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The Three I’s for HIV/TB and Rolling out IPT beyond Pilot -India
Dr. B. B. Rewari WHO National Consultant National Programme Officer (ART) National AIDS Control Organisation New Delhi, India
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Content Background about the problem
Status of implementation of 3 I’s in India Implementation of Intensified Case Finding (ICF) at HIV care settings Airborne Infection control (AIC) Isoniazid Preventive Therapy (IPT) –Progress till date
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Background
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Declining Trends of HIV Epidemic in India
Female: 38.7% of PLHA; Children: 4.4% of PLHA Source: HIV Estimations,
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District-wise Scenario of HIV/AIDS
Category NACP-III A 156 B 39 C 296 D 118 New Districts 30 Total 609 Category NACP-III Definition A > 1% ANC prevalence in any of the sites in the last 3 years B < 1% ANC prevalence in all the sites during last 3 years with > 5% prevalence in any HRG site (STD/FSW/MSM/IDU) C < 1% ANC prevalence in all sites during last 3 years with < 5% in all STD clinic attendees or any HRG, with known hot spots D < 1% ANC prevalence in all sites during last 3 years with < 5% in all STD clinic attendees or any HRG OR no or poor HIV data with no known hot spots
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HIV and TB scenario HIV: Concentrated TB: Everywhere, highest burden
0.31% adult prevalence 2.4 million persons Heterogeneous distribution NACP (National AIDS Control Programme)-1992 TB: Everywhere, highest burden About 2.3 m incident TB cases/yr 5% (110,000) HIV-infected with high mortality RNTCP (Revised National TB Control Programme) 2009 adult HIV seroprevalence Overall India has low HIV prevalence, and the HIV epidemic is concentrated to some 6-9 states and few scattered districts in the rest of the country. But in terms of absolute number of cases India ranks no.3 in the world. India has the highest burden of TB in the world, most of the TB burden is among persons without HIV. Only about 5% of TB cases are HIV infected HIV may slow down TB control efforts in India ; magnitude variable Enormous need for improved TB-HIV programme collaboration Particularly efforts to reduce mortality (0.25% – 0.39%) in The adult prevalence is 0.26% among women and 0.38% among The estimated adult HIV prevalence in India was 0.32% (0.26% – 0.41%) in 2008 and 0.31% men in 2008, and 0.25% among women and 0.36% among men in 2009. and Maharashtra (0.55%). Besides these states, Goa, Chandigarh, Gujarat, Punjab and Tamil followed by Andhra Pradesh (0.90%), Mizoram (0.81%), Nagaland (0.78%), Karnataka (0.63%) Among the states, Manipur has shown the highest estimated adult HIV prevalence of 1.40%, prevalence of %. All other states/UTs have lower levels of HIV. while Delhi, Orissa, West Bengal, Chhattisgarh & Puducherry have shown estimated adult HIV Nadu have shown estimated adult HIV prevalence greater than national prevalence (0.31%), 0.41% in 2000 to 0.31% in 2009, although variations exist across the states. The estimated incidence (new infections) in India. Adult HIV prevalence at national level has declined from The HIV estimates highlight an overall reduction in adult HIV prevalence and HIV number of new annual HIV infections has declined by more than 50% over the past decade. 0.33% in However, the low prevalence states of Chandigarh, Orissa, Kerala, Jharkhand, a clear declining trend in adult HIV prevalence. HIV has declined notably in Tamil Nadu to reach All the high prevalence states show Uttarakhand, Jammu & Kashmir, Arunachal Pradesh and Meghalaya show rising trends in adult 30.4) in Children (<15 yrs) account for 3.5% of all infections, while 83% are the in age The total number of people living with HIV/AIDS (PLHA) in India is estimated at 24 lakh (19.3 – HIV prevalence in the last four years. group years. Of all HIV infections, 39% (9.3 lakh) are among women. The four high Bengal, Gujarat, Bihar and Uttar Pradesh are estimated to have more than 1 lakh PLHA each – 2.5 lakh, Tamil Nadu – 1.5 lakh) account for 55% of all HIV infections in the country. West prevalence states of South India (Andhra Pradesh – 5 lakh, Maharashtra – 4.2 lakh, Karnataka and together account for another 22% of HIV infections in India. The states of Punjab, Orissa, number of PLHA due to the large population size. for another 12% of HIV infections. These states, in spite of low HIV prevalence, have large Rajasthan & Madhya Pradesh have 50,000 – 1 lakh HIV infections each and together account This round of estimates has confirmed the clear decline of HIV prevalence among Female Sex trends in many states. Users and Men who have Sex with Men are more and more vulnerable to HIV with increasing Workers at national levels and in most states. However, the evidence shows that Injecting Drug Using globally accepted methodologies and updated evidence on survival to HIV with and to AIDS related causes. The trend of annual AIDS deaths is showing a steady decline since the 2009 in India. Wider access to ART has resulted in a decline of the number of people dying due without treatment, it is estimated that about 1.72 lakh people died of AIDS related causes in roll out of free ART programme in India in 2004. One of the key characteristics of this round of estimations is that it allowed for generating HIV Incidence estimates of the HIV incidence (number of new HIV infections per year). Analysis of epidemic 50% during the last decade. This is one of the most important evidence on the impact of the Page 2 of 4 projections revealed that the number of new annual HIV infections has declined by more than various interventions under National AIDS Control Programme and scaled-up prevention While this trend is evident in most states, some low prevalence states have shown a slight against 2.7 lakh in 2000. strategies. It is estimated that India had approximately 1.2 lakh new HIV infections in 2009, as Of the 1.2 lakh estimated new infections in 2009, the six high prevalence states account for only the programme to focus more on these states with low prevalence, but high vulnerability. increase in the number of new infections over the past two years, that underscores the need for Madhya Pradesh and Gujarat account for 41% of new infections. 39% of the cases, while the states of Orissa, Bihar, West Bengal, Uttar Pradesh, Rajasthan, <0.3% 0.3–0.6% >0.6%
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Implementation of 3 I’s
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Status of implementation of the 3 I’s
Intensified case finding (ICF): implemented at majority of HIV care settings across the country, nearly 12,000 Infection control in HIV care settings National Airborne Infection Control policy developed by NTP Basic infection control practices implemented at all ART centres Isoniazid Preventive Therapy (IPT) National TB/HIV technical working group accepted global evidence in favor of IPT as a strategy Operational research to study feasibility and additional value over early ART initiation underway
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Intensified case finding (ICF)
ICF activity are implemented at Voluntary Counselling and testing centres (VCT centres called ICTC in India) since 2008 ICF at ART centres launched in 2009 and rapidly expanded in 2010 ICF further expanded to the Link-ART centres (a mechanism for decentralized CST) in 2012
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How ICF works in India ? Counselor at a VCT centre (or ART centre) actively looks for Tuberculosis symptoms in all clients Clients (or HIV infected individual at ART centre) having symptom are referred to NTP diagnostic facility How does ICF work in VCT centres in India. Simply, counselors are expected to ask all VCT clients about TB symptoms during pre-test and also follow-up counseling sessions. Counselors are expected to focus on cough for more than 2 weeks. Instead of an algorithm, a list of additional symptoms are provided to prompt referral. These include fever, weight loss, pleuritic chest pain, hemoptyis, and swelling in neck/axillae Counselors refer clients with symptoms to a microscopy center using the sputum referral form, similarly the ART centre nurse refers HIV infected individuals with cough of any duration for evaluation of TB.
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How ICF works …cont. All referrals are enlisted by NACP staff and the list is shared with NTP staff monthly The NTP staff provide information on Outcome of the investigations Status of TB treatment Monthly TB/HIV reports are generated jointly by NACP and NTP staff and reported in the MIS Recording is done by a register, kept at the VCT centres, where all referrals are recorded. This list is passed on to the TB programme monthly, where staff check the microscopy center and TB registers for referral completion, diagnostic outcome, and TB treatment initiation under DOTS. Then each VCT submits a monthly VCT TB-HIV report, the one-pager shown here, jointly to the AIDS and TB programmes. Throughout this process, the HIV status as per programme policies is kept confidential with the VCT counselor. The TB programme staff are not informed of the HIV status of the patients they are reporting on.
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ICF at VCT centres - Trend
Total ICTC clients reported in ICF reports – Million, and million. About 6% of ICTC clients are identified as TB suspects and referred to TB programme for diagnosis
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ICF at VCT centre- Tuberculosis detection
Total clients attending VCT Total TB suspects identified Total TB cases detected TB cases notified under the NTP Contribution by ICF to total TB notification 2010 7,678,746* 484,617 51,412 1,521,438 3.4% 2011 9,774,522 580,689 55,572 1,515,872 3.7% 2012 (Upto April 2012) 3,255,630 196,039 16,861 364,338 3.6% Total Number of VCT centres in India: 5225 * 22/29 states reported on ICF, while all states reported in 2011
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ICF in Six HIV high prevalent states -India
Total clients attending VCT Total TB suspects identified Total TB cases detected TB cases notified under NTP Contribution by ICF to total TB notification 2010 5,086,718 369,918 34,932 409,233 9% 2011 5,6479,97 419,560 36,622 404,423 2012 1,652,398 136,055 11,081 100,410 11% ICF at VCT centres is established well in the high HIV prevalent states in the country and it contribute upto 10% to the overall TB case notification under the national programme
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Reporting and performance of ICF at ART centres
About 12,000 TB suspects are identified every month and >2500 TB cases are detected through ICF at ART centres
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ICF at ART centres Year Total ARTC footfalls (cumulative)
Total TB suspects identified Total TB cases detected Total initiated on ATT 2010 1,748,431 56,739 15,911 13,318 2011 3,822,281 111,521 28,435 23,773 2012 (Upto April 2012) 1,820,100 47,185 10,722 8,822 Proportion TB suspects: Between 3% (About 5% in High prevalent states) Proportion TB suspects found TB: about 23% to 28% Proportion linked to ATT under national programme: 84%
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(Air-borne) Infection Control (AIC/IC)
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OPD and ART waiting area
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Infection Control National AIC Guidelines (NAIC) developed and adopted by National TB Programme Pilot completed (AP, GU, WB) Recommended Infection control measures included in training module for HIV care staff Officers at NACP sensitized regarding need of IC Risk assessments being undertaken by NACO at all ART centers, to be followed with site-specific interventions
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Infection Control activities implemented at ART centres
Administrative measures Infection control plan and SOPs Staff education and training – Included in training module Identification of staff for AIC activities Counseling of TB patient regarding cough etiquettes Triage: Fast-tracking of cough symptomatic through waiting area, consultation, investigation and drug collection Display of IEC material for cough etiquettes, TB screening etc. Environmental measures Promotion of Natural ventilation in waiting area Appropriate sitting arrangement considering cross-ventilation Personal protection measures Provision of surgical masks to symptomatic patients Facilities for hand wash etc.
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Recommended arrangement of patients and staff
Optimal arrangement of patients and staff being implemented in all outpatient departments, ART centers, and ICTC
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Messaging on Cough Etiquette at ART centres
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Challenges in implementation of AIC
ART centres established in space available within exiting hospital buildings State government and Hospital authorities not keen for structural modification considering cost implication Large patient burden in general and ART centres No provision for the Costly N-95 respirators/masks for staff NACP is advocating for AIC measures in all newly constructed hospital buildings
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Isoniazid Preventive Therapy (IPT)
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Progress till date… IPT strategy is under consideration at NACP since early 2010 It was deliberated in meetings of the National technical working group for TB/HIV (NTWG) The NTWG recommended conduct of operational research study at 5 ART centres to study the feasibility A workshop for development of protocol for operational research on IPT at 5 ART centres was held in April 2010 at NACO The protocol developed in this workshop a was not executed due to change of guard in both NACP and RNTCP All Key officers associated with the project were transferred
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NARI consultation The issue got a Philip with National level consultation hosted by National AIDS Research Institute of India in January. leading HIV researchers and experts participated in this consultation and deliberated on need of IPT use in the country perspective. International experts presented the evidence forming basis of WHO recommendations on IPT and other global experience in use of IPT. The overall recommendations for National Programme: The evidence on efficacy of IPT to reduce TB incidence in PLHIV is clear Trials from India have also demonstrated efficacy of IPT (Pre-ART era) The fear of increased risk of INH resistance is unfounded
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Concerns of National Programme managers
Evidence from India on usefulness of IPT from Pre-ART era Several RCT demonstrated that ART reduces TB incidence by % India adopted early ART initiation strategy in late 2011 (CD4 less than 350/cumm) Lack of evidence from India regarding add-on benefit of IPT over early ART initiation Is IPT feasible to implement in India? 1.5 million in HIV care
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NTWG decision Concerns were deliberated in NTWG meeting in June 2011
The NTWG recommended to request National Institute for research in Tuberculosis (NIRT) to conduct an IPT efficacy cum operational feasibility study and guide the National Programme The NIRT developed two separate protocols –Adult and Children and submitted for approval of NACO NACO approved the protocol in October 2011
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Proposed IPT study Study in 15 ART centres across 3 states in South India and 2 states in North Study design : A prospective cohort study Pre-post comparison –to study efficacy of IPT Implementation in routine programmatic settings with no additional human resources to test feasibility of the strategy Sample estimate: Assumption 50% reduction in TB breakdown due to IPT among patients followed up at ART centres Minimum sample required to estimate TB incidence with 95% confidence and 1% precision is 6000
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IPT Study…cont. Inputs in the study include training of staff, introduction of limited records and reports and supervision & monitoring The funds required for above inputs are proposed through the Model DOTS Project arrangement of NIRT with WHO SEARO The drugs required (Isoniazid and Vitamin B6) to be mobilized by Central TB division NIRT obtained approvals of Scientific Advisory Committee and institutional ethics clearance in January-February 2012 Preparations for the study underway Enrollment pending due to non-receipt of funds
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IPT Next step NTWG meeting held on 19th July 2012
Progress of study reviewed. Another study proposed by AIIMS on efficacy not approved and PI asked to be part of this feasibility study Informed that funding is now available from WHO Data presented on IPT study from Myanmar where CIPT is being implemented Hope to start study by next month
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Thank you
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