NATIONAL KALA-AZAR ELIMINATION PROGRAMME

A. Kala-azar Elimination Programme

Kala-azar has been a serious medical and public health problem in India since historical times. Bengal is the oldest known Kala-azar endemic area of the world. After the initial success, Kala-azar resurged in 70s. Concerned with the increasing problem of Kala-azar in the country, the Government of India (GOI) launched a centrally sponsored Kala-azar Control Programme in the endemic states in 1990-91. The GoI provided drugs, insecticides and technical support and state governments provided costs involved in implementation. The program was implemented through State/District Malaria Control Offices and the primary health care system. The programme brought a significant decline in Kala-azar morbidity, but could not sustain the pace of decline for long.

The National Health Policy-2002 set the goal of Kala-azar elimination in India by the year 2010 which was revised to 2015. Continuing focused activities with high political commitment, India signed a Tripartite Memorandum of Understanding (MoU) with Bangladesh and Nepal to achieve Kala-azar elimination from the South-East Asia Region (SEAR). Elimination is defined as reducing the annual incidence of Kala-azar to less than 1 case per 10,000 population at the sub-district (block PHCs) level in Bangladesh and India and at the district level in Nepal.

Presently all programmatic activities are being implemented through the National Vector Borne Disease Control Programme (NVBDCP) which is an umbrella programme for prevention & control of vector borne diseases and is subsumed under National Health Mission (NHM).

Goal

• To improve the health status of vulnerable groups and at-risk population living in Kala-azar endemic areas by the elimination of Kala-azar so that it no longer remains a public health problem.

Target

• To reduce the annual incidence of Kala-azar to less than one per 10,000 populations at block PHC level.

Objective

To reduce the annual incidence of Kala-azar to less than one per 10 000 population at block PHC level by the end of 2015 by:

• reducing Kala-azar in the vulnerable, poor and unreached populations in endemic areas;
• reducing case-fatality rates from Kala-azar to negligible level;
• reducing cases of PKDL to interrupt transmission of Kala-azar; and
• preventing the emergence of Kala-azar and HIV/TB co-infections in endemic areas.

B. The Elimination strategy

The national strategy for elimination of Kala-azar is a multipronged approach which is in line with WHO Regional Strategic Framework for elimination of Kala-azar from the South-East Asia Region (2011-2015) and includes:

1. Early diagnosis & complete case management
2. Integrated Vector Management and Vector Surveillance
3. Supervision, monitoring, surveillance and evaluation
4. Strengthening capacity of human resource in health
5. Advocacy, communication and social mobilization for behavioral impact and inter-sectoral convergence
6. Programme management

Early diagnosis and complete case management

This is done for eliminating the human reservoir of infection through early case detection. Effective case management includes diagnosing a case early along with complete treatment and monitoring of adverse effects. This strategy will reduce case-fatality and will improve utilization of health services by people suspected to be suffering from the disease.

The starting point of early diagnosis is to follow uniform suspect case definition.

• A ‘suspect’ case: history of fever of more than 2 weeks and enlarged spleen and liver not responding to anti malaria in a patient from an endemic area.
• All patients with above symptoms should be screened with Rapid Diagnostic Test and if found positive should be treated with an effective drug.
• In cases with past history of Kala-azar or in those with high suspicion of Kala-azar but with negative RDT test result, confirmation of Kala-azar can be done by examination of bone marrow/spleen aspirate for LD bodies at appropriate level (district hospital) equipped with such skills and facilities.

Treatment: In 2010, the WHO Expert Committee on Leishmaniasis, and subsequently the Regional Technical Advisory Group (RTAG) of WHO South-East Asia Region (SEAR) recommended Liposomal Amphotericin B (LAMB) in a single dose of 10 mg/kg as the first choice treatment regimen for the Indian Subcontinent (ISC) within the current elimination strategy, given its high efficacy, safety, ease of use and assured compliance. The decision to use Liposomal Amphotericin B for Kala Azar was taken by the Technical Advisory Committee based on the available evidences and approved by Ministry of Health and Family Welfare, Govt. of India. In selected districts, Amphotericin B emulsion has been approved. The combination regimen (Injection Paromomycin-Miltefosine for 10 days) is also recommended. Miltefosine 28 days regime and Amphotericin B as multiple doses may also be used.

Within the Indian National Programme, assuming availability of drugs, appropriate training of health personnel, infrastructure and indication, the following drugs will thus be used in order of preference at all levels

• Single Dose 10mg/kgbw Liposomal Amphotericin B (LAMB)
• Combination regimens (e.g. Miltefosine & Paromomycin)
• Miltefosine
• Amphotericin B deoxycholate in multiple doses
• Post Kala-azar Dermal Leishmaniasis (PKDL) patients are to be treated with (i) Liposomal amphotericin B: 5mg/kg per day by infusion two times per week for 3 weeks for a total dose of 30mg/kg, or (ii) Miltefosine: 100mg orally per day for 12 weeks, or (iii) Amphotericin B deoxycholate: 1mg/kg over 4 months 60-80 doses, [as per WHO guidelines on diagnosis and management of PKDL, 2012]
• Case management of special conditions like relapse, HIV-VL co-infection and others will follow NVBDCP operational guidelines of Kala-azar

It is to be noted that Miltefosine cannot be given to pregnant and lactating women, nor in young children. In women of child-bearing age Miltefosine should not be prescribed unless contraception is guaranteed during treatment and for two months after the treatment is completed. In women suffering from PKDL treated with Miltefosine, this period is extended to 5 months following completion of treatment.

Integrated vector management (IVM) including indoor residual spraying (IRS
Integrated Vector Management (IVM) is a rational decision-making process for the optimal use of resources for vector control. The main objective is to reduce longevity of the adult vectors, eliminate the breeding sites, decrease contact of vector with humans, and reduce the density of the vector. This approach improves the efficacy, cost-effectiveness, ecological soundness and sustainability of disease-vector control. The five key elements of IVM include capacity building and training, advocacy, collaboration, evidence-based decision-making and integrated approach.
IRS is the main stay of vector control for breaking the human-vector-human cycle of transmission.
The current strategy is to do IRS twice a year in all houses (upto six feet height) and complete coverage of cattle sheds in villages which had a Kala-azar case reported in the last 3 years including the current year supplemented with focused IRS in villages reporting KA cases. The spray is usually organized in two rounds, 1st round during February - March when sand fly are fairly active and 2nd round during May – June (months may vary from district-to-district based on entomological data) to limit sand fly population supplemented with focused IRS in the villages reporting KA cases.

Supervision, monitoring, surveillance and evaluation
Supervision, monitoring and surveillance are essential components to ensure success of the programme. There is a need to strengthen surveillance for KA and PKDL including line listing of cases at village level to identify hot spot areas (villages reporting five or more KA cases in previous or current year) and update areas for micro planning for spray operations. As per WHO’s Fifth Regional Technical Advisory Meeting of South-East Asia Region, 15-20% of KA patients seek treatment in the private sector. Information from private sector is essential to have better picture of burden of disease and sustain the gains achieved towards elimination. Since the emergence of VL-HIV co-infection and posing threat on the achievements, surveillance of VL-HIV cases is important apart from early and long term follow up of KA and PKDL cases (six and 12 months respectively) as well as information on relapses. Independent evaluation or validation of elimination will pave the pathway towards further reducing KA burden in the community to the lowest level.

Strengthening capacity of human resource in health

Kala-azar elimination will require effective involvement of health personnel at all levels in the continuum of care, right from the early identification of a suspect case to diagnosis and management, including complications. This can be achieved by orientation of human resource in health appropriate for different levels. There are multiple actors engaged in KA control programme like ASHA at community level, ANM at sub-health centre level, laboratory technicians and supervisory staff in the form of Kala-azar technical supervisors at primary health care centre level, district VBD consultants, PHC and district medical and programme officers. In addition, other stakeholders like BMGF/CARE has also made provisions for human resource support at the district and block level (district programme manager and link workers at block PHC respectively). Roles and responsibilities at each level need to be defined and followed.


Advocacy, communication and social mobilization for behavioral impact and Inter-sectoral convergence

The population at risk for Kala-azar is among the poorest in the community and often poorly nourished. Access to care remains an issue in at-risk population and other under privileged sections of communities. Inadequate utilization of health services and lack of faith in public health systems by the affected population are major barriers in achieving elimination. This can be addressed by intensive awareness campaigns with the involvement of communities and community health volunteers. Awareness about the disease, its features, diagnostic and treatment options, prevention, existing schemes and incentives and other aspects of the disease are not widely known. Therefore there is a need for advocacy, communication and social mobilization through all the existing methods (wall writing, hoardings, banner, pamphlets, radio gingles etc) as per the local context. Opportunities should be explored to spread the messages during weekly market or any other mass gathering (Chath puja, fares, melas etc) Display of messages particularly during campaigns which are community based and inter-personal communication are considered the best methods for spreading awareness.

Programme management

Programme management is the most important operational component for success of Kala-azar elimination. It involves coordination between centre and state level offices as well as effective coordination and harmonization of activities with different partners in the programme. Day-to-day management of the programme activities like cold chain maintenance, drug requests, procurement and transportation of drugs, diagnostics and commodities, planning and monitoring need to be strengthened at all levels of implementation.