Effectiveness of triennial screening with clinical breast examination: 14-years follow-up outcomes of randomized clinical trial in Trivandrum, India.

BACKGROUND: This study presents the preliminary results of a randomized controlled trial (RCT) initiated in January 2006 in India to evaluate the effectiveness of clinical breast examination (CBE) in reducing breast cancer mortality as compared to a no-screening control group reported significant downstaging in the intervention group. The present manuscript reports long-term follow-up outcomes. METHODS: Women 30-69 years old from 133 intervention clusters and 141 control clusters were invited to participate. Women in the intervention arm underwent three rounds of CBE every 3 years. CBE-positive women were reexamined by a physician, and triple-assessment was performed on those confirmed to have abnormalities. All participants were followed through home visits and linkage with population-based cancer registry. RESULTS: Of the 55,843 eligible women in the intervention arm, 95.7% had CBE at least once and 11.5% were CBE-positive. Breast cancers were diagnosed in 335 participants in the intervention group and 273 in the control group (N = 59,447). Age-standardized incidence rate of early cancer was 30.4 of 100,000 in the intervention and 21.9 of 100,000 in the control group, with a rate ratio (RR) of 1.4 (95% confidence interval [CI], 1.1-1.8). The age-standardized breast cancer mortality rates were 11.3 and 11.1 per 100,000 in intervention and control arms, respectively (RR, 1.1; 95% CI, 0.8-1.5) after 15 years. Five-year breast cancer survival rates were 77.0% in the intervention and 71.2% in the control groups (overall p value = .043). CONCLUSIONS: Triennial CBE screening failed to demonstrate any mortality benefit despite achieving a shift toward earlier stage at detection and improved survival in the intervention arm. CBE is a valuable tool for diagnosis of breast cancer in symptomatic women especially in areas where mammography and/or breast cancer screening programs are not widely available.

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.

Effectiveness of cryotherapy for histologically confirmed cervical intraepithelial neoplasia grades 1 and 2 in an Indian setting.

OBJECTIVE: To describe the effectiveness of cryotherapy for treating women who were histologically confirmed to have cervical intraepithelial neoplasia (CIN) in India. METHODS: Data were analyzed retrospectively from screening projects that collected data from January 2001 to May 2008 in Trivandrum, India. Women with CIN were appropriately treated with cryotherapy by a trained nurse or physician and followed up for cure, adverse events, and complications. Cure was defined as absence of CIN during any follow-up visit at least 1 year after treatment. RESULTS: Among 236 women identified with CIN and appropriately treated with cryotherapy, 173 (81.6%) were followed up (158 CIN 1 and 15 CIN 2 cases). The percentage cure for CIN 1 and 2 lesions was 93.0% and 86.7% respectively. An odds ratio of 0.2 (95% confidence interval, 0.0-0.9) was observed for treatment received more than 2 months after screening as compared with treatment received within 2 months. Complications were observed in 1.2% of treated women and adverse events (discharge and mild pain) in 26.6%. CONCLUSION: The study affirms that trained mid-level providers can appropriately perform cryotherapy in primary healthcare services and that expanding such services in low-resource settings would increase the availability and accessibility of precancer treatment.

Long term effect of visual screening on oral cancer incidence and mortality in a randomized trial in Kerala, India.

OBJECTIVES: We studied oral cancer incidence and mortality and the impact of compliance to repeat screening rounds during a 15-year follow-up in a cluster-randomized controlled trial in Trivandrum district, Kerala, India. METHODS: Healthy individuals aged 35 and above in seven clusters randomized to the intervention arm received four rounds of oral visual inspection by trained health workers at 3-year intervals, and those in six clusters randomized to the control arm received routine care during 1996-2005 and one round of visual screening during 2006-2009. Screen-positive persons were referred for diagnosis and treatment. Oral cancer incidence and mortality were compared between the study arms by intention to treat analysis. RESULTS: Of the 96,517 eligible subjects in the intervention arm, 25,144 (26.1%) had one, 22,382 (23.2%) had two, 22,008 (22.8%) had three and 19,288 (20.0%) had four rounds of screening. Of the 95,356 eligible subjects in the control group 43,992 (46.1%) received one round of screening. Although the 12% reduction in oral cancer mortality in all individuals did not reach statistical significance, there was a 24% reduction in oral cancer mortality (95% CI 3-40%) in users of tobacco and/or alcohol in the intervention arm after 4-rounds of screening; there was 38% reduction in oral cancer incidence (95% CI 8-59%) and 81% reduction in oral cancer mortality (95% CI 69-89%) in tobacco and/or alcohol users adhering to four screening rounds. CONCLUSION: Sustained reduction in oral cancer mortality during the 15-year follow-up, with larger reductions in those adhering to repeated screening rounds support the introduction of population-based screening programs targeting users of smoking or chewing tobacco or alcohol or both in high-incidence countries.

Determinants of participation in a breast cancer screening trial in trivandrum district, India.

BACKGROUND: Conspicuous differences in participation rates for breast self-examination (BSE), clinical breast examination (CBE), and referral for further investigations have been observed indicating involvement of a number of different factors. This study analysed determinants for participation in different levels of the breast cancer screening process in Indian females. MATERIALS AND METHODS: An intervention group of 52,011 women was interviewed in a breast cancer screening trial in Trivandrum district, India. In order to assess demographic, socio-economic, reproductive, and cancer-related determinants of participation in BSE, CBE, and referral, uni- and multi-variate logistic regression was employed. RESULTS: Of the interviewed women, 23.2% reported practicing BSE, 96.8% had attended CBE, and 49.1% of 2,880 screen-positives attended referral. Results showed an influence of various determinants on participation; women who were currently not married or who had no family history of cancer were significantly less likely to attend the screening process at any level. CONCLUSIONS: Increasing awareness about breast cancer, early detection methods, and the advantages of early diagnoses among women, and their families, as well as health care workers offering social support, could help to increase participation over the entire screening process in India.

Clinical breast examination: preliminary results from a cluster randomized controlled trial in India.

A cluster randomized controlled trial was initiated in the Trivandrum district (Kerala, India) on January 1, 2006, to evaluate whether three rounds of triennial clinical breast examination (CBE) can reduce the incidence rate of advanced disease incidence and breast cancer mortality. A total of 275 clusters that included 115,652 healthy women, aged 30-69 years, were randomly allocated to intervention (CBE; 133 clusters; 55,844 women) or control (no screening; 142 clusters; 59,808 women) groups. Performance characteristics (sensitivity, specificity, false-positive rate, and positive predictive value) of CBE were evaluated. An intention-to-treat analysis was performed for comparison of incidence rates between the intervention and control groups. Preliminary results for incidence are based on follow-up until May 31, 2009, when the first round of screening was completed. Of the 50,366 women who underwent CBE, 30 breast cancers were detected among 2880 women with suspicious findings in CBE screening that warranted further investigations. Sensitivity, specificity, false-positive rate, and positive predictive value of CBE were 51.7% (95% confidence interval [CI] = 38.2% to 65.0%), 94.3% (95% CI = 94.1% to 94.5%), 5.7% (95% CI = 5.5% to 5.9%), and 1.0% (95% CI = 0.7% to 1.5%), respectively. The age-standardized incidence rates for early-stage (stage IIA or lower) breast cancer were 18.8 and 8.1 per 100,000 women and for advanced-stage (stage IIB or higher) breast cancer were 19.6 and 21.7 per 100,000 women, in the intervention and control groups, respectively.

Socio-economic factors & longevity in a cohort of Kerala State, India.

BACKGROUND & OBJECTIVES: Even though Kerala State is well-known for its egalitarian policies in terms of healthcare, redistributive actions and social reforms, and its health indicators close to those of high-resource countries despite a poor per-capita income, it is not clear whether socio-economic disparities in terms of life expectancy are observed. This study was therefore carried out to study the impact of socio-economic level on life expectancy in individuals living in Kerala. METHODS: A cohort of 1,67,331 participants aged 34 years and above in Thiruvananthapuram district, having completed a lifestyle questionnaire at baseline in 1995, was followed up for mortality and cause of death until 2005. Survival estimates were based on the participants' vital status and death rates were calculated separately for men and women and for several socio-economic factors, stratified by age. RESULTS: At 40 years, men and women were expected to live another 34 and 37 years, respectively. Life expectancy varied across the participants' different socio-economic categories: those from high income households with good housing conditions, materially privileged households and small households, had a 2-3 years longer life expectancy as compared to the deprived persons. Also, those who went to college lived longer than the illiterates. The gaps between categories were wider in men than in women. INTERPRETATION & CONCLUSIONS: Socio-economic disparity in longevity was observed: wealthy people from Kerala State presented a longer life expectancy.

Effect of tobacco chewing, tobacco smoking and alcohol on all-cause and cancer mortality: a cohort study from Trivandrum, India.

OBJECTIVE: To study the risk of all-cause, cancer and tobacco-related cancer mortality associated with tobacco chewing, tobacco smoking and alcohol use. DESIGN: Prospective community-based cohort study initiated in 1996. PARTICIPANTS: 167343 adult subjects, aged 34 and older, living in 13 panchayaths (rural municipal administrative units) in South India, were regularly followed-up for a mean duration of 6.5 years. MAIN OUTCOME MEASURES: Mortality from all-causes, all cancer and tobacco-related cancer. RESULTS: The mortality risks associated with chewing (and 95% confidence intervals), after adjusting for age, sex, socio-economic and dietary variables, and for other habits, were 0.90 (0.86-0.94) for all-cause, 1.07 (0.94-1.22) for cancer and 1.22 (1.04-1.44) for tobacco-related cancer; with smoking the respective mortality risks were 1.31 (1.24-1.39), 1.63 (1.37-1.94) and 1.68 (1.36-2.08); and with alcohol use the risks were 1.13 (1.06-1.20), 1.32 (1.11-1.57) and 1.47 (1.19-1.80), respectively. Reduced risk of all-cause mortality by chewing was observed only in the 60-84 years old group (0.90 (0.85-0.94)), and detrimental effects of chewing on cancer mortality were shown in the young and middle-age groups: 34-39 years old (1.33 (0.67-2.65)), and 40-59 years old (1.26 (1.03-1.55)). CONCLUSION: Tobacco in any form and alcohol uses were harmful and a higher quality of life could be achieved by avoiding these habits. Given the demographic, epidemiological and economic transitions and changes in pattern of tobacco and alcohol use in India, the health loss from the tobacco and alcohol will grow even larger, unless effective interventions and policies to reduce these habits are implemented.

Alcohol intake and oral cavity cancer risk among men in a prospective study in Kerala, India.

OBJECTIVE: The aim of the study was to evaluate the role of alcohol drinking and patterns of consumption in oral cancer incidence and mortality in a cohort study using data from the Trivandrum Oral Cancer Screening Study, India. METHODS: At baseline, the study participants completed a lifestyle questionnaire including items on frequency and duration of alcohol consumption. They were followed up for oral cancer incidence and mortality. Data from 32 347 subjects, of whom 134 eventually developed oral cancer, were analysed to estimate risk of oral cancer incidence and mortality according to drinking patterns, using a Cox regression model adjusted for age, religion, education, occupation, body mass index (BMI), standard of living index, chewing habits, smoking habits, and vegetable and fruit intake. RESULTS: Current and past drinkers were each associated with significantly increased risk of developing oral cancer. The hazard ratio increased significantly by 49% (95% CI = 1-121%) among current drinkers and 90% (95% CI = 13-218%) among past drinkers. A significant dose-response relationship between intake frequency, duration and oral cancer risk (incidence and mortality) was observed. CONCLUSIONS: As with other lifestyle factors, alcohol intake plays an important role in oral carcinogenesis in this population, and understanding this role is relevant to developing public health policies targeting at-risk population.

Effectiveness and safety of loop electrosurgical excision procedure in a low-resource setting.

OBJECTIVE: To evaluate the effectiveness and safety of the loop electrosurgical excision procedure (LEEP) to treat cervical intraepithelial neoplasia (CIN) in a low-resource setting. METHODS: Women participating in a cervical screening study in India with histologically confirmed CIN unsuitable for cryotherapy were advised to undergo LEEP. One year after treatment the cervix was visually inspected with acetic acid, followed by colposcopy and biopsy taken from abnormal areas. Cure was defined as no clinical or histologic evidence of CIN. Factors influencing cure rates were evaluated by chi(2) tests. RESULTS: Of the 311 women who underwent LEEP, 283 reported for 1-year follow-up and 248 (87.6%) were disease free. Cure rates were 93.0% for CIN 1, 85.5% for CIN 2, and 72.7% for CIN 3. Minor adverse effects were observed in 34 women and complications were seen in 5 women. CONCLUSION: LEEP was associated with minimal complications and acceptable cure rates in a low-resource setting, although women with larger lesions had lower cure rates.

Cervical cancer: screening and therapeutic perspectives.

Cervical cancer is a major cause of mortality and premature death among women in their most productive years in low- and medium-resourced countries in Asia, Africa and Latin America, despite the fact that it is an eminently preventable cancer. While cytology screening programmes have resulted in a substantial reduction of cervical cancer mortality in developed countries, they have been shown to have a wide range of sensitivity in most routine settings including in developing countries. Although liquid-based cytology improves sample adequacy, claims on improved sensitivity remain controversial. Human papillomavirus testing is more sensitive than cytology, but whether this gain represents protection against future cervical cancer is not clear. Recently, in a randomized trial, the use of visual inspection with 4% acetic acid was shown to reduce cervical cancer incidence and mortality. Cryotherapy and large loop excision of the transformation zone are effective and safe treatment methods for cervical intraepithelial neoplasia. The clinical stage of cancer is the single most important prognostic factor and should be carefully evaluated in choosing optimal treatment between surgery and radiotherapy, with or without chemotherapy. At the public health level, health care infrastructure, affordability and capacity for initiating and sustaining vaccination and screening programmes are critical factors in cervical cancer control. On the other hand, an informed practitioner can utilize the multiple opportunities in routine primary care interactions for prevention, screening, early detection and prompt referral for treatment.

Body mass index, weight change and mortality risk in a prospective study in India.

BACKGROUND: Although the detrimental effect of overweight and obesity has been extensively reported in Western populations, little is known on the association between body weight, weight change and mortality in Asian populations whose weight distribution and mortality differ considerably from the West. METHODS: A cohort of 75 868 subjects aged 35 years and above, participants of the Trivandrum Oral Cancer Study-a cluster-randomized controlled trial originally implemented to evaluate the efficacy of visual inspection on oral cancer, in Kerala State, South India-were followed up from 1995 to 2004. Weight and height were measured both at baseline and in 3.5-year follow-up surveys. Early years of follow-up were excluded from the analyses. Relative risks of overall death and cause-specific death were estimated according to the body mass index (BMI) category of the WHO Asian population definitions, and to weight changes between two surveys. RESULTS: Low BMI was a predictor of mortality, while high BMI was not. Mortality risks in men adjusted for age, smoking habits and other potential confounders, as compared with a BMI 18.5-22.9 kg/m(2), were 1.26 (95% CI 1.03-1.55) for BMI < 16 kg/m(2); 1.16 (1.03-1.32) for BMI = 16-18.4 kg/m(2); 0.95 (0.81-1.12) for BMI = 23-24.9 kg/m(2); 0.85 (0.69-1.05) for BMI = 25-27.4 kg/m(2); and 0.89 (0.65-1.21) for BMI >/= 27.5 kg/m(2). Similar findings were observed in women. BMI was not associated with deaths from cancer, cardiovascular and cerebrovascular diseases, and diabetes. A low BMI (<16 kg/m(2)) was associated with increased deaths from chronic respiratory diseases. Smoking and socio-economical status did modify the association. A moderate weight gain of 4-10% between the two surveys was associated with decreased risk of death, while moderate and severe weight loss were predictive factors of death. Similar results were observed in both men and women. CONCLUSIONS: Among this Indian rural population, mild to severe leanness (BMI < 16 kg/m(2)) and weight loss were important determinants of mortality, especially from chronic respiratory diseases, while overweight and above (BMI > 23 kg/m(2)) did not show any detrimental effect.

Role of tobacco smoking, chewing and alcohol drinking in the risk of oral cancer in Trivandrum, India: a nested case-control design using incident cancer cases.

Oral cancer is one of the most common cancers in the world, with two-thirds of the cases occurring in developing countries. While cohort and nested case-control study designs offer various methodological strengths, the role of tobacco and alcohol consumption in the etiology of oral cancer has been assessed mainly in case-control studies. The role of tobacco chewing, smoking and alcohol drinking patterns on the risk of cancer of the oral cavity was evaluated using a nested case-control design on data from a randomized control trial conducted between 1996 and 2004 in Trivandrum, India. Data from 282 incident oral cancer cases and 1410 matched controls were analyzed using multivariate conditional logistic regression models. Tobacco chewing was the strongest risk factor associated with oral cancer. The adjusted odds ratios (ORs) for chewers were 3.1 (95% confidence interval (CI)=2.1-4.6) for men and 11.0 (95%CI=5.8-20.7) for women. Effects of chewing pan with or without tobacco on oral cancer risk were elevated for both sexes. Bidi smoking increased the risk of oral cancer in men (OR=1.9, 95%CI=1.1-3.2). Dose-response relations were observed for the frequency and duration of chewing and alcohol drinking, as well as in duration of bidi smoking. Given the relatively poor survival rates of oral cancer patients, cessation of tobacco and moderation of alcohol use remain the key elements in oral cancer prevention and control.

Assessing the gain in diagnostic performance when two visual inspection methods are combined for cervical cancer prevention.

OBJECTIVES: The objectives of this study was to establish whether combined screening with visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) improves detection of cervical intraepithelial neoplasia 2-3 (CIN 2-3) lesions and cancer beyond chance, compared with screening with VIA alone or VILI alone; and to estimate the extra number of false-positive (FP) results per additional disease case found with the combined test, and to estimate the additional costs involved. SETTING: Ten cross-sectional studies in Burkina Faso, Congo, Guinea, India, Mali and Niger, between 1999 and 2003. METHODS: Using a common protocol, health workers screened 56,147 women aged 25-65 years with VIA and VILI. All women underwent a colposcopy examination and biopsies were taken when necessary. The disease reference standard was histology or negative colposcopy. A positive result on the combined test was defined if either VIA or VILI were positive. The accuracy of the combined test compared with VIA alone or VILI alone was evaluated using likelihood ratios. RESULTS: The estimated sensitivity and specificity were 81.3% and 87.3%, respectively, for VIA; 91.5% and 86.9% for VILI; and 92.9% and 83.5% for the combined test. The ratio of the positive likelihood ratios of the combined test and VIA alone for CIN 2-3 lesions and cancer was 0.88 (95% confidense interval [CI]: 0.86-0.90), favouring use of VIA alone. The ratio of the negative likelihood ratios was 0.40 (95% CI: 0.37-0.47), favouring use of the combined test. Similar results were obtained when the combined test was compared with VILI alone. Assuming equivalent performance of VIA alone and the combined test with a disease prevalence of 2%, there will be about 16.0 (95% CI: 13.6-18.8) additional FPs for each additional true positive (TP) detected if the combined test is used. This number will be 121.1 (95% CI: 75.4-194.6) if VILI is considered as the single test. CONCLUSIONS: At the trade-off point between the combined test and VIA alone or VILI alone, given the numbers of additional FP results involved for each additional TP case of disease that were found, it would be more likely that settings already using VIA would advocate combined testing, and for settings using VILI to opt for the single test. The additional costs (per 1000 women) incurred with the combined test would be International 4117.68 dollars versus either of the tests above.

Effect of screening on oral cancer mortality in Kerala, India: a cluster-randomised controlled trial.

BACKGROUND: Oral cancer is common in men from developing countries, and is increased by tobacco and alcohol use. We aimed to assess the effect of visual screening on oral cancer mortality in a cluster-randomised controlled trial in India. METHODS: Of the 13 clusters chosen for the study, seven were randomised to three rounds of oral visual inspection by trained health workers at 3-year intervals and six to a control group during 1996-2004, in Trivandrum district, Kerala, India. Healthy participants aged 35 years and older were eligible for the study. Screen-positive people were referred for clinical examination by doctors, biopsy, and treatment. Outcome measures were survival, case fatality, and oral cancer mortality. Oral cancer mortality in the study groups was analysed and compared by use of cluster analysis. Analysis was by intention to treat. FINDINGS: Of the 96,517 eligible participants in the intervention group, 87,655 (91%) were screened at least once, 53,312 (55%) twice, and 29,102 (30%) three times. Of the 5145 individuals who screened positive, 3218 (63%) complied with referral. 95,356 eligible participants in the control group received standard care. 205 oral cancer cases and 77 oral cancer deaths were recorded in the intervention group compared with 158 cases and 87 deaths in the control group (mortality rate ratio 0.79 [95% CI 0.51-1.22]). 70 oral cancer deaths took place in users of tobacco or alcohol, or both, in the intervention group, compared with 85 in controls (0.66 [0.45-0.95]). The mortality rate ratio was 0.57 (0.35-0.93) in male tobacco or alcohol users and 0.78 (0.43-1.42) in female users. INTERPRETATION: : Oral visual screening can reduce mortality in high-risk individuals and has the potential of preventing at least 37,000 oral cancer deaths worldwide.

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.

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.