Diagnostic performance, stability, and acceptability of self-collected saliva without additives for SARS-CoV-2 molecular diagnosis.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused the coronavirus disease 2019 (COVID-19), leading to a global pandemic. The molecular diagnosis of this virus is mostly performed by collecting upper respiratory samples, which has many disadvantages, including patient discomfort and the need for trained healthcare professionals. Although saliva has emerged as a more comfortable sample, the use of additives to preserve viral RNA is expensive and, in some cases, difficult for self-collection. METHOD: This study evaluated the diagnostic performance by RT-PCR and stability of self-collected saliva using wide-mouth specimen collection cups without stabilization and/or inactivation buffers for SARS-CoV-2 detection, compared to nasopharyngeal samples and saliva collected with additives. Additionally, the study assessed the acceptability of this sample collection method among participants and healthcare personnel. RESULTS: The study included 1281 volunteers with a 24.6% positive infection rate. Saliva demonstrated comparable diagnostic performance to nasopharyngeal samples, with a sensitivity of 87.6% and specificity of 99.6%, for a total percent agreement of 96.4%. The study also showed that viral RNA in saliva remained stable for at least 72 h at different temperatures. Notably, saliva samples without additives exhibited a lower RdRp Ct compared to samples with additives, suggesting that the absence of stabilization and/or inactivation buffers does not significantly affect its performance. The study highlighted the acceptability of saliva among patients and healthcare personnel due to its noninvasive nature and ease of collection. CONCLUSIONS: This research supports the implementation of self-collected saliva as a comfortable and user-friendly alternative sample for SARS-CoV-2 diagnosis.

Implementation of an mHealth intervention to increase adherence to triage among HPV positive women with HPV-self-collection (ATICA study): post-implementation evaluation from the women's perspective.

BACKGROUND: Low adherence to triage after positive screening is a widespread problem for cervical cancer screening programs in Low- and Middle-income Countries. Adherence to cytology-based triage can be challenging, especially among women with self-collected tests. SMS-based interventions are accepted by women and can increase screening uptake. The ATICA study was an effectiveness-implementation hybrid type I trial, combining a cluster randomized controlled trial (RCT) with a mixed-methods implementation evaluation involving quantitative and qualitative methods. Although the RCT provided evidence regarding the effectiveness of the SMS-based intervention, less is known about its acceptability, relevance, and usefulness from the women´s perspective. METHODS: We carried out a cross-sectional study based on a structured questionnaire among HPV-positive women who were enrolled in ATICA's intervention group. We measured acceptability, appropriateness, and message content comprehension. Also, we evaluated if the SMS message was considered a cue to encourage women to pick up their HPV test results and promote the triage. RESULTS: We interviewed 370 HPV-positive women. Acceptability of SMS messages among women who had received at least one message was high (97%). We found high levels of agreement in all appropriateness dimensions. More than 77% of women showed high comprehension of the content. Among women who received at least one SMS message, 76% went to the health center to pick up their results. Among those who got their results, 90% reported that the SMS message had influenced them to go. We found no significant differences in acceptability, appropriateness or message comprehension between women who adhered to triage and those who did not adhere after receiving the SMS messages. CONCLUSION: The intervention was highly acceptable, and women reported SMS was an appropriate channel to be informed about HPV test results availability. SMS was also a useful cue to go to the health center to pick up results. The implementation did not encounter barriers associated with the SMS message itself, suggesting the existence of other obstacles to triage adherence. Our results support the RCT findings that scaling up SMS is a highly acceptable intervention to promote cervical screening triage adherence.

Assessing the implementation fidelity of HPV self-collection offered by community health workers during home visits (the EMA strategy): a case study in a low-middle-resource setting in Argentina.

BACKGROUND: In Argentina, HPV self-collection offered by community health workers was demonstrated to be effective to improve cervical cancer screening uptake. Based on these findings, the EMA strategy was scaled up in nine Argentinian provinces. However, there is no evidence about the degree of fidelity-in relation to the core components proposed by the National Program on Cervical Cancer Prevention-with which this strategy was implemented in the new jurisdictions. We carried out a fidelity evaluation of the EMA strategy scaling-up aimed at evaluating the level of adherence to the core components of the EMA strategy, and how different moderating factors affected the implementation fidelity. METHODS: This descriptive study used a multi-method approach involving quantitative and qualitative evaluations of the implementation fidelity using the Conceptual Framework for Implementation Fidelity. Evaluation of the degree of adherence to the core components of the EMA strategy was carried out through the analysis of a self-administered survey of health promoters, observations, and secondary data from the National Screening Information System. The analysis of moderating factors was carried out through analysis of field notes, and semi-structured interviews with key stakeholders. RESULTS: Our results showed that the core components with highest fidelity were training, sample handling, and transportation. Regarding the offer of HPV self-collection, we found some adaptations such as locations in which health promoters offered HPV self-collection, and fewer pieces of information provided to women during the offer. In the follow-up and treatment core component, we found a reduced adherence to triage and colposcopy. Some contextual factors had a negative impact on implementation fidelity, such as urban insecurity and the reduction in the number of health promoters that offered HPV self-collection. Moderating factors that contributed to achieve high level of fidelity included a well-defined strategy with clear steps to follow, permanent feedback and high level of engagement among implementers. CONCLUSIONS: Our study shows how the analysis of fidelity and adaptations of HPV self-collection in real-world contexts are key to measure and maximize its effectiveness in low-middle-income settings.

Implementation and scaling-up of an effective mHealth intervention to increase adherence to triage of HPV-positive women (ATICA study): perceptions of health decision-makers and health-care providers.

BACKGROUND: The ATICA study was a Hybrid I type randomized effectiveness-implementation trial that demonstrated effectiveness of a multicomponent mHealth intervention (Up to four SMS messages sent to HPV-positive women, and one SMS message to CHWs to prompt a visit of women with no triage Pap 60 days after a positive-test), to increase adherence to triage of HPV positive women (ATICA Study). We report data on perceptions of health decision-makers and health-care providers regarding the intervention implementation and scaling-up. METHODS: A qualitative study was carried out based on individual, semi-structured interviews with health decision-makers (n = 10) and health-care providers (n = 10). The themes explored were selected and analyzed using domains and constructs of the Consolidated Framework for Implementation Research (CFIR) and the maintenance dimension of the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. RESULTS: Both health-care providers and decision-makers had a positive assessment of the intervention through most included constructs: knowledge of the intervention, intervention source, design quality, adaptability, compatibility, access to knowledge and information, relative advantage, women's needs, and relative priority. However, some potential barriers were also identified including: complexity, leadership engagement, external policies, economic cost, women needs and maintenance. Stakeholders conditioned the strategy's sustainability to the political commitment of national and provincial health authorities to prioritize cervical cancer prevention, and to the establishment of the ATICA strategy as a programmatic line of work by health authorities. They also highlighted the need to ensure, above all, that there was staff to take Pap tests and carry out the HPV-lab work, and to guarantee a constant provision of HPV-tests. CONCLUSION: Health decision-makers and health-care providers had a positive perception regarding implementation of the multicomponent mHealth intervention designed to increase adherence to triage among women with HPV self-collected tests. This increases the potential for a successful scaling-up of the intervention, with great implications not only for Argentina but also for middle and low-income countries considering using mHealth interventions to enhance the cervical screening/follow-up/treatment process.

Effectiveness of an mHealth intervention to increase adherence to triage of HPV DNA positive women who have performed self-collection (the ATICA study): A hybrid type I cluster randomised effectiveness-implementation trial.

Background: Human Papillomavirus (HPV) self-collection offered by community health workers (CHWs) during home visits has been hampered by low levels of triage Pap among HPV-positive women. We investigated effectiveness of a mHealth intervention to increase adherence to triage Pap. Methods: We conducted a hybrid type I cluster randomised effectiveness-implementation trial in Jujuy, Argentina. CHWs (clusters) were eligible if actively offering HPV self-collection and served at least 26 women aged 30 years and over. Women were eligible if they conducted self-collection and provided a mobile phone number. 260 CHWs were randomly allocated (3:2 ratio) to a multi-component intervention (Up to four SMS messages sent to HPV-positive women, and one SMS message to CHWs to prompt a visit of women with no triage Pap 60 days after a positive-test), or control group (Usual care: Women instructed to attend their health centre 30 days after HPV self-collection to pick-up results). The primary effectiveness outcome was percentage of HPV-positive women with triage 120 days after the HPV-test result. We evaluated implementation of the intervention using the RE-AIM framework. Findings: 221 CHWs (132 intervention, 89 control group) contacted 5389 women; and 5351 agreed to participate (3241 intervention, 2110 control group). In total 314/445 (70·5%) HPV-positive women of the intervention group had triage at 120 days after the HPV result, compared to 163/292 (55·1%) in the control group: 15·5% point improvement; 95%CI: 6·8-24·1; relative risk: 1·28; 95%CI: 1·11-1·48. 97·2% of women accepted the intervention and 86·9% of CHWs agreed to its adoption. Interpretation: The multicomponent mHealth intervention was effective in increasing the percentage of HPV-positive women who had triage Pap, allowing for many more women at risk of cervical cancer to receive timely follow-up. Funding: National Cancer Institute of the National Institutes of Health (USA) under Award Number R01CA218306.

Feasibility and acceptability of self-collection of Human Papillomavirus samples for primary cervical cancer screening on the Caribbean Coast of Nicaragua: A mixed-methods study.

Background: Cervical cancer is the primary cause of cancer death for women in Nicaragua, despite being highly preventable through vaccination against high-risk genotypes of the Human Papillomavirus (hrHPV), screening for hrHPV, and early detection of lesions. Despite technological advances designed to increase access to screening in low resource settings, barriers to increasing population-level screening coverage persist. On the Caribbean Coast of Nicaragua, only 59% of women have received one lifetime screen, compared to 78.6% of eligible women living on the Pacific and in the Interior. In concordance with the WHO's call for best practices to eliminate cervical cancer, we explored the feasibility and acceptability of self-collection of samples for hrHPV testing on the Caribbean Coast of Nicaragua through a multi-year, bi-national, community-based mixed methods study. Methods: Between 2016 and 2019, focus groups (n=25), key informant interviews (n=12) [phase I] and an environmental scan [phase II] were conducted on the Caribbean Coast of Nicaragua in partnership and collaboration with long-term research partners at the University of Virginia and community-based organizations. In spring 2020, underscreened women on the Caribbean Coast of Nicaragua were recruited and screened for hrHPV, with the choice of clinician collection or self-collection of samples. Results: Over the course of the study, providers and potential patients expressed significant acceptability of self-collection of samples as a strategy to reduce barriers currently contributing to the low rates of screening (phases I and II). Ultimately 99.16% (n=1,767) of women chose to self-collect samples, demonstrating a high level of acceptability of self-collection in this pilot sample (phase III). Similarly, focus groups, key informant interviews, and the environmental scan (phases I and II) of resources indicated critical considerations for feasibility of implementation of both HPV primary screening and subsequently, self-collection of samples. Through phase III, we piloted hrHPV screening (n=1,782), with a 19.25% hrHPV positivity rate. Conclusion: Self-collection of samples for hrHPV testing demonstrated high acceptability and feasibility. Through concerted effort at the local, regional, and national levels, this project supported capacity building in reporting, monitoring, and surveilling cervical cancer screening across the continuum of cervical cancer control.

A positive HPV test with positive p16/Ki-67 double staining in self-sampled vaginal material is an accurate tool to detect women at risk for cervical cancer.

BACKGROUND: The development of efficient strategies for managing high-risk human papillomavirus (HR-HPV)-positive women is a major challenge when human papillomavirus-based primary screening is being performed. The objectives of this study were to evaluate the comparative effectiveness of HR-HPV testing based on self-collection (SC) and HR-HPV testing based on collection by a health professional (HP) and to assess the potential usefulness of HR-HPV testing combined with testing with the biomarkers p16/Ki-67, α-mannosidase, and superoxide dismutase 2 (SOD2). METHODS: This was a cross-sectional study of 232 women admitted for colposcopy because of an abnormal Papanicolaou smear. The collected material underwent liquid-based cytology, HR-HPV detection, and immunocytochemical testing (p16/Ki-67, α-mannosidase, and SOD2). The gold standard was the histopathological result; the positive reference was CIN2+. RESULTS: The overall accuracy of HR-HPV testing was 76.6%; the results for the SC group (78.1%) and the HP group (75.2%) were similar. The positive predictive values (HP, 76.5%; SC, 80.0%), the negative predictive values (HP, 66.7%; SC, 64.3%), the positive likelihood values (HP, 1.35; SC, 1.36), and the negative likelihood values (HP, 0.21; SC, 0.19) were also similar. p16/Ki-67 showed higher sensitivity than the other 2 biomarkers: 78.1% versus 45.8% for α-mannosidase and 44.5% for SOD2. The specificities of the biomarkers were equivalent: 71.4% for p16/Ki-67, 77.8% for α-mannosidase, and 71.2% for SOD2. In the HP group, accuracy also leaned more heavily toward the final score (using α-mannosidase and SOD2) without statistical significance (80.8% vs 77.9%). The contrast with the SC group yielded the same level of accuracy. CONCLUSIONS: SC, when associated with testing with biomarkers, is as accurate as collection by HPs in the detection of women at risk for cervical cancer.

Knowledge and perceptions regarding triage among human papillomavirus-tested women: A qualitative study of perspectives of low-income women in Argentina.

OBJECTIVES: Among cancer prevention studies, little is known about knowledge, attitudes, and beliefs toward triage adherence in the context of the human papillomavirus self-collection test. This formative research aims to identify knowledge, attitudes, and beliefs related to human papillomavirus and cervical cancer prevention specifically about adherence to Pap triage among women residing in a low-income province in Argentina. METHODS: We conducted six focus groups, stratified by residence and age. All participants were aged 30 or older and had performed human papillomavirus self-collection. Data collection and thematic analysis were carried out using constructs from the Health Belief Model. RESULTS: Misinformation regarding human papillomavirus and cervical cancer was common and was a source of distress. Women could not distinguish Pap screening from triage; human papillomavirus risk perception was limited but cervical cancer was perceived as a threatening disease. Women were willing to follow-up after receiving an abnormal screening result. Negative views about clinician-collected screening/triage were common, defined as painful and shameful, and comes with an economic cost (transport/time). Lack of help from family/friends was an obstacle to adhering to triage. Health issues in the family's records and a physician's recommendation were a cue to adhere to triage. CONCLUSION: Lack of knowledge or misinformation of the causes of cervical cancer, human papillomavirus, and the multi-step screening and triage process are barriers to follow-up adherence. Interventions to improve communication between women and health providers about screening results and follow-up are needed. Also, health services should be organized to respond to women's needs and reduce access barriers to follow-up.

Using self-collection HPV testing to increase engagement in cervical cancer screening programs in rural Guatemala: a longitudinal analysis.

BACKGROUND: Cervical cancer is a leading cause of death in low- and middle-income countries. Self-collection testing for human papillomavirus (HPV) is an alternative form of cervical cancer screening that can be completed privately and at home. Understanding how the use of HPV testing influences follow-up care in low-resourced settings is crucial before broad implementation. This study aimed to identify if access to self-collection HPV testing impacts participation in established cervical cancer screening programs among women in two rural communities in Guatemala. METHODS: A cohort of 956 women was recruited in 2016 and followed for 2 years for the HPV Multiethnic Study (HPV MES). At baseline, women answered a questionnaire assessing cervical cancer screening history and were offered self-collection HPV testing. Women were re-contacted yearly to determine receipt of additional screening. Statistical changes in screening behavior before and throughout study participation, stratified by self-collection status, were assessed using McNemar pair tests for proportions. Alluvial plots were constructed to depict changes in individual screening behavior. The odds of changes in Pap-compliance (screened in past 3 years), given collection status, were assessed using multivariate logistic regressions. RESULTS: Reported screening rates increased 2 years after enrollment compared to rates reported for the 3 years before study entry among women who collected a sample (19.1% increase, p < 0.05), received results of their test (22.1% increase, p < 0.05), and received positive (24.2% increase, p < 0.1) or negative results (21.7% increase, p < 0.05). However, most increases came from one community, with minimal changes in the other. The adjusted odds of becoming Pap compliant were higher for women who collected a sample vs. did not (OR: 1.48, 95% CI: 0.64, 3.40), received their result vs. did not (OR: 1.29, 95% CI: 0.52, 3.02), and received a positive result vs. negative (OR: 2.43, 95% CI: 0.63, 16.10). CONCLUSIONS: Participation in self-collection HPV testing campaigns may increase likelihood of involvement in screening programs. However, results varied between communities, and reporting of screening histories was inconsistent. Future work should identify what community-specific factors promote success in HPV testing programs and focus on improving education on existing cervical cancer interventions.

The cost-effectiveness of human papillomavirus self-collection among cervical cancer screening non-attenders in El Salvador.

Cervical cancer screening with human papillomavirus (HPV) DNA testing has been incorporated into El Salvador's national guidelines. The feasibility of home-based HPV self-collection among women who do not attend screening at the clinic (i.e., non-attenders) has been demonstrated, but cost-effectiveness has not been evaluated. Using cost and compliance data from El Salvador, we informed a mathematical microsimulation model of HPV infection and cervical carcinogenesis to conduct a cost-effectiveness analysis from the societal perspective. We estimated the reduction in cervical cancer risk, lifetime cost per woman (2017 US$), life expectancy, and incremental cost-effectiveness ratio (ICER, 2017 US$ per year of life saved [YLS]) of a program with home-based self-collection of HPV (facilitated by health promoters) for the 18% of women reluctant to screen at the clinic. The model was calibrated to epidemiologic data from El Salvador. We evaluated health and economic outcomes of the self-collection intervention for women aged 30 to 59 years, alone and in concert with clinic-based HPV provider-collection. Home-based self-collection of HPV was projected to reduce population cervical cancer risk by 14% and cost $1210 per YLS compared to no screening. An integrated program reaching 99% coverage with both provider- and home-based self-collection of HPV reduced cancer risk by 74% (compared to no screening), and cost $1210 per YLS compared to provider-collection alone. Self-collection facilitated by health promoters is a cost-effective strategy for increasing screening uptake in El Salvador.

Self-Collection and Molecular Diagnosis for Detection of Human Papillomavirus: Why Incorporate It?

PURPOSE OF REVIEW: Cervical cancer, the third cause of death by cancer among Brazil's women, is associated with human papillomavirus (HPV) infection. In some countries of South America, North America, Europe, and Oceania, initial screening for HPV DNA and subsequent follow-up with HPV-positive patients using colposcopy and cytological testing are used as preventative measures. RECENT FINDINGS: For HPV DNA detection, it is necessary to obtain cervical cells by conventional clinical collection method or self-collection of the cells that flake off from the uterine cervix and vaginal canal. Self-collection has been shown to be a viable option for obtaining samples and is a less invasive method that is more accepted by women. Thus, it can potentially decrease the limitations of the conventional clinical collection methods. The efficiency of the self-collection method aligned with the implementation of HPV molecular testing, if adopted by public and private health care systems, may extend the reach of current cervical cancer prevention efforts. In addition, considering all phases from triage to treatment, this method may reduce health care costs and the time spent by patients and health care teams to conduct examinations and collect samples.

Mixed-methods approach to evaluate an mHealth intervention to increase adherence to triage of human papillomavirus-positive women who have performed self-collection (the ATICA study): study protocol for a hybrid type I cluster randomized effectiveness-implementation trial.

BACKGROUND: Cervical cancer is one of the leading causes of cancer death among women worldwide, with more than 85% of cases occurring in low- and middle-income countries. Human papillomavirus (HPV) screening allows for self-collection with the potential to increase coverage, but still requires triage to identify which HPV+ women need diagnostic and treatment procedures. However, achieving high levels of triage adherence can be challenging, especially among socially vulnerable women. This paper describes the ATICA protocol (Application of Communication and Information Technologies to Self-Collection, for its initials in Spanish), aimed at evaluating the implementation strategy and the effectiveness of a multi-component mobile health (mHealth) intervention to increase adherence to triage among women with HPV+ self-collected tests. METHODS: We will use an effectiveness-implementation hybrid type I trial with a mixed-methods evaluation approach. A cluster randomized trial design including 200 community health workers (CHWs) will evaluate whether the mHealth intervention increases adherence to triage among HPV+ women who self-collected at home during a CHW visit within 120 days after a positive result. The intervention includes an initial mobile phone text message (SMS) alert and subsequent reminders sent to HPV+ women. For those who do not adhere to triage within 60 days of a positive HPV test, an email and SMS will be sent to the CHWs to promote contact with these women during home visits. We will use the Consolidated Framework for Implementation Research (CFIR) as an organizing and analytic framework to evaluate the implementation of the intervention while also drawing on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). We will conduct a self-administered, semi-structured survey of CHWs, semi-structured interviews with local health authorities, and a survey of HPV+ women. Combining both qualitative and quantitative data will provide rich insights into local implementation challenges and successes. DISCUSSION: Findings from the implementation evaluation will be applicable to programs that use or are planning to incorporate HPV self-collection and/or mHealth interventions in different settings and countries. This innovative study will also serve as a model for using implementation science in the region. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03478397 . Registered on 20 March 2018.

T. vaginalis in riverside women in Amazonia, Brazil: an experience using the EVALYN® BRUSH vaginal self-collection device.

INTRODUCTION: The challenges related to the diagnosis of sexually transmitted infections present more complex factors in remote and hard-to-reach areas. The use of self-collection devices that facilitate the obtaining of a biological sample with high quality for sensitive molecular tests have been examined. This study aimed to evaluate the performance and acceptance of the Evalyn® Brush (Rovers® Medical Devices) for detection of T. vaginalis among women living in the riverside communities of Amazonas, Brazil. METHODOLOGY: The study included 300 riverside women. They received instructions for self-collection, carried out the task, and then answered a questionnaire on the use of the device. T. vaginalis was detected by Polymerase Chain Reaction, using primers TVK3/TVK7. RESULTS: The mean age of the women was 35.8 years, and most of them presented low schooling, low income, agricultural activity and lived in a marital union. All samples were positive for human genomic DNA (100%) and the prevalence of T. vaginalis infection was 5.6% (n = 17). Of the 300 women, 293 (97.7%) indicated that they liked the use of the device, 287 (95.7%) reported having had no difficulty in handling it, 265 (88.3%) did not feel any type of discomfort and 228 (76%) said they preferred the self-collection to the collection made by the professional, mainly due to privacy and comfort. CONCLUSIONS: The Evalyn® Brush proved reliable as a device for the collection of biological samples for molecular analysis and was well-accepted by women. Its use can be indicated in remote and hard to reach places.

Cervico-vaginal self-collection in HIV-infected and uninfected women from Tapajós region, Amazon, Brazil: High acceptability, hrHPV diversity and risk factors.

OBJECTIVE: We evaluated acceptability of cervico-vaginal self-collection (CVSC) and prevalence of human papillomavirus (HPV) in Human immunodeficiency virus (HIV)-infected and HIV-uninfected women living in the Tapajós region, Amazon, Brazil. METHODS: Cross-sectional study recruited 153 non-indigenous women (HIV-uninfected, n = 112 and HIV-infected, n = 41) who voluntarily sought assistance in health services. Peripheral blood for HIV screening and cervical scraping (CS) for HPV detection were collected. Women who accepted to perform CVSC received instructions and individual collection kits. Risk factors for high-risk HPV genotypes (hrHPV) were identified by uni- and multivariate analyses. RESULTS: The overall acceptability of CVSC was 87%. Only HIV-infected women had cytological abnormalities (12.2%). Prevalence of any HPV and hrHPV infection was 42.9% and 47.9% for HIV-uninfected and 97.6% and 77.5% for HIV-infected women, respectively. There was significant agreement in the detection of HPV (88%, 0.76, 95% confidence interval [CI], 0.65-0.87) and hrHPV (79.7%, 0.56, 95% CI, 0.41-0.71) between self-collected and clinician-collected samples. The most prevalent hrHPV types were HPV16 and HPV18 in HIV-uninfected and HPV16, HPV51 and HPV59 in HIV-infected women. HIV-infected women with hrHPV infection had multiple hrHPV infections (p = 0.005) and lower CD4 count (p = 0.018). Risk factors for hrHPV infection included being HIV-infected and having five or more sexual partners. CONCLUSIONS: CVSC had high acceptability and high prevalence of hrHPV types in women living in the Tapajós region, Amazon, Brazil.

Documento: Chlamydia trachomatis: fundamentos de la importancia del cribado en el sistema público de salud / Document: Chlamydia trachomatis: fundamentals of the importance of screening in the public health system

Resumen La infección de transmisión sexual por Chlamydia trachomatis, tiene una alta prevalencia en Chile y otras latitudes, y se asocia a graves riesgos para la salud reproductiva de quienes se infectan. El cribado con autotoma de la muestra y detección mediante amplificación de ácidos nucleicos es la forma más eficaz de control sanitario. Hasta ahora, en Chile, el diagnóstico y manejo epidemiológico de C. trachomatis no se realiza en la salud pública. El Ministerio de Salud de Chile está haciendo importantes avances para iniciar esta implementación. La Sociedades Médicas se comprometen a participar en este proceso para lograr el eficaz control de esta infección en nuestra población.

The sexually transmitted infection caused by Chlamydia trachomatis has a high prevalence in Chile and other latitudes and is associated with serious risks to the reproductive health of those who become infected. Screening with self- collected samples and detection by amplification of nucleic acids is the most effective form of sanitary control. Until now, in Chile, the diagnosis and epidemiological management of C. trachomatis is not carried out in public health. The Ministry of Health of Chile is making important progress to start this implementation. The Medical Societies are committed to participate in this process to achieve effective control of this infection in our population.

The Role of Self-Collection by Vaginal Lavage for the Detection of HPV and High-Grade Intraepithelial Neoplasia.

OBJECTIVE: To compare the results of cervical cytology and high-risk HPV tests using samples obtained using two different collection modalities in a population of Brazilian women: self-collection (vaginal lavage) and cervical Pap testing. METHODS: We enrolled 204 women who were aged 18-64 years and had previously obtained abnormal cervical cytology test results; 83.8% of them agreed to participate. The sample was divided into two aliquots: one for the cytological study and one for the molecular analysis of high-risk HPV. RESULTS: Fifty-eight percent of the participants preferred to utilize self-collection as an alternative screening method. However, we noticed that the HPV positivity rate was significantly lower in self-collected samples when compared to those obtained using the conventional collection method (p = 0.035). The cytology tests of the samples obtained via self-collection were sensitive and had a positive predictive value and an area under the curve (AUC) that were significantly lower than those of the Pap test. However, the specificity and negative predictive value of these tests were similar. When compared with the HPV test, the self-collected samples demonstrated lower accuracy in predicting high-grade cervical intraepithelial neoplasia or worse, with a significantly lower sensitivity, positive predictive value, and AUC than the cervical Pap test samples. CONCLUSION: Self-collection by vaginal lavage is simple and well accepted by women. Due to its limitations, however, self-collection by lavage should be utilized with caution.

The acceptability of vaginal smear self-collection for screening for cervical cancer: a systematic review

Cervical cancer is a major cause of death in adult women. However, many women do not undergo cervical cancer screening for the following reasons: fear, shame, physical limitations, cultural or religious considerations and lack of access to health care services. Self-collected vaginal smears maybe an alternative means of including more women in cervical cancer screening programs. The objective of this systematic review was to evaluate the acceptability of vaginal smear self-collection for cervical cancer screening. We selected articles from PubMed, the Cochrane Library and Embase that were published between January 1995 and April 2016. Studies written in English, French, Italian, Portuguese or Spanish that involved women between 18 and 69 years of age who had engaged in sexual intercourse were included in this review. The review was performed in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Nineteen studies were ultimately evaluated in this review. Most of the included studies (n=17) demonstrated that the self-collection method exhibited outstanding acceptability among women with respect to cervical cancer screening, and only two studies indicated that self-collection exhibited low acceptability among women in this context. The acceptability of self-collection was determined subjectively (without standardized questionnaires) in 10 studies (53%) and via structured and validated questionnaires in the remaining studies. The results of our review suggest that the self-collection method is well-accepted and may therefore encourage greater participation in cervical cancer screening programs. However, additional studies are required to verify these results.

Evaluation of scaling-up of HPV self-collection offered by community health workers at home visits to increase screening among socially vulnerable under-screened women in Jujuy Province, Argentina.

BACKGROUND: Self-collection has been proposed as a strategy to increase cervical screening coverage among hard-to-reach women. However, evaluations of the implementation of this strategy on a large scale are scarce. This paper describes the process and measurement of the scaling-up of self-collection offered by community health workers during home visits as a strategy to reach under-screened women aged 30+ with public health coverage, defined as the target women. METHODS: We used an adaptation of the Health System Framework to analyze key drivers of scaling-up. A content analysis approach was used to collect and analyze information from different sources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) model was used to evaluate the impact of the strategy. RESULTS: HPV self-collection was scaled-up in the province of Jujuy in 2014 after a RCT (Self-collection Modality Trial, initials EMA in Spanish) was carried out locally in 2012 and demonstrated effectiveness of the strategy to increase screening uptake. Facilitators of scaling-up were the organizational capacity of the provincial health system, sustainable funding for HPV testing, and local consensus about the value of the technology. Reach: In 2014, 9% (2983/33,245) of target women were screened through self-collection in the Jujuy public health sector. Effectiveness: In 2014, 17% (n = 5657/33,245) of target women were screened with any HPV test (self-collected and clinician-collected tests) vs. 11.7% (4579/38,981) in 2013, the pre-scaling-up period (p < 0.0001). IMPLEMENTATION: Training about the strategy was provided to 84.2% (n = 609/723) of total community health workers (CHWs). Of 414 HPV+ women, 77.5% (n = 320) had follow-up procedures. Of 113 women with positive triage, 66.4% (n = 75) had colposcopic diagnosis. Treatment was provided to 80.7% of CIN2+ women (n = 21/26). Adoption: Of trained CHWs, 69.3% (n = 422/609) had at least one woman with self-collection; 85.2% (n = 315/368) of CHWs who responded to an evaluation survey were satisfied with self-collection strategy. Maintenance: During 2015, 100.0% (723/723) CHWs were operational and 63.8% (461/723) had at least one woman with self-collection. CONCLUSIONS: The strategy was successfully scaled-up, with a high level of adoption among CHWs, which resulted in increased screening among socially vulnerable under-screened women.

HPV testing: a mixed-method approach to understand why women prefer self-collection in a middle-income country.

BACKGROUND: HPV test self-collection has been shown to reduce barriers to cervical screening and increase uptake. However, little is known about women's preferences when given the choice between self-collected and clinician-collected tests. This paper aims to describe experiences with HPV self-collection among women in Jujuy, the first Argentinean province to have introduced HPV testing as the primary screening method, provided free of cost in all public health centers. METHODS: Between July and December 2012, data on acceptability of HPV self-collection and several social variables including past screening were collected from 2616 self-collection accepters and 433 non-accepters, and were analyzed using multivariate regression. In addition, in-depth interviews (n = 30) and 2 focus groups were carried out and analyzed using thematic analysis. RESULTS: Quantitative findings indicate that main reasons for choosing self-collection are those reducing barriers related to women's roles of responsibility for domestic work and work/family organization, and to health care services' organization. No social variables were significantly associated with acceptability. Among those who preferred clinician-collection, the main reasons were trust in health professionals and fear of hurting themselves. Qualitative findings also showed that self-collection allows women to overcome barriers related to the health system (i.e. long wait times), without sacrificing time devoted to work/domestic responsibilities. CONCLUSIONS: Findings have implications for self-collection recommendations, as they show it is the preferred method when women are given the choice, even if they are not screening non-attenders. Findings also highlight the importance of incorporating women's needs/preferences in HPV screening recommendations.