Compliance to post-exposure prophylaxis among patients attending anti-rabies vaccination clinic in a tertiary health care centre in central India: a cross sectional study

INTRODUCTION

Rabies is a zoonotic, viral disease and once clinical symptoms appear, rabies is virtually 100% fatal.¹ Rabies is a fatal but vaccine-preventable disease. Rabies is classified as one of the Neglected Tropical Diseases (NTD). Rabies is caused by lyssavirus type 1. The virus enters the body through wounds or by direct contact with mucosal surfaces, it cannot cross intact skin. The virus may replicate in muscle or other local tissues after exposure and gain access to motor endplates and motor axons to reach the central nervous system and infect the central nervous system (CNS). If a person does not receive the appropriate medical care after a potential rabies exposure, the virus can affect the brain, ultimately leading to death.² As per WHO estimates, India accounts for 36% of the global and 65% of the human Rabies deaths in the South East Asia region.³ In India, Rabies is transmitted commonly by dogs and cats (~97%), followed by wild animals (2%) such as mongoose, foxes, jackals, and wild dogs, and occasionally by horses, donkeys, monkeys, cows, goats, sheeps, and pigs. As per the National Rabies Control Program, between 2012 to 2020, 6644 clinically suspected Human Rabies cases and deaths have been reported as per the reports received from the states and UTs.⁴ The number of animal bites reported under the Integrated Disease Surveillance Project, has increased from 42 lakhs in 2012 to 72 lakhs in 2020.⁴ Prevention of rabies in exposed individuals is possible by providing them with the timely and complete Post-exposure Prophylaxis (PEP) which consists of: Extensive washing and local treatment of the bite wound or scratch as soon as possible after a suspected exposure; a course of potent and effective rabies vaccine that meets WHO standards; and the administration of Rabies Immunoglobulin (RIG), if indicated. Starting the treatment soon after an exposure to rabies virus can effectively prevent the onset of symptoms and death. In the 12^th five year plan, the objectives of the National Rabies Control Program were to prevent human deaths due to rabies by capacity building, advocacy for scaling up inoculation of anti-rabies vaccine by ID route for Rabies and PEP, increasing awareness in the general community, strengthening surveillance of animal bites and Rabies cases and strengthening rabies diagnostics and intersectoral coordination.⁴ The objectives of this study are to assess compliance to anti-rabies vaccination among patients attending anti-rabies vaccination OPD, to assess compliance to rabies immunoglobulin in Category III animal bite cases, to assess hypersensitivity reactions after skin sensitivity testing with ERIG (Equine Rabies Immunoglobulin) and to study socio demographic and clinical profile of animal bite cases.

METHODS

A cross sectional study was conducted in the anti-rabies vaccination clinic, Indira Gandhi Government Medical College, Nagpur between September 2022 to November 2022 among patients fulfilling inclusion criteria until sample size was achieved. Animal bite cases attending anti-rabies vaccination clinic were included in the study. Exclusion criteria were patients not willing to give consent, patients coming for pre-exposure prophylaxis, patients with ARV immunization history within the last 3 months with its record and patients coming with rat/any other rodent bite.⁵ Informed consent was obtained from patients after explaining the purpose of the study. Data was collected by face to face interview method. A predesigned pre-tested proforma was used for collecting information regarding socio demographic details, information regarding the animal bite, post exposure prophylaxis management, compliance to anti-rabies vaccine, compliance to rabies immunoglobulin. As per WHO guidelines, post-exposure prophylaxis measures as per Categories of contact with suspect rabid animal is as follows : Category I touching or feeding animals, animal licks on intact skin (no exposure)- Washing of exposed skin surfaces, no PEP ; Category II- nibbling of uncovered skin, minor scratches or abrasions without bleeding (exposure)- Wound washing and immediate vaccination; Category III- single or multiple transdermal bites or scratches, contamination of mucous membrane or broken skin with saliva from animal licks, exposures due to direct contact with bats (severe exposure)- Wound washing, immediate vaccination and administration of rabies immunoglobulin/monoclonal antibodies. Patients who completed all prescribed doses of the 2 site intradermal regimen of Post-exposure prophylaxis of ARV were considered as compliant and patients who did not come for the last dose were considered non-compliant. Among patients requiring Rabies Immunoglobulin (RIG), those who took RIG were considered compliant and those who refused were considered non-compliant.

Sample size estimation

From a study conducted by Lilare et al taken as reference, taking prevalence of 73.5% with 5% absolute error, the sample size estimated was 299.⁶ The final sample size was rounded off to 300. Data collected was entered in MS Excel Sheet and analyzed using SPSS software Version 20. The qualitative data was expressed by number and percentage. The quantitative data was expressed in terms of mean and standard deviation. Chi square test was applied to observe the differences between proportions. p value <0.05 was considered significant.

RESULTS

Table 1 shows the socio-demographic profile of study participants. It was seen that mean age of patients was 33.29 (±19.83). Majority of patients were males, that is 199 (66.3%). With regards to religion, the majority were Hindus 216 (72%) followed by Bouddha 53 (17.6%). 270 (90%) participants were literate, 16 (5.3%) were illiterate whereas 14 (4.7%) were children yet to join school. 286 (95.3%) belonged to a higher socio-economic class (Class I, II, III as per modified BG Prasad scale).

*14 (4.7%) patients were less than 3 years old and had not started school yet.

Table 2 shows clinical profile of study participants. 267 (89%) bites were due to dogs followed by 24 (8%) bites due to cats. 269 (89.7%) patients knew the status of the animal after 10 days and 31 (10.3%) did not. 268 (89.3%) patients belonged to Category 3 animal bite, followed by 32 (10.7%) patients who belonged to Category 2. Out of all the patients, 67 (22.3%) patients had a previous history of animal bite but only 4 (1.3%) patients had a record of completed vaccination including RIG administration.

Total 125 (41.7%) patients washed the wound with water, soap and applied antiseptic, whereas 47 (15.7%) patients did not wash the wound. All patients took the tetanus vaccine and 1^st dose of ARV but only 234 (78%) patients took the last dose of ARV. 36 (12%) patients did not require rabies immunoglobulin (32 of Category 2 animal bite and 4 with record of vaccination after previous bite).

Among the total 300 patients, 36 patients did not have an indication for rabies immunoglobulin as 32 patients had Category 2 animal bite and 4 patients had record of prior RIG administration. Price of immunoglobulin being high was the most common reason for not taking RIG among 47 (48.5%) patients followed by small wound size among 40 (41.2%) patients and animal being pet in 10 (10.3%) patients. Among the 167 patients who took RIG, 156 (93.4%) patients opted for ERIG and 11 (6.6%) patients opted for rabies human monoclonal antibody. Hypersensitivity testing with a test dose was done for all 156 patients taking ERIG and reaction on test dose was present in 7 (4.5%) patients.

Table 3 shows association of compliance to ARV with sociodemographic and epidemiological profile of patients. Chi square test was applied. There was significant association between compliance to ARV with the type of animal (p value 0.004) and status of animal after 10 days (p value 0.0001).

Table 4 shows association of compliance to rabies immunoglobulin with sociodemographic and epidemiological profile of patients. Chi square test was applied to check for significance. There was significant association found between compliance to RIG with gender (p value 0.04), socio-economic status (p value 0.028), type of animal (p value 0.02) and type of wound (p value 0.007).

#Others: Monkey-4, Pig-4, Mongoose-1. *36 patients did not have an indication for rabies immunoglobulin: 32- Category 2 animal bite,

4-had record of prior RIG administration.

*High SES- Class I, Class II and Class III, Low SES- Class IV and Class V (according to modified BG Prasad).

*High SES- Class I, Class II and Class III, Low SES- Class IV and Class V (according to modified BG Prasad).

DISCUSSION

In this study, cases of animal bites were more in males than females, similar to findings of Sharma et al.⁷ We also found that the majority of patients that is 89% were exposed to dog bites, similar to the findings of Karmakar et al and Nishant et al but more than findings by Gadapani et al.^8-10 In our study, lower limb was the most commonly injured site in 59.3% patients and similar findings were observed in a study conducted by Domple et al.¹¹

In the present study, 45 (15.7%) patients did not wash wound after bite as compared to study by Kawale et al where 3206 (53%) did not manage their wound.¹² In our study, it was seen that 78% of patients completed all doses of ARV which was similar to findings of Lilare et al and Jena et al.^6,13 The compliance to ARV in our study was more than findings by Nishant et al , Titoria et al and Praveen et al.^9,14,15 Compliance to RIG in our study was 63.3% which is in accordance with findings by Kawale et al and Datta et al.^12,16 There was significant association between compliance to ARV last dose with the type of animal. Similar results were found in a study conducted by Shivasakthimani et al and Wadde et al.^17,18 There was significant association found between compliance to RIG with gender, socioeconomic status, type of animal and type of wound. The findings were consistent with findings by Sahu et al where significant association was found between RIG compliance and gender and a study by Gaikwad et al where there was significant association between economic status and taking RIG.^19,20

CONCLUSION

Compliance to ARV in our study was 78%. Compliance to RIG in our study was 63.3% of all cases requiring Immunoglobulin. Major reason for poor compliance to RIG was the price of immunoglobulin. There was significant association found between compliance to ARV with type of animal and status of animal after 10 days. There was also significant association found between compliance to RIG with gender, socio-economic status, type of animal and type of wound. Hypersensitivity reaction on test dose was present in 7 (4.5%) patients of those who took ERIG.

Recommendations

Health education and creating awareness regarding fatality of disease and significance of immediate post-exposure prophylaxis after animal bite among the population. Counselling to patients attending anti-rabies vaccination clinic regarding completion of all doses of ARV regimen and taking rabies immunoglobulin when indicated to increase compliance. Awareness regarding pre-exposure prophylaxis among high risk groups. Increased availability and constant supply of anti-rabies vaccines and rabies immunoglobulin.

ACKNOWLEDGEMENTS

We would like to thank the faculty and interns present at the anti-rabies vaccination clinic for their support throughout the study. We would also like to thank all the study participants for their cooperation to conduct this study.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the Institutional Ethics Committee

REFERENCES

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