HPV self-sampling among cervical cancer screening users in Spain: A randomized clinical trial of on-site training to increase the acceptability

A randomized clinical trial was conducted to compare the impact of two different instructions on vaginal selfsampling in its acceptability and willingness for future screening rounds among women attending cervical cancer screening (CCS).From November 2018 to May 2021, women aged 30-65 living in Spain attending CCS were randomized 1:1 in two arms. In the On-site training arm (TRA), women took a self-sample at the primary health care centre following provider's instructions. In the No on-site training arm (NO-TRA) women only received instructions to take self-sample at home. All women had to return a new sample collected at home one month after the baseline visit and an acceptability questionnaire. The proportion of self-samples returned, and acceptability was computed by the study arm.A total of 1158 women underwent randomization, 579 women per arm. At follow-up, women in TRA were more likely to return the home sample than women in the NO-TRA (82.4% and 75.5% respectively; p = 0.005). Over 87% of all participants favoured home-based self-sampling approach for future CCS, similar by arm. Over 80% of women in both arms chose to collect and return the self-sample at a health centre or pharmacy.Home-based self-sampling was a highly accepted strategy for CCS in Spain. Trying it first with prior on-site training at the health centre significantly increased the sample's return suggesting that a provider's supervision raised confidence and adherence. It is an option to consider when moving to self-sampling in established CCS. Preferred delivery sites most likely contextual.Registration on ClinicalTrials.gov: NCT05314907

Increasing Cervical Cancer Screening Coverage: A Randomised, Community-based Clinical Trial

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 "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

Pilot study to introduce a notification card for partner notification of sexually transmitted infections in Catalonia, Spain, June 2010 to June 2011

We conducted a cross-sectional study in 10 primary care centres in Catalonia, to determine applicability, acceptability and effectiveness of partner notification cards used by patients diagnosed of a sexually transmitted infection (STI) and to characterise these and their sexual partners. Statutorily notifiable STIs included Chlamydia infection, gonorrhoea, syphilis, human immunodeficiency virus (HIV) infection or other STIs as deemed necessary by the treating physician. Between June 2010 and June 2011, 219 index cases were enrolled, of whom 130 were men (59.4%), 71 of them men who have sex with men (54.6%). Chlamydia infection (41.1%), gonorrhoea (17.8%) and syphilis (16.0%) were the STIs most frequently diagnosed. HIV infection accounted for 4% of cases. A total of 687 sexual partners were reported, and 300 of these were traceable through the notification card (45.7%). Those who did not report traceable contacts were older (mean age: 34 years versus 31 years, p=0.03). The main reason for not distributing the card was anonymous sexual intercourse (38%). Patient referral notification cards can reach a high percentage of sexual partners at risk. However, only few notified sexual partners attended participating health centres. Internet-based partner notification may be considered in order to reach those partners not otherwise traceable

Nutritional status of iodine in pregnant women in Catalonia (Spain): study on hygiene-dietetic habits and iodine in urine

<p>Abstract</p> <p>Background</p> <p>It is a priority to achieve an adequate nutritional status of iodine during pregnancy since iodine deficiency in this population may have repercussions on the mother during both gestation and post partum as well as on the foetus, the neonate and the child at different ages. According to the WHO, iodine deficiency is the most frequent cause of mental retardation and irrreversible cerebral lesions around the world. However, few studies have been published on the nutritional status of iodine in the pregnant population within the Primary Care setting, a health care level which plays an essential role in the education and control of pregnant women. Therefore, <b>the aim of the present study </b>is: 1.- To know the hygiene-dietetic habits related to the intake of foods rich in iodine and smoking during pregnancy. 2.- To determine the prevalence of iodine deficiency and the factors associated with its appearance during pregnancy.</p> <p>Methods/design</p> <p>We will perform a cluster randomised, controlled, multicentre trial. Randomisation unit: Primary Care Team. Study population: 898 pregnant women over the age of 17 years attending consultation to a midwife during the first trimester of pregnancy in the participating primary care centres. Outcome measures: consumption of iodine-rich foods and iodine deficiency. Points of assessment: each trimester of the gestation. Intervention: group education during the first trimester of gestation on healthy hygiene-dietetic habits and the importance of an adequate iodine nutritional status. Statistical analysis: descriptive analysis of all variables will be performed as well as multilevel logistic regression. All analyses will be done carried out on an intention to treat basis and will be fitted for potential confounding factors and variables of clinical importance.</p> <p>Discussion</p> <p>Evidence of generalised iodine deficiency during pregnancy could lead to the promotion of interventions of prevention such as how to improve and intensify health care educational programmes for pregnant women.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01301768">NCT01301768</a></p

Evaluación de tres estrategias para la captación de mujeres con cribado incorrecto de cáncer de cérvix: Estudio CRICERVA

[spa] El cribado regular para el cáncer cervical ha demostrado reducir la incidencia y la mortalidad por esta enfermedad. El objetivo de este estudio fue mejorar la participación y la cobertura del cribado de cáncer de cérvix en las mujeres de 30 a 70 años, evaluar el impacto en la cobertura y conocer las características (lugar y periodicidad) de la misma, tras invitación personalizada en tres formas diferentes dirigida a las mujeres que en nuestra base de datos constaba una ausencia de cribado o un cribado insuficiente. Métodos El estudio CRICERVA es un ensayo clínico dirigido a las mujeres de 30 a 70 años que residían, en diciembre de 2010, en el área SAP Cerdanyola (Vallès Occidental) Barcelona. Se identificaron 32.858 mujeres residentes y con médico asignado en alguna ABS del área del estudio (datos actualizados en la RCP en diciembre 2010). Se extrajo informáticamente de la historia clínica electrónica los registros de citología y se identificaron aquellas en las que no constaba una citología cervical durante los últimos 3,5 años. Se identificaron cómo cribado no registrado a 15.965 mujeres. Estas se randomizaron al cluster asignado. Los cluster incluían las siguientes intervenciones: El cluster o grupo 1 (GI1) carta de invitación personalizada, el cluster of grupo 2 (GI2) carta más folleto informativo, el cluster del grupo 3 (GI3) al que se realizó una llamada telefónica personalizada previa a la cita y el cluster o grupo de no intervención (GNI) se utilizó como grupo control, donde se realizó el control habitual oportunista. 13.886 mujeres se asignaron a los 3 grupos con intervención y 2.079 al cluster de no intervención. No fue posible contactar con 4.263 mujeres, mientras que 4.282 mujeres fueron evaluadas como no suceptibles de cribado y rescatamos a 5.341 con un cribado insuficiente. A estas últimas se les aplicó las recomendaciones sobre el cribado de cáncer de cuello uterino del Departament de Salut de la Generalitat de Catalunya y se complementó con una prueba de detección de Virus de Papiloma Humano (VPH) concomitante a la citologia a todas las mujeres con indicación. Se realizó un análisis de costes de la intervención en función del aumento de cobertura. Se realizó una entrevista individualizada a todas las mujeres que o bien recibieron una citación de visita en el caso de los grupos de intervención o al finalizar el estudio en el grupo control. El reclutamiento para el estudio finalizó en Diciembre 2013. Análisis estadístico: La participación en cada grupo se evaluó como la proporción de las mujeres que al final del estudio estaban adecuadamente cribadas sobre todas las mujeres suceptibles de serlo. Se entiende como cobertura final la conseguida en el periodo de total de 4 años. Las variables cualitativas se describen con frecuencia absoluta y porcentaje. Las variables cuantitativas se expresan con media y desviación estándar. La prueba de Chi-cuadrado se utilizó en la comparación de variables cualitativas, y el análisis de la varianza para el análisis de las variables cuantitativas y se consideró que una diferencia era estadísticamente significativa, si el valor de p era menor de 0, 05. Se incluyen intérvalos de confianza al 95%. Los análisis se realizaron con el paquete statisical SPSS para Windows v. 20.0 Resultados De las mujeres inicialmente registradas con un cribado insuficiente, un 20,6% refirieron acudir regularmente a centros privados y un 10,2% no requerían seguimiento activo, por estar histerectomizadas o ser controladas por patología cervical activa en el hospital. La cobertura de cribado cervical para el SAP Cerdanyola al final del estudio CRICERVA en los grupos de intervención se estimo en 84% lo que representó un aumento del 31% de la cobertura basal. La cobertura más alta se registró en mujeres menores de 40 años (95.2%) y la más baja en mujeres mayores de 60 años (64.3%). La estrategia que obtuvo una mayor cobertura fue la del grupo IG3 para todos los grupos de edad. En el análisis por edad se observó una cobertura inicial y final mayor en las mujeres menores de 40 años. La cobertura en el grupo control aumento un 9% en el periodo de estudio. El análisis de las entrevistas personalizadas indican que aproximadamente un 30% de las mujeres con historia de cribado refieren su realización en centros privados. Las mujeres con mayor nivel educativo y económico son las que mayoritariamente se realizan el cribado en centros privados. La falta de información sobre la importancia de la detección fue el factor más importante para no seguir la recomendación de cribado. El estudio concomitante con citología y determinación de VPH en las mujeres con un cribado inadecuado según criterios del Departament de Salut, identificó en 2.500 mujeres: 18 CIN2 , 10 CIN3 y 4 Cáncer infiltrante cervical. La evaluación económica de las intervenciones estimó que la implementación de enviar una carta costaría en media unos 490€ por cada 1.000 mujeres. Conclusiones * El estudio CRICERVA ha estimado la cobertura poblacional de cribado de cáncer de cuello uterino en el SAP Cerdanyola con una aproximación metodológica mixta que incluye el análisis de la historia clínica informatizada, entrevistas personalizadas y visita ginecológica en el marco de un ensayo randomizado de intervención. * El análisis de la historia clínica informatizada y la entrevista personalizada ha permitido estimar que un 34% de las mujeres del SAP Cerdanyola tenian un cribado insuficiente en relación a las recomendaciones del Departament de Salut vigentes. * La estrategia de intervención que obtuvo la mayor cobertura incluyó una invitación personalizada, un folleto informativo y una llamada telefónica de recordatorio los tres días previos a la cita. * En una población como en Cataluña con aproximadamente un 40% de mujeres entre 30 y 70 años con cribado insuficiente, la implementación de enviar una carta costaría en media unos 490€ por cada 1.000 mujeres. * Los resultados del estudio CRICERVA son informativos para facilitar la implementación de estrategias eficaces que permitan una transición de cribados oportunistas organizados a estrategias poblacionales. * La revisión de la historia clínica informatizada (ICS) realizada en el estudio CRICERVA ha permitido eliminar una proporción de errores considerables del registro, lo que sugiere la necesidad de validaciones puntuales de la eCAP clínica y su concordancia con la eCAP administrativa para potenciar la calidad de los sistemas de registro.[eng] Regular screening for cervical cancer has proven to reduce the incidence and the mortality from this disease. The objective of this study was to improve the participation and the coverage of the screening for cervical cancer in women from 30 to 70 years, to evaluate the impact in the coverage and to know the characteristics (place and periodicity) of it, after the women that in our database had no screening or were poorly screened received one personalized invitation, of three different kinds. Methods The CRICERVA study is a cluster clinical trial targeted to women from 30 to 70 years of age that were registered, in December 2010, in the Primary Health Care Service (SAP) Cerdanyola area in Barcelona. A total of 32,858 women were registered and had an assigned doctor in one of the ABS (Public Health Care) within the study area (checked from the Register on December 2010). After this, the screening registers were extracted from the clinical history of each woman, and all the women with no record of cervical cytology during the previous 3.5 years were identified, making a total of 15,965 women. These women were randomly assigned to one of four different clusters. The first one (GI1) consisted of a personalized invitation letter to participate in the screening program. The women in the second cluster (GI2) received the invitation plus an informative leaflet. The third cluster (GI3) also received a personalized phone call. Finally, the cluster with no intervention (GNI) was used as a control group, and was based on spontaneous demand. From the 15,965 women, 13,886 were assigned to one of the Intervention Groups (GI) and 2,079 to the No Intervention Group (GNI). Out of these 13,886, it was not possible to contact with 4,263 women, and 4,263 didn’t need screening. The remaining 5,341 were rescued with an insufficient screening. The protocol about the cervical cancer screening of the Departament de Salut de la Generalitat de Catalunya was applied to these final women, and it was complemented with an HPV test if indicated. An analysis of costs of intervention versus increase of coverage was made. A personalized interview offered to all women that participated in the Intervention Groups during the visit, and also to women in the No Intervention Group, but after the study was complete. The last screening visit was performed in December 2013. Statistical Analysis The coverage in every group was estimated as the proportion of women that were correctly screened at the end over all the women susceptible of being screened. It is considered as final coverage the one reached in the total period of 4 years. The qualitative variables are described with absolute frequency and percent value. The quantitative variables, however, are expressed with averages and standard deviations. The Chi Squared test was used in the comparison of qualitative variables, and the Analysis of Variance for the analysis of quantitative variables. The comparison between groups was performed by Chi Squared Distributions, and it was considered that a difference was statistically significant when the p-Value was lower than 0.05. The Confidence Intervals are of the 95%. The analyses were performed with the software Statistical SPSS for Windows, v.20.0. Results From all women initially registered with a poor screening, a 20.6% went to Private Health Care regularly, and a 10.2% did not need active following. The cervical screening coverage for the Cerdanyola SAP after the CRICERVA study in the intervention groups was estimated to be at 84%, which represents an increase of the 31% from the baseline coverage. The highest coverage was registered within women with less than 40 years (95.2%) and the lowest in women older than 60 years (64.3%). The strategy that obtained the highest coverage was the GI3 group for all ages. In the analysis by age it was also observed that the coverage before and after the study were higher with women younger than 40 years. The coverage of the control group (GNI) increased in a 9% during the study. The analyses of the personalized interviews show that approximately a 30% of women with screening records went to Private Health Care. The women with the highest educative and economic level are those who mostly go to Private Health Care. The lack of information about the importance of the detection was the most important factor for not following the screening recommendation. The study identified in 2,500 women with criteria of insufficient screening: 18 CIN2, 10 CIN3 and 4 cases of invasive cervical cancer. The economic evaluation of the interventions estimated that the implementation of sending a letter would cost an average of 490€ per thousand women. Conclusions * The CRICERVA study has estimated the population coverage of cervical cancer screening in the Cerdanyola SAP with a mixt approach, which includes the analysis of the electronic clinical history, personalized interviews and a gynecological visit in the frame of a randomized test of intervention. * The analysis of the clinical history and the personalized interviews show that a 34% of the women of the Cerdanyola SAP had a poor screening compared to the Departament de Salut recommendations. * The intervention strategy that obtained the highest coverage included a personalized invitation letter, an informative leaflet and a phone call three days before the visit. * In a population like Catalonia’s, with approximately 40% of women between 30 and 70 years with poor screening, the implementation of the first intervention strategy (sending a letter) would cost 490€ per thousand women. * The CRICERVA Study results are informative; to ease the implementation of efficient strategies that allow a transition from opportunistic screening to planned population strategies. * The clinical history analysis performed in the CRICERVA Study has allowed eliminating a considerable proportion of errors in the register, which would point to the necessity to regularly check the validaty of the clinical electronic medical records to improve the quality of these registering systems

Increasing Cervical Cancer Screening Coverage: A Randomised, Community-based Clinical Trial

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 "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

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

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 (sic)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 (sic)490 for every 1000 women

Pilot study to introduce a notification card for partner notification of sexually transmitted infections in Catalonia, Spain, June 2010 to June 2011

We conducted a cross-sectional study in 10 primary care centres in Catalonia, to determine applicability, acceptability and effectiveness of partner notification cards used by patients diagnosed of a sexually transmitted infection (STI) and to characterise these and their sexual partners. Statutorily notifiable STIs included Chlamydia infection, gonorrhoea, syphilis, human immunodeficiency virus (HIV) infection or other STIs as deemed necessary by the treating physician. Between June 2010 and June 2011, 219 index cases were enrolled, of whom 130 were men (59.4%), 71 of them men who have sex with men (54.6%). Chlamydia infection (41.1%), gonorrhoea (17.8%) and syphilis (16.0%) were the STIs most frequently diagnosed. HIV infection accounted for 4% of cases. A total of 687 sexual partners were reported, and 300 of these were traceable through the notification card (45.7%). Those who did not report traceable contacts were older (mean age: 34 years versus 31 years, p=0.03). The main reason for not distributing the card was anonymous sexual intercourse (38%). Patient referral notification cards can reach a high percentage of sexual partners at risk. However, only few notified sexual partners attended participating health centres. Internet-based partner notification may be considered in order to reach those partners not otherwise traceable

Nutritional status of iodine in pregnant women in Catalonia (Spain): study on hygiene-dietetic habits and iodine in urine

Background: It is a priority to achieve an adequate nutritional status of iodine during pregnancy since iodine deficiency in this population may have repercussions on the mother during both gestation and post partum as well as on the foetus, the neonate and the child at different ages. According to the WHO, iodine deficiency is the most frequent cause of mental retardation and irrreversible cerebral lesions around the world. However, few studies have been published on the nutritional status of iodine in the pregnant population within the Primary Care setting, a health care level which plays an essential role in the education and control of pregnant women. Therefore, the aim of the present study is: 1.- To know the hygiene-dietetic habits related to the intake of foods rich in iodine and smoking during pregnancy. 2.- To determine the prevalence of iodine deficiency and the factors associated with its appearance during pregnancy. Methods/design: We will perform a cluster randomised, controlled, multicentre trial. Randomisation unit: Primary Care Team. Study population: 898 pregnant women over the age of 17 years attending consultation to a midwife during the first trimester of pregnancy in the participating primary care centres. Outcome measures: consumption of iodine-rich foods and iodine deficiency. Points of assessment: each trimester of the gestation. Intervention: group education during the first trimester of gestation on healthy hygiene-dietetic habits and the importance of an adequate iodine nutritional status. Statistical analysis: descriptive analysis of all variables will be performed as well as multilevel logistic regression. All analyses will be done carried out on an intention to treat basis and will be fitted for potential confounding factors and variables of clinical importance. Discussion: Evidence of generalised iodine deficiency during pregnancy could lead to the promotion of interventions of prevention such as how to improve and intensify health care educational programmes for pregnant women