44 results on '"Sheela Godbole"'
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2. The Role of Library Outreach in Community Building
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Dr. Sheela Godbole Paikrao
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Library outreach, Community building, Social inclusion - Abstract
This article explores the role of academic libraries outreached in community building connecting communities outside of the usual library environment. This article also evaluates the special initiatives and their impacts on communities accessing the information, improving community relationships encouraging library and lifelong learning. This paper study also focus on the role of librarians in their skill & strong willingness in going into community building.
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- 2023
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3. Prevalence of Long COVID Symptoms: An Observational, Cross-Sectional Follow-Up Study in Haryana, India
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Dhruva Chaudhry, Shweta Khandelwal, Chandrika Bahadur, Benjamin Daniels, Malay Bhattacharyya, Raman Gangakhedkar, Sapna Desai, Jishnu Das, Usha Gupta, Veena Singh, Shalu Garg, Liza Bharadwaj, Vinod Chayal, Varun Arora, Pawan Kumar Singh, Nizamuddin Khan, and Sheela Godbole
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- 2023
4. Sexually transmitted infections among HIV serodiscordant partners: A secondary analysis of HIV Prevention Trial Network 052
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Myron S. Cohen, Victor Akelo, Emily Shava, José Henrique Pilotto, Mulinda Nyirenda, Ravindre Panchia, Maganizo Chagomerana, Suwat Chariyalertsak, Mina C. Hosseinipour, Sheela Godbole, and Sharlaa Badal-Faesen
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Male ,HPTN 052 ,medicine.medical_specialty ,Sexually Transmitted Diseases ,Human immunodeficiency virus (HIV) ,Chlamydia trachomatis ,HIV Infections ,Dermatology ,urologic and male genital diseases ,medicine.disease_cause ,Gonorrhea ,03 medical and health sciences ,0302 clinical medicine ,Secondary analysis ,Environmental health ,Prevalence ,Humans ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,030505 public health ,business.industry ,Public health ,Public Health, Environmental and Occupational Health ,virus diseases ,Chlamydia Infections ,Antiretroviral therapy ,Neisseria gonorrhoeae ,female genital diseases and pregnancy complications ,Infectious Diseases ,Serodiscordant ,Female ,0305 other medical science ,business - Abstract
Sexually transmitted infections (STIs) remain a public health concern because of their interaction(s) with HIV. In the HPTN 052 study, STIs were evaluated in both HIV-positive index cases and their HIV-negative partners at enrollment and at yearly follow-up visits. Our definition for STI was based on any infection with Chlamydia trachomatis, Neisseria gonorrhoeae, syphilis, or Trichomonas vaginalis. We used log-binomial regression models to identify factors associated with prevalent STIs. Generalized estimating equation models with the Poisson distribution were used to compare STI incidence between HIV-positive index cases and HIV-negative partners. 8.1% of the participants had STIs at enrollment. The prevalence of STIs (8.9 vs. 7.2) was higher in HIV-positive index cases than HIV-negative partners. Being female (prevalence ratio (PR) = 1.61; 95% CI: 1.20–2.16) or unmarried (PR = 1.92; 95% CI: 1.17–3.14) was associated with prevalent STIs. Compared to HIV-negative male partners, HIV-positive female index cases had a higher risk of STI acquisition (incidence rate ratio (IRR) = 2.25; 95% CI: 1.70–2.97). While we are implementing HIV prevention interventions for HIV-negative people, we should also intensify targeted STI prevention interventions, especially among HIV-positive women.
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- 2021
5. A protocol for feasibility of plasma based GeneXpert platform and Dried Blood Spot (DBS) based Abbott platform for HIV-1 viral load testing among the people living with HIV attending ART centers in India
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Suchit Kamble, Pallavi Shidhaye, Anupam Mukherjee, Madhuri Tak, Shilpa Bembalkar, Sumit Aggarwal, Arpita Deb, Neha Kapoor, Vinita Verma, Chinmoyee Das, Smita Kulkarni, Manisha Ghate, and Sheela Godbole
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Multidisciplinary - Abstract
Background HIV-1 Viral load (VL) measures efficiency of the antiretroviral therapy (ART) after treatment initiation and helps to diagnose virological failures at an early stage. Current VL assays require sophisticated laboratory facilities. As well as there are other challenges pertaining to insufficient laboratory access, cold-chain management and sample transportation. Hence the number of HIV-1 VL testing laboratories is inadequate in the resource limited settings. The revised national tuberculosis elimination programme (NTEP) in India has developed a vast network of point of care (PoC) testing facilities for diagnosis of tuberculosis and several GeneXpert platforms are functional under this programme. Both the GeneXpert HIV-1 assay and HIV-1 Abbott real time assay are comparable and GeneXpert HIV-1 assay can be used as PoC for HIV-1 Viral load testing. Also, the dried blood spot (DBS) as a sample type has been considered as a good option for HIV-1 VL testing in hard to reach areas. This protocol is therefore developed to assess the feasibility of integrating HIV-1 VL testing among people living with HIV (PLHIV) attending ART centres using the two public health models under the current programme: 1. HIV-1 VL testing using GeneXpert platform and plasma as a sample type, and 2. HIV-1 VL testing using Abbott m2000 platform and DBS as a sample type. Methods This ethically approved feasibility study will be implemented at two moderate to high burden ART centres where VL testing facility is not available in the town. Under Model-1, arrangements will be made to carry out VL testing on the adjacent GeneXpert facility and under Model-2, DBS will be prepared on site and couriered to identified viral load testing laboratories. In order to assess the feasibility, data will be collected on pretested questionnaire pertaining to number of samples tested for VL testing, number of samples tested for tuberculosis (TB) diagnosis and the turnaround time (TAT). In-depth interviews will be conducted among the service providers at ART centre and different laboratories for addressing any issues regarding the model implementation. Results The proportion of PLHIV tested for VL at ART centres, total TAT for both models including TAT for sample transportation, sample testing and receipt of results as well as proportion of sample rejections and reasons for the same, correlation coefficient between DBS based and plasma based VL testing will be estimated using various statistical tools. Conclusion If found promising, these public health approaches will be helpful for the policy makers and program implementation in scaling up HIV-1 viral load testing within India.
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- 2023
6. Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study
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Prasad S. Kulkarni, Abhijit Kadam, Sheela Godbole, Varsha Bhatt, Abhishek Raut, Sunil Kohli, Santanu Tripathi, Praveen Kulkarni, Rakhi Ludam, Madhav Prabhu, Ashish Bavdekar, Nithya J. Gogtay, Sushant Meshram, Tamilarasu Kadhiravan, Sonali Kar, D.H. Ashwath Narayana, Clarence Samuel, Govind Kulkarni, Abhay Gaidhane, Dipu Sathyapalan, Sidram Raut, Vijay Hadda, Hira Lal Bhalla, Chetanraj Bhamare, Abhijeet Dharmadhikari, Joyce S. Plested, Shane Cloney-Clarke, Mingzhu Zhu, Melinda Pryor, Stephanie Hamilton, Madhuri Thakar, Ashwini Shete, Manish Gautam, Nivedita Gupta, Samiran Panda, Umesh Shaligram, Cyrus S. Poonawalla, Balram Bhargava, Bhagwat Gunale, Dhananjay Kapse, Shubhangi A. Kanitkar, Arjun L. Kakrani, Srikanth P. Tripathy, Abhijit V. Tilak, Akshay A. Dhamne, Shahzad Beg Mirza, Prachi V. Athavale, Mandakini Bhowmik, Parag J. Ratnakar, Subodh Gupta, Vijayshri Deotale, Jyoti Jain, Ashwini Kalantri, Vineet Jain, Nidhi Goyal, Alok Arya, Temsunaro Rongsen-Chandola, Shreyasi Dasgupta, Pratibha Periera, Vanmathi A, Anand Kawade, Arunkumar Gondhali, Palvi Kudyar, Abhishek Singh, Ravi Yadav, Alina Alexander, Venugopalan Gunasekaran, Sekar Dineshbabu, P.C. Samantaray, H.S. Ravish, Deepshikha Kamra, Shilpa Gaidhane, Quazi Syed Zahiruddin, Merlin Moni, Anil Kumar, Ameet Dravid, Anant Mohan, Tejas Suri, Tejas K. Patel, Surekha Kishore, Rahul Choche, Deepak Ghatage, and Sugam Salvi
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- 2023
7. Safety and Immunogenicity of SII-NVX-CoV2373 (COVID-19 Vaccine) In Adults in a Phase 2/3, Observer-Blind, Randomised, Controlled Study
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Prasad S. Kulkarni, Abhijit Kadam, Sheela Godbole, Varsha Bhatt, Abhishek Raut, Sunil Kohli, Santanu Tripathi, Praveen Kulkarni, Rakhi Ludam, Madhav Prabhu, Ashish Bavdekar, Nithya J. Gogtay, Sushant Meshram, Tamilarasu Kadhiravan, Sonali Kar, Ashwath Narayana, Clarence Samuel, Govind Kulkarni, Abhay Gaidhane, Dipu Sathyapalan, Sidram Raut, Vijay Hadda, Hira Lal Bhalla, Chetanraj Bhamare, Abhijeet Dharmadhikari, Joyce Plested, Shane Cloney-Clarke, Mingzhu Zhu, Melinda Pryor, Madhuri Thakar, Ashwini Shete, Manish Gautam, Nivedita Gupta, Samiran Panda, Umesh Shaligram, Cyrus Poonawalla, Balram Bhargava, Bhagwat Gunale, Dhananjay Kapse, and for the COVOVAX Study Group
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History ,Polymers and Plastics ,Business and International Management ,Industrial and Manufacturing Engineering - Published
- 2022
8. Diversity in HIV epidemic transitions in India: An application of HIV epidemiological metrices and benchmarks
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Pradeep Kumar, Chinmoyee Das, Arvind Kumar, Damodar Sahu, Sanjay K. Rai, Sheela Godbole, Elangovan Arumugam, Lakshmi P. V. M., Shanta Dutta, H. Sanayaima Devi, Vishnu Vardhana Rao Mendu, Shashi Kant, Arvind Pandey, Dandu Chandra Sekhar Reddy, Sanjay Mehendale, and Shobini Rajan
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Acquired Immunodeficiency Syndrome ,Benchmarking ,Multidisciplinary ,Prevalence ,Humans ,India ,HIV Infections ,Epidemics - Abstract
Background The Joint United Nations Programme on AIDS (UNAIDS) has emphasized on the incidence-prevalence ratio (IPR) and incidence-mortality ratio (IMR) to measure the progress in HIV epidemic control. In this paper, we describe the status of epidemic control in India and in various states in terms of UNAIDS’s recommended metrices. Method The National AIDS Control Programme (NACP) of India spearheads work on mathematical modelling to estimate HIV burden based on periodically conducted sentinel surveillance for providing guidance to program implementation and policymaking. Using the results of the latest round of HIV Estimations in 2019, IPR and IMR were calculated. Results National level IPR was 0.029 [0.022–0.037] in 2019 and ranged from 0.01 to 0.15 in various States and Union Territories (UTs). Corresponding Incidence-Mortality Ratio was at 0.881 [0.754–1.014] nationally and ranged between 0.20 and 12.90 across the States/UTs. Conclusions Based on UNAIDS recommended indicators for HIV epidemic control, namely IPR and IMR; national AIDS response in India appears on track. However, the program success is not uniform and significant heterogeneity as well as expanding epidemic was observed at the level of States or UTs. Reinforcing States/UTs specific and focused HIV prevention, testing and treatment initiatives may help in the attainment of 2030 Sustainable Development Goals of ending AIDS as a public health threat by 2030.
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- 2021
9. 980Quantifying inadvertent data-duplication- findings from validation of antenatal-registration and HIV-testing data-sets from an Indian state
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Ashok Kumar, Raman R. Gangakhedkar, Arvind Pandey, Vijay Bawiskar, Shweta Chidrawar, D.C.S. Reddy, Nicole Seguy, Kuldeep Singh Sachdeva, Laxmi Ramakrishnan, Tobi Saidel, Sheela Godbole, Shrikala Acharya, Asha Hegde, Suchit Kamble, Yashika Bansal, Yujwal Raj, Megha Mamulwar, Suvarna Sane, Naina Rani, and Shilpa Bembalkar
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medicine.medical_specialty ,Pregnancy ,Epidemiology ,business.industry ,Human immunodeficiency virus (HIV) ,General Medicine ,Prenatal care ,Hiv testing ,medicine.disease_cause ,Private sector ,medicine.disease ,Private Facility ,Family medicine ,medicine ,Data deduplication ,State (computer science) ,business - Abstract
Background India plans elimination of HIV-Mother-to-Child-Transmission in 2020. Targets include >95% coverage of Antenatal-care (ANC) and HIV-testing. In 2015-16, while 43% of the estimated Indian pregnant-women (PW) received HIV-tests, one state reported >95% testing. Indian public-health-care is a three-tiered system from primary-level sub-centres (population-5000) to tertiary-level hospitals. ANC involves multiple-visits per pregnancy at different care-levels and data are aggregated in the Health-Management-Information-System (HMIS) at all levels. We validated (public and private-sector data from this state, for duplication in ANC registration and HIV-testing using mixed methods. Methods In the absence of guidelines for assessing aggregate-data duplication, we used mixed-methods, including surveys among 9845 PW and providers from 240 facilities in 10/36 representative districts; in-depth-interviews; case-studies and analysis of HMIS and HIV-program data (April 2015-Mar 2017). Interviews and case-studies highlighted inadvertent duplicate data-capture. Surveys quantified levels of duplication and adjustment factors (public and private-sector) were developed. Results Twenty-four% PW, visited multiple facilities for ANC, while 81% providers reported all the PW coming to their facilities as new ANC registrations (irrespective of lower-tier registration); identifying a minimum duplication of 19% (24%*81%) in ANC coverage. Twenty-nine% and 28% PW from public and private-facilities reported >1 HIV-test; while 75% and 36% reported visiting another public-facility where HIV test was likely to be reported again. Minimum duplication of 22% and 10% in HIV testing was noted in public and private-sectors respectively. Conclusions We report methods to quantify repeat HIV-testing and duplicate-reporting, due to inherent processes in ANC in public-healthcare in India. Modification of data-capture was recommended and adopted across India. Key messages Assessing duplication in aggregate health data is key to developing robust datasets for disease elimination
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- 2021
10. Repurposed antiviral drugs for COVID-19 –interim WHO SOLIDARITY trial results
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Sibylle McGinty, Mariam Hassan, K. Srinath Reddy, Narvina Sinani, Reza Malekzadeh, Najada Como, Jana Kirwan, Carlos Alvarez-Moreno, Athari Alotaibi, Suzana Manevska, Oriol Manuel, Gustavo Lopardo, Nicola Magrini, Ting S. Chow, Quarraisha Abdool Karim, Marie-Pierre Preziosi, Antonio Portolés, Patricia J. Garcia, Abdullah Asiri, Peter Lennon, Srinivas Murthy, Estevão Portela Nunes, Pierre Abi Hanna, Maria C. Miranda-Montoya, Marie-Paule Kieny, Irmansyah Irmansyah, Soumya Swaminathan, Rasha Hamra, Marina I. Salvadori, Kolawole Salami, Hala Zaid, Pan Hongchao, Andreas Barratt-Due, Sheela Godbole, David W. Hutton, Jonathan A C Sterne, Almonther Alhasawi, Abdullah M. Al-Bader, Heike B. C. Cappel-Porter, Aun Raza, Nery Cerrato, John-Arne Røttingen, Kari A.O. Tikkinen, Suresh Kumar, Sven Trelle, Evelina Tacconelli, Mirta Roses Periago, Patrick Lydon, Laimonas Griskevicius, Jeremy Nel, Ligita Jancoriene, Florence Ader, Joseph A. Eustace, Vasee Sathiyamoorthy, Helen Rees, Richard Peto, Sheila Appadoo, Ana-Maria Henao-Restrepo, Emma Allum, Samir Bellani, Teresa Maguire, Mattia Branca, Eduardo Gotuzzo, Marissa M. Alejandria, Pål Aukrust, Marco T. Medina, Menaldi R. Rasmin, Múltipla ver em Notas, Chris A Rogers, Mohamed Hassany, César Hernández García, María L. Mesa Rubio, Paula P. S. Reges, Markus Perola, and Milena Stevanovikj
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0303 health sciences ,medicine.medical_specialty ,education.field_of_study ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Public health ,Population ,Library science ,Population health ,Solidarity ,3. Good health ,03 medical and health sciences ,0302 clinical medicine ,Interim ,Epidemiology ,medicine ,030212 general & internal medicine ,education ,business ,030304 developmental biology ,Reproductive health - Abstract
Hongchao Pan (University of Oxford. Nuffield Department of Population Health. Medical Research Council Population Health Research Unit. Oxford, United Kingdom); Richard Peto (University of Oxford. Nuffield Department of Population Health. Medical Research Council Population Health Research Unit. Oxford, United Kingdom); Ana-Maria Henao-Restrepo (World Health Organization. Geneva, Switzerland); Marie-Pierre Preziosi (World Health Organization. Geneva, Switzerland); Vasee Sathiyamoorthy (World Health Organization. Geneva, Switzerland); Quarraisha Abdool Karim (Centre for the AIDS Programme of Research in South Africa. Durban, South Africa); Marissa M. Alejandria (University of the Philippines. National Institutes of Health. Institute of National Epidemiology. Manila, Philippines); Cesar Hernandez Garcia (Spanish Agency of Medicines and Medical Devices. Madrid, Spain / Hospital Clinico San Carlos. Madrid, Spain); Marie-Paule Kieny (Institut National de la Sante et de la Recherche Medicale. Paris, France); Reza Malekzadeh (Tehran University of Medical Sciences. Digestive Disease Research Institute. Tehran, Iran); Srinivas Murthy (University of British Columbia. Vancouver, Canada); K. Srinath Reddy (Public Health Foundation of India. New Delhi, India); Mirta Roses Periago (National Academy of Sciences of Buenos Aires. Buenos Aires, Argentina); Pierre Abi Hanna (Rafic Hariri University Hospital. Beirut, Lebanon); Florence Ader (Hospices Civils de Lyon. Lyon, France); Abdullah M. Al-Bader (Ministry of Health. Kuwait City, Kuwait); Almonther Alhasawi (Infectious Diseases Hospital. Kuwait City, Kuwait); Emma Allum (University of Bristol. Bristol, United Kingdom); Athari Alotaibi (Ministry for Preventive Health. Riyadh, Saudi Arabia); Carlos A. Alvarez-Moreno (Universidad Nacional de Colombia. Bogota, Colombia / Clinica Colsanitas. Bogota, Colombia); Sheila Appadoo (University of Bern. Bern, Switzerland); Abdullah Asiri (Ministry for Preventive Health. Riyadh, Saudi Arabia); Pal Aukrust (Oslo University Hospital. Oslo, Norway); Andreas Barratt-Due (Oslo University Hospital. Oslo, Norway); Samir Bellani (University of Bristol. Bristol, United Kingdom); Mattia Branca (University of Bern. Bern, Switzerland); Heike B.C. Cappel-Porter (University of Bristol. Bristol, United Kingdom); Nery Cerrato (Secretaria de Salud de Honduras. Tegucigalpa, Honduras); Ting S. Chow (Penang Hospital. Penang, Malaysia); Najada Como (University Hospital Center "Mother Teresa". Tirana, Albania); Joe Eustace (University College Cork. HRB Clinical Research Facility. Cork, Ireland); Patricia J. Garcia (Universidad Peruana Cayetano Heredia. Lima, Peru); Sheela Godbole (Indian Council of Medical Research. New Delhi, India / National AIDS Research Institute. Pune, Maharashtra, India); Eduardo Gotuzzo (Universidad Peruana Cayetano Heredia. Lima, Peru); Laimonas Griskevicius (Vilnius University Hospital Santaros Klinikos. Vilnius, Lithuania); Rasha Hamra (Ministry of Public Health. Beirut, Lebanon); Mariam Hassan (Shaukat Khanum Memorial Cancer Hospital and Research Centre. Lahore, Pakistan); Mohamed Hassany (National Hepatology and Tropical Medicine Research Institute. Cairo, Egypt); David Hutton (University of Bristol. Bristol, United Kingdom); Irmansyah Irmansyah (National Institute of Health Research and Development. Jakarta, Indonesia); Ligita Jancoriene (Vilnius University. Faculty of Medicine. Institute of Clinical Medicine. Vilnius, Lithuania); Jana Kirwan (University of Bristol. Bristol, United Kingdom); Suresh Kumar (Sungai Buloh Hospital. Selangor, Malaysia / Jalan Hospital. Selangor, Malaysia); Peter Lennon (Department of Health and Children. Dublin, Ireland); Gustavo Lopardo (Fundacion del Centro de Estudios Infectologicos. Buenos Aires, Argentina); Patrick Lydon (World Health Organization. Geneva, Switzerland); Nicola Magrini (Italian Medicines Agency. Rome, Italy); Teresa Maguire (Department of Health and Children. Dublin, Ireland); Suzana Manevska (Ministry of Health. Skopje, North Macedonia); Oriol Manuel (Lausanne University Hospital. Lausanne, Switzerland); Sibylle McGinty (University of Bern. Bern, Switzerland); Marco T. Medina (Universidad Nacional Autonoma de Honduras. Tegucigalpa, Honduras); Maria L. Mesa Rubio (Ministry of Health. Bogota, Colombia); Maria C. Miranda-Montoya (World Health Organization. Geneva, Switzerland); Jeremy Nel (University of the Witwatersrand. Johannesburg, South Africa); Estevao Portela Nunes (Fundacao Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil); Markus Perola (National Institute for Health and Welfare of Finland. Helsinki, Finland / University of Finland. Helsinki, Finland); Antonio Portoles (Universidade Complutense de Madrid. Madrid, Spain / Spanish Clinical Research Network. Madrid, Spain / Hospital Clinico San Carlos. Instituto de Investigacion Sanitaria San Carlos. Madrid, Spain); Menaldi R. Rasmin (Rumah Sakit Umum Pusat Persahabatan. Jakarta, Indonesia); Aun Raza (Shaukat Khanum Memorial Cancer Hospital and Research Centre. Lahore, Pakistan); Helen Rees (Wits Reproductive Health and HIV Institute. Johannesburg, South Africa); Paula P. S. Reges (Fundacao Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil); Chris A. Rogers (University of Bristol. Bristol, United Kingdom); Kolawole Salami (World Health Organization. Geneva, Switzerland); Marina I. Salvadori (Public Health Agency of Canada. Ottawa, Canada); Narvina Sinani (National Agency for Medicines and Medical Devices. Tirana, Albania); Jonathan A. C. Sterne (University of Bristol. Bristol, United Kingdom); Milena Stevanovikj (University Clinic of Infectious Diseases and Febrile Conditions. Skopje, North Macedonia); Evelina Tacconelli (University of Verona. Verona, Italy); Kari A. O. Tikkinen (Helsinki University Hospital. Helsinki, Finland / South Karelian Central Hospital. Lappeenranta, Finland); Sven Trelle (University of Bern. Bern, Switzerland); Hala Zaid (Ministry of Health and Population. Cairo, Egypt); John-Arne Rottingen (Research Council of Norway. Oslo, Norway); Soumya Swaminathan (World Health Organization. Geneva, Switzerland).
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- 2020
11. Evaluation of key survey components of bio-behavioral surveillance among HIV high-risk subpopulation in Western India
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Kuldeep Singh Sachdeva, Arun Risbud, Radhika G Brahme, Sheela Godbole, Vinita Verma, and Raman R. Gangakhedkar
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Male ,Interview ,media_common.quotation_subject ,Sexual Behavior ,Population ,India ,HIV Infections ,survey data ,Interviews as Topic ,Surveys and Questionnaires ,questionnaire design ,data quality ,Humans ,Quality (business) ,Human resources ,education ,media_common ,Medical education ,education.field_of_study ,Data collection ,business.industry ,lcsh:Public aspects of medicine ,lcsh:RA1-1270 ,General Medicine ,Cross-Sectional Studies ,Data quality ,Population Surveillance ,Structured interview ,Survey data collection ,Female ,hiv high-risk population ,business ,Psychology - Abstract
Background: High-quality data are of prime importance in any health survey because survey data are considered as a gold standard for nationally representative data. The quality of data collection largely depends on the design of the questionnaire, training, and skills of the interviewer. Objectives: In the present study, we tried to evaluate three key components, such as questionnaire design, human resource and training of the field staff for Integrated Biological and Behavioural Surveillance carried out among the HIV high-risk subpopulation. Methods: A mixed-methods approach was used. Qualitative and quantitative data collection was carried out in the year 2015 with cross-sectional survey design in western states of India. The in-depth interviews of 10 stakeholders, structured interviews of the survey respondents (n = 560), and field investigators (n = 71) were conducted. Data triangulation was used to find out the concurrence of the qualitative and quantitative data. Results: Comprehensive and standardized survey questionnaire, structured training agenda, and strategic preparation for recruiting human resources were the overall strengths of the survey. However, during the implementation of the survey, there were some difficulties reported in data collection process. Overall, the respondents and investigators felt that the questionnaire was long and exhaustive. Difficulties were faced while collecting data on sexual history. The field staffs were not adequately experienced to work with sensitive population. Conclusions: In order to have accurate, reliable data, especially on sexual behavior; emphasis should be given on simple questionnaire with the use of community-friendly language, skilled and experienced interviewers for data collection, and extensive field training.
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- 2020
12. Higher expression of human telomerase reverse transcriptase in productively-infected CD4 cells possibly indicates a mechanism for persistence of the virus in HIV infection
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Sheela Godbole, Poonam Suryawanshi, Ashwini Shete, Madhuri Thakar, and Jyoti Pawar
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0301 basic medicine ,Telomerase ,medicine.diagnostic_test ,Immunology ,T-cell receptor ,virus diseases ,Biology ,Microbiology ,Flow cytometry ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,Immune system ,Virology ,medicine ,Cancer research ,Cytokine secretion ,Telomerase reverse transcriptase ,CD5 ,Primary isolate ,030215 immunology - Abstract
Mechanisms involved in survival of productively-infected memory CD4+cells after initial antigenic stimulation and their subsequent reversion to the resting state are critical for the development of a predominant replication-competent HIV reservoir. These mechanisms may also counter their elimination after HIV reactivation through latency-reversing agents (LRA). Thus, their evaluation is critical when using an appropriate HIV latency model that recapitulates the predominant replication-competent HIV reservoir to develop strategies for HIV eradication. The model for evaluating the possible survival mechanisms after T cell receptor (TCR) stimulation was developed by infecting memory CD4+cells with an HIV-1C primary isolate and cytokine secretion and gene expression patterns determined. Infected cells showed compromised functionality as evident from 6.8-fold lower secretion of IL-2 than from uninfected control cells. After TCR stimulation, the infected cells showed significantly higher fold increases in CD27 and CCR5 and smaller increases in CD5 mRNA over baseline values. Because CD27 expression may influence telomerase activity through AKT phosphorylation, CD27, human telomerase reverse transcriptase (hTERT) and pAKT expression in productively-infected cells from HIV-infected patients was evaluated by flow cytometry. HIV harbored in memory CD4+ cells was reactivated by HIV-1 envelope peptides, which have been shown to act as effective LRA. P24+CD4+cell showed significantly higher expression of CD27, hTERT and pAKT than P24-CD4+cells. These findings indicate compromised functionality of HIV-infected cells after TCR stimulation, which may interfere with their elimination by the immune system. They also indicate that pAKT and hTERT induction are possible survival mechanisms of productively-infected CD4+cells.
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- 2018
13. Antibiotic susceptibility pattern of Neisseria gonorrhoeae strains isolated from five cities in India during 2013–2016
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Manju Bala, G. Sasikala, H. Kambli, Sheela Godbole, Sangeeta Kulkarni, Jyoti Sawant, Arun Risbud, Raman R. Gangakhedkar, Syeeda A. Muqeeth, R. Thorat, and Amit Nirmalkar
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Adult ,Male ,0301 basic medicine ,Microbiology (medical) ,Spectinomycin ,030106 microbiology ,India ,Drug resistance ,medicine.disease_cause ,Microbiology ,Gonorrhea ,03 medical and health sciences ,Antibiotic resistance ,Drug Resistance, Multiple, Bacterial ,medicine ,Humans ,Cities ,Etest ,business.industry ,General Medicine ,Neisseria gonorrhoeae ,Anti-Bacterial Agents ,Penicillin ,Ceftriaxone ,Female ,business ,Cefixime ,medicine.drug - Abstract
Purpose. Emergence of multidrug resistance in Neisseria gonorrhoeae, an STI of public health significance is the biggest challenge to gonorrhoea control. Monitoring for antimicrobial resistance is essential for the early detection of emergent drug resistance patterns. Methodology. One hundred and twenty four N. gonorrhoeae strains were isolated between September 2013-August 2016 [82-New Delhi, 3-Pune, 3-Mumbai, 20-Secunderabad and 16-Hyderabad] to determine antimicrobial susceptibility and to compare the CLSI disc diffusion method with Etest for these strains. The results of the two methods were compared by using kappa statistics. Results. Ninety eight percent [CI: 96.2–100] of isolates were resistant to ciprofloxacin, 52 % [CI: 43.2–60.8] to penicillin, 56 % [CI: 47.2–64.7] to tetracycline and 5 % [CI: 1.2–8.8] to azithromycin. All the strains were susceptible to spectinomycin, ceftriaxone and cefixime except for two strains which showed decreased susceptibility to ceftriaxone and cefixime. Kappa scores for penicillin, azithromycin, ciprofloxacin, ceftriaxone and cefixime showed that the CLSI method had high agreement with Etest while tetracycline had substantial agreement. Conclusion. Our data suggest that the disc diffusion method which is both cost effective and more feasible, can effectively be used routinely for monitoring antibiotic susceptibility in N. gonorrhoeae, in limited resource countries like India. We demonstrate the emergence of decreased susceptibility to ceftriaxone and cefixime and threshold levels of resistance to azithromycin in India. This underscores the importance of maintaining continued surveillance for antibiotic resistance in N. gonorrhoeae and a potential requirement for strategic change in guidelines in the not so distant future.
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- 2018
14. Cross-reactive influenza-specific antibody-dependent cellular cytotoxicity-mediating antibodies in HIV-infected Indian individuals
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Sheela Godbole, Sanketkumar Nehul, Manisha Ghate, Madhuri Thakar, Archana Kulkarni, and Shailesh D. Pawar
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Adult ,Male ,0301 basic medicine ,Microbiology (medical) ,Influenza vaccine ,Human immunodeficiency virus (HIV) ,India ,HIV Infections ,chemical and pharmacologic phenomena ,Cross Reactions ,Antibodies, Viral ,medicine.disease_cause ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Antibody Specificity ,Influenza, Human ,medicine ,Influenza A virus ,Humans ,030212 general & internal medicine ,Young adult ,Cell-mediated cytotoxicity ,Antibody-dependent cell-mediated cytotoxicity ,General Immunology and Microbiology ,biology ,business.industry ,Antibody-Dependent Cell Cytotoxicity ,virus diseases ,General Medicine ,Hemagglutination Inhibition Tests ,Middle Aged ,Virology ,Killer Cells, Natural ,Specific antibody ,030104 developmental biology ,Infectious Diseases ,Influenza Vaccines ,Immunology ,biology.protein ,Female ,Antibody ,business - Abstract
The influenza-specific antibodies mediating antibody-dependent cellular cytotoxicity (ADCC) may be important in protection against influenza. However, it is not known whether immunocompromised individuals such as HIV-infected persons who have never been vaccinated with influenza vaccine have such a response.The anti-influenza ADCC responses were investigated in plasma samples from 50 HIV positive persons [25 long-term nonprogressors (LTNPs) and 25 progressors] and from 20 HIV-uninfected healthy individuals. None of the participants had received influenza vaccine.The frequencies and the magnitude of ADCC responses against two influenza A virus strains (pH1N1-A/California/7/2009 and H3N2-A/Brisbane/10/2007) were comparable in HIV-infected individuals and in healthy controls (p .05). However, the magnitude of the ADCC response was slightly higher in LTNPs than in progressors (p = .025). The level of ADCC antibodies against pH1N1 and H3N2 correlated significantly indicating the cross-reactive nature of these antibodies (p .0001). Additionally, the level of these ADCC antibodies was significantly associated with antibodies against the highly pathogenic avian influenza H5N1 virus (H5N1-A/Chicken/India/NIV/33487/2007).This is the first report of anti-influenza ADCC antibodies in HIV-infected Indian individuals. Identification of cross-reactive ADCC epitopes in HIV-infected individuals could improve the design of influenza vaccine for immunocompromised individuals.
- Published
- 2017
15. Development of IFN-γ secretory ELISPOT based assay for screening of ADCC responses
- Author
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Chetan Chavan, Archana Kulkarni, Sheela Godbole, Ashwini Shete, Manisha Ghate, Madhuri Thakar, and Poonam Suryawanshi
- Subjects
Adult ,Male ,0301 basic medicine ,Enzyme-Linked Immunospot Assay ,Chemokine ,medicine.medical_treatment ,Immunology ,HIV Infections ,chemical and pharmacologic phenomena ,gag Gene Products, Human Immunodeficiency Virus ,Interferon-gamma ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,Immunology and Allergy ,Interferon gamma ,HIV vaccine ,Antigen-presenting cell ,Aged ,Antibody-dependent cell-mediated cytotoxicity ,biology ,Immunogenicity ,ELISPOT ,Antibody-Dependent Cell Cytotoxicity ,env Gene Products, Human Immunodeficiency Virus ,virus diseases ,Middle Aged ,Virology ,030104 developmental biology ,Cytokine ,030220 oncology & carcinogenesis ,HIV-1 ,biology.protein ,Female ,medicine.drug - Abstract
Antibody dependent cell mediated cytotoxicity has been established as one of the important protective immune mechanisms against HIV making it essential to evaluate it while testing immunogenicity of emerging vaccine candidates. IFN-γ secretory ELISPOT assay, widely used for evaluation of CTL response in HIV vaccine trials, was adapted for measuring ADCC responses and the results were compared with the standard ICS based assays. IFN-γ responses elicited by plasma samples of 23 HIV infected individuals against Env and Gag peptides using granulocytes as antigen presenting cells were assessed by both the methods. Supernatants of the activated cells in ELISPOT assay were also assessed for cytokine/chemokine estimation. ELISPOT assays detected significantly more ADCC responders against HIV-Env and Gag peptide pools than ICS assay. The magnitude of IFN-γ response in both the assay correlated significantly (p=0.002). NK cells were found to be the predominant cell type secreting IFN-γ in the assay. Although IFN-γ and IL-6 levels were significantly higher in supernatants of Env peptides stimulated cells, IP-10 and MCP-1α levels were found to be more against Gag peptides. Thus, IFN-γ secretory ELISPOT assay was found to be more sensitive in detecting ADCC responders than ICS assay making it a valuable tool for screening of ADCC responses in future vaccine trials. Differences in cytokine pattern of Env versus Gag stimulated cells warrants a need for investigating their role in protection against HIV infection.
- Published
- 2017
16. Declining Trends in HIV Prevalence Among Women Attending Antenatal Care Clinics Obfuscate the Continued Vulnerability of Adolescent Girls in Maharashtra, India (2005-2017)
- Author
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Rajesh Yadav, Chitra Kadu, Nisha Dulhani, Radhika Brahme, Shreekala Acharya, S. Venkatesh, Pradeep Kumar, Sheela Godbole, Shobini Rajan, Amit Lokhande, Pramod Deoraj, and Suvarna Sonawale
- Subjects
Adult ,Pregnancy ,Adolescent ,business.industry ,Vulnerability ,MEDLINE ,India ,HIV Infections ,Prenatal Care ,Prenatal care ,medicine.disease ,Hiv prevalence ,Ambulatory Care Facilities ,Young Adult ,Infectious Diseases ,Environmental health ,medicine ,Prevalence ,Humans ,Pharmacology (medical) ,Female ,Young adult ,business - Published
- 2019
17. Findings from the 2017 HIV estimation round & trend analysis of key indicators 2010-2017: Evidence for prioritising HIV/AIDS programme in India
- Author
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M Vishnu Vardhana Rao, Arumugam Elangovan, Shashi Kant, Sheela Godbole, Saritha Nair, Shobini Rajan, Arvind Pandey, Deepika Joshi, Pradeep Kumar, Amol Palkar, P V M Lakshmi, Amitabh Das, S. K. Singh, Anil Kumar, Savina Ammassari, Poonam Bakshi, Sabyasachi Chakraborty, D. K. Shukla, S. Srikanth Reddy, S. Venkatesh, Damodar Sahu, D C S Reddy, Jitenkumar Singh, T Gambhir, Nalini Chandra, Sanjay K Rai, and Malay Kumar Saha
- Subjects
AIDS impact module ,Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,antiretroviral therapy ,030106 microbiology ,Population ,Human immunodeficiency virus (HIV) ,lcsh:Medicine ,India ,HIV Infections ,medicine.disease_cause ,General Biochemistry, Genetics and Molecular Biology ,03 medical and health sciences ,0302 clinical medicine ,Acquired immunodeficiency syndrome (AIDS) ,Pregnancy ,Environmental health ,Epidemiology ,Prevalence ,medicine ,Humans ,030212 general & internal medicine ,education ,Reference group ,aids impact module - aids related deaths - antiretroviral therapy - hiv estimates - hiv prevalence - plhiv ,HIV estimates ,Estimation ,education.field_of_study ,Sex Workers ,Incidence ,lcsh:R ,PLHIV ,General Medicine ,medicine.disease ,Medical statistics ,Infectious Disease Transmission, Vertical ,HIV prevalence ,Trend analysis ,Geography ,AIDS related deaths ,Original Article ,Female - Abstract
Background & objectives: The National AIDS Control Organisation (NACO) and the ICMR-National Institute of Medical Statistics, the nodal agency for conducting HIV estimations in India, have been generating HIV estimates regularly since 2003. The objective of this study was to describe India's biennial HIV estimation 2017 process, data inputs, tool, methodology and epidemiological assumptions used to generate the HIV estimates and trends of key indicators for 2010-2017 at national and State/Union Territory levels. Methods: Demographic Projection (DemProj) and AIDS Impact Modules (AIM) of Spectrum 5.63 software recommended by the United Nations Programme on HIV and AIDS Global Reference Group on HIV Estimates, Modelling and Projections, were used for generating HIV estimations on key indicators. HIV sentinel surveillance, epidemiological and programme data were entered into Estimation Projection Package (EPP), and curve fitting was done using EPP classic model. Finally, calibration was done using the State HIV prevalence of two rounds of National Family Health Survey (NFHS) -3 and -4 and Integrated Biological and Behavioural Surveillance (IBBS), 2014-2015. Results: The national adult prevalence of HIV was estimated to be 0.22 per cent in 2017. Mizoram, Manipur and Nagaland had the highest prevalence over one per cent. An estimated 2.1 million people were living with HIV in 2017, with Maharashtra estimated to have the highest number. Of the 88 thousand annual new HIV infections estimated nationally in 2017, Telangana accounted for the largest share. HIV incidence was found to be higher among key population groups, especially people who inject drugs. The annual AIDS-related deaths were estimated to be 69 thousand nationally. For all indicators, geographic variation in levels and trends between States existed. Interpretation & conclusions: With a slow decline in annual new HIV infections by only 27 per cent from 2010 to 2017 against the national target of 75 per cent by 2020, the national target to end AIDS by 2030 may be missed; although at the sub-national level some States have made better progress to reduce new HIV infection. It calls for reinforcement of HIV prevention, diagnosis and treatment efforts by geographical regions and population groups.
- Published
- 2020
18. Cervical determinants of anal HPV infection and high-grade anal lesions in women: a collaborative pooled analysis
- Author
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Marianne A B van der Sande, Timothy J. Wilkin, Lynette Menezes, Alessandra Pierangeli, Jiri Slama, Isabelle Heard, Beatriz Grinsztejn, Byron Romero, Adhemar Longatto-Filho, Ningshao Xia, Joel M. Palefsky, Ting Wu, Steve Simpson, Chunqing Lin, Sheela Godbole, K.W.M. D'Hauwers, Fernanda K. Tso, Yurii B. Shvetsov, Racheal S. Dube Mandishora, Borek Sehnal, Marc T. Goodman, Carmen Hidalgo-Tenorio, Silvia Franceschi, María del Refugio González Losa, Ana P. Ortiz, Lays Paula Bondi Volpini, Feixue Wei, Maarten F. Schim van der Loeff, Gary M. Clifford, Alexandra de Pokomandy, Erna Milunka Kojic, Lois Conley, Brenda Y. Hernandez, Ina U. Park, Annette H. Sohn, Nancy A. Hessol, Reshmie Ramautarsing, Paula N. Gonzalez, Anna-Barbara Moscicki, Katina Robison, Aimée R. Kreimer, Sandra A. Heráclio, Zizipho Z. A. Mbulawa, and Universidade do Minho
- Subjects
medicine.medical_specialty ,health care facilities, manpower, and services ,education ,Medicina Básica [Ciências Médicas] ,Uterine Cervical Neoplasms ,Cochrane Library ,Global Health ,Anal lesions ,Article ,03 medical and health sciences ,0302 clinical medicine ,All institutes and research themes of the Radboud University Medical Center ,HIV Seropositivity ,medicine ,Journal Article ,Prevalence ,Anal cancer ,Humans ,030212 general & internal medicine ,health care economics and organizations ,Early Detection of Cancer ,Intraepithelial neoplasia ,Human papillomavirus 16 ,Science & Technology ,business.industry ,Obstetrics ,Papillomavirus Infections ,HPV infection ,Cancer ,virus diseases ,Papillomavirus ,Anal Cancer ,Cervical infection ,medicine.disease ,Anus ,Anus Neoplasms ,Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10] ,medicine.anatomical_structure ,Pooled analysis ,Infectious Diseases ,030220 oncology & carcinogenesis ,Ciências Médicas::Medicina Básica ,Female ,business - Abstract
Cervical cancer screening might contribute to the prevention of anal cancer in women. We aimed to investigate if routine cervical cancer screening results-namely high-risk human papillomavirus (HPV) infection and cytohistopathology-predict anal HPV16 infection, anal high-grade squamous intraepithelial lesions (HSIL) and, hence, anal cancer., International Agency for Research on Cancer
- Published
- 2018
19. HIV-specific CD4+Th17 cells from HIV infected long-term non-progressors exhibit lower CTLA-4 expression and reduced apoptosis
- Author
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Akshay Patil, Sheela Godbole, Rupali Tayde, Madhuri Thakar, Varsha Chinchkar, Vandana Saxena, Rajani Bagul, and Shubhangi Bichare
- Subjects
0301 basic medicine ,Mrna expression ,Immunology ,Human immunodeficiency virus (HIV) ,chemical and pharmacologic phenomena ,Apoptosis ,HIV Infections ,Biology ,medicine.disease_cause ,T-Lymphocytes, Regulatory ,HIV Long-Term Survivors ,03 medical and health sciences ,0302 clinical medicine ,Hiv infected ,medicine ,Immunology and Allergy ,Humans ,CTLA-4 Antigen ,Gene ,Hepatitis A Virus Cellular Receptor 2 ,Cells, Cultured ,Caspase 3 ,Interleukin-17 ,Inhibitory receptors ,hemic and immune systems ,Hematology ,030104 developmental biology ,Chronic disease ,Cross-Sectional Studies ,CTLA-4 ,CD4 Antigens ,Chronic Disease ,Disease Progression ,HIV-1 ,Th17 Cells ,030215 immunology ,Follow-Up Studies - Abstract
Progressive HIV infection is marked with reduced frequency and impaired function of Th17 cells. Since T-cell functional responses are regulated by various inhibitory receptors; we examined the expression profile of CTLA-4, PD-1, Tim-3 and apoptotic marker: Caspase-3 on virus-specific Th17 cells from HIV-infected Long-Term Non-Progressors (LTNPs), chronic disease progressors and HIV-uninfected healthy controls (HC) using flowcytometry. Real-time PCR was done to analyze the mRNA expression of Th17 and Treg specific genes. LTNPs showed higher frequencies of HIV-specific Th17 cells; higher mRNA expression of IL-17, IL-22 while lower expression of IL-10; along with lower Caspase-3 expression than the progressors. Among inhibitory receptors, expression of CTLA-4 was 27 and 8 fold; PD-1 was 8 and 6 fold while Tim-3 was 7 and 6 fold higher in progressors and LTNPs respectively than HC. Among HIV-infected patients, LTNPs had 3-fold lower expression of CTLA-4 on HIV-specific Th17 cells than progressors (p = 0.06). Caspase-3+ve Th17 cells were associated with HIV-specific Th17 cells expressing CTLA-4 (r = 0.66;p 0.0001), PD-1 (r = 0.40;p = 0.02) and Tim-3 (r = 0.35;p = 0.04). To conclude, virus-specific Th17 cells from LTNP maintained IL-17 production, expressed low levels of CTLA-4 and reduced apoptosis. The study suggests that such functional competence of Th17 cells could be one of the factors in maintenance of non-progressive HIV infection.
- Published
- 2018
20. Higher expression of human telomerase reverse transcriptase in productively-infected CD4 cells possibly indicates a mechanism for persistence of the virus in HIV infection
- Author
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Poonam, Suryawanshi, Sheela, Godbole, Jyoti, Pawar, Madhuri, Thakar, and Ashwini, Shete
- Subjects
CD4-Positive T-Lymphocytes ,Receptors, CCR5 ,HIV Antigens ,Gene Expression Profiling ,DNA Viruses ,Receptors, Antigen, T-Cell ,Gene Expression ,HIV Infections ,CD5 Antigens ,Flow Cytometry ,Virus Replication ,Tumor Necrosis Factor Receptor Superfamily, Member 7 ,Virus Latency ,Viral Envelope Proteins ,HIV-1 ,Cytokines ,Humans ,Virus Activation ,RNA, Messenger ,Telomerase - Abstract
Mechanisms involved in survival of productively-infected memory CD4+cells after initial antigenic stimulation and their subsequent reversion to the resting state are critical for the development of a predominant replication-competent HIV reservoir. These mechanisms may also counter their elimination after HIV reactivation through latency-reversing agents (LRA). Thus, their evaluation is critical when using an appropriate HIV latency model that recapitulates the predominant replication-competent HIV reservoir to develop strategies for HIV eradication. The model for evaluating the possible survival mechanisms after T cell receptor (TCR) stimulation was developed by infecting memory CD4+cells with an HIV-1C primary isolate and cytokine secretion and gene expression patterns determined. Infected cells showed compromised functionality as evident from 6.8-fold lower secretion of IL-2 than from uninfected control cells. After TCR stimulation, the infected cells showed significantly higher fold increases in CD27 and CCR5 and smaller increases in CD5 mRNA over baseline values. Because CD27 expression may influence telomerase activity through AKT phosphorylation, CD27, human telomerase reverse transcriptase (hTERT) and pAKT expression in productively-infected cells from HIV-infected patients was evaluated by flow cytometry. HIV harbored in memory CD4+ cells was reactivated by HIV-1 envelope peptides, which have been shown to act as effective LRA. P24+CD4+cell showed significantly higher expression of CD27, hTERT and pAKT than P24-CD4+cells. These findings indicate compromised functionality of HIV-infected cells after TCR stimulation, which may interfere with their elimination by the immune system. They also indicate that pAKT and hTERT induction are possible survival mechanisms of productively-infected CD4+cells.
- Published
- 2018
21. HIV Drug Resistance in Adults Receiving Early vs. Delayed Antiretroviral Therapy: HPTN 052
- Author
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Johnstone Kumwenda, Sarah E. Hudelson, Mariza G. Morgado, Theresa Gamble, Myron S. Cohen, Joel E. Gallant, Stephen Hart, Marybeth McCauley, Ying Q. Chen, Sharlaa Badal-Faesen, Victor Akelo, Joseph J. Eron, Maria A. Papathanasopoulos, Susan H. Eshleman, Shanmugam Saravanan, Mina C. Hosseinipour, José Henrique Pilotto, Breno Santos, Beatriz Grinsztejn, Nagalingeswaran Kumarasamy, Carole L. Wallis, Estelle Piwowar-Manning, Srikanth Tripathy, James Hakim, Laura Hovind, Sheela Godbole, Ravindre Panchia, Joseph Makhema, Ethan Wilson, Jessica M. Fogel, Suwat Chariyalertsak, and Philip J. Palumbo
- Subjects
0301 basic medicine ,HPTN 052 ,Adult ,Male ,medicine.medical_specialty ,Efavirenz ,Genotype ,030106 microbiology ,HIV Infections ,Drug resistance ,Microbial Sensitivity Tests ,Article ,Time-to-Treatment ,03 medical and health sciences ,chemistry.chemical_compound ,Zidovudine ,0302 clinical medicine ,Internal medicine ,Antiretroviral Therapy, Highly Active ,Drug Resistance, Viral ,medicine ,Secondary Prevention ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Treatment Failure ,Clinical Trials as Topic ,business.industry ,Lamivudine ,HIV ,Viral Load ,Regimen ,Infectious Diseases ,chemistry ,Anti-Retroviral Agents ,Female ,business ,Viral load ,HIV drug resistance ,medicine.drug - Abstract
Introduction: We evaluated HIV drug resistance in adults who received early vs. delayed antiretroviral therapy (ART) in a multinational trial [HIV Prevention Trials Network (HPTN) 052, enrollment 2005-2010]. In HPTN 052, 1763 index participants were randomized to start ART at a CD4 cell count of 350-550 cells/mm 3 (early ART arm) or 1000 copies/mL >24 weeks after ART initiation. Drug resistance testing was performed for pretreatment (baseline) and failure samples from participants with virologic failure. Results: HIV genotyping results were obtained for 211/249 participants (128 early ART arm and 83 delayed ART arm) with virologic failure. Drug resistance was detected in 4.7% of participants at baseline; 35.5% had new resistance at failure. In univariate analysis, the frequency of new resistance at failure was lower among participants in the early ART arm (compared with delayed ART arm, P = 0.06; compared with delayed ART arm with ART initiation before May 2011, P = 0.032). In multivariate analysis, higher baseline viral load (P = 0.0008) and ART regimen (efavirenz/lamivudine/zidovudine compared with other regimens, P = 0.024) were independently associated with higher risk of new resistance at failure. Conclusions: In HPTN 052, the frequency of new drug resistance at virologic failure was lower in adults with early ART initiation. The main factor associated with reduced drug resistance with early ART was lower baseline viral load.
- Published
- 2018
22. CD1d-Restricted Natural Killer T Cells Are Preserved in Indian Long-Term Nonprogressors
- Author
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Dharmendra Singh, Madhuri Thakar, Manisha Ghate, Sheela Godbole, and Smita Kulkarni
- Subjects
0301 basic medicine ,Male ,India ,chemical and pharmacologic phenomena ,HIV Infections ,Flow cytometry ,HIV Long-Term Survivors ,03 medical and health sciences ,0302 clinical medicine ,Immune system ,Antigen ,Immunity ,medicine ,Humans ,Pharmacology (medical) ,biology ,medicine.diagnostic_test ,Viral Load ,Natural killer T cell ,Immunity, Innate ,CD4 Lymphocyte Count ,Virus Latency ,030104 developmental biology ,Infectious Diseases ,CD1D ,Immunology ,biology.protein ,Disease Progression ,HIV-1 ,Natural Killer T-Cells ,Female ,Antigens, CD1d ,Viral load ,030215 immunology - Abstract
BACKGROUND Natural killer T (NKT) cells act as a bridge between innate and adaptive immune responses. Limited information is available regarding the role of NKT cells in the HIV disease progression especially HIV-1 C infection. METHODOLOGY NKT cells were characterized for their frequency and the activation, aging, exhaustion status, and their proliferation ability in 32 long-term nonprogressors (LTNPs), 40 progressors, 18 patients before and after suppressive combination antiretroviral therapy (cART) along with 35 HIV-1-negative subjects using multicolor flow cytometry. RESULTS The frequencies of total NKT cells and their subpopulation were significantly higher in LTNPs as compared with those obtained in progressors (P < 0.0001) and were significantly associated with higher CD4 counts and with lower plasma viral loads. The percentage of activated, aged, and exhausted NKT cells were significantly lower in LTNPs as compared with the progressors and inversely correlated with CD4 count and positively with plasma viral loads. The NKT cells from the LTNPs showed higher proliferation ability. The frequency and proliferation ability of the NKT cells were partially restored after 12 months of suppressive cART but still lower than the levels in LTNPs. The degree of restoration after cART was similar in both CD4 and CD4 NKT cells. CONCLUSION The findings demonstrate significant association of preserved NKT cells with the nonprogressive HIV infection and also showed that exhausted NKT cells are associated with disease progression. Further characterization of their functionality and assessment of sustenance in HIV infection will help to understand the HIV pathogenesis and to develop immune therapies.
- Published
- 2017
23. Indian Long-term Non-Progressors Show Broad ADCC Responses with Preferential Recognition of V3 Region of Envelope and a Region from Tat Protein
- Author
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Ramesh S. Paranjape, Sheela Godbole, Archana Kulkarni, Stephen J. Kent, Swarali N. Kurle, Manisha Ghate, Ashwini Shete, Madhuri Thakar, and Vijaya Madhavi
- Subjects
0301 basic medicine ,Immunology ,chemical and pharmacologic phenomena ,NK cells ,envelope ,V3 loop ,Hiv 1 tat ,Epitope ,Flow cytometry ,03 medical and health sciences ,0302 clinical medicine ,Antigen ,medicine ,Immunology and Allergy ,Secretion ,Original Research ,Antibody-dependent cell-mediated cytotoxicity ,biology ,medicine.diagnostic_test ,LTNP ,virus diseases ,Virology ,030104 developmental biology ,biology.protein ,Tat ,Antibody ,ADCC ,030215 immunology - Abstract
HIV-specific antibody-dependent cell cytotoxicity (ADCC) is likely to be important in governing protection from human immunodeficiency virus (HIV) and slowing disease progression. Little is known about the ADCC responses to HIV-1 subtype C. We characterized ADCC responses in HIV-1 subtype C-infected Indian subjects with slow disease progression and identified the dominant antigenic regions recognized by these antibodies. ADCC responses were measured in plasma from 34 long-term non-progressors (LTNPs), who were asymptomatic and maintained CD4 count above 500 cells/mm3 for the last 7 years in the absence of antiretroviral therapy (ART), and 58 ART naïve progressors with CD4 count
- Published
- 2017
24. Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial
- Author
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Johnstone Kumwenda, Marineide Gonçalves de Melo, Myron S. Cohen, Theresa Gamble, Max Essex, José Henrique Pilotto, Ying Q. Chen, Heather J. Ribaudo, James Hakim, Susan Swindells, Estelle Piwowar-Manning, Taha E. Taha, Joseph J. Eron, Susan H. Eshleman, Marybeth McCauley, Lei Wang, Joel E. Gallant, Karin Nielsen-Saines, Ravindre Panchia, Lisa A. Mills, Diane V. Havlir, Beatriz Grinsztejn, San San Ou, Kenneth H. Mayer, Sheela Godbole, Mina C. Hosseinipour, Ian Sanne, David D. Celentano, Joseph Makhema, Suwat Chariyalertsak, Maija Anderson, N. Kumarasamy, and Irving F. Hoffman
- Subjects
HPTN 052 ,medicine.medical_specialty ,Sexual transmission ,Intention-to-treat analysis ,business.industry ,Incidence (epidemiology) ,Hazard ratio ,medicine.disease ,Article ,law.invention ,Surgery ,Infectious Diseases ,Randomized controlled trial ,Acquired immunodeficiency syndrome (AIDS) ,law ,Internal medicine ,Medicine ,Young adult ,business - Abstract
Summary Background Use of antiretroviral treatment for HIV-1 infection has decreased AIDS-related morbidity and mortality and prevents sexual transmission of HIV-1. H owever, the best time to initiate antiretroviral treatment to reduce progression of HIV-1 infection or non-AIDS clinical events is unknown. We reported previously that early antiretroviral treatment reduced HIV-1 transmission by 96%. We aimed to compare the eff ects of early and delayed initiation of antiretroviral treatment on clinical outcomes. Methods The HPTN 052 trial is a randomised controlled trial done at 13 sites in nine countries. We enrolled HIV-1-serodiscordant couples to the study and randomly allocated them to either early or delayed antiretroviral treatment by use of permuted block randomisation, stratifi ed by site. Random assignment was unblinded. The HIV-1-infected member of every couple initiated antiretroviral treatment either on entry into the study (early treatment group) or after a decline in CD4 count or with onset of an AIDS-related illness (delayed treatment group). Primary events were AIDS clinical events (WHO stage 4 HIV-1 disease, tuberculosis, and severe bacterial infections) and the following serious medical conditions unrelated to AIDS: serious cardiovascular or vascular disease, serious liver disease, end-stage renal disease, new-onset diabetes mellitus, and non-AIDS malignant disease. Analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00074581. Findings 1763 people with HIV-1 infection and a serodiscordant partner were enrolled in the study; 886 were assigned early antiretroviral treatment and 877 to the delayed treatment group (two individuals were excluded from this group af ter randomisation). Median CD4 counts at randomisation were 442 (IQR 373–522) cells per μL in patients assigned to the early treatment group and 428 (357–522) cells per μL in those allocated delayed antiretroviral treatment. In the delayed group, antiretroviral treatment was initiated at a median CD4 count of 230 (IQR 197–249) cells per μL. Primary clinical events were reported in 57 individuals assigned to early treatment initiation versus 77 people allocated to delayed antiretroviral treatment (hazard ratio 0·73, 95% CI 0·52–1·03; p=0·074). New-onset AIDS events were recorded in 40 participants assigned to early antiretroviral treatment versus 61 allocated delayed initiation (0·64, 0·43–0·96; p=0·031), tuberculosis developed in 17 versus 34 patients, respectively (0·49, 0·28–0·89, p=0·018), and primary nonAIDS events were rare (12 in the early group vs nine with delayed treatment). In total, 498 primary and secondary outcomes occurred in the early treatment group (incidence 24·9 per 100 person-years, 95% CI 22·5–27·5) versus 585 in the delayed treatment group (29·2 per 100 person-years, 26·5–32·1; p=0·025). 26 people died, 11 who were allocated to early antiretroviral treatment and 15 who were assigned to the delayed treatment group.
- Published
- 2014
25. Short Communication: Low Immune Activation Is Associated with Higher Frequencies of Central Memory T Cell Subset in a Cohort of Indian Long-Term Nonprogressors
- Author
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Smita Kulkarni, Vandana Saxena, Ramesh S. Paranjape, Sheela Godbole, Shubhangi Bichare, Raman R. Gangakhedkar, Dharmendra Singh, Madhuri Thakar, and Manisha Ghate
- Subjects
0301 basic medicine ,Adult ,Male ,T cell ,Immunology ,Population ,India ,HIV Infections ,Biology ,Lymphocyte Activation ,Virus ,HIV Long-Term Survivors ,03 medical and health sciences ,0302 clinical medicine ,Immune system ,T-Lymphocyte Subsets ,Virology ,medicine ,Humans ,education ,Aged ,education.field_of_study ,Middle Aged ,Phenotype ,030104 developmental biology ,Infectious Diseases ,medicine.anatomical_structure ,Apoptosis ,Female ,Immunologic Memory ,CD8 ,030215 immunology - Abstract
Persistent immune activation in human immunodeficiency virus (HIV) infection is responsible for alterations in immune system such as activation, apoptosis, and reduced frequencies. Reduced immune activation is known to be associated with virus control. Limited information is available on the influence of pan-immune activation on memory responses. Hence, we compared the T cell activation and memory profile in HIV-infected individuals exhibiting disease control such as long-term nonprogressors (LTNPs) and progressors. The activated CD4+ and CD8+ T cells were significantly lower and the CD4+ and CD8+ central memory T cell phenotypes were significantly higher in the LTNPs compared to the progressors. In addition, we observed significant inverse association between the T cell activation and frequencies of central memory T cells. Our findings indicate that patients with absence of disease progression have preserved central memory T cell population associated with lesser immune activation.
- Published
- 2016
26. Optimization of extraction of genomic DNA from archived dried blood spot (DBS): potential application in epidemiological research & bio banking
- Author
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Sheela Godbole, Prabhat Jha, Rajesh Dikshit, Abhinendra Kumar, and Sharayu Mhatre
- Subjects
0301 basic medicine ,Whole Genome Amplification ,Chromatography ,Epidemiology ,Whatman 903 cards ,Health Policy ,Public Health, Environmental and Occupational Health ,Medicine (miscellaneous) ,Articles ,Dried blood spot (DBS) ,030105 genetics & heredity ,Biology ,Bio-banking ,Biochemistry, Genetics and Molecular Biology (miscellaneous) ,Dried blood spot ,FTA cards ,03 medical and health sciences ,genomic DNA ,030104 developmental biology ,Immunology and Microbiology (miscellaneous) ,Magnetic bead ,Human genomic DNA ,Extraction methods ,Genotyping ,Research Article - Abstract
Background:Limited infrastructure is available to collect, store and transport venous blood in field epidemiological studies. Dried blood spot (DBS) is a robust potential alternative sample source for epidemiological studies & bio banking. A stable source of genomic DNA (gDNA) is required for long term storage in bio bank for its downstream applications. Our objective is to optimize the methods of gDNA extraction from stored DBS and with the aim of revealing its utility in large scale epidemiological studies. Methods:The purpose of this study was to extract the maximum amount of gDNA from DBS on Whatman 903 protein saver card. gDNA was extracted through column (Qiagen) & magnetic bead based (Invitrogen) methods. Quantification of extracted gDNA was performed with a spectrophotometer, fluorometer, and integrity analyzed by agarose gel electrophoresis. Result:Large variation was observed in quantity & purity (260/280 ratio, 1.8-2.9) of the extracted gDNA. The intact gDNA bands on the electrophoresis gel reflect the robustness of DBS for gDNA even after prolonged storage time. The extracted gDNA amount 2.16 – 24 ng/µl is sufficient for its PCR based downstream application, but unfortunately it can’t be used for whole genome sequencing or genotyping from extracted gDNA. Sequencing or genotyping can be achieved by after increasing template copy number through whole genome amplification of extracted gDNA. The obtained results create a base for future research to develop high-throughput research and extraction methods from blood samples.Conclusion:The above results reveal, DBS can be utilized as a potential and robust sample source for bio banking in field epidemiological studies.
- Published
- 2019
27. Understanding racial diversities in Kaposi's sarcoma
- Author
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Manisha Ghate, Sheela Godbole, and Sanjay Mehendale
- Subjects
Adult ,Male ,medicine.medical_specialty ,business.industry ,Incidence (epidemiology) ,Racial Groups ,lcsh:R ,lcsh:Medicine ,HIV Infections ,General Medicine ,medicine.disease ,Dermatology ,United States ,General Biochemistry, Genetics and Molecular Biology ,Race Factors ,Commentary ,Humans ,Medicine ,Female ,Sarcoma ,business ,Sarcoma, Kaposi ,Kaposi's sarcoma ,SEER Program - Abstract
In the United States (US), Kaposi's sarcoma (KS) is usually seen in the patients affected by human immunodeficiency virus (HIV). The racial differences in the incidence rates and survival of patients with KS have been reported in the US. We undertook this study to analyse the disparities in the race-specific incidence rate and survival of KS patients of two different races in the US based on SEER (Surveillance, Epidemiology and End Results) database.Data on KS patients of African-American (AA) and non-Hispanic White (NHW) races who were diagnosed during 1973-2013 were extracted from SEER database to estimate the incidence rates and survival of KS patients.A total of 18,388 NHWs and 3,455 AAs were diagnosed with KS. The age-adjusted incidence rate (AAIR) of KS in patients aged 20-44 yr was 3.8 times higher in AAs than in NHWs. The decline in AAIR of KS among NHWs started during 1989-1994 and preceded decline in the AAIR of AAs. After introduction of highly active antiretroviral therapy (HAART), the incidence continued to decline, but the decrease in the AAIR in AAs [annual percentage change (APC): -6.2; 95% confidence interval (CI): -8.8 to -3.5] was slower than that in NHWs (APC: -10.9; 95% CI: -12.6 to -9.1). The hazard ratio for all-cause mortality in KS patients of the AA race increased from 1.1 (95% CI: 1-1.2) in 1981-1995 to 1.55 (95% CI: 1.4-1.7) in 1996-2013 as compared to those of the NHW race.: Several significant racial disparities that emerged after HAART introduction in the incidence and survival of KS patients continued to persist, despite improvement in care of patients with HIV. Further studies need to be done to find out the underlying factors leading to these disparities.
- Published
- 2019
28. Persons living with HIV continue to present late for care: A trend analysis from 2011 to 2015
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Megha Mamulwar, Narayan Panchal, Abhijit Vasantrao Kadam, Ashwini Shete, Shilpa Bembalkar, and Sheela Godbole
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trends ,0301 basic medicine ,Pediatrics ,medicine.medical_specialty ,CD4 cell count at presentation ,Referral ,HIV diagnosis ,030106 microbiology ,Human immunodeficiency virus (HIV) ,Context (language use) ,Dermatology ,medicine.disease_cause ,Early initiation ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Acquired immunodeficiency syndrome (AIDS) ,Bayesian multivariate linear regression ,medicine ,business.industry ,Public Health, Environmental and Occupational Health ,medicine.disease ,Trend analysis ,Infectious Diseases ,Original Article ,business - Abstract
Context: The clinical and prevention benefits of early initiation of antiretroviral therapy (ART) have led to the adoption of test and treat policy for HIV. Early diagnosis of HIV is crucial for maximal benefits from ART. Aims: This study aims to assess trends in CD4 cell counts at diagnosis and determinants of late presentation. Settings and Design: We analyzed 5-year data from a free HIV/sexually transmitted infection referral clinic immune. Subjects and Methods: Persons presenting for HIV testing from January 2011 to December 2015, for whom CD4 cell count results were available within 3 months of HIV diagnosis, were included in the analysis. Persons on ART were excluded from the study. Statistical Analysis: The predictors of CD4 cell count at presentation were assessed using univariate and multivariate linear regression. Results: Of 1001 persons diagnosed HIV-1 positive, 659 had received CD4 test within 3 months of diagnosis. The median CD4 count at presentation ranged from 212 to 352 cells/cmm in these 5 years and did not show any significant change with time. Nearly 40% had CD4 cell counts below 200 cells/cmm (AIDS); additionally, 23% presented below 350 cells/cmm. Older age (beta: -5.78; P = 0.001), education above matriculation (beta: -123.72; P = 0.014), having current opportunistic infections (beta: -173.58; P = 0.037), and being symptomatic (beta: -101.8; P = 0.002) were predictors of presenting at lower CD4 counts. Conclusion: Between 2011 and 2015, persons with HIV continued to present late in spite of changes in ART access program. Education focused on the benefits of early diagnosis and availability of free immediate treatment in the public sector, are crucial to the achievement of the India's 90-90-90 goals.
- Published
- 2019
29. Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial
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San San Ou, Myron S. Cohen, Victor Akelo, Beatriz Grinsztejn, Joseph Makhema, Johnstone Kumwenda, Mariza G. Morgado, Srikanth Tripathy, Kenneth H. Mayer, Stephen Hart, Theresa Gamble, Nagalingeswaran Kumarasamy, Sharlaa Badal-Faesen, Joseph J. Eron, Devin Sabin, Suwat Chariyalertsak, Sarah E. Hudelson, Shanmugam Saravanan, Breno Santos, James Hakim, Jessica M. Fogel, Joel E. Gallant, Laura Hovind, Ravindre Panchia, José Henrique Pilotto, Marybeth McCauley, Susan H. Eshleman, Mina C. Hosseinipour, Xinyi C. Zhang, Carole L. Wallis, Ying Q. Chen, Sheela Godbole, and Estelle Piwowar-Manning
- Subjects
0301 basic medicine ,HPTN 052 ,Adult ,Male ,medicine.medical_specialty ,Anti-HIV Agents ,Human immunodeficiency virus (HIV) ,HIV Infections ,Drug resistance ,medicine.disease_cause ,Drug Administration Schedule ,Article ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Drug Resistance, Viral ,Medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Treatment Failure ,business.industry ,HIV ,Viral Load ,030112 virology ,CD4 Lymphocyte Count ,Clinical trial ,Observational Studies as Topic ,Infectious Diseases ,Disease Progression ,Female ,Prevention trials ,business ,Viral load ,HIV drug resistance - Abstract
Early initiation of antiretroviral treatment (ART) reduces HIV transmission and has health benefits. HIV drug resistance can limit treatment options and compromise use of ART for HIV prevention. We evaluated drug resistance in 85 participants in the HIV Prevention Trials Network 052 trial who started ART at CD4 counts of 350-550 cells per cubic millimeter and failed ART by May 2011; 8.2% had baseline resistance and 35.3% had resistance at ART failure. High baseline viral load and less education were associated with emergence of resistance at ART failure. Resistance at ART failure was observed in 7 of 8 (87.5%) participants who started ART at lower CD4 cell counts.
- Published
- 2016
30. Sexually Transmitted Infections and Risk Behaviors Among Transgender Persons (Hijras) of Pune, India
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Sheela Godbole, Robert C. Bollinger, Sanjay Mehendale, Sushant Sahastrabuddhe, Arun Risbud, Amita Gupta, A. D. Divekar, Raman R. Gangakhedkar, Elizabeth A. Stuart, Manisha Ghate, and Seema Sahay
- Subjects
Adult ,Male ,medicine.medical_specialty ,Multivariate analysis ,Cross-sectional study ,Sexual Behavior ,media_common.quotation_subject ,Sexually Transmitted Diseases ,India ,HIV Infections ,Human sexuality ,Disease ,Young Adult ,Risk-Taking ,Risk Factors ,Surveys and Questionnaires ,Prevalence ,Humans ,Medicine ,Pharmacology (medical) ,Homosexuality ,Homosexuality, Male ,Young adult ,Heterosexuality ,media_common ,Gynecology ,business.industry ,Odds ratio ,Genital ulcer ,Cross-Sectional Studies ,Infectious Diseases ,medicine.symptom ,business ,Transsexualism ,Demography - Abstract
The objectives of this cross-sectional study were to determine the prevalence of HIV and sexually transmitted infections (STI) in Hijras (self-identified transgenders of South Asia), study associated risk factors, and compare the prevalence with that in heterosexual men and men having sex with men (MSM) in Pune, India, between 1993 and 2002.After informed consent, individuals attending 3 STI clinics were administered a questionnaire regarding their demographic, socioeconomic, and sexual behaviors. Blood samples were collected for STI and HIV diagnosis. Bivariate and multivariate analyses were performed to determine the correlates of HIV infection.The prevalence of HIV (45.2% in Hijras vs 20% in heterosexual men vs 18.9% in MSM, P0.0001) and warts (10.3% vs 4.6% vs 7.0%; P = 0.004) was higher in Hijras as compared with heterosexual men and MSM; whereas that of genital ulcer disease (15.3% vs 32.6% vs 21.5%; P0.0001) and discharge (5.4% vs 13.6% vs 9.0%; P0.0001) was lower. Hijras were more likely to have received money for sex and have an earlier sexual debut than the comparison groups. In multivariate analysis, receiving money for sex (adjusted odds ratio: 4.49; P0.04) and having genital ulcer disease (odds ratio: 3.87; P0.08) were independently associated with high HIV prevalence in Hijras.Considering the high HIV and STI burden, it is important to review current prevention strategies and stress the need to engage Hijra community members through appropriate targeted intervention programs.
- Published
- 2012
31. Incidence of common opportunistic infections in HIV-infected individuals in Pune, India: analysis by stages of immunosuppression represented by CD4 counts
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Sheela Godbole, Madhura Nene, Madhuri Thakar, Manisha Ghate, Robert C. Bollinger, Swapna Deshpande, Preeti Gedam, Srikanth Tripathy, Sanjay Mehendale, and Arun Risbud
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Adult ,Male ,Microbiology (medical) ,medicine.medical_specialty ,Tuberculosis ,medicine.medical_treatment ,India ,HIV Infections ,CD4 count ,Meningitis, Cryptococcal ,Herpes Zoster ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Candidiasis, Oral ,Internal medicine ,medicine ,Humans ,Opportunistic infections ,030212 general & internal medicine ,Young adult ,Prospective cohort study ,Immunodeficiency ,Immunosuppression Therapy ,0303 health sciences ,AIDS-Related Opportunistic Infections ,030306 microbiology ,business.industry ,Incidence (epidemiology) ,Incidence ,HIV ,Immunosuppression ,General Medicine ,Middle Aged ,medicine.disease ,3. Good health ,CD4 Lymphocyte Count ,Infectious Diseases ,Immunology ,Female ,business ,Cryptococcal meningitis ,Meningitis - Abstract
Summary Background Opportunistic infections (OIs) influence the morbidity and mortality due to HIV infections. Data from India on the incidence of OIs among HIV-infected individuals by stages of immunodeficiency are scarce. Methods Between September 2002 and November 2004, HIV-infected individuals were enrolled in a prospective study in Pune. They were clinically and immunologically evaluated quarterly. Incidence rates of specific OIs were calculated. Results Median CD4 counts in HIV-infected male and female patients at baseline were 197/mm 3 and 413/mm 3 , respectively. Tuberculosis was the most common OI with an incidence of 15.4 (95% CI 12.2–19.2) per 100 person-years, followed by oral candidiasis 11.3 (95% CI 8.6–14.5), herpes zoster 10.1 (95% CI 7.6–13.1), and cryptococcal meningitis 1.7 (95% CI 0.8–3.1) per 100 person-years. Patients with baseline CD4 counts of 3 were six times more likely to develop OIs compared to those with CD4 counts of >350/mm 3 ( p Conclusions The high incidence of commonly reported OIs in Indian HIV-infected individuals highlights the need for early screening and also the need to increase awareness in healthcare providers, in order to improve decisions regarding prophylaxis for prevention and appropriate therapeutic intervention. Emphasis needs to be given to the early diagnosis and management of tuberculosis in HIV-infected individuals.
- Published
- 2009
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32. HIV infection in India: Epidemiology, molecular epidemiology and pathogenesis
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Madhuri Thakar, Samir K. Lakhashe, Ramesh S. Paranjape, Srikanth Tripathy, and Sheela Godbole
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medicine.medical_specialty ,Molecular epidemiology ,Anti-HIV Agents ,India ,HIV Infections ,Context (language use) ,General Medicine ,Drug resistance ,Biology ,medicine.disease ,Virology ,General Biochemistry, Genetics and Molecular Biology ,Virus ,Acquired immunodeficiency syndrome (AIDS) ,Drug Resistance, Viral ,Immunology ,Epidemiology ,HIV-1 ,Prevalence ,medicine ,biology.protein ,Humans ,General Agricultural and Biological Sciences ,Neutralizing antibody ,HIV drug resistance - Abstract
The year 1986 saw first case of HIV infection as well as first report of AIDS case in India. Since then the epidemic has spread throughout the country. In the recent years there is evidence of epidemic being stabilized with decrease in new infections reported from some parts of the country. The absolute number of HIV infections in the country is expected to be close to 2.5 million and National AIDS Control Programme, phase III is geared to contain the epidemic. HIV viruses circulating in India predominantly belong to HIV-1 subtype C. However, there have been occasional reports of HIV-1 subtype A and B. Matter of concern is reports of A/C and B/C mosaic viruses that are being reported from different parts of the country. The data on HIV drug resistance from India is rather limited. Most of the studies have shown that the virus strains from drug naive patients do not show significant level of drug resistance mutations. The few immunological studies in Indian patients show that the Indian HIV infected patients show both HIV-specific CTL responses as well as neutralizing antibody response. Mapping of CTL epitopes showed that while Indian patients identify same regions of Gag antigen as recognized by South African subtype C infected patients, some regions are uniquely recognized by Indian patients. There are very few studies on host genetic factors in India in context with HIV infection. However there are evidences reported of association of host genetic factors such as HLA types and haplotypes and HIV disease.
- Published
- 2008
33. Declining HIV Incidence Among Patients Attending Sexually Transmitted Infection Clinics in Pune, India
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Sanjay Mehendale, Arun Risbud, Nikhil Gupte, Rewa Kohli, Radhika Brahme, Ron Brookmeyer, Neelam Joglekar, Ramesh S. Paranjape, Smita Joshi, B. Kishore Kumar, Sheela Godbole, Seema Sahay, Robert C. Bollinger, Raman R. Gangakhedkar, and Manisha Ghate
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Adult ,Male ,Safe Sex ,Sexually transmitted disease ,Population ,India ,HIV Infections ,Women in development ,law.invention ,Cohort Studies ,Condoms ,Condom ,Acquired immunodeficiency syndrome (AIDS) ,Risk Factors ,law ,medicine ,Humans ,Pharmacology (medical) ,Prospective Studies ,Risk factor ,education ,education.field_of_study ,business.industry ,Incidence ,Incidence (epidemiology) ,virus diseases ,medicine.disease ,Sex Work ,Genital ulcer ,Infectious Diseases ,HIV-2 ,Immunology ,HIV-1 ,Regression Analysis ,Female ,medicine.symptom ,business ,Demography - Abstract
A recent report suggesting declining HIV transmission rates in southern India has been based on HIV seroprevalence data to estimate HIV incidence. We analyzed HIV incidence rates among 3 cohorts (male female non-sex worker female sex worker [FSW]) presenting to sexually transmitted infection (STI) clinics in Pune India over 10 years. Between 1993 and 2002 consenting HIV-uninfected individuals were enrolled in a prospective study of the risks for HIV seroconversion. Standardized HIV incidence estimates were calculated separately for the 3 cohorts. HIV acquisition risk declined by more than 70% for FSWs (P = 0.02) and men (P < 0.001) attending the STI clinics. There was no significant reduction in HIV incidence among women attending STI clinics (P = 0.74). The decline in HIV acquisition risk among male patients with STIs was associated with an increase in reported condom use with recent FSW contact and a decrease in genital ulcer disease. We report the first direct evidence for a decline in HIV incidence rates in FSWs and male patients with STIs over time. The lack of change in HIV infection risk among non-sex worker women highlights the need for additional targeted HIV prevention interventions. (authors)
- Published
- 2007
34. HIV-infected CD4+ T Cells Use T-bet-dependent Pathway for Production of IL-10 Upon Antigen Recognition
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Jyoti Pawar, Sheela Godbole, Madhuri Thakar, Ramesh S. Paranjape, Ashwini Shete, and Poonam Suryawanshi
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0301 basic medicine ,Adult ,CD4-Positive T-Lymphocytes ,Male ,Immunology ,Antigen presentation ,HIV Core Protein p24 ,HIV Infections ,Quinolones ,Lymphocyte Activation ,03 medical and health sciences ,Interleukin 21 ,Interferon-gamma ,Young Adult ,0302 clinical medicine ,Cytotoxic T cell ,Humans ,IL-2 receptor ,Antigen-presenting cell ,Extracellular Signal-Regulated MAP Kinases ,Cells, Cultured ,Flavonoids ,CD40 ,biology ,Antigen processing ,Chemistry ,hemic and immune systems ,Forkhead Transcription Factors ,General Medicine ,Middle Aged ,CD4 Lymphocyte Count ,Interleukin-10 ,Interleukin 10 ,030104 developmental biology ,biology.protein ,Cancer research ,Cyclosporine ,Female ,T-Box Domain Proteins ,030215 immunology - Abstract
Interleukin (IL)-10 has been implicated in persistence of pathogens in a number of chronic infections. Infected CD4+ cells upon reactivation with HIV antigens were also shown to produce IL-10, which might contribute to their persistence. Hence, it is crucial to determine mechanisms regulating IL-10 production after activation with HIV antigens for devising effective blocking strategies. In this study, ERK-, T-bet- and FoxP3-dependent pathways were evaluated for their possible roles in IL-10 production by infected CD4+ cells after reactivation with HIV Env. Intracellular and secreted IL-10 levels were determined by flow cytometry and Bioplex assay after treating PBMCs with PD98059, tipifarnib and cyclosporin A for blocking of ERK-, T-bet-and FoxP3-dependent pathways, respectively. Baseline levels of T-bet, pERK were higher in P24+ CD4+ cells as compared to uninfected CD4+ cells, which increased further after activation with Env. Inhibition of T-bet resulted in 2.3-fold reduction of IL-10 expression whereas ERK and FoxP3 inhibition failed to cause suppression of IL-10 expression. Conversely, IL-10 secreted by PBMCs was inhibited maximally after ERK inhibition suggesting its role in regulation of cytokine secretory pathway. IFN-γ was found to be suppressed after treatment with inhibitors of all these pathways. Thus, the study highlighted need for IL-10 blockade along with the use of antigens for therapeutic vaccinations or latency reversal and identified the T-bet-dependent pathway as an important pathway regulating IL-10 production by infected CD4+ cells. However, simultaneous blockade of IFN-γ precludes use of inhibitor of this pathway as an IL-10 blocking strategy.
- Published
- 2015
35. Fitting HIV Prevalence 1981 Onwards for Three Indian States Using the Goals Model and the Estimation and Projection Package
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Sheela Godbole, Tarun Bhatnagar, Rajat Goyal, Shilpa Bembalkar, Sanjay Mehendale, Damodar Sahu, John Stover, Kangusamy Boopathi, Arvind Pandey, Kh. Jitenkumar Singh, and Tapati Dutta
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Male ,RNA viruses ,Epidemiology ,Human immunodeficiency virus (HIV) ,Psychological intervention ,lcsh:Medicine ,HIV Infections ,medicine.disease_cause ,Pathology and Laboratory Medicine ,Risk groups ,Mathematical and Statistical Techniques ,Immunodeficiency Viruses ,Environmental protection ,Prevalence ,Ethnicities ,lcsh:Science ,Projection (set theory) ,Multidisciplinary ,Middle Aged ,Hiv prevalence ,Curve Fitting ,Geography ,HIV epidemiology ,Medical Microbiology ,Viral Pathogens ,Viruses ,language ,Female ,Pathogens ,Goals ,Research Article ,Adult ,medicine.medical_specialty ,Computer and Information Sciences ,Adolescent ,India ,Men WHO Have Sex with Men ,Research and Analysis Methods ,Microbiology ,Computer Software ,Young Adult ,Retroviruses ,medicine ,Humans ,Heterosexuals ,Microbial Pathogens ,Estimation ,Medicine and health sciences ,Behavior ,Models, Statistical ,lcsh:R ,Lentivirus ,Organisms ,Biology and Life Sciences ,HIV ,language.human_language ,Tamil ,People and Places ,lcsh:Q ,Population Groupings ,Mathematical Functions ,Tamil People ,Demography ,Sexuality Groupings - Abstract
Models are designed to provide evidence for strategic program planning by examining the impact of different interventions on projected HIV incidence. We employed the Goals Model to fit the HIV epidemic curves in Andhra Pradesh, Maharashtra and Tamil Nadu states of India where HIV epidemic is considered to have matured and in a declining phase. Input data in the Goals Model consisted of demographic, epidemiological, transmission-related and risk group wise behavioral parameters. The HIV prevalence curves generated in the Goals Model for each risk group in the three states were compared with the epidemic curves generated by the Estimation and Projection Package (EPP) that the national program is routinely using. In all the three states, the HIV prevalence trends for high-risk populations simulated by the Goals Model matched well with those derived using state-level HIV surveillance data in the EPP. However, trends for the low- and medium-risk populations differed between the two models. This highlights the need to generate more representative and robust data in these sub-populations and consider some structural changes in the modeling equation and parameters in the Goals Model to effectively use it to assess the impact of future strategies of HIV control in various sub-populations in India at the sub-national level.
- Published
- 2015
36. High HIV Prevalence Among a High-Risk Subgroup of Women Attending Sexually Transmitted Infection Clinics in Pune, India
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Sanjay Mehendale, Arun Risbud, Sheela Godbole, Robert C. Bollinger, Seema Sahay, Shruti H. Mehta, Amita Gupta, Smita Joshi, Steven J. Reynolds, and David D. Celentano
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Adult ,Sexually transmitted disease ,medicine.medical_specialty ,Adolescent ,Cross-sectional study ,Sexual Behavior ,India ,HIV Infections ,law.invention ,Condoms ,Gonorrhea ,Risk-Taking ,Condom ,Acquired immunodeficiency syndrome (AIDS) ,HIV Seroprevalence ,law ,Epidemiology ,Humans ,Medicine ,Pharmacology (medical) ,Community Health Services ,Syphilis ,Sex work ,Marital Status ,business.industry ,Age Factors ,Odds ratio ,medicine.disease ,Genital ulcer ,Infectious Diseases ,Socioeconomic Factors ,Multivariate Analysis ,Immunology ,Female ,medicine.symptom ,business ,Demography - Abstract
The objective was to investigate changes over a decade in prevalence and correlates of HIV among high-risk women attending sexually transmitted infection (STI) clinics in Pune India who deny a history of commercial sex work (CSW). Design: Cross-sectional. Methods: From 1993 to 2002 2376 women attending 3 STI clinics in Pune were offered HIV screening. Women who denied CSW were included (n = 1020). Of 1020 women 21% were HIV infected. The annual HIV prevalence increased from 14% in 1993 to 29% in 2001-2002 (P < 0.001). The change in HIV prevalence over time was paralleled by changes in clinic visitor characteristics; in later periods women were older more often employed less likely to be currently married and more likely to report condom use. In multivariate analysis factors independently associated with HIV were calendar period (adjusted odds ratio [AOR] 1.9 for 1997-1999 vs. 1993-1996; 95% CI 1.2- 3.0; AOR 2.3 for 2000-2002 vs. 1993-1996; 95% CI 1.5-3.6) lack of formal education (AOR 2.0; 95% CI 1.4-2.9) having been widowed (AOR 3.1; 95% CI 1.6-6.1) current employment (AOR 1.8; 95% CI 1.2-2.6) and genital ulcer disease on examination (AOR 1.8; 95% CI 1.2-2.7). Women attending STI clinics in India who deny a history of CSW represent a small hidden subgroup likely put at risk for HIV because of high-risk behavior of their male partners generally their husbands. Educational and awareness efforts that have targeted other subgroups in India (men and CSWs) should also focus on these hard-to-reach women. Risk reduction in this subgroup of Indian women would also be expected to reduce perinatal infections in India. (authors)
- Published
- 2006
37. Prevalence of anal human papillomavirus infection among HIV-infected women from India
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Sheela Godbole, Prachi V. Athavale, Ramesh S. Paranjape, Shweta Chidrawar, Manisha M. Ratnaparkhi, Jyoti Pawar, Arati Mane, Usha Katti, Arun Risbud, Mallika Alexander, and Shubhangi Kalgutkar
- Subjects
Adult ,Anus Diseases ,business.industry ,Papillomavirus Infections ,Anal Canal ,India ,HIV Infections ,Virology ,Young Adult ,Infectious Diseases ,Cross-Sectional Studies ,Logistic Models ,Risk Factors ,Hiv infected ,DNA, Viral ,Prevalence ,Medicine ,Humans ,Pharmacology (medical) ,Female ,Human papillomavirus ,business ,Papillomaviridae - Published
- 2014
38. Self-Report of STI Symptoms, Inconsistent Condom use and Condom Nonuse are Poor Predictors of STI Prevalence among Men who have Sex with Men
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Sheela Godbole, Lakshmi Ramakrishnan, Deepika Ganju, Mandar K Mainkar, Ramesh S. Paranjape, Karikalan Nagarajan, and Sowmya Ramesh
- Subjects
Gynecology ,medicine.medical_specialty ,education.field_of_study ,business.industry ,Immunology ,Population ,Prevalence ,virus diseases ,Dermatology ,urologic and male genital diseases ,medicine.disease ,law.invention ,Men who have sex with men ,Infectious Diseases ,Condom ,Acquired immunodeficiency syndrome (AIDS) ,law ,Virology ,Epidemiology ,medicine ,Syphilis ,Sample collection ,education ,business ,Demography - Abstract
Background: Biological testing for Sexually Transmitted Infections (STI) are challenged by sample collection and high testing costs, where self-reports are used in predicting STI status. The validity of self-reports among populations at STI risk has not been established clearly. The objective of this paper is to assess the validity of selfreported ‘STI symptoms’, self-reported ‘recent condom non- use’ and ‘inconsistent condom use’ in comparison with laboratory diagnosed STIs among men who have sex with men (MSM) in India. Methods: Data were drawn from a cross sectional Integrated Behavioural and Biological Assessment survey conducted among MSM between 2005-2007 in India. Sensitivity analysis was used to assess the validity of selfreported ‘STI symptoms’, ‘recent condom non-use’ and ‘inconsistent condom use’ with laboratory diagnosed STIs (syphilis/Neisseria gonorrhoeae/ Chlamydia trachomatis). Multiple logistic regressions were used to identify population characteristics which were predictive of concordant self-reporting. Results: Of 3895 MSM surveyed, 14.3% were diagnosed with any STI while 8.3% and 3% reported any STI symptom in past and current respectively. Recent condom non-use and inconsistent condom use was reported by 43.1% and 77.6% of respondents. Self-reported STI symptoms showed very low sensitivity (5-13) in predicting laboratory diagnosis of STIs. Self-reported inconsistent condom use and recent condom non-use showed higher sensitivity than self-reported STI symptoms (50-74.4), but were less specific (21-52.9). Combined self reports showed relatively higher sensitivity (52.3-77.9) and low specificity (18.9 -51.8). Overall self reports showed very high negative predictive value (84.4-87.9) and low positive predictive value (12.4-15.7). Education grade more than 12 [AOR: 3.2 (CI 1.7-5.9)], and STI/HIV information exposure [AOR: 1.4 (CI 1.0-2.0)] were predictive of concordant self-reporting of STI symptoms and inconsistent condom use respectively. Knowledge about STIs [AOR: 1.4 (CI 0.9-2.2)] and education grade more than12 [AOR: 2.5 (CI 1.2-5.3)] were predictive of concordant self-reporting of symptoms/risk. Conclusions: Self-reports of STI symptoms, recent condom non-use and inconsistent condom use were not reliable in predicting true STI status of MSM and thus highlights the limitations in the validity of self-reports collected at different levels in the program setting. The study identified MSM education status, STI/HIV knowledge and information exposure, as predictors of concordant self-reporting of ‘symptoms’ and ‘inconsistent condom use’ with STI laboratory diagnosis, which could be utilized in future survey efforts for improving validity of self-reports.
- Published
- 2013
39. Risk reduction and perceived collective efficacy and community support among female sex workers in Tamil Nadu and Maharashtra, India: the importance of context
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Angela Baschieri, Suvarna Sane, Shalini Bharat, Mohua Guha, Joseph Williams, Tarun Bhatnagar, Martine Collumbien, Sheela Godbole, Mandar K Mainkar, and Saravanamurthy P S
- Subjects
Adult ,Male ,Safe Sex ,Health Knowledge, Attitudes, Practice ,Epidemiology ,Psychological intervention ,Vulnerability ,Developing country ,India ,Context (language use) ,HIV Infections ,Vulnerable Populations ,Condoms ,Interviews as Topic ,Medicine ,Humans ,Propensity Score ,Sex work ,Sex Workers ,business.industry ,Public Health, Environmental and Occupational Health ,Social Support ,Middle Aged ,Sex Work ,language.human_language ,Collective efficacy ,Self-Help Groups ,Cross-Sectional Studies ,Logistic Models ,Tamil ,Propensity score matching ,Collective Bargaining ,language ,Female ,Perception ,business ,Risk Reduction Behavior ,Demography - Abstract
Background Empowering sex workers to mobilise and influence the structural context that obstructs risk reduction efforts is now seen an essential component of successful HIV prevention programmes. However, success depends on local programme environments and history. Methods The authors analysed data from the Integrated Behavioural and Biological Assessment Round I cross-sectional survey among female sex workers in Tamil Nadu and Maharashtra. The authors used propensity score matching to estimate the impact of participation in intervention activities on reduction of risk (consistent condom use) and vulnerability (perceived collective efficacy and community support). Results Background levels of risk and vulnerability as well as intervention impact varied widely across the different settings. The effect size ATT of attending meetings/trainings on consistent condom use was as high as 21% in Tamil Nadu (outside of Chennai) where overall use was lowest at 51%. Overall, levels of perceived collective efficacy were low at the time of the survey; perceived community support was high in Tamil Nadu and especially in Chennai (93%) contrasting with 33% in Mumbai. Consistent with previous research, the context of Mumbai seems least conducive to vulnerability reduction, yet self-help groups had a significant impact on consistent condom use (ATT=10%) and were significantly associated with higher collective efficacy (ATT=31%). Conclusions Significant risk reduction can be achieved by large-scale female sex worker interventions, but the impact depends on the history of programming, the complexity of the context in which sex work happens and pre-existing levels of support sex workers perceive from their peers.
- Published
- 2012
40. Same-sex behavior and high rates of HIV among men attending sexually transmitted infection clinics in Pune, India (1993-2002)
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A. D. Divekar, Raman R. Gangakhedkar, Amita Gupta, Shruti H. Mehta, Steven J. Reynolds, Seema Sahay, Sanjay Mehendale, Sheela Godbole, Arun Risbud, Robert C. Bollinger, Louise Walshe, and Manisha Ghate
- Subjects
Sexually transmitted disease ,Adult ,Male ,Cross-sectional study ,Sexual Behavior ,Gonorrhea ,Population ,Sexually Transmitted Diseases ,India ,HIV Infections ,Men who have sex with men ,Disease Outbreaks ,Risk-Taking ,medicine ,Ambulatory Care ,Prevalence ,Humans ,Pharmacology (medical) ,Risk factor ,Homosexuality, Male ,education ,education.field_of_study ,business.industry ,virus diseases ,medicine.disease ,Genital ulcer ,Infectious Diseases ,Immunology ,HIV-1 ,Syphilis ,medicine.symptom ,business ,Sentinel Surveillance ,Demography - Abstract
To determine HIV/sexually transmitted infection (STI) prevalence, trends, and risk behaviors of men who have sex with men (MSM) and compare these with those of non-MSM attending STI clinics in Pune, India over a 10-year period.Cross-sectional.From 1993 through 2002, men attending 3 STI clinics in Pune underwent HIV/STI screening. Demographic, risk behavior, clinical, and laboratory data were collected using standardized questionnaires and laboratory procedures.Of 10,785 men screened, 708 (6.6%) were MSM. Among these 708 MSM, 189 (31.7%) had 10 or more lifetime partners, 253 (35.7%) were married, 163 (23.1%) had sex with a hijra (eunuch), and 87 (13.3%) had exchanged money for sex. A total of 134 (18.9%) were HIV-positive, 149 (21.5%) had genital ulcer disease (GUD), 37 (5.8%) had syphilis, and 29 (4.3%) had gonorrhea (GC). Over the decade, neither HIV nor GC prevalence changed among MSM (P = 0.7), but syphilis and GUD decreased significantly (P0.0001). Compared with non-MSM, MSM were more likely to initiate sexual activity at age16 years, to have10 lifetime partners, to have sex with a hijra, and to use condoms regularly, but they did not differ significantly in HIV prevalence and had a lower prevalence of GC, GUD, and syphilis. Independent factors associated with HIV among MSM were employment (adjusted odds ratio [AOR] = 3.08; P = 0.02), history of GUD (AOR = 1.86; P = 0.003), and syphilis (AOR = 2.09; P = 0.05).Same-sex and high-risk sexual behaviors are prevalent among men attending STI clinics in India. Although syphilis and GUD rates decreased, HIV prevalence remained high during the decade, highlighting the importance of additional targeted efforts to reduce HIV risk among all men, including MSM, in India.
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- 2006
41. Low HIV-1 incidence among married serodiscordant couples in Pune, India
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Seema Sahay, Ramesh S. Paranjape, Madhuri Thakar, A. K. Gupta, Theresa Gamble, Satish Kulkarni, B. Kishore Kumar, Sanjay Mehendale, Raman R. Gangakhedkar, Arun Risbud, Manisha Ghate, Sheela Godbole, Robert C. Bollinger, and A. D. Divekar
- Subjects
Adult ,Male ,medicine.medical_specialty ,Population ,Developing country ,India ,HIV Infections ,law.invention ,Condom ,law ,Epidemiology ,medicine ,Humans ,Pharmacology (medical) ,Marriage ,education ,education.field_of_study ,biology ,business.industry ,Incidence (epidemiology) ,Incidence ,virus diseases ,biology.organism_classification ,Infectious Diseases ,Sexual Partners ,Serodiscordant ,Lentivirus ,Immunology ,Marital status ,Female ,business ,Demography - Abstract
Unlike commercial sex workers and patients attending sexually transmitted infection (STI) clinics, married couples are not typically targeted for HIV risk reduction programs in India. Thus, married partners of HIV-infected persons are at particularly high risk for HIV infection. Between September 2002 and November 2004, 457 HIV-1 sero-discordant, married couples were enrolled in a one-year prospective study of HIV transmission in Pune, India. The HIV incidence among uninfected partners was 1.22 per 100 person-years (95% CI 0.45-2.66), which is much lower than what has been previously reported among discordant couples in Africa. This may be due to higher rates of condom use, lower rates of STIs and higher CD4 T lymphocyte counts, among the Indian HIV sero-discordant couples.
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- 2006
42. Phase I safety study of Praneem polyherbal vaginal tablet use among HIV-uninfected women in Pune, India
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Smita Joshi, Kishore Kumar B, Sheela Godbole, Kapila Bharucha, Sanjay Mehendale, Arun Risbud, Sangeeta Kulkarni, and Usha Katti
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Sexually transmitted disease ,Adult ,medicine.medical_specialty ,Population ,India ,Spermatocidal Agents ,Internal medicine ,Microbicide ,Breakthrough bleeding ,HIV Seronegativity ,Medicine ,Humans ,education ,Adverse effect ,education.field_of_study ,Traditional medicine ,Quinine ,business.industry ,Plant Extracts ,Public Health, Environmental and Occupational Health ,General Medicine ,Microbicides for sexually transmitted diseases ,Administration, Intravaginal ,Infectious Diseases ,medicine.anatomical_structure ,Patient Satisfaction ,Vagina ,Parasitology ,Intravaginal administration ,Female ,medicine.symptom ,business ,Tablets - Abstract
Praneem polyherbal formulations containing purified extracts of Azadirachta indica (neem tree) have shown activity against HIV and sexually transmitted disease pathogens in studies in vitro. The product also has contraceptive properties. This has prompted its development as a possible microbicide. We evaluated the safety of Praneem polyherbal tablet use among HIV-uninfected women. Twenty eligible women were enrolled in a Phase I open-label study requiring 14 days of consecutive intravaginal use of Praneem polyherbal tablets. Nine (45%) participants experienced 17 episodes of genital irritation. Transient genital itching was reported by eight (40%) participants, burning micturation by two (10%) and lower abdominal pain, genital burning and intermenstrual spotting by one (5%) each. On colposcopy, petechial haemorrhage was observed in two participants, one on day 7 and the other on day 14, and both were resolved without any treatment. There were no serious adverse events. Praneem polyherbal tablets were found to be safe for once daily intravaginal use for 14 consecutive days in sexually active HIV-uninfected women and a Phase II study may be taken up as a priority.
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- 2004
43. Fluconazole resistant non-albicans vaginal yeast in HIV seronegative women with vaginal discharge in Pune, India
- Author
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Sheela Godbole, S Sane, K Bharucha, Sanjay Mehendale, Arun Risbud, A Shrotri, Manisha Ghate, R Kairon, and Smita Kulkarni
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Microbiology (medical) ,Vaginal discharge ,medicine.medical_specialty ,Antifungal Agents ,Population ,Drug resistance ,Microbial Sensitivity Tests ,Acquired immunodeficiency syndrome (AIDS) ,Drug Resistance, Fungal ,Internal medicine ,HIV Seronegativity ,Medicine ,Humans ,Medical history ,education ,Vaginitis ,Fluconazole ,Candidiasis, Vulvovaginal ,Gynecology ,education.field_of_study ,business.industry ,Broth microdilution ,General Medicine ,medicine.disease ,Infectious Diseases ,Female ,medicine.symptom ,business ,medicine.drug - Abstract
Vaginal candidiasis due to azole-resistant non-C. albicans strains is increasingly seen in women with vaginitis. This study was conducted to assess the fluconazole susceptibility and potential host factors associated with vaginal Candida species from women with vaginal discharge. Vaginal swabs were obtained from133 of 186 women who presented with discharge due to reproductive tract infections at an STI clinic in a tertiary care government hospital fromApril 2001 to August 2002. The swabs were processed by standard mycological techniques. Candida isolates obtained were speciated and evaluated for in vitro fluconazole susceptibility by broth microdilution according to standard recommended guidelines. Infections were diagnosed by recommended methods and HIV testing conducted for all women based on guidelines issued by the National AIDS Control Organisation India. All procedures and tests were conducted following written informed consent. Sociodemographic variables and patient history were recorded in a questionnaire. Data were analysed using the x/2 test. (excerpt)
- Published
- 2003
44. Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings
- Author
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David Chilongozi, Sharla Faesen, Breno Santos, Mamta K. Jain, Pablo Tebas, Apsara Nair, Cynthia Riviere, Beatriz Grinsztejn, Sima Berendes, Steve Tabet, Joan Gormley, M. Graham Ray, Johnstone Kumwenda, Judith Feinberg, Todd Stroberg, Kenneth H. Mayer, Nikki Gettinger, Vicki L. Bailey, James Hakim, Selvamuthu Poongulali, Sandra W. Cardoso, Marineide Gonçalves de Melo, Karin L. Klingman, Rosie Mngqibisa, Thomas B. Campbell, Amneris E. Luque, Beverly Putnam, Thira Sirisanthana, Janice M. Fritsche, Ann Walawander, Ge Youl Kim, Roberto Corales, Richard B. Pollard, Ronald T. Mitsuyasu, Martha Silberman, Rita Alves Lira, Janet Forcht, Norbert Bischofberger, Ana Martinez, Barbara Brizz, Laura M. Smeaton, Asmita Gaikwad, Farida Amod, Srikanth Tripathy, Babafemi Taiwo, Anthony Chisada, Chiedza Maponga, Charles van der Horst, Michael Wulfsohn, Javier R. Lama, Taha E. Taha, Manuel Revuelta, Christine Hurley, David Currin, Wendy Snowden, Keith A. Pappa, Rosa Infante, T. Petersen, Donna V. McGregor, Susan Cu-Uvin, Susan A. Fiscus, Eric S. Daar, Jody Lawrence, P. Jan Geiseler, Irving F. Hoffman, Luis Lopez-Detres, Karen T. Tashima, Larisa Zifchak, Victor De Gruttola, Timothy P. Flanigan, Laura Moran, Farideh Said, Alberto La Rosa, Raman R. Gangakhedkar, Maria Palmer, Michael F. Para, Joel E. Gallant, Nancy Webb, Cecilia Kanyama, Wadzanai Samaneka, Jabin Sharma, Yvonne J. Bryson, Mark A. Winters, Ian Sanne, David Shugarts, Yun Chen, Sampada Dhayarkar, Peter N. Kazembe, Scott M. Hammer, Adriana Andrade, Robert T. Schooley, Beth D. Mullan, Henry H. Balfour, Patrice Severe, Beverly E. Sha, Madeline Torres, Cathi Basler, Andrew K. Cheng, Jolene Noel-Connor, Vladimir Berthaud, Jonathan Uy, Michael K. Klebert, Virginia Kayoyo, Donna Mildvan, David W. Haas, Joseph J. Eron, Cheryl Mogridge, David D. Celentano, Ruben Lopez, Ronald L. Barnett, Karin Nielsen, Helen Patterson, Renard S. Descallar, Jenifer Baer, Deise Lucia Faria, Cheryl Marcus, Khuanchai Supparatpinyo, Mina C. Hosseinipour, Newton Kumwenda, Yvette Delph, Smanga Ntshele, Edith Swann, Steven A. Safren, David M. Asmuth, Kelly Burke, Laurie Frarey, Joseph Steele, Gary M. Cox, Umesh G. Lalloo, Richard B. Pendame, Mary Adams, Bharat Ramratnam, Christine Wanke, James F. Rooney, Francis Martinson, Edde Loeliger, Anjali A. Joglekar, John Martin, Myron S. Cohen, Sheela Godbole, Robert C. Bollinger, Roy M. Gulick, Cynthia Firnhaber, Charles Flexner, William A. O'Brien, Suniti Solomon, Jorge Sanchez, Yue Chen, Susan H. Eshleman, Kathy J. Watson, N. Kumarasamy, David H. Haas, Ann C. Collier, Bartolo Santos, Suwat Chariyalertsak, Michelle S. Cespedes, Howard Jaffe, Judith S. Currier, and Deeks, Steven G
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Male ,Comparative Effectiveness Research ,Time Factors ,Internationality ,HIV Infections ,Medical and Health Sciences ,law.invention ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,Pregnancy ,law ,030212 general & internal medicine ,0303 health sciences ,education.field_of_study ,Coinfection ,Hazard ratio ,virus diseases ,General Medicine ,3. Good health ,Infectious Diseases ,Treatment Outcome ,6.1 Pharmaceuticals ,Combination ,HIV/AIDS ,Medicine ,Female ,Patient Safety ,Infection ,medicine.drug ,medicine.medical_specialty ,Efavirenz ,Anti-HIV Agents ,Clinical Trials and Supportive Activities ,Population ,Antiretroviral Therapy ,Emtricitabine ,03 medical and health sciences ,Drug Therapy ,Clinical Research ,General & Internal Medicine ,Internal medicine ,PEARLS study team of the ACTG ,medicine ,Humans ,Highly Active ,Dosing ,education ,030306 microbiology ,business.industry ,Evaluation of treatments and therapeutic interventions ,Mycobacterium tuberculosis ,Surgery ,Atazanavir ,Regimen ,Withholding Treatment ,chemistry ,HIV-1 ,business ,Follow-Up Studies - Abstract
BackgroundAntiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world.Methods and findings1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was ≤1.35 when 30% of participants had treatment failure. An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72-1.27; p = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54-0.76; pConclusionEFV+FTC-TDF had similar high efficacy compared to EFV+3TC-ZDV in this trial population, recruited in diverse multinational settings. Superior safety, especially in HIV-1-infected women, and once-daily dosing of EFV+FTC-TDF are advantageous for use of this regimen for initial treatment of HIV-1 infection in resource-limited countries. ATV+DDI+FTC had inferior efficacy and is not recommended as an initial antiretroviral regimen.Trial registrationwww.ClinicalTrials.gov NCT00084136. Please see later in the article for the Editors' Summary.
- Published
- 2012
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