Perceived barriers to cervical cancer screening and motivators for at-home human papillomavirus self-sampling during the COVID-19 pandemic: Results from a telephone survey.

Background: Home-based self-sampling for human papillomavirus (HPV) testing may be an alternative for women not attending clinic-based cervical cancer screening. Methods: We assessed barriers to care and motivators to use at-home HPV self-sampling kits during the COVID-19 pandemic as part of a randomized controlled trial evaluating kit effectiveness. Participants were women aged 30-65 and under-screened for cervical cancer in a safety-net healthcare system. We conducted telephone surveys in English/Spanish among a subgroup of trial participants, assessed differences between groups, and determined statistical significance at p<0.05. Results: Over half of 233 survey participants reported that clinic-based screening (Pap) is uncomfortable (67.8%), embarrassing (52.4%), and discomfort seeing male providers (63.1%). The last two factors were significantly more prevalent among Spanish vs English speakers (66.4% vs 30% (p=0.000) and 69.9 vs 52.2% (p=0.006), respectively). Most women who completed the kit found Pap more embarrassing (69.3%), stressful (55.6%), and less convenient (55.6%) than the kit. The first factor was more prevalent among Spanish vs English speakers (79.6% vs 53.38%, p=0.001) and among patients with elementary education or below. Conclusions: The COVID-19 pandemic influenced most (59.5%) to participate in the trial due to fear of COVID, difficulty making appointments, and ease of using kits. HPV self-sampling kits may reduce barriers among under-screened women in a safety-net system. Funding: This study is supported by a grant from the National Institute for Minority Health and Health Disparitie s (NIMHD, R01MD013715, PI: JR Montealegre). Clinical trial number: NCT03898167.

European Cancer Summit 2022 submission for HPV Action NetworkHPV SCREENING FOR CERVICAL CANCER USING THE SELF-SAMPLING MODEL IN UKRAINE DURING THE WAR

Background: The Covid pandemic and the war created the conditions for the growth of cancer in Ukraine. Violence against women and mass migration of the population have increased the risk of HPV infection in the population, which may provoke a surge in the incidence of cervical cancer shortly (1). Method(s): In the front-line city of Zaporizhzhia (eastern Ukraine), HPV screening for cervical cancer was organized using the Self-sampling model from the first weeks of the war. Women aged 25-60 were offered to take part in the screening at the refugee reception centre where they received humanitarian assistance. For Self-sampling, the Swedish test Qvintip Aprovix AB (2) was used. Screening participants returned the test through volunteers to a certified PCR laboratory, where they tested viral DNA for six oncogenic HPV strains. Women received a response with further recommendations for monitoring and treatment via SMS or email. The organization and financing of screening in Ukraine during the war were taken over by the charitable foundation "World Against Cancer". Result(s): Consent for HPV screening was obtained from 180 women. A positive result of HPV testing was obtained in 12 (6.7%) women. Systematic analysis of screening results and the use of "Test and treat" tactics is the subject of our further research. Conclusion(s): Due to the small number of participants in the program and the short follow-up period, it is not yet possible to conclude the impact of the war on the risk of developing cervical cancer in Ukrainian women. Our pilot study showed that the Self-sampling model is the most optimal for HPV screening in a military conflict. However, this model can only be applied after the end of active hostilities in the region and the low probability of a missile and bomb strike on the city, when relative stability sets in after the phase of a humanitarian catastrophe. This model of cancer prevention can also be used during the mass migration of refugees in the aftermath of environmental disasters as part of a program of humanitarian assistance to the population.Copyright © 2023

Perspectives on Self-Sampling for Cancer Screening From Staff at Federally Qualified Health Centers in Rural and Segregated Counties: A Preliminary Qualitative Study.

BACKGROUND: Self-sampling for colorectal and cervical cancer screening can address the observed geographic disparities in cancer burden by alleviating barriers to screening participation, such as access to primary care. This preliminary study examines qualitative themes regarding cervical and colorectal cancer self-sampling screening tools among federally qualified health center clinical and administrative staff in underserved communities. METHODS: In-depth interviews were conducted with clinical or administrative employees (≥18 years of age) from FQHCs in rural and racially segregated counties in Pennsylvania. Data were managed and analyzed using QSR NVivo 12. Content analysis was used to identify themes about attitudes towards self-sampling for cancer screening. RESULTS: Eight interviews were conducted. Average participant age was 42 years old and 88% of participants were female. Participants indicated that a shared advantage for both colorectal and cervical cancer self-sampling tests was their potential to increase screening rates by simplifying the screening process and offering an alternative to those who decline traditional screening. A shared disadvantage to self-sampling was the potential for inaccurate sample collection, either through the test itself or the sample collection by the patient. CONCLUSIONS: Self-sampling offers a promising solution to increase cervical and colorectal cancer screening in rural and racially segregated communities. This study's findings can guide future research and interventions which integrate self-sampling screening into routine primary care practice.

Analysis of the Practice of Community-Based Self-Sampling and Its Implication on Prevention and Control of Infectious Diseases - Fengtai District, Beijing Municipality, China, 2022.

What is already known about this topic?: So far, no descriptive analysis has been conducted on community residents with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid self-sampling in China. What is added by this report?: This report found that self-sampling had a wide age and regional distribution, with the time from self-sampling to result-reporting typically taking less than one day. Additionally, self-sampling was found to save a considerable amount of manpower and medical resources compared to regular sampling. What are the implications for public health practice?: The experience of prevention and control measures during the coronavirus disease 2019 (COVID-19) pandemic has provided a reference for the prevention and control of other infectious diseases through self-sampling.

HPV-Based Self-Sampling in Cervical Cancer Screening: An Updated Review of the Current Evidence in the Literature.

Identifying and reaching women at higher risk for cervical cancer is all-important for achieving the ambitious endpoints set in 2020 by the WHO for global cervical cancer control by 2030. HPV-based (vaginal) self-sampling (SS) represents a cost-effective screening strategy, which has been successfully implemented during the last decade both in affluent and constrained settings. Among other advantages, SS strategies offer convenience, diminished costs, flexibility to obtain a sample in the office or home, avoiding a pelvic exam and uncomfortable appointment with a healthcare professional, as well as social and cultural acceptability. SS implementation has been globally boosted during the COVID-19 pandemic. In pragmatic terms, social distancing, local lockdowns, discontinuation of clinics and reallocation of human and financial resources challenged established clinician-based screening; self-collection strategies apparently surpassed most obstacles, representing a viable and flexible alternative. With time, sufficient reassuring data has accumulated regarding specially designed SS devices, aspects of sample preparation, transport and storage and, importantly, optimization of validated PCR-based HPV testing platforms for self-collected specimens. Suboptimal rates of clinical follow-up post-SS screening, as well as overtreatment with reliance solely on molecular assays, have both been documented and remain concerning. Therefore, effective strategies are still required to ensure linkage to follow-up testing and management following positive SS results by trained health professionals with knowledge of HPV biology and management algorithms. Because of the prolonged SS screening intervals, implementation data are limited regarding subsequent screening rounds of SS-screened individuals; however, these are accumulating gradually. With further refinement of assays and validation of novel biomarkers in self-collected samples, there is a clear potential for increasing SS accuracy and PPV. The potential differentiation of self-collection protocols for vaccinated versus non-vaccinated individuals also represents an open issue. In conclusion, HPV-based self-collection techniques can effectively address limited uptake alongside other conventional cervical screening drawbacks; however, assays, logistics and infrastructures need further optimization to increase the efficacy, effectiveness and cost-effectiveness of SS approaches.

From disgusting and complicated to simple and brilliant: Implementation perspectives and lessons learned from users and rejectors of mail-in SARS-CoV-2 gargle tests.

Background: Despite the important role of testing as a measure against the COVID-19 pandemic, user perspectives on SARS-CoV-2 tests remain scarce, inhibiting an improvement of testing approaches. As the world enters the third year of the pandemic, more nuanced perspectives of testing, and opportunities to expand testing in a feasible and affordable manner merit consideration. Methods: Conducted amid the second pandemic wave (late 2020-early 2021) during and after a multi-arm trial evaluating SARS-CoV-2 surveillance strategies in the federal state Baden-Württemberg, Germany, this qualitative sub-study aimed to gain a deeper understanding of how test users and test rejectors perceived mail-in SARS-CoV-2 gargle tests. We conducted 67 semi-structured in-depth interviews (mean duration: 60 min) via telephone or video call. Interviews were audio-recorded, transcribed verbatim and analyzed inductively using thematic analysis. The Consolidated Framework for Implementation Research guided the findings' presentation. Results: Respondents generally described gargle sampling as simple and comfortable. However, individual perceptions of the testing method and its feasibility varied widely from disgusting and complicated to simple and brilliant. Self-sampling was appreciated for lowering infection risks during testing, but also considered more complex. Gargle-sampling increased participants' self-efficacy to sample correctly. Communication (first contact, quantity and content of information, reminders, support system) and trust (in the study, its institutional affiliation and test method) decisively influenced the intervention's acceptability. Conclusion: User-driven insights on how to streamline testing include: consider communication, first impressions of tests and information as key for successful mail-in testing; pay attention to the role of mutual trust between those taking and administering tests; implement gargle self-sampling as a pleasant alternative to swab testing; offer multiple test methods to increase test up-take.

Disruptions of sexually transmitted and blood borne infections testing services during the COVID-19 pandemic: accounts of service providers in Ontario, Canada.

BACKGROUND: Since the onset of the COVID-19 pandemic in March 2020 in Canada, the availability of sexual health services including sexually transmitted and blood-borne infection (STBBI) testing has been negatively impacted in the province of Ontario due to their designation as "non-essential" health services. As a result, many individuals wanting to access sexual healthcare continued to have unmet sexual health needs throughout the pandemic. In response to this, sexual health service providers have adopted alternative models of testing, such as virtual interventions and self-sampling/testing. Our objective was to investigate service providers' experiences of disruptions to STBBI testing during the COVID-19 pandemic in Ontario, Canada, and their acceptability of alternative testing services. METHODS: Between October 2020-February 2021, we conducted semi-structured virtual focus groups (3) and in-depth interviews (11) with a diverse group of sexual health service providers (n = 18) including frontline workers, public health workers, sexual health nurses, physicians, and sexual health educators across Ontario. As part of a larger community-based research study, data collection and analysis were led by three Peer Researchers and a Community Advisory Board was consulted throughout the research process. Transcripts were transcribed verbatim and analysed with NVivo software following grounded theory. RESULTS: Service providers identified the reallocation of public health resources and staff toward COVID-19 management, and closures, reduced hours, and lower in-person capacities at sexual health clinics as the causes for a sharp decline in access to sexual health testing services. Virtual and self-sampling interventions for STBBI testing were adopted to increase service capacity while reducing risks of COVID-19 transmission. Participants suggested that alternative models of testing were more convenient, accessible, safe, comfortable, cost-effective, and less onerous compared to traditional clinic-based models, and that they helped fill the gaps in testing caused by the pandemic. CONCLUSIONS: Acceptability of virtual and self-sampling interventions for STBBI testing was high among service providers, and their lived experiences of implementing such services demonstrated their feasibility in the context of Ontario. There is a need to approach sexual health services as an essential part of healthcare and to sustain sexual health services that meet the needs of diverse individuals.

Evaluation of Non-Invasive Gargle Lavage Sampling for the Detection of SARS-CoV-2 Using rRT-PCR or Antigen Assay.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable disruption worldwide. For efficient SARS-CoV-2 detection, new methods of rapid, non-invasive sampling are needed. This study aimed to investigate the stability of SARS-CoV-2 in a novel medium for gargle-lavage (GL) self-sampling and to compare the performance of SARS-CoV-2 detection in paired self-collected GL and clinician-obtained nasopharyngeal swab (NPS) samples. The stability study for SARS-CoV-2 preservation in a novel medium was performed over 14 days (4 °C, 24-27 °C, and 37 °C). In total, 494 paired GL and NPS samples were obtained at the University Hospital in Olomouc in April 2021. SARS-CoV-2 detection in paired samples was performed with a SARS-CoV-2 Nucleic Acid Detection Kit (Zybio, Chongqing Municipality, Chongqing, China), an Elecsys® SARS-CoV-2 Antigen assay (Roche Diagnostics, Mannheim, Germany), and a SARS-CoV-2 Antigen ELISA (EUROIMMUN, Lübeck, Germany). The stability study demonstrated excellent SARS-CoV-2 preservation in the novel medium for 14 days. SARS-CoV-2 was detected in 55.7% of NPS samples and 55.7% of GL samples using rRT-PCR, with an overall agreement of 91.9%. The positive percent agreement (PPA) of the rRT-PCR in the GL samples was 92.7%, and the negative percent agreement (NPA) was 90.9%, compared with the NPS samples. The PPA of the rRT-PCR in the NPS and GL samples was 93.2% when all positive tests were used as the reference standard. Both antigen detection assays showed poor sensitivity compared to rRT-PCR (33.2% and 36.0%). rRT-PCR SARS-CoV-2 detection in self-collected GL samples had a similar PPA and NPA to that of NPSs. GL self-sampling offers a suitable and more comfortable alternative for SARS-CoV-2 detection.

At-home blood self-sampling in rheumatology: a qualitative study with patients and health care professionals.

BACKGROUND: The goal of the study was to investigate patients' with systemic rheumatic diseases and healthcare professionals' experiences and preferences regarding self-sampling of capillary blood in rheumatology care. METHODS: Patients performed a supervised and consecutive unsupervised capillary blood self-collection using an upper arm based device. Subsequently, patients (n = 15) and their attending health care professionals (n = 5) participated in an explorative, qualitative study using problem-centered, telephone interviews. Interview data were analyzed using structured qualitative content analysis. RESULTS: Interviewed patients reported easy application and high usability. Patients and health care professionals alike reported time and cost savings, increased independence and flexibility, improved monitoring and reduction of risk of infection during Covid-19 as benefits. Reported drawbacks include limited blood volume, limited usability in case of functional restrictions, and environmental concerns. Older, immobile patients with long journeys to traditional blood collection sites and young patients with little time to spare for traditional blood collection appointments could be user groups, likely to benefit from self-sampling services. CONCLUSIONS: At-home blood self-sampling could effectively complement current rheumatology telehealth care. Appropriateness and value of this service needs to be carefully discussed with patients on an individual basis. TRIAL REGISTRATION: WHO International Clinical Trials Registry: DRKS00024925. Registered on 15/04/2021.

Efficacy of the Examination of Saliva Sample by Reverse Transcriptase-Polymerase Chain Reaction in Detection of SARS-CoV-2 in Al-Fallujah City, Iraq

Saliva samples could be used as a non-invasive method to diagnose COVID-19. We aimed to assess the results of the reverse transcriptase-polymerase chain reaction (RT-PCR) of saliva specimens in the detection of COVID-19. We collected saliva and nasopharyngeal (NP) samples from consecutive COVID-19 suspects in Al-Fallujah Teaching Hospital, Anbar, Iraq from November 29, 2021 to February 15, 2022. The results of the two specimens were compared using RT-PCR. For the positive saliva tests, repetition of the test was undertaken at weekly intervals for four weeks from the time of the presentation. There were 55% men and 60% people <= 35 years. The majority of cases presented within 2-5 days (92%) and were of mild severity (89%). A hundred pairs of samples were taken. COVID-19 was diagnosed by NP swab RT-PCR in 56% and 31% of the saliva samples. The saliva samples had 100% sensitivity (95% confidence interval ICI] 60.4% e96.6%), 63.8% specificity (95% CI 96.1% e99.9%), and mild coefficient agreement (kappa coefficient = 0.522). The positive test for the saliva samples remained as such in all examined cases in the first and second weeks after the first test, 31/31 and 30/30, respectively. While half of them were positive in the third week (15/30). All cases became negative in the fourth week (0/15). We recommend not using the saliva swab as an alternative to the NP swab in the detection of the SARS-CoV-2 by RT-PCR. However, saliva sample can be used for the follow-up of the COVID-19 subjects, in children, elderly, and handicapped patients.

Self-collection of capillary blood and saliva to determine COVID-19 vaccine immunogenicity in patients with immune-mediated inflammatory diseases and health professionals.

Introduction: Being able to independently determine vaccine induced antibody responses by minimal-invasive methods is of great interest to enable a flexible and effective vaccination strategy. This study aimed to evaluate (1) the accuracy, feasibility, usability and acceptability of capillary blood and saliva self-sampling to determine SARS-CoV-2 antibody responses in patients with immune-mediated inflammatory diseases (IMIDs) and health professionals (HP). Methods: IMID patients and HP having received two doses of SARS-CoV-2 vaccines, self-collected capillary blood (Tasso+) and saliva samples. Capillary samples were considered interchangeable with venous blood if three criteria were met: Spearman's correlation coefficient (r) > 0.8, non-significant Wilcoxon signed-rank test (i.e., p > 0.05), and a small bias or 95% of tests within 10% difference through Bland-Altman. Participants completed a survey to investigate self-sampling usability (system usability scale; SUS) and acceptability (net promoter score; NPS). Study personnel monitored correct self-sampling completion and recorded protocol deviations. Results: 60 participants (30 IMID patients and 30 HP) were analyzed. We observed interchangeability for capillary samples with an accuracy of 98.3/100% for Anti-SARS-CoV-2 IgG/IgA antibodies, respectively. Fifty-eight capillary blood samples and all 60 saliva samples were successfully collected within the first attempt. Usability of both self-sampling procedures was rated as excellent, with significantly higher saliva ratings (p < 0.001). Capillary self-sampling was perceived as significantly (p < 0.001) less painful compared to traditional venous blood collection. Participants reported a NPS for capillary and saliva self-sampling of +68% and +63%, respectively. The majority of both groups (73%) preferred capillary self-sampling over professional venous blood collection. Conclusion: Our results indicate that capillary self-sampling is accurate, feasible and preferred over conventional venous blood collection. Implementation could enable easy access, flexible vaccination monitoring, potentially leading to a better protection of vulnerable patient groups. Self-collection of saliva is feasible and safe however more work is needed to determine its application in clinical practice.

Intention to use and acceptability of home-based sexual health care among men who have sex with men who previously attended clinic-based sexual health care.

The COVID-19 pandemic has temporarily disrupted access to clinic-based sexual health care for men who have sex with men (MSM) in the Netherlands. The importance of home-based sexual health care has been underpinned as an extension of clinic-based care. This paper aims to assess intention to use, and acceptability of home-based sexual health care among MSM who previously attended clinic-based sexual health care. In November 2020, 424 MSM who had attended an STI clinic pre-pandemic were invited to participate in an online survey; 154 MSM completed the survey (response 36%). Intention to use self-sampling STI/HIV tests was assessed (median; scale 0-100) and compared across sociodemographic and sexual behavior characteristics by Kruskal-Wallis H tests. Descriptive analyses provided insights in acceptability of home-based sexual health care. Of participants (median age 47), 60.4% (93/154) tested for STI/HIV in the past 6 months, most of them attended a clinic. The median score on intention to use self-sampling tests was 86.5 (SD = 33.4) and did not differ by sociodemographic or sexual behavioral characteristics (all p-values > 0.1). Participants were positive toward online sexual health counseling (median attitude = 75.0, SD = 29.6) and their main preferred topics were PrEP use and STI/HIV testing. MSM who attended clinic-based care expressed intention to use self-sampling tests and a positive attitude toward online sexual health counseling. Home-based sexual health care elements are not currently integrated within Dutch clinic-based sexual health care and should be considered an addition for continued provision of care and extended reach of MSM.

The Implementation of a Primary HPV Self-Testing Cervical Screening Program in Malaysia through Program ROSE-Lessons Learnt and Moving Forward.

Program ROSE (removing obstacles to cervical screening) is a primary HPV-based cervical screening program that incorporates self-sampling and digital technology, ensuring that women are linked to care. It was developed based on the principles of design thinking in the context of Malaysia. The program illustrates the importance of collaborative partnerships and addressing the multi-faceted barriers from policy changes, and infrastructure readiness to the implementation of a radically new cervical screening program in communities. The paradigm shift in cervical cancer requires a monumental and concerted effort in educating both the healthcare providers and the general public. In this short review, we highlight how Pilot Project ROSE incorporated evidence-based tools that rapidly scaled up to Program ROSE. These ideas and solutions can be adapted and adopted by other countries. Notwithstanding the impact of COVID-19, it is incumbent on countries to pave the road towards the elimination of cervical cancer with pre-existing footpaths.

Self-collected gargle fluids and nasopharyngeal swabs as a strategy for molecular diagnostics of respiratory viruses

Diagnosis of respiratory viruses traditionally relies on deep oropharynx or nasopharynx swabs collected by healthcare workers (HCW). However, outpatients must make an appointment, and the procedure can cause discomfort in patients. Self-collecting has the potential as a strategy to improve participants’ willingness to participate in diagnostics, surveillance, or studies. We compared self-collected gargle fluids and nasopharyngeal swabs as a strategy for molecular diagnostics of respiratory viruses and compared the average cycle threshold (Ct)-values with those of samples collected by HCW. The study was conducted among technicians of the Laboratory of Clinical Microbiology and Infectious Diseases, Zwolle, the Netherlands, and their family members, between April 2019 and March 2020. It included a questionnaire regarding the severity and date of first symptoms and an assessment of the sampling experience. The primary outcome was the mean Ct of positive PCRs. Similar mean Ct values were obtained using self- or HCW-collected swabs. In addition, gargle fluids and self-swabbed specimens had comparable detection rates of respiratory viruses. Notably, most participants preferred gargling over self-swabbing. Interestingly, but not surprisingly, the time between the onset of symptoms and sampling was shorter in PCR-positive compared to PCR-negative participants. Though this study was abrogated by the SARS-CoV-2 pandemic, the results indicate that both self-swabs and gargle fluids are acceptable for diagnosing common respiratory viruses in the outpatient population, including influenza virus, rhinovirus, adenovirus, SARS-CoV-2 and endemic human coronaviruses. Gargling could be considered an alternative sampling strategy and may enhance willingness to participate in screenings or diagnostics for respiratory viruses.

Diagnostic Performance, Stability, and Usability of Self-Collected Combo Swabs and Saliva for Coronavirus Disease 2019 Diagnosis: A Case-Control Study.

BACKGROUND: Self-sampling procedures to detect severe acute respiratory syndrome coronavirus 2 is important for patients who have difficulty visiting the hospital and may decrease the burden for health care workers (HCWs). The objective of this study was to evaluate the diagnostic performance, stability and usability of self-collected nasal and oral combo swabs and saliva specimens. MATERIALS AND METHODS: We conducted a case-control study with 50 patients with coronavirus disease 2019 (COVID-19) and 50 healthy volunteers from March, 2021 to June, 2021. We performed real-time reverse-transcription polymerase chain reaction to compare the diagnostic performance of self-collected specimens using positive percent agreements (PPAs). RESULTS: The PPAs between self-collected and HCW-collected specimens were 77.3 - 81.0% and 80.5 -86.7% for the combo swabs and saliva specimens, respectively. The PPAs increased to 88.9 - 89.2% and 81.2 - 82.1% with a cycle threshold value ≤30. CONCLUSION: The diagnostic performance of self sampling was comparable to that of HCW sampling in patients with high viral loads and may thus assist in the early diagnosis of COVID-19.

A Family-Centered Sexual Health Intervention to Promote Cervical Cancer Screening Uptake Among Low-Income Rural Women in India: Protocol for a Community-Based Mixed Methods Pilot Study.

BACKGROUND: Human papillomavirus (HPV) is the primary cause of cervical cancer, which is preventable through screening and early treatment. The Papanicolaou (Pap) test and visual inspection with acetic acid (VIA), which are traditionally performed in clinical settings, have been used effectively to screen for cervical cancer and precancerous changes and reduce cervical cancer mortality in high-income countries for many decades. However, these screening methods are not easily accessible to women living in low- and middle-income countries, especially women living in rural areas. OBJECTIVE: The project will use HPV self-sampling, which will be supported by a sexual health literacy intervention, to increase rural women's participation in cervical cancer screening. The objectives are to determine the effectiveness of this program in (1) increasing sexual health literacy, (2) reducing the gendered stigma of HPV and cervical cancer, and (3) promoting cervical cancer screening by using HPV self-sampling. METHODS: The pilot study will use a community-based, family-centered, mixed methods design. We will recruit 120 women aged 30 to 69 years who are underscreened or were never screened for cervical cancer, along with 120 supportive male relatives or friends from 3 low-income rural/tribal villages in Maharashtra, India. Participants will attend gender-specific sexual health education sessions, followed by a movie matinee. Data will be collected through an interviewer-administered questionnaire before and after sexual health education sessions. The questionnaire will include items on social demographics, medical histories, attitudes, sexual health stigma, cervical cancer knowledge, and screening practices. Women will self-select whether to use HPV self-sampling. Those who do not may undergo a Pap test or VIA. Participants' views regarding barriers and facilitators and their suggestions for improving access and uptake will also be elicited. This protocol was approved by the research ethics boards of Toronto Metropolitan University (formerly known as Ryerson University; reference number: REB 2020-104) and Tata Memorial Center (reference number: OIEC/3786/2021 /00003). RESULTS: The Preventing Cervical Cancer in India Through Self-Sampling study was funded in January 2020 for 15 months. Due to the COVID-19 pandemic, the project was extended by 1 year. The study outcome measures will include changes in knowledge and attitudes about cervical cancer screening, the proportion of participants who self-select into each cohort, the proportion of positive test results in each cohort, and the proportion of participants with confirmed cervical cancer. Women's experiences regarding barriers and facilitators of screening uptake will be captured. CONCLUSIONS: Our multifaceted work could lead to reduced cervical cancer mortality and morbidity and increased community capacity in sexual health promotion and cervical cancer prevention. The insights and lessons learned from our project can be used to inform the adaptation and scale-up of HPV self-sampling among women across India and in other countries; promote collective commitment to family-centered wellness; and support women to make healthful, personalized cervical screening decisions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/35093.

Pasifika women's knowledge and perceptions of cervical-cancer screening and the implementation of self-testing in Aotearoa New Zealand: A qualitative study.

Background: In Aotearoa New Zealand, Pasifika women have a higher rate of cervical cancer incidence and mortality than European/Other women and a lower screening rate. Despite actions to reduce the barriers, there has been little change in screening coverage for Pasifika women since 2007. Novel strategies are therefore required. Persistent cervical infection with oncogenic human papillomavirus (HPV) causes virtually all cervical cancers and HPV testing will be implemented in Aotearoa in 2023, with women being able to choose to self-test. We undertook a qualitative focus group (FG) study with Pasifika women to explore their perspectives on the barriers to, and facilitators of, HPV self-testing and how best to implement this in Aotearoa. Methods: A trained female Pasifika Research Assistant facilitated participant recruitment and the FGs. Eligible participants self-identified as Pasifika, were aged 30-69 years, in the Wellington area, who had never been screened or who were overdue (≥5 years) for cervical-cancer screening. Recruitment was predominantly through Pasifika key-informant networks and in collaboration with Pasifika primary care providers. Participants were offered face-to-face FGs but, due to occasional Covid-19 restrictions and personal preferences, FGs via Zoom were also used. The FGs were audio-recorded and transcribed verbatim. The FG transcripts were thematically analysed. Findings: Seven FGs were conducted with 24 participants. We identified five main themes around barriers and potential facilitators of HPV self-testing in Pasifika women: 1) perceptions and knowledge of cervical-cancer screening; 2) challenges to engaging in organised cervical screening; 3) perceptions of self-testing for HPV and challenges women face when deciding to self-test; 4) enthusiasm for an HPV self-test; and 5) information and communication. Knowledge about cervical cancer and screening varied considerably among participants, with some never having heard about cervical-cancer screening. The main challenges that were raised were personal privacy and confidentiality and time management. There was consensus around the need for adequate, consistent, and accurate accessible information to boost the confidence of women undertaking self-testing. In general, the participants were eager for self-testing to be made available soon. This was accompanied by the need for the promotion and implementation of self-testing to include a collective/community approach consistent with Pasifika worldviews. Interpretation: Although participants were enthusiastic about HPV self-testing, multi-level and interacting barriers exist to participation by Pasifika women in HPV self-testing. Implementation of self-testing in Aotearoa New Zealand should be accompanied by clear information about the entire process, using culturally appropriate tailored educational campaigns in different Pasifika languages. Funding: The study was supported by the Collaboration for Cancer Research Aotearoa New Zealand (CCR).

Acceptability of Human Papilloma Virus Self-Sampling for Cervical Cancer Screening in a Cohort of Patients from Romania (Stage 2).

(1) Background: Low patient's adherence to conventional cervical cancer screening methods determined the need to take into consideration alternative approaches, and vaginal HPV self-sampling is one of them. We aimed to evaluate, using an online survey, the Romanian women's acceptability of vaginal HPV self-sampling. (2) Methods: A 13-questions online survey was distributed on three Facebook groups, and the results were summarized. (3) Results: Despite of good educational background, 10.8% (n = 60) of the respondents did not know what a Pap smear is, and 33% (n = 183) were not informed about the free national cervical cancer screening program. Multivariate analysis revealed an increased likelihood of vaginal self-sampling acceptance among respondents who did not know about Pap test (OR: 7.80; 95%CI: 1.062-57.431; p = 0.021), national cervical cancer screening program (OR: 1.96; 95%CI: 1.010-3.806; p = 0.02), HPV infection (OR: 7.35; 95%CI: 3.099-17.449; p< 0.001) or HPV test (OR: 1.67; 95%CI: 0.950-2.948; p = 0.03). Moreover, women who did not previously undergo a cervical cancer screening program were more likely to accept the new screening method (OR: 1.62; 95%CI: 0.878-3.015; p = 0.04). (4) Conclusions: Our results showed high acceptability rates of vaginal HPV self-sampling among participants.

Self-Sampled Gargle Water Direct RT-LAMP as a Screening Method for the Detection of SARS-CoV-2 Infections.

We assessed the viability of self-sampled gargle water direct RT-LAMP (LAMP) for detecting SARS-CoV-2 infections by estimating its sensitivity with respect to the gold standard indirect RT-PCR of paired oro-nasopharyngeal swab samples. We also assessed the impact of symptom onset to test time (STT)-i.e., symptom days at sampling, on LAMP. In addition, we appraised the viability of gargle water self-sampling versus oro-nasopharyngeal swab sampling, by comparing paired indirect RT-PCR results. 202 oro-nasopharyngeal swab and paired self-sampled gargle water samples were collected from hospital patients with COVID-19 associated symptoms. LAMP, indirect and direct RT-PCR were performed on all gargle water samples, and indirect RT-PCR was performed on all oro-nasopharyngeal samples. LAMP presented a sensitivity of 80.8% (95% CI: 70.8-90.8%) for sample pairs with sub-25 Ct oro-nasopharyngeal indirect RT-PCR results, and 77.6% (66.2-89.1%) sensitivity for sub-30 Ct samples with STT ≤ 7 days. STT, independently of Ct value, correlated negatively with LAMP performance. 80.7% agreement was observed between gargle water and oro-nasopharyngeal indirect RT-PCR results. In conclusion, LAMP presents an acceptable sensitivity for low Ct and low STT samples. Gargle water may be considered as a viable sampling method, and LAMP as a screening method, especially for symptomatic persons with low STT values.

Role of Self-Sampling for Cervical Cancer Screening: Diagnostic Test Properties of Three Tests for the Diagnosis of HPV in Rural Communities of Cuenca, Ecuador.

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.