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Cervical cancer remains a significant public health issue, particularly in regions with low screening uptake. This study evaluates the effectiveness of self-sampling and the 7-type HPV mRNA E6/E7 test in improving cervical cancer screening outcomes among a referral population in Mexico. A cohort of 418 Mexican women aged 25 to 65, referred for colposcopy and biopsy due to abnormal cytology results (ASC-US+), participated in this study. Self-samples were analyzed using both the 14-type HPV DNA test and the 7-type HPV mRNA E6/E7 test. The study assessed the sensitivity, specificity, positive predictive value (PPV), and the necessity of colposcopies to detect CIN3+ lesions. Participant acceptability of self-sampling was also evaluated through a questionnaire. The 7-type HPV mRNA E6/E7 test demonstrated equivalent sensitivity but significantly higher specificity (77.0%) and PPV for CIN3+ detection compared to the 14-type HPV DNA test (specificity: 45.8%, p < 0.001). The use of the HPV mRNA test as a triage tool reduced the number of colposcopies needed per CIN3+ case detected from 16.6 to 7.6 (p < 0.001). Self-sampling was highly accepted among participants, with the majority reporting confidence in performing the procedure, minimal discomfort, and willingness to undertake self-sampling at home. Self-sampling combined with the 7-type HPV mRNA E6/E7 testing offers a promising strategy to enhance cervical cancer screening by improving accessibility and ensuring precise diagnostics. Implementing these app roaches could lead to a significant reduction in cervical cancer morbidity and mortality, especially in underserved populations. Future research should focus on the long-term impact of integrating these methods into national screening programs and explore the cost-effectiveness of widespread implementation.
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Introduction: Cervical cancer screening has demonstrated high efficacy in reducing cervical cancer mortality worldwide. However, clinician sampling is often perceived as an uncomfortable procedure that could reduce screening uptake. Self-sampling methods for HPV diagnosis have shown high sensitivity, which could increase acceptance and screening rates among women. Purpose: This study aims to identify the perceived barriers and advantages of self-sampling methods versus clinician sampling for cervical cancer screening in a rural setting in Ecuador. Patients and Methods: A qualitative study was conducted. Seven focus group discussions took place in the rural Parish of El Valle in Azuay Province, Cuenca, Ecuador. Women native to this rural area were included in the study. FGDs were recorded and transcribed, and content analysis was performed to categorize and analyze the data. Results: A total of 45 women participated in the study. Clinician sampling was perceived as a painful and intrusive method. However, participants believed that it is more reliable compared to self-sampling methods, attributing this to the direct visualization of the cervix, which facilitates the detection of cervical pathologies. The perceived advantages of self-sampling included increased comfort, pain reduction, time savings, the ability to perform the test at home, and the potential for widespread availability through pharmacies or local traditional healers. Nevertheless, doubts about the test's reliability as well as the user's proficiency in self-testing posed barriers to the adoption of this technique. Conclusion: Self-sampling methods offer several advantages over clinician sampling, such as enhanced privacy, comfort, and accessibility to cancer screening. Barriers primarily revolved around users' proficiency in performing the test and the reliability of the results. Providing training for using self-sampling tests could address these barriers.
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AIM: To inform the implementation of Human Papillomavirus Self-Sampling (HPV-SS) in the workplace, we assessed the perspectives of healthcare professionals and managers on the benefits, barriers, and opportunities for improvement of a pilot program. METHODS: A qualitative descriptive study based on in-depth telephone interviews was conducted between June and August 2023. Data were analyzed through inductive thematic analysis. Fifteen health professionals from different companies and fifteen managers from the Mexican Institute of Social Security (IMSS) were interviewed. RESULTS: Participants identified several benefits of the HPV-SS, including ease of use, privacy, convenience, affordability, reduced workplace absences, and promotion of a prevention culture. However, there were also individual and organizational barriers to program implementation. The former consisted of women's concerns about collecting a reliable sample or injuring themselves, lack of confidence in the HPV test, fear of positive results, and discomfort caused by the brush used to collect the sample. Organizational barriers included failure to follow up on positive test results, lack of knowledge of program indicators, perceived negative impact on the established Pap smear cervical cancer screening indicator, and the lack of government regulations supporting HPV testing. To improve the program, participants suggested disseminating information through mass media campaigns and social networks, providing companies with additional support from IMSS preventive staff, extending the work hours of IMSS Family Medicine clinics, and training IMSS health staff on the follow-up of women with HPV test results. CONCLUSIONS: The study findings suggest potential areas for improvement in HPV-SS programs.
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Pessoal de Saúde , Infecções por Papillomavirus , Pesquisa Qualitativa , Local de Trabalho , Humanos , Feminino , Infecções por Papillomavirus/diagnóstico , Infecções por Papillomavirus/prevenção & controle , Adulto , Pessoal de Saúde/psicologia , México , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/prevenção & controle , Neoplasias do Colo do Útero/virologia , Pessoa de Meia-Idade , Manejo de Espécimes/métodos , Masculino , Detecção Precoce de Câncer/métodos , PapillomaviridaeRESUMO
Cervical cancer is the third most common gynecological cancer worldwide. Its origin is linked to intraepithelial lesions caused by high-risk Human Papillomavirus (HPV) types, detected in 99.7% of cases. Early screening is essential to prevent cancer development from these lesions. Molecular methods are more specific and offer the possibility of being performed through a self-collected sample by the patient, thus contributing to increasing screening coverage for this pathology. This study aim was to map the medical-scientific literature on existing protocols for self-sampling for HPV testing in cervical cancer screening. A search strategy was developed using the following keywords and their synonyms: "self-sampling," "professional sampling," and "HPV", on the databases: MEDLINE, Cochrane Library, Virtual Health Library - BVS, Scopus, National Institute for Health Research NHS EED, Web of Science, and EMBASE. The search strategy was formulated to identify relevant studies and describe their main characteristics, such as patient acceptance of self-sampling, cost differences between the tests used, and the accuracy of self-sampling compared to the gold standard test. A total of 876 studies were found, and 33 of those studies were included in this review. Out of these, 10 studies were domized clinical trials involving 46,751 patients, and 23 observational studies included 142,795 patients. Regarding acceptance, most studies reported a preference for self-sampling. Sensitivity analyses from various studies also showed that the low cost of self-sampling kits generally increased cost-effectiveness. The study concluded that using HPV testing on self-collected samples is a viable strategy for monitoring women with HPV.
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Detecção Precoce de Câncer , Infecções por Papillomavirus , Manejo de Espécimes , Neoplasias do Colo do Útero , Humanos , Feminino , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/virologia , Detecção Precoce de Câncer/métodos , Infecções por Papillomavirus/diagnóstico , Manejo de Espécimes/métodos , Autocuidado , Papillomaviridae/isolamento & purificaçãoRESUMO
Objective: Cervical cancer is one of the deadliest cancers among women in Latin America and Caribbean (LAC), where most of the countries have not been successful in implementing population-level cytology-based screening programs. An increasing body of evidence supports the validity of self-sampling as an alternative to clinician collection for primary Human papillomavirus (HPV) screening. Therefore, this work aims to summarize recent HPV self-sampling approaches in LAC. Method: We performed a systematic review to identify studies focused on "Self-sampling", and "Human Papillomavirus DNA test" and "Latin America" in PubMed, Embase, Web of Science, Cochrane library and SCOPUS databases for publications dating between 01 January 2017 and 15 March 2022 based on the Preferred Reporting Items for systematic reviews and meta-analysis (PRISMA) statement. Additionally, the references of the articles were carefully reviewed. Results: Of the 97 records selected, 20 studies including 163,787 participants, with sample sizes for individual studies ranging from 24 to 147,590 were included in this review. Studies were conducted in 10 LAC countries (18.5%), most with upper medium-income economies (70%). The range of age was 18 to ≥65 years. The vast majority of the studies (85%) addressed the HPV self-sampling strategy for primary cervical cancer screening with overall success for all women including under/never screened and those from special populations (rural, indigenous and gender minorities). Women generally found HPV self-sampling highly acceptable regardless of age, setting of collection, target population or country of residence. Conclusions: HPV self-sampling is a promising strategy to overcome the multiple barriers to cervical cancer screening in LAC settings and increasing attendance in underscreened women in countries/territories with well-established screening programs. Furthermore, this strategy is useful even in LAC countries/territories without organized cervical cancer screening and in special populations such as indigenous, rural and transgender women. Therefore, the information generated by the recent initiatives for HPV self-sampling approach in LAC can be beneficial for decision-making in both new and existing programs in the region.
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Self-sampling methods for HPV testing have been demonstrated to be highly sensitive and specific. The implementation of these methods in settings with a lack of infrastructure or medical attention has been shown to increase the coverage of cervical cancer screening and detect cervical abnormalities in the early stages. The aim of this study is to compare the acceptability of urine and vaginal self-sampling methods versus clinician sampling among rural women. A total of 120 women participated. Each participant self-collected urine and vaginal samples and underwent clinician sampling for Pap smear and HPV testing. After the sample collection, a questionnaire to qualify the device, technique, and individual acceptability was applied, and the additional overall preference of three sample tests was evaluated. Results: The characteristics of the participants were as follows: median age of 35 years; 40.8% were married; 46.7% had a primary level of education; median age of sexual onset of 17.6 years. Compared with clinician sampling, both vaginal self-sampling, OR 20.12 (7.67-52.8), and urine sampling, OR 16.63 (6.79-40.72), were more comfortable; granted more privacy: vaginal self-sampling, OR 8.07 (3.44-18.93), and urine sampling, OR 19.5 (5.83-65.21); were less painful: vaginal self-sampling, OR 0.07 (0.03-0.16), and urine sampling, OR 0.01 (0-0.06); were less difficult to apply: vaginal self-sampling, OR 0.16 (0.07-0.34), and urine sampling, OR 0.05 (0.01-0.17). The overall preference has shown an advantage for vaginal self-sampling, OR 4.97 (2.71-9.12). No statistically significant preference was demonstrated with urine self-sampling versus clinician sampling. Conclusions: Self-sampling methods have a high acceptance in rural communities. Doubts on the reliability of self-sampling often appear to be a limitation on its acceptability. However, the training and education of the community could increase the uptake of these methods.
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Introduction: Understanding community women's relational and financial empowerment in social entrepreneurship could be the key to scaling up community-based human papillomavirus (HPV) self-sampling programs in low- and middle-income countries. The Hope Project, social entrepreneurship in Peru, trains women (Hope Ladies) to promote HPV self-sampling among other women in their communities. This study aims to evaluate the Hope Ladies' relational and financial empowerment after participating in the program. Materials and Methods: We evaluated the Hope Ladies' experiences of empowerment in social entrepreneurship using a parallel convergent mixed methods design. The Hope Ladies participated in semi-structured in-depth interviews (n = 20) and an eight-questions five-point Likert scale survey that evaluated their relational (n = 19)/financial (n = 17) empowerment. The interview and the survey questions were developed using three empowerment frameworks: Kabeer's conceptual framework, International Center for Research on Women's economic empowerment indicators, and the Relational Leadership Theory. Deductive content analysis was used to evaluate the interviews with pre-determined codes and categories of empowerment. Descriptive statistics were used to analyze the survey results. Qualitative and quantitative data were integrated through a cross-case comparison of emergent themes and corresponding survey responses during the results interpretation. Results: All Hope Ladies reported experiencing increased empowerment in social entrepreneurship. Interviews: The women reported challenges and improvement in three categories of empowerment: (1) resources (balancing between household and Hope Lady roles, recognition from the community as a resource, camaraderie with other Hope Ladies); (2) agency (increased knowledge about reproductive health, improved confidence to express themselves, and ability to speak out against male-dominant culture); and (3) achievement (increased economic assets, improved ability to make financial decisions, and widened social network and capital, and technology skills development). Survey: All (100%) agreed/totally agreed an increase in social contacts, increased unaccompanied visits to a healthcare provider (86%), improved confidence in discussing reproductive topics (100%), improved ability to make household decisions about money (57% pre-intervention vs. 92% post-intervention). Conclusions: The Hope Ladies reported improved relational and financial empowerment through participating in community-based social entrepreneurship. Future studies are needed to elucidate the relationship between empowerment and worker retention/performance to inform the scale-up of HPV self-sampling social entrepreneurship programs.
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Alphapapillomavirus , Infecções por Papillomavirus , Empreendedorismo , Feminino , Humanos , Masculino , Papillomaviridae , PeruRESUMO
Background: Cost data of human papillomavirus (HPV) self-sampling programs from low-and-middle-income countries is limited. We estimated the total and unit costs associated with the Hope Project, a community-based HPV self-sampling social entrepreneurship in Peru. Methods: We conducted a micro-costing analysis from the program perspective to determine the unit costs of (1) recruitment/training of community women (Hope Ladies); (2) Hope Ladies distributing HPV self-sampling kits in their communities and the laboratory testing; and (3) Hope Ladies linking screened women with follow-up care. A procedural manual was used to identify the program's activities. A structured questionnaire and in-depth interviews were conducted with administrators to estimate the resource/time associated with activities. We obtained unit costs for each input previously identified from budgets and expenditure reports. Findings: From November 2018 to March 2020, the program recruited and trained 62 Hope Ladies who distributed 4,882 HPV self-sampling kits in their communities. Of the screened women, 586 (12%) tested HPV positive. The annual cost per Hope Lady recruited/trained was $147·51 (2018 USD). The cost per HPV self-sampling kit distributed/tested was $45·39, the cost per woman followed up with results was $55·64, and the cost per HPV-positive woman identified was $378·14. Personnel and laboratory costs represented 56·1% and 24·7% of the total programmatic cost, respectively. Interpretation: Our findings indicate that implementation of a community-based HPV self-sampling has competitive prices, which increases its likelihood to be feasible in Peru. Further economic evaluation is needed to quantify the incremental benefits of HPV self-sampling compared to more established options such as Pap tests. Funding: Thomas Francis Jr. Fellowship provided funding for data collection. The Hope Project was funded by grants from Grand Challenges Canada (TTS-1812-21131), Uniting for Health Innovation, Global Initiative Against HPV and Cervical Cancer, University of Manitoba, and the John E. Fogarty International Center (5D43TW009375-05).
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This study conducted among transgender women in São Paulo, Brazil assessed the acceptability and suitability of screening sexually transmitted infections (STIs), such as Chlamydia trachomatis and Neisseria gonorrhoeae, by sampling multiple anatomical sites (i.e. urethral, anorectal, oropharyngeal, and neovaginal), and utilizing self- or provider-collection methods. First, a convenience sample of 23 cohort participants were recruited during a scheduled study visit between October and November 2018. Data collection was through a short investigator-led quantitative survey in Portuguese, and included presentation of investigator-designed, gender-neutral instructional diagrams to guide self-sampling. Three supplemental focus group discussions (FGDs) with a total of 30 participants guided by semi-structured script were conducted in Portuguese between September and October 2019. All participants reported being assigned male sex at birth and self-identified with a feminine gender identity at time of study. All survey respondents (100%; n = 23) indicated willingness to provide samples for STI screening during a future study visit. Preference was for self-collection of urine samples (83%; n = 19), urethral swabs (82%; n = 18), and anorectal swabs (77%; n = 17). A lower preference for self-collection of oropharyngeal swabs (48%; n = 11) was observed. Most respondents (78%; n = 18) indicated that they would not prefer specimens to be collected by a health professional, mainly due to 'more privacy' (72%; n = 13). All respondents indicated that they would feel comfortable to provide a self-collected sample based on instructional diagrams shown. In FGDs, although the collection by a health professional was described as a technically safer option for some participants, there was a preference for self-collection to avoid discomfort and embarrassment in exposing the body. Overall, this sub-study suggested acceptability among transgender women of introducing self-sampling for etiological diagnosis of STIs from potential infection sites. Uptake and usability will be explored further in a cross-sectional STI prevalence study of transgender women in Brazil.
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Infecções por Chlamydia , Gonorreia , Infecções Sexualmente Transmissíveis , Pessoas Transgênero , Brasil/epidemiologia , Infecções por Chlamydia/diagnóstico , Chlamydia trachomatis , Estudos Transversais , Feminino , Identidade de Gênero , Gonorreia/diagnóstico , Humanos , Recém-Nascido , Estudos Longitudinais , Masculino , Neisseria gonorrhoeae , Prevalência , Infecções Sexualmente Transmissíveis/diagnóstico , Infecções Sexualmente Transmissíveis/epidemiologiaRESUMO
BACKGROUND: HPV primary screening has shown effectiveness for cancer prevention; however, gynaecological examination is considered uncomfortable. Self-sampling methods increase the acceptance of screening. The aim of this study is to compare the sensitivity and specificity of clinician sampling versus vaginal and urine self-sampling for HPV diagnosis. METHODS: A diagnostic test study was conducted in a rural parish of Cuenca, Ecuador. A total of 120 women participated. Each participant self-collected urine and vaginal samples and underwent clinician sampling for HPV testing. The latter was considered as the golden standard. All three samples were processed with the same amplification and hybridization protocol for HPV detection (Hybribio) following the manufacturer's instructions. RESULTS: Characteristics of the participants were: median age 35 years; 40.8% married; 46.7% had a primary level of education; and median age of sexual onset, 17.6 years. The prevalence of any type of HPV with clinician sampling was 15.0%, 17.5% with urine sampling and 18.3% with vaginal self-sampling. Self-sampling sensitivity reached 94.4% (IC 74.2-99.9), and specificity 92.1% (IC 85.2-95.9). Urine sampling had a sensitivity of 88.8% (IC 67.2, 96.9), and specificity 94.1% (IC 67.2-96.9). The negative predictive value was 98.9% (IC 94.2-99.8) for vaginal self-sampling and 97.6% (IC 92.6-99.4) for urine sampling. CONCLUSIONS: This study shows that vaginal and urine self-sampling methods have similar sensitivity and specificity compared with clinician sampling for the diagnosis of HPV. The correlation between HPV genotypes among the three tests is satisfactory.
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Infecções por Papillomavirus , Displasia do Colo do Útero , Neoplasias do Colo do Útero , Adolescente , Adulto , Testes Diagnósticos de Rotina , Detecção Precoce de Câncer/métodos , Equador/epidemiologia , Feminino , Humanos , Masculino , Papillomaviridae/genética , Infecções por Papillomavirus/diagnóstico , Infecções por Papillomavirus/epidemiologia , População Rural , Sensibilidade e Especificidade , Manejo de Espécimes/métodos , Neoplasias do Colo do Útero/prevenção & controle , Esfregaço Vaginal , Displasia do Colo do Útero/diagnósticoRESUMO
METHODS: The descriptive, cross-sectional design included a convenience sample of Mexican women with a previous diagnosis of cervical dysplasia. RESULTS: Women (n = 61) were young adults (M = 27 years, SD = 6.92) reporting single marital status (55%) and sexually active (93%). Mean age at onset of sexual activity was 17 years; a majority of women (78.8%) had more than one sexual partner in their lifetime with 56.6% reporting between two and five partners. All (100%) of the women indicated that they would "choose self-sampling for HPV detection" and would recommend it to other women. Concerning "attitudes toward HPV," the women responded that it is necessary to comply with HPV treatment and understand that preventative measures can avoid HPV transmission. CONCLUSION: Women reported high acceptability for self-sampling and positive attitudes toward HPV diagnostic procedures. Women indicated substantial interest in learning more about HPV, its transmission, preventive measures, routine testing, and recommended self-sampling for HPV detection.
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Infecções por Papillomavirus , Neoplasias do Colo do Útero , Adolescente , Estudos Transversais , Detecção Precoce de Câncer , Feminino , Humanos , Infecções por Papillomavirus/prevenção & controle , Aceitação pelo Paciente de Cuidados de Saúde , Autocuidado , Neoplasias do Colo do Útero/prevenção & controle , Adulto JovemRESUMO
ABSTRACT This study conducted among transgender women in São Paulo, Brazil assessed the acceptability and suitability of screening sexually transmitted infections (STIs), such as Chlamydia trachomatis and Neisseria gonorrhoeae, by sampling multiple anatomical sites (i.e. urethral, anorectal, oropharyngeal, and neovaginal), and utilizing self- or provider-collection methods. First, a convenience sample of 23 cohort participants were recruited during a scheduled study visit between October and November 2018. Data collection was through a short investigator-led quantitative survey in Portuguese, and included presentation of investigator-designed, gender-neutral instructional diagrams to guide self-sampling. Three supplemental focus group discussions (FGDs) with a total of 30 participants guided by semi-structured script were conducted in Portuguese between September and October 2019. All participants reported being assigned male sex at birth and self-identified with a feminine gender identity at time of study. All survey respondents (100%; n = 23) indicated willingness to provide samples for STI screening during a future study visit. Preference was for self-collection of urine samples (83%; n = 19), urethral swabs (82%; n = 18), and anorectal swabs (77%; n = 17). A lower preference for self-collection of oropharyngeal swabs (48%; n = 11) was observed. Most respondents (78%; n = 18) indicated that they would not prefer specimens to be collected by a health professional, mainly due to 'more privacy' (72%; n = 13). All respondents indicated that they would feel comfortable to provide a self-collected sample based on instructional diagrams shown. In FGDs, although the collection by a health professional was described as a technically safer option for some participants, there was a preference for self-collection to avoid discomfort and embarrassment in exposing the body. Overall, this sub-study suggested acceptability among transgender women of introducing self-sampling for etiological diagnosis of STIs from potential infection sites. Uptake and usability will be explored further in a cross-sectional STI prevalence study of transgender women in Brazil.
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Resumen OBJETIVO: Conocer el grado de aceptación de la autotoma vaginal y su relación con variables psicosocioculturales que prevalecen en México. MATERIALES Y MÉTODOS: Estudio observacional, prospectivo, transversal y descriptivo, efectuado entre 2017 y 2018 en mujeres del estado de Guanajuato. Se aplicaron cuestionarios y entrevistas antes y después de la toma de la muestra mediante la autotoma. El análisis estadístico incluyó medidas de tendencia central, medidas de dispersión, frecuencias y proporciones. Las diferencias entre grupos se analizaron con las pruebas de Wilcoxon y t de Student. RESULTADOS: Se estudiaron 85 mujeres con edad promedio de 37.82 años (± 9.82). Si bien 75 participantes declararon no conocer el procedimiento, 80 accedieron a practicarlo. Se encontró que la mayoría de las mujeres prefiere la autotoma a la inspección ginecológica tradicional. Se observaron dos perfiles sociopsicológicos opuestos entre las mujeres que prefieren la autotoma por "pena" y las que optan por ella por su "facilidad". CONCLUSIONES: La autotoma fue un método de muestreo completamente viable en el contexto en el que se llevó a cabo esta investigación. Si bien se observaron barreras psicosocioculturales, la autotoma se prefirió entre las mujeres que informaron acudir menos al ginecólogo, por lo que puede constituir una estrategia para las mujeres con baja vigilancia médica.
Abstract OBJECTIVE: To know the degree of acceptance of vaginal autotomy and its relationship with psychosocial-cultural variables prevailing in Mexico. MATERIALS AND METHODS: Observational, prospective, cross-sectional and descriptive study, carried out between 2017 and 2018 in women in the state of Guanajuato. Questionnaires and interviews were applied before and after sampling by autotoma. Statistical analysis included measures of central tendency, measures of dispersion, frequencies and proportions. Differences between groups were analyzed with Wilcoxon and Student's t-tests. RESULTS: Eighty-five women with a mean age of 37.82 years (± 9.82) were studied. Although 75 participants stated that they were unaware of the procedure, 80 agreed to undergo it. It was found that the majority of women preferred autotoma to traditional gynecological inspection. Two opposite socio-psychological profiles were observed between women who prefer autotomy for "embarrassment" and those who opt for it because of its "ease". CONCLUSIONS: Autotomography was a completely feasible sampling method in the context in which this research was conducted. Although psychosocio-cultural barriers were observed, autotoma was preferred among women who reported less frequent visits to the gynecologist, so it may be a strategy for women with low medical vigilance.
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BACKGROUND: HPV self-sampling has been widely supported by the scientific community following a strong body of literature on the subject. Self-sampling is important in cervical cancer screening as it has been shown to improve participation. It is well documented that HPV-testing has proven superior to cytology with regards to sensitivity in detection of CIN and cancer. The value of self-collected samples is reliant on the quality of the molecular testing performed, as well as the patients' preference in sampling procedure and compliance to follow up on positive test results. Due to the incompatibility of self-samples and cytology, triage of HPV-DNA positives by testing for molecular biomarkers is highly warranted. METHODS: Our objective was to compare the detection rate of genital Human Papillomavirus (HPV) infection in self- and clinician-collected samples by a 14-type HPV-DNA test and a 7-type mRNA E6/E7 test. RESULTS: Five hundred five women were recruited. Each study participant had two sample collection procedures performed upon the same visit, alternating order in execution of the self-collection or the clinician-taken procedure first or second, 1010 samples in total. HPV-DNA prevalence was 22.8% in self-collected versus 19.2% in clinician-collected samples (P = 0.19). Overexpression of mRNA E6/E7 from 7 HPV types was 7.1 and 6.3%, respectively (P = 0.71). The difference between HPV-DNA and HPV-mRNA positivity rates were statistically significant in both self-collected (22.8% versus 7.1%, P < 0.001) and clinician-collected samples (19.2% versus 6.3%, P < 0.001). Overall agreement between the two collection methods was fair, with a concordance rate of 78.2% (390/505), k = 0.34 (95% CI: 0.25-0.44), P < 0.001, for the HPV-DNA test and 92.5% (467/505), k = 0.40 (95% CI, 0.25-0.56), P < 0.001, for the mRNA test, respectively. 96.8% of the participants reported they felt confident carrying out the self-collection themselves, and 88.8% reported no discomfort at all performing the procedure. CONCLUSIONS: This comparative study of two sampling methods reports fair agreement of HPV positivity rates between the self-collected and clinician-collected specimens using Abbott hrHPV and PreTect HPV-Proofer'7 tests. Only one third of HPV-DNA positive women had overexpression of mRNA E6/E7. TRIAL REGISTRATION: ISRCTN77337300 .
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Técnicas de Diagnóstico Molecular/métodos , Papillomaviridae/isolamento & purificação , Infecções por Papillomavirus/diagnóstico , Manejo de Espécimes/métodos , Adulto , DNA Viral/genética , Detecção Precoce de Câncer/métodos , Feminino , Humanos , Pessoa de Meia-Idade , Papillomaviridae/genética , RNA Mensageiro/genética , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/virologiaRESUMO
INTRODUCTION: Screening for cervical cancer (CC) prevention has substantially changed with the introduction of human papillomavirus (HPV) tests. This technology compared to cytology has increased the detection of pre-malignant and malignant cervical lesions in real-world programmes in different settings. Very importantly, through self-collection, HPV testing can reduce barriers to screening and increase coverage. However, when using HPV self-collection, triage tests are a key step in the CC prevention process, and high adherence to triage has been difficult to obtain in low-middle income settings. The aim of this study was to measure adherence to triage among women with HPV+ self-collection and analysed factors associated with this adherence in a middle-low resource setting in Argentina. We also evaluated key indicators related to the implementation of the HPV self-collection strategy. METHODS: We analysed data on screening/triage/diagnosis/treatment from women aged 30+ who performed self-collection between 2015 and 2017 (n = 15,763), in the public health system in Tucuman, Argentina. We analysed secondary data from the national screening information system. The primary outcomes were: 1) adherence to cytology triage within the recommended timeframe (120 days) and 2) overall adherence to cytology triage including data at 18 months after screening. Multivariable regression was used to examine the association between age group, year of the screening test, record of the previous Pap-based screening and health insurance status with adherence to triage test as a primary outcome. We reported odds ratios, 95% confidence intervals and p-value of 0.05, which was considered the threshold for p-values). RESULTS: We analysed data of 2,389 HPV+ women. The overall adherence to triage at 18 months was 42.9%. The percentage of women completing cytology triage within the recommended timeframe of 120 days was lower (25.2%). Women with the record of a previous Pap-based screening had 1.86 times the odds of having a triage compared to women without a record of a previous Pap-based screening (95% CI: 1.64-2.64, p <0.001). Furthermore, the probability of having triage at the recommended timeframe was higher among women who were older and women with public health insurance. CONCLUSIONS: Our results showed that adherence to triage in the recommended timeframe was low. In addition, the probability of having triage at the recommended timeframe was higher among women with a record of a previous Pap-based screening, a proxy of the use of health services. Our results showed that adherence to triage in the context of the HPV-self-collection strategy is challenging. The implementation of alternative approaches that might facilitate adherence to triage should be further investigated.
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Purpose: Sexual and gender minority persons in low-income countries have very limited access to routine health services. This study evaluated the feasibility of using a self-sampled human papillomavirus (HPV) test to increase access to screening for cervical cancer among transgender men in El Salvador. Methods: We partnered with a local advocacy organization for recruitment. A total of 24 transgender men (men assigned female at birth) ages 19-55 were enrolled and provided consent. Questionnaires assessed sociodemographics, health and sexual histories, and knowledge about HPV and cervical cancer. Screening was performed with a self-sampled HPV test. Participants with a positive test were offered colposcopy and cryotherapy treatment, if appropriate. Those with a negative test were advised to return in 5 years for rescreening. Results: Out of 24 consenting participants, 23 (95.83%) agreed to conduct HPV self-sampling, and 22/23 (95.65%) expressed willingness to self-sample in the future. Among self-sampled individuals, 3/23 (13%) tested positive and accepted colposcopy and biopsy. Analyses of biopsied tissue revealed one case of cervical intraepithelial neoplasia grade 1. Conclusion: HPV self-sampling and subsequent procedures were accepted by the majority of participants. This screening method may be a viable alternative to cytology among transgender men in El Salvador.
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Detecção Precoce de Câncer , Programas de Rastreamento/métodos , Infecções por Papillomavirus/diagnóstico , Aceitação pelo Paciente de Cuidados de Saúde , Pessoas Transgênero , Transexualidade , Neoplasias do Colo do Útero/diagnóstico , Adulto , Alphapapillomavirus , Colposcopia , El Salvador , Feminino , Identidade de Gênero , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Infecções por Papillomavirus/complicações , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/virologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Prevalência , Autocuidado , Manejo de Espécimes , Neoplasias do Colo do Útero/complicações , Neoplasias do Colo do Útero/epidemiologia , Neoplasias do Colo do Útero/virologia , Esfregaço Vaginal/métodos , Adulto JovemRESUMO
BACKGROUND: In Nicaragua, cervical cancer is the leading cause of cancer death among women. Human papillomavirus (HPV) testing, primarily using self-sampling, was introduced between 2014 and 2018 in three provinces. We analyzed data from the HPV screening program with the goal of describing key characteristics including reach, HPV prevalence, triage and treatment, and factors associated with follow-up completion. METHODS: We analyzed individual-level data from routinely collected forms for women attending HPV-based cervical cancer screening. HPV-positive women were triaged with Pap or visual inspection with acetic acid (VIA) prior to treatment. Logistic regression was used to identify factors associated with receiving triage and treatment; analyses were adjusted for province, age, and self- vs. provider-collected sampling. RESULTS: Forty-four thousand six hundred thirty-five women were screened with HPV testing; 96.6% of women used self-sampling. Six thousand seven hundred seventy-six women were HPV positive (15.2%), 54.0% of screen-positive women received triage, and 53.1% of triage-positive women were treated, primarily with cryotherapy. If women lost at triage are included, the overall treatment percentage was 27.8%. Province and provider sampling were significantly associated with completing triage. Province and triage type were significantly associated with receiving treatment. The odds of receiving treatment after Pap triage as compared to VIA was significantly lower (aOR: 0.05, 95% CI: 0.04-0.08, p < 0.001), and the relative proportion of women receiving treatment after Pap triage versus VIA was 0.29. CONCLUSIONS: Introduction of HPV testing resulted in a substantial number of women screened, and acceptance of self-sampling was high. Management of screen-positive women remained a challenge, particularly with Pap triage. Our results can inform other developing countries as they work to reach World Health Organization (WHO) elimination targets.
Assuntos
Detecção Precoce de Câncer/métodos , Papillomaviridae/isolamento & purificação , Infecções por Papillomavirus/diagnóstico , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/terapia , Adulto , Detecção Precoce de Câncer/estatística & dados numéricos , Feminino , Humanos , Pessoa de Meia-Idade , Nicarágua/epidemiologia , Infecções por Papillomavirus/epidemiologiaRESUMO
BACKGROUND: To determine whether age is a barrier against acceptability of cervicovaginal self-sampling in screening for cervical cancer at two gynecology outpatient clinics. METHODS: This is a cross-sectional study involving 116 women over 21 years of age with an abnormal Pap smear. Clinical and laboratorial data were recorded in electronic files. Women received detailed self-collection instructions. After the self-sampling procedure (Evalyn Brush®), women were instructed to answer a questionnaire about vaginal self-sampling acceptability that consisted of seven multiple-choice items. The participants were divided into three age brackets: 21 to 29 years, 30 to 49 years, and 50 years and over. Chi-square, Fischer exact, Kolmogorov-Smirnov and Kruskal-Wallis tests were used. RESULTS: The analysis of the participants' perception of the procedure stratified according to age groups showed a decline in the fear of hurting oneself during the procedure as age increased. Most participants reported that it was very easy to understand how to use the self-sampling brush and that it was easy to use it. Most of them were neither embarrassed nor afraid of getting hurt during the procedure. The majority preferred self-sampling to collection by a healthcare professional. The main reason was practicality: the possibility of choosing the place and time for sampling. CONCLUSIONS: The participating women found self-collection simple to understand and easy to accept regardless of age. The younger women indicated more fear and discomfort in self-sampling, which points to the need for attraction strategies that are more appealing to the younger generations.
Assuntos
Fatores Etários , Detecção Precoce de Câncer/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Autocuidado/psicologia , Neoplasias do Colo do Útero/prevenção & controle , Esfregaço Vaginal/psicologia , Adulto , Estudos Transversais , Detecção Precoce de Câncer/métodos , Feminino , Hospitais Universitários , Humanos , Pessoa de Meia-Idade , Papillomaviridae , Infecções por Papillomavirus/prevenção & controle , Infecções por Papillomavirus/psicologia , Projetos Piloto , Autocuidado/métodos , Inquéritos e Questionários , Neoplasias do Colo do Útero/psicologia , Esfregaço Vaginal/métodos , Adulto JovemRESUMO
BACKGROUND: Incidence and mortality rates of cervical cancer in Bolivia are the highest in Latin America. Vaginal cell self-sampling can improve screening coverage. Information on common reasons for low screening coverage and preferences for future screening are essential to reduce cervical cancer incidence. We aimed to evaluate the knowledge about human papillomavirus (HPV) and cervical cancer of Bolivian women from urban, peri-urban and rural areas of Cochabamba and to determine their degree of acceptability and confidence towards vaginal HPV self-sampling. In addition, we assessed the impact of self-sampling on cervical cancer screening coverage in a selected peri-urban area. METHODS: We gathered information from women living in urban, peri-urban and rural areas of Cochabamba province in Bolivia using two different structured questionnaires. In Survey1, we collected information from 222 women about their knowledge on HPV and cervical cancer. In Survey 2, the acceptance and confidence towards vaginal HPV self-sampling compared to the physician-sampling was assessed in 221 women. A non-probabilistic stratified sampling by areas was carried out for the two questionnaires. In the third phase of the study, we determined the impact of HPV self-sampling collection on screening coverage in a peri-urban area of Cochabamba. RESULTS: Bolivian women knew little or nothing about cervical cancer and HPV infection in all areas. They all found self-sampling collection easier to perform (86.9 to 93.2%) and more comfortable (79.4 to 83.3%) compared to physician sampling. Sampling accuracy to detect cervical cancer was probably higher in their point of view when it was taken by physician (35.1 to 63.5%). However in rural areas women preferred self-sampling. Accordingly, the campaign of vaginal HPV self-sampling in this peri-urban area increased screening coverage, reaching in three months the annual rate average. CONCLUSIONS: The knowledge about cervical cancer and HPV infection is poor in Bolivia. Despite greater acceptance of the vaginal HPV self-sampling in all areas, women kept greater confidence in the screening performed by the gynecologist although HPV self-sampling improved coverage rate.
Assuntos
Detecção Precoce de Câncer/métodos , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Autocuidado , Manejo de Espécimes/métodos , Neoplasias do Colo do Útero/prevenção & controle , Adulto , Bolívia/epidemiologia , Estudos Transversais , Detecção Precoce de Câncer/estatística & dados numéricos , Feminino , Pesquisas sobre Atenção à Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Pessoa de Meia-Idade , Papillomaviridae/isolamento & purificação , Infecções por Papillomavirus , Inquéritos e Questionários , Neoplasias do Colo do Útero/epidemiologia , Vagina/virologia , Adulto JovemRESUMO
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.