Current status and challenges in timely detection of cervical cancer in Mexico: expert consensus.

Cervical cancer is a significant public health problem in low- and middle-income countries, accounting for 85% of new cases worldwide. Due to poorly organized screening programs, cervical cancer is more likely to develop in vulnerable groups who do not initiate or rarely undergo screening. Cervical cytology and detecting high-risk human papillomavirus types are the recommended screening tools. Further, these strategies allow for accurately identifying women at a higher risk of cervical cancer and establishing screening times. New detection tools, such as novel biomarkers or automatic HPV detection in the vagina or urine, can improve screening coverage. This review aims to identify the challenges faced by detection programs and screening tools in Mexico to provide evidence-based recommendations to improve early detection programs for cervical cancer.

Cervical cancer prevention program in Mexico disrupted due to COVID-19 pandemic: Challenges and opportunities.

Introduction: The COVID-19 pandemic disrupted the preventive services for cervical cancer (CC) control programs in Mexico, which will result in increased mortality. This study aims to assess the impact of the pandemic on the interruption of three preventive actions in the CC prevention program in Mexico. Methods: This study is a retrospective time series analysis based on administrative records for the uninsured population served by the Mexican Ministry of Health. Patient data were retrieved from the outpatient service information system and the hospital discharge database for the period 2017-2021. Data were aggregated by month, distinguishing a pre-pandemic and a pandemic period, considering April 2020 as the start date of the pandemic. A Poisson time series analysis was used to model seasonal and secular trends. Five process indicators were selected to assess the disruption of the CC program, these were analyzed as monthly data (N=39 pre-pandemic, N=21 during the pandemic). HPV vaccination indicators (number of doses and coverage) and diagnostic characteristics of CC cases were analyzed descriptively. The time elapsed between diagnosis and treatment initiation in CC cases was modeled using restricted cubic splines from robust regression. Results: Annual HPV vaccination coverage declined dramatically after 2019 and was almost null in 2021. The number of positive Papanicolaou smears decreased by 67.8% (90%CI: -72.3, -61.7) in April-December 2020, compared to their expected values without the pandemic. The immediate pandemic shock (April 2020) in the number of first-time and recurrent colposcopies was -80.5% (95%CI:-83.5, -77.0) and -77.9% (95%CI: -81.0, -74.4), respectively. An increasing trend was observed in the proportion of advanced stage and metastatic CC cases. The fraction of CC cases that did not receive medical treatment or surgery increased, as well as CC cases that received late treatment after diagnosis. Conclusions: Our analyses show significant impact of the COVID-19 pandemic with declines at all levels of CC prevention and increasing inequalities. The restarting of the preventive programs against CC in Mexico offers an opportunity to put in place actions to reduce the disparities in the burden of disease between socioeconomic levels.

Social inequalities in supportive care needs and quality of patient-centered care of cancer patients in Mexico.

PURPOSE: To evaluate educational and health insurance-related inequalities in supportive care (SC) needs and quality of patient-centered care (PCC) for cancer patients in Mexico. METHODS: We conducted a cross-sectional survey in one Mexican Institute of Social Security (IMSS) and one Ministry of Health (MoH) oncology hospital in Mexico City. Formal labor market workers and their families have access to social health insurance that IMSS provides, while unemployed and informal workers receive care at the MoH. The study population comprised breast, colorectal, prostate, and hematologic cancer patients, aged ≥ 18 years, who attended outpatient consultations. Patients responded a short-form SC-needs questionnaire and a quality of PCC questionnaire. We used multiple logistic regression models to determine the independent association between educational attainment and high SC-needs and quality of PCC after controlling for sociodemographic and clinical covariates. RESULTS: We included 1058 IMSS and 606 MoH cancer patients. MoH patients perceived higher SC-needs and lower quality of PCC than IMSS patients. MoH patients with low education had a greater probability of high psychological and health system SC needs and lower likelihood of being informed for treatment decision-making and care for their biopsychosocial needs. IMSS patients with low educational levels had lower probability of receiving timely care and clarity of information than those with high education. Receiving high-quality PCC was associated with decreased SC needs. CONCLUSION: Uninsured cancer patients with low educational attainment have higher SC-needs and receive lower quality of PCC than their counterparts. Health services should face these challenges to reduce inequalities in Mexico.

THERAPEUTIC USE OF HUMAN PAPILLOMAVIRUS VACCINES IN CERVICAL LESIONS.

Human papillomavirus (HPV) has been associated with the development of precancerous lesions of the cervix and cervical cancer (CC). Prophylactic HPV vaccination induces the development of a specific memory immune response that facilitates HPV elimination once the natural infection occurs. At present, in addition to the prophylactic vaccine, therapeutic vaccines are being developed and researched with the aim of inducing an immune response that allows the elimination of HPV-infected cells. The purpose of this study is to describe the current evidence on the use of therapeutic vaccines and their effect on cervical precancerous lesions, to establish recommendations on their clinical use. So far, the studies that have generated results have described a marginal beneficial effect of the prophylactic vaccine in the management of infection and pre-invasive lesions. Based on the evidence, continuing research on the efficacy and safety of therapeutic vaccines for the treatment of cervical intraepithelial lesions is recommended. The use of the HPV prophylactic vaccine as treatment for pre-existing lesions is not advised, but it is recommended to prevent new lesions.

Therapeutic use of human papillomavirus vaccines in cervical lesions

ABSTRACT Human papillomavirus (HPV) has been associated with the development of precancerous lesions of the cervix and cervical cancer (CC). Prophylactic HPV vaccination induces the development of a specific memory immune response that facilitates HPV elimination once the natural infection occurs. At present, in addition to the prophylactic vaccine, therapeutic vaccines are being developed and researched with the aim of inducing an immune response that allows the elimination of HPV-infected cells. The purpose of this study is to describe the current evidence on the use of therapeutic vaccines and their effect on cervical precancerous lesions, to establish recommendations on their clinical use. So far, the studies that have generated results have described a marginal beneficial effect of the prophylactic vaccine in the management of infection and pre-invasive lesions. Based on the evidence, continuing research on the efficacy and safety of therapeutic vaccines for the treatment of cervical intraepithelial lesions is recommended. The use of the HPV prophylactic vaccine as treatment for pre-existing lesions is not advised, but it is recommended to prevent new lesions.

Psychometric validation of a Patient-Centred Quality of Cancer Care Questionnaire in Mexico.

OBJECTIVES: To develop and validate a Patient-Centred Quality of Cancer Care Questionnaire in Spanish (PCQCCQ-S) appropriate to the Mexican context. DESIGN: Psychometric validation of a questionnaire. SETTING: Two public oncology hospitals in Mexico City. PARTICIPANTS: 1809 patients with cancer aged ≥18 years. SOURCE OF INFORMATION: Cross-sectional survey. METHODS: The validation procedures comprised (1) content validity through a group of experts and patients; (2) item reduction and evaluation of the factor structure, through an exploratory factor analysis based on the polychoric correlation matrix; (3) internal consistency using Cronbach's alpha; (4) convergent validity between the PCQCCQ-S and supportive care needs scale; (5) correlation analysis between the PCQCCQ-S and quality of life scale by calculating Spearman's rank-correlation coefficient; and (6) differentiation by 'known groups' through the Wilcoxon rank-sum test. RESULTS: The PCQCCQ-S has 30 items with the following five factors accounting for 96.5% of the total variance: (1) timely care; (2) clarity of the information; (3) information for treatment decision-making; (4) activities to address biopsychosocial needs; and (5) respectful and coordinated care. Cronbach's alpha values ranged from 0.73 to 0.90 among the factors. PCQCCQ-S has moderate convergent validity with supportive care needs scale, revealing that higher quality is correlated with lower patient needs. PCQCCQ-S has acceptable ability to differentiate by 'known groups', showing that older patients and those with low levels of education perceived lower total quality of care as compared with their counterparts. CONCLUSION: PCQCCQ-S has acceptable psychometric properties and can be used to measure quality of patient-centred cancer care in Mexico and serve as a reference to develop PCQCCQ-S in other Spanish-speaking countries.

Prevention and control of neoplasms associated with HPV in high-risk groups in Mexico City: The Condesa Study / Prevención y control de neoplasias asociadas a VPH en grupos de alto riesgo de la Ciudad de México: el Estudio Condesa

Abstract: Objective: To evaluate the effectiveness of a combined strategy of human papillomavirus virus (HPV) vaccination and high-risk HPV screening to reduce the occurrence of anogenital and oropharyngeal neoplasms among men who have sex with men, people with HIV, homeless people, transgender women, female sex workers and rape victims. Materials and methods: This mixed methods study evaluates the effectiveness of a combined vaccination-screening strategy to reduce HPV prevalence/incidence and occurrence of cervical intraepithelial neoplasms grade 2+ and/or anal intraepithelial neoplasms grade 2+, using Kaplan-Meier. The time-to-event method will evaluate time from positive results for specific anogenital HPV to incidence of anogenital lesions containing that HPV type. Results: People vaccinated against HPV and screened for HPV as a primary test will have lower prevalence and incidence of HPV infection and consequently lower frequency of HPV-related anogenital and oropharyngeal lesions. Conclusions: This study will generate scientific evidence on effectiveness of a combined vaccination-screening strategy to reduce the burden of HPV-associated neoplasms.

Resumen: Objetivo: Evaluar la efectividad de una estrategia combinada de vacunación contra el virus de papiloma humano (VPH) y tamizaje de VPH de alto riesgo para reducir neoplasias anogenitales y orofaringeas entre hombres que tienen sexo con hombres, personas con VIH, personas en situación de calle, mujeres transgénero, trabajadoras sexuales y víctimas de violación. Material y métodos: Este estudio evaluará la efectividad de una estrategia combinada de vacunación y tamizaje para reducir la ocurrencia de neoplasias intraepiteliales cervicales grado 2+ o neoplasias intraepiteliales anales grado NIA2+ utilizando Kaplan-Meier. Se evaluará tiempo de resultados positivos para tipos específicos de VPH anogenital a incidencia de lesiones anogenitales con ese tipo de VPH. Resultados: Las personas vacunadas contra VPH y con tamizaje de VPH tendrán menor prevalencia e incidencia de infecciones por VPH y por ende menor frecuencia de lesiones anogenitales y orofaringeas relacionadas con VPH. Conclusiones: Este estudio generará evidencia científica sobre la efectividad de una estrategia combinada de vacunación y tamizaje para reducir la carga de neoplasias asociadas al VPH.

Epidemiological Data on the Nutritional Status of Cancer Patients Receiving Treatment with Concomitant Chemoradiotherapy, Radiotherapy or Sequential Chemoradiotherapy to the Abdominopelvic Area.

Cancer patients are particularly susceptible to undernourishment so associated weight loss is frequent. Approximately 15% of patients lose >10% of their usual body weight, 40-80% become undernourished, and about 20% die as a result. Well-nourished patients have a higher survival rate when compared with patients at risk of undernourishment (19.9 vs. 3.7 months); hence, nutritional intervention is pivotal. Undernourishment negatively influences the patient's prognosis, and its prevalence depends on the tumor type and location, disease stage, treatment, and the applied nutritional evaluation tool. During abdominopelvic radiotherapy, up to 90% of patients experience symptoms of varying severity; weight loss during radiotherapy is an early indicator of nutritional deterioration, and he the use of radiation is associated with a higher likelihood of undernourishment. In patients with gynecological malignancies, 12.5-54% are malnourished before receiving oncological treatment, worsening after treatment in 35.8-82% of cases. There is also deterioration of the nutritional status in patients with colorectal cancer once pelvic radiotherapy is initiated, whereby 50% of cases are malnourished at the beginning of treatment, and 66.7% are so when it ends. Although there are notable differences in the impact of radiotherapy on weight according to the radiated region, 88% patients receiving abdominal radiotherapy were found to lose weight compared to 38% of patients whose treatment was limited to the pelvis.

Prevention and control of neoplasms associated with HPV in high-risk groups in Mexico City: The Condesa Study.

OBJECTIVE: To evaluate the effectiveness of a combined strategy of human papillomavirus virus (HPV) vaccination and high-risk HPV screening to reduce the occurrence of anogenital and oropharyngeal neoplasms among men who have sex with men, people with HIV, homeless people, transgender women, female sex workers and rape victims. MATERIALS AND METHODS: This mixed methods study evaluates the effectiveness of a combined vaccination-screening strategy to reduce HPV prevalence/incidence and occurrence of cervical intraepithelial neoplasms grade 2+ and/or anal intraepithelial neoplasms grade 2+, using Kaplan-Meier. The time-to-event method will evaluate time from positive results for specific anogenital HPV to incidence of anogenital lesions containing that HPV type. RESULTS: People vaccinated against HPV and screened for HPV as a primary test will have lower prevalence and incidence of HPV infection and consequently lower frequency of HPV-related anogenital and oropharyngeal lesions. CONCLUSIONS: Thisstudy will generate scientific evidence on effectiveness of a combined vaccination-screening strategy to reduce the burden of HPV-associated neoplasms.

OBJETIVO: Evaluar la efectividad de una estrategia combinada de vacunación contra el virus de papiloma humano (VPH) y tamizaje de VPH de alto riesgo para reducir neoplasias anogenitales y orofaringeas entre hombres que tienen sexo con hombres, personas con VIH, personas en situación de calle, mujeres transgénero, trabajadoras sexuales y víctimas de violación. MATERIAL Y MÉTODOS: Este estudio evaluará la efectividad de una estrategia combinada de vacunación y tamizaje para reducir la ocurrencia de neoplasias intraepiteliales cervicales grado 2+ o neoplasias intraepiteliales anales grado NIA2+ utilizando Kaplan-Meier. Se evaluará tiempo de resultados positivos para tipos específicos deVPH anogenital a incidencia de lesiones anogenitales con ese tipo de VPH. RESULTADOS: Las personas vacunadas contra VPH y con tamizaje de VPH tendrán menor prevalencia e incidencia de infecciones por VPH y por ende menor frecuencia de lesiones anogenitales y orofaringeas relacionadas con VPH. CONCLUSIONES: Este estudio generará evidencia científica sobre la efectividad de una estrategia combinada de vacunación y tamizaje para reducir la carga de neoplasias asociadas al VPH.

[Infection with human papillomavirus in men]. / Infección por el virus del papiloma humano en varones.

OBJECTIVE: Review updated (HPV) HPV in Man virus information, the role as a sexually transmitted infection (STI) that negatively impacts your partner(s) sexual(s) and represents a public health problem globally. In the case of men they have been identified specific risk factors that place it as the main factor in the transmission of the disease (infection, cancer and cancer precursor lesions in the genital tract), both heterosexual and homosexual practice as the subjects infected with HIV (HIV) in whom HPV prevalence rises to 95%. SEARCH METHODOLOGY: A systematic review of the literature of the past six years to date (2015) was made. Human papilloma virus vaccine, warts and sexually transmitted: In the database PubMed, LILACS and EMBASE were searched keywords. Only items that directly related to studies in men and that referred to the vaccine were analyzed. RESULTS: The mean time of disappearance of persistent injuries HPV-6, 11, 16, and 18 (defined as two consecutive negative results) was 6.7; 3.2; 9.2; and 4.7 months respectively. In conclusion, this study showed that the acquisition of HPV-6, 11, 16, or 18 is common among men. Differences in detection rates of HPV DNA in anogenital different anatomical sites were found. It has been found that the average time of dlisappearance of lesions is ≥ 6 months. In another study conducted on a sample that included Mexican population, the median duration of HPV infection was 7.52 months (6.80-8.61) for any type of HPV and 12-19 months (7.16-18.17) for HPV-16. CONCLUSION: The prevention of this disease has had a significant change with the introduction of the HPV vaccine, which has led organizations like the World Health Organization (WHO) to take a position in favor of including these biological in national immunization programs, to thereby contribute to the eradication of not only genital cancer in women, also in man, which is being reflected gradually in such programs.

[Third National Ovarian Consensus. 2011. Grupo de Investigación en Cáncer de Ovario y Tumores Ginecológicos de México "GICOM"]. / Tercer Consenso Nacional de Cáncer de Ovario 2011. Grupo de Investigación en Cáncer de Ovario y Tumores Ginecológicos de México "GICOM".

INTRODUCTION: Ovarian cancer (OC) is the third most common gynecologic malignancy worldwide. Most of cases it is of epithelial origin. At the present time there is not a standardized screening method, which makes difficult the early diagnosis. The 5-year survival is 90% for early stages, however most cases present at advanced stages, which have a 5-year survival of only 5-20%. GICOM collaborative group, under the auspice of different institutions, have made the following consensus in order to make recommendations for the diagnosis and management regarding to this neoplasia. MATERIAL AND METHODS: The following recommendations were made by independent professionals in the field of Gynecologic Oncology, questions and statements were based on a comprehensive and systematic review of literature. It took place in the context of a meeting of two days in which a debate was held. These statements are the conclusions reached by agreement of the participant members. RESULTS: No screening method is recommended at the time for the detection of early lesions of ovarian cancer in general population. Staging is surgical, according to FIGO. In regards to the pre-surgery evaluation of the patient, it is recommended to perform chest radiography and CT scan of abdomen and pelvis with IV contrast. According to the histopathology of the tumor, in order to consider it as borderline, the minimum percentage of proliferative component must be 10% of tumor's surface. The recommended standardized treatment includes primary surgery for diagnosis, staging and cytoreduction, followed by adjuvant chemotherapy Surgery must be performed by an Oncologist Gynecologist or an Oncologist Surgeon because inadequate surgery performed by another specialist has been reported in 75% of cases. In regards to surgery it is recommended to perform total omentectomy since subclinic metastasis have been documented in 10-30% of all cases, and systematic limphadenectomy, necessary to be able to obtain an adequate surgical staging. Fertility-sparing surgery will be performed in certain cases, the procedure should include a detailed inspection of the contralateral ovary and also negative for malignancy omentum and ovary biopsy. Until now, laparoscopy for diagnostic-staging surgery is not well known as a recommended method. The recommended chemotherapy is based on platin and taxanes for 6 cycles, except in Stage IA, IB and grade 1, which have a good prognosis. In advanced stages, primary cytoreduction is recommended as initial treatment. Minimal invasion surgery is not a recommended procedure for the treatment of advanced ovarian cancer. Radiotherapy can be used to palliate symptoms. Follow up of the patients every 2-4 months for 2 years, every 3-6 months for 3 years and anually after the 5th year is recommended. Evaluation of quality of life of the patient must be done periodically. CONCLUSIONS: In the present, there is not a standardized screening method. Diagnosis in early stages means a better survival. Standardized treatment includes primary surgery with the objective to perform an optimal cytoreduction followed by chemotherapy Treatment must be individualized according to each patient. Radiotherapy can be indicated to palliate symptoms.

[Adnexal tumor and pregnancy: diagnosis and treatment]. / Tumor anexial y embarazo: diagnóstico y tratamiento.

BACKGROUND: The finding of adnexal masses during pregnancy is an exceptional event. Its reported incidence is less than 5% and most cases resolve spontaneously as the pregnancy progresses. OBJECTIVE: Describe a case series of patients with adnexal mass and pregnancy. MATERIAL AND METHODS: We retrospectively reviewed the medical records of patients who had diagnosis of pregnancy and adnexal over a period of five years. RESULTS: The incidence was 0.22%. The mean age was 26 +/- 7.3 years, mean gestational age was 17 +/- 6.6 weeks. The diagnosis was established by ultrasound (USG) in 95% of cases, 48% had cystic characteristics, the mean diameter of the tumor was 99 +/- 42 mm. Cistectomy was performed during pregnancy or trans-cesarean section in 30% and 58% of patients respectably. The mean tumor size was 118 mm (range 2 a 40 mm), weight 1,370 g (range 10 a 5,800 g). The most frequent histological diagnosis were serous cyst (40%), mature teratoma (28%), mucinous (6%), malignancy (4%). There were not complications related to the surgical procedure. CONCLUSIONS: The USG constitute a safe method for the diagnosis, but the image method with the highest positive predictive value is the MRI. Tumor markers (CA-125, AFP, GCH-B,DHL, ACE), are not useful during pregnancy. If the tumor doesn't achieve surgical criteria the recommended follow up is clinical observation and USG. If surgery is decided, it should be performed between 16 a 23 weeks of pregnancy, and it's recommended to send the tumor to histological diagnosis, in case of malignancy the surgery will continue according to the tumor stage. The time and delivery route will be decided by the obstetrician.

[The first Mexican consensus of endometrial cancer. Grupo de Investigación en Cáncer de Ovario y Tumores Ginecológicos de México]. / Primer consenso Mexicano de cancer de endometrio.

INTRODUCTION: Endometrial cancer (EC) is the second most common gynecologic malignancy worldwide in the peri and postmenopausal period. Most often for the endometrioid variety. In early clinical stages long-term survival is greater than 80%, while in advanced stages it is less than 50%. In our country there is not a standard management between institutions. GICOM collaborative group under the auspice of different institutions have made the following consensus in order to make recommendations for the management of patients with this type of neoplasm. MATERIAL AND METHODS: The following recommendations were made by independent professionals in the field of Gynecologic Oncology, questions and statements were based on a comprehensive and systematic review of literature. It took place in the context of a meeting of four days in which a debate was held. These statements are the conclusions reached by agreement of the participant members. RESULTS: Screening should be performed women at high risk (diabetics, family history of inherited colon cancer, Lynch S. type II). Endometrial thickness in postmenopausal patients is best evaluated by transvaginal US, a thickness greater than or equal to 5 mm must be evaluated. Women taking tamoxifen should be monitored using this method. Abnormal bleeding in the usual main symptom, all post menopausal women with vaginal bleeding should be evaluated. Diagnosis is made by histerescopy-guided biopsy. Magnetic resonance is the best image method as preoperative evaluation. Frozen section evaluates histologic grade, myometrial invasion, cervical and adnexal involvement. Total abdominal hysterectomy, bilateral salpingo oophorectomy, pelvic and para-aortic lymphadenectomy should be performed except in endometrial histology grades 1 and 2, less than 50% invasion of the myometrium without evidence of disease out of the uterus. Omentectomy should be done in histologies other than endometriod. Surgery should be always performed by a Gynecologic Oncologist or Surgical Oncologist, laparoscopy is an alternative, especially in patients with hypertension and diabetes for being less morbid. Adjuvant treatment after surgery includes radiation therapy to the pelvis, brachytherapy, and chemotherapy. Patients with Stages III and IV should have surgery with intention to achieve optimal cytoreduction because of the impact on survival (51 m vs. 14 m), the treatment of recurrence can be with surgery depending on the pattern of relapse, systemic chemotherapy or hormonal therapy. Follow-up of patients is basically clinical in a regular basis. CONCLUSIONS: Screening programme is only for high risk patients. Multidisciplinary treatment impacts on survival and local control of the disease, including surgery, radiation therapy and chemotherapy, hormonal treatment is reserved to selected cases of recurrence. This is the first attempt of a Mexican Collaborative Group in Gynecology to give recommendations is a special type of neoplasm.

[Pregnancy after conservative management of endometrial cancer]. / Embarazo después del tratamiento conservador de cáncer de endometrio.

OBJECTIVE: To show the reproductive future of a case of endometrial cancer with conservative management. MATERIAL AND METHODS: a case report and literature review. 31 years old woman, with a history of infertility of three years and abnormal uterine bleeding of one year, diagnosed with well differentiated endometrial adenocarcinoma IA GI. Treatment was initiated with 500 mg of progesterone three times a week for 6 months, after an endometrial curettage reporting healthy endometrium, pregnancy was achieved with homologous artificial insemination after hysteroscopy and directed biopsy with laparoscopic control by assisted reproduction service. RESULTS: Exploratory laparotomy and cesarean section was performed at 38 weeks of pregnancy, giving a 3.340 g weight male with Apgar score 9/9. A review of abdominal cavity and an obstetric curettage were performed. Biopsies were taken from slides and peritoneal lavage, Neoplastic changes were not reported by pathology. CONCLUSIONS: Endometrial cancer is common in adult women and is increasingly affecting young women, associated with infertility, obesity and nulliparity. The treatment of choice: total hysterectomy with bilateral salpingooforectomy. The prognosis in well-differentiated early, and infertility, permits conservative management based on progestins, with good results, low recurrence rate and preserving fertility.

Impact of a quadrivalent HPV6/11/16/18 vaccine in Mexican women: public health implications for the region.

BACKGROUND AND AIMS: Recognition of human papillomavirus (HPV) as a necessary cause of cervical cancer (CC) led to new perspectives for its control and the demonstration of an effective primary prevention strategy through vaccination. We undertook this study to evaluate the safety, efficacy and immunogenicity of a quadrivalent HPV6/11/16/18 vaccine in Mexican women. METHODS: A total of 679 Mexican women between 18 and 23 years old participated in two Phase III double-blind, randomized, placebo-controlled clinical trials of a quadrivalent HPV 6/11/16/18 vaccine. Women were enrolled who tested negative for pregnancy and reported having four or less sexual partners during their lifetime. Vaccine or placebo was administered at day 1, month 2 and month 6. RESULTS: Among Mexican women who were naïve to the respective vaccine type at enrollment, the quadrivalent vaccine was highly efficacious, preventing 100% of HPV6/11/16/18-related cervical intraepithelial neoplasia grade 2/3, adenocarcinoma in situ, condyloma and vaginal intraepithelial neoplasia. Statistical significance was not reached for every endpoint due to the limited sample size. Vaccination was generally well tolerated and immunogenic. DISCUSSION: To widely administer the vaccine, collaborative efforts should be coordinated among public, private and local community sectors. In light of the scarce knowledge of many health professionals with respect to the primary prevention of CC, it will be necessary to educate health providers on the advantages and specific recommendations of HPV vaccines and secondary prevention. Decision making should be based on scientific evidence, allowing health professionals to provide an organized social response that supports the universal right to health.

Strategies and ethical considerations for the recruitment of young men who have sex with men: challenges of a vaccination trial in Mexico.

BACKGROUND: The importance of recruiting and retaining study participants from minority groups is well recognized; however, there are no established rules for recruitment as its success depends on the setting and population. PURPOSE: To describe and analyze recruitment strategies, ethical considerations, and recruitment outcomes from a study to evaluate the efficacy the Human Papilloma Virus vaccine in young men who have sex with men (MSM). METHODS: The recruitment settings were university and community sites in the state of Morelos, Mexico. Eligibility requirement were men between 18 and 23 years old, who were free of anal-genital lesions as confirmed by clinical exploration, HIV negative, with no history of sexual relations with female partners and with fewer than five male lifetime sexual partners. Recruitment goals were 25 study participants in a four and a half month period. In addition to traditional recruitment strategies (flyers and media advertising, specific training of the recruitment team and adequate choice of recruitment sites)-engagement of local leaders in the MSM community formed a crucial part of the strategy. Special consideration was given to confidentiality and respect for study participants and a Bill of Participant Rights was developed as an explicit commitment to respect and acceptance. RESULTS: In total 723 MSM were initially contacted, 243 filled out the recruitment questionnaire, of which 151 met the criteria to be invited to the clinical examination. After clinical examination and interviews with the recruitment team, 131 fulfilled the inclusion criteria, of whom 73 were enrolled in the study - nearly triple the recruitment goal. Among the initial recruitment strategies (application of the screening questionnaire) attending meetings with MSM activist organizations was the most successful (326), followed by recruitment at bars and dance clubs (107). LIMITATIONS: The recruitment strategies should be formally evaluated for their effectiveness to identify those which are most successful. In addition, future studies should consider the evaluation of study participants' perceptions of the recruitment strategies. CONCLUSIONS: Recruiting MSM in a developing country such as Mexico presented multiple challenges. We recommend that future studies actively engage the local MSM community and pay special attention to designing recruitment strategies that guarantee the confidentiality of and respect for participants.