1. National Programme Officer (ART) National AIDS Control Organization
Indian Experience with Treatment as Prevention Key approaches & challenges
Dr. B .B .Rewari
MD,FRCP, FICP,FIACM,FIMSA WHO National consultant Care , Support and Treatment
National Programme Officer (ART)
National AIDS Control Organization
India

2. Presentation Outline Current Epidemiological scenario
National Response
Improving access to testing
Linkage between testing and treatment
Retention in care
Moving towards NACP IV-Scale up needed
Challenges in Treatment as Prevention

3. Declining Trends of HIV Epidemic in India
Female: 39% of PLHIV; Children: 7% of PLHIV
Source: Technical Report India HIV Estimates 2012, NACO & NIMS

4. 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

5. Routes of HIV Transmission, 2012-13

6. HIV Concentrated in HRG & Bridge Pop.
Source: HIV Sentinel Surveillance – A Technical Brief, NACO

7. However, Regional Variations Exist…
HP-NE-3
HP-South-4
Distribution of Estimated
New HIV Infections (2011)
India
LP-North-7
LP-North-6
Declining trends in high prev. states of South & North East, but still at higher levels;
Stable to rising trends in low prev. states of Central & North India
Source: HSS & HIV Estimations 2012
Note: 3-yr moving averages based on consistent sites; India – 385; HP-South-4 (AP,TN,KR,MH) – 233, HP-NE-3 (MN,NG,MZ) – 31, LP-North-6 (BI,DL,HP,PJ,RJ,UP) – 45, LP-North-7 (AS,CH,GJ,HR,JH,OR, UK) – 33

8. Declining trends, but higher levels…
Declining trends among general population, FSW & MSM;
Stable trends among IDU
Need to sustain efforts in High Prevalence areas to consolidate gains
Source: HIV Sentinel Surveillance – A Technical Brief, NACO
Note: 3-yr moving averages based on consistent sites; ANC–385 sites, FSW–89 sites, MSM–22 sites, IDU–38 sites

9. Emerging Vulnerabilities: IDU
Higher levels of HIV among IDU in Punjab, Chandigarh, Delhi and Mumbai, in addition to North East
Emerging epidemics among IDUs in low prevalence states of Kerala, Orissa, MP, Bihar and Haryana
Focus on saturation with Needle-Syringe Exchange Programme & Scale-up of OST
States with higher vulnerability among IDU
Source: NACO HIV Sentinel Surveillance – Provisional Findings; NACO Mapping of HRG ;

10. Emerging Vulnerabilities: Migration
Rising trends in low prevalence states among ANC attendees despite low level, stable epidemics among HRG in these states
HIV prevalence – higher among rural ANC than urban; higher among those whose spouse is a migrant
Mapped migration corridors with large volumes of out-migration to high prevalence destinations
Need to strengthen coverage of migrants at transit & destinations & along with their spouses at source
Focus on IEC for general population
States with higher vulnerability due to Migration
Source: NACO HIV Sentinel Surveillance – Provisional Findings; Source: Population Council Study -- Reference: Saggurti N, Mahapatra BB, Swain SN, Jain AK. Male out-migration and sexual risk behavior in India: Is the place of origin critical for HIV prevention programs?. BMC Public Health :S6;

11. HIV/AIDS – India’s Response
1986: 1st case of HIV detected in Chennai
1990: HIV/AIDS Cell set up in MoHFW
1992: NACP-I launched with a outlay of US$ 84 m
1992: National AIDS Control Organisation (NACO) established within MoHFW
: NACP-II Budgetary outlay of US$ 191.9m
: NACP-III Budgetary outlay of US$ 1.3 billion
NACP IV ( ) on the anvil with projected outlay of more than US$ 2 billion

12. NACP Strategies Prevention is the main stay
Care, Support and Treatment
High risk populations
Low risk populations
People living with HIV/AIDS
Targeted Interventions for High Risk Groups (FSW, MSM, IDU, Truckers & Migrants)
Link Worker Scheme for rural population
Prevention & Control of Sexually Transmitted Infections
IEC, Social Mobilization & Mainstreaming
Condom promotion
Blood safety
Counselling & Testing Services (ICTC, PPTCT, HIV/TB)
First line & second line ART
Care &Support Centres
HIV-TB Coordination
Focus on PPTCT
Treatment of Opportunistic Infections
ICTC: Integrated Counseling and Testing Centres about 5000 in numbers
PPTCT: Prevention of Parent to Child Transmission Centres for antenatal mothers
Opportunistic infections are mainly tuberculosis, chronic diarrhoea, skin infections, pneumonias, fungal and viral infections like herpes etc
Strategic Information Management
Institutional Strengthening

13. Evidence of Programme Impact
57% Reduction in New Infections ( ) with Scale-up of Prevention Strategies
29% Reduction in AIDS-related Deaths ( ) with Scale-up of Anti-Retroviral Treatment
Source: Technical Report India HIV Estimates 2012, NACO & NIMS

14. Key Approaches towards Improving Access to testing and Treatment Services
Designing for scale-up
Use of Evidence for improved program
Early Initiation of ART
ART for All - HIV/TB coinfection, Pregnant women
Making ARV drugs affordable
Retention in care
Addressing programmatic & operational Challenges
Institutionalizing quality assurance
Simplifying drug regimen while adopting newer guidelines

15. COMMUNITY and high risk groups at centre
How we scaled up…
PREVENTION focused
COMMUNITY and high risk groups at centre
QUALITY assurance through institutional mechanisms
Increased ACCESS to testing, care and treatment
SCALE – expanded service delivery

16. Significant Expansion of Service Delivery
NACP-III Achievements
Scale up of counseling and testing services to 195 lakh persons through 10,515 centres ( : Total lakh :81.9 lakh general clients & 62.8 lakh pregnant women by Jan 2013)
Scale up of prevention of parent to child transmission of HIV through testing of lakh pregnant women and provision of Nevirapine to around 13,000 mother baby pairs. (( : 9,451 pregnant women detected +ve & 96.4% received Niverapine, up to Dec 2012)
Estimated Pregnancies (2011) – 296 lakh; Pregnant women tested (2011) – lakh (16.5% of all pregnancies); Estimated HIV positive Pregnant women (2011) – 38,204; Pregnant women detected positive (2011) – 15,362 (40% of estimate); Pregnant women covered by Niverapine (2011) – 13,013 (85% of detections).
3. No. of blood units screened for HIV increased from 53 lakhs to 93 lakhs in 2012; and 90% of them were collected through voluntary blood donation ( : 45.3 lakh units collected & 83.3% through VBD by Jan 2013)
4. Scale up of Treatment services with over 13 lakh registered for treatment and 5.2 lakh persons receiving free treatment, including over 25,000 children; This is provided through a network of 1,112 ART centres & Link ART Centres. ( : 6.05 lakh by Dec 2012)
Estimated no. of PLHIV (2011): 20,88,641; Cumulative no. of PLHIV Detected at ICTC (Dec 2012): 22,94,647; Cum. No. of PLHIV registered at ART centres (Dec 2012): lakh; Cum. No. of PLHIV alive & on ART (Dec 2012): 6,04,987
Source: NACO-CMIS

17. Counseling & testing Services
1997: VCT services started in the country
2006: Integration of VCT and PPTCT as ICTC
Special focus on key population and MARPs
ICTCs have been set up, nearly half are facility integrated
HIV testing offered to all ANC , TB patients and STI patients
Still around 40% do not know their status
: NACP IV strategies for scale up at least to CHC level across the country and 24X7 PHCs in high prevalence districts

18. Scale up of HIV Testing Facilities (ICTCs)
5018 facility integrated ICTCs in the Government facilities & 964 ICTCs under Public Private Partnership model currently functional, besides 4533 Stand alone ICTCs

19. Significant Expansion of PPTCT but still far away
Source: NACO-CMIS

21. Trend in HIV testing of TB patients

22. Care, Support & Treatment Programme in India
The ART programme in India was launched on 1st April 2004 at 8 institutions in 6 high prevalence states & Delhi
Rapidly scaled up to network of 1100 ART centers and Link ART centers
All PLHIV including children registered in HIV care are provided free diagnostic & treatment services
Nearly 1.5 million PLHIV registered in HIV care
0.65 million are currently on ART
Concept of Link ART centers evolved in 2008 for decentralization of services so as to facilitate easy access to services
All ART centers linked to Care & Support Centers run by Positive networks and NGOs 22

23. Anti-retroviral Treatment (ART): Policy Package
Free Diagnostic services (CD4 count and other baseline tests) --CD 4 count twice a year or earlier if required, Viral load –targeted approach
Standardized Free ART:
First line ARV drugs
Alternate first line ARV drugs
Second line ARV drugs
Free diagnosis & Treatment of Opportunistic Infections
Linkage to various social protection schemes of Govt.
Robust mechanism for Retention in Care

24. Accessibility to ART services
Three tier model of ART services evolved-CoE , ART centers, Link ART centers
Need based and evidence based scale up to address concentrated epidemic in a geographically large & diverse country
District-wise ICTC data for sero-positives detected is analysed and geographic locations and catchment areas are mapped to select the sites for setting up ART Centres
Existing health care systems strengthened by providing additional technical, human, infrastructure support and additional laboratory investigation like CD4 tests under NACP

25. Scale up of Treatment High level political commitment.
9 fold increase in ART provision in last 5 years
58% coverage of those in need as per spectrum model
85% coverage of those in need among those detected
ART services available in 609/671 (90%) districts of country
Strong partnership with PLHIV network and civil society
220 networks of PLHIV functional
Plan to increase no. of ART facilities to nearly 2100 and provide ART to 1 million PLHIV in public sector over next 5 years

29. linkage to CPT and ART - Trend

30. Key Approaches towards Improving Access to Treatment
Designing for scale-up
Use of Evidence for improved program
Early Initiation of ART
ART for All - HIV/TB co-infection, Pregnant women
Making ARV drugs affordable
Retention in care
Addressing Programmatic & operational Challenges
Institutionalizing quality assurance
Simplifying drug regimen while adopting newer guidelines

31. Guidelines on initiation of ART in adult and adolescents
Guidelines on initiation of ART in adult and adolescents
WHO Clinical Stage
Recommendations
HIV infected Adults & Adolescents
Clinical Stage I and II
Start ART if CD4 < 350 cells/mm3
Clinical Stage III and IV
Start ART irrespective of CD4 count
For HIV and TB co-infected patients
Patients with HIV and TB co-infection
(Pulmonary/ Extra-Pulmonary)
Start ART irrespective of CD4 count and type of tuberculosis (Start ATT first, initiate ART as early as possible between 2 weeks to 2 months, when TB treatment is tolerated)

32. HIV infected pregnant women
Guidelines on initiation of ART in Pregnant women for Prevention of Mother to Child transmission
To prevent transmission of infection from positive mothers to newborns, it has been decided to use multidrug ARV regimen and provide ART/ARV prophylaxis to all positive pregnant women irrespective of CD count. (Option B)
WHO Clinical Stage
Recommendations
HIV infected pregnant women
Clinical Stage I and II
Start ART if CD4 < 350 cells/mm3
Clinical Stage III and IV
Start ART irrespective of CD4 count
Multidrug ARV prophylaxis to be given to all HIV infected pregnant women if CD4 >350, during pregnancy & continued till breast feeding period is over

33. First line ART Regimens ( July 2012)
ZIDOVUDINE NEVIRAPINE
OR LAMIVUDINE OR
Tenofovir EFAVIRENZ
NRTI Backbone
NNRTI

34. Key Approaches towards Improving Access to Treatment
Designing for scale-up
Use of Evidence for improved program
Early Initiation of ART
ART for All - HIV/TB co-infection, Pregnant women
Making ARV drugs affordable
Retention in care
Addressing Programmatic & operational Challenges
Institutionalizing quality assurance
Simplifying drug regimen while adopting newer guidelines

35. Monitoring and supervision
Significant increase in number of facilities providing ART and the decentralization necessitated the need for a strong monitoring & supervisory structure .
Realizing the need for Uniformity and Quality of care , NACO appointed Regional Coordinators (RC) for Care, Support & Treatment services in different parts of country . They are mandated to travel for at least days a month to the ART centers and LAC in their region
The RC’s (and SACS officials) visit allotted ART Centres at least once in two months and send regular weekly and monthly reports to NACO. They also mentor the sites on technical issues during the visit and through e- communication.
Special focus is given on centers which have high LFU/ death rate etc or are facing some operational problems .

36. Key Approaches towards Improving Access to Treatment
Designing for scale-up
Use of Evidence for improved program
Early Initiation of ART
ART for All - HIV/TB coinfection, Pregnant women
Making ARV drugs affordable
Retention in care
Addressing Programmatic & operational Challenges
Institutionalizing quality assurance
Simplifying drug regimen while adopting newer guidelines

37. Risk factors and barriers for linkage and retention
Policy related factors
Patient related factors
Environmental & Social factors
Operational /systemic factors
This categorization will help the counsellor in addressing each barrier. For example, a client related barrier can be addressed with the client himself/herself. If required support can be sought from family members or friends or other providers. When the barrier is related with counsellor, he/she may need to modify the approaches in an appropriate way. If it is something with other providers or is a problem with the society, the counsellor may have limited scope of intervention. However, client should be helped to reduce the impact upon him/her and continue the treatment.

38. Enhancing patient retention in HIV Care- How?
Addressing Operational/systemic factors
Standard Operating Procedures for patient follow up
Standardized reporting & recording mechanism
Operational research commissioned to identify the factors
Data collected through M & E, research & field experience is used for:
updating standard operating procedures for the facilities
monitoring quality of care including CD4 test for all, early ART initiation, ART for all those eligible, LFU/Missed rates
for policy making , planning scale up and launching new initiatives to address the gaps for better outcomes
Structured training curriculums for all staff on issues related to HIV, SoPs & M & E systems

39. ….Enhancing patient retention in HIV Care- Facilitators
Addressing Patient related factors
Care coordinator appointed at all ART centers to make services more patient friendly and reduce stigma
Scale up and decentralization of ART services done so as to improve accessibility to services.
50% concession in rail fare and free bus travel in many states
CCC and DLN outreach workers involved in patient tracking and monthly meeting held between CCC & ART centre for exchange of lists and information
Laisoning with other ministries & departments so that PLHIV can take benefits of existing social protection schemes

40. Key Approaches towards Improving Access to Treatment
Designing for scale-up
Use of Evidence for improved program
Early Initiation of ART
ART for All - HIV/TB coinfection, Pregnant women
Making ARV drugs affordable
Retention in care
Addressing Programmatic & operational Challenges
Institutionalizing quality assurance
Simplifying drug regimen while adopting newer guidelines

41. NACP IV ( )strategies
Evidence based approach – focus on key districts
Scale up to CHC level across the country
Focus on HRGs, Bridge population, TB and STI patients
Universal coverage for ANC population
Meaningful involvement of private sector

42. NACP-IV – Targets (ICTC)
COMPONENT
Year 1
Year 2
Year 3
Year 4
Year 5
Number of Stand Alone ICTC
5219
Facility Integrated ICTC (Govt)
2400
5600
6400
7200
7600
F-ICTC (PPP Model)
812
1050
1120
1260
1330
Number of Tests
(in million)
16.8
22.4
23.6
26.4
28.0
No of pregnant mothers tested under PPTCT (in million) (Out of the above)
8.4
11.2
11.8
13.2
14.0
No of HIV +ve mother and child receiving prophylaxis
18,060
24,080
25,435
28,445
30,100

43. NACP IV-Way forward in Treatment
NACP IV will provide “Universal access to comprehensive, equitable, stigma-free, quality care, support and treatment services to all PLHIV using an integrated approach”.

44. Baseline NACP IV (March 2012)
Next Five Years………
Target
Baseline NACP IV (March 2012)
Year
Year
Year
No of ART Centers (cumulative)
340
400
450
500
550
600
No of Link ART Centres
800
1,000
1,200
1,300
1,400
1,500
No of PLHIV (adults&Children) on ART (cumulative)
632,345
735,467
815,130
903,656
953,914
10,500,00
PLHIV requiring Second Line ART
10,000
16,000
25,000
35,000
50,000
60,000

45. Challenges Ahead
Need for further decentralization and expansion of ART services but up to what level ??
Sustainability
Universal access will lead 2 fold increase in PLHA on ART
Increasing need for 2nd line as ART programme matures
2nd line failure? What further ?
Increased costs of ARV in view of introduction of newer drugs
Quantifying the quality of care at ART centers- quarterly indicators to judge the quality of care at ART centers- leading to accreditation of ART centres

46. Most Important challenge with 99.73 % population uninfected
Treatment
Prevention
Prevention no doubt requires a larger focus particularly in our context but care, support and Treatment is also an important pillar and with new evidence on treatment as prevention, the balance between two is also important

47. Sustainability - A critical agenda
In NACP III, donor funding accounted for 86% and domestic funding only 14% in total AIDS spending
This will reverse in NACP IV now
Incremental rise in treatment costs with increased testing and coverage– What would be impact of interventions like TIs, which may not be quantifiable but have been instrumental in reducing new infections.

48. Additional consideration with New Guidelines on ART (2013)
Need for further decentralization and expansion of ART services but up to what level ?? Quality issues
Additional Numbers on ART, CD 4 cut off 500—12 to 20%
VL in first Line ART, feasibility, costs
Need for third line drugs
Newer drugs—patented, rising costs

49. Treatment as Prevention
Data from2 Indian sites in HPTN 052 did not show any difference in two arms, sample size small
Need for OR studies to see feasibility of TsAP in terms of acceptability, increased burden at centers and cost
Addressing challenges of long term adherence in PLHIV who are asymptomatic and do not require ART for their own health, toxicity?? Drug Resistance
TsAP for whom ?
Sero-discordant couples
No data about TsAP among IDU , none in HPTN 052 study
Only 37 HIV discordant MSM couples in the study
No information on peno-anal sex among heterosexuals
Whom to Focus in concentrated epidemic settings- Sero discordant or Key Populations—evidence?

50. HRGs found HIV Positive and Linked to ART during 2012-13 (till Dec, 2012) – NACO CMIS
Good linkages of key population to testing and care but retention remains an issue.

51. Test, Link & Treat –leaky Cascade

52. Estimated ART Needs & Unmet Need among adults

53. Issues to consider while we strive for treatment as prevention
Accessibility to ART services-
Large country with different capacities of health systems in different states
Loss from detection to enrollment in HIV care
Late detection of HIV, base line CD –initially 119; now 188 for males and 250 for females
Already burdened health systems
Sustainability- sharp decline in donor funding
Treatment fatigue & retention in care
Routine Prevention strategies versus treatment as prevention 53

54. Thank You