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Introduction Tuberculosis (TB) continues to be one of the deadliest infectious diseases over the centuries, killing more people worldwide than any other single infectious disease. There is an urgent need for additional strategies which can expedite efforts to combat TB including a preventive vaccine. In this endeavour, we have developed a protocol for a multisite, double-blind, placebo-controlled clinical trial in India that aims to evaluate the efficacy and safety of two TB vaccines; namely, VPM1002 and Immuvac (M.w) (Mycobacterium Indicus Pranii) (MIP) among healthy household contacts (HHCs) of sputum smear-positive pulmonary TB (PTB) patients.Methods and analysis In the three-arm randomised double-blind placebo-controlled trial study protocol, a total of 12 000 HHCs (aged 6−99 years) of sputum smear-positive PTB patients will be randomised to receive either of the two vaccine candidates VPM1002 and MIP or placebo. The primary efficacy endpoint is the prevention of microbiologically confirmed TB. Secondary endpoints will include (1) prevention against Latent TB infection, (2) incidence of adverse events and serious adverse events in study participants, (3) efficacy of vaccine in prevention of PTB/extra PTB in different age groups (6–18 years, 19–35 years, 36–60 years and above 60 years) and (4) immunogenicity of VPM1002 and MIP at month 2 and month 6 after first vaccination in terms of flow cytometric analysis of M.Tb specific CD4+ and CD8+ T cells secreting cytokines and Luminex assays for the presence of different cytokines in the sera and supernatants of peripheral blood mononuclear cells cultures stimulated with whole cell lysates of M.Tb and subsequently similar analysis for the cases who develop TB postvaccination during the follow-up period.Ethics and dissemination Ethics committees’ approvals have been granted by the Institutional Human Ethics Committees of all participating centres in this study and the names of the ethics committees and approvals are as follows: (1) National Institute for Research in Tuberculosis (NIRT)-Chennai (including subsites): ECR/135/Inst/TN/2013/RR-19, Approval No. 390/NIRT-Institutional Ethics Committee (IEC)/2018 dated 5 December 2018 (NIRT-Madurai-ECR/1365/Inst/TN/2020; approval dated 8 June 2020; NIRT, Vellore: ECR/1215/Inst/TN/2019; approval dated 26 September 2020); (2) All India Institute of Medical Sciences (AIIMS), Delhi (including subsites)-Institute Ethics Committee, ECR/547/Inst/DL/2014/RR-17 ECR/538/Inst/DL/2014/RR-20; approval No.IEC-385/06-07-2018, approval OP-28/05.04.2019 and SFH- ECR/593/Inst/DL/2014/RR-20 IEC/VMMC/SJH/project/2019-05/25 ; 23 May 2019; (3) National Institute of Tuberculosis and Respiratory Diseases (NITRD), Delhi: ECR/315/Inst/DL/2013/RR-19; approval IEC-No-NITRD/EC/2019/9004; 8 January 2019; (4) Pune-National AIDS Research Institute (NARI) and subsite-ECR/23/Inst/MH/2013/RR-19; IEC-NARI/EC/approval/2018/196; 29 May 2018; (5) Regional Medical Research Centre-Bhubaneshwar-ECR/911/Inst/OR-2017/RR-21; approval, dated 25 April 2018; Subsites- AIIMS, Bhubaneshwar ECR/534/Inst/OD/2014/RR-17 and 20 approval No. T/EMF/Pulm. Med/19/01 dated 13 May 2019; SCB, Cuttack No. No.ECR/84/Inst/OR/2013/RR-20; approval no.186 dated 7 February 2020; (6) NTI-Bengaluru: Ethics Committee-No-ECR/1819/Inst/KA/2019; approval No NTI-IEC/1.2019/principal investigator, dated 31 January 2019; (7) BMMRC, Hyderabad- ECR/450/Inst/AP/2013/RR-16 approval No. 779/BMMRC/2018/IEC, dated 11 June 2018 (Subsite Share India- Mediciti Ethics Committee-ECR/283/Inst/AP/2013/RR-20; Approval no. EC/11/VII/2K20(1) dated 11 July 2020) and (8) SJMC-Bengaluru: ECR/238/Inst/KA/2013/RR-19; approval IEC/1/491/2020; 7 August 2020.The trial findings will be published in accordance with the Consolidated Standards of Reporting Trials guidance. The results of this clinical trial will be presented at scientific conferences and disseminated through publications in peer-reviewed journals, conference presentations and shared with Ministry of Health and Family Welfare, policy-makers and other stakeholders.Trial registration number CTRI/2019/01/017026.

Objectives: The effectiveness of lactobacilli-containing vaginal tablets (VT) in bacterial vaginosis (BV) recurrence prevention among women infected with HIV treated with standard oral metronidazole in Pune, India was studied. Methods: Women infected with HIV with confirmed BV diagnosis (Nugent score ≥7 and Amsel criteria >3) were enrolled in a 12-month, double-blind, randomized, placebo-controlled, phase IV study between 2018 and 2021. After a standard course of oral metronidazole for 7 days (400 mg three times a day), women were randomly assigned to either lactobacilli-containing or placebo VT arms to receive VTs for 4 months. BV recurrence was assessed after the initial cure from BV. Results: Of the 464 women infected with HIV, 80 women with confirmed BV were enrolled. The retention was affected due to the COVID-19 pandemic (6-month retention rates 78%). The cure was seen in 85% and 93.5% of participants from the treatment and placebo arms, respectively, after four VT cycles. BV recurrence was seen in 41.4% and 44.8% in the treatment and placebo arm, respectively, with no significant difference in the two groups. Conclusion: The lactobacilli-containing VT was acceptable and safe; however, the addition of VT over standard oral metronidazole did not show any additional benefit in the prevention of BV recurrence in women infected with HIV, indicating the need for long-term randomized trials among them. Registered at Clinical Trials Registry- India, (CTRI) Number: CTRI/2018/04/013298

Abstract Background Development of emotional distress (ED) among adolescents living with perinatally acquired HIV (ALPHIV) affects their adherence behaviour and social and psychological functioning. Data on stressors among ALPHIV demonstrates the gap on the predictors of ED experienced by ‘perinatally infected ALHIV’ in the Indian socio-cultural milieu. This study aimed to identify the predictors of ED and examine their mediating and moderating role in the development of ED among Indian ALPHIV. Methods Utilizing the sequential exploratory mixed-methods design, 43 qualitative interviews were conducted with ALPHIV, parents/guardians, and health care providers, followed by the cross-sectional survey among 100 ALPHIV (10–19 years). The distress subscale of the Weinberger Adjustment Inventory was used to measure ED. Qualitative data, analyzed using grounded theory were utilized to develop a survey tool. Bivariate and regression analyses were conducted to identify predictors of ED. Mediation and moderation models were tested to examine underlying mechanisms associated with ED. The study was approved by the institutional ethics committee. Results Strong parental control, compulsive asexuality, perceived negatively different from peers, and anger toward parents were the major themes emerging from the qualitative component which eventually led to survey tool domains viz., HIV awareness, parental control, hypervigilance, adolescent-parent relationship, adolescent-parent communication, body image and perceived negatively different from peers (PNDP). Quantitative analysis indicated high ED among ALPHIV and ED was significantly associated with PNDP, anger, body image, and hypervigilance. The relationship between PNDP and ED was significantly mediated by anger, and moderated by body image and hypervigilance. Conclusions The study stresses the need for early mental health interventions for Indian ALPHIV before an ALPHIV develops ED. Focused counseling on anger assessment, body image issues, and self-perception is critical for leading a 'normal' life by ALPHIV. Besides, skill building of primary caregivers is recommended to draw a line between protection and overprotection.

Abstract We describe a case of a 30-year-old MSM recently diagnosed with HIV, immunocompromised with a purplish or brown rash all over the body for 3 to 4 months. The histopathology of the cutaneous lesions and pleural effusion aspirate confirmed the diagnosis of Kaposi’s sarcoma (KS) and primary effusion lymphoma (PEL). While KS is one of the AIDS-defining illnesses seen in immunocompromised patients having low CD4 count, PEL is a rare and distinct subset of AIDS-related lymphoma. Despite the widespread availability of HIV testing, HIV diagnosis gets delayed due to stigma among MSM. This case report emphasizes the importance of early suspicion for symptoms of HIV-associated opportunistic infections in high-risk populations like MSM. The report reiterates the need for an ambient stigma-free environment for improving HIV screening in this high-risk population.

BackgroundIndia has successfully reduced Human Immuno-deficiency Virus (HIV) incidence, with a 66% decline since the year 2000 has been seen; however, control among Men having sex with Men (MSM) and transgender women (TGW) remains a critical challenge. Oral Pre-Exposure Prophylaxis (PrEP) may help close a critical HIV prevention gap for MSM and TGW in India; however, no studies to date have evaluated the feasibility of oral PrEP among MSM and TGW in India.MethodsThe proposed study aims at understanding the implementation of the provision of daily oral-Tenofovir (TDF) containing PrEP among MSM and TGW through the clinic and community-based delivery models in Pune, Maharashtra, and Jalandhar, Punjab respectively in India. The study aims at estimating PrEP adherence, facilitators, and barriers to PrEP use, retention, acceptability, and willingness to pay for PrEP. After the screening, eligible participants (n = 600) will receive PrEP medicines and will be monitored quarterly for HIV, STIs, and renal and liver toxicity for 12 months as per the schedule of events. The primary outcomes of interest are PrEP acceptability, PrEP adherence, retention rate, adverse medical events, and sexual behavioural changes with PrEP use and breakthrough infections while on PrEP. The study will assess the feasibility of two service delivery models; however, the data from the two service delivery models will be analyzed independently and will not be compared for feasibility and other outcome indicators. The study has been initiated after obtaining appropriate regulatory approvals.DiscussionPrEP is efficacious in preventing HIV among high-risk population however there are scarce data on providing PrEP to MSM and TGW. The study will provide critical evidence to programs and policymakers on the implementation of PrEP in a "real world" setting, among MSM and TGW in India including identifying populations that can benefit most from this additional HIV prevention intervention along with acceptable delivery strategies and means of support for adherence.Trial registrationNot applicable being a demonstration project. Efficacy is already proven.

BackgroundDespite the Link Worker Scheme to address the HIV risk and vulnerabilities in rural areas, reaching out to unreached men having sex with men (MSM) remains a challenge in rural India. This study explored issues around health care access and programmatic gaps among MSM in rural settings of India.MethodsWe conducted eight Focused Group Discussions (FGDs), 20 Key Informant Interviews (KIIs), and 20 In-Depth Interviews (IDIs) in four rural sites in Maharashtra, Odisha, Madhya Pradesh, and Uttar Pradesh between November 2018 and September 2019. The data in the local language were audio-recorded, transcribed, and translated. Data were analyzed in NVivo version 11.0 software using the grounded theory approach.ResultsPrimary barriers to health care access were lack of knowledge, myths and misconceptions, not having faith in the quality of services, program invisibility in a rural setting, and anticipated stigma at government health facilities. Government-targeted intervention services did not seem to be optimally advertised in rural areas as MSM showed a lack of information about it. Those who knew reported not accessing the available government facilities due to lack of ambient services, fear of the stigma transforming into fear of breach of confidentiality. One MSM from Odisha expressed, "…they get fear to go to the hospital because they know that hospital will not maintain confidentiality because they are local people. If society will know about them, then family life will be disturbed" [OR-R-KI-04]. Participants expressed the desire for services similar to those provided by the Accredited Social Health Activists (ASHA), frontline health workers for MSM.ConclusionProgramme invisibility emerges as the most critical issue for rural and young MSM. Adolescent and panthis emerged as Hidden MSM and they need focused attention from the programme. The need for village-level workers such as ASHA specifically for the MSM population emerged. MSM-friendly health clinics would help to improve healthcare access in rural MSMs under Sexual and Reproductive Health Care.

BackgroundThe public health interventions among Female Sex Workers (FSWs) have mainly addressed HIV/ STI prevention. The focus of the HIV prevention program on FSWs' Reproductive and Sexual Health (RSH) has been limited, thus, rendering them at a higher risk of unintended pregnancies, delayed pregnancy detection, and utilizing unsafe abortion methods.MethodsA multistakeholder analysis was performed to study access and use of RSH services among FSWs in urban and rural India. Between January 2016 and June 2019, a qualitative grounded theory approach was used to explore the FSWs' perspectives and experiences about services pertaining to HIV prevention, Antenatal Care (ANC), child delivery, abortion, and pregnancy prevention. Using purposive and convenience sampling, 29 In-Depth Interviews (IDIs), 2 Focus Group Discussions (FGDs) and 22 Key Informant Interviews (KIIs) were conducted with consenting FSWs and indirect stakeholders, respectively. Verbatim translated data was entered in NVivo12 Software and analyzed inductively.ResultsThe following themes emerged: (1) Condomless sex, unintended pregnancy, vertical transmission, (2) Signs/ indication used for pregnancy detection causing delay (3) Pregnancy prevention methods used, (4) Pregnancy prevention or AIDS prevention, (5) Legal formalities as a barrier to access RSH, (6) Differential facility preference.ConclusionPregnancy prevention is a greater motivation for condom use than HIV prevention among FSWs. Therefore, there is an emerging need to reallocate public health resources and redesign policies to meet the RSH needs of FSWs, especially for the prevention of unintended pregnancies. FSW-focused Information Education Communication (IEC) strategies for RSH service utilization are essential to reduce the burden of unintended pregnancies. The National HIV Targeted Intervention (TI) program needs to include pregnancy testing services and information to non-barrier contraceptive methods. An ambient policy environment calls for examining the need for male involvement in pregnancy, family planning and abortion decisions.

ObjectiveTo assess factors associated with COVID-19 stigmatizing attitudes in the community and stigma experiences of COVID-19 recovered individuals during first wave of COVID-19 pandemic in India.MethodsA cross-sectional study was conducted in 18 districts located in 7 States in India during September 2020 to January 2021 among adults > 18 years of age selected through systematic random sampling. Data on socio demographic and COVID-19 knowledge were collected from 303 COVID-19 recovered and 1,976 non-COVID-19 infected individuals from community using a survey questionnaire. Stigma was assessed using COVID-19 Stigma Scale and Community COVID-19 Stigma Scale developed for the study. Informed consent was sought from the participants. Univariate and multivariate binary logistic regression analysis were conducted.ResultsHalf of the participants (51.3%) from the community reported prevalence of severe stigmatizing attitudes toward COVID-19 infected while 38.6% of COVID-19 recovered participants reported experiencing severe stigma. Participants from the community were more likely to report stigmatizing attitudes toward COVID-19 infected if they were residents of high prevalent COVID-19 zone (AOR: 1.5; CI: 1.2–1.9), staying in rural areas (AOR: 1.5; CI:1.1–1.9), belonged to the age group of 18–30 years (AOR: 1.6; CI 1.2–2.0), were male (AOR: 1.6; CI: 1.3–1.9), illiterate (AOR: 2.7; CI: 1.8–4.2), or living in Maharashtra (AOR: 7.4; CI: 4.8–11.3). COVID-19 recovered participants had higher odds of experiencing stigma if they had poor knowledge about COVID-19 transmission (AOR: 2.8; CI: 1.3–6.3), were staying for 6–15 years (AOR: 3.24; CI: 1.1–9.4) in the current place of residence or belonged to Delhi (AOR: 5.3; CI: 1.04–26.7).ConclusionFindings indicated presence of stigmatizing attitudes in the community as well as experienced stigma among COVID-19 recovered across selected study sites in India during the first wave of COVID-19 pandemic. Study recommends timely dissemination of factual information to populations vulnerable to misinformation and psychosocial interventions for individuals affected by stigma.

Abstract Background Empowering female sex workers (FSWs) through women controlled HIV prevention option has been in focus globally. FSWs are important target for oral pre exposure prophylaxis (PrEP). A multi-centric qualitative study was conducted to explore the FSWs’ willingness to use oral PrEP in India. Methods Seventy three interviews and 02 focus group discussions were conducted at 3 high HIV prevalent states in India during 2013–14. Study explored issues around willingness to use oral PrEP. The study was approved by the respective institutional ethics committee of the study sites. Thematic analysis using grounded theory approach was used to analyze the data in N-VIVO version 8.0. Results Thematic analysis showed events of forced condom-less sex. FSWs believed that oral PrEP could provide independence, financial gains, and privacy and therefore hoped to use it as an alternative to male condom. However, any impact on physical/ aesthetic attributes and reproductive system were not acceptable and could become a barrier. Provider initiated oral PrEP was not preferred. Providers voiced safety monitoring concerns. Adherence emerged as a challenge because of: (1) alcohol use; (2) taking PrEP tablet each day being boring; (3) Stigma because Oral PrEP is ARV based. Alcohol use and dread of repetitive dose brings forth the need for long acting oral PrEP. Conclusion Oral PrEP is acceptable among FSWs; it should be rolled out alongside strong messages on STI protection and PrEP as compliment to condoms. PrEP roll out requires educating communities about HIV treatment versus prevention. Long-acting oral PrEP could address both ‘boredom’ and alcoholism and sustain adherence.

Background: Earlier serosurveys in India revealed seroprevalence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) of 0.73% in May–June 2020 and 7.1% in August–September 2020. A third serosurvey was conducted between December 2020 and January 2021 to estimate the seroprevalence of SARS-CoV-2 infection among the general population and healthcare workers (HCWs) in India. Methods: The third serosurvey was conducted in the same 70 districts as the first and second serosurveys. For each district, at least 400 individuals aged ≥10 years from the general population and 100 HCWs from subdistrict-level health facilities were enrolled. Serum samples from the general population were tested for the presence of immunoglobulin G (IgG) antibodies against the nucleocapsid (N) and spike (S1-RBD) proteins of SARS-CoV-2, whereas serum samples from HCWs were tested for anti-S1-RBD. Weighted seroprevalence adjusted for assay characteristics was estimated. Results: Of the 28,598 serum samples from the general population, 4585 (16%) had IgG antibodies against the N protein, 6647 (23.2%) had IgG antibodies against the S1-RBD protein, and 7436 (26%) had IgG antibodies against either the N protein or the S1-RBD protein. Weighted and assay-characteristic-adjusted seroprevalence against either of the antibodies was 24.1% [95% confidence interval (CI) 23.0–25.3%]. Among 7385 HCWs, the seroprevalence of anti-S1-RBD IgG antibodies was 25.6% (95% CI 23.5–27.8%). Conclusions: Nearly one in four individuals aged ≥10 years from the general population as well as HCWs in India had been exposed to SARS-CoV-2 by December 2020.

Abstract Background The potential use of the broadly neutralizing monoclonal antibodies (bnAbs) towards prophylaxis and treatment to HIV-1 is currently being explored. While a number of promising bnAbs have been discovered and a few of them have progressed towards clinical development, their extent of neutralization coverage with respect to global HIV-1 variants given the existence of genetically distinct subtypes and recombinants circulating globally is not clearly known. In the present study, we examined the variation in the neutralization susceptibility of pseudoviruses expressing 71 full length primary HIV-1 subtype C envs obtained from limited cross-sectional individuals over different time points against four bnAbs that target gp120 with distinct specificities: VRC01, CAP256-VRC26.25, PGDM1400 and PGT121. Results We found significant variations in the susceptibility of Indian clade C to these four bnAbs. These variations were found to be distinct to that observed in African subtype C based on the existing datasets and concordant with their sequence diversity. Trend analysis indicated an increasing neutralization resistance observed over time with CAP25-VRC26.25, PGDM1400 and PGT121 when tested on pseudoviruses expressing envs obtained from 1999 to 2016. However, inconsistent trend in neutralization susceptibility was observed, when pseudoviruses expressing envs obtained from three followed up individuals were examined. Finally, through predictive analysis of the 98 Indian subtype C including those assessed in the present study by employing additive model implemented in CombiNAber ( http://www.hiv.lanl.gov ), we observed two possibilities where combinations of three bnAbs (VRC01/CAP56-VRC26.25/PGT121 and PGDM1400/CAP256-VRC26.25/PGT121) could achieve near 100% neutralization coverage. Conclusions Our findings not only indicate disparate intra-clade C genetic vis-à-vis neutralization diversities but also warrant the need for more comprehensive study using additional isolates towards comparing inter and intra-clade neutralization diversities which will be necessary for selecting the bnAb combinations suitable for optimal coverage of the region-specific HIV-1 circulating subtypes. Expanding these efforts is imperative for designing efficacious bnAb based intervention strategies for India as well as subtype C in general.

Abstract Little is known about the interactive effects of exogenous nitric oxide (NO) and abscisic acid (ABA) on nitrogen (N) metabolism and related changes at molecular and biochemical levels under drought stress. The present study highlights the independent and combined effect of NO and ABA (grouped as “nitrate agonists”) on expression profiles of representative key genes known to be involved in N-uptake and assimilation, together with proline metabolism, N–NO metabolism enzyme’s activity and nutrient content in polyethylene glycol (PEG) treated roots of Indian mustard (B. juncea cv. Varuna). Here we report that PEG mediated drought stress negatively inhibited growth performance, as manifested by reduced biomass (fresh and dry weight) production. Total N content and other nitrogenous compounds (NO3 −, NO2 −) were decreased; however, NH4 +, NH4 +/ NO3 − ratio and total free amino acids content were increased. These results were positively correlated with the PEG induced changes in expression of genes and enzymes involved in N-uptake and assimilation. Also, PEG supply lowered the content of macro- and micro-nutrients but proline level and the activity of ∆1-pyrroline-5-carboxylate synthetase increased indicating increased oxidative stress. However, all these responses were reversed upon the exogenous application of nitrate agonists (PEG + NO, PEG + NO + ABA, and PEG + ABA) where NO containing nitrate agonist treatment i.e. PEG + NO was significantly more effective than PEG + ABA in alleviating drought stress. Further, increases in activities of L-arginine dependent NOS-like enzyme and S-nitrosoglutathione reductase were observed under nitrate agonist treatments. This indicates that the balanced endogenous change in NO and ABA levels together during synthesis and degradation of NO mitigated the oxidative stress in Indian mustard seedlings. Overall, our results reveal that NO independently or together with ABA may contribute to improved crop growth and productivity under drought stress.

Background: To control the transmission of the coronavirus disease 2019 (COVID-19) infection, the Government of India (GoI) had taken stringent precautionary measures during the lockdown period. This study aimed to explore determinants affecting adherence to protective measures against COVID-19 infection among rural and semi-urban settings of Maharashtra, India.Methods: A cross-sectional telephonic survey among 1,016 adults from randomly selected households was conducted between June 5 and July 16, 2020. The data were explored for knowledge, awareness, practices related to protective measures, and self-risk perception. Socio-demographic and attitudinal correlates of failure to use protective measures against COVID-19 were measured.Results: In the survey, 72% of the participants were men. The mean age was 46 years (SD: 13.8). The main source of information was television (91%); however, information from healthcare providers (65%) and mass media announcements (49%) was trustworthy. Washing hands immediately with soap after returning from outdoors was reported by 95% of the respondents, always using a mask while outdoors by 94%, never attended social gatherings by 91%, always using hand sanitizer while outside by 77%, and 68% of the respondents followed all protective measures. The knowledge score [mean score 20.3 (SD: 2.4) out of 24] was independently associated with the risk of not using protective measures, with each unit increase in knowledge score, the risk of not using protective measures reduced by 16%. No source of income was independently associated with not using protective measures [AOR 1.5 95% CI (1.01–2.3)].Conclusions: The COVID-19 public health interventions and behavior change communication strategies should be specifically directed towards the low socio-economic populations through trusted sources. The association between knowledge and practices demonstrates the importance of accurate public health communication to optimally follow preventive measures, such as structural interventions to address poverty and employment policies to address the unemployment crisis are required. Surveillance activity is needed to understand the actual behavior change among the population.

Treatment transition for 'adolescents living with perinatally acquired HIV' (ALPH) from paediatric to adult care is not addressed adequately. This study explores the ALPH's health care needs and programmatic gaps in health systems for the care of ALPH in India. Forty-nine in-depth interviews were conducted with purposively selected primary and key stakeholders in India. Thematic analysis utilizing grounded theory was performed in QSR NUD*IST 6. Stakeholders explicitly recognized adolescent HIV to be a critical public health issue which requires a separate mandate in India. It was found that none of the health policies in India focus on adolescent age group; ALPH is therefore even more neglected population. No/partial HIV disclosure to ALPH is the first crisis for retention in care continuum and adherence to the treatment becomes sub-optimal. Unmet needs of transitioning from paediatric to adult care in existing settings was the major gap. Age-specific counselling guidelines and counselling skills among HCPs were found lacking where tailored counseling and capacity building of HCPs was an expectation. Need of holistic approach for adolescents led to consensus on establishing 'adolescent transition clinic' with a strict 'no' for 'standalone Adolescent HIV' clinics. School setting having peer-based counselling provision was recommended. Age disaggregated health data is required to inform the policymakers about adolescents' specific needs for developing interventions. Situational analysis to identify and shape health priorities of adolescents is recommended.

The high risk of experiencing domestic violence (DV) among married women in India who reside in slum communities underscores the need for effective, evidence-based, and culturally-tailored primary prevention. To inform such DV primary prevention strategies for this population, we herein aimed to identify correlates of DV experience in early marriage. Utilizing a cross-sectional design, potential correlates of DV experience were explored among a geographically-clustered random sample of 100 recently-married women residing in slums in Pune, India. In multivariable regression, DV experience was associated with less educational attainment by the participant's spouse (standardized β = -0.281, p = 0.004), less satisfaction of the spouse's family with the maanpaan (wedding-related gifts provided by the bride's family) they received at the time of marriage (standardized β = -0.298, p

Domestic violence (DV) is prevalent in low-income and slum-dwelling communities in India. To date, the focus of DV prevention in resource-poor settings has largely been with women. We herein aim to identify correlates of DV perpetration to help inform future primary prevention efforts that focus on behavioral change in men. Utilizing a cross-sectional design, potential correlates of DV perpetration were explored among a geographically-clustered random sample of 100 recently-married men residing in slums in Pune, India. In multivariable regression, DV perpetration was associated with less time spent alone in the relationship post-marriage (standardized β = -0.230, p

The high prevalence of domestic violence (DV) among married women in India and associated negative health repercussions highlight the need for effective prevention strategies and tools to measure the efficacy of such interventions. Literature supporting differing manifestations of DV by culture underscores the need for a culturally-tailored scale to more effectively measure DV in the Indian context. We therefore aimed to develop and validate such a tool, the Indian Family Violence and Control Scale (IFVCS), through a mixed-methods study. The psychometric development of IFVCS is herein discussed. After field pre-testing and expert review, a 63-item questionnaire was administered to a random sample of 630 married women from May-July 2013 in Pune, India. The item response theory approach for binary data to explore the IFVCS structure suggested that IFVCS is reliable, with the majority of items having high (>0.5) and significant factor loadings. Concurrent validity, assessed by comparing responses to IFVCS with the validated, abridged Conflict Tactics Scale-2, was high (r = 0.899, p

Waste for fertilization of crop plants has received attention during recent years. The present experiment was conducted for a year on Brassica nigra cv. IC247 using two wastes, i.e. fly ash and wastewater with fertilizers and without fertilizers. The crop was irrigated with ground water and wastewater alone and along with the application of different levels of fly ash (FA0, FA10 and FA20) and different levels of NPK (N0P0K0, N40P15K15, N60P30K30 and N80P45K45). Growth, photosynthesis and yield attributes of the test crop were evaluated at different plant age (A). Result showed that wastewater with fertilizers enhanced growth, photosynthesis and yield parameters as compared to that of ground water with fertilizers. The use of fly ash at 20 t ha−1 performed better than 10 t ha−1. Furthermore, the interactive use of wastewater and fly ash proved to be applicable in making N, P and K optimum at their lower doses, as maximum enhancement in growth, photosynthesis and yield was observed with N60P30K30FA20 + WW and further input of N80P45K45FA20 + WW was not beneficial. It was due to the application of fly ash and wastewater has shown the improvement in physiochemical properties of soil and also in the nutrient status.

Domestic violence (DV) is reported by 40% of married women in India and associated with substantial morbidity. An operational research definition is therefore needed to enhance understanding of DV epidemiology in India and inform DV interventions and measures. To arrive at a culturally-tailored definition, we aimed to better understand how definitions provided by the World Health Organization and the 2005 India Protection of Women from Domestic Violence Act match the perceptions of behaviors constituting DV among the Indian community. Between September 2012 and January 2013, 16 key informant interviews with experts in DV and family counseling and 2 gender-concordant focus groups of lay community members were conducted in Pune, India to understand community perceptions of the definition of DV, perpetrators of DV, and examples of DV encountered by married women in Pune, India. Several key themes emerged regarding behaviors and acts constituting DV including 1) the exertion of control over a woman's reproductive decision-making, mobility, socializing with family and friends, finances, and access to food and nutrition, 2) the widespread acceptance of sexual abuse and the influences of affluence on sexual DV manifestations, 3) the shaping of physical abuse experiences by readily-available tools and the presence of witnesses, 4) psychological abuse for infertility, dowry, and girl-children, and 5) the perpetration of DV by the husband and other members of his family. Findings support the need for a culturally-tailored operational definition that expands on the WHO surveillance definition to inform the development of more effective DV intervention strategies and measures.

Sustained or consistent use of condoms by men remains a challenge. A study was carried out to identify factors associated with failure to use condoms consistently by men attending STD clinics in Pune, India.Among 14137 STI clinic attendees, 8360 HIV sero-negative men were enrolled in a cohort study. The changes in condom usage behavior were studied among 1284 men who returned for first scheduled quarterly follow up, 309 reported consistent condom use at the time of enrollment in the cohort. Data pertaining to heterosexual men practicing high risk behavior were analyzed to identify factors associated with change in condom use behavior using logistic regression model. Demographic, behavioral and biological factors observed to be associated with condom use were fitted in five Cox proportional hazards models to calculate hazard ratios and their 95% confidence intervals to identify independent predictors of failure to sustain condom use behavior.The univariate analysis showed that men who were 30 years or older in age (p = 0.002) and those who did not have contact female sex worker (FSW) were more likely to fail to sustain consistent condom use. However both these factors did not show significant association in multivariable analysis. Marital status and contact with Hijra (eunuch) in lifetime were associated with failure to change in their condom use behavior [AOR 0.33 (CI 0.13-0.82; p = 0.017)]. During the follow up of 2 years, 61 events (15.5 per 100 person years, 95% CI 12.3-19.5 years) of 'failure of condom use' were recorded despite counseling. Older age, contact with non CSW partner and presence of genital ulcer disease / discharge syndrome were significant predictors of failure to sustain condom use.Married monogamous older men, who report contact with sex worker and present with genital ulcer disease are at risk of failure to use condom after first exposure to voluntary HIV counseling and testing. This is a scenario of primary prevention program. Condom promotion and counseling needs to be reinforced through follow up counseling among this population.

Although male circumcision (MC) is recommended as an HIV prevention option, the religious, cultural and biomedical dimensions of its feasibility, acceptability and practice in India have not been explored till date. This study explores beliefs, experiences and understanding of the community and healthcare providers (HCPs) about adult MC as an HIV prevention option in India.This qualitative study covered 134 in-depth interviews from Belgaum, Kolkata, Meerut and Mumbai cities of India. Of these, 62 respondents were the members of circumcising (CC)/non-circumcising communities (NCC); including medically and traditionally circumcised men, parents of circumcised children, spouses of circumcised men, and religious clerics. Additionally, 58 registered healthcare providers (RHCPs) such as general and pediatric surgeons, pediatricians, skin and venereal disease specialists, general practitioners, and operation theatre nurses were interviewed. Fourteen traditional circumcisers were also interviewed. The data were coded and analyzed in QSR NUD*IST ver. 6.0. The study has not explored the participants' views about neonatal versus adult circumcision.Members of CC/NCC, traditional circumcisers and RCHPs expressed sharp religious sensitivities around the issue of MC. Six themes emerged: Male circumcision as the religious rite; Multiple meanings of MC: MC for 'religious identity/privilege/sacrifice' or 'hygiene'; MC inflicts pain and cost; Medical indications outweigh faith; Hesitation exists in accepting 'foreign' evidence supporting MC; and communication is the key for acceptance of MCs. Medical indications could make members of NCC accept MC following appropriate counseling. Majority of the RHCPs demanded local in-country evidence.HCPs must educate high-risk groups regarding the preventive and therapeutic role of MC. Communities need to discuss and create new social norms about male circumcision for better societal acceptance especially among the NCC. Feasibility studies on MC as an individual specific option for the high risk groups in health care setting needs to be explored.

STUDY DESIGN: A randomized, double-blind, placebo controlled phase I trial. METHODS: The trial was conducted in 32 HIV-uninfected healthy volunteers to assess the safety and immunogenicity of prime-boost vaccination regimens with either 2 doses of ADVAX, a DNA vaccine containing Chinese HIV-1 subtype C env gp160, gag, pol and nef/tat genes, as a prime and 2 doses of TBC-M4, a recombinant MVA encoding Indian HIV-1 subtype C env gp160, gag, RT, rev, tat, and nef genes, as a boost in Group A or 3 doses of TBC-M4 alone in Group B participants. Out of 16 participants in each group, 12 received vaccine candidates and 4 received placebos. RESULTS: Both vaccine regimens were found to be generally safe and well tolerated. The breadth of anti-HIV binding antibodies and the titres of anti-HIV neutralizing antibodies were significantly higher (p

INTRODUCTION: In low resource settings, the vast majority of 'Person/people Living with HIV' (PLHIV/s) and inadequate healthcare delivery systems to meet their treatment and care needs, caregivers play a vital role. Home based caregivers are often unrecognized with limited AIDS policies and programs focusing on them. We explored the perceptions and norms regarding care being provided by family caregivers of PLHIVs in India. METHODOLOGY: A community based qualitative study to understand the issues pertaining to home based care for PLHIV was conducted in urban settings of Pune city, in Maharashtra, India. Eight Focus Group Discussions (FGDs) among men, women and peer educators were carried out. A total of 44 in-depth Interviews (IDIs) with PLHIVs (20) and their caregivers (24), were conducted using separate guides respectively. Data was analyzed thematically. RESULTS: Home based care was perceived as economically viable option available for PLHIVs. 'Care' comprised of emotional, adherence, nursing and financial support to PLHIV. Home based care was preferred over hospital based care as it ensured confidentiality and patient care without hampering routine work at home. Women emerged as more vital primary caregivers compared to men. Home based care for men was almost unconditional while women had no such support. The natal family of women also abandoned. Their marital families seemed to provide support. Caregivers voiced the need for respite care and training. DISCUSSION: Gender related stigma and discrimination existed irrespective of women being the primary family caregivers. The support from marital families indicates a need to explore care and support issues at natal and marital homes of the women living with HIV respectively. Home based care training and respite care for the caregivers is recommended. Gender sensitive interventions addressing gender inequity and HIV related stigma should be modeled while designing interventions for PLHIVs and their family caregivers.

Retention is critical in HIV prevention programs and clinical research. We studied retention in the three modeled scenarios of primary prevention programs, cohort studies and clinical trials to identify predictors of retention.Men attending Sexually Transmitted Infection (STI) clinics (n = 10, 801) were followed in a cohort study spanning over a ten year period (1993-2002) in Pune, India. Using pre-set definitions, cases with optimal retention in prevention program (n = 1286), cohort study (n = 940) and clinical trial (n = 896) were identified from this cohort. Equal number of controls matched for age and period of enrollment were selected. A case control analysis using conditional logistic regression was performed. Being employed was a predictor of lower retention in all the three modeled scenarios. Presence of genital ulcer disease (GUD), history of commercial sex work and living away from the family were predictors of lower retention in primary prevention, cohort study and clinical trial models respectively. Alcohol consumption predicted lower retention in cohort study and clinical trial models. Married monogamous men were less likely to be retained in the primary prevention and cohort study models.Predicting potential drop-outs among the beneficiaries or research participants at entry point in the prevention programs and research respectively is possible. Suitable interventions might help in optimizing retention. Customized counseling to prepare the clients properly may help in their retention.

Prevalence estimates of cervical intraepithelial neoplasia (CIN) among HIV-infected women in India have been based on cervical cytology, which may have underestimated true disease burden. We sought to better establish prevalence estimates and evaluate risk factors of CIN among HIV-infected women in Pune, India using colposcopy and histopathology as diagnostic tools.Previously unscreened, non-pregnant HIV-infected women underwent cervical cancer screening evaluation including standardized diagnostic colposcopy by a gynecologist. Histopathologic confirmation was conducted among consenting women with clinical suspicion of CIN. The prevalence of CIN was evaluated by a composite diagnosis based on colposcopy and histopathology results. Multivariable ordinal logistic regression analysis was conducted to determine independent predictors of increasing severity of CIN.The median age of the n = 303 enrolled HIV-infected women was 30 years (interquartile range, 27-34). A majority of the participants were widowed or separated (187/303, 61.7%), more than one-third (114/302, 37.7%) were not educated beyond primary school, and nearly two-thirds (196/301, 64.7%) had a family per capita income of or =CIN1 lesions and a sixth [50/303: 16.5% (95% CI: 12.2-21.9)] had evidence of advanced (> or =CIN2) neoplastic disease. The independent predictors of increasing severity of CIN as revealed by a proportional odds model using multivariable ordinal logistic regression included (i) currently receiving antiretroviral therapy [adjusted odds ratios (aOR): 2.24 (1.17, 4.26), p = 0.01] and (ii) presence of cervical high-risk HPV-DNA [aOR: 1.93 (1.13, 3.28), p = 0.02].HIV-infected women in Pune, India have a substantial burden of cervical precancerous lesions, which may progress to invasive cervical cancer unless appropriately detected and treated. Increased attention should focus on recognizing and addressing this entirely preventable cancer among HIV-infected women, especially in the context of increasing longevity due to antiretroviral therapy.