. The study confirms that using individual contact methods and assigning a fixed screening date notably increases participation in screening. The response to the invitation is strongly dependent on age

Economic evaluation of three populational screening strategies for cervical cancer in the county of Valles Occidental: CRICERVA clinical trial

Copyright @ 2011 Acera et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.A high percentage of cervical cancer cases have not undergone cytological tests within 10 years prior to diagnosis. Different population interventions could improve coverage in the public system, although costs will also increase. The aim of this study was to compare the effectiveness and the costs of three types of population interventions to increase the number of female participants in the screening programmes for cancer of the cervix carried out by Primary Care in four basic health care areas.Fondo de Investigación Sanitaria del Instituto Carlos III de Madri

Increasing Cervical Cancer Screening Coverage: a Randomised, Community-Based Clinical Trial

Cervical cancer; Screening; Clinical trialCàncer de cèrvix; Cribratge; Assaig clínicCáncer de cérvix; Cribado; Ensayo clínicoBACKGROUND: Opportunistic cervical cancer screening can lead to suboptimal screening coverage. Coverage could be increased after a personalised invitation to the target population. We present a community randomized intervention study with three strategies aiming to increase screening coverage. METHODS: The CRICERVA study is a community-based clinical trial to improve coverage of population-based screening in the Cerdanyola SAP area in Barcelona.A total of 32,858 women residing in the study area, aged 30 to 70 years were evaluated. A total of 15,965 women were identified as having no registration of a cervical cytology in the last 3.5 years within the Public Health data base system. Eligible women were assigned to one of four community randomized intervention groups (IGs): (1) (IG1 N = 4197) personalised invitation letter, (2) (IG2 N = 3601) personalised invitation letter + informative leaflet, (3) (IG3 N = 6088) personalised invitation letter + informative leaflet + personalised phone call and (4) (Control N = 2079) based on spontaneous demand of cervical cancer screening as officially recommended. To evaluate screening coverage, we used heterogeneity tests to compare impact of the interventions and mixed logistic regression models to assess the age effect. We refer a "rescue" visit as the screening visit resulting from the study invitation. RESULTS: Among the 13,886 women in the IGs, 2,862 were evaluated as having an adequate screening history after the initial contact; 4,263 were lost to follow-up and 5,341 were identified as having insufficient screening and thus being eligible for a rescue visit. All intervention strategies significantly increased participation to screening compared to the control group. Coverage after the intervention reached 84.1% while the control group reached 64.8%. The final impact of our study was an increase of 20% in the three IGs and of 9% in the control group (p<0.001). Within the intervention arms, age was an important determinant of rescue visits showing a statistical interaction with the coverage attained in the IGs. Within the intervention groups, final screening coverage was significantly higher in IG3 (84.4%) (p<0.001). However, the differences were more substantial in the age groups 50-59 and those 60+. The highest impact of the IG3 intervention was observed among women 60+ y.o with 32.0% of them being rescued for screening. The lowest impact of the interventions was in younger women. CONCLUSIONS: The study confirms that using individual contact methods and assigning a fixed screening date notably increases participation in screening. The response to the invitation is strongly dependent on age. TRIAL REGISTRATION: ClinicalTrials.gov NCT01373723

Cost-effectiveness of strategies to increase screening coverage for cervical cancer in Spain: the CRIVERVA study

Abstract Background The aim of the study is to carry out a cost-effectiveness analysis of three different interventions to promote the uptake of screening for cervical cancer in general practice in the county of Valles Occidental, Barcelona, Spain. Methods Women aged from 30 to 70 years (n = 15,965) were asked to attend a general practice to be screened. They were randomly allocated to one of four groups: no intervention group (NIG); one group where women received an invitation letter to participate in the screening (IG1); one group where women received an invitation letter and informative leaflet (IG2); and one group where women received an invitation letter, an informative leaflet and a phone call reminder (IG3). Clinical effectiveness was measured as the percentage increase in screening coverage. A cost-effectiveness analysis was performed from the perspective of the public health system with a time horizon of three to five years – the duration of the randomised controlled clinical trial. In addition, a deterministic sensitivity analysis was performed. Results are presented according to different age groups. Results The incremental cost-effectiveness ratio (ICER) for the most cost-effective intervention, IG1, compared with opportunistic screening was € 2.78 per 1% increase in the screening coverage. The age interval with the worst results in terms of efficiency was women aged < 40 years. Conclusions In a population like Catalonia, with around 2 million women aged 30 to 70 years and assuming that 40% of these women were not attending general practice to be screened for cervical cancer, the implementation of an intervention to increase screening coverage which consists of sending a letter would cost on average less than € 490 for every 1000 women. Trial registration ClinicalTrials.gov Identifier: NCT01373723

Increasing Cervical Cancer Screening Coverage: A randomised, Community-Based Clinical Trial

Altres ajuts: The project received a research grant from the Carlos III Institute of Health, Ministry of Economy and Competitiveness (Spain), awarded on the 2010 call under the Health Strategy Action 2013-16, within the National Research Program oriented to Societal Challenges within the Technical, Scientific and Innovation Research National Plan 2013-16 with reference PI10/01275 co-funded with European Union ERDF funds. Additional support was provided by the European Regional Development Fund (ERDF), public grants from the Carlos III Institute of Health (RTIC RD06/0020/0095 RD12/0036/0056 and CIBERESP) and the Agència de Gestió d'Ajuts Universitaris i de Recerca (grants AGAUR 2014SGR1077 and 2014SGR2016) and the Primary Health Care Unit IDIAP Jordi Gol and the Catalan Institute of Health resolved 07/04/2014.Background. Opportunistic cervical cancer screening can lead to suboptimal screening coverage. Coverage could be increased after a personalised invitation to the target population. We present a community randomized intervention study with three strategies aiming to increase screening coverage.Methods. The CRICERVA study is a community-based clinical trial to improve coverage of population based screening in the Cerdanyola SAP area in Barcelona.A total of 32,858 women residing in the study area, aged 30 to 70 years were evaluated. A total of 15,965 women were identified as having no registration of a cervical cytology in the last 3.5 years within the Public Health data base system. Eligible women were assigned to one of four community randomized intervention groups (IGs): (1) (IG1 N = 4197) personalised invitation letter, (2) (IG2 N =3601) personalised invitation letter + informative leaflet, (3) (IG3 N = 6088) personalised invitation letter + informative leaflet + personalised phone call and (4) (Control N = 2079) based on spontaneous demand of cervical cancer screening as officially recommended. To evaluate screening coverage, we used heterogeneity tests to compare impact of the interventions and mixed logistic regression models to assess the age effect. We refer a ªrescueº visit as the screening visit resulting from the study invitation. Results. Among the 13,886 women in the IGs, 2,862 were evaluated as having an adequate screening history after the initial contact; 4,263 were lost to follow-up and 5,341 were identified as having insufficient screening and thus being eligible for a rescue visit. All intervention strategies significantly increased participation to screening compared to the control group. Coverage after the intervention reached 84.1% while the control group reached 64.8%. The final impact of our study was an increase of 20% in the three IGs and of 9% in the control group (p<0.001). Within the intervention arms, age was an important determinant of rescue visits showing a statistical interaction with the coverage attained in the IGs. Within the intervention groups, final screening coverage was significantly higher in IG3 (84.4%) (p<0.001). However, the differences were more substantial in the age groups 50±59 and those 60+. The highest impact of the IG3 intervention was observed among women 60+ y.o with 32.0% of them being rescued for screening. The lowest impact of the interventions was in younger women.Conclusions. The study confirms that using individual contact methods and assigning a fixed screening date notably increases participation in screening. The response to the invitation is strongly dependent on age

Analysis of three strategies to increase screening coverage for cervical cancer in the general population of women aged 60 to 70 years: the CRICERVA study

Background: Cervical cancer is a frequently diagnosed cancer in women worldwide. Despite having easy preventive and therapeutic approaches, it is an important cause of mortality among women. Methods: The CRICERVA study is a cluster clinical trial which assigned one of three interventions to the target population registered in Cerdanyola, Barcelona. Among the 5,707 resident women aged 60 to 70 years in the study area, women with no record of cervical cytology over the last three years were selected. The study included four arms: three interventions all including a pre-assigned date for screening visit and i) personalized invitation letter; ii) adding to i) an informative leaflet; and, iii) in addition to ii) a personalized appointment reminder phone call, and iv) no specific action taken (control group). Participants were offered a personal interview about social-demographic characteristics and about screening attitudes. Cervical cytology and HPV DNA test (HC2) were offered as screening tests. In the case of screening positive in any of these tests, the women were followed up until a full diagnosis could be obtained. The effect size of each study arm was estimated as the absolute gain in coverage between the original coverage and the final coverage. Results: From the intervention groups (4,775 women), we identified 3,616 who were not appropriately screened, of which 2,560 women answered the trial call and 1,376 were amenable to screening. HPV was tested in 920 women and cervical cytology in all 1,376. Overall, there was an absolute gain in coverage of 28.8% in the intervention groups compared to 6% in the control group. Coverage increased from 51.2% to 76.0% in strategy i); from 47.4% to 79.0% in strategy ii) and from 44.5% to 74.6% in strategy iii). Lack of information about the relevance of screening was the most important factor for not attending the screening program. Conclusions: The study confirms that actively contacting women and including a date for a screening visit, notably increased participation in the screening program. Efforts to improve health education in preventative activities are warranted. Trial registration: Clinical Trials.gov Identifier NCT01373723. Registered 14 June 2011.This protocol has received financial Grant from the Fondo de Investigacion Sanitaria del Instituto Carlos III de Madrid (exp PI10/01275