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The Centers for Disease Control and Prevention (CDC) recommends recombinant zoster vaccination (RZV) for adults ≥ 50 years to prevent herpes zoster (HZ) and its sequelae. Initially, no distinct recommendation was made for immunocompromised adults, who experience higher HZ rates and more severe outcomes. We characterized receipt of first RZV dose (initiation) and both doses (completion) over time, and the impact of immune function on RZV uptake among adults aged 50-64 years in the United States.We identified RZV claims from the IBM MarketScan database between 1/1/2018 and 12/31/2019. We characterized immunocompromised enrollees as having malignancy, HIV, solid organ transplant, primary immunosuppression, or medication-induced immunosuppression using inpatient, outpatient, and prescription claims in the 6 months prior to study start. We evaluated patterns of vaccine uptake by demographic and healthcare access characteristics and immune status.The cumulative incidence of RZV initiation during the study period was 10.0%. Incidence increased with age and number of medical office visits, and was higher among women, urban residents, high-deductible insurance beneficiaries, and those who were immunocompromised compared to immunocompetent. Among immunocompromised adults, RZV initiation was highest among those with HIV and primary immunodeficiencies. Of those who initiated RZV, 89.5% received both doses. RZV completion was highest among those who received the first dose at a pharmacy. Most enrollees (88.6%) who completed RZV vaccination did so within the recommended dosing schedule.RZV uptake was low in the two years since the CDC recommendation, and differed by demographic, healthcare access, and clinical characteristics. Initiation rates were higher among immunocompromised adults compared to immunocompetent adults, despite no CDC recommendation for vaccination in these groups during the study period. The CDC has since recommended RZV for immunocompromised individuals, and our findings may inform efforts to increase RZV uptake in individuals at higher risk of severe disease.

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.

Background Cervical cancer screening through self-collected high-risk human papillomavirus (HPV) testing has increased screening uptake, particularly in low-resource settings. Improvement ultimately depends, however, on women with positive results accessing follow-up treatment. Identifying the barriers to timely treatment is needed to tailor service delivery for maximum impact. Materials and Methods This qualitative study was conducted within a self-collected HPV screening trial in Migori County, Kenya. HPV-positive women were referred for no-cost cryotherapy treatment at the county hospital. Women not attending within 60 days of receiving HPV-positive results were randomly selected for in-depth interviews (IDIs). IDIs were coded and analyzed to develop an analytical framework and identify treatment barriers. Results Eighty-one women were interviewed. IDIs showed a poor understanding of HPV and cervical cancer, impacting comprehension of screening results and treatment instructions. All 81 had not undergone treatment but reported intending to in the future. Eight reported seeking treatment unsuccessfully or not qualifying, primarily due to pregnancy. Transportation costs and long distances to the hospital were the most reported barriers to treatment. Other obstacles included work, household obligations, and fear of treatment. Impacts of social influences were mixed; some women reported their husbands prevented seeking treatment, others reported their husbands provided financial or emotional support. Few women experienced peer support. Conclusions Women faced many barriers to treatment following HPV screening in rural Kenya. Transportation barriers highlight a need for local treatment capacity or screen-and-treat approaches. Ensuring women understand their results and how to seek treatment is essential to improving cervical cancer screening in low-resource settings.

Background: We evaluate the cost-effectiveness of HPV self-collection (followed by scheduling assistance for those who were HPV+ or inconclusive) compared to scheduling assistance only and usual care among underscreened persons with a cervix (PWAC). Methods: A decision tree analysis was used to estimate the incremental cost-effectiveness ratios (ICERs), or the cost per additional PWAC screened, from the Medicaid/state and clinic perspectives. A hypothetical cohort represented 90,807 low-income, underscreened individuals. Costs and health outcomes were derived from the MyBodyMyTest-3 randomized trial except the usual care health outcomes were derived from literature. We performed probabilistic sensitivity analyses (PSA) to evaluate model uncertainty. Results: Screening uptake was highest in the self-collection alternative (n=65,721), followed by the scheduling assistance alternative (n=34,003) and usual care (n=18,161). The self-collection alternative cost less and was more effective than the scheduling assistance alternative from the Medicaid/state perspective. Comparing the self-collection alternative to usual care, the ICERs were $284 per additional PWAC screened from the Medicaid/state perspective and $298 per additional PWAC screened from the clinic perspective. PSAs demonstrated that the self-collection alternative was cost-effective compared to usual care at a willingness-to-pay threshold of $300 per additional PWAC screened in 66% of simulations from the Medicaid/state perspective and 58% of simulations from the clinic perspective. Conclusion: Compared to usual care and scheduling assistance, mailing HPV self-collection kits to underscreened individuals appears to be cost-effective in increasing screening uptake. Impact: This is the first analysis to demonstrate the cost-effectiveness of mailed self-collection in the US.

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.

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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.

PDF file, 69K, Appendix Table A: Codes Used to Identify Procedures.

PDF file, 60K, Appendix Figure A: Change in Median Procedure Cost between 2001 and 2006.

PDF file, 59K, Appendix Table B: Procedures by Age Group.

PDF file, 59K, Appendix Table E: Median (Mean SD) Cost Per Procedure in 2005 for HPV Vaccination Target Age Groups.

Purpose. Self-sampling is increasingly being used in screening programs, yet no studies to date have examined the impact of bodily characteristics on self-sampling experiences. Our objective was to assess whether body mass index (BMI) and physical disability were associated with anal self-sampling difficulty. Methods.We recruited sexual minority men (SMM) and trans persons in Milwaukee, Wisconsin to participate in an anal cancer screening study. Between January 2020 and August 2022, 240 participants were randomized to a home (n=120) or clinic (n=120) screening arm. Home participants received a mailed at-home anal self-sampling kit and were asked to attend a baseline clinic visit where biometric measurements were collected. Participants were asked to complete a survey about their experience with the kit. This research utilizes data from participants who used the kit and completed a baseline clinic visit and post-swab survey (n=82). We assessed the impact of BMI and physical disability on reported body or swab positioning difficulty. Results. Most participants reported no or little difficulty with body positioning (90.3%) or swab positioning (82.9%). Higher BMI was significantly associated with greater reported difficulty with body positioning (aOR=1.10, 95% CI 1.003-1.20, p=.04) and swab positioning (aOR=1.11, 95% CI 1.02-1.20, p=.01). Physical disability was not significantly associated with body or swab positioning difficulty. Specimen adequacy did not differ by BMI category (p=.76) or physical disability (p=.88). Conclusion. Anal self-sampling may be a viable option to reach obese persons who may be more likely to avoid screening due to weight-related barriers.

PDF file, 58K, Appendix Table D: Median (Mean SD) Cost Per Procedure, 2001-2006, by Age Group.

Background: Oncogenic types of human papillomavirus (HPV) have been linked to 99.7% of cervical cancer cases worldwide.Methods: This retrospective claims-based analysis was conducted to assess patterns of use and costs associated with diagnostic and treatment procedures for disease attributed to HPV performed before the introduction of HPV vaccination (January 1, 2001–May 31, 2006). Percentages of commercially insured health plan enrollees who underwent each procedure of interest were calculated for each year. Annual costs (combined patient and health plan-paid amounts) were calculated from qualifying medical claims. Descriptive statistics were used to assess trends in procedure rates and costs.Results: Data for approximately 14.2 million enrollees were obtained. Hysterectomy was the most commonly administered treatment. With the exception of colposcopy with LEEP, all other treatment procedures experienced a decline in rate of use. The most frequently performed diagnostic procedure was colposcopy with endocervical curettage (ECC). With the exception of ECC, rates of diagnostic procedures reached a peak among 20- to 24-year-olds, and followed a downward trend across older groups. Hysterectomy was the most expensive treatment (median $7,383; mean $8,384) per procedure in 2006.Conclusion: Results reveal high rates of use and high-associated costs of diagnostic procedures and treatments related to disease attributed to HPV.Impact: The data presented may be useful in cost-effectiveness analyses and to guide decision makers evaluating how best to optimize prevention strategies. Cancer Epidemiol Biomarkers Prev; 21(9); 1469–78. ©2012 AACR.

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 Low-income and uninsured people with a cervix (PWC) are at highest risk of being underscreened for cervical cancer. We evaluated the prevalence of high-risk HPV (hrHPV) on home self-collected samples, as well as rates of in-clinic follow-up and risk factors associated with hrHPV positivity in this at-risk population. METHODS My-Body-My-Test-3 was conducted between 2016-2019 in North Carolina among individuals aged 25-64 years, overdue for cervical cancer screening, and with incomes of

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.

Background Epigenetic mechanisms are hypothesized to contribute substantially to the progression of cervical intraepithelial neoplasia (CIN) to cervical cancer, although empirical data are limited. Methods Women (n = 419) were enrolled at colposcopic evaluation at Duke Medical Center in Durham, North Carolina. Human papillomavirus (HPV) was genotyped by HPV linear array and CIN grade was ascertained by biopsy pathologic review. DNA methylation was measured at differentially methylated regions (DMRs) regulating genomic imprinting of the IGF2/H19, IGF2AS, MESTIT1/MEST, MEG3, PLAGL1/HYMAI, KvDMR and PEG10, PEG3 imprinted domains, using Sequenom-EpiTYPER assays. Logistic regression models were used to evaluate the associations between HPV infection, DMR methylation and CIN risk overall and by race. Results Of the 419 participants, 20 had CIN3+, 52 had CIN2, and 347 had ≤ CIN1 (CIN1 and negative histology). The median participant age was 28.6 (IQR:11.6) and 40% were African American. Overall, we found no statistically significant association between altered methylation in selected DMRs and CIN2+ compared to ≤CIN1. Similarly, there was no significant association between DMR methylation and CIN3+ compared to ≤CIN2. Restricting the outcome to CIN2+ cases that were HR-HPV positive and p16 staining positive, we found a significant association with PEG3 DMR methylation (OR: 1.56 95% CI: 1.03–2.36). Conclusions While the small number of high-grade CIN cases limit inferences, our findings suggest an association between altered DNA methylation at regulatory regions of PEG3 and high grade CIN in high-risk HPV positive cases.

Background: Male circumcision reduces the risk of human immunodeficiency virus infection in men. We assessed the effect of male circumcision on the incidence and natural history of human papillomavirus (HPV) in a randomized clinical trial in Kisumu, Kenya. Methods: Sexually active, 18- to 24-year-old men provided penile exfoliated cells for HPV DNA testing every 6 months for 2 years. HPV DNA was detected via GP5+/6+ PCR in glans/coronal sulcus and in shaft samples. HPV incidence and persistence were assessed by intent-to-treat analyses. Results: A total of 2,193 men participated (1,096 randomized to circumcision; 1,097 controls). HPV prevalence was 50% at baseline for both groups and dropped to 23.7% at 24 months in the circumcision group, and 41.0% in control group. Incident infection of any HPV type over 24 months was lower among men in the circumcision group than in the control group [HR = 0.61; 95% confidence interval (CI), 0.52–0.72]. Clearance rate of any HPV infection over 24 months was higher in the circumcision group than in the control group (HR = 1.87; 95% CI, 1.49–2.34). Lower HPV point-prevalence, lower HPV incidence, and higher HPV clearance in the circumcision group were observed in glans but not in shaft samples. Conclusion: Male circumcision reduced the risk of HPV acquisition and reinfection, and increased HPV clearance in the glans. Impact: Providing voluntary, safe, and affordable male circumcision should help reduce HPV infections in men, and consequently, HPV-associated disease in their partners.

We conducted a cluster randomized trial of two models for integrating HPV self-collection into family-planning (FP) services at 16 health facilities in Malawi between March 2020–December 2021. Model 1 involved providing only clinic-based HPV self-collection, whereas Model 2 included both clinic-based and community-based HPV self-collection. An endline household survey was performed in sampled villages and households between October-December 2021 in the catchment areas of the health facilities. We analyzed 7664 surveys from 400 villages. Participants from Model 2 areas were more likely to have ever undergone cervical cancer screening (CCS) than participants from Model 1 areas, after adjusting for district, facility location (urban versus rural), and facility size (hospital versus health center) (adjusted odds ratio = 1.73; 95% CI: 1.29, 2.33). Among participants who had ever undergone CCS, participants from Model 2 were more likely to report having undergone HPV self-collection than participants from Model 1 (50.5% versus 22.8%, p = 0.023). Participants from Model 2 were more likely to be using modern FP (adjusted odds ratio = 1.01; 95% CI: 1.41, 1.98) than Model 1 participants. The integration of FP and HPV self-collection in both the clinic and community increases CCS and modern FP uptake more than integration at the clinic-level alone.

Mental health disorders are highly prevalent among veterans in primary care, yet most of these patients do not receive adequate treatment due to provider time constraints, patient travel costs, and stigma associated with mental health care. Mobile health (mHealth) can overcome these impediments to care access; however, poor patient engagement with mHealth limits its routine implementation. Peer specialists may increase patient engagement with mHealth by offering supportive accountability and support through shared experiences. This study sought to identify barriers and facilitators of peer-supported mHealth implementation with veteran primary care patients. Qualitative interviews, guided by the Consolidated Framework of Implementation Research ([CFIR] Damschroder et al., 2009), were conducted with 28 key informants (17 peer specialists and 11 primary care providers) from 14 sites participating in a Department of Veterans Affairs national evaluation of peers in primary care. Thematic analysis was used to identify CFIR determinants to peer-supported mHealth implementation. CFIR barrier domains included Inner Setting (e.g., lack of implementation infrastructure, limited peer training on mHealth, and ineffective promotion of mHealth) and Characteristics of Individuals (e.g., lack of knowledge of the peer role and limited tech literacy). CFIR facilitator domains comprised Intervention Characteristics (e.g., strong support for peers in this role), Characteristics of Individuals (e.g., role alignment with a holistic care approach), and Outer Setting (e.g., emphasizing app benefits, the importance of app demonstrations, and follow-up encounters). The findings inform the development of a strategy for implementing peer-supported mental health mobile apps with veterans in primary care.

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.

In the United States, medically underserved women carry a heavier burden of cancer incidence and mortality, yet are largely underrepresented in cancer prevention studies. My Body, My Test is a n observational cohort, multi-phase cervical cancer prevention study in North Carolina that recruited low-income women, aged 30–65 years and who had not undergone Pap testing in ≥ 4 years. Participants were offered home-based self-collection of cervico-vaginal samples for primary HPV testing. Here, we aimed to describe the recruitment strategies utilized by study staff, and the resulting recruitment and self-collection kit return rates for each specific recruitment strategy. Participants were recruited through different approaches: either direct (active, staff-effort intensive) or indirect (passive on the part of study staff). Of a total of 1,475 individuals screened for eligibility, 695 were eligible (47.1%) and 487 (70% of eligible) participants returned their self-collection kit. Small media recruitment resulted in the highest number of individuals found to be study eligible, with a relatively high self-collection kit return of 70%. In-clinic in-reach resulted in a lower number of study-eligible women, yet had the highest kit return rate (90%) among those sent kits. In contrast, 211 recruitment which resulted in the lowest kit return of 54%. Small media, word of mouth, and face-to-face outreach resulted in self-collection kit return rates ranging from 72 to 79%. The recruitment strategies undertaken by study staff support the continued study of reaching under-screened populations into cervical cancer prevention studies.

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.

OBJECTIVES/GOALS: Rural teens have lower human papillomavirus (HPV) vaccination rates than urban teens, promoting geographical cervical cancer disparities. Giving HPV vaccination earlier than the recommended 11-12 years might increase vaccination rates. We describe a feasibility study for recruiting rural clinics to participate in early HPV vaccination studies. METHODS/STUDY POPULATION: Leveraging professional contacts, we identified two clinics in North Carolina that serve predominantly rural populations. To assess the feasibility of adapting clinic monitoring systems to promote early vaccination, we requested to review electronic medical records (EMR) to identify the size of the vaccine-eligible patient population, HPV vaccination coverage, and the accuracy of EMR queries to monitor HPV vaccination status. Next, we completed in-depth interviews with clinic staff to collect insights on perceived advantages and disadvantages of promoting early HPV vaccination at 9-10 years, and potential facilitators and barriers to doing so. RESULTS/ANTICIPATED RESULTS: We expect that existing clinic systems will easily accommodate early recommendation and administration of HPV vaccine by expanding EMR queries and vaccination status indicators to include 9- and 10-year-olds. Clinics that are interested in promoting early HPV vaccination can use these adapted tools to monitor vaccine coverage over time. From in-depth interviews we expect to encounter a mix of support and hesitation to promote early HPV vaccination, based on personal beliefs on safety and effectiveness of HPV vaccination, perceptions of adolescent HPV risk, perceptions of parental acceptability of HPV vaccination, and perceived burden of changing current clinic protocols. DISCUSSION/SIGNIFICANCE: This feasibility study’s findings will help determine clinic readiness to recommend early HPV vaccination, and intervention components that maximize staff acceptability of early HPV vaccination. A subsequent randomized effectiveness study will evaluate early HPV vaccination as a method to increase rural adolescent vaccination coverage.

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.

We assessed the association of state legislation with adolescent human papillomavirus (HPV) vaccination rates in states that legislated information dissemination or administration of HPV vaccination. Using insurance claims, we calculated monthly HPV vaccination rates (November 2009–December 2017) among adolescents in states that passed HPV vaccination legislation during that period: Missouri (July 2010), Kentucky (February 2012), Indiana (March 2013), Oregon (June 2013). We used segmented regression to estimate levels and trends of HPV vaccination rates, comparing pre-legislation to post-legislation segments, adjusting for seasonal vaccination patterns and changes to the vaccination recommendation among males during the study period. Indiana’s legislation allowed pharmacists to administer HPV vaccination; legislation in Kentucky, Missouri, and Oregon included provisions HPV and cervical cancer education. No statistically significant increases in HPV vaccination levels or trends were observed in the post-legislation segments among adolescents overall; however, a significant post-legislation increase in vaccination trends was observed among boys in Missouri (β = 0.16, p = 0.03). Evidence for a positive impact of legislation on HPV vaccination rates is limited. The scarcity of policies that directly facilitate or promote HPV vaccination, and the breadth of exemptions to school vaccination requirements, may limit the effectiveness of these policies. Continuing efforts to introduce and pass legislation that directly facilitates HPV vaccination, combined with promoting existing evidence-based interventions, can provide opportunities to identify the most effective strategies to increase adolescent HPV vaccination rates.

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.