RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, …



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARANATAKA

BANGALORE

PERFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

| |Name of the candidate and Address |: |Dr. Praveen Kulkarni |

| | | |S/o Shri B D Kulkarni Retd. Postal Asst. |

| | | |S R Deshpande house, Jambukeshwar Galli Jamakhandi.- 587301 |

| | | |Dist. Bagalkot |

| | | |Karnataka |

| |Name of the Institution |: |Kempegowda Institute of Medical Sciences, Banashankari 2nd stage, |

| | | |Bangalore-560070. |

| |Course of Study and Subject |: |M.D in Community Medicine |

| |Date of Admission to Course |: |23rd June 2009 |

| |Title of the Topic |: |Implementation and Evaluation of a Novel Rabies Prevention Strategy |

| | | |in the Rural Field Practice Area of Kempegowda Institute of Medical |

| | | |Sciences, Bangalore. |

1. Brief resume of the intended work

1. Need for the study:

An estimated 55,000 human rabies deaths occur every year globally, of which 30,000 (56 %) of human rabies deaths occur in Asia. In India, an estimated 20,000 human rabies deaths occur annually which constitutes 36% of the rabies deaths in the world.

In India 17.4 million animal bite cases occur annually which accounts to animal bite incidence rate of 17.4/1000 population. Frequency of animal bites was found to be 1 case every 2 seconds. Annual man days lost due to animal bites was 38 million days. Annual medicinal cost for treating animal bites was approximately Rs. 2 billion1.

The main vectors of transmission of rabies are dogs which are responsible for 95% of human rabies deaths. Majority of them are street dogs (75.2%).1 There are many myths and false beliefs associated with wound management. There is more faith in the indigenous medicines that are of unproven efficacy and not washing wounds properly because of the fear that it would get infected 5,6. The importance of proper wound care, post exposure vaccination with modern tissue culture vaccines and administration of human rabies immunoglobulin, where indicated must be reinforced1. Now intra dermal rabies vaccination (IDRV) is implemented in the country as a safer, ethical and cost effective replacement of intra muscular rabies vaccination in government hospitals7.

Dog bite is one of the most common childhood event causing significant morbidity and mortality among children4. Hence, there is a need to provide pre exposure vaccination with IDRV for children at risk2.

Majority of human rabies victims are from rural areas, and belong to lower socio economic status1 .As 2/3rd of Indian population live in the rural areas and are at risk for dog bites and rabies, appraisal of their knowledge about practices in the prevention of rabies is of premier importance1.There is a need for extensive public educational programmes for the general population, medical fraternity and veterinarians, regarding the danger of dog bites and rabies1, 2 .

In this back ground, the present study will be undertaken to Implement and evaluate a novel rabies prevention strategy in the rural field practice area of Kempegowda Institute of Medical Sciences, Bangalore.

2. Review of Literature:

1. The WHO / APCRI sponsored national multi-centric rabies survey (2004)1 showed that in India 17.4 million animal bite cases occur annually which need post exposure prophylaxis. Animal bite incidence rate per 1000 population is 17.4%. Frequency of animal bites is found to be 1 per 2 seconds. Annual man days lost per animal bile is 38 million. Annual medicinal cost for animal bite treatment is approximately Rs. 2 billion. The authors recommend the need for extensive public educational programmes regarding dangers of inadequately managed animal bites.

2. Madhusudana SN2 (2002) states that incidence of rabies and dog bites are more common in children. Thus likely age for pre exposure vaccination is when the child starts going to school. Pre exposure vaccination with any cell culture vaccine produces adequate antibody titers which last for minimum 5 years or more.

3. A multi centric study conducted by Ichhpujani RL et al3 (2006) on Knowledge, Attitude and Practices about animal bites and rabies in general community suggests that there is need to create awareness amongst the masses regarding epidemiology of the disease and merits of prompt and appropriate post exposure treatment through enhanced IEC activities.

4. A study conducted by K. M Kale, S. K. Wadhva, N. R. Aswar, N. D. Vasudeo4 (2006) on dog bites in children opine that dog bite is one of the most common accident in childhood and demonstrates the need for educating people regarding the correct methods of wound treatment, more lay on professional education and action on the growing problem of dog bite.

5. In a study conducted by A. S. Sekhon, Amarjit Singh, Paramjit Kaur, Sonia Gupta5 (2002) on Misconceptions and myths in the management of animal bites suggest that main danger of rabies is posed by ignorance about the disease and common non scientific practices in management of wounds and hence emphasize on need for the IEC activities to dispel all misconceptions and false beliefs.

6. The study conducted by Thai Red Cross Society8 (2004) Thailand has established the safety and efficacy of the IDRV using Updated TRC regimen.

7. WHO (2004), TRS-931, approved modified Thai Red Cross regimen in India (2-2-2-0-2).

6.3 Objectives:

• To describe the socio-demographic characteristics of study population.

• To assess the knowledge, attitude & practice of people regarding rabies & its prevention.

• To monitor the incidence of animal bites & rabies in humans and animals.

• To develop IEC materials for rabies prevention.

• To deliver timely rabies Post exposure prophylaxis to animal bite victims.

• To assess the safety & immunogenicity of IDRV administered as pre exposure vaccination for school children and other risk groups.

2. Materials and Methods:

7.1 Source of Data:

7.1 (a) Study Area: 3 villages will be chosen based on the incidence of human and animals rabies, which come under the rural field practice area of Kempegowda Institute of Medical Sciences, Bangalore.

7.1 (b) Study subjects: Population in the study area.

7.1 (c) Study Period: One year.

7.1 (d) Study Design: Prospective, interventional study.

7.1 (e) Inclusion Criteria:

• Population in the study area.

• Parents ready to give written consent for preventive vaccination for their children for IDRV.

• Parents ready to give consent for collecting blood samples of their children for assessment of immunogenicity of IDRV.

• Animal bite victims willing to take Post Exposure Prophylaxis.

7.2 (f) Exclusion Criteria:

• Children with acute illness for pre exposure vaccination with IDRV.

7.2(g) Sample Size: Population from the study villages.

7.2 (h) Methodology:

1. Baseline data collection:

A baseline survey regarding socio-demographic profile of study population, KAP on rabies will be done by using a preformed standardized questionnaire.

2. Development IEC materials:

Teaching modules will be developed on rabies focusing on, rabies as a disease, transmission, how to avoid dog bites, prevention of rabies once the exposure occurred, importance of vaccination in preventing rabies in man and animals. The modules will be used effectively to educate the village population.

3. Post exposure prophylaxis to animal bite victims:

Timely post exposure prophylaxis using Updated TRC regimen (2-2-2-0-2) and Rabies Immunoglobulin for category III exposure are given to all the animal bite victims in these villages

4. Preventive IDRV to school children and assessment of safety and immunogenicity:

Preventive IDRV (0.1 mL of vaccine on days 0, 7 & 28) will be administered to school children and other risk groups in the study area. 5 mL blood sample collected from antecubital vein on day 35 from 10 % of vaccinees to assess the safety and immunogenicity of IDRV.

Assessment of Safety:

The Adverse Events (both local & systemic) will be recorded by observing the subjects for about 30 minutes after administration of vaccine & also subsequent to vaccination. Adverse events will be evaluated using 4- point scale.

|0 |None |Absence of Symptoms |

|1 |Mild |Presence of mild symptoms |

|2 |Moderate |Symptoms which have an effect on daily normal |

| | |activities |

|3 |Severe |Symptoms which prevent daily normal activities |

Assessment of Immunogenicity

According to WHO, a rabies virus neutralizing antibody (RvnAb) titer of ≥ 0.5 IU / mL is considered as protective antibody titer indicating protection against rabies. In this study rabies virus neutralizing antibody (RvnAb) titer will be estimated using RFFIT at the department of Neurovirology, NIMHANS Bangalore.

5. To initiate monitoring of rabies in dogs and other domestic animals

The rabies in dogs and other domestic animals will be monitored by co-ordination with veterinarians.

6. Evaluation of benefits of the study:

Improvement in knowledge, attitude and practice regarding rabies and its prevention in the people of the study villages will be assessed at the end of the study.

7.2 (i) Statistical analysis : Descriptive statistics.

3. Has ethical clearance been obtained from your institution: Yes

3. References:

1. Association for Prevention and Control of Rabies in India. Assessing the Burden of Rabies in India, WHO sponsored National Multi-centric Rabies Survey 2004, KIMS, Bangalore.

2. S N Madhusudana, Rabies in Children: Is There a Need for Pre Exposure Vaccination?. Journal of APCRI 2002; Volume IV issue 1&2, 7.

3. Ichhpujani RL, Chhabra M, Mittal V, Bhattacharya D, Singh J, Lal S, Knowledge, attitude and practices about animal bites and rabies in general community- a multicentric study, Journal of Communicable Diseases 2006;38(4):355-61.

4. K. M Kale, S. K. Wadhva, N. R. Aswar, N. D. Vasudeo, Dog Bites in Children, Indian Journal of Community Medicine vol.31, No.1 (2006-01-2006-03).

5. A. S. Sekhon, Amarjit Singh, Paramjit Kaur, Sonia Gupta, Misconceptions and Myths in the Management of Animal bite cases. Indian Journal of Community Medicine 2002; Vol XXVII, No1, 9-11.

6. U S Singh, S K Choudhary, Knowledge, attitude and practice study on Dog bites and it’s management in the Context of prevention of Rabies in a rural community of Gujarat. Indian Journal of Community Medicine 2005; Vol 30, No 3, 81-83.

7. M.K. Sudarshan, B.J. Mahendra and D H Ashwath Narayana, A Community Survey of Dog bites, Anti-rabies Treatment, Rabies and Dog Population management in Bangalore City, Journal of Communicable Diseases 2001;33(4):245-251.

8. World Health Organization, WHO Expert Consultation on Rabies Technical Report Series 931. Geneva, Switzerland: WHO: 2004.

9. Signature of the Candidate:

10. Remarks of the Guide: As animal bite and rabies is more common among rural population in the country, this study will help in implementation and evaluation of different strategies for human rabies prevention in rural area.

11. Names and Designation:

|11.1 |Guide |Dr. N R Ramesh Masthi, MD |

| | |Associate Professor |

| | |Department of Community Medicine |

| | |KIMS, Bangalore. |

|11.2 |Signature | |

| | | |

| | | |

|11.3 |Head of the Department |Dr. B. G. Parasuramalu, MD |

| | |Professor and Head |

| | |Department of Community Medicine |

| | |KIMS, Bangalore. |

|11.4 |Signature | |

| | | |

| | | |

12.1 Remarks of Chairman and Principal:

12.2 Signature:

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