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We sought to understand how opioid treatment programs (OTPs) adapted OTP operations to the COVID-19 pandemic and new federal regulations around methadone and buprenorphine.In fall 2020, we conducted an online survey of all 103 OTPs licensed by the Pennsylvania Department of Drug and Alcohol Programs, including clinical directors. Survey domains included changes to methadone take-home and telehealth practices; overdose and diversion prevention tactics; perceptions regarding how such changes influence patient well-being; and financial/operational concerns related to the new policies and practices. We calculated descriptive statistics and conducted Chi-square test to test for differences between not-for-profit versus for-profit and large versus small OTPs.Forty-seven percent (46%) OTPs responded to the survey. 10% and 25%, respectively, endorsed offering telephone and video-based telemedicine buprenorphine induction. Sixty-six percent endorsed extending take-home supplies of methadone, but most indicated that these extensions applied to a minority of their patients. Most respondents agreed that provision of buprenorphine via telehealth and extended take-home methadone reduced patient burden in accessing medications and prevented exposure to COVID-19, while not significantly increasing risk of overdose. We did not find major differences in COVID-19 practice modifications by nonprofit status or size of OTP.In Pennsylvania, the COVID-19 pandemic led to rapid changes in provision of opioid treatment services. Findings on relatively low uptake of longer methadone take-home regimens and virtual buprenorphine initiation despite general support for these practices imply a need to further develop guidelines for best clinical practices and understand/address barriers to their implementation.

OBJECTIVE: Moral Reconation Therapy (MRT) is a cognitive-behavioral intervention to reduce risk for criminal recidivism. Despite being implemented widely in correctional settings, there are no randomized controlled trials of MRT, and its effectiveness for reducing recidivism among justice-involved adults in non-correctional settings is unknown. METHODS: In a pragmatic trial, 341 justice-involved patients (95.3% male; 57.8% White/Non-Hispanic) admitted to one of three mental health residential treatment programs were randomly assigned to usual care (UC) or UC plus two MRT groups per week for 12 weeks. Follow-ups were conducted at 6- and 12-months post-baseline (71.3% and 74.8% retention, respectively). Primary outcomes were criminal thinking and criminal associates. Secondary outcomes were legal problem severity, days incarcerated in the past 30, rearrested/charged (per official records), substance use, and employment and family/social problems. The study design, analysis, and outcomes were preregistered (ClinicalTrials.gov; ID:NCT02524171). RESULTS: Patients in both conditions improved over time on most outcomes. In intent-to-treat analyses, the rate of change in outcomes over time did not differ by condition, nor did the prevalence of being rearrested and charged within one year of baseline (UC=20.2%, MRT=24.9%; OR=1.14; 95% CI[0.67,1.94], p=.63). MRT engagement was low; 37% of those randomized to MRT received a minimum dose–i.e., completed at least Step 3. In per-protocol analyses, this subgroup, relative to UC, improved more on criminal associates, days incarcerated, legal problem severity, and alcohol use severity. CONCLUSIONS: In this study, MRT was not more effective than usual care at reducing recidivism risk for patients in mental health residential treatment.

We compared human papillomavirus messenger RNA testing using urine, self-, and provider-collected samples for the detection of high-grade cervical cytology and assessed acceptability of urine self-collection among females who engage in sex work in Kenya. Participants found urine sampling comfortable, but high-risk human papillomavirus messenger RNA detection in urine samples was less likely to detect high-grade lesions than self- and provider-collected cervical samples.

Mobile apps can only increase access to alcohol treatment if patients actively engage with them. Peers may be able to facilitate such engagement by providing supportive accountability and instruction and encouragement for app use. We developed a protocol for peers to support engagement in the Stand Down app for unhealthy alcohol use in veterans and tested the acceptability and utility of the protocol. Thirty-one veteran primary care patients who screened positive for unhealthy alcohol use and were not currently in addiction treatment were given access to Stand Down for four weeks and concurrently received weekly phone support from a Department of Veterans Affairs peer specialist to facilitate engagement with the app. App usage was extracted daily, and pre/post treatment assessments measured changes in drinking patterns, via the Timeline Followback interview, and satisfaction with care, via quantitative and qualitative approaches. A priori benchmarks for acceptability were surpassed: time spent in the app (M = 93.89 min, SD = 92.1), days of app use (M = 14.05, SD = 8.0), and number of daily interviews completed for tracking progress toward a drinking goal (M = 12.64, SD = 9.7). Global satisfaction, per the Client Satisfaction Questionnaire, was high (M = 26.4 out of 32, SD = 4.5). Pre to post, total standard drinks in the prior 30 days (MPre = 142.7, MPost = 85.6), Drinks Per Drinking Day (MPre = 5.4, MPost = 4.0), and Percent Heavy Drinking Days (MPre = 35.3%, MPost = 20.1%) decreased significantly (ps < .05). Findings indicate that Peer-Supported Stand Down is highly acceptable to veteran primary care patients and may help reduce drinking in this population. A larger controlled trial of this intervention is warranted. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

We compared detection of Chlamydia trachomatis , Neisseria gonorrhoeae , and Trichomonas vaginalis using dry and wet self-collected samples using brushes among females who engage in sex work in Mombasa, Kenya. Detection of T. vaginalis and N. gonorrhoeae in dry and wet samples was similar, but C. trachomatis detection in dry samples appeared lower.

Background Community health workers (CHWs) are essential field-based personnel and increasingly used to deliver priority interventions to achieve universal health coverage. Existing literature allude to the potential for detrimental effects of multi-tasking CHWs. This study objective was to assess the impact of integrating cervical cancer screening and prevention therapy (CCSPT) with family planning (FP) on time utilization among CHWs. Methods A time and motion study was conducted in 7 health facilities in Malawi. Data was collected at baseline between October-July 2019, and 12 months after CCSPT implementation between July and August 2021. CHWs trained to deliver CCSPT were continuously observed in real time while their activities were timed by independent observers. We used paired sample t-test to assess pre-post differences in average hours CHWs spent on the following key activities, before and after CCSPT implementation: clinical and preventive care; administration; FP; and non-work-related tasks. Regression models were used to ascertain impact of CCSPT on average durations CHWs spent on key activities. Results Thirty-seven (n = 37) CHWs were observed. Their mean age and years of experience were 42 and 17, respectively. Overall, CHWs were observed for 323 hours (inter quartile range: 2.8–5.5). Compared with the period before CCSPT, the proportion of hours CHWs spent on clinical and preventive care, administration and non-work-related activities were reduced by 13.7, 8.7 and 34.6%, respectively. CHWs spent 75% more time on FP services after CCSPT integration relative to the period before CCSPT. The provision of CCSPT resulted in less time that CHWs devoted towards clinical and preventive care but this reduction was not significant. Following CCPST, CHWs spent significantly few hours on non-work-related activities. Conclusion Introduction of CCSPT was not very detrimental to pre-existing community services. CHWs managed their time ensuring additional efforts required for CCSPT were not at the expense of essential activities. The programming and policy implications are that multi-tasking CHWs with CCSPT will not have substantial opportunity costs.

Moral Reconation Therapy (MRT), an evidence-based intervention to reduce risk for criminal recidivism among justice-involved adults, was developed and primarily tested in correctional settings. Therefore, a better understanding of the implementation potential of MRT within non-correctional settings is needed. To address this gap in the literature, we evaluated the adoption and sustainment of MRT in the US Veterans Health Administration (VHA) following a national training initiative in fiscal years 2016 and 2017. In February 2019, surveys with 66 of the 78 VHA facilities that participated in the training were used to estimate the prevalence of MRT adoption and sustainment, and qualitative interviews with key informants from 20 facilities were used to identify factors associated with sustainment of MRT groups. Of the 66 facilities surveyed, the majority reported adopting (n = 52; 79%) and sustaining their MRT group until the time of the survey (n = 38; 58%). MRT sustainment was facilitated by strong intra-facility (e.g., between veterans justice and behavioral health services) and inter-agency collaborations (e.g., between VHA and criminal justice system stakeholders), which provided a reliable referral source to MRT groups, external incentives for patient engagement, and sufficient staffing to maintain groups. Additional facilitators of MRT sustainment were adaptations to the content and delivery of MRT for patients and screening of referrals to the groups. The findings provide guidance to clinics and healthcare systems that are seeking to implement MRT with justice-involved patient populations, and inform development of implementation strategies to be formally tested in future trials.

BACKGROUND: Anal cancer incidence has increased in Western countries in recent decades and currently there are no consensus screening guidelines. Home-based self-sampling kits might facilitate screening for anal precancer/cancer but could require travel through postal mail where they may experience extreme temperatures or long transport times. OBJECTIVE: To determine the effect of the environment on specimen adequacy for HPV genotyping of a mailed home-based self-sampling anal cancer screening kit. STUDY DESIGN: The Prevent Anal Cancer (PAC) Study in Milwaukee, Wisconsin recruited men who have sex with men (MSM) and transgender persons 25 years of age and older. Participants were randomized to receive a mailed self-sampling kit or attend a clinic for screening. Kits were insulated with foam and included a device to record temperature every twenty minutes. Samples were returned via mail and underwent HPV genotyping using the SPF(10)-LiPA(25) assay which also detected human RNase P to determine specimen adequacy by qPCR. For the first 93 kits, logistic regression assessed associations between specimen inadequacy and temperature, freeze-thaw cycle, presence of fecal matter, and number of days in an uncontrolled environment. RESULTS: Most specimens (92.5%) were adequate for HPV genotyping. Specimen inadequacy was not associated with temperature, freeze-thaw cycle, or transit time. Fecal matter was present more often in inadequate (71.4%) compared to adequate specimens (16.3%) (p = .004). CONCLUSIONS: These real-world data from mailed home-based anal self-sampling kits found that environmental conditions did not affect specimen adequacy. While over 90% of specimens were adequate, presence of fecal matter predicted specimen inadequacy.

In sub-Saharan Africa, Kaposi's sarcoma-associated herpesvirus (KSHV) is endemic, and Kaposi's sarcoma (KS) is a significant public health problem. Until recently, KSHV genotype analysis was performed using variable gene regions, representing a small fraction of the genome, and thus the contribution of sequence variation to viral transmission or pathogenesis are understudied. We performed near full-length KSHV genome sequence analysis on samples from 43 individuals selected from a large Cameroonian KS case-control study. KSHV genomes were obtained from 21 KS patients and 22 control participants. Phylogenetic analysis of the K1 region indicated the majority of sequences were A5 or B1 subtypes and all three K15 alleles were represented. Unique polymorphisms in the KSHV genome were observed including large gene deletions. We found evidence of multiple distinct KSHV genotypes in three individuals. Additionally, our analyses indicate that recombination is prevalent suggesting that multiple KSHV infections may not be uncommon overall. Most importantly, a detailed analysis of KSHV genomes from KS patients and control participants did not find a correlation between viral sequence variations and disease. Our study is the first to systematically compare near full-length KSHV genome sequences between KS cases and controls in the same endemic region to identify possible sequence variations associated with disease risk.

Under-screened women are more likely to be diagnosed with invasive cervical cancer at later stages and have worse survival outcomes. Under- or un-insured women, low-income women, and minoritized groups face barriers to screening. Intention to screen is an indicator of future screening behavior, yet is understudied among low-income, under-screened women. Participants were 710 low-income, uninsured or publicly insured women ages 25–64 years in North Carolina who were not up to date on cervical cancer screening according to national guidelines. Participants were asked about barriers to screening and intention to screen. We estimated reported barriers to cervical cancer screening stratified by race and ethnicity (categorized as White, Black, and Hispanic) and assessed predictors of intention to screen. Sixty-one percent of all participants reported 5 or more barriers to screening. The most commonly reported reasons for not getting screened were lack of insurance (White: 71%, Black: 62%, Hispanic/Latina: 63%) and cost (White: 55%, Black: 44%, Hispanic/Latina: 61%). Women were more likely to have an intention to screen if they reported “it was not hard to get screening” (OR: 1.47 (1.00, 2.15)). Older women reported being less likely to intend to screen. Black women reported being more likely to intend to screen than White women. Lack of health insurance and cost were frequently reported barriers to cervical cancer screening. Increasing knowledge of affordable clinics and expanding access to Medicaid may reduce barriers and increase cervical cancer screening uptake.

Retrospective cohort.Over 44 million adults are estimated to have either osteoporosis or osteopenia. Adult spinal deformity (ASD) is estimated to affect between 32 and 68% of the elderly population.Retrospective investigation comparing rates of postoperative complications following thoracolumbar scoliosis surgery in patients with normal bone mineral density (BMD) to those with osteopenia or osteoporosis in addition to analyzing the effects of pretreatment with anti-osteoporotic medications in patients with low BMD.Using administrative database of Humana beneficiaries, ICD-9 and ICD-10 diagnosis codes were used to identify ASD patients undergoing multilevel thoracolumbar fusions between 2007 and 2017.The propensity matched population analyzed in this study contained 1044 patients equally represented by those with a history of osteopenia, osteoporosis, or normal BMD. Osteopenia and osteoporosis were associated with increased odds of revision surgery (OR 2.01 95% CI 1.36-2.96 and OR 1.57, 95% CI 1.05-2.35), respectively. Similarly, there was an almost twofold increased odds of proximal and distal junctional kyphosis in patients with osteopenia and osteoporosis (OR 1.95, 95% CI 1.40-2.74 and OR 1.88, 95% CI 1.34-2.64), respectively. A total of 258 (37.1%) patients with osteoporosis were pretreated with anti-osteoporotic medications and there was no statistically significant decrease in odds of proximal or distal junctional kyphosis or revision surgery in these patients.Patients with ASD undergoing multilevel thoracolumbar fusion surgery have significantly higher rates of postoperative pseudarthrosis, proximal and distal junctional kyphosis, and revision surgery rates compared to patients with normal BMD.

Spinal synovial cysts are acquired, fluid-filled lesions of the facet joint that most commonly occur in the lumbar spine. They are thought to arise from degenerative changes and to result from segmental instability. Although the treatment of these lesions has been studied, the long-term implications and effects of the different strategies for surgical intervention (i.e., decompression and fusion vs. decompression alone) have not yet been elucidated or established.Using an all-payer database with 53 million patient records (MARINER-53), patients with a diagnosis of lumbar synovial cysts were identified. Patients who had undergone lumbar fusion versus laminectomy were matched 1:1 using binomial and gaussian logistic regression models to evaluate the need for future lumbar surgery within 5 years after their index procedure.No statistically significant differences were noted between the 5-year rates of subsequent intervention, additional laminectomy, or fusion among patients who had undergone index decompression and fusion (n = 51; 10.5%) versus decompression alone (n = 43; 8.8%; P = 0.39). Furthermore, no significant differences were found in the odds of intervention type after index decompression and fusion versus decompression alone (subsequent laminectomy: odds ratio, 0.59; 95% confidence interval, 0.32-1.09; subsequent fusion: odds ratio, 1.14; 95% confidence interval, 0.64-2.02).Patient-specific factors and surgeon-patient-shared decision-making should be used when planning interventions for these lesions. However, synovial cysts might not require a fusion procedure for presumed instability. Further investigation is required, using randomized and prospective studies, to further evaluate the effective treatment of this entity.

Background: Primary high-risk human papillomavirus (hr-HPV) testing of self-collected cervico-vaginal swabs could increase cervical cancer screening coverage, although triage strategies are needed to reduce unnecessary colposcopies. We evaluated the use of extended hr-HPV genotyping of self-collected samples for cervical cancer screening. Methods: We recruited women ages 25–65 years at two colposcopy clinics in North Carolina between November 2016 and January 2019, and obtained self-collected cervico-vaginal samples, provider-collected cervical samples, and cervical biopsies from all enrolled women. Self- and provider-collected samples were tested for 14 hr-HPV genotypes using the Onclarity Assay (Becton Dickinson). We calculated hr-HPV genotype–specific prevalence and assessed agreement between results in self- and provider-collected samples. We ranked the hr-HPV genotypes according to their positive predictive value (PPV) for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or higher (CIN2+). Results: A total of 314 women participated (median age, 36 years); 85 women (27%) had CIN2+. More women tested positive for any hr-HPV on self-collected (76%) than on provider-collected samples (70%; P = 0.009) with type-specific agreement ranging from substantial to almost perfect. HPV-16 was the most common genotype in self-collected (27%) and provider-collected samples (20%), and HPV-16 prevalence was higher in self- than provider-collected samples (P < 0.001). In self- and provider-collected samples, HPV-16 had the highest PPV for CIN2+ detection. Conclusions: Overall sensitivity for CIN2+ detection was similar for both sample types, but the higher HPV-16 prevalence in self-collected samples could result in increased colposcopy referral rates. Impact: Additional molecular markers might be helpful to improve the triage of women who are hr-HPV positive on self-collected samples.

Given that high-risk human papillomavirus (HPV) is the necessary cause of virtually all cervical cancer, the clinical meaning of HPV-negative cervical precancer is unknown. We, therefore, conducted a literature search in Ovid MEDLINE, PubMed Central, and Google Scholar to identify English-language studies in which (i) HPV-negative and -positive, histologically confirmed cervical intraepithelial neoplasia grade 2 or more severe diagnoses (CIN2+) were detected and (ii) summarized statistics or deidentified individual data were available to summarize proportions of biomarkers indicating risk of cancer. Nineteen studies including 3,089 (91.0%) HPV-positive and 307 (9.0%) HPV-negative CIN2+ were analyzed. HPV-positive CIN2+ (vs. HPV-negative CIN2+) was more likely to test positive for biomarkers linked to cancer risk: a study diagnosis of CIN3+ (vs. CIN2; 18 studies; 0.56 vs. 0.24; P < 0.001) preceding high-grade squamous intraepithelial lesion cytology (15 studies; 0.54 vs. 0.10; P < 0.001); and high-grade colposcopic impression (13 studies; 0.30 vs. 0.18; P = 0.03). HPV-negative CIN2+ was more likely to test positive for low-risk HPV genotypes than HPV-positive CIN2+ (P < 0.001). HPV-negative CIN2+ appears to have lower cancer risk than HPV-positive CIN2+. Clinical studies of human high-risk HPV testing for screening to prevent cervical cancer may refer samples of HPV test–negative women for disease ascertainment to correct verification bias in the estimates of clinical performance. However, verification bias adjustment of the clinical performance of HPV testing may overcorrect/underestimate its clinical performance to detect truly precancerous abnormalities.

Malaria remains a significant cause of morbidity and mortality in Malawi, with an estimated 18–19% prevalence of Plasmodium falciparum in children 2–10 years in 2015–2016. While children report the highest rates of clinical disease, adults are thought to be an important reservoir to sustained transmission due to persistent asymptomatic infection. The 2015–2016 Malawi Demographic and Health Survey was a nationally representative household survey which collected dried blood spots from 15,125 asymptomatic individuals ages 15–54 between October 2015 and February 2016. We performed quantitative polymerase chain reaction on 7,393 samples, detecting an overall P. falciparum prevalence of 31.1% (SE = 1.1). Most infections (55.6%) had parasitemias ≤ 10 parasites/µL. While 66.2% of individuals lived in a household that owned a bed net, only 36.6% reported sleeping under a long-lasting insecticide-treated net (LLIN) the previous night. Protective factors included urbanicity, greater wealth, higher education, and lower environmental temperatures. Living in a household with a bed net (prevalence difference 0.02, 95% CI − 0.02 to 0.05) and sleeping under an LLIN (0.01; − 0.02 to 0.04) were not protective against infection. Our findings demonstrate a higher parasite prevalence in adults than published estimates among children. Understanding the prevalence and distribution of asymptomatic infection is essential for targeted interventions.

Background: We compared women's acceptability of urine and cervico-vaginal sample self-collection for high-risk (oncogenic) human papillomavirus (hrHPV) testing and assessed whether acceptability v...

Female sex workers (FSWs) have a notably high risk of acquiring human papillomavirus (HPV) infections. Relatively few studies address the type-specific prevalence and incidence of HPV among FSWs in sub-Saharan Africa. FSWs (n = 348) attending the Korogocho clinic in Nairobi, Kenya participated from August 2009 to March 2011. HPV DNA was detected using the SPF10-LiPA25 PCR assay. Baseline prevalence of HPV infection and cervical dysplasia were calculated, stratified by HIV-serostatus. Incidence rate (IR) of infection was calculated as number of new infections from baseline over person-months among 160 HPV-negative participants with complete 12-month follow-up. Baseline HPV prevalence was 23.6% for any HPV and 20.4% for high-risk HPV (hrHPV) types. Most prevalent types were HPV52 (10.1%), HPV35 (2.3%), and HPV51 (2.3%). A quarter (24%) of participants were HIV-positive. HPV prevalence was higher in HIV-positive (32.1%) than HIV-negative (20.8%) participants. hrHPV prevalence was higher in HIV-positive (27.4%) than HIV-negative (18.2%) women. During follow-up, HPV IR was 31.4 (95% CI: 23.8–41.5) for any HPV and 24.2 (95% CI: 17.9–32.8) for hrHPV types. HPV52 had the highest IR (6.0; 95% CI: 6.5–10.3). Overall HPV and hrHPV prevalence were lower than expected, but both prevalence and incidence were higher in HIV-positive than in HIV-negative women.

Background Opioid treatment programs (OTPs) serve as daily essential services for people with opioid use disorder. This study seeks to identify modifications to operations and adoption of safety measures at Pennsylvania OTPs during the COVID-19 pandemic. Methods A 25-min online survey to clinical and administrative directors at all 103 state-licensed OTPs in Pennsylvania was fielded from September to November 2020. Survey domains included: 1) changes to services, client volume, hours and staffing during the COVID-19 pandemic 2) types of services modifications 3) safety protocols to reduce COVID-19 transmission 4) challenges to operations during the pandemic. Results Forty-seven directors responded, for a response rate of 45%. Almost all respondents reported making some service modification (96%, n = 43). Almost half (47%, n = 21) of respondents reported reductions in the number of clients served. OTPs were more likely to adopt safety protocols that did not require significant funding, such as limiting the number of people entering the site (100%, n = 44), posting COVID-safety information (100%, n = 44), enforcing social distancing (98%, n = 43), and increasing sanitation (100%, n = 44). Only 34% (n = 14) of OTPS provided N95 masks to most or all staff. Respondents reported that staff’s stress and negative mental health (86%, n = 38) and staff caregiving responsibilities (84%, n = 37) during the pandemic were challenges to maintaining OTP operations. Conclusion OTPs faced numerous challenges to operations and adoption of safety measures during the COVID-19 pandemic. Funding mechanisms and interventions to improve adoption of safety protocols, staff mental health as well as research on patient experiences and preferences can inform further OTP adaptation to the COVID-19 pandemic and future emergency planning.

Criminal recidivism is common among patients in mental health residential treatment programs. Moral reconation therapy (MRT) has empirical support for reducing criminal recidivism by modifying antisocial cognitions and behaviors; however, its implementation potential in noncorrectional settings has been rarely studied. This potential was examined in a three-site effectiveness-implementation trial of MRT for justice-involved veterans receiving residential mental health treatment in the U.S. Veterans Health Administration.Semistructured interviews were conducted with 36 veterans who received MRT and 13 residential program staff who were involved in its implementation during the trial. Interviews were guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework and a focus on patient engagement and context. Content analysis was used to identify facilitators of and barriers to MRT implementation in residential mental health treatment.Participants viewed MRT as unique and complementary to usual residential care, with benefits beyond recidivism reduction. However, time intensity of the MRT curriculum, challenges in adapting its content and format, and long-term costs of maintaining MRT were viewed as barriers to implementation. To facilitate implementation, participants suggested streamlining the MRT curriculum, adding motivational components, and establishing partnerships in- and outside the health care system.The findings suggest strategies and modifications to MRT, which, if shown to be effective, may facilitate its wider implementation in mental health residential treatment programs.

Background: High-risk human papillomavirus (hrHPV) testing is utilized in primary cervical cancer screening, generally along with cytology, to triage abnormalities to colposcopy. Most screening-based hrHPV testing involves pooled detection of any hrHPV or of HPV16/18. Cervical neoplasia progression risks based on extended hrHPV genotyping—particularly non-16/18 hrHPV types—are not well characterized. HPV genotype-specific incidence of high-grade cervical intraepithelial neoplasia or more severe (CIN2+) following an abnormal screening result was examined. Methods: We assessed a US-based prospective, multiracial, clinical cohort of 343 colposcopy patients with normal histology (n = 226) or CIN1 (n = 117). Baseline cervical samples underwent HPV DNA genotyping, and participants were followed up to 5 years. Genotype-specific CIN2+ incidence rates (IR) were estimated with accelerated failure time models. Five-year CIN2+ risks were estimated nonparametrically for hierarchical hrHPV risk groups (HPV16; else HPV18/45; else HPV31/33/35/52/58; else HPV39/51/56/59/68). Results: At enrollment, median participant age was 30.1 years; most (63%) were hrHPV-positive. Over follow-up, 24 participants progressed to CIN2+ (7.0%). CIN2+ IR among hrHPV-positive participants was 3.4/1,000 person-months. CIN2+ IRs were highest for HPV16 (8.3), HPV33 (7.8), and HPV58 (4.9). Five-year CIN2+ risk was higher for HPV16 (0.34) compared with HPV18/45 (0.12), HPV31/33/35/52/58 (0.12), and HPV39/51/56/59/68 (0.16) (P = 0.05). Conclusions: Non-16/18 hrHPV types are associated with differential CIN2+ progression rates. HPV16, 33, and 58 exhibited the highest rates over 5 years. HPV risk groups warrant further investigation in diverse US populations. Impact: These novel data assessing extended HPV genotyping in a diverse clinical cohort can inform future directions to improve screening practices in the general population.

Isothermal amplification-based tests have been introduced as rapid, low-cost, and simple alternatives to real-time reverse transcriptase PCR (RT-PCR) tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection. The clinical performance of two isothermal amplification-based tests (Atila Biosystems iAMP coronavirus disease of 2019 [COVID-19] detection test and OptiGene COVID-19 direct plus RT-loop-mediated isothermal amplification [LAMP] test) was compared with that of clinical RT-PCR assays using different sampling strategies. A total of 1,378 participants were tested across 4 study sites. Compared with standard of care RT-PCR testing, the overall sensitivity and specificity of the Atila iAMP test for detection of SARS-CoV-2 were 76.2% and 94.9%, respectively, and increased to 88.8% and 89.5%, respectively, after exclusion of an outlier study site. Sensitivity varied based on the anatomic site from which the sample was collected. Sensitivity for nasopharyngeal sampling was 65.4% (range across study sites, 52.8% to 79.8%), for midturbinate was 88.2%, for saliva was 55.1% (range across study sites, 42.9% to 77.8%), and for anterior nares was 66.7% (range across study sites, 63.6% to 76.5%). The specificity for these anatomic collection sites ranged from 96.7% to 100%. Sensitivity improved in symptomatic patients (overall, 82.7%) and those with a higher viral load (overall, 92.4% for cycle threshold [CT] of ≤25). Sensitivity and specificity of the OptiGene direct plus RT-LAMP test, which was conducted at a single study site, were 25.5% and 100%, respectively. The Atila iAMP COVID test with midturbinate sampling is a rapid, low-cost assay for detecting SARS-CoV-2, especially in symptomatic patients and those with a high viral load, and could be used to reduce the risk of SARS-CoV-2 transmission in clinical settings. Variation of performance between study sites highlights the need for site-specific clinical validation of these assays before clinical adoption. IMPORTANCE Numerous SARS-CoV-2 detection assays have been developed and introduced into the market under emergency use authorizations (EUAs). EUAs are granted primarily based on small studies of analytic sensitivity and specificity with limited clinical validations. A thorough clinical performance evaluation of SARS-CoV-2 assays is important to understand the strengths, limitations, and specific applications of these assays. In this first large-scale multicentric study, we evaluated the clinical performance and operational characteristics of two isothermal amplification-based SARS-CoV-2 tests, namely, (i) iAMP COVID-19 detection test (Atila BioSystems, USA) and (ii) COVID-19 direct plus RT-LAMP test (OptiGene Ltd., UK), compared with those of clinical RT-PCR tests using different sampling strategies (i.e., nasopharyngeal, self-sampled anterior nares, self-sampled midturbinate, and saliva). An important specific use for these isothermal amplification-based, rapid, low-cost, and easy-to-perform SARS-CoV-2 assays is to allow for a safer return to preventive clinical encounters, such as cancer screening, particularly in low- and middle-income countries that have low SARS-CoV-2 vaccination rates.

Background Cervical cancer is highly preventable with regular screening, yet over 4,000 women die from it annually in the United States. Over half of new cervical cancer cases in the U.S. are attributable to insufficient screening. Methods Participants were 23 low-income, uninsured or Medicaid-insured women in North Carolina who were overdue for cervical cancer screening according to national guidelines. Semi-structured interviews examined perspectives on barriers to cervical cancer screening and on interventions to reduce these barriers. We also elicited feedback on three proposed evidence-based interventions: one-on-one education, coupons to reduce out-of-pocket costs, and self-collection of samples for detection of high-risk human papillomavirus (HPV) infection, the primary cause of cervical cancer. Results Reported barriers included high cost, inconvenient clinic hours, lack of provider recommendation, poor transportation, difficulty finding a provider, fear of pain, and low perceived need. Participants suggested interventions including reducing cost, improving convenience through community-based screening or extended clinic hours, strengthening provider recommendations, and providing one-on-one counseling and education outreach. HPV self-collection was most frequently selected as the “most helpful” of 3 proposed interventions (n = 11), followed by reducing out-of-pocket costs (n = 7) and one-on-one education (n = 5). Conclusion Cost was the most reported barrier to cervical cancer screening, although women experience multiple simultaneous barriers. Novel interventions such as HPV self-collection promise to reduce some, but not all, barriers to primary screening. Interventions that work on reducing multiple barriers, including obstacles to receiving follow-up care, may be most effective to prevent cervical cancer among these high-risk women.

Background: Despite screening's effectiveness in reducing cervical cancer incidence and mortality, disparities in cervical cancer screening uptake remain, with lower rates documented among uninsured and low-income individuals. We examined perceived financial barriers to, and the perceived cost burden of, cervical cancer screening. Materials and Methods: We surveyed 702 low-income, uninsured or publicly insured women ages 25–64 years in North Carolina, U.S., who were not up to date on cervical cancer screening according to national guidelines. Participants were asked about perceived financial barriers to screening and how much they perceived screening would cost. We used multivariable logistic regression to assess the sociodemographic predictors of perceived financial barriers. Results: Seventy-two percent of participants perceived financial barriers to screening. Screening appointment costs (71%) and follow-up/future treatment costs (44%) were most commonly reported, followed by lost pay due to time missed from work (6%) and transportation costs (5%). In multivariable analysis, being uninsured (vs. publicly insured), younger (25–34 vs. 50–64 years), White (vs. Black), and not reporting income data were associated with perceiving screening costs and future treatment costs as barriers to screening. Participants reported wide-ranging estimates of the perceived out-of-pocket cost of screening ($0–$1300), with a median expected cost of $245. Conclusions: The majority of our sample of low-income women perceived substantial financial barriers to screening, particularly related to screening appointment costs and potential follow-up/future treatment costs. Providing greater cost transparency and access to financial assistance may reduce perceived financial barriers to screening, potentially increasing screening uptake among this underserved population. Clinicaltrials.gov registration number NCT02651883.

BackgroundScreening substantially reduces cervical cancer incidence and mortality. More than half of invasive cervical cancers are attributable to infrequent screening or not screening at all. The current study, My Body My Test (MBMT), evaluates the impact of mailed kits for self-collection of samples for human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening.Methods/designThe study will enroll at least 510 US women aged 25–64 years who report no Pap test in the last 4 years and no HPV test in the last 6 years. We will randomize participants to an intervention or control arm. The intervention arm will receive kits to self-collect a sample at home and mail it for HPV testing. In both the intervention and control arms, participants will receive assistance in scheduling an appointment for screening in clinic. Study staff will deliver HPV self-collection results by phone and assist in scheduling participants for screening in clinic. The primary outcome is completion of cervical cancer screening. Specifically, completion of screening will be defined as screening in clinic or receipt of negative HPV self-collection results. Women with HPV-negative self-collection results will be considered screening-complete. All other participants will be considered screening-complete if they obtain co-testing or Pap test screening at a study-affiliated institution or other clinic. We will assess whether the self-collection intervention influences participants’ perceived risk of cervical cancer and whether perceived risk mediates the relationship between HPV self-collection results and subsequent screening in clinic. We also will estimate the incremental cost per woman screened of offering at-home HPV self-collection kits with scheduling assistance as compared to offering scheduling assistance alone.DiscussionIf mailed self-collection of samples for HPV testing is an effective strategy for increasing cervical cancer screening among women overdue for screening, this method has the potential to reduce cervical cancer incidence and mortality in medically underserved women at higher risk of developing cervical cancer.Trial registrationClinicalTrials.govNCT02651883, Registered on 11 January 2016.

Kaposi's sarcoma-associated herpesvirus (KSHV) and Epstein-Barr virus (EBV) are prevalent in sub-Saharan Africa, together with HIV; the consequent burden of disease is grave. The cofactors driving transmission of the two viruses and pathogenesis of associated malignancies are not well understood. We measured KSHV and EBV DNA in whole blood and saliva as well as serum antibodies levels in 175 Cameroonians with Kaposi's sarcoma and 1,002 age- and sex-matched controls with and without HIV. KSHV seroprevalence was very high (81%) in controls, while EBV seroprevalence was 100% overall. KSHV DNA was detectable in the blood of 36-46% of cases and 6-12% of controls; EBV DNA was detected in most participants (72-89%). In saliva, more cases (50-58%) than controls (25-28%) shed KSHV, regardless of HIV infection. EBV shedding was common (75-100%); more HIV+ than HIV- controls shed EBV. Cases had higher KSHV and EBV VL in blood and saliva then controls, only among HIV+ participants. KSHV and EBV VL were also higher in HIV+ than in HIV- controls. Cases (but not controls) were more likely to have detectable KSHV in blood if they also had EBV, whereas shedding of each virus in saliva was independent. While EBV VL in saliva and blood were modestly correlated, no correlation existed for KSHV. Numerous factors, several related to parasitic coinfections, were associated with detection of either virus or with VL. These findings may help better understand the interplay between the two gammaherpesviruses and generally among copathogens contributing to cancer burden in sub-Saharan Africa.

Background: Approximately one-half of cervical cancer cases in the United States occur in underscreened or never-screened women. We examined predictors to completing Papanicolaou (Pap) testing and whether a positive human papillomavirus (HPV) self-collection result affects Pap testing adherence among underscreened women. Materials and Methods: Low-income women aged 30–65 years who reported no Pap testing in ≥4 years were recruited in North Carolina. Knowledge, attitudes, and barriers regarding cervical cancer and Pap testing were assessed by telephone questionnaires. We mailed self-collection kits for HPV testing and provided information regarding where to obtain affordable Pap testing. Participants received $45 for completing all activities. We used multivariable logistic regression to assess the predictors of longer reported time since last Pap (≥10 vs. 4–9 years) and of completion of Pap testing following study enrollment (follow-up Pap). Results: Participants (n = 230) were primarily black (55%), uninsured (64%), and with ≤high school education (59%). Cost and finding an affordable clinic were the most commonly reported barriers to screening. White women and those with ≤high school education reported longer intervals since last Pap test. Half of the participants reported completing a follow-up Pap test (55%). Women with a positive HPV self-collection were five times more likely to report completing a follow-up Pap test than those with negative self-collection (odds ratio = 5.1, 95% confidence interval 1.4–25.7). Conclusions: Improving awareness of resources for affordable screening could increase cervical cancer screening in underserved women. Home-based HPV self-collection represents an opportunity to re-engage infrequently screened women into preventive screening services.

Purpose: To examine provider knowledge of HPV vaccination age guidelines in five countries. Methods: A total of 151 providers of adolescent vaccinations in Argentina, Malaysia, South Africa, South Korea, and Spain were interviewed between October 2013 and April 2014. Univariate analyses compared providers’ understanding of recommended age groups for HPV vaccination to that of each country’s national guidelines. Results: In three of five countries surveyed, most providers (97% South Africa, 95% Argentina, 87% Malaysia) included all nationally recommended ages in their target age group. However, a relatively large proportion of vaccinators in some countries (83% Malaysia, 55% Argentina) believed that HPV vaccination was recommended for women above age 26, far exceeding national guidelines, and beyond the maximum recommended age in the United States. National median minimum and maximum age recommendations cited by the respondents for HPV vaccination were 11 and 29 years in Argentina (national guideline: 11–14), 13 and 48 years in Malaysia (guideline 13–14), 8 and 14 years in South Africa (guideline 9–14), 10 and 20 years in South Korea (guideline 11–14), and 11 and 12 years in Spain (guideline 11–14). In all countries, a higher percentage of vaccinators included all nationally recommended ages for vaccination, as compared to providers who did not administer HPV vaccination. Conclusions: Overall, a substantial proportion of providers incorrectly reported their country’s age guidelines for HPV vaccination, particularly the upper age limit. As provider recommendation is among the strongest predictors of successful vaccination uptake among adolescents, improved education and clarification of national guidelines for providers administering HPV vaccination is essential to optimize prevention of infection and associated disease.

Background Trichomonas vaginalis (TV) is the most common curable sexually transmitted infection (STI) worldwide. Trichomonas vaginalis infection is associated with an increased risk of pelvic inflammatory disease, human immunodeficiency virus transmission, and preterm birth in women. Data on the prevalence and risk factors for TV infection in sub-Saharan African countries remain scarce. Methods A total of 350 Kenyan female sex workers, aged 18 to 50 years, participated in a 2-year longitudinal study of the acquisition of STIs, including TV infection. Every 3 months, cervical and vaginal brush samples were collected for STI testing. At baseline, a sociodemographic and behavior questionnaire was administered. Testing for TV, Chlamydia trachomatis (CT), Neisseria gonorrhoeae, Mycoplasma genitalium, and high-risk human papillomavirus was performed using APTIMA assays. Results The TV baseline prevalence was 9.2% (95% confidence interval [95% CI], 6.3-12.7%) and 2-year cumulative TV incidence was 8.1 per 1000 person months (6.9-9.3). Risk factors for higher TV prevalence at baseline were CT infection (adjusted prevalence ratio [PR], 8.53; 95% CI, 3.35-21.71), human immunodeficiency virus seropositivity (PR, 3.01; 95% CI, 1.45, 6.24) and greater than 4 years of sex work (PR, 2.66; 95% CI, 1.07-6.60). Risk factors for elevated 2-year TV incidence were CT (hazard ratio [HR], 4.28; 95% CI, 1.36-13.50), high-risk human papillomavirus infection (HR, 1.91; 95% CI, 1.06-3.45) and history of smoking (HR, 2.66; 95% CI, 1.24-5.73). Discussion CT infection was positively associated with both prevalent and 2-year incident TV infections.

ObjectiveStrong persuasive messaging by providers is a key predictor for patient acceptance of prophylactic human papillomavirus vaccination. We aimed to determine optimal messaging to promote human papillomavirus adolescent vaccination across different geographical sites.MethodsAdolescent providers (n = 151) from Argentina, Malaysia, South Africa, South Korea, and Spain were surveyed on messages, family decision makers, and sources of communication to best motivate parents to vaccinate their adolescent daughters overall, and against human papillomavirus. Multivariate logistic regression assessed the likelihood of recommending messages specifically targeted at cervical cancer with providers’ characteristics: gender, medical specialization, and previous administration of human papillomavirus vaccination.ResultsMothers were considered the most important human papillomavirus vaccination decision makers for their daughters (range 93%–100%). Television was cited as the best source of information on human papillomavirus vaccination in surveyed countries (range 56.5%–87.1%), except Spain where one-on-one discussions were most common (73.3%). Prevention messages were considered the most likely to motivate parents to vaccinate their daughters overall, and against human papillomavirus, in all five countries (range 30.8%–55.9%). Optimal messages emphasized cervical cancer prevention, and included strong provider recommendation to vaccinate, vaccine safety and efficacy, timely vaccination, and national policy for human papillomavirus vaccination. Pediatricians and obstetricians/gynecologists were more likely to cite that the best prevention messages should focus on cervical cancer (OR: 4.2, 95% CI: 1.17 to 15.02 vs other medical specialists).ConclusionsProvider communication messages that would motivate parents to vaccinate against human papillomavirus were based on strong recommendation emphasizing prevention of cervical cancer. To frame convincing messages to increase vaccination uptake, adolescent providers should receive updated training on human papillomavirus and associated cancers, while clearly addressing human papillomavirus vaccination safety and efficacy.

IntroductionSquamous cell carcinoma of the anus is a common cancer among sexual minority men, especially HIV-positive sexual minority men; however, there is no evidenced-based national screening protocol for detection of anal precancers. Our objective is to determine compliance with annual anal canal self-sampling or clinician-sampling for human papillomavirus (HPV) DNA.Methods and analysisThis is a prospective, randomised, two-arm clinical study to evaluate compliance with annual home-based versus clinic-based HPV DNA screening of anal canal exfoliated cells. The setting is primary care community-based clinics. Recruitment is ongoing for 400 HIV-positive and HIV-negative sexual minority men and transgender persons, aged >25 years, English or Spanish speaking, no current use of anticoagulants other than nonsteroidal anti-inflammatory drugs and no prior diagnosis of anal cancer. Participants are randomised to either receive a swab in the mail for home-based collection of an anal canal specimen at 0 and 12 months (arm 1) or attend a clinic for clinician collection of an anal canal specimen at 0 and 12 months (arm 2). Persons will receive clinic-based Digital Anal Rectal Examinations and high-resolution anoscopy-directed biopsy to assess precancerous lesions, stratified by study arm. Anal exfoliated cells collected in the study are assessed for high-risk HPV persistence and host/viral methylation. The primary analysis will use the intention-to-treat principle to compare the proportion of those who comply with 0-month and 12-month sampling in the home-based and clinic-based arms. The a priori hypothesis is that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm versus clinic-based arm.Ethics and disseminationThe study has been approved by the Medical College of Wisconsin Human Protections Committee. Results will be disseminated to communities where recruitment occurred and through peer-reviewed literature and conferences.Trial registration numberNCT03489707.

Our group has recently demonstrated that chimeric antigen receptor T-cell therapy targeting the CD30 antigen (CD30.CAR-T) is highly effective in patients with relapsed and refractory (r/r) classical Hodgkin lymphoma (cHL). Despite high rates of clinical response, relapses and progression were observed in a subset of patients. The objective of this study was to characterize clinical and correlative factors associated with progression-free survival (PFS) after CD30.CAR-T cell therapy. We evaluated correlatives in 27 patients with r/r cHL treated with lymphodepletion and CD30.CAR-T cells. With a median follow-up of 9.5 months, 17 patients (63%) progressed, with a median PFS of 352 days (95% confidence interval: 116-not reached), and 2 patients died (7%) with a median overall survival of not reached. High metabolic tumor volume (MTV, >60 mL) immediately before lymphodepletion and CD30.CAR-T cell infusion was associated with inferior PFS (log rank, P = .02), which persisted after adjusting for lymphodepletion and CAR-T dose (log rank, P = .01 and P = .006, respectively). In contrast, receiving bridging therapy, response to bridging therapy, CD30.CAR-T expansion/persistence, and percentage of CD3+PD-1+ lymphocytes over the first 6 weeks of therapy were not associated with differences in PFS. In summary, this study reports an association between high baseline MTV immediately before lymphodepletion and CD30.CAR-T cell infusion and worse PFS in patients with r/r cHL. This trial was registered at www.clinicaltrials.gov as #NCT02690545.

Background National human papillomavirus (HPV) vaccination programs could reduce global cervical cancer morbidity and mortality with support from health care providers. We assessed providers' perceptions of HPV vaccination in five countries. Methods We identified providers from five countries where national HPV vaccination programs were at various stages of implementation: Argentina, Malaysia, South Africa, South Korea, and Spain. Providers authorized to administer adolescent vaccines completed an in-depth survey, reporting perceptions of barriers and facilitators to initiating and completing HPV vaccination, and logistical challenges to HPV vaccination. Results Among 151 providers, common barriers to HPV vaccination initiation across all countries were parents' lack of awareness(39%), concerns about vaccine safety or efficacy(33%), and cost to patients(30%). Vaccination education campaign(70%) was the most commonly cited facilitator of HPV vaccination initiation. Common barriers to series completion included no reminder system or dosing schedule(37%), loss to follow-up or forgetting appointment(29%), and cost to patients(25%). Cited facilitators to completing the vaccine series were education campaigns(45%), affordable vaccination(32%), and reminder/recall systems(22%). Among all countries, high cost of vaccination was the most common logistical challenge to offering vaccination to adolescents(33%). Conclusions Incorporating provider insights into future HPV vaccination programs could accelerate vaccine delivery to increase HPV vaccination rates globally.

Introduction: Uptake of cervical cancer screening services in Chinese migrant workers is unknown and may be lower than non-migrant workers in China. Methods: We conducted a cross-sectional study among migrant and non-migrant women aged 21-65 at 7 provinces across China and administered a questionnaire investigating knowledge and attitudes regarding cervical cancer, human papillomavirus (HPV), and HPV vaccine. We used multivariable logistic regression to evaluate odds of previous cervical cancer screening in migrant workers. Results: 737 women participated in the study. Mean age was 41.9 ± 7.2 years. 50.2% of the participants were migrant workers. 27.6% of the migrant workers reported previous cervical cancer screening compared to 33.2% of local participants. 36.6% migrant workers reported awareness of HPV compared to 40.2% of local participants. In adjusted analysis migrant status was not associated with increased odds of previous cervical cancer screening (aOR = 1.11 95%CI: 0.76-1.60). High school or higher education compared to less than high school education and employer-sponsored insurance compared to uninsured were associated with increased odds of previous cervical cancer screening (aOR = 2.15 95%CI: 1.41-3.27 and aOR = 1.67 95% CI: 1.14-2.45, respectively). Having heard of HPV compared to no awareness of HPV was associated with increased odds of cervical cancer screening (aOR = 2.02 95%CI: 1.41-2.91). Awareness of HPV among migrant workers was associated with increased odds of cervical cancer screening compared to migrant and local participants without awareness (aOR = 2.82 95% CI: 1.70-4.69 and 2.97 95%CI: 1.51-5.83, respectively). Conclusions: Efforts to increase education opportunities, provide insurance, and promote HPV awareness could increase cervical cancer screening uptake in migrant women in China.

STUDY DESIGN Retrospective cohort. OBJECTIVE The aim of this study was to analyze association between social determinants of health (SDH) disparity on postoperative complication rates, and 30-day and 90-day all-cause readmission in patients undergoing single-level lumbar fusions. SUMMARY OF BACKGROUND DATA Decreasing postoperative complication rates is of great interest to surgeons and healthcare systems. Postoperative complications are associated with poor convalescence, inferior patient reported outcomes measures, and increased health care resource utilization. Better understanding of the association between Social Determinants of Health (SDH) on postoperative outcomes maybe helpful to decrease postoperative complication rates. METHODS MARINER 2020, an all-payer claims database, was utilized to identify patients undergoing single-level lumbar fusions between 2010 and 2018. The primary outcomes were the rates of any postoperative complication, symptomatic pseudarthrosis, need for revision surgery, or 30-day and 90-day all-cause readmission. RESULTS The exact matched population analyzed in this study contained 16,560 patients (8280 [50.0%] patients undergoing single-level lumbar fusion with an SDH disparity; 8280 [50.0%] patients undergoing single-level lumbar fusion without a disparity). Both patient groups were balanced at baseline. The rate of symptomatic pseudarthrosis (1.0% vs. 0.6%, P

The objective of this study is to document the prevalence of traditional, complementary, and alternative medicine (TCAM) use by adult cancer patients at a national teaching hospital in Malawi. We aim to document the products/therapies used, the reason for use, as well as patient-reported satisfaction with TCAM practitioners and modalities.We conducted investigator-administered interviews with adult cancer patients presenting to the Kamuzu Central Hospital (KCH) Cancer Clinic in Lilongwe, Malawi between January and July 2018. The KCH is a national teaching hospital in the capital of Lilongwe, which serves patients with cancer from the northern half of Malawi. Descriptive statistics were used to describe TCAM use and logistic regression was applied to identify predictors of TCAM.A total of 263 participants completed the survey, of which 70% (n = 183) were female and average age was 45 (SD 14) years old. The prevalence of overall TCAM use was 84% (n = 222), and 60% (n = 157) of participants reported combining TCAM with conventional cancer treatment. The majority of patients used TCAM to directly treat their cancer versus for symptom management. Patients reported using faith-based healing (64%, n = 168), herbal medicine (56%, n = 148), diet change (46%, n = 120), and vitamins/minerals (23%, n = 61). Participants reported the highest satisfaction for physicians among practitioners and diet change for modalities. Female gender was found to be a predictor of TCAM with conventional treatment use, no other significant predictors were observed.There is a high prevalence of TCAM use among an adult population with cancer in Malawi, and a wide variety in the TCAM modalities used among patients. Additional studies are needed to identify risks and benefits of TCAM use to assist with policy and public health, patient safety, and holistically address the global burden of cancer.

Prospective data are limited on human papillomavirus (HPV) acquisition and clearance among circumcised men from resource-limited geographical regions, particularly Africa. The goal of this study was to estimate incidence and clearance of type-specific genital HPV infection in men. Penile exfoliated cell specimens were collected from the glans/coronal sulcus and shaft of 1,037 circumcised Kenyan men at baseline and 6-, 12- and 18-month follow-up visits between 2003–2007. Specimens were tested with GP5+/6+ PCR to detect 44 HPV types. The median age of participants at baseline was 21 years (range 18–28). The 12- and 18-month incidence rates (IRs) for any HPV were 34.9/100 person-years (95% confidence interval [CI]: 31.2–39.0) and 36.4/100 person-years (95% CI: 32.9–40.2), respectively. The 18-month cumulative risk for high-risk HPV was 30% compared to 16% for low-risk HPV. Cumulative risk was not associated with age or anatomical site. The estimated probability of any HPV infection clearing by 12 months was 0.92. Time until HPV clearance was not associated with age, anatomical site, or whether HPV infection type was high-risk or low-risk. HPV IRs among circumcised men in this study were comparable to other circumcised populations.

Cervical cancer is a significant public health problem, especially in low- and middle-income countries, where women have little access to cervical cancer screening; consequently 80% of cervical cancer related mortality occurs in these regions. The development of screening methods that need less infrastructure thus represents an urgent medical need. The study aims to compare the detection rates of high-risk human papillomavirus 16 and 18 E6 oncoprotein in urine, vaginal self-collected, and cervical scrapes of women using the OncoE6™ Cervical Test and compare the HPV16 and/or HPV18 E6 detection rates with the HPV DNA testing. Paired urine, vaginal self-collected and cervical specimens were collected from 124 women who participated in cervical cancer screening or treatment in this proof-of-concept study and underwent to HPV16/18-E6 testing and high-risk HPV DNA testing prior to treatment of cervical neoplasia or cancer. Concordance between urinary, vaginal and cervical HPV16/18-E6 and HPV-DNA testing was evaluated for patients classified as negative group (

Background Self-collection for high-risk human papillomavirus (hr-HPV) messenger RNA (mRNA) testing may improve cervical cancer screening. High-risk HPV mRNA with self-collected specimens stored dry could enhance feasibility and acceptance of specimen collection and storage; however, its performance is unknown. We compared the performance of hr-HPV mRNA testing with dry- as compared with wet-stored self-collected specimens for detecting high-grade squamous intraepithelial lesion or more severe (≥HSIL). Methods A total of 400 female sex workers in Kenya participated (2013-2018), of which 50% were HIV positive based on enrollment procedures. Participants provided 2 self-collected specimens: one stored dry (sc-DRY) using a Viba brush (Rovers) and one stored wet (sc-WET) with Aptima media (Hologic) using an Evalyn brush (Rovers). Physician-collected specimens were collected for HPV mRNA testing (Aptima) and conventional cytology. We estimated test characteristics for each hr-HPV screening method using conventional cytology as the reference standard (≥HSIL detection). We also examined participant preference for sc-DRY and sc-WET collection. Results High-risk HPV mRNA positivity was higher in sc-WET (36.8%) than sc-DRY samples (31.8%). Prevalence of ≥HSIL was 6.9% (10.3% HIV positive, 4.0% HIV negative). Sensitivity of hr-HPV mRNA for detecting ≥HSIL was similar in sc-WET (85%; 95% confidence interval [CI], 66%-96%), sc-DRY specimens (78%; 95% CI, 58%-91%), and physician-collected specimens (93%; 95% CI, 76%-99%). Overall, the specificity of hr-HPV mRNA for ≥HSIL detection was similar when comparing sc-WET with physician collection. However, specificity was lower for sc-WET (66% [61%-71%]) than sc-DRY (71% [66%-76%]). Women preferred sc-DRY specimen collection (46.1%) compared with sc-WET (31.1%). However, more women preferred physician collection (63.9%) compared with self-collection (36.1%). Conclusions Self-collected stored-dry specimens seemed to perform similarly to sc-WET for the detection of ≥HSIL.

The objective was to assess the diagnostic test accuracy of high-risk human papillomavirus (hrHPV) testing of self-collected urine and cervicovaginal samples for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+). We recruited a convenience sample of women 25 to 65 years of age who were undergoing clinically indicated colposcopy at two medical centers in North Carolina between November 2016 and January 2019. Women with normal cytology results and positive hrHPV results were also recruited. Urine samples, self-collected cervicovaginal samples, provider-collected cervical samples, and cervical biopsy samples were obtained from all enrolled women. Samples were tested for hrHPV DNA using the Onclarity assay (Becton Dickinson, Sparks, MD). Biopsy samples were histologically graded as CIN2+ or

ObjectiveHIV infection increases the risk of high-grade cervical neoplasia and invasive cervical carcinoma. The study addresses the limited data describing human papillomavirus (HPV) infection and cervical neoplasia among HIV-infected women in HIV-discordant relationships in sub-Saharan Africa, which is needed to inform screening strategies.MethodsA cross-sectional study of HIV-infected women with HIV-uninfected partners was conducted to determine the distribution of type-specific HPV infection and cervical cytology. This study was nested in a prospective cohort recruited between September 2007 and December 2009 in Nairobi, Kenya. Cervical cells for HPV DNA testing and conventional cervical cytology were collected. HPV types were detected and genotyped by Roche Linear Array PCR assay.ResultsAmong 283 women, the overall HPV prevalence was 62%, and 132 (47%) had ≥1 high-risk (HR)-HPV genotype. Of 268 women with cervical cytology results, 18 (7%) had high-grade cervical lesions or more severe by cytology, of whom 16 (89%) were HR-HPV-positive compared with 82 (41%) of 199 women with normal cytology (pConclusionHR-HPV prevalence was high in this population of HIV-infected women with an uninfected partner. Choice of screening for all HR genotypes versus a subset of HR genotypes in these HIV-infected women will strongly affect the performance of an HPV screening strategy relative to cytological screening. Regional and subpopulation differences in HR-HPV genotype distributions could affect screening test performance.

Cervical cancer is the leading cause of female cancer deaths in Senegal which is ranked 17th in incidence globally, however, the screening rate there is very low. Nuanced gendered perceptions and health behaviors of both women and men play a significant role in women's health. Our study analyzed gender differences on perceptions of gender roles, discrimination, cancer attitudes, cancer stigma, and influences in healthcare decision making within our study population to inform ongoing cervical cancer prevention work in the rural region of Kedougou, Senegal. We conducted a cross-sectional survey of 158 participants, 101 women and 57 men (ages 30-59) across nine non-probability-sampled communities from October 2018 through February 2019. Bivariate analysis was conducted to assess gender differences across all variables. We also conducted analyses to determine whether there were significant differences in beliefs and attitudes, by screening behavior and by education. We found significant gender differences regarding the perception of a woman's role (P < 0.001) and a man's role (P = 0.007) as well as in the everyday discrimination questions of "decreased respect by spouse" (P < 0.001). Regarding cancer stigma, among women, 18.00% disagreed and 10.00% strongly disagreed while among men, 3.6% disagreed and 1.8% strongly disagreed that "If I had cancer, I would want my family to know that I have it." When making decisions about one's healthcare, women are more likely than men to trust social contacts such as their spouse (46.5% vs 5.3%, p < 0.001) while men are more likely than women to trust health service personnel such as a nurse (50.9% vs 18.8%, p < 0.001). Furthermore, men and women were both more likely to state that men have the final decision regarding the healthcare decisions of women (p < 0.001). Our data reveal structural disadvantages for women within our study population as well as gender differences in the adapted everyday discrimination scale and cancer stigma scale. Higher rates of both personal and perceived cancer stigma among women has profound implications for how population and community level communication strategies for cancer prevention and control should be designed. Efforts to advance the goal of the elimination of cervical cancer should, in the short-term, seek to gain a more profound understanding of the ways that gender, language, and other social determinants impact negative social influences and other barriers addressable through interventions. Social and behavior change communication may be one approach that can focus both on education while seeking to leverage the social influences that exist in achieving immediate and long-term goals.

To evaluate the validity and acceptability of at-home self-collection to test for high-risk human papillomavirus (HPV) and sexually transmitted infections among women overdue for cervical cancer screening by national guidelines.Low-income, infrequently screened women were recruited from the general population in North Carolina to participate in an observational study. Participants provided two self-collected cervicovaginal samples (one at home and one in the clinic) and a clinician-collected cervical sample. Samples were tested for high-risk HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Cervical samples were also tested by liquid-based cytology.Overall, 193 women had conclusive high-risk HPV results for all three samples and cytology results. Prevalence of high-risk HPV within self-home samples (12.4%) was not different from that within clinician samples (11.4%; P=.79) and from that within self clinic samples (15.5%; P=.21). Positivity for high-risk HPV in all sample types increased with increasing grades of cervical abnormality (P.001). Self-home samples detected high-risk HPV in all identified cases of high-grade squamous intraepithelial lesions and of cervical intraepithelial neoplasia 2 or worse. Detection was comparable across sample types for T vaginalis (range 10.2-10.8%), M genitalium (3.3-5.5%), C trachomatis (1.1-2.1%), and N gonorrhoeae (0-0.5%). Kappa values between sample types ranged from 0.56 to 0.66 for high-risk HPV, 0.86-0.91 for T vaginalis, and 0.65-0.83 for M genitalium. Most participants reported no difficulty understanding self-collection instructions (93.6%) and were willing to use self-collection in the future (96.3%).Mail-based, at-home self-collection for high-risk HPV and sexually transmitted infection detection was valid and well accepted among infrequently screened women in our study. These findings support the future use of high-risk HPV self-collection to increase cervical cancer screening rates among higher risk women in the United States.

Overuse of clinical preventive services increases healthcare costs and may deprive underserved patients of necessary care. Up to 45% of cervical cancer screening is overuse. We conducted a systematic review of correlates of overuse of cervical cancer screening and interventions to reduce overuse. The search identified 25 studies (20 observational; 5 intervention). Correlates varied by the type of overuse measured (i.e., too frequent, before/after recommended age to start or stop screening, after hysterectomy), the most common correlates of overuse related to patient age (n = 7), OBGYN practice or provider (n = 5), location (n = 4), and marital status (n = 4). Six observational studies reported a decrease in overuse over time. Screening overuse decreased in all intervention studies, which used before-after designs with no control or comparison groups. Observational studies suggest potential targets for de-escalating overuse. Randomized clinical trials are needed to establish best practices for reducing overuse.

PURPOSE: The use of traditional, complementary, and alternative medicine (TCAM) for cancer may influence the delivery or effectiveness of conventional cancer treatment. In this systematic review, we aimed to 1.) summarize the available prevalence data on traditional medicine use by cancer patients in less developed countries (LDCs), and 2.) stratify the prevalence data by world region and country income level. METHODS: A literature search for cancer, TCAM, and low income (LI) and lower-middle income (LMI) countries was conducted across 5 databases. A total of 2,365 publications were reviewed for eligibility, of which 25 studies met inclusion criteria. RESULTS: The combined sample size was 6,878 cancer patients, with a median of 54.5% reporting the use of TCAM for cancer care. Of the studies providing data on the concomitant use of TCAM and conventional cancer treatment (n = 4,872 cancer patients), a median of 26.7% of participants reported combining the two systems of medicine. CONCLUSION: From the data available, it is apparent that TCAM use among cancer patients in less developed countries is common; however, additional studies are needed to support the safe and effective management of cancer for patients in LI and LMI countries.

Esophageal squamous cell carcinoma (ESCC) is one of the most predominant malignancies worldwide. The 5-year survival rate is still relatively low due to few symptoms presenting with the early disease, diagnosis at middle to late stage, and high risk of recurrence after therapy. Novel protein biomarkers for early detection and treatment of ESCC have the potential to reduce incidence and mortality rates, and significantly prolong the 5-year survival rate. To date, several ESCC biomarkers are being investigated for screening, diagnosis, and treatment to decrease the disease burden. This review summarizes recent developments in candidate protein biomarkers for early diagnosis, predictors for precancerous disease progression, and prognosis of ESCC. Protein biomarkers that enable identification of the different pathologic grades of ESCC will need to be identified. ESCC biomarkers have the potential to improve screening and treatment strategies; multicenter prospective studies with large sample sizes will be required to confirm the usefulness of these candidate biomarkers.

Moral Reconation Therapy (MRT) is a cognitive-behavioral intervention aimed at reducing risk for criminal recidivism by restructuring antisocial attitudes and cognitions (i.e., “criminogenic thinking”). MRT has empirical support for reducing risk for criminal recidivism among civilian offenders. Recently, a version of MRT was developed for military veterans; however, no randomized controlled trials (RCT) have been conducted with the veteran-specific protocol, and the effectiveness and implementation potential of MRT outside of correctional settings has not been established. Using a Hybrid Type 1 RCT design, this study will test the effectiveness of MRT to reduce risk for criminal recidivism and improve health-related outcomes among justice-involved veterans entering mental health residential treatment at three US Veterans Health Administration (VHA) Medical Centers. Upon admission to the treatment program, justice-involved veterans will complete a baseline assessment, be randomized to usual care (UC) or UC + MRT, and be followed 6 and 12 months post-baseline. A process evaluation will also be conducted to identify barriers and facilitators to implementation of MRT in residential treatment. The primary aim of this study is to evaluate the effectiveness of MRT with justice-involved veterans. If MRT proves effective in this trial, the findings can provide large healthcare systems that serve veterans with an evidence-based intervention for addressing criminogenic thinking among justice-involved adults, as well as guidance on how to facilitate future implementation of MRT in non-correctional settings. This trial is funded by the VA Health Services Research & Development Program (IIR 14–081) and is registered with ClinicalTrials.gov (ID: NCT02524171 ).

OBJECTIVE: To determine the effectiveness of community health campaigns (CHCs) as a strategy for human papillomavirus (HPV)-based cervical cancer screening in rural western Kenya. METHODS: Between January and November 2016, a cluster-randomized trial was carried out in 12 communities in western Kenya to investigate high-risk HPV testing offered via self-collection to women aged 25–65 years in CHCs versus government health facilities. Outcome measures were the total number of women accessing cervical cancer screening and the proportion of HPV-positive women accessing treatment. RESULTS: In total, 4944 women underwent HPV-based cervical cancer screening in CHCs (n=2898) or health facilities (n=2046). Screening uptake as a proportion of total eligible women in the population was greater in communities assigned to CHCs (60.0% vs 37.0%, P

Background Testing for high-risk human papillomavirus (HPV) infection using mailed, self-collected samples is a promising approach to increase screening in women who do not attend clinic screening at recommended intervals. Methods To assess this intervention among high-risk women in the United States, 429 women without a Papanicolaou (Pap) test in 4 or more years (overdue by US guidelines) were recruited from the general population. Participants aged 30 to 65 years were mailed a kit to self-collect a cervicovaginal sample at home, return the sample by mail, and receive HPV results by telephone, with referral to follow-up cytological Pap testing at a local clinic. Cervicovaginal self-samples were collected with a Viba brush, stored in Scope mouthwash, and tested by Hybrid Capture 2. Data were collected in 2010 to 2011 and analyzed in 2017. Results Two-thirds (64%) of participants returned a self-collected sample, of whom 15% tested HPV DNA positive. Human papillomavirus self-test-positive women reported higher rates of follow-up Pap tests (82%) than did those with self-test negative results (51%). No demographic differences were found in self-test return rate or HPV positivity. High acceptability was reported in participant surveys: most women (81%) had "mostly positive" overall thoughts about the self-test, and most reported being comfortable receiving the kit in the mail (99%), returning their self-collected sample by mail (82%), and receiving their test results by telephone (97%). Conclusions Conducting HPV self-testing through population-based recruitment, mailed kit delivery and return by mail, and results delivery by telephone has the potential to reach a broad segment of US underscreened women.

The aim of the study was to evaluate the performance of the HPV-HR test to detect high-risk human papillomavirus (HPV) in urine samples in comparison with a commercial molecular HPV test., The aim of the study was to evaluate the performance of the HPV-HR test to detect high-risk human papillomavirus (HPV) in urine samples in comparison with a commercial molecular HPV test. Materials and Methods This is a prospective study, in which 350 patients diagnosed previously with cervical intraepithelial neoplasia (CIN) grade 2 or higher were enrolled. Urine and cervical specimens were collected. Urine was tested with the HPV-HR test and cervical specimens were tested with the Cobas. Results Of the 336 evaluable patients, there were 271 cases of CIN 2+, of which 202 were CIN 3+ and the remaining 65 patients were less than CIN 2. Positivity was 77.1% (95% confidence interval [CI] = 72.5–81.5) for the urine samples and 83.6% (95% CI = 79.6–87.6) for the cervical samples. Agreement between cervical and urine samples for HPV detection was 79.8% (κ = 0.363; 95% CI = 0.243–0.484). Sensitivity for CIN 2+ was 83.4% (95% CI = 78.4–87.6) for urine and 90.8% (95% CI = 86.7–92.9) for cervical samples. The sensitivity for CIN 3+ was 85.6% (95% CI = 80.0–90.2) for urine and 92.6% (95% CI = 88.0–95.8) for cervical samples. Specificity for worse than CIN 2 was 50.8% (95% CI = 33.7–59.0) and 46.2% (95% CI = 33.7–59.0) for urine and cervical samples, respectively. Conclusions Although these results demonstrated slightly higher detection rates for HR-HPV and clinical sensitivity in cervical samples than in urine, when compared with histological diagnoses, urine sampling is a viable alternative to access women who do not participate in routine screening programs., (undefined), info:eu-repo/semantics/publishedVersion

Background Breast cancer survivors are at high risk for fracture due to cancer treatment-induced bone loss, however, data is scarce regarding the scope of this problem from an epidemiologic and health services perspective among Chinese women with breast cancer. Methods We designed a cross-sectional study comparing prevalence of vertebral fractures among age- and BMI-matched women from two cohorts. Women in the Breast Cancer Survivors cohort were enrolled from a large cancer hospital in Beijing. Eligibility criteria included age 50–70 years, initiation of treatment for breast cancer at least 5 years prior to enrollment, and no history of metabolic bone disease or bone metastases. Data collected included sociodemographic characteristics; fracture-related risk factors, screening and preventive measures; breast cancer history; and thoracolumbar x-ray. The matched comparator group was selected from participants enrolled in the Peking Vertebral Fracture Study, an independent cohort of healthy community-dwelling postmenopausal women from Beijing. Results Two hundred breast cancer survivors were enrolled (mean age 57.5 ± 4.9 years), and compared with 200 matched healthy women. Twenty-two (11%) vertebral fractures were identified among breast cancer survivors compared with 7 (3.5%) vertebral fractures in the comparison group, yielding an adjusted odds ratio for vertebral fracture of 4.16 (95%CI 1.69–10.21, p