Field experience with the 8-HPV-type oncoprotein test for cervical cancer screening among HPV-positive women living with and without HIV in LMICs.

Overexpression of HPV-oncoproteins E6 and E7 is necessary for HPV-driven cervical carcinogenesis. Hence, these oncoproteins are promising disease-specific biomarkers. We assessed the technical and operational characteristics of the 8-HPV-type OncoE6/E7 Cervical Test in different laboratories using cervical samples from HPV-positive women living with (WLWH) and without HIV. The 8-HPV-type OncoE6/E7 Test (for short: "OncoE6/E7 test") was performed in 2833 HIV-negative women and 241 WLWH attending multicentric studies in Latin America (ESTAMPA study), and in Africa (CESTA study). Oncoprotein positivity were evaluated at each testing site, according to HIV status as well as type-specific agreement with HPV-DNA results. A feedback questionnaire was given to the operators performing the oncoprotein test to evaluate their impression and acceptability regarding the test. The OncoE6/E7 test revealed a high positivity rate heterogeneity across all testing sites (I2: 95.8%, p < .01) with significant lower positivity in WLWH compared to HIV-negative women (12% vs 25%, p < .01). A similar HPV-type distribution was found between HPV DNA genotyping and oncoprotein testing except for HPV31 and 33 (moderate agreement, k = 0.57). Twenty-one laboratory technicians were trained on oncoprotein testing. Despite operators' concerns about the time-consuming procedure and perceived need for moderate laboratory experience, they reported the OncoE6/E7 test as easy to perform and user-friendly for deployment in resource-limited settings. The high positivity rate variability found across studies and subjectivity in test outcome interpretation could potentially results in oncoprotein false positive/negative, and thus the need for further refinements before implementation of the oncoprotein testing in screen-triage-and-treat approaches is warranted.

Performance of visual inspection of the cervix with acetic acid (VIA) for triage of HPV screen-positive women: results from the ESTAMPA study.

VIA is recommended for triage of HPV-positive women attending cervical screening. In the multicentric ESTAMPA study, VIA performance for detection of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) among HPV-positive women was evaluated. Women aged 30-64 years were screened with HPV testing and cytology and referred to colposcopy if either test was positive. At colposcopy visit, study-trained midwives/nurses/GPs performed VIA ahead of colposcopy. VIA was considered positive if acetowhite lesions were observed in or close to the transformation zone. Ablative treatment eligibility was assessed for VIA positives. Performance indicators were estimated. Three thousand one hundred and forty-two HPV-positive women were included. Sensitivity for CIN3+ was 85.9% (95% CI 81.2-89.5) among women <50 years and, although not significant, slightly lower in women 50+ (78.0%, 95% CI 65.9-86.6). Overall specificity was 58.6% (95% CI 56.7-60.5) and was significantly higher among women 50+ (70.3%, 95% CI 66.8-73.5) compared to women <50 (54.3%, 95% CI 52.1-56.5). VIA positivity was lower among women 50+ (35.2%, 95% CI 31.9-38.6) compared to women <50 (53.2, 95% CI 51.1-55.2). Overall eligibility for ablative treatment was 74.5% and did not differ by age. VIA sensitivity, specificity, and positivity, and ablative treatment eligibility varied highly by provider (ranges: 25%-95.4%, 44.9%-94.4%, 8.2%-65.3%, 0%-98.7%, respectively). VIA sensitivity for cervical precancer detection among HPV-positive women performed by trained providers was high with an important reduction in referral rates. However, scaling-up HPV screening triaged by VIA will be challenging due to the high variability of VIA performance and providers' need for training and supervision.

Breast cancer in Colombia: a growing challenge for the healthcare system.

AIM: To provide a comprehensive overview of breast cancer in Colombia. METHODS: Data on breast cancer in Colombia are scarce. We present incidence data from population-based cancer registries that represent 4 distinct regions of the country. Other data originate from non-governmental institutions and healthcare providers within Colombia, official sources, expert opinion, Colombian legislation, and the Cancer Mortality Atlas publishes by Colombian National Cancer Institute. RESULTS: In Colombia, the age-standardized incidence rate remained relatively stable between 2012 and 2020 (43.1 to 47.8 cases per 100,000 women-years); Additionally, survival since 1995 has presented a substantial improvement from 65.7 to 72.1. In 33% of cases, the diagnosis of breast cancer was made in advanced stages, stage III or higher. The health demography survey conducted in 2015 showed that the participation in mammography screening in women aged 40 to 69 remains low 48.1%. Some limitations regarding access to early detection and diagnosis include economic strata, health insurance coverage, origin, and accessibility. On average, a 90-day period was reported from onset of symptoms to diagnosis of breast cancer. CONCLUSION: The first action towards improving outcomes in breast cancer should be to improve stage at diagnosis and timely access to care.

Accuracy of combined molecular and morphology-based triage for HPV-positive women in routine cervical cancer screening services from Colombia.

WHO cervical cancer elimination goals comprise 70% of highly-sensitive screening coverage and 90% treatment of precancerous lesions. Triage for HPV-positive women may challenge sensitivity of screening algorithms and women's follow-up, particularly in low- and middle-income countries (LMIC) where screening quality and protocol adherence are frequently deficient. We aimed to determine the accuracy of triage for HPV positive women in routine screening services from Colombia by a prospective cross-sectional study. Consecutively, HPV DNA-positive women underwent six triage strategies (conventional cytology, two methods of visual inspection, HPV16/18/45-genotyping, telomerase, and HPV mRNA). Positive triage results underwent regular colposcopy/biopsy in public hospitals. Adjusted sensitivity, specificity, and predictive values for CIN2+/CIN3+ were estimated for stand-alone and combined tests. We explored the impact of triage strategies on referral rates and the complete screening algorithm (screening plus triage). Overall 16,242 women underwent HPV screening and 1789 (11.0%) were HPV-positive. In total, 20.1% of women were lost to follow-up. mRNA showed the highest positivity rate (0.64 among HPV-positive and 0.05 among the total screened cohort), the highest sensitivity (0.94 95%CI 0.75-0.96), and the lowest specificity (0.36 95%CI 0.29-0.43). Parallel testing with HPV-mRNA revealed the highest increase in sensitivity for all triage strategies. Accuracy of cytology and visual inspection differ between screening units but parallel testing with HPV16/18/45 genotyping significantly increased their sensitivity (over 0.80). Morphology-based triage for HPV-positive women remains a suitable alternative for routine practice in LMIC if combined with HPV16/18/45-genotyping; however, point-of-care triage would be preferable to reduce losses to follow-up. HPV-mRNA triage deserves cost-benefit analyses.

Performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus: results from the ESTAMPA multicentric screening study.

BACKGROUND: Colposcopy, currently included in WHO recommendations as an option to triage human papillomavirus (HPV)-positive women, remains as the reference standard to guide both biopsy for confirmation of cervical precancer and cancer and treatment approaches. We aim to evaluate the performance of colposcopy to detect cervical precancer and cancer for triage in HPV-positive women. METHODS: This cross-sectional, multicentric screening study was conducted at 12 centres (including primary and secondary care centres, hospitals, laboratories, and universities) in Latin America (Argentina, Bolivia, Colombia, Costa Rica, Honduras, Mexico, Paraguay, Peru, and Uruguay). Eligible women were aged 30-64 years, sexually active, did not have a history of cervical cancer or treatment for cervical precancer or a hysterectomy, and were not planning to move outside of the study area. Women were screened with HPV DNA testing and cytology. HPV-positive women were referred to colposcopy using a standardised protocol, including biopsy collection of observed lesions, endocervical sampling for transformation zone (TZ) type 3, and treatment as needed. Women with initial normal colposcopy or no high-grade cervical lesions on histology (less than cervical intraepithelial neoplasia [CIN] grade 2) were recalled after 18 months for another HPV test to complete disease ascertainment; HPV-positive women were referred for a second colposcopy with biopsy and treatment as needed. Diagnostic accuracy of colposcopy was assessed by considering a positive test result when the colposcopic impression at the initial colposcopy was positive minor, positive major, or suspected cancer, and was considered negative otherwise. The main study outcome was histologically confirmed CIN3+ (defined as grade 3 or worse) detected at the initial visit or 18-month visit. FINDINGS: Between Dec 12, 2012, and Dec 3, 2021, 42 502 women were recruited, and 5985 (14·1%) tested positive for HPV. 4499 participants with complete disease ascertainment and follow-up were included in the analysis, with a median age of 40·6 years (IQR 34·7-49·9). CIN3+ was detected in 669 (14·9%) of 4499 women at the initial visit or 18-month visit (3530 [78·5%] negative or CIN1, 300 [6·7%] CIN2, 616 [13·7%] CIN3, and 53 [1·2%] cancers). Sensitivity was 91·2% (95% CI 88·9-93·2) for CIN3+, whereas specificity was 50·1% (48·5-51·8) for less than CIN2 and 47·1% (45·5-48·7) for less than CIN3. Sensitivity for CIN3+ significantly decreased in older women (93·5% [95% CI 91·3-95·3] in those aged 30-49 years vs 77·6% [68·6-85·0] in those aged 50-65 years; p<0·0001), whereas specificity for less than CIN2 significantly increased (45·7% [43·8-47·6] vs 61·8% [58·7-64·8]; p<0·0001). Sensitivity for CIN3+ was also significantly lower in women with negative cytology than in those with abnormal cytology (p<0·0001). INTERPRETATION: Colposcopy is accurate for CIN3+ detection in HPV-positive women. These results reflect ESTAMPA efforts in an 18-month follow-up strategy to maximise disease detection with an internationally validated clinical management protocol and regular training, including quality improvement practices. We showed that colposcopy can be optimised with proper standardisation to be used as triage in HPV-positive women. FUNDING: WHO; Pan American Health Organization; Union for International Cancer Control; National Cancer Institute (NCI); NCI Center for Global Health; National Agency for the Promotion of Research, Technological Development, and Innovation; NCI of Argentina and Colombia; Caja Costarricense de Seguro Social; National Council for Science and Technology of Paraguay; International Agency for Research on Cancer; and all local collaborative institutions.

Reduction in Vaccine HPV Type Infections in a Young Women Group (18-25 Years) Five Years after HPV Vaccine Introduction in Colombia.

In Colombia, the human papillomavirus (HPV) vaccine was launched in 2012 in the context of a school-based national vaccination program targeting girls ages 9 to 14 and offering catch-up vaccination for girls ages 14 to 17. In this study, we evaluated the program's impact on type-specific HPV infection by comparing HPV cervical prevalence among vaccinated and nonvaccinated women. This is a comparative cross-sectional study conducted 5 years after the quadrivalent HPV vaccination implementation in a sentinel Colombian City. This study included young women (18-25 years old) who had been vaccinated in the catch-up group and were attending universities and technical institutions, and women who attended primary health care facilities for Pap smear screening. The HPV prevalence of 1,287 unvaccinated women was compared with the prevalence of 1,986 vaccinated women. The prevalence of HPV16/18 infections was significantly lower in vaccinated compared with unvaccinated women (6.5% vs. 15.4%; P < 0.001), whereas for HPV6/11 infections, a decrease of 63.7% in vaccinated women (1.02% vs. 2.81%) was observed. The adjusted effectiveness to HPV16/18 was 61.4%; 95% CI, 54.3%-67.6%. However, the effectiveness against HPV16/18 was significantly higher among women vaccinated before their sexual debut 91.5%; 95% CI, 86.8-94.5, compared with effectiveness for vaccination after their sexual debut, 36.2%; 95% CI, 23.6-46.7. Five years after the introduction of HPV vaccines in Colombia, high effectiveness of HPV to prevent HPV16/18 infections is observed in the catch-up cohorts including virgin and sexually active women. PREVENTION RELEVANCE: Monitoring HPV vaccines post-licensure plays an important role in assessing the progress of immunization programs, demonstrating the impact of vaccines on the population, and providing data for policy needs. In Colombia, HPV vaccines showed effectiveness when administered before start of sexual activity, and two doses are sufficient to achieve good protection.

Distribution of human papillomavirus genotypes by severity of cervical lesions in HPV screened positive women from the ESTAMPA study in Latin America.

The proportion of HPV16 and 18-associated cervical cancer (CC) appears rather constant worldwide (≥70%), but the relative importance of the other HR-HPV differs slightly by geographical region. Here, we studied the HPV genotype distribution of HPV positive Latin American (LA) women by histological grade, in a sub-cohort from the ESTAMPA study; we also explored the association of age-specific HPV genotypes in severe lesions. Cervical samples from 1,252 participants (854 ≤CIN1, 121 CIN2, 194 CIN3 and 83 CC) were genotyped by two PCRs-Reverse Blotting Hybridization strategies: i) Broad-Spectrum General Primers 5+/6+ and ii) PGMY9/11 PCRs. HPV16 was the most frequently found genotype in all histological grades, and increased with the severity of lesions from 14.5% in ≤ CIN1, 19.8% in CIN2, 51.5% in CIN3 to 65.1% in CC (p < 0.001). For the remaining HR-HPVs their frequency in CC did not increase when compared to less severe categories. The nonavalent vaccine HR-types ranked at the top in CC, the dominant ones being HPV16 and HPV45. HR-HPV single infection occurs, respectively, in 57.1% and 57.0% of ≤CIN1 and CIN2, increasing to 72.2% and 91.6% in CIN3 and CC (p<0.001). No association between age and HPV type was observed in CC, although the risk of HPV16 infection in CIN3 cases increased with age. Results confirm the relevance of HPV16 in the whole clinical spectrum, with a strong rise of its proportion in CIN3 and cancer. This information will be relevant in evaluating the impact of HPV vaccination, as a baseline against which to compare genotype changes in HPV type-specific distribution as vaccinated women participate in screening in LA region. Likewise, these data may help select the best HPV testing system for HPV-based efficient, affordable, and sustainable screening programmes.

Implementing HPV testing in 9 Latin American countries: The laboratory perspective as observed in the ESTAMPA study.

Background: Replacement of cytology screening with HPV testing is recommended and essential for cervical cancer elimination. HPV testing for primary screening was implemented in 12 laboratories within 9 Latin American countries, as part of the ESTAMPA cervical cancer screening study. Our observations provide information on critical operational aspects for HPV testing implementation in diverse resource settings. Methods: We describe the implementation process of HPV testing in ESTAMPA, focusing on laboratory aspects. We assess the readiness of 12 laboratories to start HPV testing and their continuity capacity to maintain good quality HPV testing until end of recruitment or up to December 2021. Readiness was based on a checklist. Information from the study database; regular meetings and monitoring visits; and a questionnaire on laboratory operational aspects sent in May 2020 were used to assess continuity capacity. Compliance with seven basic requirements (readiness) and eight continuity requirements (continuity capacity) was scored (1 = compliant, 0 = not compliant) and totaled to classify readiness and continuity capacity as very limited, limited, moderate or high. Experiences, challenges, and enablers of the implementation process are also described. Results: Seven of 12 laboratories had high readiness, three moderate readiness, and of two laboratories new to HPV testing, one had limited readiness and the other very limited readiness. Two of seven laboratories with high readiness also showed high continuity capacity, one moderate continuity capacity, and the other four showed limited continuity capacity since they could not maintain good quality HPV testing over time. Among three laboratories with moderate readiness, one kept moderate continuity capacity and two reached high continuity capacity. The two laboratories new to HPV testing achieved high continuity capacity. Based on gained expertise, five laboratories have become part of national screening programs. Conclusion: High readiness of laboratories is an essential part of effective implementation of HPV testing. However, high readiness is insufficient to guarantee HPV testing high continuity capacity, for which a "culture of quality" should be established with regular training, robust monitoring and quality assurance systems tailored to local context. All efforts to strengthen HPV laboratories are valuable and crucial to guarantee effective implementation of HPV-based cervical screening.

Comprehensive evaluation of cervical cancer screening programs: the case of Colombia.

OBJECTIVE: To identify critical screening program factors for reducing cervical cancer mortality in Colombia. MATERIAL AND METHODS: Coverage, quality, and screening follow-up were evaluated in four Colombian states with different mortality rates. A case-control study (invasive cancer and healthy controls) evaluating screening history was performed. RESULTS: 3-year cytology coverage was 72.7%, false negative rate 49%, positive cytology follow-up 64.2%. There was no association between screening history and invasive cancer in two states having high cytology coverage but high false negative rates. Two states revealed association between deficient screening history and invasive cancer as well as lower positive-cytology follow-up. CONCLUSIONS: Reduced number of visits between screening and treatment is more relevant when low access to health care is present. Improved quality is a priority if access to screening is available. Suitable interventions for specific scenarios and proper appraisal of new technologies are compulsory to improve cervical cancer screening. Comprehensive process-failure audits among invasive cancer cases could improve program evaluation since mortality is a late outcome.

Estimation of the Need for Radiation Therapy Services According to the Incidence of Cancer in Colombia to 2035.

PURPOSE: To estimate the supply and demand of current and future radiation therapy services by 2035 for Colombia. METHODS AND MATERIALS: The present study was performed by surveying different radiation therapy services identified in Colombia through the Colombian Association of Radiation Oncology. The demand was estimated based on incident cases and published information on the use of radiation therapy by type of cancer. Future demand was estimated under the assumption that incidence rates do not change and therefore the change in the number of cases is due to the change in the age structure of the Colombian population. Sensitivity analyses were conducted on the percentage of radiation therapy use by type of cancer. A Monte Carlo simulation was carried out to estimate the distribution of cases requiring radiation therapy, the amount of equipment, and the number of staff needed for care with the use of this technology. RESULTS: In total, Colombia has 69 linear accelerators, 2 radiosurgery equipment, 30 high-dose-rate brachytherapy pieces of equipment, 124 radiation therapy oncologists (113 working, 9 not working, and 2 not informed), and 275 radiation therapy technologists as of June 2020. It was estimated that to meet the current cancer burden the country would need a total of 162 radiation therapy oncologists, 121 medical physicists, and 323 radiation therapy technologists and to increase the number of radiation therapy technologists, radiation therapy oncologists, and medical physicists to 491, 246, and 184, respectively, to meet the disease burden by 2035 (73,684-88,743 cases per year). CONCLUSIONS: In Colombia it is estimated that there is a deficit of human resources and technology for radiation therapy; therefore, there is need to investment resources from the public and private sectors to provide timely and quality care to cancer patients requiring this treatment.

Psycho-social impact of positive human papillomavirus testing in Jujuy, Argentina results from the Psycho-Estampa study.

Human papillomavirus (HPV) testing can have a negative impact on women's lives which might also result in abandoning the follow-up and treatment process. This study measured the psycho-social impact of HPV-positivity among HPV-tested women from Jujuy, Argentina, a middle-low income setting. In this cross-sectional study (2015-2016), the psycho-social impact of HPV-positivity was measured using the Psycho-Estampa Scale, specifically designed and validated to be used in screening contexts. We measured mean scores for each of the five scale domains, and the Overall Impact score (Values from 1: No impact to 4: Heavy impact). We compared scores according to cytology triage diagnosis using ordinal logistic regression. A total of 163 HPV-positive women were recruited at the Centro Carlos Alvarado hospital and included in the study sample; of these, 124 (76.1%) had normal triage cytologies. The overall Impact score was between low and moderate (mean:2.56, SD:0.65). The highest psycho-social impact was measured in the Worries about cancer and treatment domain (mean score:3.60, SD:0.60), followed by Sexuality domain (mean:2.50; SD:1.00). The Uncertainty about information provided by health providers domain had the lowest mean score (mean:2.14, SD:0.73). Compared to women with normal cytologies (n = 124), women with abnormal cytologies (n = 39) had a higher likelihood of greater overall Psycho-social Impact (OR: 2.91; p = 0.0036). No statistically significant differences were found in scores of specific domains according to cytology results. It is important to devise specific counseling interventions to reduce the psycho-social impact of HPV-Testing as primary screening and its potential effect on completion of the diagnosis/ treatment process.

Prevention and control of HPV infection and HPV-related cancers in Colombia- a meeting report.

The Human Papillomavirus (HPV) Prevention and Control Board is an independent multidisciplinary board of international experts that disseminates relevant information on HPV to a broad array of stakeholders and provides guidance on strategic, technical and policy issues in the implementation of HPV control programs. In response to drastic drop of vaccine coverage following the adverse event crisis in Carmen del Bolivar, Colombia, the HPV Prevention and Control Board in collaboration with the Colombian National Cancer Institute and Colombian League Against Cancer convened a meeting in Bogota, Columbia (November 2018). The goal of the meeting was to bring together national and international group of experts to report the disease burden, epidemiology and surveillance of HPV and HPV-related cancers, to discuss the successes and especially the challenges of HPV vaccination and screening in Colombia, as well as the lessons learnt from neighbouring countries. The meeting provided a platform to confer various stakeholder's perspectives, including the role of the Colombian healthcare system and to catalyse various parts of the public health community in Colombia into effective action. The conclusion of the meeting included following suggestions to strengthen HPV prevention and control: 1) Re-introducing school-based vaccine programs, 2) Integrating primary and secondary prevention programs, 3) Developing an innovative crisis communication plan targeting healthcare workers, teachers and general population, 4) Building trust through efficient and timely communication, 5) Building strong relationship with media to ensure a stable vaccination campaign support, and 6) Promoting empathy among healthcare professionals towards patients to build trust and communicate effectively.

Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: the ESTAMPA screening study protocol.

INTRODUCTION: Human papillomavirus (HPV) testing is replacing cytology in primary screening. Its limited specificity demands using a second (triage) test to better identify women at high-risk of cervical disease. Cytology represents the immediate triage but its low sensitivity might hamper HPV testing sensitivity, particularly in low-income and middle-income countries (LMICs), where cytology performance has been suboptimal. The ESTAMPA (EStudio multicéntrico de TAMizaje y triaje de cáncer de cuello uterino con pruebas del virus del PApiloma humano; Spanish acronym) study will: (1) evaluate the performance of different triage techniques to detect cervical precancer and (2) inform on how to implement HPV-based screening programmes in LMIC. METHODS AND ANALYSIS: Women aged 30-64 years are screened with HPV testing and Pap across 12 study centres in Latin America. Screened positives have colposcopy with biopsy and treatment of lesions. Women with no evident disease are recalled 18 months later for another HPV test; those HPV-positive undergo colposcopy with biopsy and treatment as needed. Biological specimens are collected in different visits for triage testing, which is not used for clinical management. The study outcome is histological high-grade squamous intraepithelial or worse lesions (HSIL+) under the lower anogenital squamous terminology. About 50 000 women will be screened and 500 HSIL+ cases detected (at initial and 18 months screening). Performance measures (sensitivity, specificity and predictive values) of triage techniques to detect HSIL+ will be estimated and compared with adjustment by age and study centre. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethics Committee of the International Agency for Research on Cancer (IARC), of the Pan American Health Organisation (PAHO) and by those in each participating centre. A Data and Safety Monitoring Board (DSMB) has been established to monitor progress of the study, assure participant safety, advice on scientific conduct and analysis and suggest protocol improvements. Study findings will be published in peer-reviewed journals and presented at scientific meetings. TRIAL REGISTRATION NUMBER: NCT01881659.

Oncology services supply in Colombia.

OBJECTIVE: To characterize the current status of oncological services supply in Colombia. METHODS: A descriptive analysis of oncological services for cancer care in the adult and infant population that meet the requirements for operation according to the Special Register of Health Service Providers was carried out. The case - by - provider ratio was calculated based on the cancer incidence estimated for Colombia by the National Cancer Institute. RESULTS: Were identified 1,780 qualified oncology health services in the country related to specialties for providing care to cancer patients. Twenty five providers nationwide had all three qualified services: chemotherapy, radiotherapy and surgery. Nearly 50% of the offer was concentrated in Bogotá, Antioquia and Valle del Cauca. Putumayo and the Amazonas group departments, with the exception of Vaupés, did not show any oncological services. Healthcare Providers were responsible for 87.8%, and independent professionals provided 12.2%. Outpatient services were 66.7% of oncology services, 17.4% was diagnostic support services and therapeutic complementation, and 15.9% was surgical services. 87.9% of the oncological service offer in Colombia takes place in the private sector. CONCLUSIONS: The ratio between the service groups is asymmetric, with few providers jointly offering the basic services for oncology treatment, which reflects how provision is fragmented. It is necessary to redefine the concept of oncology service under a comprehensive care approach and the importance of enabling functional units, comprehensive treatment centers and other forms of care.

OBJETIVO: Caracterizar la situación actual de la oferta de servicios oncológicos en Colombia. MÉTODOS: Se realizó un análisis descriptivo de los servicios oncológicos para la atención de cáncer en población adulta e infantil, que cumplieron con los requisitos para su funcionamiento de acuerdo al Registro Especial de Prestadores de Servicios de Salud. La razón de casos por prestador se calculó a partir de la incidencia de cáncer estimada para Colombia por el Instituto Nacional de Cancerología. RESULTADOS: Se identificaron 1,780 servicios de salud oncológicos habilitados en el país relacionados con especialidades para la atención de pacientes con cáncer. 25 prestadores a nivel nacional contaron con los tres servicios habilitados: quimioterapia, radioterapia y cirugía. Cerca del 50% de la oferta se concentró en Bogotá, Antioquia y Valle del Cauca. Los departamentos de Putumayo y del grupo Amazonas, con excepción de Vaupés, no registraron servicios oncológicos. El 87.8% fue ofertado por Instituciones Prestadoras de Salud y el 12.2% fue provisto por profesionales independientes. El 66.7% de los servicios oncológicos eran de consulta externa, el 17.4% eran servicios de apoyo diagnóstico y complementación terapéutica y el 15.9% servicios quirúrgicos. El 87.9% de la oferta de servicios oncológicos en Colombia está en el sector privado. CONCLUSIONES: La relación entre los grupos de servicios es asimétrica, con pocos prestadores que ofertan de forma conjunta los servicios bases del tratamiento oncológico, lo cual refleja la fragmentación en la prestación. Es necesario redefinir el concepto de servicio oncológico bajo el enfoque de atención integral y la importancia de habilitar unidades funcionales, centros integrales de tratamiento y otras formas de atención.

Pediatric oncology services in Colombia.

In low-income countries, a child diagnosed with cancer has an 80% chance of dying, while in high-income countries more than 80% survive the disease. In Colombia, a middle-income country, the government issued new legislation that promotes the generation of comprehensive care units; nevertheless, seven years after its expedition, no institution has been recognized as such by the Ministry of Health. The objective of this study was to characterize the current offer of oncological services for cancer care in children and to identify the institutions that can be constituted in Units of Comprehensive Care of Childhood Cancer in Colombia. METHODS: descriptive study of secondary source, the Special Register of Health Providers of the Ministry of Health and Social Protection was consulted, in order to identify the institutions that had enabled hospitalization services of medium or high complexity, chemotherapy, specialized consultation, emergencies, oncological surgery, and radiotherapy or nuclear medicine. The information is reported in absolute frequencies. RESULTS: Seventy one institutions have hematology-oncology consultation, 39 institutions have chemotherapy and hospitalization services of medium or high complexity, and 18 have radiotherapy enabled. Only nine of the institutions include all the services that are necessary for comprehensive care. CONCLUSION: Colombia has a sufficient supply of services for the care of children with cancer. Only a minority are in institutions that have the capacity to guarantee the integrality of the attention.

ANTECEDENTES: En los países de bajos ingresos un niño diagnosticado con cáncer tiene un 80% de probabilidad de morir mientras que en los países de ingresos altos más del 80% sobrevive a la enfermedad. En Colombia, un país de ingresos medios, el gobierno expidió una nueva legislación que promueve la generación de unidades de atención integral; sin embargo, siete años después de su expedición, ninguna Institución ha sido reconocida como tal por el Ministerio de Salud. OBJETIVO: Caracterizar la actual oferta de servicios oncológicos para atención de cáncer en niños e identificar las instituciones que podrían ser constituirse en Unidades de Atención Integral de Cáncer Infantil en Colombia. MÉTODOS: estudio descriptivo de fuente secundaria, se consultó el Registro Especial de Prestadores de Salud del Ministerio de Salud y Protección Social; identificando las instituciones que tenían habilitados servicio de hospitalización de mediana o alta complejidad, quimioterapia, consulta especializada, urgencias, cirugía oncológica, radioterapia o medicina nuclear. Se reporta la información en frecuencias absolutas. RESULTADOS: Setenta y una instituciones cuentan con consulta de hemato-Oncología, 39 instituciones tienen servicios de quimioterapia y hospitalización de mediana o alta complejidad y 18 tienen habilitada radioterapia. Solo nueve de las instituciones incluyen la totalidad de los servicios necesarios para la atención integral. CONCLUSIÓN: Colombia cuenta con una oferta suficiente de servicios para atención de niños con cáncer. Solo una minoría se encuentra en Instituciones que tienen la capacidad de garantizar la integralidad de la atención.

Detection and Genotyping of HPV DNA in a Group of Unvaccinated Young Women from Colombia: Baseline Measures Prior to Future Monitoring Program.

In 2012, Colombia launched human papillomavirus (HPV) vaccination program for girls ages 9 to 12, and in 2013, the target age was expanded to 9 to 17 years. Monitoring the changes of HPV infection prevalence among young women has been proposed as an endpoint for early assessment of HPV vaccination programs. However, the data on HPV prevalence in young ages are very limited. The purpose of this study was to determine the prevalence of HPV infection and the distribution of genotypes in a group of nonvaccinated women ages 18 to 25 years old in three Colombian cities as baseline for the monitoring of the HPV national vaccination program. A total of 1,782 sexually active women were included. Cervical smear samples were collected to perform the Pap smear and HPV DNA detection using a Linear Array HPV assay. Of the 1,782 specimens analyzed, 60.3% were positive for any HPV type; 42.2% were positive for high-risk HPV (HR-HVP) types, and 44.4% for low-risk HPV (LR-HPV) types. Multiple and single infections were identified in 37.1% and 23.2% of samples, respectively. HR-HPV types -16, -52, and -51 were the most predominant with proportions of 11.3%, 7.92%, and 7.9%, correspondingly. The prevalence for HR-HPV 16/18 was 14.4%. HR-HPV prevalence in women with abnormal cytology (75.16%) was higher than in women with normal cytology (38.6%). In conclusion, a high prevalence of HR-HPV was observed among younger women. This HPV type-specific prevalence baseline may be used to monitor postvaccination longitudinal changes and to determine its impact on HPV-related disease incidence in Colombia population. Cancer Prev Res; 11(9); 581-92. ©2018 AACR.

Impact of operational factors on HPV positivity rates in an HPV-based screening study in Colombia.

OBJECTIVE: To assess the effect of operational factors on the positivity rates of three HPV assays. METHODS: Within the cross-sectional ESTAMPA study, women aged 30-64 years were recruited at healthcare centers from Soacha, Colombia, during 2012-2015. Cervical samples were collected for cotesting with Hybrid Capture 2 (HC2; Qiagen, Gaithersburg, MD, USA), and either Aptima (Hologic, Marlborough, MA, USA) or Cobas 4800 (Roche Diagnostics, Indianapolis, IN, USA). The effect of operational factors on assay performance was assessed using adjusted positivity rates obtained from logistic regression models. RESULTS: There were 4168 women included. For samples collected in assay-specific medium, positivity rate differences were associated with the expertise of the nurse collecting the sample (P=0.014 HC2; P=0.091 Aptima) and if sample collection occurred after an initial cytology (P=0.025 HC2; P=0.033 Aptima). If PreservCyt medium (Hologic) was used, HC2 positivity differences were observed depending on the time between sample collection and processing (P=0.026) and on the laboratory technician processing the samples (P=0.003). No differences were observed for PreservCyt samples processed with Aptima or Cobas. CONCLUSION: Nurse expertise, collection of previous cytology, processing time, and laboratory technician could influence HPV assay performance. Suitable quality assurance protocols for HPV-based screening programs are required. ClinicalTrials.gov: NCT01881659.

Comparison between Urine and Cervical Samples for HPV DNA Detection and Typing in Young Women in Colombia.

Urine sampling for HPV DNA detection has been proposed as an effective method for monitoring the impact of HPV vaccination programs; however, conflicting results have been reported. The goal of this study was to evaluate the performance of optimized urine HPV DNA testing in women aged 19 to 25 years. Optimization process included the use of first void urine, immediate mixing of urine with DNA preservative, and the concentration of all HPV DNA, including cell-free DNA fragments. Urine and cervical samples were collected from 535 young women attending cervical screening at health centers from two Colombian cities. HPV DNA detection and genotyping was performed using an HPV type-specific multiplex genotyping assay, which combines multiplex polymerase chain reaction with bead-based Luminex technology. Concordance between HPV DNA detection in urine and cervical samples was determined using kappa statistics and McNemar tests. The accuracy of HPV DNA testing in urine samples was evaluated measuring sensitivity and specificity using as reference the results obtained from cervical samples. Statistical analysis was performed using STATA11.2 software. The findings revealed an overall HPV prevalence of 60.00% in cervical samples and 64.72% in urine samples, HPV-16 being the most frequent HPV type detected in both specimens. Moreover, our results indicate that detection of HPV DNA in first void urine provides similar results to those obtained with cervical samples and can be used to monitor HPV vaccination trials and programs as evidenced by the substantial concordance found for the detection of the four vaccine types. Cancer Prev Res; 9(9); 766-71. ©2016 AACR.