Publications by authors named "Jennifer S Smith"

258 Publications

Testing for Sexually Transmitted Infection using Wet and Dry Self-Collected Brush Samples among Women in Mombasa, Kenya.

Sex Transm Dis 2021 Oct 22. Epub 2021 Oct 22.

Lineberger Cancer Center, University of North Carolina at Chapel Hill, NC, USA Department of Medical Microbiology, University of Nairobi, Nairobi, Kenya Department of Medicine, University of Washington, Seattle, WA, USA Department of Family Medicine, University of North Carolina at Chapel Hill, NC, USA Pathcare Laboratories, Mombasa, Kenya Department of Epidemiology, University of Washington, Seattle, WA, USA Department of Global Health, University of Washington, Seattle, WA, USA Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, NC, USA.

Abstract: We compared detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV) using dry and wet self-collected samples using brushes among females who engage in sex work in Mombasa, Kenya. Detection of TV and GC in dry and wet samples was similar, but CT detection in dry samples appeared lower.
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http://dx.doi.org/10.1097/OLQ.0000000000001575DOI Listing
October 2021

Multisite Clinical Validation of Isothermal Amplification-Based SARS-CoV-2 Detection Assays Using Different Sampling Strategies.

Microbiol Spectr 2021 Oct 20:e0084621. Epub 2021 Oct 20.

Division of Cancer Epidemiology and Genetics, National Cancer Institute, NIH, Rockville, Maryland, USA.

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 [] 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. 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.
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http://dx.doi.org/10.1128/Spectrum.00846-21DOI Listing
October 2021

Prevalence of high-risk HPV by RNA assay in home self-collected samples among underscreened people in North Carolina.

Sex Transm Dis 2021 Sep 13. Epub 2021 Sep 13.

Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC Lineberger Comprehensive Cancer Center, University of North Carolina Department of Health Behavior, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, NC, USA American Sexual Health Association, Research Triangle Park, NC, USA Laboratory Corporation of America Holdings, Burlington, NC, USA.

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 <250% of the U.S. Federal Poverty Level. Our analytic sample included participants randomized to the self-collection arm who returned self-collected cervico-vaginal brush samples for HPV testing (n = 329). Samples were tested for 14 hrHPV types by an HPV RNA assay and further genotyped for HPV 16 and HPV 18/45. We examined behavioral risk factors for hrHPV positivity using logistic regression and between-subjects t-tests.

Results: HrHPV RNA prevalence was 16% (n = 52/329) in self-collected samples. Of the hrHPV-positive participants, 24 (46%) presented for in-clinic cervical cancer screening, compared to 56 (20%) of hrHPV-negative participants. Those with ≥2 sexual partners in the past year were twice as likely to be hrHPV positive in adjusted analyses (adjusted OR = 2.00 (95% CI: 1.03-3.88). HrHPV-positive and negative participants had similar attitudes towards screening, with the exception of hrHPV-positive participants who reported a lower perceived risk of cervical cancer than those who were hrHPV-negative (p < .05).

Conclusion: The hrHPV RNA prevalence was similar to findings in other underscreened PWC in the US. Efforts to reach underscreened PWC is critical for cervical cancer prevention. Future studies aimed at home self-collection should address methods of increasing clinic attendance and completion of treatment among those with HPV-positive results.
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http://dx.doi.org/10.1097/OLQ.0000000000001557DOI Listing
September 2021

Rationale and design of the Prevent Anal Cancer Self-Swab Study: a protocol for a randomised clinical trial of home-based self-collection of cells for anal cancer screening.

BMJ Open 2021 06 29;11(6):e051118. Epub 2021 Jun 29.

Department Epidemiology, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Introduction: Squamous 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 Analysis: This 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 Dissemination: The 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 Number: NCT03489707.
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http://dx.doi.org/10.1136/bmjopen-2021-051118DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8245463PMC
June 2021

Association between PEG3 DNA methylation and high-grade cervical intraepithelial neoplasia.

Infect Agent Cancer 2021 Jun 13;16(1):42. Epub 2021 Jun 13.

Department of Biological Sciences, Center for Human Health and the Environment, North Carolina State University, Raleigh, NC, USA.

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.
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http://dx.doi.org/10.1186/s13027-021-00382-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8201933PMC
June 2021

Health Care Provider Perceptions of Facilitators and Barriers to Human Papillomavirus Vaccination Delivery in Five Countries.

Sex Transm Dis 2021 08;48(8):557-564

Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.

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 5 countries.

Methods: We identified providers from 5 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.
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http://dx.doi.org/10.1097/OLQ.0000000000001389DOI Listing
August 2021

Male Circumcision Reduces Penile HPV Incidence and Persistence: A Randomized Controlled Trial in Kenya.

Cancer Epidemiol Biomarkers Prev 2021 06 10;30(6):1139-1148. Epub 2021 May 10.

Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Illinois.

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.
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http://dx.doi.org/10.1158/1055-9965.EPI-20-1272DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8172477PMC
June 2021

Effectiveness of a national mass distribution campaign of long-lasting insecticide-treated nets and indoor residual spraying on clinical malaria in Malawi, 2018-2020.

BMJ Glob Health 2021 05;6(5)

University of North Carolina Project-Malawi, Lilongwe, Malawi.

Introduction: Malawi's malaria burden is primarily assessed via cross-sectional national household surveys. However, malaria is spatially and temporally heterogenous and no analyses have been performed at a subdistrict level throughout the course of a year. The WHO recommends mass distribution of long-lasting insecticide-treated bed nets (LLINs) every 3 years, but a national longitudinal evaluation has never been conducted in Malawi to determine LLIN effectiveness lifespans.

Methods: Using District Health Information Software 2 (DHIS2) health facility data, available from January 2018 to June 2020, we assessed malaria risk before and after a mass distribution campaign, stratifying by age group and comparing risk differences (RDs) by LLIN type or annual application of indoor residual spraying (IRS).

Results: 711 health facilities contributed 20 962 facility reports over 30 months. After national distribution of 10.7 million LLINs and IRS in limited settings, malaria risk decreased from 25.6 to 16.7 cases per 100 people from 2018 to 2019 high transmission seasons, and rebounded to 23.2 in 2020, resulting in significant RDs of -8.9 in 2019 and -2.4 in 2020 as compared with 2018. Piperonyl butoxide (PBO)-treated LLINs were more effective than pyrethroid-treated LLINs, with adjusted RDs of -2.3 (95% CI -2.7 to -1.9) and -1.5 (95% CI -2.0 to -1.0) comparing 2019 and 2020 high transmission seasons to 2018. Use of IRS sustained protection with adjusted RDs of -1.4 (95% CI -2.0 to -0.9) and -2.8% (95% CI -3.5 to -2.2) relative to pyrethroid-treated LLINs. Overall, 12 of 28 districts (42.9%) experienced increases in malaria risk in from 2018 to 2020.

Conclusion: LLINs in Malawi have a limited effectiveness lifespan and IRS and PBO-treated LLINs perform better than pyrethroid-treated LLINs, perhaps due to net repurposing and insecticide-resistance. DHIS2 provides a compelling framework in which to examine localised malaria trends and evaluate ongoing interventions.
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http://dx.doi.org/10.1136/bmjgh-2021-005447DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8098915PMC
May 2021

Prevention of cervical cancer through two HPV-based screen-and-treat implementation models in Malawi: protocol for a cluster randomized feasibility trial.

Pilot Feasibility Stud 2021 Apr 20;7(1):98. Epub 2021 Apr 20.

Department of OB-GYN, University of North Carolina, 4002 Old Clinic Building, CB #7570, Chapel Hill, NC, 27599-7570, USA.

Background: Cervical cancer is the leading cause of cancer incidence and mortality among Malawian women, despite being a largely preventable disease. Implementing a cervical cancer screening and preventive treatment (CCSPT) program that utilizes rapid human papillomavirus (HPV) testing on self-collected cervicovaginal samples for screening and thermal ablation for treatment may achieve greater coverage than current programs that use visual inspection with acetic acid (VIA) for screening and cryotherapy for treatment. Furthermore, self-sampling creates the opportunity for community-based screening to increase uptake in populations with low screening rates. Malawi's public health system utilizes regularly scheduled outreach and village-based clinics to provide routine health services like family planning. Cancer screening is not yet included in these community services. Incorporating self-sampled HPV testing into national policy could address cervical cancer screening barriers in Malawi, though at present the effectiveness, acceptability, appropriateness, feasibility, and cost-effectiveness still need to be demonstrated.

Methods: We designed a cluster randomized feasibility trial to determine the effectiveness, acceptability, appropriateness, feasibility, and budget impact of two models for integrating a HPV-based CCSPT program into family planning (FP) services in Malawi: model 1 involves only clinic-based self-sampled HPV testing, whereas model 2 includes both clinic-based and community-based self-sampled HPV testing. Our algorithm involves self-collection of samples for HPV GeneXpert® testing, visual inspection with acetic acid for HPV-positive women to determine ablative treatment eligibility, and same-day thermal ablation for treatment-eligible women. Interventions will be implemented at 14 selected facilities. Our primary outcome will be the uptake of cervical cancer screening and family planning services during the 18 months of implementation, which will be measured through an Endline Household Survey. We will also conduct mixed methods assessments to understand the acceptability, appropriateness, and feasibility of the interventions, and a cost analysis to assess budget impact.

Discussion: Our trial will provide in-depth information on the implementation of clinic-only and clinic-and-community models for integrating self-sampled HPV testing CCSPT with FP services in Malawi. Findings will provide valuable insight for policymakers and implementers in Malawi and other resource-limited settings with high cervical cancer burden.

Trial Registration: ClinicalTrials.gov identifier: NCT04286243 . Registered on February 26, 2020.
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http://dx.doi.org/10.1186/s40814-021-00839-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8056631PMC
April 2021

Perceived Financial Barriers to Cervical Cancer Screening and Associated Cost Burden Among Low-Income, Under-Screened Women.

J Womens Health (Larchmt) 2021 09 13;30(9):1243-1252. Epub 2021 Apr 13.

Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.

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. 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. 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. 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.
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http://dx.doi.org/10.1089/jwh.2020.8807DOI Listing
September 2021

Inequalities in Cervical Cancer Screening Uptake Between Chinese Migrant Women and Local Women: A Cross-Sectional Study.

Cancer Control 2021 Jan-Dec;28:1073274820985792

Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/ Cancer Hospital, 12501Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

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.
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http://dx.doi.org/10.1177/1073274820985792DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8482714PMC
September 2021

Recidivism Treatment for Justice-Involved Veterans: Evaluating Adoption and Sustainment of Moral Reconation Therapy in the US Veterans Health Administration.

Adm Policy Ment Health 2021 Nov 30;48(6):992-1005. Epub 2021 Jan 30.

Veterans Justice Programs, Veterans Health Administration, Washington, DC, USA.

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.
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http://dx.doi.org/10.1007/s10488-021-01113-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7847225PMC
November 2021

Association Between Social Determinants of Health and Postoperative Outcomes in Patients Undergoing Single-Level Lumbar Fusions: A Matched Analysis.

Spine (Phila Pa 1976) 2021 May;46(9):E559-E565

Department of Neurosurgery, University of Texas Southwestern Medical School, Dallas, TX.

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 < 0.05) or any postoperative complication (16.3% vs. 10.4%, P < 0.05) in the matched analysis was higher in the disparity group. The presence of a disparity was associated with 70% increased odds of developing any complication (OR 1.7, 95% CI 1.53-1.84) or symptomatic pseudarthrosis (OR 1.7, 95% CI 1.17-2.37). Unadjusted and adjusted sensitivity analyses yielded similar results as the primary analysis.

Conclusion: Social Determinants of Health affect outcomes in spine surgery patients and are associated with an increased risk of developing postoperative complications following lumbar spine fusion.Level of Evidence: 3.
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http://dx.doi.org/10.1097/BRS.0000000000003829DOI Listing
May 2021

Asymptomatic Plasmodium falciparum malaria prevalence among adolescents and adults in Malawi, 2015-2016.

Sci Rep 2020 10 30;10(1):18740. Epub 2020 Oct 30.

Division of Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.

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.
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http://dx.doi.org/10.1038/s41598-020-75261-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7603306PMC
October 2020

Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening.

Cancer Epidemiol Biomarkers Prev 2020 12 17;29(12):2651-2661. Epub 2020 Sep 17.

Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina.

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%; = 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 ( < 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.
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http://dx.doi.org/10.1158/1055-9965.EPI-20-0674DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7710587PMC
December 2020

Incidence and clearance of penile human papillomavirus infection among circumcised Kenyan men.

Int J STD AIDS 2020 10 14;31(12):1202-1211. Epub 2020 Sep 14.

Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.

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.
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http://dx.doi.org/10.1177/0956462420948370DOI Listing
October 2020

Overcoming barriers to adolescent vaccination: perspectives from vaccine providers in North Carolina.

Women Health 2020 Nov-Dec;60(10):1129-1140. Epub 2020 Aug 9.

Department of Epidemiology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.

To capture strategies for achieving high adolescent coverage of tetanus-diphtheria-acellular pertussis (Tdap), meningococcal conjugate (MenACWY), and human papillomavirus (HPV) vaccination, we surveyed employees of 20 North Carolina (N.C.) clinics that achieved adolescent vaccination coverage higher than the state average. One employee per clinic completed a surveysummarizing clinic practices regarding adolescent vaccination; perceived barriers and facilitators to Tdap/MenACWY/HPV vaccination; and the role of "champions" who made special efforts to promote adolescent vaccination. Common perceived barriers for all vaccinations were parental opposition and logistical barriers to receiving vaccination. For HPV vaccination, employees cited parental concerns about sexual behavior and injection site pain; no school vaccination requirement; and low-perceived benefit in boys. Most clinics (80%) implemented successful changes to increase adolescent vaccination: consistently offering vaccination, tracking vaccination status using existing data, providing appointment reminders, updating providers on vaccination recommendations, and expanding vaccination hours. Strategies to improve HPV vaccination included co-administration with Tdap and MenACWY, and providing reminders to complete the vaccination series. Vaccine champions strongly recommended vaccination to parents (55%) and educated parents on vaccination recommendations (36%). Clinics in N.C.and similar settings can implement these and other low-resource strategies to overcome adolescent vaccination barriers.

Abbreviations: CDC=Centers for Disease Control and Prevention; EHR=Electronic health record; HPV=Human papillomavirus; Tdap=Tetanus-diphtheria-acellular pertussis vaccine; MenACWY=Meningococcal Conjugate Vaccine; NCIB=North Carolina Immunization Branch; NCIR=North Carolina Immunization Registry; ACIP=Advisory Committee on Immunization Practices.
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http://dx.doi.org/10.1080/03630242.2020.1802639DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7556355PMC
March 2021

Reasons for hormonal contraceptive use in a cohort of African-American women living in the Detroit area.

Contraception 2020 11 6;102(5):346-348. Epub 2020 Aug 6.

National Institute of Environmental Health Sciences (NIEHS), Durham, NC, United States.

Objectives: To characterize reasons for hormonal contraceptive (HC) use in 1,455 African-American women, aged 23-35 years.

Study Design: The community-based cohort members were recruited from the Detroit, Michigan area in 2010-2012. HC history was collected via telephone interview.

Results: Seven percent reported HC use exclusively for non-contraceptive purposes, and 49% reported non-contraceptive reasons in addition to contraception. Non-contraceptive reasons were reported for all HC types, but were most common for combined oral contraceptives. Primary reasons were for irregular cycles, heavy bleeding, and pain.

Conclusions: In this large cohort of Black women, HC use to treat menstrual problems was common.

Implications: HCs were commonly used for both pregnancy prevention and management of menstrual symptoms, but some women used HCs exclusively for menstrual symptom relief. The importance for women of non-contraceptive reasons for HC use may not be adequately recognized, and published data on Black women's reasons for HC use remain limited.
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http://dx.doi.org/10.1016/j.contraception.2020.07.093DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7606661PMC
November 2020

A Pooled Analysis to Compare the Clinical Characteristics of Human Papillomavirus-positive and -Negative Cervical Precancers.

Cancer Prev Res (Phila) 2020 10 12;13(10):829-840. Epub 2020 Jul 12.

HPV Research Group, University of Washington, Seattle, Washington.

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; < 0.001) preceding high-grade squamous intraepithelial lesion cytology (15 studies; 0.54 vs. 0.10; < 0.001); and high-grade colposcopic impression (13 studies; 0.30 vs. 0.18; = 0.03). HPV-negative CIN2+ was more likely to test positive for low-risk HPV genotypes than HPV-positive CIN2+ ( < 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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http://dx.doi.org/10.1158/1940-6207.CAPR-20-0182DOI Listing
October 2020

Using peers to increase veterans' engagement in a smartphone application for unhealthy alcohol use: A pilot study of acceptability and utility.

Psychol Addict Behav 2020 Jun 29. Epub 2020 Jun 29.

Department of Clinical and Community Psychology, University of Alaska Anchorage.

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).
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http://dx.doi.org/10.1037/adb0000598DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7769861PMC
June 2020

Role of gender in perspectives of discrimination, stigma, and attitudes relative to cervical cancer in rural Sénégal.

PLoS One 2020 28;15(4):e0232291. Epub 2020 Apr 28.

Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois, United States of America.

Cervical cancer is the leading cause of female cancer deaths in Sénégal 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 Kédougou, Sénégal. 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.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0232291PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7188246PMC
July 2020

Detection of HPV E6 oncoprotein from urine via a novel immunochromatographic assay.

PLoS One 2020 22;15(4):e0232105. Epub 2020 Apr 22.

Teaching and Research Institute-Barretos Cancer Hospital, Brazil.

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 (
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0232105PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7176116PMC
July 2020

Racial and Ethnic Differences in Acceptability of Urine and Cervico-Vaginal Sample Self-Collection for HPV-Based Cervical Cancer Screening.

J Womens Health (Larchmt) 2020 07 26;29(7):971-979. Epub 2020 Mar 26.

Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina.

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 varied across racial/ethnic groups. As part of a test accuracy study of urine-based hrHPV testing, we recruited a convenience sample of women 25-65 years of age at two colposcopy clinics in North Carolina between November 2016 and January 2019. After self-collection of urine and cervico-vaginal samples, women completed a questionnaire on the acceptability of the sample collection methods. We coded open-ended questions inductively. All results are presented stratified by racial/ethnic group. We included 410 women (119 Hispanic, 115 non-Hispanic Black, 154 non-Hispanic White, and 22 women with other racial identities). Most women (79%, 95% confidence interval [CI] = 76%-83%) had positive feelings about urine-based hrHPV testing. Women generally preferred urine (78%, 95% CI = 74%-82%) over cervico-vaginal self-collection (18%, 95% CI = 14%-22%), but the degree differed by racial/ethnic group, increasing from 75% in non-Hispanic Black to 82% in Hispanic women ( = 0.011). Most women reported at least one positive aspect of urine (89%) and cervico-vaginal self-collection (85%) for hrHPV testing with the most common positive aspect being easy sample collection, although 16% of women were concerned about performing the cervico-vaginal self-collection correctly. Self-collection for hrHPV-based cervical cancer screening is highly acceptable to women across different racial/ethnic groups in the United States, and most women in our study would be more likely to attend future cervical cancer screening appointments if screening were urine based. Urine-based hrHPV testing is a promising approach to improve cervical cancer screening coverage.
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http://dx.doi.org/10.1089/jwh.2019.8132DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7371548PMC
July 2020

Evaluating the implementation of cervical cancer screening programs in low-resource settings globally: a systematized review.

Cancer Causes Control 2020 May 17;31(5):417-429. Epub 2020 Mar 17.

University of Rochester Department of Obstetrics and Gynecology, Rochester, NY, USA.

Purpose: Cervical cancer disproportionately burdens low-resource populations where access to quality screening services is limited. A greater understanding of sustainable approaches to implement cervical cancer screening services is needed.

Methods: We conducted a systematized literature review of evaluations from cervical cancer screening programs implemented in resource-limited settings globally that included a formal evaluation and intention of program sustainment over time. We categorized the included studies using the continuum of implementation research framework which categorizes studies progressively from "implementation light" to more implementation intensive.

Results: Fifty-one of 13,330 initially identified papers were reviewed with most study sites in low-resource settings of middle-income countries (94.1%) ,while 9.8% were in low-income countries. Across all studies, visual inspection of the cervix with acetic acid (58.8%) was the most prevalent screening method followed by cytology testing (39.2%). Demand-side (client and community) considerations were reported in 86.3% of the articles, while 68.6% focused scientific inquiry on the supply side (health service). Eighteen articles (35.3%) were categorized as "Informing Scale-up" along the continuum of implementation research.

Conclusions: The number of cervical cancer screening implementation reports is limited globally, especially in low-income countries. The 18 papers we classified as Informing Scale-up provide critical insights for developing programs relevant to implementation outcomes. We recommend that program managers report lessons learnt to build collective implementation knowledge for cervical cancer screening services, globally.
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http://dx.doi.org/10.1007/s10552-020-01290-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7105425PMC
May 2020

High-risk Human Papillomavirus Messenger RNA Testing in Wet and Dry Self-collected Specimens for High-grade Cervical Lesion Detection in Mombasa, Kenya.

Sex Transm Dis 2020 07;47(7):464-472

From the Department of Epidemiology, Gillings School of Global Public Health.

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.
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http://dx.doi.org/10.1097/OLQ.0000000000001167DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7837412PMC
July 2020

Human papillomavirus and abnormal cervical lesions among HIV-infected women in HIV-discordant couples from Kenya.

Sex Transm Infect 2020 09 9;96(6):457-463. Epub 2020 Jan 9.

Department of Epidemiology, Lineberger Comprehensive Cancer Center, University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina, USA

Objective: HIV 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.

Methods: A 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.

Results: Among 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 (p<0.001). The most common HR-HPV types in women with a high-grade lesion or more severe by cytology were HPV-52 (44%), HPV-31 (22%), HPV-35 (22%), HPV-51 (22%) and HPV-58 (22%). HR-HPV genotypes HPV-16 or HPV-18 were found in 17% of women with high-grade lesions or more severe. HR-HPV screening applied in this population would detect 89% of those with a high-grade lesion or more severe, while 44% of women with normal or low-grade cytology would screen positive.

Conclusion: HR-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.
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http://dx.doi.org/10.1136/sextrans-2019-054052DOI Listing
September 2020

Test Accuracy of Human Papillomavirus in Urine for Detection of Cervical Intraepithelial Neoplasia.

J Clin Microbiol 2020 02 24;58(3). Epub 2020 Feb 24.

Department of Epidemiology, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA

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
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http://dx.doi.org/10.1128/JCM.01443-19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7041584PMC
February 2020

Impact of human papillomavirus (HPV) self-collection on subsequent cervical cancer screening completion among under-screened US women: MyBodyMyTest-3 protocol for a randomized controlled trial.

Trials 2019 Dec 27;20(1):788. Epub 2019 Dec 27.

Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.

Background: Screening 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/design: The 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.

Discussion: If 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 Registration: ClinicalTrials.gov NCT02651883, Registered on 11 January 2016.
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http://dx.doi.org/10.1186/s13063-019-3959-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6935089PMC
December 2019

Correction to: Preference of specimen collection methods for human papillomavirus detection for cervical cancer screening: a cross-sectional study of high-risk women in Mombasa, Kenya.

Reprod Health 2019 10 30;16(1):156. Epub 2019 Oct 30.

Partnership for Advanced Clinical Education (PACE), Kamilisha, Kenya.

Following publication of the original article [1], we have been notified that another author should be added to the team of authors. The Name and affiliation details are below.
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http://dx.doi.org/10.1186/s12978-019-0812-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6822477PMC
October 2019
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