Test characteristics of visual inspection with 4% acetic acid (VIA) and Lugol's iodine (VILI) in cervical cancer screening in Kerala,India

Simple and inexpensive methods based on visual examination of the cervix are currently being investigated as alternative methods of cervical screening. The test characteristics of visual inspection with 4% acetic acid (VIA), and Lugol's iodine (VILI) and conventional cytology were investigated in a cross-sectional study involving 4,444 women aged 25 to 65 years in Kerala, India. While detection of any acetowhite area constituted a low-threshold positive VIA, detection of well-defined, opaque acetowhite lesions close to or touching the squamocolumnar junction constituted a high-threshold positive VIA test. Detection of definite yellow iodine nonuptake areas in the transformation zone close to or touching the squamocolumnar junction constituted a positive VILI test. Cytology was considered positive if reported as atypia or worse lesions. All screened women were evaluated by colposcopy and biopsies were directed in 1,644 women (37.0%), which allowed the direct estimation of sensitivity, specificity and predictive values. The reference diagnosis was based on a combination of histology and/or colposcopy. True disease status was defined as CIN 2 and worse lesions. A total of 149 (3.4%) women had CIN 2 or worse lesions. The sensitivities of low-threshold VIA, high-threshold VIA, VILI and cytology to detect CIN 2 or worse disease were 88.6%, 82.6%, 87.2% and 81.9%, respectively; the corresponding specificities were 78.0%, 86.5%, 84.7% and 87.8%. Our results indicate that VIA and VILI are suitable alternate screening tests to cytology for detecting cervical neoplasia in low-resource settings.     

Effectiveness, safety and acceptability of 'see and treat' with cryotherapy by nurses in a cervical screening study in India

We evaluated a 'see and treat' procedure involving screening, colposcopy, biopsy and cryotherapy by trained nurses in one-visit in field clinics in a cervical screening study in South India for its acceptability, safety and effectiveness in curing cervical intraepithelial neoplasia (CIN). Women positive on visual inspection with acetic acid (VIA) were advised colposcopy, directed biopsies and cryotherapy if they had colposcopic impression of CIN in one visit by nurses in field clinics supervised by a doctor. Side effects and complications were assessed and cure rates were evaluated with VIA, colposcopy and biopsy if colposcopic abnormalities were suspected. Cure was defined as no clinical or histological evidence of CIN at > or =6 months from treatment. Of the 2513 women offered 'see and treat' procedure, 1879 (74.8%) accepted. Of the 1397 women with histologically proved CIN treated with cryotherapy, 1026 reported for follow-up evaluation. Cure rates were 81.4% (752 out of 924) for women with CIN 1; 71.4% (55 out of 77) for CIN 2 and 68.0% (17 out of 25) for CIN 3. Minor side effects and complications were documented in less than 3% of women. 'See and treat' with cryotherapy by nurses under medical supervision is acceptable, safe and effective for cervical cancer prevention in low-resource settings.     

Screen‐and‐Treat Approach to Cervical Cancer Prevention Using Visual Inspection With Acetic Acid and Cryotherapy: Experiences,Perceptions, and Beliefs From Demonstration Projects in Peru,Uganda, and Vietnam

Cervical cancer is preventable but continues to cause the deaths of more than 270,000 women worldwide each year, most of them in developing countries where programs to detect and treat precancerous lesions are not affordable or available. Studies have demonstrated that screening by visual inspection of the cervix using acetic acid (VIA) is a simple, affordable, and sensitive test that can identify precancerous changes of the cervix so that treatment such as cryotherapy can be provided. Government partners implemented screening and treatment using VIA and cryotherapy at demonstration sites in Peru, Uganda, and Vietnam. Evaluations were conducted in the three countries to explore the barriers and facilitating factors for the use of services and for incorporation of screen‐and‐treat programs using VIA and cryotherapy into routine services. Results showed that use of VIA and cryotherapy in these settings is a feasible approach to providing cervical cancer prevention services. Activities that can help ensure successful programs include mobilizing and educating communities, organizing services to meet women's schedules and needs, and strengthening systems to track clients for follow‐up. Sustainability also depends on having an adequate number of trained providers and reducing staff turnover. Although some challenges were found across all sites, others varied from country to country, suggesting that careful assessments before beginning new secondary prevention programs will optimize the probability of success.     

Performance of a low cost magnifying device,magnivisualizer, versus colposcope for detection of pre-cancer and cancerous lesions of uterine cervix

Objective

To assess the performance of a low cost magnifying device (Magnivisualizer) compared to a standard optical colposcope for detection of precancerous and cancerous lesions of the uterine cervix.

Methods

A total of 659 consecutive symptomatic women attending a gynecologic outpatient clinic underwent unaided visual inspection followed by cytology, visual inspection of the cervix using 5% acetic acid (VIA), and VIA under magnification (VIAM) with the Magnivisualizer. All women, independently of test results, were referred for colposcopic examination. Colposcopic-directed biopsies were obtained from all positive lesions and compared to positive VIAM cases.

Results

The detection rate for VIA positive lesions was 12% (134/659), while it was 29% for VIAM positive lesions (191/659). The sensitivities of detection of cervical intraepithelial neoplasia (CIN) 2 and higher lesions were 61.7% for VIA, 88.3% for VIAM, and 86.7% for colposcopy, with a specificity of 58.5% for VIA, 55.8% for VIAM, and 90.4% for colposcopy. The performance of colposcopy and VIAM was moderate (κ, 0.48; 95% confidence interval [CI], 0.41 to 0.54) for detection of CIN 1 and higher lesions and excellent (κ, 0.87; 95% CI, 0.82 to 0.94) for detection of CIN 2 and higher lesions.

Conclusion

In low resource settings, where colposcopic facilities are not available at the community level, a simple low-cost, handheld Magnivisualizer can be considered a valid option for detection of cervical precancerous and cancerous lesions. However, it cannot replace traditional colposcopy because it has a low specificity that results in many unnecessary biopsies.     

Accuracy of Visual Inspection with Acetic Acid (VIA) for Early Detection of Cervical Dysplasia in Tehran,Iran

Objective: To evaluate the accuracy of visual inspection with 5% acetic acid (VIA) when used to detect cervical ‍cancer and its precursors. ‍Methods: The study population included women attended Family Planning and Gynecological Clinic in Bagher ‍Abad Health Center and Mirza Koochak Khan Hospital for regular cervical screening tests. After obtaining informed ‍consent from each woman, VIA was performed. One hundred with a positive VIA test and 100 women with a ‍negative VIA test were randomly selected for this study. Cytology and colposcopy examination were performed for ‍all 200 cases and cervical biopsies were conducted for those individuals showing abnormal colposcopic findings. ‍Results: Nine cases in VIA-positive group and two cases in VIA-negative group had an abnormal cytology. Ninety ‍five women in the VIA-positive group and 25 in the VIA-negative group had abnormal colposcopic findings. From ‍biopsy examination, 67 (71%) of cases in the VIA-positive group and 3 (12%) cases in the VIA-negative group had ‍a final diagnosis of dysplasia. Among biopsied samples, only 7 cases of VIA-positive group showed abnormal result ‍and the remaining were normal. Based on these results, VIA test sensitivity and specificity were 95.7% and 44.0% ‍respectively, while they were 10% and 92% for cytology tests. ‍Conclusions: The results of this study indicate that although VIA is a sensitive screening test for detection of ‍cervical dysplasia, it can not be used by itself. Applying VIA along with Pap smears helps to detect a higher number ‍of cases with cancer precursor lesions.     

Single-visit approach of cervical cancer screening: See and Treat in Indonesia

Background:

We performed a cross-sectional study in Indonesia to evaluate the performance of a single-visit approach of cervical cancer screening, using visual inspection with acetic acid (VIA), histology and cryotherapy in low-resource settings.

Methods:

Women having limited access to health-care facilities were screened by trained doctors using VIA. If the test was positive, biopsies were taken and when eligible, women were directly treated with cryotherapy. Follow-up was performed with VIA and cytology after 6 months. When cervical cancer was suspected or diagnosed, women were referred. The positivity rate, positive predictive value (PPV) and approximate specificity of the VIA test were calculated. The detection rate for cervical lesions was given.

Results:

Screening results were completed in 22 040 women, of whom 92.7% had never been screened. Visual inspection with acetic acid was positive in 4.4%. The PPV of VIA to detect CIN I or greater and CIN II or greater was 58.7% and 29.7%, respectively. The approximate specificity was 98.1%, and the detection rate for CIN I or greater was 2.6%.

Conclusion:

The single-visit approach cervical cancer screening performed well, showing See and Treat is a promising way to reduce cervical cancer in Indonesia.     

A cluster randomized controlled trial of visual, cytology and human papillomavirus screening for cancer of the cervix in rural India

The impact of screening by visual inspection with acetic acid (VIA), cytology or HPV testing on cervical cancer incidence and mortality is investigated in a cluster randomized controlled trial in India. We report findings after the screening phase, when 52 clusters, with a total of 142,701 women aged 30-59 years in Osmanabad District, India, were randomized into 4 arms for a single round of screening by trained midwives with either VIA, cytology or HPV testing as well as a control group. All laboratory tests were done locally. Test-positive women underwent investigations (colposcopy/biopsy) and treatment in the base hospital. Data on participation, test positivity, positive predictive value and detection rates of cervical neoplasia were analyzed using cluster design methodology. Of the eligible women, 72-74% were screened. Test positivity rates were 14.0% for VIA, 7.0% for cytology and 10.3% for HPV. The detection rate of high-grade lesions was similar in all intervention arms (0.7% for VIA, 1.0% for cytology and 0.9% for HPV testing) (p = 0.06, Mann-Whitney test). While the detection rate for VIA dropped to 0.5% with declining test positivity during the course of the study, it remained constant for cytology and HPV testing. Over 85% of women with high-grade lesions received treatment. Our results show that a high level of participation and good-quality cytology can be achieved in low-resource settings. VIA is a useful alternative but requires careful monitoring. Detection rates obtained by HPV testing were similar to cytology, despite higher investments.     

Cervical screening by visual inspection, HPV testing, liquid-based and conventional cytology in Amazonian Peru

Cervical cancer is an important public health problem in many developing countries, where cytology screening has been ineffective. We compared four tests to identify the most appropriate for screening in countries with limited resources. Nineteen midwives screened 5,435 women with visual inspection (VIA) and collected cervical samples for HPV testing, liquid-based cytology (LBC) and conventional cytology (CC). If VIA was positive, a doctor performed magnified VIA. CC was read locally, LBC was read in Lima and HPV testing was done in London. Women with a positive screening test were offered colposcopy or cryotherapy (with biopsy). Inadequacy rates were 5% and 11% for LBC and CC respectively, and less than 0.1% for VIA and HPV. One thousand eight hundred eighty-one women (84% of 2,236) accepted colposcopy/cryotherapy: 79 had carcinoma in situ or cancer (CIS+), 27 had severe- and 42 moderate-dysplasia on histology. We estimated a further 6.5 cases of CIS+ in women without a biopsy. Sensitivity for CIS+ (specificity for less than moderate dysplasia) was 41.2% (76.7%) for VIA, 95.8% (89.3%) for HPV, 80.3% (83.7%) for LBC, and 42.5% (98.7%) for CC. Sensitivities for moderate dysplasia or worse were better for VIA (54.9%) and less favourable for HPV and cytology. In this setting, VIA and CC missed the majority of high-grade disease. Overall, HPV testing performed best. VIA gives immediate results, but will require investment in regular training and supervision. Further work is needed to determine whether screened-positive women should all be treated or triaged with a more specific test.     

Accuracy of visual inspection with acetic acid to detect cervical cancer precursors among HIV‐infected women in Kenya

Visual inspection with acetic acid (VIA) is becoming a more widely recommended and implemented screening tool for cervical cancer prevention programs in low‐resource settings. Many of these settings have a high prevalence of HIV‐infected women. We carried out a cross‐sectional validation study to define the sensitivity, specificity and predictive values of VIA among HIV‐infected women. Women enrolled in HIV care at the Family AIDS Care and Education Services clinic in Kisumu, Kenya, were recruited for participation. All participants underwent VIA followed by colposcopy performed by a second blinded clinician. At colposcopy, lesions suspicious for cervical intraepithelial neoplasia 2 or greater (CIN2+) were biopsied. Disease status was determined by final histopathologic diagnosis in women who underwent biopsies. A satisfactory colposcopy with no lesions was considered a negative result. From October 2010 to June 2012, 1,432 women underwent VIA and colposcopy. A total of 514 (35.7%) women had a positive VIA, and 179 (12.2%) had CIN2+ confirmed by colposcopically directed biopsy. Sensitivity, specificity, positive and negative predictive values of VIA for CIN2+ were 86.6, 71.6, 30.3 and 97.4%, respectively. Specificity, but not sensitivity, increased with older age. Among older women, sensitivity was affected by CD4+ count and use of antiretroviral therapy. Although they are impacted by age and immune status, test characteristics for VIA among HIV‐infected women are similar to what has been reported for general populations. Recommendations to use VIA as a screening tool should not vary by HIV status.     

Comparison of visual inspection with acetic acid and cervical cytology to detect high-grade cervical neoplasia among HIV-infected women in India

Human immunodeficiency virus (HIV)-infected women in India and other developing country settings are living longer on antiretroviral therapy, yet their risk for human papillomavirus (HPV)-induced cervical cancer remains unabated because of lack of cost-effective and accurate secondary prevention methods. Visual inspection after application of dilute acetic acid on the cervix (VIA) has not been adequately studied against the current standard: conventional cervical cytology (Pap smears) among HIV-infected women. We evaluated 303 nonpregnant HIV-infected women in Pune, India, by simultaneous and independent screening with VIA and cervical cytology with disease ascertainment by colposcopy and histopathology. At the cervical intraepithelial neoplasia (CIN2+) disease threshold, the sensitivity, specificity and positive and negative predictive value estimates of VIA were 80, 82.6, 47.6 and 95.4% respectively, compared to 60.5, 59.6, 22.4 and 88.7% for the atypical squamous cells of undetermined significance or severe (ASCUS+) cutoff on cytology, 60.5, 64.6, 24.8 and 89.4% for the low-grade squamous intraepithelial cells or severe (LSIL+) cutoff on cytology and 20.9, 96.0, 50.0 and 86.3% for high-grade squamous intraepithelial lesion or severe (HSIL+) cutoff on cytology. A similar pattern of results was found for women with the presence of carcinogenic HPV-positive CIN2+ disease, as well as for women with CD4+ cell counts <200 and <350 μL(-1) . Overall, VIA performed better than cytology in this study with biologically rigorous endpoints and without verification bias, suggesting that VIA is a practical and useful alternative or adjunctive screening test for HIV-infected women. Implementing VIA-based screening within HIV/acquired immunodeficiency syndrome care programs may provide an easy and practical means of complementing the highly anticipated low-cost HPV-based rapid screening tests in the near future, thereby contributing to improve program effectiveness of screening.     

Initial results from a randomized trial of cervical visual screening in rural south India

The impact of a single round of screening of visual inspection with acetic acid (VIA) on cervical cancer incidence and mortality was investigated in a cluster randomized trial in south India. Women 30-59 years of age in 113 clusters in Dindigul District were randomized to VIA screening (57 clusters, 48,225 women) by nurses and to a control group (56 clusters, 30,167 women). 30,577 eligible women were screened between May 2000 and April 2003; 2,939 (9.6%) screen-positive women were investigated with colposcopy by nurses and 2,777 (9.1%) women had biopsy. CIN 1 was diagnosed in 1,778 women, CIN 2-3 lesions were found in 222, and there were 69 screen detected invasive cervical cancers. The detection rates of lesions per 1,000 screened women were 58.2 for CIN 1, 7.3 for CIN 2-3, and 2.3 for invasive cancer. The detection rate of high-grade lesions in our study was 2-3-fold higher than those observed in repeatedly screened populations in developed countries. 71% of women with CIN 1 and 80% of those with CIN 2-3 lesions accepted cryotherapy provided by nurses and surgical treatment by mid-level clinicians. Overall, 97 and 34 incident cervical cancer cases were observed in the intervention and control arms, respectively. The intervention arm accrued 124,144 person years and the control arm accrued 90,172 during the study period. The age standardized cervical cancer incidence rates were 92.4/100,000 person-years in the intervention and 43.1/100,000 in the control arms. In the screened arm, 35.0% of cases were in Stage I as opposed to none in the control arm. The preliminary findings from our study indicate that not only is a VIA-based screening programme feasible, safe and acceptable to a population in rural settings, it also results in early detection of cervical neoplasia.     

山西省襄垣县2009~2015年农村女性宫颈癌筛查项目结果分析

[目的]通过分析襄垣县2009～2015年农村妇女宫颈癌筛查结果,为国家宫颈癌筛查项目的评价和优化提供理论依据.[方法]对襄垣县35～64岁妇女开展宫颈癌筛查.2009～2013年采用醋酸/碘染色后肉眼观察(VIA/VILI),2014年开始部分引入人乳头状瘤病毒(HPV)检测,2015年又引入新柏氏液基细胞学(TCT)检测,根据卫生资源情况在不同人群中分别使用三种方法.任意筛查结果阳性者转诊阴道镜,镜下有病变时取活检,以病理诊断为金标准.通过评价不同方法对宫颈上皮内瘤变(CIN)2级及以上病变的检出率评价不同方法对宫颈癌的筛查效果.[结果] 2009～2015年共筛查62 618名女性,其中CIN2级及以上(CIN2+)病变的患病率为0.76％,早诊率为90.53％,下生殖道感染率为25.68％,其中滴虫性阴道炎、细菌性阴道炎和宫颈炎与HPV感染相关.根据2014及2015年数据,VIA/VILI的CIN2+病变检出率为0.74％,TCT的病变检出率为0.70％,两者相似,但均低于HPV检测,其病变检出率为1.37％.[结论]HPV检测是首选的宫颈癌初筛方法,在资源匮乏地区,培训合格的基层医生使用VIA/VILI或TCT方法对适龄妇女开展宫颈癌筛查是有效的备选方案.     

Evidence-based screening, early diagnosis and treatment strategy of cervical cancer for national policy in low- resource countries: example of India

Cervical cancer remains the most frequent cancer in women from the developing world. More than 88% of deaths occur in low-income countries, and it is predicted to climb to 91.5% by 2030. Although Pap-based screening programmes have shown to be effective in reducing the disease burden in high-resource countries, implementation and sustention of cytology-based programmes is quite challenging in low-resource settings. The present paper reviews evidence-based alternatives of screening methods, triaging algorithm, treatment of cervical precancerous lesions, and age-group at screening appropriate for low-income countries. Evidence shows that visual inspection methods using diluted acid acetic or Lugol's iodine, and HPV-DNA testing are more sensitive tests than the Pap-smear screening test. Visual inspection allows an immediate result and, when appropriate, may be immediately followed by cryotherapy, the so called "screen-and-treat" approach, achieved in a single visit, by trained nurses and midwives. Examples of cervical cancer prevention programmes in India and selected low-income countries are given.     

Accuracy of concurrent visual and cytology screening in detecting cervical cancer precursors in rural India

The high burden of cervical cancer and inadequate/suboptimal cytology screening in developing countries led to the evaluation of visual screening tests, like visual inspection with acetic acid (VIA) and Lugol's iodine (VILI). We describe the performance of VIA, VILI and cytology, carried out in a multinational project called "Screening Technologies to Advance Rapid Testing" in 5,519 women aged 30-49 years, in detecting cervical intraepithelial neoplasia (CIN). VIA, VILI and cytology were positive in 16.9%, 15.6% and 6.1% women, respectively. We found 57 cases of CIN2, 55 of CIN3 and 12 of cervical cancer; 90% of CIN3 and 43% CIN2 cases were positive for p16 overexpression and high-risk HPV infection, indicating a high validity of histological diagnosis. The sensitivity of VIA, VILI and cytology to detect high-grade CIN were 64.5%, 64.5% and 67.7%, respectively; specificities were 84.2%, 85.5% and 95.4%. A high proportion of p16 positive CIN 3 (93.8%) and 2 (76.9%) were positive on cytology compared with visual tests (68.8% and 53.8%, respectively) indicating a higher sensitivity of cytology to detect p16 positive high-grade CIN. However, the immediate availability of the results from the visual tests permits diagnosis and/or treatment to be performed in the same sitting, which can potentially reduce loss to follow-up when women must be recalled following positive cytology. Organizing visual screening services in low-resource countries may facilitate the gradual building of an infrastructure committed to screening allowing the eventual introduction of more sensitive, highly objective, reproducible and affordable human papillomavirus screening tests in future.     

VIA-VILI结合电子阴道镜检随访筛查早期发现宫颈病变

目的 在宫颈癌高发区通过对高危人群实施跟踪随访筛查以达到宫颈癌早期诊断和早期治疗。方法 对目标人群的30~59岁适龄妇女应用醋染（VIA）和碘染（VILI）进行初筛,结合子阴道镜检和病理检查进而明确诊断。结果 2006~2007年共筛查5595人,随访检查3676人,最终病理诊断结果证实CIN Ⅰ189例,CIN Ⅱ25例,CIN Ⅲ/原位癌19例,宫颈浸润癌8例。结论 碘染、醋染作为宫颈癌的初筛方法其符合率分别为41.6%和64%,但结合阴道镜及镜下定位活检病理检查可大大提高宫颈癌癌前病变及早期宫颈癌的诊断率。     

Evaluation of cytology and visual triage of human papillomavirus‐positive women in cervical cancer prevention in India

Although virtually all cervical cancers and most cervical intraepithelial neoplasia (CIN) are caused by persistent human papillomavirus (HPV) infection, only a small proportion of HPV‐positive women have or will develop CIN. Triaging HPV‐positive women has been suggested to reduce the false‐positive rate and proportion of women referred for CIN confirmation and/or treatment. In two cross‐sectional studies and one randomized trial in India, we evaluated the impact of using cytology or visual inspection with acetic acid (VIA) to triage HPV‐positive women on the proportion of women who would be referred for CIN confirmation and on the detection rates of high‐grade CIN. We present the numbers of HPV test‐positive women found and the CIN detected among them. We further assess the proportions that would be referred for CIN confirmation with colposcopy/biopsy and CIN that would be detected if cytology triage or VIA triage were used. Using cytology triage at atypical squamous cells of undetermined significance threshold or VIA triage reduced referrals for colposcopy by about 62% and 59%, respectively (p‐value = 0.012), but missed around 16% and 18%, respectively, of the high‐grade CIN (p‐value = 0.539) indicating similar performance of both triaging approaches. The choice of a triage test in different low‐ and middle‐income countries (LMIC) would depend on the availability and affordability in the particular setting. Cytology triage may be considered in settings where adequate infrastructure exists, whereas VIA triage may be suitable in settings with limited or no cytology infrastructure.     

Comparison between Visual Inspection of Cervix and Cytology Based Screening Procedures in Bangladesh

Background: Cervical cancer continues to be a major problem in Bangladesh with approximately 18,000 newcases annually of which over 10,000 women die from it. Visual inspection of the cervix after 3-5% acetic acid(VIA) application is a simple and easy to learn method for cervical cancer screening, although cytology-basedscreening is more often applied in developed countries where it has successfully reduced the prevalence of cervicalcancer. Objective: To compare the efficacy of VIA and cytology-based primary methods for cervical cancerscreening in Bangladesh. Materials and Methods: This hospital based comparative study was conducted at theVIA centre and Colposcopy Clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU) from October2008 to October 2010. Results: Among 650 women, 74 (11.4%) were VIA+ve and 8 (1.2%) had abnormalitiesin their Pap smear reports. During colposcopy, 38 (7.7%) women had different grades of CIN and 4 (0.6%)had cervical cancer. The gold standard histology findings proved 20 women had CIN I, 14 had CIN II/II and 4had cervical cancer. Among the 38 histology diagnosed abnormalities, VIA test could identify 30 abnormalitiesincluding two cervical cancers. However, Pap smear could detect only 8 cases of histological abnormalities (2low grade and 6 had high grade lesion) and it missed all the cervical cancer cases. The sensitivity and specificityof VIA were 88.9% and 52.1%. The positive predictive value (PPV) and negative predictive value (NPV) were41.0%, and 92.6% respectively. Moreover, the sensitivity, specificity, PPV and NPV of Pap smear were 33.3%,95.8%, 75.0% and 79.3%, respectively. Conclusions: VIA test should be used as the primary screening tool evenwith its low sensitivity and specificity in low resource countries like Bangladesh. False positive results may begreater, but overtreatment can be minimized by colposcopy evaluation of the VIA positive women.     

A comparison of human papillomavirus testing of clinician-collected and self-collected samples during follow-up after screen-and-treat

Screen-and-treat cervical cancer prevention programs based on high-risk human papillomavirus (HPV) testing and cryotherapy have been shown to be effective in resource-limited settings. However, because cryotherapy is not 100% effective, follow-up is needed after treatment to detect post-treatment failures. We compared the test performances of high-risk HPV testing (Hybrid Capture 2) using self-collected and clinician-collected samples as well as cervical cytology for identifying cervical intraepithelial neoplasia grades 2 or 3 or invasive cervical cancer (CIN2+) among women who did (n=812) and did not (n=1858) undergo cryotherapy in a South African screen-and-treat trial. At 6 months after enrolment (and after cryotherapy, if performed), women were tested using all three screening methods and then underwent colposcopy/biopsy. A predefined subset of women (n=1,455) had extended follow-up with colposcopy/biopsy at 12 months. A total of 33 and 91 cases of CIN2+ were detected among treated and untreated women, respectively. The sensitivity of HPV testing using clinician-collected samples and cervical cytology did not differ by treatment status. HPV testing of clinician-collected samples detected the most cases of CIN2+ among both treated (85%) and untreated (91%) women (p=0.31). Cytology (at a cutoff of atypical squamous cells of undetermined significance or greater) detected 76% of cases among both treated and untreated women. However, the sensitivity of HPV testing using self-collected samples was significantly lower among treated versus untreated women (55% vs. 78%, p=0.01). HPV testing using self-collected vaginal specimens may be useful in primary screening but performs poorly for detecting post-treatment failures.     

Accuracy of Visual Inspection with Acetic acid in Detecting High-Grade Cervical Intraepithelial Neoplasia in Pre- and Post-Menopausal Thai Women with Minor Cervical CytologicalAbnormalities

Purpose: To determine the accuracy of visual inspection with acetic acid (VIA) in detecting high-gradecervical intraepithelial neoplasia (CIN) in pre- and post-menopausal women with atypical squamous cells ofundetermined significance (ASC-US) and low grade squamous intraepithelial lesion (LSIL) Papanicolaou (Pap)smears. Materials and Methods: Two hundred women (150 pre-menopausal and 50 post-menopausal) with ASCUSand LSIL cytology who attended the colposcopy clinic, Thammasat University Hospital, between March 2013and August 2014 were included. All women underwent VIA testing and colposcopy by gynecologic oncologists.Diagnostic values of VIA testing including sensitivity, specificity, positive predictive value (PPV) and negativepredictive value (NPV) for detecting high-grade CIN were determined using the histopathology obtained fromcolposcopic-directed biopsy as a gold standard. Results: VIA testing was positive in 54/150 (36%) pre-menopausalwomen and 5/50 (10%) post-menopausal women. Out of 54 pre-menopausal women with positive VIA testing,15 (27.8%) had high-grade CIN and 39 (72.2%) had either CIN 1 or insignificant pathology. Ten (10.4%), 43(44.8%) and 43 (44.8%) out of the remaining 96 pre-menopausal women with negative VIA testing had highgradeCIN, CIN 1 and insignificant pathology, respectively. Out of 5 post-menopausal women with positive VIAtesting, there were 4 (80%) women with high-grade CIN, and 1 (20%) women with insignificant pathology. Outof 45 VIA-negative post-menopausal women, 42 (93.3%) women had CIN 1 and insignificant pathology, and 3(6.7%) had high-grade CIN. Sensitivity, specificity, PPV and NPV of the VIA testing were 59.4%, 76.2%, 32.2%and 90.8%, respectively (60%, 68.8%, 27.8% and 89.6% in pre-menopausal women and 57.1%, 97.7%, 80%and 93.3% in post-menopausal women). Conclusions: VIA testing may be used as a screening tool for detectinghigh-grade CIN in women with minor cervical cytological abnormalities in a low-resource setting in order tolower the rate of colposcopy referral.     

A Prospective Randomized Trial to Compare Safety,Acceptability and Efficacy of Thermal Ablation and Cryotherapy in a Screen and Treat Setting

Background: The prospective randomized study aimed to compare the safety, acceptability and efficacy of thermal ablation (TA) to that of cryotherapy in screen and treat setting. Methods: The participants were recruited prospectively in a community-based screening clinic in India. Women positive on visual inspection with acetic acid (VIA) test and/or Human Papillomavirus (HPV) test were assessed for eligibility for ablative treatment. Total 286 eligible women were randomized to receive either cryotherapy (N=150) or TA (N=136) performed by health workers. Colposcopy and cervical biopsy were performed on all, prior to treatment. Post-treatment follow-up was after one year with colposcopy and biopsy. Results: Both the treatment methods had high acceptability. Significantly higher proportion of women treated by cryotherapy reported pain compared to women treated by TA, though intensity was mild in vast majority of them. Approximately 30% of women in both arms had histologic abnormalities, mainly CIN 1, and among those who attended follow-up 74.1% and 81.0% didn’t have any CIN after cryotherapy and TA respectively. Conclusion: TA is as acceptable and safe as cryotherapy in screen and treat setting. TA has the logistic advantages for the low-resourced settings as the machines are more portable, do not require costly refrigerant gas and battery-driven models are available. The cure rates for CIN 1+ lesions in our study were comparable between cryotherapy and TA.