Cohort Study In India Research Articles

Are two doses of human papillomavirus vaccine sufficient for girls aged 15–18 years? Results from a cohort study in India

Extending two-dose recommendations of HPV vaccine to girls between 15 and 18 years will reduce program cost and improve compliance. Immunogenicity and vaccine targeted HPV infection outcomes were compared between 1795 girls aged 15–18 years receiving two (1–180 days) and 1515 girls of same age receiving three (1–60–180 days) doses. Immunogenicity outcomes in 15–18 year old two-dose recipients were also compared with the 10–14 year old three-dose (N = 2833) and two-dose (N = 3184) recipients. The 15–18 year old two-dose recipients had non-inferior L1-binding antibody titres at seven months against vaccine-targeted HPV types compared to three-dose recipients at 15–18 years and three-dose recipients at 10–14 years of age. Neutralizing antibody titres at 18 months in 15–18 year old two-dose recipients were non-inferior to same age three-dose recipients for all except HPV 18. The titres were inferior to those in the 10–14 year old three-dose recipients for all targeted types. Frequency of incident infections from vaccine-targeted HPV types in the 15–18 year old two-dose recipients was similar to the three dose recipients. None of the girls receiving two or three doses had persistent infection from vaccine-targeted types. These findings support that two doses of HPV vaccine can be extended to girls aged 15–18 years.

Development, design, and experience related to Android application-based data collection for the MAASTHI cohort study in India

Background With the increasing use of smartphones or tablets due to wide availability and costs use for such devices in data capturing and storage becomes more advantageous especially in healthcare and research across the world.Objective To present the development and usage of a specially designed app for data collection of the Maternal Antecedents of Adiposity and Studying the Trans generational role of Hyperglycaemia and Insulin MAASTHI cohort. Methods We designed an android-based application app for a large cohort study ndash ldquoMaternal Antecedents of Adiposity and Studying the Trans generational role of Hyperglycaemia and Insulin MAASTHI currently on going in public sector prenatal clinics in Bangalore India. Through this paper we highlight the advantages of app-based data collection along with the detailed process of app-development and usage at field-level in Bangalore.Results Research staff have shown preference for using the Android app-based tablets for data collection with the real-time monitoring of data and the secured nature of storage appreciated by the supervisors over paper-based system. Highlighted features include individual login features easy-to-use navigation in-built skip patterns both online and offline usage especially for the high number of variables involved. The Android app is designed for compatibility with devices of multiple screen-sizes that is linked to the server and website that allows continuous monitoring for senior research staff and the principal investigator. The development costs along with the on-going maintenance costs are comparatively much less thus cost-effective over the course of our study.Conclusions App-based data collection and storage offers many opportunities for efficient data collection as compared to paper-based system. This mode of data collection explores the usability and acceptability of real-time data by rapidly developing technology used for large cohort studies that has potential for following participants over the years. We highly recommend the use of technology as such for future cohort studies and other population-based studies in similar settings.

Comparative associations between anthropometric and bioelectric impedance analysis derived adiposity measures with blood pressure and hypertension in India: a cross-sectional analysis

BackgroundThe utility of bioelectrical impedance analysis (BIA) derived adiposity measures as compared to anthropometric measures for the assessment of adiposity-related health risk is not clear. We aimed to clarify the relationships of BIA and anthropometric derived adipose measures with blood pressure and hypertension, and to compare the discriminative ability of the respective measures for hypertension.MethodsWe used baseline data collected between 2015 and 2016 from the Indian Study on Health of Adults (ISHA), an ongoing population based cohort study in India (N = 5990; age 30–69 years). We examined and compared the associations and discriminative ability between anthropometric (body mass index, waist circumference, hip circumference, waist-hip ratio, waist-height ratio) and BIA (whole body and trunk fat percentage) derived adiposity measures with blood pressure components (systolic pressure, diastolic pressure, pulse pressure, mean arterial pressure, mid-blood pressure) and hypertension.ResultsRegardless of whether the adiposity measure was derived from BIA or anthropometry, all were strongly and positively associated with blood pressure and hypertension. For both men and women, the magnitude of association of BIA measures with blood pressure and hypertension were comparable to those of anthropometric measures. Further, the ability of BIA derived adiposity measures to distinguish between those with and without hypertension was similar to the discriminative ability of anthropometric measures.ConclusionsAs compared to simple anthropometric measures, BIA derived estimates of adiposity provide no apparent advantage in the assessment of blood pressure and hypertension. The observed similarities between adiposity measures suggest that simple anthropometrics may be sufficient to assess adiposity and adiposity-related risks.

Mortality in HIV-infected patients with tuberculosis treated with streptomycin and a two-week intensified regimen: data from an HIV cohort study using inverse probability of treatment weighting.

Background. Despite the dramatic scale-up of antiretroviral therapy in low- and middle-income countries, tuberculosis (TB) is still the main cause of death among HIV-infected patients in resource-limited settings. Previous studies in patients with TB meningitis suggest that the use of higher doses of common anti-TB drugs could reduce mortality.Methods. Using clinical data from an HIV cohort study in India, we compared the mortality among HIV-infected patients diagnosed with TB according to the regimen received during the first two weeks of treatment: standard anti-tuberculosis therapy (ATT) (N = 847), intensified ATT (N = 322), and intensified ATT with streptomycin (N = 446). The intensified ATT comprised double dose of rifampicin and substitution of ethambutol with levofloxacin. Multivariate analysis was performed using Cox proportional hazard models and inverse probability of treatment weighting (IPTW) based on propensity scores. Patients with TB meningitis were excluded.Results. The use of intensified ATT alone did not improve survival. However, when streptomycin was added, the use intensified ATT was associated with reduced mortality in Cox models (adjusted hazard ratio 0.72, 95% CI [0.57–0.91]) and after IPTW (hazard ratio 0.77, 95% CI [0.67–0.96]). Other factors associated with improved survival were high serum albumin concentration, high CD4 lymphocyte cell-counts, and high glomerular filtration rates. Factors associated with increased mortality were high urea concentrations, being on antiretroviral therapy at the time of ATT initiation and high BUN/creatinine ratio. In an effect modification analysis, the survival benefits of the intensified ATT with streptomycin disappeared in patients with severe hypoalbuminemia.Conclusion. The results of this study are in accordance with a previous study from our cohort involving patients with TB meningitis, and suggest that an intensified 2-week ATT with streptomycin could reduce mortality in HIV infected patients with TB. As this is an observational study, we should be cautious about our conclusions, but given the high mortality of HIV-related TB, our findings deserve further research.

Mortality and Loss to Follow up Before Initiation of Antiretroviral Therapy Among HIV-Infected Children Eligible for HIV Treatment.

Data on attrition due to mortality or loss to follow-up (LTFU) from antiretroviral therapy (ART) eligibility to ART initiation of HIV-infected children are scarce. The aim of this study is to describe attrition before ART initiation of 247 children who were eligible for ART in a cohort study in India. Multivariable analysis was performed using competing risk regression. The cumulative incidence of attrition was 12.6% (95% confidence interval, 8.7-17.3) after five years of follow-up, and the attrition rate was higher during the first months after ART eligibility. Older children (>9 years) had a lower mortality risk before ART initiation than those aged <2 years. Female children had a lower risk of LTFU before ART initiation than males. Children who belonged to scheduled tribes had a higher risk of delayed ART initiation and LTFU. Orphan children had a higher risk of delayed ART initiation and mortality. Children who were >3 months in care before ART eligibility were less likely to be LTFU. The 12-month risk of AIDS, which was calculated using the absolute CD4 cell count and age, was strongly associated with mortality. A substantial proportion of ART-eligible children died or were LTFU before the initiation of ART. These findings can be used in HIV programmes to design actions aimed at reducing the attrition of ART-eligible children in India.

Factors associated with loss to follow up after entry into care of HIV infected children ineligible for antiretroviral therapy: data from an HIV cohort study in India

Results The cumulative incidence of attrition (mortality and LTFU) was 15.6% (95% confidence interval [CI], 11.320.5) after six years of follow-up, and the attrition rate was higher during the first year after enrolment. Children with a 12-month risk of AIDS 4%. Those children whose father had died had a lower risk of LTFU (SHR 0.26, 95% CI 0.09-0.75) than those whose parents were alive and were living in a rented house. Children aged 10-14 had a lower risk of LTFU (SHR 0.12, 95% CI 0.03-0.55) than those aged 5-9 years. Conclusions A substantial proportion of children ineligible for ART were LTFU before ART eligibility. These findings can be used by HIV programmes to design interventions aimed at reducing the attrition in pre-ART care of HIV infected children in India.

Description of the cascade of care and factors associated with attrition before and after initiating antiretroviral therapy of HIV infected children in a cohort study in India

In low- and middle-income countries, the attrition across the continuum of care of HIV infected children is not well known. The aim of this study was to investigate predictors of mortality and loss to follow up (LTFU) in HIV infected children from a cohort study in India and to describe the cascade of care from HIV diagnosis to virological suppression after antiretroviral therapy (ART) initiation. Multivariable analysis was performed using competing risk regression. The cumulative incidence of attrition due to mortality or LTFU after five year of follow-up was 16% from entry into care to ART initiation and 24.9% after ART initiation. Of all children diagnosed with HIV, it was estimated that 91.9% entered into care, 77.2% were retained until ART initiation, 58% stayed in care after ART initiation, and 43.4% achieved virological suppression on ART. Approximately half of the attrition occurred before ART initiation, and the other half after starting ART. Belonging to socially disadvantaged communities and living >90 min from the hospital were associated with a higher risk of attrition. Being >10 years old and having higher 12-month risk of AIDS (calculated using the absolute CD4 lymphocyte count and the age) were associated with an increased risk of mortality. These findings indicate that we should consider placing more emphasis on promoting research and implementing interventions to improve the engagement of HIV infected children in pre-ART care. The results of this study can be used by HIV programmes to design interventions aimed at reducing the attrition across the continuum of care of HIV infected children in India.

Predictors of loss to follow-up after engagement in care of HIV-infected children ineligible for antiretroviral therapy in an HIV cohort study in India

Previous studies performed in low- and middle-income countries have shown that nearly half of HIV-infected adults not eligible for antiretroviral therapy (ART) at the time of enrolment in care are lost to follow-up (LTFU). However, data about the attrition from enrolment in care to ART eligibility of HIV-infected children are scarce, especially outside sub-Saharan Africa. This is a retrospective study about the attrition before ART eligibility of 282 children ineligible for ART at enrolment in care in a cohort study in India. Multivariate analysis was performed using competing risk regression. During 5695 child-months of follow-up, three children died, 36 were LTFU and 144 became ART eligible. The cumulative incidence of attrition (mortality and LTFU) was 15.6% (95% confidence interval [CI], 11.3-20.5) at five years, and the attrition rate was higher during the first year after enrolment in care. The cumulative incidence of LTFU and mortality was 14.4% (95% CI, 10.2-19.2) and 1.2% (95% CI, 0.3-3.3) at five years, respectively. Children with a 12-month AIDS risk <3% had a higher risk of LTFU (subdistribution hazard ratio [SHR] 10.77, 95% CI 1.93-60.07) than those with a risk >4%. Those children whose father had died had a lower risk of LTFU (SHR 0.26, 95% CI 0.09-0.75) than those whose parents were alive and were living in a rented house. Children aged 10-14 had a lower risk of LTFU (SHR 0.12, 95% CI 0.03-0.55) than those aged 5-9 years. In our setting, a substantial proportion of children ineligible for ART are lost to follow-up before ART eligibility, especially those with younger age, less severe immunosuppression or living with parents in poor socio-economic conditions. These findings can be used by HIV programmes to design interventions aimed at reducing the attrition of pre-ART care of HIV-infected children in India.

The Effect of Surveillance and Appreciative Inquiry on Puerperal Infections: A Longitudinal Cohort Study in India

ObjectiveTo evaluate the effects of an intervention comprising surveillance and an organisational change called Appreciative Inquiry on puerperal infections in hospitals in Gujarat state, India.MethodsThis longitudinal cohort study with a control group was conducted over 16 months between 2010 and 2012. Women who delivered in six hospitals were followed-up. After a five month pre-intervention period, the intervention was introduced in three hospitals. Monthly incidence of puerperal infection was recorded throughout the study in all six hospitals. A chi-square test and logistic regression were used to examine for associations, trends and interactions between the intervention and control groups.FindingsOf the 8,124 women followed up, puerperal infections were reported in 319 women (3.9%) over the course of the study. Puerperal sepsis/genital tract infections and urinary tract infections were the two most common puerperal infections. At the end of the study, infection incidence in the control group halved from 7.4% to 3.5%. Levels in the intervention group reduced proportionately even more, from 4.3% to 1.7%. A chi-square test for trend confirmed the reduction of infection in the intervention and control groups (p<0.0001) but the trends were not statistically different from one another. There was an overall reduction of infection by month (OR = 0.94 95% CI 0.91–0.97). Risk factors like delivery type, complications or delivery attendant showed no association with infection.ConclusionInterruption of resource flows in the health system occurred during the intervention phase, which may have affected the findings. The incidence of infection fell in both control and intervention groups during the course of the study. It is not clear if appreciative inquiry contributed to the reductions observed. A number of practical and methodological limitations were faced.Trial RegistrationControlled-Trials.com ISRCTN03513186

Incidence and mortality of tuberculosis before and after initiation of antiretroviral therapy: an HIV cohort study in India.

IntroductionIndia has the highest burden of tuberculosis (TB) in the world, but the epidemiology of HIV-associated TB is not well known.MethodsWe describe the incidence and the mortality of TB from HIV diagnosis to antiretroviral therapy (ART) initiation (pre-ART group) and after ART initiation (on-ART group) in an HIV cohort study in Anantapur, India. Multivariable analysis of factors associated with TB was performed using competing risk regression and restricted cubic spline methods.ResultsA total of 4590 patients and 3133 person-years (py) of follow-up were included in the pre-ART group, and 3784 patients and 4756 py were included in the on-ART group. In the pre-ART group, the incidence of TB was high during the first month after HIV diagnosis and dropped nearly four times soon after. In the on-ART group, the incidence of TB increased after ART initiation reaching a peak in the third month. The probability of having TB within 30 months was 22.3% (95% confidence interval [CI], 21.1–23.6) in the pre-ART group and 17.8% (95% CI, 16.3–19.3) in the on-ART group. In a multivariable analysis, women had a lower risk of TB in both groups. Poor socio-economical conditions were associated with an increased risk of TB in the pre-ART group, but not in the group on-ART. While the association between low CD4 counts and TB was strong in the pre-ART group, this association was weaker in the on-ART group, and the highest risk of TB was seen in those patients with CD4 counts around 110 cells/mm3. The cumulative incidence of mortality at 12 months in patients with TB was 29.6% (95% CI, 26.9–32.6) in pre-ART TB and 34.9% (95% CI, 31–39.1) in on-ART TB. Half deaths before ART initiation and two thirds of deaths after ART initiation occurred in patients with TB.ConclusionsThe high incidence and mortality of TB seen in this study underscore the urgent need to improve the prevention and diagnosis of HIV-associated TB in India. We found substantial differences between TB before and after ART initiation.

Factors associated with attrition, mortality, and loss to follow up after antiretroviral therapy initiation: data from an HIV cohort study in India

BackgroundStudies from sub-Saharan Africa have shown high incidence of attrition due to mortality or loss to follow-up (LTFU) after initiating antiretroviral therapy (ART). India is the third largest country in the world in terms of HIV infected people, but predictors of attrition after ART initiation are not well known.DesignWe describe factors associated with attrition, mortality, and LTFU in 3,159 HIV infected patients who initiated ART between 1 January 2007 and 4 November 2011 in an HIV cohort study in India. The study included 6,852 person-years with a mean follow-up of 2.17 years.ResultsAfter 5 years of follow-up, the estimated cumulative incidence of attrition was 37.7%. There was no significant difference between attrition due to mortality and attrition due to LTFU. Having CD4 counts <100 cells/µl and being homeless [adjusted hazard ratio (aHR) 3.1, 95% confidence interval (CI) 2.6–3.8] were associated with a higher risk of attrition, and female gender (aHR 0.64, 95% CI 0.6–0.8) was associated with a reduced risk of attrition. Living near a town (aHR 0.82, 95% CI 0.7–0.999) was associated with a reduced risk of mortality. Being single (aHR 1.6, 95% CI 1.2–2.3), illiteracy (aHR 1.3, 95% CI 1.1–1.6), and age <25 years (aHR 1.3, 95% CI 1–1.8) were associated with an increased risk of LTFU. Although the cumulative incidence of attrition in patients diagnosed with tuberculosis after ART initiation was 47.4%, patients who started anti-tuberculous treatment before ART had similar attrition to patients without tuberculosis (36 vs. 35.2%, P=0.19) after four years of follow-up.ConclusionsIn this cohort study, the attrition was similar to the one found in sub-Saharan Africa. Earlier initiation of ART, improving the diagnosis of tuberculosis before initiating ART, and giving more support to those patients at higher risk of attrition could potentially reduce the mortality and LTFU after ART initiation.

Diagnostic and Prognostic Value of Serum Albumin for Tuberculosis in HIV Infected Patients Eligible for Antiretroviral Therapy: Datafrom an HIV Cohort Study in India.

Tuberculosis is difficult to diagnose and it is the leading cause of death in HIV infected individuals in developing countries. There is an urgent need of low-cost diagnostic markers for resource-limited settings. The study involved 1571 patients from an HIV cohort study in India with known serum albumin concentrations at the time of becoming eligible for antiretroviral therapy (ART). We investigated the diagnostic accuracy of serum albumin to predict tuberculosis within six months of ART eligibility and the prognostic value in patients who experienced tuberculosis. The diagnostic accuracy of serum albumin, measured by the area under the receiver operating characteristic curve, to predict tuberculosis was 0.81 (95% confidence interval 0.78-0.83). Serum albumin concentrations <3.2 g/dL were associated with 85% specificity and <4.1 g/dL were associated with negative predictive values >90%, even in settings with high tuberculosis prevalence. Hypoalbuminemia was associated with an increased risk of mortality in patients with tuberculosis. Serum albumin can be a useful low-cost diagnostic marker for tuberculosis in HIV infected patients eligible for ART. However, we failed to find thresholds to rule out or rule in tuberculosis. If these results are confirmed by other studies, serum albumin could be used to improve the diagnostic accuracy of intensive case finding algorithms for HIV-related tuberculosis. In patients who experience tuberculosis, hypoalbuminemia is associated with poor prognosis.

HIV incidence from the first population-based cohort study in India

BackgroundUnderstanding about who acquires new HIV infection and the determinants of why some persons get infected and others do not is fundamental to controlling HIV in the population. We assess HIV incidence and its associations in the population of a high HIV burden district in Andhra Pradesh state in southern India by a population-based longitudinal cohort study.MethodsWe re-surveyed a population-based cohort of 12,617 adults in Guntur district of Andhra Pradesh for which we had reported a baseline HIV prevalence of 1.72% (rural 1.64%, urban 1.89%) among the 15–49 years age group in 2004–2005. We conducted interviews to assess risk behaviour and performed HIV testing again in 2010–2011. We assessed the rate of new HIV infection and its associations using multiple logistic regression.ResultsThe participation rate in the follow-up was 74.9% and 63.9% of the baseline rural and urban samples, respectively. Over a mean follow-up of 5.63 years, the incidence of HIV was 1.26 per 1000 person-years (95% CI 0.83-1.69), after adjusting for slight compositional bias in the follow-up sample. The incidence per 1000 person-years was higher among rural men (1.68) than urban men (0.85), and among rural women (1.28) than urban women (0.54). The strongest association with incidence was a HIV positive spouse in the baseline for both men (odds ratio 266, 95% CI 62–1137) and women (odds ratio 28, 95% CI 9–88). Among men the other significant associations with HIV incidence were frequent use of condom for sex over the past 6 months, non-circumcision, more than one lifetime woman sex partner or ever visited sex worker, and transport-related occupation; for women the other significant associations were having had HIV testing other than antenatal check-up, previously married but currently not, and tobacco use.ConclusionThese first population-based cohort incidence data from India suggest that rural areas of high HIV burden states would need more attention to prevent new HIV infections, and that spouses of HIV positive persons and some other risk groups need to be targeted more effectively by HIV prevention programmes.

Factors associated with delayed entry into HIV medical care after HIV diagnosis in a resource-limited setting: Data from a cohort study in India

Studies from sub-Saharan Africa have shown that a substantial proportion of patients diagnosed with HIV enter into HIV medical care late. However, data from low or middle-income countries outside Africa are scarce. In this study, we investigated risk factors associated with delayed entry into care stratified by gender in a large cohort study in India. 7701 patients were diagnosed with HIV and 5410 entered into care within three months of HIV diagnosis. Nearly 80% entered into care within a year, but most patients who did not enter into care within a year remained lost to follow up or died. Patient with risk factors related to having a low socio-economic status (poverty, being homeless, belonging to a disadvantaged community and illiteracy) were more likely to enter into care late. In addition, male gender and being asymptomatic at the moment of HIV infection were factors associated with delayed entry into care. Substantial gender differences were found. Younger age was found to be associated with delayed entry in men, but not in women. Widows and unmarried men were more likely to enter into care within three months. Women belonging to disadvantaged communities or living far from a town were more likely to enter into care late. The results of this study highlight the need to improve the linkage between HIV diagnosis and HIV treatment in India. HIV programmes should monitor patients diagnosed with HIV until they engage in HIV medical care, especially those at increased risk of attrition.

Predictors of Attrition in Patients Ineligible for Antiretroviral Therapy after Being Diagnosed with HIV: Data from an HIV Cohort Study in India

In newly HIV-diagnosed patients, the CD4+ lymphocyte count is measured to determine the need for antiretroviral therapy (ART). Studies from Sub-Saharan Africa have shown that patients who are ART ineligible at the first assessment have poor retention in care, but data from other low- or middle-income countries are scarce. In this study we describe the retention in pre-ART care of 1696 patients who were ineligible for ART after being diagnosed with HIV in a cohort study in India. More than one-third of ART ineligible patients had poor retention in care, and the attrition was higher in those with longer follow-up periods. Of those patients with poor retention, only 10% came back to the clinics, and their CD4 cell counts were lower than the ones of patients retained in care. After 4.5 years of follow-up, the cumulative incidence of loss to follow-up was 50%. Factors associated with attrition were being homeless, being illiterate, belonging to a disadvantaged community, being symptomatic at the time of the HIV diagnosis, male gender, and not living near a town. Widows were given nutritional support and, therefore, had better retention in care. The results of this study highlight the need to improve the retention in care of ART ineligible patients in India.

Entry, Retention, and Virological Suppression in an HIV Cohort Study in India: Description of the Cascade of Care and Implications for Reducing HIV-Related Mortality in Low- and Middle-Income Countries

HIV treatment, care, and support programmes in low- and middle-income countries have traditionally focused more on patients remaining in care after the initiation of antiretroviral therapy (ART) than on earlier stages of care. This study describes the cumulative retention from HIV diagnosis to the achievement of virological suppression after ART initiation in an HIV cohort study in India. Of all patients diagnosed with HIV, 70% entered into care within three months. 65% of patients ineligible for ART at the first assessment were retained in pre-ART care. 67% of those eligible for ART initiated treatment within three months. 30% of patients who initiated ART died or were lost to followup, and 82% achieved virological suppression in the last viral load determination. Most attrition occurred the in pre-ART stages of care, and it was estimated that only 31% of patients diagnosed with HIV engaged in care and achieved virological suppression after ART initiation. The total mortality attributable to pre-ART attrition was considerably higher than the mortality for not achieving virological suppression. This study indicates that early entry into pre-ART care along with timely initiation of ART is more likely to reduce HIV-related mortality compared to achieving virological suppression.

Predictors of Delayed Entry into Medical Care of Children Diagnosed with HIV Infection: Data from an HIV Cohort Study in India

Data about the attrition before entry into care of children diagnosed with HIV in low- or middle-income countries are scarce. The aim of this study is to describe the attrition before engagement in HIV medical care in 523 children who were diagnosed with HIV from 2007 to 2012 in a cohort study in India. The cumulative incidence of children who entered into care was 87.2% at one year, but most children who did not enter into care within one year were lost to followup. The mortality before entry into care was low (1.3% at one year) and concentrated during the first three months after HIV diagnosis. Factors associated with delayed entry into care were being diagnosed after mother's HIV diagnosis, belonging to scheduled castes, age <18 months, female gender, and living >90 minutes from the HIV centre. Children whose parents were alive and were living in a rented house were at a higher risk of delayed entry into care than those who were living in an owned house. The results of this study can be used to improve the linkage between HIV testing and HIV care of children diagnosed with HIV in India.

Predictors of Delayed Antiretroviral Therapy Initiation, Mortality, and Loss to Followup in HIV Infected Patients Eligible for HIV Treatment: Data from an HIV Cohort Study in India

Studies from Sub-Saharan Africa have shown that a substantial number of HIV patients eligible for antiretroviral therapy (ART) do not start treatment. However, data from other low- or middle-income countries are scarce. In this study, we describe the outcomes of 4105 HIV patients who became ART eligible from January 2007 to November 2011 in an HIV cohort study in India. After three years of ART eligibility, 78.4% started ART, 9.3% died before ART initiation, and 10.3% were lost to followup. Diagnosis of tuberculosis, being homeless, lower CD4 count, longer duration of pre-ART care, belonging to a disadvantaged community, being widowed, and not living near a town were associated with delayed ART initiation. Diagnosis of tuberculosis, being homeless, lower CD4 count, shorter duration of pre-ART care, belonging to a disadvantaged community, illiteracy, and age >45 years were associated with mortality. Being homeless, being single, not living near a town, having a CD4 count <150 cells/μL, and shorter duration of pre-ART care were associated with loss to followup. These results highlight the need to improve the timely initiation of ART in HIV programmes in India, especially in ART eligible patients with tuberculosis, low CD4 counts, living in rural areas, or having a low socioeconomic status.

Effect of Formula Feeding and Breastfeeding on Child Growth, Infant Mortality, and HIV Transmission in Children Born to HIV-Infected Pregnant Women Who Received Triple Antiretroviral Therapy in a Resource-Limited Setting: Data from an HIV Cohort Study in India.

We describe a programme for the prevention of mother-to-child transmission (PMTCT) of HIV that provided universal antiretroviral therapy (ART) to all pregnant women regardless of the CD4 lymphocyte count and formula feeding for children with high risk of HIV transmission through breastfeeding in a district of India. The overall rate of HIV transmission was 3.7%. Although breastfeeding added a 3.1% additional risk of HIV acquisition, formula-fed infants had significantly higher risk of death compared to breastfed infants. The cumulative 12-month mortality was 9.6% for formula-fed infants versus 0.68% for breastfed infants. Anthropometric markers (weight, length/height, weight for length/height, body mass index, head circumference, mid-upper arm circumference, triceps skinfold, and subscapular skinfold) showed that formula-fed infants experience severe malnutrition during the first two months of life. We did not observe any death after rapid weaning at 5-6 months in breastfed infants. The higher-free-of HIV survival in breastfed infants and the low rate of HIV transmission found in this study support the implementation of PMTCT programmes with universal ART to all HIV-infected pregnant women and breastfeeding in order to reduce HIV transmission without increasing infant mortality in developing countries.

Early HIV viral load determination after initiating first-line antiretroviral therapy for indentifying patients with high risk of developing virological failure: data from a cohort study in a resource-limited setting

To evaluate the performance of a single determination of HIV viral load (VL) 6-12 months after starting antiretroviral therapy (ART) for identifying patients who will subsequently develop virological failure. We selected HIV-infected patients with at least two VL determinations after 6 months of ART from an HIV cohort study in India. Patients were divided in two groups depending on whether the first VL was below (Group 1) or above (Group 2) 1000 copies/ml. Cut-off for virological failure was defined according to World Health Organization recommendation (>5000 copies/ml). The study included 584 patients and 560.1 person-years of follow-up. Of all virological failures, 83% were diagnosed at the first VL determination. The cumulative incidence of virological failure after 1 and 2 years since the first VL was 0.9% [95% confidence interval (CI), 0.3-2.7] and 1.7% (95% CI, 0.6-5), respectively, for Group 1, and 58.2% (95% CI, 47-69.7) and 63.1% (95% CI, 49.8-76.4), respectively, for Group 2. Compared with Group 1, patients from Group 2 had a hazard ratio for virological failure of 78.3 (95% CI, 27.8-220.2). A single VL determination after 6 months of ART was able to identify patients with high risk of virological failure.