scholarly journals Feasibility, Acceptability, and Efficacy of a Community Health Worker–Driven Approach to Screen Hard-to-Reach Periurban Women Using Self-Sampled HPV Detection Test in India

2020 ◽  
pp. 658-666
Author(s):  
Usha Rani Poli ◽  
Richard Muwonge ◽  
Triveni Bhoopal ◽  
Eric Lucas ◽  
Partha Basu

PURPOSE Detection of high-risk human papillomavirus (HPV) in self-collected vaginal samples can significantly improve participation of hard-to-reach women; however, the implementation of such an approach in a real-life setting, especially in countries with limited resources, has certain challenges. Our study aimed to evaluate the feasibility, acceptability, and efficacy of implementing an HPV self-sampling–based approach to screen a socioeconomically disadvantaged, unscreened population with support from community health workers (CHWs) for community mobilization, counseling, and navigation. Different triaging options for HPV-positive women were also assessed. METHODS Women age 30 to 65 years from low socioeconomic periurban areas who had never been screened before were motivated by CHWs to attend local community centers and provide self-collected vaginal samples for careHPV testing. Screen-positive women were informed and navigated by CHWs to attend colposcopy clinics where cervical biopsy and same-day ablative treatment were offered. RESULTS Women readily accepted to provide self-collected samples after counseling by CHWs. Screen positivity was 6.4%, and CHWs successfully navigated 65% of HPV-positive women to colposcopy. Cervical intraepithelial neoplasia (CIN) 2+ detection rate was 9.7 per 1,000 women screened. The HPV test had a positive predictive value of 15.3% to detect CIN 2+ lesions. Triage using visual inspection with acetic acid significantly improved the positive predictive value (49.5% to detect CIN 2+), but missed a significant number of CIN 2+ lesions. Colposcopy sensitivity was also suboptimal. Of 51 women with lesions, 80% underwent ablative treatment and the majority accepted same-day treatment. CONCLUSION CHW-driven self-sampling for HPV testing is feasible, well-accepted, and effective for screening unscreened hard-to-reach women. The screen-and-treat approach can ensure strong linkage between screening and treatment.

2020 ◽  
Vol 27 (4) ◽  
pp. 207-214
Author(s):  
Luigi Pasquale ◽  
Paolo G Rossi ◽  
Francesca Carozzi ◽  
Serena Domenighini ◽  
Cristina Ruggeri ◽  
...  

Objective To present performance indicators from the second round of the Vallecamonica-Sebino HPV screening programme in women who had tested negative about four years earlier (mean 45 months). Methods From 2010 to 2012, the target female population (aged 25–64) was invited to the first HPV screening round. In 2013–2017, women were rescreened for the second round. HPV-negative women at the first round were initially rescreened after three years. The interval was gradually increased to five years. HPV-positive women underwent cytology triage: positives were referred to colposcopy and negatives to repeat testing after one year. If HPV was persistently positive, women were referred to colposcopy, if negative, to normal interval rescreening. Results In the second round, of 13,824 previously HPV-negative women, 598 were HPV-positive (4.3%), of whom 297 were positive at cytology triage. Of those referred to one-year HPV test, 291 complied (98.0%), 133 (50.2%) of whom were persistently positive. Total referral was 3.1% compared with 6.6% in the first round (age-adjusted relative referral 0.59, 95% CI: 0.53–0.65). There were 24 cervical intraepithelial neoplasia 2+ (three cervical intraepithelial neoplasia 3+). Detection was 0.17%, compared with 0.9% in the first round. Age-adjusted relative detections were 0.25 (95% CI: 0.16–0.39) and 0.18 (95% CI: 0.05–0.61) for cervical intraepithelial neoplasia 2+ and cervical intraepithelial neoplasia 3+, respectively. Positive predictive value was 5.7%, compared with 14.6% in the first round. Conclusions At second round, referral was half that at first round, while cervical intraepithelial neoplasia 2+ detection decreased nine-fold. Consequently, positive predictive value decreased dramatically. Rescreening four years after an HPV-negative test makes the process inefficient due to the low prevalence of lesions.


2017 ◽  
Vol 61 (6) ◽  
pp. 425-433 ◽  
Author(s):  
Larissa de Melo Kuil ◽  
Adriana Tarla Lorenzi ◽  
Maíra Degiovani Stein ◽  
Júlio César Possati Resende ◽  
Márcio Antoniazzi ◽  
...  

Objective: To compare the results of cervical cytology and high-risk HPV tests using samples obtained using two different collection modalities in a population of Brazilian women: self-collection (vaginal lavage) and cervical Pap testing. Methods: We enrolled 204 women who were aged 18-64 years and had previously obtained abnormal cervical cytology test results; 83.8% of them agreed to participate. The sample was divided into two aliquots: one for the cytological study and one for the molecular analysis of high-risk HPV. Results: Fifty-eight percent of the participants preferred to utilize self-collection as an alternative screening method. However, we noticed that the HPV positivity rate was significantly lower in self-collected samples when compared to those obtained using the conventional collection method (p = 0.035). The cytology tests of the samples obtained via self-collection were sensitive and had a positive predictive value and an area under the curve (AUC) that were significantly lower than those of the Pap test. However, the specificity and negative predictive value of these tests were similar. When compared with the HPV test, the self-collected samples demonstrated lower accuracy in predicting high-grade cervical intraepithelial neoplasia or worse, with a significantly lower sensitivity, positive predictive value, and AUC than the cervical Pap test samples. Conclusion: Self-collection by vaginal lavage is simple and well accepted by women. Due to its limitations, however, self-collection by lavage should be utilized with caution.


PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257474
Author(s):  
Omar Vesga ◽  
Maria Agudelo ◽  
Andrés F. Valencia-Jaramillo ◽  
Alejandro Mira-Montoya ◽  
Felipe Ossa-Ospina ◽  
...  

Timely and accurate diagnostics are essential to fight the COVID-19 pandemic, but no test satisfies both conditions. Dogs can scent-identify the unique odors of volatile organic compounds generated during infection by interrogating specimens or, ideally, the body of a patient. After training 6 dogs to detect SARS-CoV-2 by scent in human respiratory secretions (in vitro diagnosis), we retrained 5 of them to search and find the infection by scenting the patient directly (in vivo screening). Then, efficacy trials were designed to compare the diagnostic performance of the dogs against that of the rRT-PCR in 848 human subjects: 269 hospitalized patients (COVID-19 prevalence 30.1%), 259 hospital staff (prevalence 2.7%), and 320 government employees (prevalence 1.25%). The limit of detection in vitro was lower than 10−12 copies ssRNA/mL. During in vivo efficacy experiments, our 5 dogs detected 92 COVID-19 positive patients among the 848 study subjects. The alert (lying down) was immediate, with 95.2% accuracy and high sensitivity (95.9%; 95% C.I. 93.6–97.4), specificity (95.1%; 94.4–95.8), positive predictive value (69.7%; 65.9–73.2), and negative predictive value (99.5%; 99.2–99.7) in relation to rRT-PCR. Seventy-five days after finishing in vivo efficacy experiments, a real-life study (in vivo effectiveness) was executed among the riders of the Metro System of Medellin, deploying the human-canine teams without previous training or announcement. Three dogs were used to examine the scent of 550 volunteers who agreed to participate, both in test with canines and in rRT-PCR testing. Negative predictive value remained at 99.0% (95% C.I. 98.3–99.4), but positive predictive value dropped to 28.2% (95% C.I. 21.1–36.7). Canine scent-detection in vivo is a highly accurate screening test for COVID-19, and it detects more than 99% of infected individuals independent of key variables, such as disease prevalence, time post-exposure, or presence of symptoms. Additional training is required to teach the dogs to ignore odoriferous contamination under real-life conditions.


2019 ◽  
Vol 63 (5) ◽  
pp. 379-384
Author(s):  
Bernhard Reinhold Mangold

Objective: In order to increase overall participation in cervical cancer screening, several investigators propose a concept of introducing self-tests. The study presented here compared test results of the Pap test and 4 different HPV test systems of self-collected and physician-collected vaginal specimens. Study Design: 208 patients of a colposcopy clinic had physician-taken and self-taken vaginal samples. All cell samples enabled a liquid-based Pap test and testing for carcinogenic HPV genotypes. In addition, all patients had a colposcopy with or without cervical biopsy and/or conisation. Results: 99 patients had the histological diagnosis of CIN2+. The HPV test sensitivity of self-collected samples differed significantly in this patient group depending on the test system performed. The sensitivity of the self-collected Pap test was significantly lower than HPV testing, but the positive predictive value of the Pap self-test was very high. Conclusion: The results of this study indicate that under the circumstances of self-testing HPV test systems differ in test sensitivity and specificity. Self-collected Pap tests can provide a test result with a very high positive predictive value and introduce therapeutic strategies. In order to improve screening strategies, it could be an opportunity to combine HPV and Pap tests in self-taken vaginal samples, especially in countries with a low income level. In countries with a good medical infrastructure, self-testing has to be introduced with caution.


2021 ◽  
pp. 096914132199282
Author(s):  
A Mongia ◽  
G Pompeo ◽  
C Sani ◽  
E Burroni ◽  
G Fantacci ◽  
...  

Objective To compare, in a primary human papillomavirus screening setting, two different validated human papillomavirus tests, considering their analytical and clinical screening performances. Methods In Tuscany, a human papillomavirus screening program was implemented in 2013. Hybrid capture 2 (Qiagen) was used for testing until May 2016, when it was replaced by the cobas® 4800 human papillomavirus test (Cobas; Roche). We evaluated the performance of Hybrid capture 2 and Cobas on: the same screening population in two different periods (before and after changing to Cobas); the same Hybrid capture 2-positive consecutive samples. Discordant samples (Hybrid capture 2-positive/Cobas negative) were typed on the L1 gene (reverse line blot, AB Analitica) and E6/E7 genes (BD Onclarity assay). Results In the considered time period ( n = 37,775), human papillomavirus positivity was 9.8% and 7.4%, respectively, for Hybrid capture 2 and Cobas ( p < 0.0001). At immediate colposcopy, the cervical intraepithelial neoplasia, grade 2 positive predictive value was, respectively, 23.8% and 34% ( p < 0.001). At one-year recall, human papillomavirus persistence was, respectively, 40.6% and 62.2% ( p < 0.0001). Of Hybrid capture 2-positive re-tested samples ( n = 620), 32.4% were Cobas negative. Of discordant samples typed on L1, 7% were positive for the 12 high-risk human papillomavirus. Of the samples found to be negative for the 12 high-risk human papillomavirus types on L1, 14.5% were positive on E6/E7 typing. Among the discordant samples, the only two cervical intraepithelial neoplasia (CIN) grade 3 lesions were non-high-risk human papillomavirus positive on both L1 and E6/E7 typing. Conclusion At baseline, Hybrid capture 2 showed greater human papillomavirus positivity and a lower CIN2+ positive predictive value than Cobas, which was more specific than Hybrid capture 2 in detection of high-risk human papillomavirus: 80% of discordant samples were confirmed as high-risk human papillomavirus negative. This higher analytical specificity determined the non-identification of two CIN3 lesions.


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e046195
Author(s):  
Mohammad Mostafa Zaman ◽  
Mohammad Moniruzzaman ◽  
Kamrun Nahar Chowdhury ◽  
Salma Zareen ◽  
AHM Enayet Hossain

ObjectiveThe aim of this study was to estimate 10-year cardiovascular disease (CVD) risk among Bangladeshi rural community residents, using the 2014 WHO/International Society of Hypertension (WHO/ISH) risk prediction charts.Study designCross-sectional population-based study done by local community healthcare workers engaging the lowest level facilities of the primary healthcare system.Setting and participantsA total of 1545 rural adults aged ≥40 years of Debhata upazila of Satkhira district of Bangladesh participated in this survey done in 2015. The community health workers collected data on age, smoking, blood pressure, blood glucose and treatment history of diabetes and hypertension.Primary outcome measuresWe estimated total 10-year CVD risk using the WHO/ISH South East Asia Region-D charts without cholesterol and categorised the risk into low (<10%), moderate (10%–19.9%), high (20%–29.9%) and very high (≥30%).ResultsThe participants’ mean age (±SD) was 53.9±11.6 years. Overall, the 10-year CVD risks (%, 95% CI) were as follows: low risk (81.6%, 95% CI 78.4% to 84.6%), moderate risk (9.9%, 95% CI 7.4% to 12.1%), high risk (5.8%, 95% CI 4.4% to 7.2%) and very high risk (2.8%, 95% CI 1.5% to 4.1%). In women, moderate to very high risks were higher (moderate 12.1%, high 6.1% and very high 3.7%) compared with men (moderate 7.5%, high 5.5% and very high 1.9%) but none of these were statistically significant. The age-standardised prevalence of very high risk increased from 2.9% (0.7%–5.2%) to 8.5% (5%–12%) when those with anti-hypertensive medication having controlled blood pressure (<140/90 mm Hg) added.ConclusionThe very high-risk estimates could be used for planning resource for CVD prevention programme at upazila level. There is a need for a national level study, covering diversities of rural areas, to contribute to national planning of CVD prevention.


2020 ◽  
Author(s):  
Linghua Kong ◽  
Xiaoping Xiao ◽  
Huiping Lou ◽  
Pengfei Liu ◽  
Shuhui Song ◽  
...  

Abstract Background: Cervical cancer is the second-most common gynecological cancer, early screening plays a key role in the diagnosis and treatment of cervical intraepithelial neoplasia (CIN). Sustained E7 protein expression is the pathological basis for CIN and cervical cancer. Methods: We collected the cervical cell samples of 205 women who visited the gynecological clinic of Peking Union Medical College Hospital between September 2018 and September 2019 and submitted them to the high-risk human papillomavirus (Hr-HPV) test. We performed a magnetic particle–based chemiluminescence enzyme immunoassay to analyze the Hr-HPV16/18 E7 protein level in CIN of different severities and compared the results with those of cervical pathology (gold standard) and the Hr-HPV test. Results: The positive rate of Hr-HPV16/18 E7 protein increased with the severity of CIN: 26.55% in normal tissue, 58.33% in CIN1, and 70.59% in CIN2/CIN3. For CIN2 and above, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the E7 protein were 70.59%, 67.88%, 52.17%, and 82.30%, respectively. These values of the Hr-HPV test were 86.76%, 44.53%, 43.70%, and 87.14%, respectively. With the combination of the E7 protein assay and Hr-HPV test, the specificity for diagnosing CIN2 and above was 78.10%, which was significantly higher than that of the Hr-HPV test alone. Conclusions: Hr-HPV16/18 E7 protein level is correlated with the severity of CIN and has a high concordance rate with the pathological result. For cervical cancer screening, the combination of HPV16/18 E7 protein assay and Hr-HPV test improves the CIN diagnostic specificity, detection rate, and detection accuracy.


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