Final Written Proposal

April 26, 2010

Dr. Regina RabinovichDirector of Infectious Disease ProgramBill & Melinda Gates FoundationPO BOX 23350Seattle, WA 98102

Dear, Dr. Rabinovich

Attached is my Final Written Proposal regarding the Leprosy Treatment and Rehabilitation Camps in Gujarat Raktapitt Nivaran Seva Sangh (GRNSS) in Vadodara, Gujarat, India that I discussed when you attended my PowerPoint Presentation at Rutgers University, New Brunswick, NJ on Wednesday, 03/24/2010.

The plan of my proposal is to gather a team of volunteers, a medical staff, and management to set up medical camps that treat and cure Leprosy as well as rehabilitate Leprosy patients both physically and economically in a Lepers’ Colony in India. By offering free treatment to these poor and illiterate Lepers, I hope to halt the prognosis of the disease before it debilitates them into severe disfigurements and disabilities. Treatment consisting of a Multidrug Therapy (MDT) will either prevent any disabilities caused by deformities such as by loss of extremities from arising or halt the deterioration of present disabilities that often cause these blue-collar workers to be dislocated from work. Once treated, these patients will be provided with physical aids such as prefabricated hand splints, foot splints, and grip-aids that will allow them to hold toothbrushes, combs, and most importantly, the tools required for their jobs. In addition, they will also be provided with tools that are most frequently required by their jobs. This relatively simple treatment plan will drastically improve the standard of living for these patients and decrease their financial burdens.

I genuinely believe this proposal deserves funding as Leprosy has plagued India since 2000 B.C. (Robbins et al., 2009), and even today, India still has over half of the world’s Lepers with about 130,000 new annual cases (“Weekly Epidemiological Record,” 2009, pg. 333-340). This program will take a step closer to eradicate the global pandemic caused by this 100% curable disease and help rehabilitate the patients by providing them with necessary physical aids to recoup their jobs. I look forward to hearing from you. Please feel free to contact me any time.

Sincerely,

215 Roanoke Street Woodbridge, NJ 07095(732) 750-0256 (H)(973) 931-6581 (C)[email protected]

ERADICATING LEPROSY: One Step Closer

Dr. Regina B. RabinovichDirector of Infectious Disease Program

Bill & Melinda Gates Foundation

By: Shashank Pandya

April 26, 2010

ii.

Abstract

Due to the pandemic prevalence of Leprosy in Gujarat, India, Eradicating Leprosy: One Step Closer proposes a plan to cure and rehabilitate the Lepers in a Lepers’ Colony named Gujarat Raktapitt Nivaran Seva Sangh (GRNSS) in Vadodara, Gujarat, India. It proposes to accomplish this by gathering a team of a dozen student volunteers, a program coordinator, a program manager, and a volunteer/paid medical staff consisting of two physiotherapist and three physicians to set up medical camps in GRNSS. In the medical camps, these patients will be put on a Multidrug Therapy (MDT) regimen to cure the disease, and then they will be provided with physical aids such as prefabricated hand splints, foot splints, and grip-aids that will allow them to hold toothbrushes, combs, and the tools required for their jobs. In addition, they will be provided with certain tools most often required by their jobs such as “hand carts, sewing machines, carpentry and masonry kits, agricultural tools, and vehicle repair tools” (NFSD, 2010). Ultimately, this proposal will be carried out with the goal of curing every single one of the Leprosy Patients in GRNSS and providing them with physical aids and tools for their jobs to physically rehabilitate and economically reintegrate them.

Having its origins from 2000 B.C. (Robbins et al., 2009), even today India accounts for nearly half of the world’s Lepers by a prevalence of 86,331 patients along with an influx of about 134,184 new yearly cases despite it being curable (“Weekly Epidemiological Record,” 2009, pg. 333-340). Most Leprosy patients in India do not have the monetary or informational resources to treat Leprosy or to prevent further deterioration of the disabilities caused by Leprosy. Due to their poverty and illiteracy, they unknowingly let the disease progress and do not seek expensive treatment until it causes disabilities resulting from their deformities (“Leprosy,” 2009). In addition, Leprosy often affects people in the most productive stages of their lives (“Leprosy,” 2009). Due to that, it tends to burden the patients and their families financially as they often lose their jobs and the developing Indian economy as lost wages, decreased workforce, and unemployment.

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Table of CONTENTS:

ABSTRACT ii

TABLE OF CONTENTS iii

Table of Figures

Figure 1 3

Figure 2 4

Figure 3 4

Figure 4 8

EXECUTIVE SUMMARY iv

PROBLEM 1

RESEARCH

Secondary Research 3

PLAN 8

EVALUATION PLAN 13

BUDGET 14

REFERENCES 15

APPENDICES

Appendix A 18

iv.

EXECUTIVE SUMMARY

Every year there are about 134,184 new cases (“Weekly Epidemiological Record,” 2009, pg. 333-340) of Leprosy in India despite it being 100% curable. Since most of these patients are illiterate, they are unaware of its progressiveness and ignore the initial symptoms. Moreover their poverty compounds the problem as they are so destitute that they often have to struggle to feed themselves on a daily basis (“Leprosy,” 2009). Combined with this lack of information and monetary resources, the societal attitudes and stigmas that involve shunning and dehumanization the Lepers due to the fear of contraction causes these Lepers to avoid treatment and hide their conditions till they cause disfigurements and disabilities (Shahani). Due to that, it tends to burden the patients and their families financially as they often lose their jobs and the developing Indian economy as lost wages and decreased workforce

Ironically 99% of the human population possesses adequate immunity to this pandemic disease but it is still easily contractible due to certain genetic immunological susceptibilities and causes havoc in underdeveloped countries like India. Leprosy is still transmittable with about half of the cases resulting from intimate contact with the diseased (Fauci, et al., 2008). Most common means of transmission of the disease is by oral and nasal droplets in air transmitted through sneezing, microinnoculation through soil residues, and insect vectors such as mosquitoes and bedbugs (Fauci, et al., 2008). Unhygienic living conditions of India provide the perfect breeding grounds for the insect vectors that transmit the disease. In addition, the overcrowding makes it easier for human to human transmission (Fauci, et al., 2008). Once transmitted, it manifests into either Tuberculoid or Lepromatous Leprosy with the latter being more severe. As mentioned, most Lepers face societal ostracization and isolation for the disfigurements due to the disease so most of the Lepers are Lepromatous in the Lepers’ Colonies. If it is left unchecked, Lepromatous Leprosy can cause loss of eyebrows and eyelashes, pendulous earlobes, and dry scaling skin, neuritis (loss of sensation), and in severe cases loss of vision and disfigurement due to loss of extremities in the limbs.

Fortunately, Leprosy is not only treatable but also 100% curable with the administration of a multidrug therapy (MDT) that consists of a cocktail of antibiotics, namely, dapsone, rifampin, and clofazimine (Katzung et al., 2009). This treatment is so effective that Leprosy becomes non-infectious/non-transmittable within a week after the first dose of the drugs (“Leprosy,” 2009). By following the footsteps of an organization for complete Leprosy prevention, treatment, and rehabilitation called Novartis Comprehensive Leprosy Care Association (NCLCA) with a focus on disability – both preventing deterioration and realizing medical rehabilitation, Eradicating Leprosy: One Step Closer will cure the Lepers, rehabilitate them physically, and reintegrate them back in society from a Lepers’ Colony named Gujarat Raktapitt Nivaran Seva Sangh (GRNSS) in Vadodara, Gujarat, India. This would be done by gathering a team of a dozen student volunteers, a program coordinator, a program manager, and a volunteer/paid medical staff consisting of two physiotherapist and three physicians to set up medical camps in GRNS. In these camps, the doctors would carefully inspect the patients and then put them on the appropriate Multidrug Therapy (MDT). Once

v.

cured, they will be provided with physical aids such as prefabricated hand splints, foot splints, and grip-aids that will allow them to hold toothbrushes, combs, and the tools required for their jobs to rehabilitate them physically. In addition, they will be provided with certain tools that are most often required by their jobs such as “hand carts, sewing machines, carpentry and masonry kits, agricultural tools, and vehicle repair tools” so they can recoup their jobs and get reintegrated into society economically (NFSD, 2010).

Lastly, strict routine checkups and photographic evidence will be used to monitor the patients’ improving conditions and keep track of the program’s success. The monitoring of the patients and their conditions will be done weekly as the doctors will evaluate the patients’ number of lesions as well as any signs of improvements in the neuritis of afflicted area. This along with the photographs taken by the student volunteers at the beginning of the treatment and during each checkup will be used to closely monitor individual patients to assess the effectiveness of the treatment. At the end of the program, the success of it will be measured by the number of cases that have been cured and provided with physical aids and tools for their jobs as requested.

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PROBLEM

Despite being completely curable, Leprosy is one of the few ancient diseases that are still prevalent in pandemic levels today in underdeveloped nations such as India. Having its origins from 2000 B.C. (Robbins et al., 2009), even today India accounts for nearly half of the world’s Lepers by a prevalence of 86,331 patients along with an influx of about 134,184 new yearly cases (“Weekly Epidemiological Record,” 2009, pg. 333-340). This tends to have a negative effect on the developing Indian economy as lost wages and decreased workforce because it often affects people in the most productive stages of their lives (“Leprosy,” 2009). Since, the majority of the sufferers are the only source of household income, the financial burdens augment for the patients and their families (“Leprosy,” 2009). In addition, these patients are often isolated from society and social set-ups such as marriage, which further hurts the economy as more financial support is needed to sustain them in isolation and support their families (“Leprosy,” 2009).

Most Leprosy patients in India do not have the monetary or informational resources to treat Leprosy or to prevent further deterioration of their disabilities. Due to their illiteracy and unawareness about the progressiveness of the disease, they unknowingly let the disease progress until it causes disabilities (“Leprosy,” 2009). Moreover, they overlook the initial symptoms and do not seek treatment as they are so poor that they do not even have enough money to feed themselves daily (“Leprosy,” 2009). Consequently, these patients often wait till their mere skin lesions lead to severe loss of sensation and other disabilities caused by deformities such as loss of extremities (“Leprosy,” 2009).

Unfortunately, by the time they become aware of the seriousness of the disease and want to seek treatment, they often get dislocated from their jobs and society into Lepers’ colonies (Shahani). The isolation is sometimes self-imposed and voluntary but mostly it is fueled by the societal attitudes and stigmas that involve shunning and dehumanization of the Lepers due to the fear of contraction (Shahani). These stigmas cause the Lepers to hide the initial symptoms and seek treatment due to fear and humiliation till they become disfigured (Shahani). Consequently, as soon as signs of disfigurement appear, the Lepers are compelled to go into isolation in Lepers’ Colonies. This makes targeting Lepers’ Colonies efficient as there is no real need to diagnose the patients and most of the patients have actual disabilities that can be rehabilitated or corrected with physical aids.

My proposed plan will take a step closer to eradicate Leprosy by completely curing the isolated Lepers in a Lepers’ Colony named the Gujarat Raktapitt Nivaran Seva Sangh (GRNSS) in Vadodara, Gujarat, India. Medical camps will be set up in that colony where these patients will be put on a Multidrug Therapy (MDT) regimen that will cure them completely. In addition, the MDT will either prevent any major disabilities from arising or halt the deterioration of present disabilities. Once cured, these Lepers will be provided with physical aids such as prefabricated hand splints, foot splints, and grip-aids that will allow them to hold toothbrushes, combs, and most importantly, the tools required for their jobs. In addition, they will also be provided with certain tools most often required by their jobs such as “hand carts, sewing machines, carpentry and

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masonry kits, agricultural tools, and vehicle repair tools” (NFSD, 2010). By utilizing this approach proscribed by an organization for complete Leprosy prevention, treatment, and rehabilitation called Novartis Comprehensive Leprosy Care Association (NCLCA) with a focus on disability – both preventing deterioration and realizing medical rehabilitation, these Lepers will be cured and given an opportunity to reintegrate back in society by reclaiming their jobs. This reintegration will not only benefit the patients and their families by decreasing their financial hardships but also improve the economy as the unemployment rates will decrease.

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RESEARCH

Leprosy: The Disease in India

Leprosy, which is also known as Hansen’s Disease after the famous Norwegian physician who indentified its cause (Irgens, 2002), has affected humanity for well over 4000 years and had its origins in India (Robbins et al., 2009). It is caused by an obligate acid-fast intracellular bacillus known as Mycobacterium leprae (Fauci, et al., 2008). Commonly known as M. leprae, these bacteria cannot carry out all their metabolic

activities without relying on a host’s biochemical support as almost half of this organism’s genome is non-functional due to reductive evolution (Fauci, et al., 2008). However, they can survive without a host’s body for months, thus making them ideal for being infectious (Fauci, et al., 2008). Moreover, it is the only bacteria that can invade the peripheral nerves due to its glycolipid receptors’ ability to bind to the basal lamina of Schwann Cells (type of glial cells of the nervous system); this is the prime cause for the disease’s characteristic loss of sensation and deformities (Fauce, et al., 2008). An image of these rod shaped bacteria can be seen in Figure 1.

Even though, the majority of the population is naturally immune to Leprosy, certain people can still develop the disease after being in contact with M.leprae due to their inadequate immune response caused by their genetic susceptibilities (“Leprosy,” 2009). Ironically, it is considered to be one of the least infectious diseases with over 99% of the population having adequate natural immunity to it and 85% of the cases are noninfectious (“Leprosy,” 2009). Nonetheless, Leprosy is still transmittable with about half of the cases resulting from intimate contact with the diseased (Fauci, et al., 2008). Most common means of transmission of the disease is by oral and nasal droplets in air transmitted through sneezing, which may contain over 1010 AFB (acid fast bacilli - viable bacteria) (Fauci, et al., 2008). In rural nations such as India, it is also microinnoculated through the residues in soil as indicated by children’s buttocks and thighs being infection sites (Fauci, et al., 2008). In addition, common insects from the Indian subcontinent such as mosquitoes and bedbugs are also known disease vectors (Fauci, et al., 2008).

Leprosy can be hard to detect before the onset of the clinical disease as its incubation period can vary from 2 to 40 years and even then it has to be diagnosed from its two types depending on its severity (Fauci, et al., 2008). The two types of Leprosy are Tuberculoid Leprosy and Lepromatous Leprosy. The diagnoses of onset Leprosy can be easily picked up by the “suggestive skin lesions and peripheral neuropathy [loss of sensation]” (Fauci, et al., 2008). Specifically, the diagnosis of the less severe form, Tuberculoid Leprosy, can be picked up from skin lesions that “consist of [sic] hypopigmented macules or plaques that are sharply demarcated and hypesthetic, [sic]

Source: http://www.ciriscience.org/ph_130-Mycobacterium_leprae_Copyright_Dennis_Kunkel_Microscopy

Figure 1: A gram stain (positive) of Mycobacterium leprae (M. leprae)

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have [sic] raised borders, and are devoid of the normal skin organs” (Fauci, et al., 2008). In layman’s terms, Tuberculoid Leprosy as observed in Figure 2 causes slightly raised pale or reddish skin lesions that have little to no sensitivity. Lepromatous Leprosy as observed in Figure 3 can be diagnosed by observing “symmetrically distributed skin nodules, raised plaques, [sic] diffuse dermal infiltration, [sic] loss of eyebrows and eyelashes, pendulous earlobes, and dry scaling skin” (Fauci, et al., 2008). Even though around 90% of the Leprosy cases in India are Tuberculoid (Fauci, et al., 2008), Lepromatous Leprosy is the culprit for most of severe deformities that are observed in the majority of cases. Not surprisingly, these patients are concentrated in the Lepers’ Colonies as they tend to have the very characteristic disabilities caused by Lepromatous Leprosy that results their segregation. Figure 2: Tuberculoid Leprosy Lesion Figure 3: Lepromatous Leprosy Lesions

Disabilities caused by deformities resulting mainly from Lepromatous Leprosy in these patients are classified according to three progressive grades that describe the degree of disabilities of the limbs and eyes (Rad, et al., 2007). Grade zero category means that there are no disabilities in the limbs (hands, feet, and their extremities) or in the eye (Rad, et al., 2007). Grade one categorizes disabilities of the limbs as loss of sensation and eye problems are minimum (Rad, et al., 2007). Lastly, grade two disabilities are the worst with visible deformities present in the limbs and severe visual impairment (Rad, et al., 2007). Considering the difficulty of progressing to grade two disabilities, an usually high 3% (3,763) of Lepers suffer from grade two disabilities in India (“Weekly Epidemiological Record,” 2009, pg. 333-340).

Treatment Regimen:

Granted that Leprosy tends to cause some irreversible deformities but it can still be cured completely to stop its prognosis from furthering. The current treatments used are so effective that Leprosy becomes non-infectious/non-transmittable within a week after the first dose of the drugs (“Leprosy,” 2009).

Source: http://www.stanford.edu/class/humbio103/ParaSites2005/Leprosy/pictures/borderline%20tuberculoid%20leprosy.jpg

Source: http://www.stanford.edu/class/humbio103/ParaSites2005/Leprosy/pictures/face%20nodules.jpg

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The treatment regimen is the usage of a multidrug therapy (MDT) that consists of a cocktail of antibiotics, namely, dapsone, rifampin, and clofazimine (Katzung et al., 2009). To determine the required dosage and regimen of the drugs, the disease whether it is Tuberculoid or Lepromatous, it is divided into either Paucibacillary (PB) or Multibacillary (MB) Leprosy (“Leprosy,” 2009). Generally, Paucibacillary Leprosy is defined as having one to five lesions and Multibacillary Leprosy is defined as having more than five lesions (“Leprosy,” 2009). A regimen of dapsone and rifampin is administered for six months for PB Leprosy and a regimen of dapsone, rifampin, and clofazimine is administered for twelve months for MB Leprosy (“Leprosy,” 2009). These drugs are endorsed and supplied by the World Health Organization (WHO), which distribute it in specific blister packets for each type of cases (“Leprosy,” 2009). To see a complete list of the exact Treatment regimen for Leprosy endorsed by the WHO, please refer to Appendix A.

Complications:

Complicating the treatment, there are certain immunological reactions that normally occur at the administration of the chemotherapy (Fauci, et al., 2008) with the usage of a multidrug therapy (MDT) (Fauci et al., 2008). These reactions are classified into two types, namely Type 1 and Type 2 reactions with Type 1 being less severe (Fauci, et al., 2008). Type 1 reactions occur mainly in Tuberculoid Leprosy as signs of “inflammation within previously involved macules, papules, and plaques and, on occasion, the appearance of new skin lesions, neuritis, and (less commonly) fever” (Fauci, et al., 2008). These are just mere “side-effects” of the treatment as they do disappear with the course of regular treatment; however, sever side-effects can be treated with glucocorticoids/corticosteroids (Fauci, et al., 2008). Type 2 reactions, which are commonly known as Erythema Nodosum Leprosum (ENL), occur in Lepromatous Leprosy 90% of the time after the chemotherapy (Fauci, et al., 2008). The typical features of ENL are painful erythematous papules and neuritis (loss of sensation) and this can be treated in severe conditions with again glucocorticoids/corticosteroids and thalidomine (Katzung et al., 2009).

Indian Lepers:

Leprosy is a disease that primarily affects the destitute and illiterate people of underdeveloped nations such as India (Fauci, et al., 2008). This is mainly due to their unhygienic living conditions that provide breeding grounds for the insect vectors that transmit the disease. In addition, the overcrowding makes it easier for human to human transmission (Fauci, et al., 2008). Since they are illiterate as well, they do not know how the disease is transmitted or whether it is curable. Together, these reasons contribute to make India home to half of the world’s Lepers with about 135,000 new yearly cases (“Weekly Epidemiological Record,” 2009, pg. 333-340).

Complicating the treatment regimen, ignorance and superstition shrouding the real causes of Leprosy in India are still prevalent even in the modern Indian Society (Shahani). The general population of India still often believes that the disease is divine punishment and that the diseased are “unclean” (Shahani). Due to these societal attitudes and stigmas, most Lepers are scorned, ostracized, discriminated,

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dehumanized, and even insulted for their conditions (Shahani). Moreover, the Lepers are shunned due to fear of instant contraction of the disease and possible outbreaks (Shahani). Consequently, the Lepers hide the initial symptoms and refuse to seek treatment due to fear and humiliation till they become disfigured (Shahani). Ironically, this creates a vicious cycle that furthers the misconceptions that Leprosy is highly contagious and incurable because it is only observed when it causes disfigurement and the patients are unable to hide it (Shahani).

This isolation combined with such high prevalence of Leprosy in India tends to burden the rising Indian Economy as lost wages, decreased workforce, and unemployment. This happens because Leprosy often affects people in the most productive stages of their lives (“Leprosy,” 2009). As soon as signs of disfigurement appear, the Lepers are compelled to go into isolation in Lepers’ Colonies. Since, most of the sufferers are males (64.83%) who are normally the only source of household income in India, isolating them bankrupts their families (“Weekly Epidemiological Record,” 2009, pg. 333-340). In addition, the isolation of these patients hurts the economy further as more financial support is needed to sustain them in isolation and support their families (“Leprosy,” 2009).

Therefore, this situation of poverty and isolation from society makes Lepers’ colonies ideal places to treat the patients as there is no real need to diagnose the patients (the symptoms are noticeably visual) and most of them have actual disabilities that can be corrected with physical aids. In addition, the lack of tort law system involving malpractice suing in India also makes it ideal for this operation as it keeps the overall expenses low and removes the possibility of unexpected expenses in the form of compensation. Consequently, this treatment and rehabilitation program will help these patients who are mainly blue-collar workers by not only curing them and rending them un-infectious but also by providing them with physical aids that will help them use the necessary tools to recoup their jobs.

Novartis Comprehensive Leprosy Care Association (NCLCA) with a focus on disability – both preventing deterioration and realizing medical rehabilitation:

An organization for complete Leprosy prevention, treatment, and rehabilitation called Novartis Comprehensive Leprosy Care Association (NCLCA) with a focus on disability – both preventing deterioration and realizing medical rehabilitation, has been so successful in Gujurat, India that “it was dubbed the “Gujarat Model” by the Government of India” (NFSD, 2010). In addition, its methods have been so successful that it has managed to benefit over 18,000 patients so far (NFSD, 2010). It had such an impact in Leprosy Prevention in India that it was awarded the prestigious Golden Peacock Award for Innovative Products/Services by the Institute of Directors, India. Founded in 1989 with a goal of providing comprehensive treatment for Leprosy, it has since become a precedent and supporter for other similar projects such as missionary sisters of Canossa Convent and Missionaries of Charity (NFSD, 2010). By working with the Indian State Ministry of Health, religious aid organizations, and a hospital named JJ Hospital, Novartis Foundation for Sustainable Development (NFSD, 2010) has established this non-profit organization housed by Novartis India Limited. This organization operates mainly operates in JJ Hospital in Surat, Gujarat, India and other

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parts of India but it hasn’t done any work in Vadodara, Gujarat, India (the location of the proposal) where a significant number of cases do exist. Therefore, its footsteps can be followed for this proposal and establish a similar service there.

Using a holistic and systematic approach, NCLCA first collects standardized patient information to determine prioritization, materials, staff, services, and plans needed to start their project in a specific area. After the initial evaluation is performed, photographic documentation is recorded to monitor “individual patients’ progress as well as clearer project oversight and management” (NFSD, 2010). Then expertise is exported in the form of visiting NFSD consultants who not only provide care but also gain experience by training to work with these patients. To start the treatment regimen, patients are given MDT to stop the disease from progressing, rendering them un-infectious, cure the disease, and halt any further disabilities from arising (NFSD, 2010).

A multistep rehabilitation service is provided to the patients involves education about disability prevention, reconstructive surgery, physical aids for the disabled, and economic reintegration. Cured patients are provided with rehabilitation services that educate them about the prevention of physical disabilities that can be caused by the lack of sensation. They are also provided with basic self care kits as well as other Leper modified necessities, e.g. footwear, Modulan® grip aids, prefabricated hand/foot splints, etc. (NFSD, 2010). Physiotherapy and reconstructive surgery is offered as well depending on the severity of their condition. Once complete physical rehabilitation is provided, economic reintegration of the patients is also aided by not only providing them physical aids but also tools such as hand carts, sewing machines, carpentry/masonry kits, agricultural tools, etc (NFSD, 2010). This helps these patients get back to work and support themselves and their families. Lastly, certain approaches used by them make this project not only cheap but sustainable as well. For example, surgeons learn the criteria for surgery selection and practice reconstructive surgery, and physiotherapists get to practice rehabilitation procedures all while helping the patients rehabilitate (NFSD, 2010).

Documentation such as photographs and follow up clinics are used to extensively monitor the effects of the treatment and the improvement in severity of the condition, i.e. the physical disabilities. This is the primary method of success evaluation used my NCLCA for over a decade.

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PLAN

The primary goal is to gather a team of a dozen student volunteers, a program coordinator, a program manager, and a volunteer/paid medical staff consisting of two physiotherapist and three physicians to set up medical camps in a Lepers’ Colony named Gujarat Raktapitt Nivaran Seva Sangh (GRNSS) in Vadodara, Gujarat in India to treat and cure Leprosy as well as provide physical aids and tools for economic reintegration of the Leprosy patients.

Source: Google Earth

End Program:

Medical camps consisting of small tents to treat and cure Leprosy patients will be set up in GRNSS from 05/24/2010 to 05/25/2011 so that the physicians with the help of student volunteers can initiate the treatment process. To initiate the process, the entire GRNSS Lepers’ Colony will be informed about the medical camps by the volunteer students as they will walk to every single house over there. This would not be a cumbersome task as the colony is really small and is segregated in a large parking-lot type field. In addition, this would be done while the camps would be set-up in the first week of the operation from 05/17/2010 to 05/23/2010.

The medical camp will be operated by the three physicians and the four student volunteers assigned to each of the physicians every Monday starting from 05/24/2010 to 05/25/2011. The student volunteers will shadow the physicians and perform the tasks of maintaining the clinic and anything else assigned by the physicians. As soon as a patient walks in, he/she will be first examined by one of the three physicians to determine the type of leprosy, which will be either Tuberculoid or Lepromatous Leprosy. Tuberculoid Leprosy as seen in Figure 2, would be diagnosed if the skin lesions “consist of [sic] hypopigmented macules or plaques that are sharply demarcated and hypesthetic, [sic] have [sic] raised borders, and are devoid of the normal skin organs”

Figure 4:Gujarati Raktpitt Nivaran Seva Sanghin (GRNSS)

Junigadhi, Near Municipal Quarters

Mill Road

Yakutpura,Vadodara

Baroda - 390006.

Gujarat

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(Fauci, et al., 2008). Lepromatous Leprosy as observed in Figure 3 would be diagnosed by observing “symmetrically distributed skin nodules, raised plaques, [sic] diffuse dermal infiltration, [sic] loss of eyebrows and eyelashes, pendulous earlobes, and dry scaling skin” (Fauci, et al., 2008). After determining the type of Leprosy, the doctor will determine its subcategory based on the number of lesions, which will be either Paucibacillary (PB) or Multibacillary (MB) Leprosy (“Leprosy,” 2009). Paucibacillary Leprosy would be determined if there are one to five lesions and Multibacillary Leprosy would be determined if there are more than five lesions (“Leprosy,” 2009). Before the treatment starts, the student volunteers assigned to each physician will take photographs of the patient’s initial conditions and lesions to measure the progress both qualitatively and quantitatively. Once the patients have been categorized, the physicians will put the patient on the appropriate chemotherapy consisting of a Multidrug Treatment (MDT) regimen: a regimen of dapsone and rifampin would be administered for six months for PB Leprosy and a regimen of dapsone, rifampin, and clofazimine would be administered for twelve months for MB Leprosy (“Leprosy,” 2009). The medication would be provided in the form of WHO Blister Packs (see Appendix A for details).

Weekly routine checkups will be an integral aspect of the medical camps as the doctors will evaluate the patients’ number of lesions as well as any signs of improvements or even complications resulting from immunological reactions arising due to the administration of the chemotherapy. The possible immunological reactions are classified into two types, namely Type 1 and Type 2 reactions with Type 1 being less severe (Fauci, et al., 2008). Type 1 reactions occur mainly in Tuberculoid Leprosy and would be determined by signs of “inflammation within previously involved macules, papules, and plaques and, on occasion, the appearance of new skin lesions, neuritis, and (less commonly) fever” (Fauci, et al., 2008). If these mere “side-effects” of the treatment would not disappear or become severe with the course of regular treatment, the physicians would treat them with glucocorticoids (Fauci, et al., 2008). Type 2 reactions, which are commonly known as Erythema Nodosum Leprosum (ENL) that occur in Lepromatous Leprosy 90% of the time after the chemotherapy would be determined by painful erythematous papules and neuritis (loss of sensation), (Fauci, et al., 2008). Since most of the Lepers are likely to be Lepromatous, they are likely to suffer from ENL, and they would be treated with glucocorticoids/corticosteroids and thalidomine in severe conditions (Katzung et al., 2009). Again, the student volunteers will take photographs of the patients’ lesions during the routine checkups. This particular approach of routine checkups will enable the doctors to closely monitor the patients and their improving conditions without any expensive, tedious, and time consuming laboratory tests to detect the decrease in AFB (acid fast bacilli - viable bacteria).

Rehabilitation services will start operating from about a week (05/31/2010) from the treatment sessions since it takes that much time to render the disease uninfectious. This week’s worth of waiting period would be beneficial because the physical aids used by the Lepers can carry and transmit the disease more readily and effectively than by human contact (NFSD 2010). Since the treatment to completely cure Leprosy on a histological level can take as long as a year and the deformities are often irreversible,

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the physiotherapists will start as soon as possible by providing the Lepers’ appropriate physical aids such as prefabricated hand splints, foot splints, and grip-aids that will allow them to hold toothbrushes, combs, and most importantly, the tools required for their jobs. To determine who will receive the physical aids, the physiotherapists will assess the disabilities caused by the deformities according to three progressive grades that describe the degree of disabilities of the limbs and eyes (Rad, et al., 2007). However, the physiotherapists will only focus on the “correcting” the deformities of the limbs as correcting vision is often impossible and beyond the scope of this proposal. Grade zero category means that there are no disabilities in the limbs (hands, feet, and their extremities), grade one means that there is loss of sensation in the limbs, and grade two means that there are visible deformities present in the limbs (Rad, et al., 2007). Normally, most of the physical aids will be provided to patients with grade two disabilities. The usage of this categorization will enable the physiotherapists to not only sort out the possible contenders but also help the physicians keep track of the disabilities. In addition, this approach will also prevent further disabilities from arising because the loss of sensation in the limbs of the Lepers causes them injuries as they perform daily tasks, i.e. using open fire while cooking (NFSD, 2010). Finally, as the Lepers are cured completely, they will also be provided with certain tools most often required by their jobs such as “hand carts, sewing machines, carpentry and masonry kits, agricultural tools, and vehicle repair tools” (NFSD, 2010). These tools will be provided upon the specific request of the Lepers on a case by case basis at the culmination of the treatment and rehabilitation. By providing tools, the financial burdens of these blue collar workers will be decreased and it will also enable them to recoup their jobs.

At the termination of the medical camps, every single Leper from the GRNSS will be cured and then provided with rehabilitation services if necessary. Medical camps will cure these patients completely by putting them on Multidrug Therapy (MDT) regime. In addition, the MDT will also either prevent any major disabilities from arising or halt the deterioration of present disabilities. At the same time, these Lepers will be provided with physical aids that will enable them to carry out routine tasks and operate the tools required for their jobs. In addition, they will also be provided with certain tools most often required by their jobs upon their request. Utilizing this approach proscribed by NCLCA, these Lepers will be cured and given an opportunity to decrease their financial burdens and to reintegrate back in society by recouping their jobs. This reintegration will not only benefit the patients and their families by decreasing their financial hardships but also improve the economy as the unemployment rate will decrease.

Important Dates:05/15/2010 – Departure for GRNSS, Vadodara, Gujarat, India.05/17/2010 to 05/23/2010 – Setting up the camps.05/24/2010 – Starting of the treatment regimen in the medical camps.05/31/2010 – Starting the Rehabilitation Services.05/24/2011 – End of the entire program.

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Development Process:

The steps of the proposal will be split into three phases: Phase I – Permissions and Approvals, Phase II – Recruitment, and Phase III – Operation. For Phase I – Permissions and Approvals, Purshottam Jivanlal Panchal, the supervisor of Gujarat Raktapitt Nivaran Seva Sangh, would be contacted at 91-265-2646361 to set up a phone conference to discuss the procedures and paperwork required to obtain permissions for the project. This will include information on where the camps can be set up and how many patients live in GRNSS. In addition, there are no specific strict laws in India regarding such foreign interference because the government stays out of the matters of the private operations such as this. Lastly, the lack of a tort law system involving malpractice suing in India also makes it ideal for this operation as it keeps the overall expenses low and removes the possibility of unexpected expenses in the form of compensation.

Once the permissions are obtained, Phase II – Recruitment will start. First, the physicians and the physiotherapists will be employed by posting advertisements in medical journals such as The Journal of the American Medical Association (JAMA). Also an alternative plan of sending requests to United Nations Volunteer program will be used to maximize the chances of obtaining motivated physicians and physiotherapists. Three physicians and two physiotherapists will be recruited based on the premises that they’re licensed and demand reasonable accommodations and salary. i.e. less than $100,000. Of course preference will be given to the volunteers from United Nations Volunteer Program Doctors if they’re available as they tend to be more compassionate and involved. This approach will help to filter doctors whose main motivation is monetary gains. To counteract the cultural and language differences, doctors who are bilingual or trilingual in English, Gujarati, and/or Hindi would be given a preference as well. This would not be a difficult task as there are about 35,000 Indian doctors practicing medicine in the USA according to American Association of Physicians of Indian Origin; that makes them a majority after Caucasians.

After the doctors are to be found, the student volunteers from Rutgers University would be recruited using several strategies: distributing basic flyers, sending Facebook group invitations, and e-mailing their university e-mail addresses with our contact information to schedule an interview. In the interview process, twelve students will be selected. The students will have to be over 18 and willing to sign a consent form to take responsibility of their own well-being so lawsuits can be avoided. In addition, they should have enough credits for graduation so missing college for this program will not affect their graduation. More importantly, the students should be familiar with the Indian culture and languages to be given a preference over others. Again, this should not be a difficult task since Rutgers University has one of the largest Indian populations especially Gujarati among any other New Jersey Universities/Colleges.

Next, a program coordinator with previous experience in medicine and management would be hired by advertising in classified career websites such as http://www.careerbuilder.com. Once the replies for the job postings are received, one candidate will be chosen based on his/her degree (most likely a BA or MBA). In addition

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, the person should agree to assume responsibilities for handling the administrative processes such as the paperwork, documentation, management, and daily assignments of the doctors to their posts. In addition, this person should also be agreeing to be responsible for overseeing any unexpected legalities of the project as well. Finally, this person would preferably be someone with a decent background in the laws, culture, and languages of Gujarat, India. This is again not that difficult because there are many first generation immigrants in New Jersey from Gujarat, India who have had their baccalaureate education in India and graduate studies in USA. This would ensure that they have the knowledge of Indian laws, customs, and languages as well as the US.

To address the needs of the staff, a program manager would be hired by advertising in classified career websites such as http://www.careerbuilder.com. In the interview process, this person should agree to take the responsibility for the transportation, setting up the camps, taking care of the supplies, and other any accommodations for the entire team. Not only would this person have to be knowledgeable of the local languages and customs but also about the city, Vadodara. The educational requirements of this individual are minimal apart from a BA, but this person would be from Vadodara and know it well.

After a successful recruitment, Phase III – Operation will commence to address the plan starting from departure from the US till the end of the program. First, visas will be obtained for them from the Indian Embassy for a cost of $150 per person for duration of six months to a year. They can be obtained from the Consulate General of India/Indian Embassy in New York, NY. After that, more than enough MDT blister packs per patients will be procured from Novartis Foundation. Glucocorticoids/corticosteroids and thalidomine to treat any immunological reactions will also be obtained from a pharmacy with the help of the physicians’ prescriptions. Then the crew will fly for GRNSS on 05/15/2010 and start building the medical camps from 05/17/2010 to 05/23/2010 after a day of rest. The entire crew would be housed in a Holiday Inn in Vadodara, Gujarat where they will also be provided with food and other daily accommodations. The materials to build the medical camps on the open field of GRNSS such as tents, poles, furniture, etc. will be bought by the program manager and set up by the volunteers under the guidance of the program manager. A total of eight camps will be built: three for each of the physicians, two for each of the physiotherapists, one for the volunteers where they can take photograph the patients and do other work for the doctors, one for the program manager, and one for the program coordinator.

A week after starting the treatment camps, the rehabilitation services will begin on the 05/31/2010. The project manager will dispense the specific physical aids such as prefabricated hand splints, foot splints, and Modulan® grip-aids, etc. upon the request of the physiotherapists on a case by case basis. These physical aids will be obtained by contacting Novartis Foundation. As the Lepers are cured and require certain tools most often required by their jobs such as “hand carts, sewing machines, carpentry and masonry kits, agricultural tools, and vehicle repair tools” (NFSD, 2010), the physiotherapists will proceed the request to the project manager on a case by case

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basis to the program manger. The manager will then buy the tools from any local shops and dispense them to the patients.

Plan of Evaluation:

Documentation such as photographs and follow up checkups will be used to extensively monitor the effects of the treatment and the improvement in severity of the condition. This will be the primary method of success evaluation. The monitoring of the patients and their conditions as mentioned before will take place in weekly routine checkups as the doctors will evaluate the patients’ number of lesions as well as any signs of improvements in the neuritis of the afflicted area or even complications resulting from immunological reactions arising due to the administration of the chemotherapy. This along with the photographs taken by the students at the beginning of the treatment and during each checkup will be used to closely monitor individual patients to assess the effectiveness of the treatment. At the end of the program, the success of it will be measured by the number of cases that have been cured and provided with physical aids and tools for their jobs. Consequently, the goal of this entire program is to cure every single Leper from GRNSS, Vadodara, Gujarat as well as provide all the physical aids and tools that are requested.

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Budget:

Year One of Eradicating Leprosy: One Step Closer:

Inventory: Estimate:

Advertising for crew: $ 1,000Student Volunteers: $500Physicians and Physiotherapists: $250Program Coordinator and Manager: $250

Salary for Staff: $465,000Physicians ($90,000 ᵡ 3): $270,000Physiotherapists ($60,000 ᵡ 2): $120,000Program Coordinator: $40,000Program Manager: $35,000

Visas ($150 ᵡ 19): $2,850

Housing in Holiday Inn in India ($8,000 ᵡ 19): $152,000

Food ($2,000 ᵡ 19): $38,000

Transportation: $28,150Air Travel To and From GRNSS ($1,150 ᵡ 19): $21,850Traveling within India: $6,300

Medical Camp Set-up: $1,500

MDT Drugs from Novartis Foundation: $25,000

Physical Aids: $3,500

Work Tools for Lepers: $2,000

Office Supplies: $1,000

Miscellaneous (including Emergency Fund): $5,000---------------------------------------------------------------------------------------------------------------------Gross Total: $725,000

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REFERENCES

Robbins G., Tripathy V.M., Misra V.N., Mohanty R.K., Shinde V.S., et al. (2009) Ancient

Skeletal Evidence for Leprosy in India (2000 B.C.). PLoS ONE 4(5): e5669.

doi:10.1371/journal.pone.0005669

This is from a journal that traces the origin of Leprosy to India and its findings from an ancient human skeleton from 2000 B.C. This resource helped me find relevant information about Leprosy’s origins and how it has since affected India. Weekly Epidemiological Record, 14 august 2009, vol./is. 84/33(333–340), 0049-8114

This is from the World Health Organization’s Weekly Epidemiological Record, a form of a periodical that gives the yearly statistics of the overall global situation of Leprosy. This source helped me find numerous statistical resources such as the recent Leprosy prevalence, influx, and the types and numbers of disabilities to back up my claims.

Leprosy. (2009) World Health Organization: Regional Office for South-East Asia.

Retrieved from http://www.searo.who.int/EN/Section10/Section20.htm

This is a form of a Web Document retrieved from the World Health Organization (WHO). Its main focus was to describe Leprosy, its treatment, eradication strategies, patients, techniques that pertain to the Indian Subcontinent. It provided me with information regarding the educational and socioeconomic background information on the Lepers from India. It also provided me with other statistics and treatment strategies such as MDT usage employed to cure Leprosy. Fauci, A.S., Braunwald, E., Kasper, D.L., Hauser, S.L, Longo, D.L., Jameson, J.L, &

Loscalzo J. (2008). Harrison's Principles of Internal Medicine, 17e. United States

of America: The McGraw-Hill Companies, Inc.

Harrison’s Principles of Internal Medicine is a reputed medical textbook that is used extensively as a means of reference by medical students and doctors alike. This book is used a lot of times for diagnosis as it covers a broad variety of diseases and their prognosis, diagnosis, and treatments. This provided me with a plethora of information regarding the cause, transmission vectors, types of Leprosy, diagnosis of each, prognosis of each, histological information, treatment regimen, complications arising from immunological reactions to treatment, disabilities, etc.

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Katzung, B. G., Masters, S.B., & Trevor, A.J. (2009). Basic & Clinical Pharmacology,

11e. China: The McGraw-Hill Companies, Inc.

This is a Pharmacological textbook used for reference by doctors and pharmacists. IT contains general information about different drugs, their usage to particular abnormally, their side effects, etc. This helped me find information on each of the different drugs used to treat Leprosy and how and when they’re used. It also helped me find drugs used to treat side effects of Leprosy.

Providing comprehensive leprosy care – The Indian approach. (n.d.) Novartis

Foundation for Sustainable Development (NFSD). Retrieved from

http://www.novartisfoundation.org/page/content/index.asp?

MenuID=558&ID=1722&Menu=3&Item=44.19

This is a Web Document that contains all the information about Novartis Comprehensive Leprosy Care Association (NCLCA) with a focus on disability – both preventing deterioration and realizing medical rehabilitation. This basically covers all aspects of the program from choosing the location to exporting the expertise, types of services provided, and evaluation methods. I used this as my model and I followed much of the same procedures for my operation, providing specific services, and plan of evaluation.

Ranjit Shahani. Leprosy: treating the disease and the social stigma. Retrieved from

http://www.corporatecitizenship.novartis.com/downloads/patients/leprosy/ranjit-

shahani-leprosy.pdf

This is a Web Adobe Reader (.pdf) document that discusses the barriers that prevent the complete rehabilitation of Leprosy Patients such as societal attitudes and stigma. I used this source to refer to define the social stigmas associated with Leprosy and how they drive the Lepers into isolation into Lepers’ Colonies.

Irgens, L.M. (2002). Tidsskrift for den Norske Lægeforening, The discovery of the

leprosy bacillus, 122 (7), 708-709.

This is a Norwegian Journal that describes the discovery of Leprosy. I used it to cite Leprosy’s alternative name, which was based after its discoverer Hansen.

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Rad, F., Ghaderi, E., Moradi, G., Salimzadeh H. (2007). Pakistani Journal of Medical

Science, The Study of Disability Status of Live Leprosy Patients in Kurdistan

Province of Iran,23(6), 857-861.

This is a Pakistani Journal of Medical Science that discusses the types of disabilities caused by the deformities of Leprosy. I used it to define the grades used to describe the disfigurements and disabilities of Leprosy and then establish them as a criterion for the physiotherapists to give physical aids.

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Appendices:

Appendix A: World Health Organization (WHO) Guidelines for MDT Treatment Regimens based on the number of lesions (PB or MB Leprosy):

Source: http://www.who.int/lep/mdt/MDT_Regimens.pdf

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