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.

Circulating tumor HPV DNA as an alternative method to determine HPV status in oropharyngeal squamous cell carcinoma.

Human Papilloma Virus (HPV) testing is mandatory for all newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC) due to its importance for prognostication and aiding in treatment decision making. Fine needle aspiration (FNA) is a widely used and accepted diagnostic tool for OPSCC. Although FNA can accurately determine histological diagnosis, results are often indeterminate or lack insufficient samples for HPV testing. For samples with an indeterminant FNA, we propose an alternate method for determining HPV status using circulating tumor tissue modified HPV DNA (ctHPVDNA). We report three cases that confirmed HPV status using ctHPVDNA following an indeterminate FNA. If validated, this non-invasive assay could prevent the need for repeat FNAs or operative biopsies for the sole purpose of determining HPV status.

Te Ara Waiora-Implementing human papillomavirus (HPV) primary testing to prevent cervical cancer in Aotearoa New Zealand: A protocol for a non-inferiority trial.

BACKGROUND: Cervical cancer is caused by high-risk types of human papillomavirus (HPV). Testing for high-risk HPV is a more sensitive screening method than cervical cytology for detecting cervical changes that may lead to cancer. Consistent with recent evidence of efficacy and acceptability, Aotearoa New Zealand plans to introduce HPV testing as the primary approach to screening, replacing cervical cytology, from mid-2023. Any equitable cervical screening programme must be effective across a diverse population, including women that the current programme fails to reach, particularly Maori and those in rural areas. Currently, we do not know the best model for implementing an equitable HPV self-testing screening programme. METHODS: This implementation trial aims to assess whether a universal offer of HPV self-testing (offered to all people eligible for cervical screening) achieves non-inferior screening coverage (equal) to a universal offer of cervical cytology alone (the present programme). The study population is all people aged from 24.5 to 70 years due for cervical screening in a 12-month period (including those whose screening is overdue or who have never had screening). A range of quantitative and qualitative secondary outcomes will be explored, including barriers and facilitators across screening and diagnostic pathways. This study takes place in Te Tai Tokerau/Northland which covers a diverse range of urban and rural areas and has a large Indigenous Maori population. A total of fourteen practices will be involved. Seven practices will offer HPV self-testing universally to approximately 2800 women and will be compared to seven practices providing routine clinical care (offer of cervical cytology) to an approximately equal number of women. DISCUSSION: This trial will answer important questions about how to implement an equitable, high-quality, effective national programme offering HPV self-testing as the primary screening method for cervical cancer prevention. TRIAL REGISTRATION: Prospectively registered with the Australian New Zealand Clinical Trials Registry 07/12/2021: ACTRN12621001675819.

Evaluation and management of male genital tract infections in the setting of male infertility: an updated review.

PURPOSE OF REVIEW: Male infertility may be secondary to male genital tract infection (MGTI) in an estimated 15% of cases. In the absence of overt clinical signs, evaluation for MGTI beyond semen analysis is not well established. Therefore, we review the literature on the evaluation and management of MGTI in the setting of male infertility. RECENT FINDINGS: A set of international guidelines recommends semen culture and PCR testing, but the significance of positive results remains unclear. Clinical trials evaluating anti-inflammatory or antibiotic treatment report improvements in sperm parameters and leukocytospermia, but data on the effect on conception rates are lacking. Human papillomavirus (HPV) and the novel coronavirus (SARS-CoV-2) have been associated with poor semen parameters and decreased conception rates. SUMMARY: The finding of leukocytospermia on semen analysis prompts further evaluation for MGTI, including focused physical examination. The role of routine semen culture is controversial. Treatment options include anti-inflammatories; frequent ejaculation; and antibiotics, which should not be used in the absence of symptoms or microbiological infection. SARS-CoV-2 represents a subacute threat to fertility that should be screened for in the reproductive history along with HPV and other viruses.

Comparison of the AmpFire and MA-6000 polymerase chain reaction platforms for high-risk human papillomavirus testing in cervical precancer screening.

High-risk human papillomavirus (hr-HPV) testing for primary cervical precancer screening offers an opportunity to improve screening in low-middle income countries (LMICs). This study aimed to compare the analytic performances of the AmpFire and MA-6000 platforms for hr-HPV DNA testing in three groups of women screened for hr-HPV types in Ghana: group 1 with 33 GeneXpert-archived ThinPrep/liquid-based samples subjected to both tests, group 2 with 50 AmpFire-archived dry brush samples subjected to MA-6000 testing, and group 3 involving 143 cotton swab samples simultaneously subjected to both tests without archiving. The overall agreement rates were 73 %, 92 %, and 84 %, for groups 1-3, respectively, and 84 % (95 % CI, 78.6-88.6) for the entire group. Neither AmpFire nor MA-6000 was more likely to test hr-HPV positive in all three groups and the combined group. Group 1 showed fair agreement without statistical significance (κ = 0.224, 95 % CI, -0.118 to 0.565), while group 3 showed significant moderate agreement (κ = 0.591, 95% CI, 0.442-0.741). Group 2 showed an almost perfect significant level of agreement (κ = 0.802; 95 % CI, 0.616-0.987). Thus, both platforms showed statistically significant moderate to near-perfect agreement for detecting hr-HPV in cervicovaginal samples, with variation according to archiving conditions and duration between sample collection and retesting. For LMICs using these platforms for COVID-19 testing, as the COVID-19 pandemic subsides, the platforms can become available for running other tests such as hr-HPV DNA testing for cervical precancer screening.

IPVS policy statement on HPV nucleic acid testing guidance for those utilising/considering HPV as primary precancer screening: Quality assurance and quality control issues.

We advise that only clinically validated HPV assays which have fulfilled internationally accepted performance criteria be used for primary cervical screening. Further, assays should be demonstrated to be fit for purpose in the laboratory in which they will ultimately be performed, and quality materials manuals and frameworks will be helpful in this endeavor. Importantly, there is a fundamental shortage of well validated, low-cost, low complexity HPV tests that have demonstrated utility in a near-patient setting; representing a significant challenge and focus for future development in order to reach the WHO's goal of eliminating cervical cancer.

Feasibility and acceptability of telehealth and contactless delivery of human papillomavirus (HPV) self-testing for cervical screening with Maori and Pacific women in a COVID-19 outbreak in Aotearoa New Zealand.

AIM: To determine the feasibility and acceptability of a telehealth offer and contactless delivery of human papillomavirus (HPV) cervical screening self-test during the 2021 COVID-19 Level 4 lockdown in Auckland, New Zealand. METHODS: A small proof-of-concept study was undertaken to test telehealth approaches in never-screened, due or overdue Maori and Pacific women enrolled in a local Primary Health Organisation (PHO). Study invitation, active follow-up, nurse-led discussions, result notification and a post-test questionnaire were all delivered through telehealth. RESULTS: A sample of 197 eligible Maori and Pacific women were invited to take part, of which 86 women were successfully contacted. Sixty-six agreed to take part. Overall uptake was 61 samples returned (31.8%) and uptake of all contactable women was 70.9%. Six of the 61 HPV self-tests (9.8%) were positive, all for non 16/18 types, and were referred for cytology. Three had negative cytology results, and three with positive cytology results were referred for colposcopy. CONCLUSION: The offer of HPV self-testing during COVID-19 lockdown was both feasible and highly acceptable for Maori and Pacific women. Importantly, HPV self-testing via telehealth and mail-out, alongside other options, offers a potential pro-equity approach for addressing the impact of deferred screens due to COVID-19 and other longstanding coverage issues.

Prevention, diagnosis and treatment of cervical cancer: A systematic review of the impact of COVID-19 on patient care.

Worldwide, the COVID-19 pandemic disrupted healthcare services, including cervical cancer management, and an increased burden for this condition is expected. This systematic review synthetizes the available evidence on the impact of the pandemic on prevention, diagnosis and treatment of cervical cancer. Searches were performed on PubMed, Embase, and Scopus for relevant studies on these topics with the purpose of comparing service access and care delivery before and during COVID-19 pandemic. Due to the methodological heterogeneity among the studies, findings were narratively discussed. Of the 715 screened titles and abstracts, 33 articles were included, corresponding to 42 reports that covered the outcomes of interest: vaccination against human papillomavirus (HPV) (6 reports), cancer screening (19), diagnosis (8), and treatment (8). Seven studies observed reductions in HPV vaccination uptake and coverage during COVID-19. Reports on cervical screening and cancer diagnosis activities showed a substantial impact of the pandemic on access to screening services and diagnostic procedures. All but one study that investigated cervical cancer treatment reported changes in the number of women with cervical lesions who received treatments, as well as treatment delay and interruption. With a major impact during the first wave in 2020, COVID-19 and restriction measures resulted in a substantial disruption in cervical cancer prevention and management, with declines in screening and delays in treatment. Taken together, findings from this systematic review calls for urgent policy interventions for recovering cervical cancer prevention and care.

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.

Screening for High-Risk Human Papillomavirus Using Passive, Self-Collected Menstrual Blood.

OBJECTIVE: To assess concordance and acceptability of a modified menstrual pad compared with a clinician-collected high-risk human papillomavirus (HPV) sample. METHODS: This was a prospective observational study. Women presenting for either cervical cancer screening or with a history of high-risk HPV positivity were eligible. Three samples were requested from participants: 1) clinician-collected cervical specimens; 2) self-collected vaginal swabs; and 3) a modified menstrual pad, which was taken home for use during the next menstruation. All samples were processed using the Cobas HPV test. Menstrual pad dried blood spots were eluted, then similarly processed. RESULTS: Of 153 women enrolled in the study, 106 provided menstrual pad samples and clinician-collected cervical specimens for high-risk HPV analysis. For samples in which the interval between the clinician-collected specimen and the menstrual pad sample was less than 2 months, the concordance was 94% (95% CI 83-98). For women who tested positive for high-risk HPV who presented for general screening and those with more than cervical intraepithelial neoplasia 2, menstrual pad and clinician-collected specimen agreement was 100% (95% CI 32.5-100). Among participants, 22.9% expressed discomfort with the self-collected vaginal swabs and opted out of collection. Overall, 94.0% of participants preferred the menstrual pad over clinician-collected sampling. Twelve patients were found to be positive for HPV on the menstrual pad sample but negative on the clinician-collected specimen. CONCLUSION: Among women who tested positive for HPV, the menstrual pad showed highly concordant results compared with clinician-collected sampling. This collection approach shows promise for integration into cervical cancer prevention programs.

Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening.

The NeuMoDx HPV assay is a novel fully automated, real-time PCR-based assay for the qualitative detection of high-risk human papillomavirus (HPV) DNA in cervical specimens. The assay specifically identifies HPV16 and HPV18 and concurrently detects 13 other high-risk HPV types at clinically relevant infection levels. Following the international guidelines, the clinical performance of the NeuMoDx HPV assay for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) against the reference standard Hybrid Capture 2, as well as intra- and inter-laboratory reproducibility were assessed on PreservCyt samples. The clinical accuracy of the assay was additionally evaluated against the clinically validated Alinity m HR HPV and COBAS 4800 HPV Test on PreservCyt samples, and against the clinically validated HPV-Risk assay on SurePath samples. The NeuMoDx HPV assay performance for CIN2+ was non-inferior to the reference methods on both sample types (all p < 0.05), and showed excellent intra- and inter-laboratory reproducibility (95.7%; 95% CI: 93.9-97.3; kappa value 0.90 (95% CI: 0.86-0.94); and 94.5%; 95% CI: 92.6-96.2; kappa value 0.87 (95% CI: 0.82-0.92), respectively). In conclusion, the NeuMoDx HPV assay meets international guideline criteria for cross-sectional accuracy and reproducibility, and performs equally well on cervical screening specimens collected in two widely used collection media. The NeuMoDx HPV assay fulfils the requirements to be used for primary cervical screening.

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.

Low rates of HPV vaccination and cervical cancer screening: Challenges and opportunities in the context of the COVID-19 pandemic.

This invited commentary discusses the article by Richards et al. describing differences in rates of on-time HPV vaccination and cervical cancer screening in 2018 among enrollees in different insurance plans. The commentary focuses on the larger problem of low vaccination HPV rates and decreasing cervical cancer screening rates seen across all sectors. We outline challenges posed by the COVID-19 pandemic on HPV vaccination and cervical cancer screening, and discuss opportunities to improve cervical cancer prevention.

Adaptation of patients diagnosed with human papillomavirus: a grounded theory study.

BACKGROUND: Human papillomavirus is the most common cause of sexually transmitted diseases. Various studies report that positive human papillomavirus diagnosis results in psychosexual issues for the infected and reduces their quality of life. However, the adaptation of the infected has not been addressed yet. The present study aims to identify the process by which individuals infected with human papillomavirus adapt to their disease. METHOD: This is a qualitative work of research with a grounded theory design. The setting of the study was the skin clinic of Shahid Faghihi Hospital in Shiraz. The participants consisted of 27 individuals: 18 patients, 3 doctors, 2 counselors, and 4 spouses of patients. The subjects were selected via purposeful and theoretical sampling method until data saturation was reached. Data were collected through face-to-face, in-depth, semi-structured interviews from April 2019 to December 2020. The collected data were analyzed using Corbin and Strauss's method (2015) and MAXQDA 2018. RESULTS: The theory which emerged from the data was "trying to maintain resilience in the absence of psychological security." Analysis of data showed the main concern of participants in adapting to their diagnosis with human papillomavirus was "life stress". "Stigma and ignorance" was found to be a contextual condition and "paradox in support" was an intervening condition in the patients' adaptation. The patients' action/interaction responses to their main concern in the context in question were "emotional confrontation" and "maintaining resilience." The outcome was "oscillation between tension and tranquility." CONCLUSION: The present study explains the process by which patients with human papillomavirus adapt to their condition. Identification of the concerns of patients with human papillomavirus and the factors which affect their adaptation can help healthcare policy-makers and providers develop effective support plans in order to increase patients' quality of life. Early interventions, e.g. counseling care providers to modify their behaviors toward alleviating the psychosexual tension of the infected, can facilitate the adaptation of the infected and decrease the consequences of the infection for them.

Human papillomavirus (HPV) is the most common cause of sexually transmitted diseases. Almost all men and women get the infection at least once throughout their lives. The high-risk types of HPV account for about 5% of cancer cases globally. HPV can cause anogenital cancers and warts in both genders. In this grounded theory study, we conducted 27 in-depth interviews with Iranian patients, their spouses, and health care providers from April 2019 to December 2020. The collected data were analyzed using Corbin and Strauss's method (2015) and MAXQDA 2018. The participants were concerned about tension in family relationships, being stigmatized, getting cancer, recurrence of warts, transferring their disease to others, and changes in the appearance of their genitalia. They stated that HPV is regarded as a shameful disease in society. Most of the participants said they had never heard anything about HPV. The patients' action/interaction responses to their concerns were "emotional confrontation" and "maintaining resilience." These strategies helped the patients recover some of their tranquility. However, some of patients' concerns were persistent and kept them oscillating between tension and tranquility. An understanding of the patients' perception of their disease is essential to development of effective educational interventions to change patients' perspective on their situation and improve their recovery. Furthermore, because of the low level of public awareness about HPV and sexual health and the flow of misinformation to the infected, it is recommended that educational interventions focus on the patients' concerns.

HPV knowledge, screening barriers and facilitators, and sources of health information among women living with HIV: perspectives from the DC community during the COVID-19 pandemic.

BACKGROUND: High-risk human papillomavirus (HPV) causes 99% of cervical cancer cases. Despite available prevention methods through the HPV vaccine and two screening modalities, women continue to die from cervical cancer worldwide. Cervical cancer is preventable, yet affects a great number of women living with HIV (WLH). Low screening rates among WLH further exacerbate their already high risk of developing cervical cancer due to immunosuppression. This study explores WLH's current cervical cancer knowledge, screening barriers and facilitators, and sources of health information. METHODS: Focus group discussions were conducted with 39 WLH aged 21 years old or older, who resided in the Washington-Baltimore Metropolitan Area. Emergent themes were classified and organized into overarching domains and assembled with representative quotations. RESULTS: The women had limited knowledge of HPV and the cervical cancer screening guidelines for WLH. Coronavirus 2019 (COVID-19) pandemic has amplified screening barriers due to decreased accessibility to usual medical appointment and cervical cancer screenings. Screening facilitators included knowing someone diagnosed with cervical cancer and provider recommendations. WLH indicated that they obtained health information through in-person education (providers, peer groups) and written literature. Due to the pandemic, they also had to increasingly rely on remote and technology-based communication channels such as the internet, social media, television, radio, email, and short message service (SMS) text messaging. CONCLUSIONS: Future health interventions need to explore the possibility of sharing messages and increasing cervical cancer and HPV knowledge of WLH through the use of SMS and other technology-based channels.

Human Papillomavirus Self-Sampling for Primary Cervical Cancer Screening in Under-Screened Women in Hong Kong during the COVID-19 Pandemic.

The aim of this study was to assess the effectiveness of HPV self-sampling for cervical cancer screening and the best means of service delivery, with a specific focus on under-screened women, particularly during the COVID-19 pandemic. Using three arms of service delivery (social media, school outreach and underserved outreach), we recruited under-screened women aged 30-65 years from two population groups: the general public and specific underserved communities, from whom self-sampled specimens and optional clinician-sampled cervical specimens were obtained for HPV testing. A total of 521 self-sampling kits were distributed, of which 321 were returned, giving an overall uptake rate of 61.6%. The response rate was higher in the face-to-face underserved outreach (65.5%) compared to social media (22.8%) and school outreach (18.2%). The concordance for HPV detection between self-sampled and clinician-sampled specimens was 90.2% [95% confidence interval (CI) 85.1-93.8%; Cohen's kappa 0.59 (95% CI 0.42-0.75)]. Overall, 89.2% of women were willing to have self-sampling again. In conclusion, HPV self-sampling is an effective method for cervical cancer screening and can be considered as an option, particularly in women who are reluctant or unable to attend regular screening. Various service deliveries could be considered to increase participation in cervical cancer screening.