Screen-positive Women Research Articles

Inefficiencies of over-screening and under-screening for cervical cancer prevention in the U.S.

There is limited information on the cost-inefficiencies of non-adherence to recommended cervical cancer screening or the potential value for improving non-adherence. We estimated the incremental value of adhering to recommended screening every three years with cytology, using a disease simulation model that integrated real-world screening practice data from New Mexico. The amount that can be spent to improve adherence was estimated by calculating the incremental net monetary benefit (INMB) under scenarios of Current Practice (assuming a population of mixed adherence) and Uniformly Non-Adherent populations with imperfect or perfect adherence to follow-up of screen-positive women. Getting unscreened women screened every three years by cytology was a better value than increasing screening in the under-screened or reducing screening in the over-screened. For example, INMBs were $3998 for screening previously unscreened women versus $136 for eliminating annual screening at a willingness-to-pay threshold of $100,000 per quality-adjusted life-year gained. Strategies to reach unscreened women are potentially high-value investments.

A comparison of the PHQ-2 and MGMQ for screening for emotional health difficulties during pregnancy

BackgroundRoutine screening for emotional health difficulties in women during pregnancy is now advocated in several countries. There is a need therefore to compare the performance of different self-report measures to accomplish this. This study reports on the comparative performance of two such measures– the well-established PHQ-2, which aims to detect depression, and the more recent MGMQ, which aims to detect a wide array of negative emotions. MethodWomen (N = 2292) attending a public hospital antenatal clinic over a 14-month period completed the two measures, either on their own (72%), verbally administered by the midwife (25%), or with an interpreter (3%). ResultsSimilar rates of women screened positive on each instrument (PHQ-2: 11.6%; MGMQ: 12.3%), but the overlap between the two measures was low. The PHQ-2 only detected 58% of the MGMQ screen positive women, while the MGMQ detected 89.5% of the PHQ-2 screen positive women. No clinically meaningful difference in screen positive rates on either measure was evident for the administration method. LimitationsNo demographic data were available apart from gestational age, and only about half the women presenting to the clinic during the time period were screened with the measures. ConclusionThe MGMQ detected a greater proportion of women screening positive on the PHQ-2 than vice-versa. This is part due to the MGMQ's focus on a wider range of negative emotions than just depression. Accumulating evidence for this MGMQ indicates that clinical services can consider using this simple measure if they wish to screen for a broad range of negative emotions during pregnancy and postnatally.

Provider Discussions of Genetic Tests With U.S. Women at Risk for a BRCA Mutation

The U.S. Preventive Services Task Force recommends that primary care providers screen unaffected women with a family history of BRCA mutation-associated cancers, but without a personal history of BRCA-related cancer, for referral to genetic counseling and potential genetic testing. The 2015 National Health Interview Survey was analyzed in January 2017 to determine the rates at which unaffected adult women with a positive family history of BRCA-related cancers, assessed using the Family History Screen-7, reported discussing genetic testing with a provider, using genetic counseling services, and having genetic testing for increased cancer risk. Clinical correlates associated with these outcomes were assessed using multivariable logistic regression (AOR with 95% CI). Among unaffected Family History Screen-7 screen-positive women, 9.5% reported discussing genetic testing with a provider, 5.1% reported genetic counseling, and 2.7% reported uptake of genetic testing. Younger women (aged 18-39 and 40-49 years) were more likely to discuss genetic testing than women aged ≥60 years (AOR=1.50, 95% CI=1.09, 2.06 and AOR=1.64, 95% CI=1.15, 2.33, respectively). Women of black race (AOR=1.50, 95% CI=1.09, 2.07) and women with greater than a high school education (AOR=1.85, 95% CI=1.41, 2.43) were more likely to discuss genetic testing than women of white race and women with a high school education or less, respectively. Among a higher risk subgroup with an even stronger family history of BRCA-associated cancers, 18.5% of women reported discussions. Despite a decade-old U.S. Preventive Services Task Force recommendation, few unaffected women at risk for BRCA-associated cancer report discussing genetic testing with a provider.

Delivering perinatal depression care in a rural obstetric setting: a mixed methods study of feasibility, acceptability and effectiveness

Objectives: Universal screening for depression during pregnancy and postpartum is recommended, yet mental health treatment and follow-up rates among screen-positive women in rural settings are low. We studied the feasibility, acceptability and effectiveness of perinatal depression treatment integrated into a rural obstetric setting. Methods: We conducted an open treatment study of a screening and intervention program modified from the Depression Attention for Women Now (DAWN) Collaborative Care model in a rural obstetric clinic. Depression screen-positive pregnant and postpartum women received problem-solving therapy (PST) with or without antidepressants. A care manager coordinated communication between patient, obstetrician and psychiatric consultant. We measured change in the Patient Health Questionnaire 9 (PHQ-9) score. We used surveys and focus groups to measure patient and provider satisfaction and analyzed focus groups using qualitative analysis. Results: The intervention was well accepted by providers and patients, based on survey and focus group data. Feasibility was also evidenced by recruitment (87.1%) and retention (92.6%) rates and depression outcomes (64% with >50% improvement in PHQ 9) which were comparable to clinical trials in similar urban populations. Conclusions for practice: DAWN Collaborative Care modified for treatment of perinatal depression in a rural obstetric setting is feasible and acceptable. Behavioral health services integrated into rural obstetric settings could improve care for perinatal depression.

EP06.05: Did women's hepatitis B status affect their uptake of invasive prenatal diagnosis after a positive conventional aneuploidy screening?

Use of invasive prenatal diagnosis (IPD) in hepatitis B surface antigen (HBsAg)-positive women carries a potential risk of vertical transmission especially when the viral load is high. The objective of the present study is to investigate HBsAg-positive women's uptake of invasive prenatal diagnosis (IPD) after a positive conventional aneuploidy screening. We hypothesis that more HBSAg-positive than- negative women would choose cell free DNA (cfDNA) testing to avoid IPD and its potential risk of vertical transmission. We retrospectively reviewed the women's choice on further testing after a positive conventional aneuploidy screening in our centre from August 2010 to July 2014. HBsAg status was checked routinely in all pregnant women. All women with a positive aneuploidy screening result were counselled by maternal fetal medicine team. With the use of descriptive statistics and Chi-square test, we compared their choice between HBsAg-positive and -negative women. Of 1398 screen positive women, 78 (5.6%) were HBsAg carriers. Of these carriers, 38.5%, 38.5%, 15.4% and 7.7% opted for chorionic villus sampling (CVS), amniocentesis, cfDNA and no further testing respectively. The corresponding figures for non-carriers were 43.2%, 31.2%. 20.0% and 5.6% respectively. The differences were not significant (p=0.3978). There was also no difference in the miscarriage rate between HBsAg-positive and -negative women (1.3% vs 1.0%, p=0.7401). In the present study, screen positive women's choice on the use or method of IPD was not affected by HBsAg status. Women should be adequately counselled on the potential risks of vertical transmission after an IPD.

Cost-effectiveness of an HPV self-collection campaign in Uganda: comparing models for delivery of cervical cancer screening in a low-income setting.

With the availability of a low-cost HPV DNA test that can be administered by either a healthcare provider or a woman herself programme planners require information on the costs and cost-effectiveness of implementing cervical cancer screening programmes in low-resource settings under different models of healthcare delivery. Using data from the START-UP demonstration project and a micro-costing approach we estimated the health and economic impact of once-in-a-lifetime HPV self-collection campaign relative to clinic-based provider-collection of HPV specimens in Uganda. We used an individual-based Monte Carlo simulation model of the natural history of HPV and cervical cancer to estimate lifetime health and economic outcomes associated with screening with HPV DNA testing once in a lifetime (clinic-based provider-collection vs a self-collection campaign). Test performance and cost data were obtained from the START-UP demonstration project using a micro-costing approach. Model outcomes included lifetime risk of cervical cancer total lifetime costs (in 2011 international dollars [I$]) and life expectancy. Cost-effectiveness ratios were expressed using incremental cost-effectiveness ratios (ICERs). When both strategies achieved 75% population coverage ICERs were below Ugandas per capita GDP (self- collection: I$80 per year of life saved [YLS]; provider-collection: I$120 per YLS). When the self-collection campaign achieved coverage gains of 15-20% it was more effective than provider-collection and had a lower ICER unless coverage with both strategies was 50% or less. Findings were sensitive to cryotherapy compliance among screen-positive women and relative HPV test performance. The primary limitation of this analysis is that self-collection costs are based on a hypothetical campaign but are based on unit costs from Uganda. Once-in-a-lifetime screening with HPV self-collection may be very cost-effective and reduce cervical cancer risk by > 20% if coverage is high. Demonstration projects will be needed to confirm the validity of our logistical costing and compliance assumptions. (c) The Author 2017. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine. All rights reserved. For permissions please e-mail: journals.permissions@oup.com.

A Clinical Trial to Increase the Identification, Genetic Counseling Referral and Genetic Testing of Women at risk for Hereditary Breast and/or Ovarian Cancer

Background: Approximately 1/300 individuals in the general population are at risk for hereditary breast and ovarian cancer due to an inherited mutation in the BRCA1/BRCA2 genes. BRCA mutations are associated with dramatically increased risks for breast cancer, especially at younger ages, in addition to ovarian cancer. Enhanced screening and risk reduction strategies can significantly reduce associated morbidity and mortality. The United States Preventive Services Task Force (USPSTF) recommends identifying women at-risk for BRCA mutations for receipt of genetic counseling and if appropriate, testing. The Breast Cancer Genetics Referral Screening Tool (B-RST) is a validated screen endorsed by USPSTF to facilitate this process. This implementation study seeks to evaluate the most effective means of follow-up for screen-positive women to maximize the number who are referred to, and receive, cancer genetic counseling (CGC) services.

Management algorithms for cervical cancer screening and precancer treatment for resource-limited settings.

Management algorithms for screen-positive women in cervical cancer prevention programs have undergone substantial changes in recent years. The WHO strongly recommends human papillomavirus (HPV) testing for primary screening, if affordable, or if not, then visual inspection with acetic acid (VIA), and promotes treatment directly following screening through the screen-and-treat approach (one or two clinic visits). While VIA-positive women can be offered immediate ablative treatment based on certain eligibility criteria, HPV-positive women need to undergo subsequent VIA to determine their eligibility. Simpler ablative methods of treatment such as cryotherapy and thermal coagulation have been demonstrated to be effective and to have excellent safety profiles, and these have become integral parts of new management algorithms. The challenges faced by low-resource countries are many and include, from the management perspective, identifying an affordable point-of-care HPV detection test, minimizing over-treatment, and installing an effective information system to ensure high compliance to treatment and follow-up.

Cervical cancer prevention in El Salvador (CAPE)—An HPV testing-based demonstration project: Changing the secondary prevention paradigm in a lower middle-income country

•CareHPV tests were used to compare screen-and-treat and colposcopy management.•Screen-and-treat strategy with HPV testing was found to be very cost-effective.•CAPE has screened >25,000 women in the Paracentral region.•Over 70% of screen-positive women received recommended treatment within six months.•CAPE is an example of public-private partnership resulting in paradigm change.

Cost-effectiveness of an HPV self-collection campaign in Uganda: comparing models for delivery of cervical cancer screening in a low-income setting.

With the availability of a low-cost HPV DNA test that can be administered by either a healthcare provider or a woman herself, programme planners require information on the costs and cost-effectiveness of implementing cervical cancer screening programmes in low-resource settings under different models of healthcare delivery. Using data from the START-UP demonstration project and a micro-costing approach, we estimated the health and economic impact of once-in-a-lifetime HPV self-collection campaign relative to clinic-based provider-collection of HPV specimens in Uganda. We used an individual-based Monte Carlo simulation model of the natural history of HPV and cervical cancer to estimate lifetime health and economic outcomes associated with screening with HPV DNA testing once in a lifetime (clinic-based provider-collection vs a self-collection campaign). Test performance and cost data were obtained from the START-UP demonstration project using a micro-costing approach. Model outcomes included lifetime risk of cervical cancer, total lifetime costs (in 2011 international dollars [I$]), and life expectancy. Cost-effectiveness ratios were expressed using incremental cost-effectiveness ratios (ICERs). When both strategies achieved 75% population coverage, ICERs were below Uganda’s per capita GDP (self-collection: I$80 per year of life saved [YLS]; provider-collection: I$120 per YLS). When the self-collection campaign achieved coverage gains of 15–20%, it was more effective than provider-collection, and had a lower ICER unless coverage with both strategies was 50% or less. Findings were sensitive to cryotherapy compliance among screen-positive women and relative HPV test performance. The primary limitation of this analysis is that self-collection costs are based on a hypothetical campaign but are based on unit costs from Uganda. Once-in-a-lifetime screening with HPV self-collection may be very cost-effective and reduce cervical cancer risk by > 20% if coverage is high. Demonstration projects will be needed to confirm the validity of our logistical, costing and compliance assumptions.

Harms of cervical cancer screening in the United States and the Netherlands

We studied harms related to cervical cancer screening and management of screen-positive women in the United States (US) and the Netherlands. We utilized data from four US integrated health care systems (SEARCH), the US National Health Interview Survey, New Mexico state, the Netherlands national histopathology registry, and included studies on adverse health effects of cervical screening. We compared the number of Papanicolaou (Pap) smear tests, abnormal test results, punch biopsies, treatments, health problems (anxiety, pain, bleeding and discharge) and preterm births associated with excisional treatments. Results were age-standardized to the 2007 US population. Based on SEARCH, an estimated 36 million Pap tests were performed in 2007 for 91 million US women aged 21-65 years, leading to 2.3 million abnormal Pap tests, 1.5 million punch biopsies, 0.3 million treatments for precancerous lesions, 5 thousand preterm births and over 8 million health problems. Under the Netherlands screening practice, fewer Pap tests (58%), abnormal test results (64%), punch biopsies (75%), treatment procedures (40%), preterm births (60%) and health problems (63%) would have occurred. The SEARCH data did not differ much from other US data for 2007 or from more recent data up to 2013. Thus compared to the less intensive screening practice in the Netherlands, US practice of cervical cancer screening may have resulted in two- to threefold higher harms, while the effects on cervical cancer incidence and mortality are similar. The results are also of high relevance in making recommendations for HPV screening. Systematic collection of harms data is needed for monitoring and for better incorporation of harms in making screening recommendations.

Using the Edinburgh Postnatal Depression Scale for women and men—some cautionary thoughts

The objective of the study was to critically consider some of the possible limitations in the Edinburgh Depression Scale (EDS), given that great emphasis is put on the results of this measure within both clinical and research fields. Using findings and discussion points from other studies, as well as from a critical analysis of issues by the authors based upon their clinical and research experience, possible limitations with the scale in nine areas are discussed. Possible limitations include the following: (1) ambiguous items, (2) exclusion of certain types of distress, (3) scoring difficulties, (4) low positive predictive value, (5) frequent use of incorrect cut-off scores, (6) a vast array of validated cut-off scores, (7) validation against a questionable gold-standard, (8) limited anxiety detection and of depressive symptoms in men, and (9) many screen positive women only have transient distress. While the EDS has unquestionably been an extremely valuable instrument in aiding in the recognition of the importance of perinatal mental health, users of the scale should be aware that it, like other measures, has limitations. We discuss possible strategies to overcome these limitations and describe a recent scale that has been developed to surmount these shortcomings more effectively.

Feasibility of thermocoagulation in a screen-and-treat approach for the treatment of cervical precancerous lesions in sub-Saharan Africa

BackgroundThe use of thermocoagulation for the treatment of cervical precancerous lesions has recently generated a great deal of interest. Our aim was to determine the feasibility of this outpatient procedure in the context of a cervical cancer (CC) screen-and-treat campaign in sub-Saharan Africa.MethodsBetween July and December 2015, women living in the area of Dschang (Cameroon) aged between 30 and 49 years, were enrolled in a CC screening study.HPV self-sampling was performed as a primary screening test and women who were either “HPV 16/18/45-positive” or “positive to other HPV types and to VIA” were considered screen-positive, thus requiring further management. The primary outcome was the percentage of screen-positive patients who met the criteria to undergo thermocoagulation. The secondary outcome was the assessment of the procedure’s side effects immediately after treatment and at the 1-month follow-up visit.ResultsA total of 1012 women were recruited in the study period. Among 121 screen-positive women, 110 of them (90.9%) were eligible to be treated with thermocoagulation. No patients discontinued treatment because of pain or other side effects. The mean ± SD (Standard Deviation) score measured on the 10-point Visual Analogue Scale (VAS) was 3.0 ± 1.6. Women having less than 2 children were more likely to report a higher pain score than those with more than two (4.2 ± 2.0 versus 2.9 ± 1.5, respectively; p value = 0.016). A total of 109/110 (99.1%) patients came to the 1-month follow-up visit. Vaginal discharge was reported in 108/109 (99.1%) patients throughout the month following treatment. Three patients (2.8%) developed vaginal infection requiring local antibiotics. No hospitalizations were required.ConclusionThe majority of screen-positive women met the criteria and could be treated by thermocoagulation. The procedure was associated to minor side effects and is overall feasible in the context of a CC screen-and-treat campaign in sub-Saharan Africa.Trial registrationThe trial was retrospectively registered on November 11, 2015 with the identifier: ISRCTN99459678.

Accuracy of triage strategies for human papillomavirus DNA-positive women in low-resource settings: A cross-sectional study in China.

CareHPV is a human papillomavirus (HPV) DNA test for low-resource settings (LRS). This study assesses optimum triage strategies for careHPV-positive women in LRS. A total of 2,530 Chinese women were concurrently screened for cervical cancer with visual inspection with acetic acid (VIA), liquid-based cytology and HPV testing by physician- and self-collected careHPV, and physician-collected Hybrid Capture 2 (HC2). Screen-positive women were referred to colposcopy with biopsy and endocervical curettage as necessary. HPV-positivity was defined as ≥1.0 relative light units/cutoff (RLU/CO) for both careHPV and HC2. Primary physician-HC2, physician-careHPV and self-careHPV and in sequential screening with cytology, VIA, or increased HPV test-positivity performance, stratified by age, were assessed for cervical intraepithelial neoplasia (CIN) grade 2/3 or worse (CIN2/3+) detection. The sensitivities and specificities of primary HPV testing for CIN2+ were: 83.8%, 88.1% for physician-careHPV; 72.1%, 88.2% for self-careHPV; and 97.1%, 86.0% for HC2. Physician-careHPV test-positive women with VIA triage had a sensitivity of 30.9% for CIN2+ versus 80.9% with cytology triage. Self-careHPV test-positive women with VIA triage was 26.5% versus 66.2% with cytology triage. The sensitivity of HC2 test-positive women with VIA triage was 38.2% versus 92.6% with cytology triage. The sensitivity of physician-careHPV testing for CIN2+ decreased from 83.8% at ≥1.0 RLU/CO to 72.1% at ≥10.00 RLU/CO, while the sensitivity of self-careHPV testing decreased from 72.1% at ≥1.0 RLU/CO to 32.4% at ≥10.00 RLU/CO; similar trends were seen with age-stratification. VIA and cytology triage improved specificity for CIN2/3 than no triage. Sensitivity with VIA triage was unsuitable for a mass-screening program. VIA provider training might improve this strategy. Cytology triage could be feasible where a high-quality cytology program exists. Triage of HPV test-positive women by increased test positivity cutoff adds another LRS triage option.

Abstract 12903: Low-molecular Weight Heparin Improves Endothelial Function in Pregnant Women at High-risk of Preeclampsia

Introduction: Women who develop preeclampsia (PE) demonstrate cardiovascular abnormalities during pregnancy and postpartum. Low-molecular weight heparin (LMWH) significantly reduces the incidence of PE, although the mechanisms of action are unknown. Hypothesis: LMWH improves cardiovascular function in pregnant women at high-risk of PE. Methods: Pregnant women at high-risk of PE (n=25) and low-risk pregnant controls (n=20) at 22-26 weeks’ gestation underwent cardiovascular assessments. High-risk women were then randomized to LMWH or saline placebo (30mg IV bolus and 1mg/kg subcutaneous dose). Cardiovascular function was assessed 1 and 3 hours post-randomization. The in vitro endothelial effects of patient serum and LMWH on human umbilical venous endothelial cells (HUVEC) were determined through angiogenesis assays, gene expression and protein secretion. Results: High-risk women demonstrated a low-volume, high resistance hemodynamic profile with significantly impaired radial artery flow-mediated dilation (FMD) when compared to low-risk controls (6.5±0.9% vs 9.7±1.0%, P=0.03). Baseline plasma and urine levels of placental growth factor (PlGF) were significantly lower in high-risk women compared with controls (P=0.003 and P=0.01, respectively). LMWH significantly increased FMD in high-risk women following randomization compared to baseline (10.8±1.0% vs 7.6±1.0%, P=0.008). LMWH also significantly increased plasma levels of PlGF, soluble fms-like tyrosine kinase-1 and myeloperoxidase (P=0.006, P=0.03 and P=0.03, respectively). Serum from high-risk women significantly impaired HUVEC angiogenesis and significantly increased PlGF-1 and PlGF-2 transcription compared to serum from controls (0.79±0.05 vs 0.99±0.05, P=0.03; P=0.03 and P=0.01, respectively). Co-exposure of high-risk serum with LMWH improved the in vitro angiogenic response such that it was equivalent to that of control serum and promoted PlGF secretion. Conclusions: Our data indicate that LMWH improves maternal endothelial function in pregnant women at high-risk of developing PE, possibly mediated through increased PlGF bioavailability. Future trials are needed to assess the effectiveness of LMWH for the prevention of severe PE in screen-positive women.

Parental Decisions about Prenatal Screening and Diagnosis among Infants with Trisomy 21 in a National Cohort with High Uptake of Combined First-Trimester Screening

Introduction: The aim was to investigate the parental decisions about prenatal screening and diagnosis among infants with trisomy 21 (T21) in a national cohort with high uptake of combined first-trimester screening (cFTS). Material and Methods: This was a nationwide population-based study including infants born in 2009-2012. Information from the cFTS, fetal karyotype results and pregnancy outcome was obtained from the Danish Fetal Medicine Database on all women with a cFTS risk assessment. Cut-off for referral for invasive testing was ≥1:300. Karyotype results from pregnancies with no cFTS were obtained from the Danish Cytogenetic Central Registry. Results: The uptake rate of cFTS was 91.6%, and 82.8% (8,032/9,704) of the screen-positive women opted for invasive testing. Overall, 82.2% (454/552) chose to terminate an affected pregnancy. In the 4-year period, 102 of 232,962 singletons were born alive with T21. The cFTS risk was true-positive, false-negative or not obtained in 21.6, 48.0 and 30.4%, respectively, of these pregnancies. Discussion: In this large national cohort, 4.4 per 10,000 live-born infants had T21. Of 102 infants with T21 from 2009 to 2012, 52.0% were born after the women had not opted for cFTS or were true-positive but declined invasive testing or termination, and 48.0% were born after a false-negative risk assessment.

Feasibility of Using Mobile Smartphone Camera as an Imaging Device for Screening of Cervical Cancer in a Low-resource Setting

ABSTRACT Objective The aim of this study is to determine the feasibility of a screening method for cervical cancer using an application developed on smartphone to aid visual inspection with acetic acid. Materials and methods A prospective study was carried out in 230 women in the Department of Gynaecology, PGIMER, Chandigarh, India. These women were divided into two groups. Among the first group, screen positive women (n = 28) were examined by two gynecologists. In the second group (n = 202), health care workers screened women in a mobile van. The two groups were examined using the smartphone and digital colposcope. Abnormal findings were confirmed by liquid-based cytology and histopathology. The image quality of ColpPhon® was compared with colposcopic images as the gold standard. Kappa was used for comparison of ColpPhon® and colposcopic findings for final diagnosis. Results Among the 230 women screened, cervical intraepithelial neoplasia (CIN) was diagnosed in six cases by histopathology (CIN 2/3 in five and CIN 1 in one). These six women belonged to the group of 28 women examined in the colposcopy clinic. Both colposcope and ColpPhon® were able to identify these six women. The individual image quality parameters for ColpPhon® were slightly inferior to the colposcope. The overall image clarity had an agreement in 82% (184/225) as being either good or excellent. The diagnosis made on images acquired from each device had an agreement in 90% (208/230) of the cases. Conclusion This study demonstrates feasibility of incorporating a smartphone device to capture images of the cervix for improving cervical cancer screening in resource-poor countries. How to cite this article Bagga R, Suri V, Srinivasan R, Khandelwal N, Keswarpu P, Naik SK, Chandrasekhar V, Gupta L, Paul S. Feasibility of Using Mobile Smartphone Camera as an Imaging Device for Screening of Cervical Cancer in a Lowresource Setting. J Postgrad Med Edu Res 2016;50(2):69-74.

HPV detection-based cervical cancer screening program in low-resource setting: lessons learnt from a community-based demonstration project in India.

A demonstration project was conducted to assess feasibility of implementing HPV detection-based cervical cancer screening in primary care settings in India and to generate local evidence on feasibility and effectiveness of HPV detection in primary screening. The project was implemented by setting up screening clinics at primary health centers. Eligible women were screened by HPV DNA test (Hybrid capture 2). All samples were processed and tested in a single laboratory. Colposcopy services were provided to screen-positive women at the same community clinics. Project utilized services of community health workers for community mobilization, recall of screen-positive and disease-positive women. Women with ≥CIN2 diagnosis were treated at tertiary hospital. Totally, 44,110 women were screened and HPV positivity was 4.7 %. Compliance to recall of HC2-positive women for colposcopy was 78 %. Detection rate of CIN3+ by HPV test was 3.9/1,000 women. Compliance of women to treatment was 80.1 %. However, compliance of HPV-positive women for follow-up at 1 year was poor (23.2 %). Concurrent use of VIA to screen the women did not have any advantage but increased number of unnecessary colposcopies and biopsies. Our project demonstrated that it was possible to implement HPV detection-based screening using existing primary healthcare infrastructure. Performing colposcopy at primary setting is feasible, improves compliance and reduces over-treatment. In settings with low to moderately high HPV prevalence, direct referral of HPV-positive women is advisable. Community health workers can be effectively used for recalling the positive women.

Three-year longitudinal data on the clinical performance of the Abbott RealTime High Risk HPV test in a cervical cancer screening setting

BackgroundTesting cervical smears for the presence of high-risk human papillomaviruses (hrHPV) increases the sensitivity for detecting women with underlying high-grade cervical intraepithelial neoplasia (CIN) and provides better and longer protection against invasive cervical cancer compared to cytology testing alone. The Abbott RealTime High Risk HPV test (RealTime) is a hrHPV DNA test with concurrent partial genotyping for HPV16 and HPV18 and aggregate detection of 12 other hrHPV types that have been extensively analytically and clinically evaluated over the last 6 years. Objectives and study designTo provide the first 3-year longitudinal data regarding the clinical performance of RealTime, the risk of CIN2+ according to various negative baseline characteristics, and baseline and future risk for CIN2+ at 3 years for women with baseline infection with various hrHPV types were assessed in a cohort of 3,920 Slovenian women that had hrHPV DNA and/or cytology in 36- to 48-month follow-up results after a baseline screening round in 2009/2010. ResultsA total of 36 CIN2+ cases were identified in the second screening round. Of these, 17 CIN2+ cases were identified passively through questionnaires/data registries and 19 cases actively as the result of actions triggered by second-round cytology and/or HPV test results. Accumulation of CIN2+ cases during follow-up occurred predominantly in woman with normal cytology at baseline. Among women >30 years old, significantly better protection against CIN2+ at 3 years was associated with a negative hrHPV DNA result at baseline (risk for CIN2+ 0.04% [95 CI, 0.00–0.22%]) than by normal cytology at baseline (risk for CIN2+ 0.68% [95 CI, 0.40–1.08%]). Women with baseline HPV16 infection had a significantly higher risk of CIN2+ at baseline (21.9% [95 CI, 15.2–30.4%]) and baseline plus future risk at 3 years for CIN2+ (33.3% [95 CI, 24.7–44.0%]) in comparison to women with baseline non-HPV16/18 hrHPV infection (7.0% [95 CI, 4.6–10.2%]) or those that were hrHPV-positive (11.7% [95 CI, 9.1–14.9%]). Conclusions3-year longitudinal data reinforce evidence from previous studies that RealTime can be safely used in primary HPV-based cervical cancer screening. Concurrent partial genotyping for HPV16/18 should be strongly considered as a triage method for HPV screen-positive women.

Effectiveness of novel, lower cost molecular human papillomavirus-based tests for cervical cancer screening in rural china.

This study examined the efficacy of the OncoE6™ Cervical Test, careHPV™ and visual inspection with acetic acid (VIA) in identifying women at risk for cervical cancer and their capability to detect incident cervical precancer and cancer at 1-year follow-up. In a population of 7,543 women living in rural China, women provided a self-collected and two clinician-collected specimens and underwent VIA. All screen positive women for any of the tests, a ∼ 10% random sample of test-negative women that underwent colposcopy at baseline, and an additional ∼ 10% random sample of test-negative women who did not undergo colposcopy at baseline (n = 3,290) were recruited. 2,904 women were rescreened 1 year later using the same tests, colposcopic referral criteria, and procedures. Sensitivities of baseline tests to detect 1-year cumulative cervical intraepithelial neoplasia Grade 3 or cancer (CIN3+) were 96.5% and 81.6% for careHPV™ on clinician-collected and self-collected specimens, respectively, and 54.4% for OncoE6™ test. The OncoE6™ test was very specific (99.1%) and had the greatest positive predictive value (PPV; 47.7%) for CIN3+. Baseline and 1-year follow-up cervical specimens testing HPV DNA positive was sensitive (88.0%) but poorly predictive (5.5-6.0%) of incident CIN2+, whereas testing repeat HPV16, 18 and 45 E6 positive identified only 24.0% of incident CIN2+ but had a predictive value of 33.3%. This study highlights the different utility of HPV DNA and E6 tests, the former as a screening and the latter as a diagnostic test, for detection of cervical precancer and cancer.