The effect of oral zinc supplementation on cervicovaginal lavage fluid zinc level.

OBJECTIVES: To investigate the effect of oral zinc supplementation on cervicovaginal lavage fluid (CVL) zinc level in pre and postmenopausal women. STUDY DESIGN: A prospective interventional cohort study was carried out by the enrollment of twelve premenopausal and ten postmenopausal women without significant gynecological conditions. Women received daily oral supplementation with 30 mg of zinc for two weeks. Clinical and demographic variables were stored in a dedicated database. Vaginal Health Index was calculated, and vaginal cytology was obtained. CVL and serum samples were collected in a standardized fashion before and after completion of the oral supplementation. Zinc and copper levels were measured by inductively coupled plasma optical emission spectrometry. Paired t-test was used to compare the before and after treatment results. RESULTS: Serum zinc levels increased significantly both in the pre and postmenopausal women (0.88 ± 0.17 vs. 1.06 ± 0.23, p < 0.01 and 0.83 ± 0.24 vs. 0.96 ± 0.33, p < 0.01) after two weeks of daily oral zinc supplementation. CVL zinc level was significantly higher in the premenopausal group compared to the postmenopausal group before and after supplementation (0.13 ± 0.05 vs. 0.06 ± 0.04, p < 0.01 and 0.10 ± 0.03 vs. 0.05 ± 0.01, p < 0.01). Zinc supplementation had no significant impact on the CVL zinc level in either group. Neither serum nor CVL copper levels were affected by the zinc supplementation. There was no significant correlation between serum and CVL zinc or copper levels. CONCLUSION: Daily oral supplementation with 30 mg of zinc had no significant impact on CVL zinc level despite a significant rise in serum zinc level.

Implementation of HPV-based Cervical Cancer Screening Combined with Self-sampling Using a Midwifery Network Across Rural Greece: The GRECOSELF Study.

Self-sampling for human papillomavirus (HPV) testing is an alternative to physician sampling particularly for cervical cancer screening nonattenders. The GRECOSELF study is a nationwide observational cross-sectional study aiming to suggest a way to implement HPV-DNA testing in conjunction with self-sampling for cervical cancer screening in Greece, utilizing a midwifery network. Women residing in remote areas of Greece were approached by midwives, of a nationwide network, and were provided with a self-collection kit (dry swab) for cervicovaginal sampling and asked to answer a questionnaire about their cervical cancer screening history. Each sample was tested for high-risk (hr) HPV with the Cobas HPV test. HrHPV-Positive women were referred to undergo colposcopy and, if needed, treatment according to colposcopy/biopsy results. Between May 2016 and November 2018, 13,111 women were recruited. Of these, 12,787 women gave valid answers in the study questionnaire and had valid HPV-DNA results; hrHPV prevalence was 8.3%; high-grade cervical/vaginal disease or cancer prevalence was 0.6%. HrHPV positivity rate decreased with age from 20.7% for women aged 25-29 years to 5.1% for women aged 50-60 years. Positive predictive value for hrHPV testing and for HPV16/18 genotyping ranged from 5.0% to 11.6% and from 11.8% to 27.0%, respectively, in different age groups. Compliance to colposcopy referral rate ranged from 68.6% (for women 25-29) to 76.3% (for women 40-49). For women residing in remote areas of Greece, the detection of hrHPV DNA with the Cobas HPV test, on self-collected cervicovaginal samples using dry cotton swabs, which are provided by visiting midwives, is a promising method for cervical cancer secondary prevention.

Nuevas estrategias de prevención y control de cáncer de cuello uterino en Chile / New strategies for the prevention and control of cervical cancer in Chile

Resumen: Objetivos: Discutir el cáncer cervicouterino (CC), el virus del papiloma humano (VPH), el programa de control del CC y proponer alternativas para Chile. Material y métodos: Se analiza el programa nacional del CC 1966-2015 y la guía clínica 2015-2020, la prevalencia de VPH en mujeres y en casos de CC; la infección y serología de VPH; la autotoma; la precisión y rentabilidad del tamizaje con VPH contra el Papanicolaou y las opciones de triaje en VPH AR positivas. Resultados: En Chile mueren 600 mujeres (principalmente de bajos recursos) al año por CC. La cobertura del Papanicolaou es < 70%, sensibilidad muy inferior al test de VPH, por lo que el cambio es rentable. Desde 2015 se vacuna contra VPH a niñas menores de 13 años. Conclusiones: Las condiciones técnicas y económicas existen en Chile para lograr una mejoría sustancial del CC: se sugiere el reemplazo del Papanicolaou por el examen de VPH; tamizaje cada cinco años con opción de autotoma; triaje con base en la tipificación de VPH 16/18 o Papanicolaou.

Abstract: Objective: To discuss cervical cancer (CC), Human Papilloma Virus (HPV), CC control program and propose alternatives for Chile. Materials and methods: We analyzed the national program of CC 1966-2015 and the clinical CC guideline 2015-2020; HPV prevalence in women and in cases of CC; HPV infection and serology; the self-vaginal sample; the accuracy and cost-effectiveness of screening with HPV versus Papanicolaou, and triage options among HPV-AR positives. Results: 600 women die of CC each year in Chile, mainly from low resources. Papanicolaou coverage is <70%; Papanicolaou sensitivity is much lower than HPV test. Change from Papanicolaou to HPV test is cost-effective. Since 2015, girls under 13 have been vaccinated against HPV. Conclusions: There are the technical and economic conditions for a substantial improvement of CC in Chile: replacement of the Papanicolaou by HPV; screening every five years, with the option of self-sampling, and triage based on HPV 16/18 or Papanicolaou typing.

[New strategies for the prevention and control of cervical cancer in Chile.] / Nuevas estrategias de prevención y control de cáncer de cuello uterino en Chile.

OBJECTIVE: To discuss cervical cancer (CC), Human PapillomaVirus (HPV),CC control program and propose alternatives for Chile. MATERIALS AND METHODS: We analyzed the national program of CC 1966-2015 and the clinical CC guideline 2015-2020;HPV prevalence in women and in cases of CC; HPV infection and serology; the self-vaginal sample; the accuracy and cost-effectiveness of screening with HPV versus Papanicolaou,and triage options among HPV-AR positives. RESULTS: 600 women die of CC each year in Chile, mainly from low resources. Papanicolaou coverage is <70%; Papanicolaou sensitivity is much lowerthan HPV test.Change from Papanicolaou to HPV test is cost-effective. Since 2015, girls under 13 have been vaccinated against HPV. CONCLUSIONS: .There are the technical and economic conditions for a substantial improvement of CC in Chile: replacement of the Papanicolaou by HPV; screening every five years, with the option of self-sampling, and triage based on HPV 16/18 or Papanicolaou typing.

OBJETIVO: Discutir el cáncer cervicouterino (CC), el virus del papiloma humano (VPH),el programa de control del CC y proponer alternativas para Chile. MATERIAL Y MÉTODOS: Se analiza el programa nacional del CC 1966-2015 y la guía clínica 2015-2020, la prevalencia deVPH en mujeres y en casos de CC; la infección y serología deVPH; la autotoma; la precisión y rentabilidad del tamizaje con VPH contra el Papanicolaou y las opciones de triaje enVPH AR positivas. RESULTADOS: En Chile mueren 600 mujeres (principalmente de bajos recursos) al año por CC. La cobertura del Papanicolaou es <70%, sensibilidad muy inferior al test de VPH, por lo que el cambio esrentable.Desde 2015 se vacuna contraVPH a niñas menores de 13 años. CONCLUSIONES: Las condiciones técnicas y económicas existen en Chile para lograr una mejoría sustancial del CC:se sugiere el reemplazo del Papanicolaou por el examen deVPH;tamizaje cada cinco años con opción de autotoma; triaje con base en la tipificación deVPH 16/18 o Papanicolaou.

Barreras percibidas por el personal de salud para la toma de la citología cervical en mujeres zapotecas de Juchitán, Oaxaca / Perceived barriers by health care professionals to cervical cancer screening in indigenous women of Juchitan, Oaxaca

Antecedentes: El cáncer cervicouterino (CaCU) representa un problema de salud pública en México. Las mujeres indígenas presentan mayor riesgo de morir por esta enfermedad. El estudio sobre las barreras que afronta la población indígena mexicana para la toma de la citología cervical es escaso. Propósitos: Objetivo: Identificar las barreras estructurales, psicosociales y culturales percibidas por el personal de salud para la toma de la citología cervical en mujeres juchitecas. Método: Tipo de estudio: exploratorio-descriptivo de corte cualitativo. Se aplicaron entrevistas semiestructuradas a personal sanitario de centros de salud públicos y privados de Juchitán. Muestreo intencional por cuotas, 9 participantes, 7 clínicas elegidas al azar. Se realizó análisis de contenido. Resultados: Se identificaron barreras estructurales, psicosociales y culturales. Las principales: tardanza en entrega de resultados, falta de material, espacios para la toma y recursos humanos, alto nivel de desinformación sobre la prueba y la enfermedad, miedo a tener algo "malo" y al dolor, el tabú de la sexualidad, la actitud de la pareja hacia la prueba, prejuicios y falta de traductores que apoyen en la comunicación entre las mujeres y el personal del sistema de salud. Conclusiones: Existe desinformación sobre el CaCu y su detección oportuna en esta población; hay múltiples barreras de tipo estructural, prejuicios y mitos rodean la enfermedad. Se detectó desinterés por parte del sistema de salud en la promoción de programas preventivos del CaCu. Informar a la población en su lengua, cuidar y ser empáticos ante la exposición del cuerpo y diseñar políticas de salud incluyentes, son aspectos fundamentales a considerar y desarrollar en programas locales (AU)

Background: Cervical cancer is a public health problem in Mexico. Rural and Indigenous women have a higher risk of dying from this disease. The study of the barriers to cervical cancer screening in indigenous population in Mexico is limited. Purpose: Objective: To identify structural, psychosocial and cultural barriers perceived by health care professionals to cervical cancer screening in indigenous women of Juchitán. Method: Exploratory-descriptive study with qualitative approach. Semi-structured interviews with health care professionals in public and private centers in Juchitán were conducted. Intentional sampling by quotas was used. There were 9 participants in 7 randomly selected clinics. Content analysis was performed. Results: Structural, psychosocial and cultural barriers were identified. Delay in delivery of results, lack of materials, specific spaces and human resources, misinformation, fear of receiving "bad news" and fear of pain, sexuality taboos, partner´s attitudes related to the test, prejudices and lack of translators who support the communication between the women and the personnel in the health system, were the most salient barriers to screening. Conclusions: There is misinformation about cervical cancer and screening in this population; prejudices and myths about the disease were reported. There was a lack of interest on the part of health workers in the promotion of preventive cervical cancer programs, even showing discriminatory behavior. Informing the population in their language, caring and being empathetic before the body's exposure and designing inclusive health policies are fundamental aspects to consider and develop in local programs (AU)

Estrategias para la implantación del cribado poblacional de cáncer de cuello uterino con test VPH-AR / Strategies for the implementation of population-based screening for cervical cancer with the HR-HPV test

Introducción: desde el año 2005 se trabaja coordinadamente Atención Primaria y especializada para revertir el cribado de cáncer de cuello de útero de oportunista a poblacional. En 2011 se añadió el test de virus de papiloma humano de alto riesgo a la citología (co-test) como cribado primario. Objetivo: potenciar el cribado poblacional de cáncer de cuello de útero. Material y métodos: captación activa de la población a través de las matronas de Atención Primaria y atención en ginecología de las mujeres positivas a virus de papiloma humano de alto riesgo. En Anatomía Patológica se realiza control de calidad de las pruebas y se monitorizan los resultados. Resultados: se ha duplicado la cobertura poblacional, el 80,7% de las pruebas de cribado se realiza en Atención Primaria y el número de neoplasias intraepiteliales cervicales se ha quintuplicado. Conclusiones: la implicación de todos los profesionales en el cribado ha permitido conseguir una cobertura del 66,6% y la introducción del test de virus de papiloma humano de alto riesgo ha incrementado los diagnósticos de neoplasias intraepiteliales cervicales (AU)

Introduction: Since 2005, a coordinated effort by primary care and gynaecology services has shifted screening from an opportunistic setting to a population-based strategy. High-risk Human papilloma viruses testing was added to the Papanicolau smear (co-testing) as the primary screening test in 2011. Objective: To implement population-based cancer screening. Material and methods: Primary care midwives arrange appointments for women and, if tested positive, they are then attended in gynaecology services. Quality control and the monitoring of results is carried out by the pathology service. Results: Coverage has doubled, 80% of screening tests are performed in primary care and the number of CIN 2/3 intraepithelial neoplasia cases have increased 5 fold. Conclusion: The participation of the entire health screening team has increased coverage to 66%. The introduction of the human papilloma viruses test has increased the detection of intraepithelial neoplasia cases (AU)

Cost-Effectiveness of Primary HPV Testing, Cytology and Co-testing as Cervical Cancer Screening for Women Above Age 30 Years.

BACKGROUND: Cervical cancer screening guidelines for women aged ≥30 years allow for co-testing or primary cytology testing. Our objective was to determine the test characteristics and costs associated with Cytology, HPV and Co-testing screening strategies. MAIN METHODS: Retrospective cohort study of women undergoing cervical cancer screening with both cytology and HPV (Hybrid Capture 2) testing from 2004 to 2010 in an integrated health system. The electronic health record was used to identify women aged ≥30 years who had co-testing. Unsatisfactory or unavailable test results and incorrectly ordered tests were excluded. The main outcome was biopsy-proven cervical intraepithelial neoplasia grade 3 or higher (CIN3+). KEY RESULTS: The final cohort consisted of 99,549 women. Subjects were mostly white (78.4 %), married (70.7 %), never smokers (61.3 %) and with private insurance (86.1 %). Overall, 5121 (5.1 %) tested positive for HPV and 6115 (6.1 %) had cytology ≥ ASCUS; 1681 had both and underwent colposcopy and 310 (0.3 %) had CIN3+. Sensitivity for CIN3+ was 91.9 % for Primary Cytology, 99.4 % for Co-testing, and 94.8 % for Primary HPV; specificity was 97.3 % for Co-testing and Primary Cytology and 97.9 % for Primary HPV. Over a 3-year screening interval, Primary HPV detected more cases of CIN3+ and was less expensive than Primary Cytology. Co-testing detected 14 more cases of CIN3+ than Primary HPV, but required an additional 100,277 cytology tests and 566 colposcopies at an added cost of $2.38 million, or $170,096 per additional case detected. CONCLUSIONS: Primary HPV was more effective and less expensive than Primary Cytology. Primary HPV screening appears to represent a cost-effective alternative to Co-testing.

Clearance of cervical human papillomavirus infection by topical application of curcumin and curcumin containing polyherbal cream: a phase II randomized controlled study.

Curcumin and curcumin containing polyherbal preparations have demonstrated anti-microbial and anti- viral properties in pre-clinical studies. Till date no therapeutic intervention has been proved to be effective and safe in clearing established cervical human papillomavirus (HPV) infection. The present study evaluated the efficacy of Basant polyherbal vaginal cream (containing extracts of curcumin, reetha, amla and aloe vera) and of curcumin vaginal capsules to eliminate HPV infection from cervix. Women were screened by Pap smear and HPV DNA test by PCR. HPV positive women without high grade cervical neoplasias (N=287) were randomized to four intervention arms to be treated with vaginal Basant cream, vaginal placebo cream, curcumin vaginal capsules and placebo vaginal capsules respectively. All subjects were instructed to use one application of the assigned formulation daily for 30 consecutive days except during menstruation and recalled within seven days of the last application for repeat HPV test, cytology and colposcopy. HPV clearance rate in Basant arm (87.7%) was significantly higher than the combined placebo arms (73.3%). Curcumin caused higher rate of clearance (81.3%) than placebo though the difference was not statistically significant. Vaginal irritation and itching, mostly mild to moderate, was significantly higher after Basant application. No serious adverse events were noted.

Innovation in cervical cancer prevention and control in Mexico.

Disparities related to cervical cancer continue to exist in Mexico, including insufficient screening coverage, problems with quality control and a resulting greater risk of mortality among women from marginalized areas. A lack of opportunities and requirements for continuing education and accreditation of healthcare personnel involved in the screening program is also an issue. HPV DNA testing and HPV vaccines are recent technological innovations that offer a potential solution to the continued negative impact of cervical cancer among Mexican women. This essay attempts to answer questions such as: Why should HPV testing be integrated into the early detection program in Mexico? How can HPV testing best be integrated into the program in Mexico? How-from a public health perspective that seeks to reduce disparities-can HPV vaccination best be implemented in Mexico? HPV testing allows increased positive predictive value while also reducing costly and unnecessary overtreatment of low-grade abnormalities, and HPV vaccines offer the possibility of primary prevention of cervical cancer. The strategy proposed for Mexico includes primary prevention with HPV vaccination for girls aged between 12 and 16 years (before sexual initiation), Pap testing with excellent quality control for women 24-34 years of age and high-risk HPV DNA testing for women 35 years and older. HPV samples would be either clinically collected or self-collected and women with positive HPV test results would receive follow-up high-quality Pap testing. This approach is creative and focuses on reducing disparities and providing high-quality care that is also cost effective.

Women's initial experience of abnormal papanicolaou smear.

To discover the early subjective experience of women affected by abnormal Papanicolaou smear, a qualitative study was undertaken with 8 North Carolina women, 4 to 12 months postnotification of their first abnormal result. Data were analyzed via grounded theory methodology to identify a core theory that could guide interventions to improve follow-up for cancer prevention. This theoretical process is described as a labyrinth journey-an imperative healing process undertaken by all participants, who undertook the following tasks: evaluating peril, seeking refuge, obtaining information, and reframing their self-image. Women who also learned they were infected with the human papillomavirus faced a prolonged sense of threat to their sense of sexual well-being. Their additional tasks related to reevaluating their sexual self-image, and they continued to work on these reframing tasks throughout their 1st year's journey. Progress through the labyrinth depended upon emotional or spiritual support, nonjudgmental acceptance and access to accurate information.

Downstaging for cervical cancer: a community-based study in the rural areas of Udupi district, Karnataka, India.

The objective of this study is to determine the feasibility of utilizing trained auxiliary nurse midwives (ANMs) in downstaging for cancer cervix in a rural area. The study population included all married women in the age group of 35-59 years in two villages of the field practice area. It was a cross-sectional study. Two ANMs were trained in history taking, visual inspection of the cervix, using of speculum and collecting Papanicolaou smears. After training, they made home visits and identified women with gynaecological symptoms suggestive of cervical cancer. These women were asked to report to Rural Maternity and Child Welfare whom homes where the ANMs did a visual inspection of the cervix and made a cervical smear. A total of 1402 women were registered of the ANMs could identify 368 women (26%) with symptoms. Only 192 (52.2%) of these women reported for examination. Chronic cervicitis accounted for the largest proportion of the cases (44.8%). In all, three cases were diagnosed as suspected cases of cancer cervix. On cytology, three cases (1.5%) turned out to be malignant. When clinical findings of the ANM were compared with results of cytological examination, a high degree of sensitivity (78.4%) and positive predictive value (97.1%) were observed in diagnosing abnormal cytological findings. However, the sensitivity for detecting specific conditions was generally low. Sensitivity for detecting erosion was 45%, for chronic cervicitis 30%, and malignancies were totally missed. In conclusion, this study clearly shows that ANMs, if trained, would be capable of identifying symptomatic women, differentiating a normal cervix from an abnormal one and taking an adequate smear for cytological examination.

The cervical cancer screening program from a midwife's perspective.

BACKGROUND: Midwives in Sweden are responsible for taking Papanicolaou (Pap) smears as part of the cervical cancer screening program. The aim of this study was to investigate midwives knowledge, experience and management of the cervical cancer screening program, and their apprehension of women's knowledge about Pap-smear screening. METHODS: A postal questionnaire was sent to midwives working in primary health care in 3 different areas in Sweden. A total of 156 (77%) out of 201 midwives completed the questionnaire. RESULTS: Four of 5 midwives considered themselves to have the education they needed to manage the screening program. However, the study indicated that midwives lacked a basic structure when giving information. As many as every third midwife refrained from or had an irrelevant answer to the proposed question, what is meant by a cellular atypia? Almost all midwives saw themselves as the main informant about Pap-smear screening. At the same time, the midwives perceived that women lacked knowledge about cellular atypia, and thought it was the same as cancer. Some 38% of the midwives expressed a wish to terminate the 'assembly line-like' screening system. The remaining midwives were completely satisfied with the organisation. CONCLUSIONS: Many midwives lacked time and a structured guidance when discussing screening and cervical atypia. Improvement in the organisation and certified education for Pap-smear screening with access to recent research, could develop a more empowering exchange between the midwives and the women participating in cervical screening.

Colposcopic management of high-grade referral smears: a retrospective audit supporting 'see and treat'?

OBJECTIVE: The National Health Service Cervical Screening Programme monitors the quality of colposcopy services through the annual KC65 returns. The 2002 returns demonstrated that Standard 7c, which specifies a biopsy rate > or = 90% at first colposcopy visit for high-grade referrals, was not met in the assessed 3-month period. This was investigated along with the other standards. METHODS: Retrospective colposcopy records were accessed for the 597 new referrals, excluding 10 pregnant patients, seen at the colposcopy clinic at the Royal Victoria Infirmary between 1 July 2001 and 31 December 2002, following an abnormal high-grade smear. Cytology and histopathology computer records were checked for confirmation. The results were assessed against the colposcopy standards applicable at that time and the revised standards (2004). RESULTS: Biopsies were taken from 94.47% (Standard > or = 90%) of women at index colposcopy visit including wire loop excision biopsies from 66.16% (87.97% of high-grade colposcopic appearances). Cervical intraepithelial neoplasia (CIN) on histology was found in 91.79% in the study group (Standard > or = 85%) and in 96.71% of index visit biopsies (Standard > or = 90%), meeting the applicable colposcopy standards. The revised 2004 standards specify a biopsy in > or = 95% of high-grade referrals and excision biopsies in 95% if colposcopic appearances are also high-grade, if colposcopy is low grade but the smear is severely dyskaryotic, or when the lesion extends into the canal. The positive predictive value of high-grade cytology for this entire group was 75.54% with CIN present in 90.95%. CONCLUSION: From this study it appears that high-grade cytology in this centre reliably indicates high-grade CIN. Therefore, in women referred for colposcopy following a high-grade smear, excision biopsies should be performed in a higher proportion at the first visit to comply with the revised standards.

Assessing the wellbeing of cytoscreeners: experience in two NHS cytology laboratories.

OBJECTIVE: Cervical screening programmes in England are in transition as the liquid-based cytology (LBC) method replaces conventional Papanicolaou screening and staff in NHS laboratories are trained to analyse LBC smears. Cytoscreeners and biomedical scientists undertake routine microscopy of slides, but the scientists usually have a wider professional role. Attitudinal surveys were carried out in laboratories where LBC was partially introduced. METHODS: Staff in two cytology laboratories in Greater Manchester were surveyed twice over 6 months. The questionnaire assessed work pressures using scales from the Measures of Work Characteristics instrument, work-related stress using the General Survey version of the Maslach Burnout Inventory, job intentions and job satisfaction. RESULTS: Cytoscreeners, many aged over 50 years, formed over 60% of respondents in both surveys (27/42 in the first survey), and biomedical scientists and doctors, 30%. Both groups were under moderate pressure from work demands in each survey, but cytoscreeners had significantly less autonomy over their working methods (P < 0.001). Although both groups experienced similar levels of exhaustion, cytoscreeners were much more cynical or indifferent towards work in the second survey (P = 0.008) and had lower expectations of being effective (P < 0.001). For the cytoscreeners, there were strong negative correlations in both surveys between cynicism and the work characteristics of influencing decisions and autonomy/control. CONCLUSIONS: The strength of the relationship between work performance and wellbeing serves to emphasize the importance of the new LBC technology in ameliorating low morale where it exists. Further attitudinal research involving larger samples of laboratories is warranted to assess the full impact of this innovation.

Design and methods of the evaluation of an HPV-based cervical cancer screening strategy in Mexico: The Morelos HPV Study.

OBJECTIVE: The purpose of this paper is to describe the design and methodology of the Morelos HPV Study. The main objective of this study is to examine the use of two different methods for obtaining HPV DNA specimens, self-collected vaginal and clinician-collected cervical, to detect pre-invasive cervical lesions and cancer. MATERIAL AND METHODS: This study was conducted within the regular population-based framework of the Mexican Institute of Social Security (IMSS) cervical cancer screening program in Morelos. A total of 7,868 women were recruited between May and October 1999 and are representative of the population of women attending cervical cancer screening services at the 23 IMSS clinics in the state of Morelos in 1999. Women were provided with a detailed description of the study before signing an informed consent form. Basic data were obtained from all participants using a standard IMSS registration form. During the initial recruitment visit, a randomly selected subsample of 1,069 participants were interviewed to collect additional information about cervical cancer risk factors, acceptability of the HPV and Pap tests, as well as patient costs. Before the pelvic exam, participants were asked to provide a self-collected vaginal specimen for HPV testing. All participants underwent a pelvic examination that involved collecting a cervical sample for the Pap smear and a clinician-collected HPV specimen. Data were evaluated from 7,732 women with complete information for the three tests. The 1,147 women who received at least one positive result (Pap, self- and/or clinician-HPV tests) were invited to return for a colposcopic examination. During colposcopy, biopsies were taken as appropriate, to histologically confirm a diagnosis of cervical intraepithelial neoplasia (CIN) 2/3 or invasive cancer. A total of 1,015 women attended colposcopy, and 101 women received a histologically-confirmed CIN 2/3 or cervical cancer diagnosis. CONCLUSIONS: The initial enrollment activities of the Morelos HPV study are the basis for a prevalent case-control study and a prospective cohort study that will investigate the natural history of HPV infections and determine if an HPV-based screening strategy is a safe and cost-effective alternative to Pap screening. The English version of this paper is available too at: http://www.insp.mx/salud/index.html.

Design and methods of the evaluation of an HPV-based cervical cancer screening strategy in Mexico: The Morelos HPV Study

OBJECTIVE: The purpose of this paper is to describe the design and methodology of the Morelos HPV Study. The main objective of this study is to examine the use of two different methods for obtaining HPV DNA specimens, self-collected vaginal and clinician-collected cervical, to detect pre-invasive cervical lesions and cancer. MATERIAL AND METHODS: This study was conducted within the regular population-based framework of the Mexican Institute of Social Security (IMSS) cervical cancer screening program in Morelos. A total of 7,868 women were recruited between May and October 1999 and are representative of the population of women attending cervical cancer screening services at the 23 IMSS clinics in the state of Morelos in 1999. Women were provided with a detailed description of the study before signing an informed consent form. Basic data were obtained from all participants using a standard IMSS registration form. During the initial recruitment visit, a randomly selected subsample of 1,069 participants were interviewed to collect additional information about cervical cancer risk factors, acceptability of the HPV and Pap tests, as well as patient costs. Before the pelvic exam, participants were asked to provide a self-collected vaginal specimen for HPV testing. All participants underwent a pelvic examination that involved collecting a cervical sample for the Pap smear and a clinician-collected HPV specimen. Data were evaluated from 7,732 women with complete information for the three tests. The 1,147 women who received at least one positive result (Pap, self- and/or clinician-HPV tests) were invited to return for a colposcopic examination. During colposcopy, biopsies were taken as appropriate, to histologically confirm a diagnosis of cervical intraepithelial neoplasia (CIN) 2/3 or invasive cancer. A total of 1,015 women attended colposcopy, and 101 women received a histologically-confirmed CIN 2/3 or cervical cancer diagnosis. CONCLUSIONS: The initial enrollment activities of the Morelos HPV study are the basis for a prevalent case-control study and a prospective cohort study that will investigate the natural history of HPV infections and determine if an HPV-based screening strategy is a safe and cost-effective alternative to Pap screening.