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BACKGROUND It is thought that there is a high risk of zinc deficiency in India, but there are no representative national estimates. OBJECTIVES We aimed to evaluate the national and state-level prevalence of low serum zinc concentrations (SZCs) in Indian children from the nationally representative Comprehensive National Nutrition Survey. METHODS Prevalence of low SZC, adjusted for C-reactive protein, was estimated among preschool (1-4 y; n = 7874) and school-age children (5-9 y; n = 10,430) and adolescents (10-19 y; n = 10,140), using SZC cutoffs defined by the International Zinc Nutrition Consultative Group. RESULTS Prevalence of low SZC was high among adolescents (31.1%; 95% CI: 29.8%, 32.4%), compared with school-age (15.8%; 95% CI: 15.3%, 16.3%) or preschool children (17.4%; 95% CI: 16.7%, 18.0%). However, stratification of prevalence by fasting status or using an alternative lower SZC cutoff independent of fasting status led to a reduction in prevalence by 3.7% or 7.8% in children

Background In India, the prevalence of overweight among adolescents is on the rise, setting the stage for an increase in metabolic syndrome (MS). This paper presents the national prevalence of MS in adolescents in India. Methods A nationally representative data of adolescents (10–19 years) from the Comprehensive National Nutrition Survey was used. MS was defined based on the NCEP–ATP III criteria for adolescents. Bivariate analysis was used to report socio-demographic differentials in prevalence and to assess interstate variability. Multivariate logistic regression model was constructed to measure the association between socio-demographic characteristics and prevalence of MS. Census data from 2011 was projected to 2017 to calculate burden. Results The prevalence of MS was 5.2% among adolescents. 11.9%, 15.4%, 26.0%, 31.9% and 3.7% had central obesity, high blood pressure, hypertriglyceridemia, low HDL-cholesterol and high fasting glucose, respectively. The prevalence was higher among males (5.7% vs. 4.7%, adjusted odds ratio (AOR): 1.3, 95% confidence interval [CI]: 1.0, 1.6), those residing in urban areas (7.9% vs 4.2%, AOR: 1.4, 95% CI: 1.1, 1.8), and from wealthier households as compared to their counterparts (8.3% vs. 2.4%, AOR: 3.4, 95% CI: 2.1, 5.5). There was wide interstate variability in the prevalence of MS (0.5% – 16.5%). In 2017, 14.2 million adolescents had MS in India. Conclusions The prevalence of MS among adolescents in India is low and clustered in urban areas and richer households. Early prevention interventions promoting a healthy lifestyle, especially in high prevalence areas, are needed to keep MS from becoming a public health issue.

Background Conventional indicators used to access the nutritional status of children tend to underestimate the overall undernutrition in the presence of multiple anthropometric failures. Further, factors contributing to the rich-poor gap in the composite index of anthropometric failure (CIAF) have not been explored. This study aims to estimate the prevalence of CIAF and quantify the contribution of factors that explain the rich-poor gap in CIAF. Methods The present study used data of 38,060 children under the age of five years and their biological mothers, drawn from the nationally representative Comprehensive National Nutrition Survey of children and adolescents aged 0–19 years in India. The CIAF outcome variable in this study provide an overall prevalence of undernutrition, with six mutually exclusive anthropometric measurements of height-for-age, height-for-weight, and weight-for-age, calculated using the World Health Organization (WHO) Multicenter Growth Reference Study. Multivariate regression and decomposition analysis were used to examine the association between covariates with CIAF and to estimate the contribution of different covariates in the existing rich-poor gap. Results An overall CIAF prevalence of 48.2% among children aged aged under 5 years of age was found in this study. 6.0% children had all three forms of anthropometric failures. The odds of CIAF were more likely among children belonging to poorest households (AOR: 2.41, 95% CI: 2.12–2.75) and those residing in urban area (AOR: 1.06, 95% CI 1.00–1.11). Children of underweight mothers and those with high parity were at higher risk of CIAF (AOR: 1.51, 95% CI: 1.42–1.61) and (AOR: 1.15, 95% CI: 1.08–1.22), respectively. Children of mother exposed to mass media were at lower risk of CIAF (AOR: 0.87, 95% CI: 0.81–0.93). Conclusion This study estimated a composite index to assess the overall anthropometric failure, which also provides a broader understanding of the extent and pattern of undernutrition among children. Findings show that maternal covariates contribute the most to the rich-poor gap. As well, the findings suggest that intervention programs with a targeted approach are crucial to reach the most vulnerable groups and to reduce the overall burden of undernutrition.

Alcohol use has a deleterious effect on the health status of persons living with HIV, negatively affecting antiretroviral adherence and increasing the risk of transmission. Alcohol use is not an isolated behavior but intimately linked to stigma and poor psychological status among other factors. This paper utilizes a crossover design to test the efficacy of three multilevel interventions, individual counselling (IC), group intervention (GI) and collective advocacy (CA) for change, among HIV positive males who consume alcohol, treated at five ART Centers in urban Maharashtra, India. While GI shows a significant effect on the largest number of outcome variables, IC through its psychosocial emphasis demonstrated a significant impact over time on stigma and depression, and CA with its emphasis on societal change showed positive impact on stigma and advocacy for self and others. Each of the interventions had variable effects on CD4 count and viral load.Clinical Registration Number: NCT03746457; Clinical Trial.Gov.

Objective Nationally representative percentiles for waist circumference (WC), waist‐to‐height‐ratio (WHtR), and body mass index (BMI) are not available for children and adolescents in India. Methods Using LMS method, age‐ and gender‐specific reference growth charts were constructed for WC (n = 68,261), WHtR (n = 68,261), and BMI (n = 67,741) from children/adolescents aged 5–19 years who participated in a nationally representative survey. General obesity, indicating overall obesity, was defined as age–sex‐specific BMI z‐scores ≥ 95th percentile. Central obesity was defined in three ways: WC ≥ 90th percentile, WHtR ≥ 0.5, and both WC ≥ 90th percentile and WHtR ≥ 0.5. Findings WC and BMI percentiles for boys and girls are lower than those previously reported from India and several other countries. The BMI percentiles are lower than the WHO 2007 reference population. The prevalence of general obesity using India specific BMI centiles was 2.9% (95% CI: 2.6–3.2). The prevalence of central obesity was 6.1% (95% CI: 5.7–6.6) using WC ≥ 90th percentile, 5.3% (95% CI: 5.0–5.7) using WHtR ≥ 0.5, and 3.6% using both criteria. Three‐fourth of children with general obesity also had central obesity based on WC ≥ 90th. Conclusions Indian children are thinner than Caucasian and other Asian children, and the global WHO reference population. Using India specific reference, the prevalence of central obesity is higher than general obesity with a significant overlap between the two.

Summary Background Anaemia is a serious public health concern in India. However, national estimates for its prevalence are not available for the 5–14 years age group, nor are estimates available for the types of anaemia among children and adolescents (1–19 years). We aimed to assess the prevalence of anaemia among children and adolescents in India and to categorise types of anaemia on the basis of micronutrient deficiencies. Methods We assessed the prevalence of anaemia among children (1–4 years and 5–9 years) and adolescents (10–19 years) using nationally representative data from the Comprehensive National Nutrition Survey. Anaemia was classified on the basis of age and sex-specific WHO cutoffs and serum ferritin, soluble transferrin receptor, folate, cyanocobalamin, and C-reactive protein concentrations as iron deficiency anaemia, folate or vitamin B12 deficiency anaemia, dimorphic anaemia (iron deficiency anaemia and folate or vitamin B12 deficiency anaemia), anaemia of other causes (anaemia not classified as iron deficiency anaemia and folate or vitamin B12 deficiency anaemia), and anaemia of inflammation. Findings We included 26 765 children (11 624 aged 1–4 years and 15 141 aged 5–9 years) and 14 669 adolescents. In the weighted sample, anaemia prevalence was 40·5% (4553 of 11 233) among 1–4 year-olds, 23·4% (3439 of 14 664) among 5–9 year-olds, and 28·4% (4064 of 14 300) among adolescents. Among 2862 children aged 1–4 years, iron deficiency anaemia (1045 [36·5%]) was the most prevalent type, followed by anaemia of other causes (702 [24·5%]), folate or vitamin B12 deficiency anaemia (542 [18·9%]), dimorphic anaemia (387 [13·5%]), and anaemia of inflammation (186 [6·5%]). Among 2261 children aged 5–9 years, anaemia of other causes was the most common (986 [43·6%]), followed by folate or vitamin B12 deficiency anaemia (558 [24·6%]), iron deficiency anaemia (353 [15·6%]), dimorphic anaemia (242 [10·7%]), and anaemia of inflammation (122 [5·4%]). 861 (31·4%) of 2740 adolescents had anaemia of other causes, 703 (25·6%) had folate or vitamin B12 deficiency anaemia, 584 (21·3%) had iron deficiency anaemia, 498 (18·2%) and dimorphic anaemia, and 94 (3·4%) had anaemia of inflammation. Interpretation Iron deficiency anaemia is the most common form of anaemia among younger children and anaemia of other causes among 5–9-year-old children and adolescents. Folate or vitamin B12 deficiency anaemia accounts for more than a third of anaemia prevalence. Anaemia prevention efforts should focus on strengthening the existing iron and folate supplementation programmes and prevention of folate or vitamin B12 deficiency anaemia. Funding The Mittal Foundation.

We examined the association between alcohol consumption, adherence and viral load (VL) in a cohort of 940 alcohol-consuming, human immunodeficiency virus (HIV)-positive men receiving antiretroviral therapy in Mumbai. Some of the participants (16.7%) had missed >1 doses in the last four days and 17.6% reported >1 treatment interruptions in the last 12 months; 60.8% of the participants consumed alcohol >2 times/month, 62.8% consumed >3 drinks/typical day and 11.5% reported binge drinking >1 times/month; 76.4% of the participants had VL

Objective To examine the prevalence of DBM at national, state, regional level and its proximate determinants in households with a mother and child under 5 years of age. Methods The present study includes data on 38,060 children under 5 years of age and their biological mothers, drawn from the nationally representative Comprehensive National Nutrition Survey (CNNS) of children and adolescents aged 0–19 years in India. The outcome variable for this study was the double burden of malnutrition at the household level. A child was classified as stunted if the height was at least -2SD below the mean for their age. A mother with a body mass index (BMI) of more than or equal to 25kg/m2 (BMI ≥ 25 kg/m2) was considered as overweight. A binary variable with coexistence of both conditions was created and categorized as 1 (existence of stunted child and overweight mother), and 0 otherwise. Multivariate regression analysis was used to examine the association between DBM and covariates at maternal, child and household level. Results 3.4% of households were found to be with DBM, with higher prevalence in urban areas (6.2%) as compared to rural areas (2.5%). Inter-state and regional variations were present in the prevalence of DBM. The proportion of DBM was higher in households with mothers aged 30 years or more, mothers not working and those who had cesarean births. Prevalence of DBM was found to be higher in urban area and rich households. Conclusion This study shows the prevalence of DBM and its proximate determinants. These findings highlight the need for a comprehensive nutrition programme that targets both undernutrition and overnutrition. While formulating standalone policies for both forms of malnutrition is relatively easier, customized policies and programmes are needed to combat the conflicting situation of dietary excess and deprivation at the household level.

Summary Background WHO's haemoglobin cutoffs to define anemia were based on five studies of predominantly White adult populations, done over 50 years ago. Therefore, a general re-examination of the existing haemoglobin cutoffs is warranted for global application, in representative healthy populations of children and adults. Such data are scarce in low-income and middle-income countries; however, a 2019, large-scale, nationally representative survey of children and adolescents aged 0–19 years in India (Comprehensive National Nutrition Survey [CNNS]) offered an opportunity for this re-examination. Using this survey, we aimed to assess the age-specific and sex-specific percentiles of haemoglobin and cutoffs to define anaemia in the CNNS population. Methods For this population-based study, we constructed age-specific and sex-specific haemoglobin percentiles from values reported for a defined healthy population in the CNNS, which used rigorous quality control measures during sample collection and in the laboratory analyses. To obtain a healthy population, we excluded participants with iron, folate, vitamin B12, and retinol deficiencies; inflammation; variant haemoglobins (haemoglobin A2 and haemoglobin S); and history of smoking. We considered age-specific and sex-specific 5th percentiles of haemoglobin derived for this healthy population as the study cutoff to define anaemia. We compared these with existing WHO cutoffs to assess significant differences between them at each year of age and sex for quantifying the prevalence of anaemia in the entire CNNS sample. Findings Between Feb 24, 2016, and Oct 26, 2018, the CNNS survey collected blood samples from 49 486 individuals. 41 210 participants had a haemoglobin value, 8087 of whom were included in our study and comprised the primary analytical sample. Compared with existing WHO cutoffs, the study cutoffs for haemoglobin were lower at all ages, usually by 1–2 g/dL, but more so in children of both sexes aged 1–2 years and in girls aged 10 years or older. Aanemia prevalence with the study cutoffs was 19·2 percentage points lower than with WHO cutoffs in the entire CNNS sample with valid haemoglobin values across all ages and sexes (10·8% with study cutoffs vs 30·0% with WHO cutoffs). Interpretation These findings support the re-examination of WHO haemoglobin cutoffs to define anaemia. Our haemoglobin reference percentiles, derived from healthy participants in a large representative Indian survey, are suitable for national use in India. Substantial variations in the 5th percentile of haemoglobin values across the 1–19 years age range and between sexes argue against constructing common cutoffs in stratified age groups for convenience. Funding None. Translations For the Hindi, Punjabi, Tamil and Kannada translations of the abstract see Supplementary Materials section.

Background The stability of biological samples is vital for reliable measurements of biomarkers in large-scale survey settings, which may be affected by freeze-thaw procedures. We examined the effect of a single freeze-thaw cycle on 13 nutritional, noncommunicable diseases (NCD), and inflammatory bioanalytes in serum samples. Method Blood samples were collected from 70 subjects centrifuged after 30 minutes and aliquoted immediately. After a baseline analysis of the analytes, the samples were stored at − 70°C for 1 month and reanalyzed for all the parameters. Mean percentage differences between baseline (fresh blood) and freeze-thaw concentrations were calculated using paired sample t-tests and evaluated according to total allowable error (TEa) limits (desirable bias). Results Freeze-thaw concentrations differed significantly (p < 0.05) from baseline concentrations for soluble transferrin receptor (sTfR) (− 5.49%), vitamin D (− 12.51%), vitamin B12 (− 3.74%), plasma glucose (1.93%), C-reactive protein (CRP) (3.45%), high-density lipoprotein (HDL) (7.98%), and cholesterol (9.76%), but they were within respective TEa limits. Low-density lipoprotein (LDL) (− 0.67%), creatinine (0.94%), albumin (0.87%), total protein (1.00%), ferritin (− 0.58%), and triglycerides (TAG) (2.82%) concentrations remained stable following the freeze-thaw cycle. In conclusion, single freeze-thaw cycle of the biomarkers in serum/plasma samples after storage at − 70°C for 1 month had minimal effect on stability of the studied analytes, and the changes in concentration were within acceptable limit for all analytes.

Tailored, one-on-one counseling delivered via cell phone was very effective in retaining mothers with HIV in care and in promoting infant HIV testing and antenatal and postnatal care attendance. The highest risk of loss to follow-up among women with HIV accessing PMTCT services was prior to delivery and then after infant HIV testing at 6 weeks. Challenges include continued limited access to cell phones, difficulty with reaching participants on the phone, and poor adherence to antiretroviral therapy for a substantial percentage of the population., Background: We evaluated the effectiveness of a cell phone counseling intervention to promote retention in care and HIV testing of infants among women with HIV accessing prevention of mother-to-child services in Kisumu, Kenya. Methods: Between May 2013 and September 2015, we recruited 404 pregnant women with HIV who were between 14 and 36 weeks of gestation and randomly assigned them to the intervention (n=207) or control arm (n=197). Retention was assessed at delivery and at 6 and 14 weeks postpartum. We also measured uptake of infant HIV testing. The intervention comprised a fixed protocol of counselor-delivered phone calls to provide one-to-one need-based support. The number of calls made varied depending on when participants presented for antenatal care services; the maximum number was 42. The control group received routine care. We evaluated retention at 3 time points using the complementary log-log regression model taking into account factors associated with retention and loss to follow-up time. We calculated the incidence rate for HIV transmission among infants and used binary logistic regression to identify predictors of HIV infection among infants. Results: Participants attended on average 63% of the required number of counseling calls during the study period. Retention was higher in the intervention arm than the control arm at delivery (95.2% vs. 77.7%, respectively); 6 weeks postpartum (93.9% vs. 72.9%, respectively); and 14 weeks postpartum (83.3% vs. 66.5%, respectively) (P90%, used to assess adherence to ART, was associated with lower odds of a positive HIV test among infants (adjusted odds ratio=0.20; 95% CI=0.04, 0.99). Attendance at antenatal and postnatal care visits was higher among participants in the intervention arm than the control arm. Conclusions: The one-on-one tailored counseling delivered via cell phone was effective in retaining mothers with HIV infection in care and promoting uptake of infant HIV testing and antenatal and postnatal care services. Phone counseling offers a practical approach to reach and retain pregnant women with HIV infection and postpartum mothers in care, but greater emphasis on collection of medications and adherence is required.

Background: Stunting and underweight are the most commonly used indicators to assess the nutritional status of children. Prior research has highlighted the problems encountered while measuring the height of child. The current paper aims to assess the relationship between stunting and underweight and derive regression equations to predict stunting from underweight prevalence among children under five years of age.Method: Data was drawn from 38,060 and 219,796 nationally representative sample of children aged 0-4 years, from Comprehensive National Nutrition Survey (CNNS, 2016-18) and National Family Health Survey 4 (NFHS-4, 2015-16), respectively. Anthropometric indicators, stunting and underweight was calculated based on the 2006 WHO Child Growth Standards. Univariate and bivariate analysis was done to obtain estimates for stunting and underweight. A series of regression models were run to obtain an estimate of percent stunted as a function of percent underweight at the national and regional level. Predicted stunting prevalence was estimated from regression equation for selected states and compared with observed prevalence from other studies. Data were analysed using STATA V.16.0. Results: Nearly one out of four children under 5 years of age were stunted and underweight in CNNS and NFHS-4. Out of those stunted, 67% and 65% were underweight in CNNS and NFHS-4, respectively. At the national level, there was high correlation between the two indicators (r > 0.7) in both CNNS and NFHS-4, whereas at the regional level in NFHS-4, the correlation coefficient ranged from 0.32 for central region to 0.86 for southern region. At the national level the slope was 0.557 in CNNS and 0.610 in NFHS-4. At the regional level, it varied from 0.334 in the central region to 0.847 in the western region. Similarly, at the national level, the intercept (α) was almost same when we analyzed CNNS data or NFHS-4 data or both together (~15), however, wide variability was observed between different regions (4.61 in western region to 30.14 in central region).Conclusion: Our analysis shows that regression equations with child underweight prevalence may be used to predict stunting where the quality of length/ height measurement is poor or unavailable, in regions where high correlation between the two indicators was found.

Background: Malnutrition is a complex phenomenon that has become a universal problem inhibiting human development. India is home of disproportionate height and weight of children including anemia are sign of malnutrition. This study aimed to examine child malnutrition by considering three parameters—stunting (short), underweight (thin), and/or anaemia—among children aged 1–9 years. Methods: This study used nationally representative data from the Comprehensive National Nutrition Survey (CNNS). The analytic sample was restricted to 25,885 children aged 1–9 years for whom data on height, weight, and haemoglobin level was available. This analytic sample was not significantly different from the total sample of 69,413. Based on World Health Organisation’s (WHO) cut-off for child growth standards, child malnutrition is defined as ‘severe’ if a child has suffered all 3 parameters—stunting, underweight, and anaemia, ‘mild/moderate’ if a child has suffered 1 or 2 parameters and ‘none’ if a child has not suffered from any of the 3 parameters. Univariate and bivariate analysis were used for descriptive associations and marginal effects probabilities were calculated using the ordinal logit regression model to identify the correlates of severe malnutrition. Results: Nine percent of children aged 1-9 years were severely malnourished in the country. The prevalence of malnutrition declined considerably with increasing age of children—13% in children aged 1–4 years to 6% in children aged 5–9 years. Severe malnutrition was significantly higher among higher birth order children, children born to illiterate mothers, children belonging to Scheduled Tribes and poor families, children living in rural areas and the eastern region of the country. Zinc deficiency was found more (22%, 95% CI:18.2–26.0) among severely malnourished children as compared to normal children (16%, 95% CI:13.9–17.3). Conclusions: Malnutrition is widely prevalent in children belonging to illiterate mothers, Scheduled Tribes, poor families, rural areas, and eastern region of the country. Frontline workers should identify such vulnerable children through regular monitoring of height, weight, and haemoglobin testing in their coverage areas.

Intra-individual coexistence of anthropometrically defined undernutrition and 'metabolic obesity', characterised by presence of at least one abnormal cardiometabolic risk factor, is rarely investigated in young children and adolescents, particularly in Low-and-Middle-Income-Countries undergoing rapid nutrition transition.Prevalence of biomarkers of metabolic obesity was related to anthropometric and socio-demographic characteristics in 5-19 years old participants from the population-based Comprehensive National Nutrition Survey in India (2016-2018). The biomarkers, serum lipid-profile (total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) and triglycerides), fasting glucose, and glycosylated hemoglobin (HbA1C), and all jointly were analysed in 22567, 23192, 25962 and 19143 participants, respectively.Overall (entire dataset), the prevalence of abnormalities was low (4.3-4.5%) for LDL and TC, intermediate for dysglycemia (10.9-16.1%), and high for HDL and triglycerides (21.7-25.8%). Proportions with ≥1 abnormal metabolic obesity biomarker(s) were 56.2% overall, 54.2% in thin (BMI-for-age -2 SD) and 59.3% in stunted (height-for-age -2 SD) participants. Comparable prevalence was evident in mild undernutrition (-1 to -2 SD). Clustering of two borderline abnormalities occurred in one-third, warranting active life-style interventions. Metabolic obesity prevalence increased with BMI-for-age. Among those with metabolic obesity, only 9% were overweight/obese (1 SD BMI-for-age). Among poor participants, triglyceride, glucose and HDL abnormalities were higher.A paradoxical, counter-intuitive prevalence of metabolic obesity biomarker(s) exists in over half of anthropometrically undernourished and normal-weight Indian children and adolescents. There is a crucial need for commensurate investments to address overnutrition along with undernutrition. Nutritional status should be characterized through additional reliable biomarkers, instead of anthropometry alone.

HIV testing services are an important component of HIV program and provide an entry point for clinical care for persons newly diagnosed with HIV. Although uptake of HIV testing has increased in Kenya, men are still less likely than women to get tested and access services. There is, however, limited understanding of the context, barriers and facilitators of HIV testing among men in the country. Data are from in-depth interviews with 30 men living with HIV and 8 HIV testing counsellors that were conducted to gain insights on motivations and drivers for HIV testing among men in the city of Nairobi. Men were identified retroactively by examining clinical CD4 registers on early and late diagnosis (e.g. CD4 of ≥500 cells/mm, early diagnosis and

Objective: Nationally representative percentiles for Waist Circumference (WC), Waist-to-Height-Ratio (WtHR) and Body Mass Index (BMI) are not available for children and adolescents in India. Methods: Using LMS method, age- and gender-specific reference growth charts were constructed for WC (n=68,261), WtHR (n=68,261) and BMI (n=67,741) from subjects aged 5-19 years who participated in a nationally representative survey. General obesity was defined as age-sex-specific BMI z-scores ≥95th percentile. Central obesity was defined in three ways: WC≥90th percentile, WtHR≥0·5 and both WC≥90th percentile and WtHR≥0·5 Findings: WC and BMI percentiles for boys and girls are lower than those previously reported from India and several other countries. The BMI percentiles are lower than the WHO 2007 reference population. The prevalence of general obesity using India specific BMI centiles was 2·9% (95%CI: 2·6,3·2). The prevalence of central obesity was 6·1% (95%CI: 5·7,6·6) using WC≥90thpercentile, 5·3% (95%CI: 5·0,5·7) using WtHR≥0·5 and 3·6% using both criteria. Three-fourth of children with general obesity also had central obesity based on WC≥90th. Conclusions: Indian children are thinner than Caucasian and other Asian children, and the global WHO reference population. Using India specific reference, the prevalence of central obesity is higher than general obesity, with a significant overlap between the two.

People living with HIV (PLHIV) on anti-retroviral treatment (ART) who drink are less adherent and more likely to engage in unprotected sex but the connections among these events are correlational. Using an adapted Timeline Follow-Back (A-TLFB) procedure, this paper examines the day by day interface of alcohol, medication adherence and sex to provide a fine grained understanding of how multiple behavioral risks coincide in time and space, explores concordance/discordance of measures with survey data and identifies potential recall bias. Data are drawn from a survey of behavior, knowledge and attitudes, and a 30 day TLFB assessment of multiple risk behaviors adapted for the Indian PLHIV context, administered to 940 alcohol-consuming, HIV positive men on ART at the baseline evaluation stage of a multilevel, multi-centric intervention study. On days participants drank they were significantly more likely to be medication non-adherent and to have unprotected sex. In the first day after their alcohol consuming day, the pattern of nonadherence persisted. Binge and regular drinking days were associated with nonadherence but only binge drinking co-occurred with unprotected sex. Asking about specific "drinking days" improved recall for drinking days and number of drinks consumed. Recall declined for both drinking days and nonadherence from the first week to subsequent weeks but varied randomly for sex risk. There was high concordance and low discordance between A-TLFB drinking and nonadherence but these results were reversed for unprotected sex. Moving beyond simple drinking-adherence correlational analysis, the A-TLFB offers improved recall probes and provides researchers and interventionists with the opportunity to identify types of risky days and tailor behavioral modification to reduce alcohol consumption, nonadherence and risky sex on those days.

Introduction Preanalytical conditions are critical for blood sample integrity and poses challenge in surveys involving biochemical measurements. A cross sectional study was conducted to assess the stability of select biomarkers at conditions that mimic field situations in surveys. Material and methods Blood from 420 volunteers was exposed to 2 - 8 °C, room temperature (RT), 22 - 30 °C and > 30 °C for 30 min, 6 hours, 12 hours and 24 hours prior to centrifugation. After different exposures, whole blood (N = 35) was used to assess stability of haemoglobin, HbA1c and erythrocyte folate; serum (N = 35) for assessing stability of ferritin, C-reactive protein (CRP), vitamins B12, A and D, zinc, soluble transferrin receptor (sTfR), total cholesterol, high density lipoprotein cholesterol (HDL), low density lipoprotein cholesterol (LDL), tryglicerides, albumin, total protein and creatinine; and plasma (N = 35) was used for glucose. The mean % deviation of the analytes was compared with the total change limit (TCL), computed from analytical and intra-individual imprecision. Values that were within the TCL were deemed to be stable. Result Creatinine (mean % deviation 14.6, TCL 5.9), haemoglobin (16.4%, TCL 4.4) and folate (33.6%, TCL 22.6) were unstable after 12 hours at 22-30°C, a temperature at which other analytes were stable. Creatinine was unstable even at RT for 12 hours (mean % deviation: 10.4). Albumin, CRP, glucose, cholesterol, LDL, triglycerides, vitamins B12 and A, sTfR and HbA1c were stable at all studied conditions. Conclusion All analytes other than creatinine, folate and haemoglobin can be reliably estimated in blood samples exposed to 22-30°C for 12 hours in community-based studies.

Unprotected sex, common among people who inject drugs, puts them and their partners at risk of sexually transmitted infections including human immunodeficiency virus (HIV). This analysis assesses the changes in sexual risk behavior with regular female partners (RFPs), among married men who inject drugs, before and after implementation of a HIV prevention intervention, and identifies correlates of unprotected sex. People who inject drugs (PWID) were assessed at three points: baseline, preintervention follow-up visit (FV)1, and postintervention FV2. Descriptive analysis was used for reporting changes in sexual behavior over time. Generalized estimating equation assessed the population-averaged change in self-reported unprotected sex with an RFP, attributable to intervention uptake. Multivariable logistic regression determined correlates of self-reported unprotected sex with an RFP at FV2. Findings suggest that the proportion of men reporting any unprotected sex remained high (baseline = 46.0%, FV1 = 43.5%, FV2 = 37.0%). A reduction was observed in unprotected sex after the intervention phase, but this could not be attributed to uptake of the intervention. Higher odds of self-reported unprotected sex with an RFP in the past three months at FV2 were associated with self-reported unprotected sex at baseline, living with family, and being HIV-negative. Married male PWID should receive counseling for safe sex with RFPs, especially those who are HIV-negative and live with their families.

To assess the prevalence and correlates of perinatal depression, 200 HIV-positive pregnant/post-partum women receiving antiretroviral therapy (ART) were interviewed at eight government ART centers in four states across India. 52.5% (105) participants had depressive symptomology (Edinburgh Postnatal Depression Scale score > 13) while 23% of the participants reported thoughts of self-harm; there was no difference between pregnant and postpartum participants. Poor illness perception was associated with depression (AOR, 1.09; 95%CI, 1.05, 1.14); there was no association between adherence and depression in this population.

Needle and syringe sharing is common among people who inject drugs and so is unprotected sex, which consequently puts their sex partners at risk of sexually transmitted infections (STIs) including HIV and other blood-borne infections, like hepatitis. We undertook a nested study with the regular female partners of men who inject drugs participating in a longitudinal HIV incidence study in Delhi, India. In-depth interviews were conducted with female partners of 32 men. The interviews aimed to gather focused and contextual knowledge of determinants of safe sex and reproductive health needs of these women. Information obtained through interviews was triangulated and linked to the baseline behavioural data of their partner (index men who injected drugs). The study findings illustrate that women in monogamous relationships have a low perception of STI- and HIV-related risk. Additionally, lack of awareness about hepatitis B and C is a cause of concern. Findings also suggest impact of male drug use on the fertility of the female partner. It is critical to empower regular female partners to build their self-risk assessment skills and self-efficacy to negotiate condom use. Future work must explore the role of drug abuse among men who inject drugs in predicting fertility and reproductive morbidity among their female partners.

Background WHO, UNODC, and UNAIDS recommend a comprehensive package for prevention, treatment, and care of HIV among people who inject drugs (PWID). We describe the uptake of services and the cost of implementing a comprehensive package for HIV prevention, treatment, and care services in Delhi, India. Methods A cohort of 3774 PWID were enrolled for a prospective HIV incidence study and provided the comprehensive package: HIV and hepatitis testing and counseling, hepatitis B (HB) vaccination, syndromic management of sexually transmitted infections, clean needles-syringes, condoms, abscess care, and education. Supplementary services comprising tea and snacks, bathing facilities, and medical consultations were also provided. PWID were referred to government services for antiretroviral therapy (ART), TB care, opioid substitution therapy, and drug dependence treatment/rehabilitation. Results The project spent USD 1,067,629.88 over 36 months of project implementation: 1.7% on capital costs, 3.9% on participant recruitment, 26.7% for project management, 49.9% on provision of services, and 17.8% on supplementary services. Provision of HIV prevention and care services cost the project USD 140.41/PWID/year. 95.3% PWID were tested for HIV. Of the HIV-positive clients, only 17.8% registered for ART services after repeated follow-up. Reasons for not seeking ART services included not feeling sick, need for multiple visits to the clinic, and long waiting times. 61.8% of the PWID underwent HB testing. Of the 2106 PWID eligible for HB vaccination, 81% initiated the vaccination schedule, but only 29% completed all three doses, despite intensive follow-up by outreach workers. PWID took an average of 8 clean needles-syringes/PWID/year over the project duration, with a mid-project high of 16 needles-syringes/PWID/year. PWID continued to also procure needles from other sources, such as chemists. One hundred five PWID were referred to OST services and 267 for rehabilitation services. Conclusions A comprehensive HIV prevention, treatment, and care package is challenging to implement. Extensive efforts are needed to ensure the uptake of and retention in services for PWID; peer educators and outreach workers are required on a continuous basis. Services need to be tailored to client needs, considering clinic timing and distance from hotspots. Programs may consider provision of ART services at selected drop-in centers to increase uptake.

We present qualitative research investigating demand-side barriers to uptake of paediatric HIV services in Kenya. We explore community perceptions of services in 3 provinces where paediatric treatment is readily available but under-utilised, aiming to focus on demand-side obstacles and derive strategies for increasing uptake. We conducted focus-group discussions with openly HIV-positive parents and caregivers of children aged up to 15 years (n = 7 groups), and clinic- and community-based healthworkers (n = 13 groups); and individual in-depth interviews with managers and Ministry of Health representatives (n = 6 interviews). Results revealed low community awareness of medical indications for paediatric HIV testing, alongside widespread anxieties about potential infection routes. Care-seeking delays reflect strong perceived associations between antiretroviral treatment (ART) and mortality. Despite free drugs available from the Kenyan government, costs for laboratory services, medications for opportunistic infections, transportation and nutritional needs remain major obstacles. Attitudinal barriers include fatalistic beliefs about early death for infected children and reliance on traditional healers. Stigma reduces access, especially as paediatric testing represents a “window” into parental HIV status. Apprehensive caregivers fear the lifelong nature of ART and report adherence struggles. Even when paediatric ART is relatively accessible, demand-side barriers impede uptake and must be addressed at community and facility levels.

BACKGROUND: India has an estimated 177000 injection drug users (IDU) with a national HIV prevalence of 7.14%. Reliable estimates of HIV incidence are not available for this population. METHODS: We report HIV incidence in a cohort of male HIV-negative IDUs recruited through peer-referral targeted outreach and as walk-in clients in Delhi from May to October 2011. Fourth-generation Antigen-Antibody tests were used to diagnose new infections and results were confirmed using Western blot tests. HIV incidence based on HIV seroconversion was calculated as number of events/person-years. Cox regression was used to identify significant (p

Objectives Country decision-making regarding adoption of new health technologies is a lengthy process that is informed by scientific, public health, and policy analyses. Key Opinion Leaders (KOLs), who include a range of influential individuals (e.g., Ministry of Health officials, leaders of medical and pharmacy associations, civil society representatives, donors), play a critical role in country decision-making around adoption and availability of new HIV-prevention tools. Their perspectives can shape public opinion and influence policy, programming, and procurement decisions. Methods In-depth face-to-face interviews with a dozen purposefully selected national KOLs in India were conducted to gain their perspectives around ARV-based prevention for women, focusing on microbicides in general and tenofovir vaginal gel specifically. Theme-based content emerged and was analyzed using ATLAS.ti software. Results While generally supportive, KOLs expressed caveats regarding the role tenofovir gel might play in the overall HIV-prevention program. Key outstanding issues that would need to be addressed include product effectiveness, potential for resistance, product cost, feasibility of HIV testing and re-testing, and effective targeting of key populations for public health impact. Conclusions As new HIV-prevention technologies advance through clinical trials, there is a concomitant necessity to engage in policy analysis exercises. Formative research with stakeholders early in the process is an important yet often overlooked step. The potential role that the tenofovir gel could play in India will depend in large part on epidemiological, public health, and economic factors. Understanding target populations' perspectives on the product will also be critical for its successful introduction.

We report baseline findings from a longitudinal cohort study to examine HIV incidence, high-risk injection and sexual behaviors of 3,792 male injection drug users (IDUs) in Delhi. The majority (95.4 %) accepted HIV testing; HIV prevalence was 21.9 %. In multivariate analysis, belonging to states adjacent to Delhi (AOR: 1.23; 95 % CI: 1.07-1.52), earning INR 500-1,500 (AOR: 2.38; 95 % CI: 1.43-3.96); duration of drug use 2-5 years (AOR: 2.02; 95 % CI: 1.09-3.73), 6-10 years (AOR: 2.81; 95 % CI: 1.55-5.11), ≥11 years (AOR: 3.35; 95 % CI: 1.84-6.11); prior HIV testing (AOR: 1.60; 95 % CI: 1.35-1.91), self-reported risky-injection behavior (AOR: 1.60; 95 % CI: 1.33-1.92), and utilization of harm-reduction services (AOR: 1.32; 95 % CI: 1.11-1.58) were positively associated with HIV infection. Alcohol use ≤2 times/week (AOR: 0.67; 95 % CI: 0.55-0.82) or ≥3 times/week (AOR: 0.74; 95 % CI: 0.54-1.01), unit increase in age (AOR: 0.99; 95 % CI: 0.98-1.00), ≥7 years of schooling (AOR: 0.82; 95 % CI: 0.66-1.02) and unsafe sex with any female partner (AOR: 0.69; 95 % CI: 0.55-0.86) were negatively associated with HIV infection. HIV prevalence remains high among male IDUs in Delhi. HIV prevention programs should include comprehensive package of services for IDUs.

Respondent-driven sampling was used to recruit female sex workers (FSWs) for a community survey conducted in southern India. After survey completion, participants were given a brochure describing a clinical trial that entailed daily use of a placebo vaginal gel for four months. This study assessed predictors of screening among survey respondents, predictors of enrollment among those eligible for the trial, and predictors of visit attendance and retention among those enrolled. FSWs who reported having symptoms of sexually transmitted infections (STI), engaging in sex work in the past month, and living in a subdistrict easily accessible by public transportation with a high concentration of FSWs, were more likely to screen. FSWs who had never been tested for HIV were more likely to enroll. This analysis suggests that the primary reason FSWs participated in the trial was a desire for health care-not other factors hypothesized to be important, e.g., HIV risk perception and poverty status.

Background The reliability and validity of self-reports of vaginal microbicide use are questionable given the explicit understanding that participants are expected to comply with study protocols. Our objective was to optimize the Population Council's previously validated dye stain assay (DSA) and related procedures, and establish predictive values for the DSA's ability to identify vaginally inserted single-use, low-density polyethylene microbicide applicators filled with hydroxyethylcellulose gel.

HIV and AIDS remain highly stigmatised. Modified directly observed therapy (m-DOT) supports antiretroviral treatment (ART) adherence but little is known about its association with perceived stigma in resource-constrained settings. In 2003, 234 HIV-infected adults enrolled in a two-arm randomised trial comparing a health centre-based m-DOT strategy with standard self-administration of ART. Data on perceived stigma were collected using Berger's HIV stigma scale prior to starting ART and after 12 months. This was a secondary analysis to examine whether perceived stigma was related to treatment delivery. Perceived stigma scores declined after 12 months of treatment from a mean of 44.9 (sd=7.6) to a mean of 41.4 (sd=7.7), (t=6.14, P

The effectiveness of modified-directly observed therapy (m-DOT), an adherence support intervention adapted from TB DOTS programmes, has been documented. Describing the implementation process and acceptability of this intervention is important for scaling up, replication in other settings and future research. In a randomised trial in Mombasa, Kenya, patients were assigned to m-DOT or standard of care for 24 weeks. m-DOT entailed twice weekly visits to a health centre for medication collection, ongoing adherence counselling and nurse-observed pill ingestion. Community health workers (CHWs) traced non-attendees, observing pill taking at participant's home. Using process indicators and a semi-structured questionnaire, implementation of m-DOT was evaluated among 94 participants who completed 24 weeks m-DOT (81%; 94/116). Two-thirds of m-DOT recipients were female (64%; 74/116) and a mean 37 years (SD = 7.8). Selection of the m-DOT observation site was determined by proximity to home for 73% (69/94), with the remainder choosing sites near their workplace, or due to perceived high-quality services. A median 42 of 48 scheduled m-DOT visits (IQR = 28-45) were attended. Most found m-DOT is very useful (87%; 82/94) and had positive attitudes to the services. A high proportion received CHWs home visits (96%; 90/94) and looked forward to these. Use of CHWs and several satellite observation sites facilitated provision of services closer to patient's homes. A substantial number, however, thought 24 weeks of m-DOT was too long (43%; 42/94). Our experience suggests that m-DOT services could be implemented widely and are acceptable if delivered with adequate attention to coordination, provision of a broad set of interventions, shifting tasks to less-specialised workers and integration within the health system. m-DOT programmes should utilise existing resources while simultaneously expanding capacity within communities and the public sector. These findings could be used to inform replication of such services and to improve the design of m-DOT in future studies.

ObjectivesTo explore contextual factors that increase vulnerabilities to negative sexual and reproductive health (SRH) outcomes and possible differences in SRH-related behaviours and the needs of women who use drugs (WUD) through non-injecting and injecting routes.DesignQualitative study design using semi-structured in-depth interviews.ParticipantsTwenty women who injected drugs in the past 3 months and 28 women who reported using drugs through non-injecting routes in the past 1 month.SettingInterviews were conducted at community-based, drop-in centres in Delhi, India.ResultsStudy findings illustrate that WUD were sexually active and had multiple sex partners including clients of sex work. Transient relationships were reported and many participants engaged in unsafe sex. Factors which affected safe sex behaviours included: gender power imbalance, limited agency for decision-making, lack of accurate information for correct self-risk assessment, and being under the influence of drugs. Despite high awareness, low and inconsistent contraceptive use was reported. Some participants were coerced to conceive while a few others reported their inability to conceive. Violence was a key determinant for SRH outcomes. Perception of certain adverse health outcomes (such as infertility) to be ‘common and expected among WUD’ influenced access to healthcare. Further, healthcare providers’ stigmatising attitudes and lack of women-centric services deterred women from uptake of healthcare services.ConclusionFindings highlight that SRH-related behaviours and needs of this group are a complex interplay of multiple determinants which need to be addressed at all levels: individual, family, community and institutional. It is imperative to roll out a ‘one-stop-shop’ for a comprehensive package of health services. Expansion of existing drop-in-centres could be considered for setting-up community-based women-centric services with appropriate linkage to drug dependence treatment and reproductive health services.

Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report duration of recruitment and lessons learned from a two-stage process to recruit female sex workers (FSWs) into a placebo microbicide trial, and examined characteristics associated with successful recruitment of peers who screened for and enrolled in the trial. FSWs were first recruited via respondent-driven sampling (RDS) to complete a survey and subsequently invited to screen for enrollment into a placebo microbicide trial taking place at a local clinic. It took 6 months to enroll 267 participants into the trial. Successful recruiters of peers who enrolled were more likely to have enrolled themselves (AOR 2.0, CI 1.3–2.9) and less likely to visit Nellore city (AOR 0.5, CI 0.3–0.9). Recruitment of FSWs via a two-stage recruitment strategy with RDS can be a good option for future clinical trials.

Female sex workers (FSWs) were recruited for a 4-month placebo vaginal gel trial in Nellore, India. Two experiments explored if prior knowledge of biomarkers for unprotected sex and insertion of gel applicators would yield more accurate self-reports. A third experiment compared self-reports of gel use and adherence levels between FSWs randomly assigned to interactive voice response survey (IVRS) and those assigned to paper diaries. Prior knowledge of biomarkers did not improve accuracy of self-reported condom or gel use, nor did it affect actual adherence. Of those who tested positive for the presence of semenogelin in the vagina, 76 % reported no unprotected sex in the previous 48 h. Overall, women reported using gel on 90 % of days whereas the biomarker indicated gel use on fewer than 50 % of days. Compliance to IVRS was low, despite familiarity with mobile phone technology. Additional explorations with other populations are needed.

Individuals testing HIV positive were interviewed at testing centers, followed prospectively and interviewed again when they registered at referral antiretroviral therapy (ART) centers (ARTCs). Those who did not register at ARTCs were traced and interviewed in the community. A total of 1057 newly diagnosed people living with HIV (PLHIV; 52% women; mean age, 34.7 years) were recruited. A total of 73.5% of PLHIV registered at referral ARTCs within 60 days, 17.9% did not register and were interviewed in the community, and 8.6% were not interviewed. The 2 main reasons cited for not registering were a perception of good health (30%) and work/family engagements (22%). Single clients (adjusted relative risk [ARR]: 1.54; 95% confidence interval [CI]: 1.02-2.34), participants who had not disclosed their HIV status (ARR: 2.32; 95%CI: 1.77-3.05), participants who knew a PLHIV (ARR: 1.89; 95% CI: 1.41-2.53), and participants from laborer households (ARR: 2.66; 95%CI:1.15-6.15) were more likely to not register. In conclusion, the majority of newly diagnosed PLHIV do reach ARTCs. Disclosure concerns and a perception of good health prevent PLHIV from accessing services.

Short Summary: Four-month placebo vaginal gel trial conducted to determine the feasibility of recruiting FSWs for future Phase 2/3 microbicide trials. RH morbidity and HIV and STI prevalence are reported. Women constitute 38% of India’s 2.4 million HIV-infected persons. Microbicides are potential HIV-prevention products currently undergoing clinical trials for efficacy. A four-month placebo vaginal gel trial was conducted in Nellore, India to determine the feasibility of recruiting a suitable cohort of female sex workers (FSWs) for a future vaginal microbicide efficacy trial. We report on the HIV and STI prevalence and reproductive health (RH) morbidity of FSWs screened for the trial. Results: 529 FSWs completed screening procedures; of those 33.6% were found ineligible. The mean age was 30.9 years; 68.6% women were married and 57.5% were home-based FSWs. Self-reported symptoms included abnormal vaginal discharge (31.6%), genital itching (3.4%), uterine mass/prolapse (3%) and painful intercourse (2.6%). Gynecological surgery was reported by 73.2% of participants; of those 10.5% had undergone a hysterectomy. Female sterilization was the most commonly reported contraceptive method. Pelvic examination showed vaginal discharge (50.7%), cervical discharge (5.3%), uterine/vaginal wall prolapse (2.6%), and cervical mass/nodule/vesicles/genital warts (4.2%). Common epithelial findings included erythema (79.1%) and vesicles/bullae (6%); 46% of participants had Papanicolaou tests graded as inflammatory and 1.1% as malignant. HSV-2 was the mostly commonly detected STI (60.7%) followed by trichomoniasis (15.5%), HIV (5.3%), syphilis (2.8%), chlamydia (2.2%) and gonorrhoea (0.7%). RTIs were more common: bacterial vaginosis (27.8%) and candidiasis (18.9%). Conclusions: The low HIV prevalence and high RH morbidity in the population makes this site unsuitable for a future phase 2 or 3 microbicide efficacy trial. HIV prevention programs targeting this population should include access to RH services.

Introduction : According to UNAIDS, the world currently has an adequate collection of proven HIV prevention, treatment and diagnostic tools, which, if scaled up, can lay the foundation for ending the AIDS epidemic. HIV operations research (OR) tests and promotes the use of interventions that can increase the demand for and supply of these tools. However, current publications of OR mainly focus on outcomes, leaving gaps in reporting of intervention characteristics, which are essential to address for the utilization of OR findings. This has prompted WHO and other international public health agencies to issue reporting requirements for OR studies. The objective of this commentary is to review experiences in HIV OR intervention design, implementation, process data collection and publication in order to identify gaps, contribute to the body of knowledge and propose a way forward to improve the focus on “implementation” in implementation research. Discussion : Interventions in OR, like ordinary service delivery programmes, are subject to the programme cycle, which continually uses insights from implementation and the local context to modify service delivery modalities. Given that some of these modifications in the intervention may influence study outcomes, the documentation of process data becomes vital in OR. However, a key challenge is that study resources tend to be skewed towards documentation and the reporting of study outcomes to the detriment of process data, even though process data is vital for understanding factors influencing the outcomes. Conclusions : Interventions in OR should be viewed using the lens of programme evaluation, which includes formative assessment (to determine concept and design), followed by process evaluation (to monitor inputs and outputs) and effectiveness evaluation (to assess outcomes and effectiveness). Study resources should be equitably used between process evaluation and outcome measurement to facilitate inclusion of data about fidelity and dose in publications in order to enable explanation of the relationship between dosing and study outcomes for purposes of scaling up and further refinement through research. Keywords: operations research; implementation research; intervention fidelity; process evaluation; intervention publication. (Published: 20 July 2016) Citation: Kalibala S et al. Journal of the International AIDS Society 2016, 19(Suppl 4) :20842 http://www.jiasociety.org/index.php/jias/article/view/20842 | http://dx.doi.org/10.7448/IAS.19.5.20842

In Mombasa, Kenya, a community-based HIV risk-reduction intervention effectively reached people living with HIV who were not receiving antiretroviral treatment (ART)—a difficult-to-reach population because they often fall outside the ambit of health care services—and succeeded in reducing reported risky sex behavior and increasing ART uptake., Background: We report effectiveness of an HIV-prevention intervention delivered by community health workers (CHWs) in Mombasa, Kenya, to PLHIV who have not initiated or who have discontinued ART—an often difficult-to-reach population because they fall outside the ambit of health care and prevention services. Methods: A 2-arm cohort study assessed a structured risk-reduction intervention involving at least 4 one-to-one counseling sessions and personalized support. The control group received standard prevention services. CHWs recruited treatment-naïve people living with HIV (PLHIV) or those who had previously taken antiretroviral drugs. Data were analyzed using a Propensity Score Matched (PSM)-sample to control for baseline differences between the groups. Results: 634 PLHIV were recruited and followed for 6 months. Median age was 35 years, and 74.3% were female. Participants in the intervention group reported reduced risky sexual behaviors both at endline compared with baseline and compared with the control group. At endline, in the PSM analysis, participants in the intervention arm were less likely than participants in the control group to report unprotected sex with a spouse (Odds Ratio [OR] = 0.08, 95% confidence interval [CI] = 0.03-0.24), and they reported fewer unprotected sex acts (12.3% versus 46.0%, respectively; OR = 0.16, 95% CI = 0.09-0.29; P

Background HIV spread continues at high rates from infected persons to their sexual partners. In 2009, an estimated 2.6 million new infections occurred globally. People living with HIV (PLHIV) receiving treatment are in contact with health workers and therefore exposed to prevention messages. By contrast, PLHIV not receiving ART often fall outside the ambit of prevention programs. There is little information on their sexual risk behaviors. This study in Mombasa Kenya therefore explored sexual behaviors of PLHIV not receiving any HIV treatment. Results Using modified targeted snowball sampling, 698 PLHIV were recruited through community health workers and HIV-positive peer counsellors. Of the 59.2% sexually-active PLHIV, 24.5% reported multiple sexual partners. Of all sexual partners, 10.2% were HIV negative, while 74.5% were of unknown HIV status. Overall, unprotected sex occurred in 52% of sexual partnerships; notably with 32% of HIV-negative partners and 54% of partners of unknown HIV status in the last 6 months. Multivariate analysis, controlling for intra-client clustering, showed non-disclosure of HIV status (AOR: 2.38, 95%CI: 1.47-3.84, p < 0.001); experiencing moderate levels of perceived stigma (AOR: 2.94, 95%CI: 1.50-5.75, p = 0.002); and believing condoms reduce sexual pleasure (AOR: 2.81, 95%CI: 1.60-4.91, p < 0.001) were independently associated with unsafe sex. Unsafe sex was also higher in those using contraceptive methods other than condoms (AOR: 5.47, 95%CI: 2.57-11.65, p < 0.001); or no method (AOR: 3.99, 95%CI: 2.06-7.75, p < 0.001), compared to condom users. Conclusions High-risk sexual behaviors are common among PLHIV not accessing treatment services, raising the risk of HIV transmission to discordant partners. This population can be identified and reached in the community. Prevention programs need to urgently bring this population into the ambit of prevention and care services. Moreover, beginning HIV treatment earlier might assist in bringing this group into contact with providers and HIV prevention services, and in reducing risk behaviors.

In 2009, Kenya had an estimated 1.5 million people living with HIV and in the same year an estimated 110,000 people were newly infected with HIV. HIV continues to spread in the population despite the existence of prevention programmes. HIV can only be spread from a HIV-positive person to HIV-negative person or in some cases even to HIV-positive person with a different viral strain. Thus PLHIV are a key target group for prevention programmes. This thesis is based on four research studies conducted with PLHIV in Mombasa, Kenya between 2004 and 2008. The first of these studies (articles 1-3) were conducted with PLHIV when ART was first rolled out in Kenya with USAID support. These studies were among the first to examine sexual risk behaviours in the context of ART. Findings from these studies documenting higher risk behaviours among PLHIV co-trimoxazole prophylaxis for opportunistic infections led to the fourth study exploring sexual risk behaviours among PLHIV in the community who were not receiving any treatment. Evidence from that study has led to a fifth study presently underway in Mombasa that evaluates a community based HIV prevention intervention delivered by CHWs for PLHIV in the community not receiving treatment. The studies presented in this thesis provide an overview of sexual behaviours of three different subgroups of PLHIV: (1) PLHIV who a receiving ART and therefore are in regular contact with health workers and prevention services; (2) PLHIV who are not eligible for ART but are visiting health services for follow up services and receiving cotrimoxazole prophylaxis for opportunistic infections and therefore continue to have contact with health workers, and (3) PLHIV in the community who are not accessing HIV care services and therefore do not have contact with health workers or prevention services. Key findings: Sexual risk behaviours defined as multiple sexual partnerships and unprotected sex with partners are prevalent to variable degree among the various PLHIV subgroups; PLHIV not receiving any treatment exhibit the highest level of risky behaviours. A major concern to prevention programmes is the reporting of unprotected sex with sero-discordant or unknown status sexual partners. A large section of PLHIV have partners of unknown HIV status or untested partners; 75 percent of the partners of PLHIV not accessing HIV care services were of unknown HIV status. Non-disclosure of HIV status to partners, perceived or internalized stigma and depression were significantly associated with unprotected sex. We did not find any evidence of an increase in sexual risk behaviours after 12 months of ART; in fact we noted a significant decrease in the proportion of participants reporting unprotected sex with HIV-negative or untested partners after 12 months on ART. Qualitative data revealed that PLHIV attempt to control risky behaviours after testing positive or starting ART, but struggle with disclosure, fear of abandonment, partner reaction or refusal to test, and misconceptions and religious beliefs pertaining to safe sex, condom use and gender norms. Further research is needed to better understand the factors that influence sexual risk behaviours. There is urgent need for intervention research to identify effective HIV prevention strategies or interventions that are acceptable in this community.

The Access-to-Treatment research initiative of the Population Council's Horizons program undertook 11 projects across Asia and sub-Saharan Africa from 2002 to 2008. The projects included a variety of cross-sectional exploratory studies, situation analyses, and longitudinal randomized, controlled intervention studies that examined service delivery, community awareness, health-seeking behaviors, adherence, cost, and other factors affecting treatment for adults and children infected with human immunodeficiency virus (HIV). This article summarizes the key findings and lessons learned from these projects, and examines cross-cutting issues such as stigma, quality of life, and sexual-risk behaviors among people living with HIV and acquired immunodeficiency syndrome on antiretroviral therapy. The article concludes with recommendations for evidence-based programming and future research around treatment for both children and adults.

In-depth interviews were conducted with 23 sexually-active adults receiving antiretroviral treatment (ART) in Mombasa Kenya to understand changes in sexual behaviour after treatment initiation and factors influencing condom use. Advanced HIV disease had previously led to marked decreases in sexual desire and function. After HIV testing, numbers of partners reduced and monogamous relationships began to predominate. Receipt of ART strengthened these changes, while improving sexual health. However, concurrent sexual partnerships continue within polygamous marriage and unprotected sex occurs with regular partners, even those who are HIV-negative. Those who used condoms inconsistently prior to ART often remained inconsistent users thereafter. While disclosure of HIV status appeared to support condom use, this does not always predict protected sex. In addition to classic perceptions about condom's effect on intimacy and trust, traditional gender roles, misconceptions about potential harm from condoms and fertility desires hinder condom use.