Detailed Mechanism Funding and Narrative

Years of mechanism: 2008 2009

Details for Mechanism ID: 3969
Country/Region: India
Year: 2009
Main Partner: U.S. Centers for Disease Control and Prevention
Main Partner Program: NA
Organizational Type: Own Agency
Funding Agency: HHS/CDC
Total Funding: $2,560,800

Funding for Biomedical Prevention: Prevention of Mother to Child Transmission (MTCT): $58,183

$58,183 in CDC GAP funding is necessary to support a percentage of expenses and activities for one

technical staff member in the Hyderabad Consulate. The amount requested includes salaries, fringe, travel

proportionate office overhead, desk, operational charges, head tax charges, and ICASS charges.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14460

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14460 11471.08 HHS/Centers for US Centers for 6846 5786.08 $44,323

Disease Control & Disease Control

Prevention and Prevention

Table 3.3.01:

Funding for Sexual Prevention: Abstinence/Be Faithful (HVAB): $70,051

$70,051 in CDC GAP funding is necessary to support a percentage of expenses and activities for one

technical staff member in the Chennai Consulate. The amount requested includes salaries, fringe, travel

proportionate office overhead, desk, operational charges, head tax charges, and ICASS charges.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14461

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14461 6241.08 HHS/Centers for US Centers for 6846 5786.08 $58,955

Disease Control & Disease Control

Prevention and Prevention

6241 6241.06 HHS/Centers for US Centers for 3969 3969.06 $2,120

Disease Control & Disease Control

Prevention and Prevention

Program Budget Code: 03 - HVOP Sexual Prevention: Other sexual prevention

Total Planned Funding for Program Budget Code: $6,355,101

Total Planned Funding for Program Budget Code: $0

Table 3.3.03:

Funding for Sexual Prevention: Other Sexual Prevention (HVOP): $137,091

$137,091 in CDC GAP funding is necessary to support a percentage of expenses and activities for one

technical staff member in the Chennai Consulate. The amount requested includes salaries, fringe, travel

proportionate office overhead, desk, operational charges, head tax charges, and ICASS charges.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14462

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14462 10947.08 HHS/Centers for US Centers for 6846 5786.08 $177,839

Disease Control & Disease Control

Prevention and Prevention

Table 3.3.03:

Funding for Care: Adult Care and Support (HBHC): $128,867

$128,867 in CDC GAP funding is necessary to support a percentage of expenses and activities for two

technical staff members - one in the Chennai Consulate and one in the Hyderabad Consulate. The amount

requested includes salaries, fringe, travel proportionate office overhead, desk, operational charges, head

tax charges, and ICASS charges.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14463

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14463 10949.08 HHS/Centers for US Centers for 6846 5786.08 $61,860

Disease Control & Disease Control

Prevention and Prevention

Program Budget Code: 09 - HTXS Treatment: Adult Treatment

Total Planned Funding for Program Budget Code: $988,260

Total Planned Funding for Program Budget Code: $0

Table 3.3.09:

Funding for Treatment: Adult Treatment (HTXS): $139,651

$139,651 in CDC GAP funding is necessary to support a percentage of expenses and activities for two

technical staff members - one in Delhi and one in the Hyderabad Consulate. The amount requested

includes salaries, fringe, travel proportionate office overhead, desk, operational charges, head tax charges,

and ICASS charges.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14466

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14466 6242.08 HHS/Centers for US Centers for 6846 5786.08 $81,131

Disease Control & Disease Control

Prevention and Prevention

6242 6242.06 HHS/Centers for US Centers for 3969 3969.06 $40,000

Disease Control & Disease Control

Prevention and Prevention

Table 3.3.09:

Funding for Care: TB/HIV (HVTB): $74,700

$74,700 in CDC GAP funding is necessary to support a percentage of expenses and activities for one

technical staff member in the Delhi office. The amount requested includes salaries, fringe, travel

proportionate office overhead, desk, operational charges, head tax charges, and ICASS charges.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14464

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14464 11470.08 HHS/Centers for US Centers for 6846 5786.08 $107,423

Disease Control & Disease Control

Prevention and Prevention

Table 3.3.12:

Funding for Prevention: HIV Testing and Counseling (HVCT): $137,091

$137,091 in CDC GAP funding is necessary to support a percentage of expenses and activities for one

technical staff member in the Chennai Consulate. The amount requested includes salaries, fringe, travel

proportionate office overhead, desk, operational charges, head tax charges, and ICASS charges.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14465

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14465 10948.08 HHS/Centers for US Centers for 6846 5786.08 $115,979

Disease Control & Disease Control

Prevention and Prevention

Program Budget Code: 15 - HTXD ARV Drugs

Total Planned Funding for Program Budget Code: $0

Program Budget Code: 16 - HLAB Laboratory Infrastructure

Total Planned Funding for Program Budget Code: $688,698

Total Planned Funding for Program Budget Code: $0

Program Area Narrative:

Overview: India has no single government oversight authority for regulating laboratories, yet has an abundance of clinical

laboratories with uneven distribution, quality and systems linkages. There are high-performing laboratories in the private sector

(for profit), and some in government research institutions and a few premier medical colleges. There are also widespread

specimen collection systems in the private sector focused on urban India. Unfortunately, most People Living with HIV/AIDS

(PLHA) do not have access to these high-quality laboratory services due to geographic and cost constraints.

Internal and external quality assurance (QA) programs are weak or non-existent in most clinical laboratories, proficiency testing

(PT) is not documented, and routine equipment maintenance is often neglected. Documentation of standard operating procedures

(SOPs) and tests is uniformly suboptimal as is preventive maintenance. There is a national Internal Quality Assurance System

(IQAS) for HIV testing supported by 13 National Reference Laboratories (NRLs) but none of the NRLs are accredited by the

National Accreditation Board for Laboratories. Some of the NRLs produce panels for PT and the External Quality Assurance

System (EQAS) of other NRLs in the country but the techniques are not standardized. At the national level, and beyond the NRLs,

most laboratories are not accredited and are unable to adequately monitor quality control for counseling and testing (CT) sites as

that program is scaled up. EQAS for CD4 testing in government laboratories has been established but private laboratories are not

required nor encouraged to participate. Laboratory test data is entered manually at most Integrated Counseling and Testing

Centers (ICTCs) and at other laboratories but is not systematically collected, reported, analyzed and used.

Beyond this general situation, the Government of India (GOI) has made some strides in HIV-related laboratory capacity over the

past three years since the national ART roll out began. FACS Caliber and FACS Count CD4 machines have been purchased by

the National AIDS Control Organization (NACO) through the Clinton Foundation and placed in an increasing number of

government institutions. Significant national policy changes related to CD4 testing and instituted this past year now encourage

baseline CD4 testing of all identified PLHAs cost-free at the NACO-sanctioned ART centers. The previous policy charged patients

between $6-12 and was retracted due to PLHA advocacy efforts and the realization by HIV leaders in India (including USG field

staff and partners) that this significantly restricted access to care and treatment.

Despite these important steps, many challenges remain. Providing baseline and follow-up CD4 testing to a significant fraction of

the 2.3 million estimated PLHAs in India is a logistical and financial challenge. An estimated 350,000 CD4 tests were done in the

public sector over the past 12 months. This is insufficient to meet current demands, leading to long waiting lists for CD4 testing.

Under the third National AIDS Control Program (NACP-III), over 125 CD4 machines will be in place by 2009 with a capacity to

perform over one million tests per year. To make this a reality, the underutilization of many existing CD4 machines will need to be

addressed. This systemic issue is related to the government's restrictions on operating hours, lack of workforce productivity

incentives, and administrative/logistical issues (such as supply chain management, staffing/HR, and equipment maintenance).

The GOI's reluctance to outsource CD4 testing to high-quality corporate or university laboratories is another unresolved issue.

Under NACP-III, laboratory services will be strengthened by expanding infant PCR testing beyond the 7 current centers and

expanding HIV resistance testing in 5 reference laboratories. Viral load testing is being piloted in a small number of ART centers

and reference laboratories. For opportunistic infection (OI) diagnosis, the challenges are: no immediate plans to upgrade

tuberculosis/bacterial culture systems, and non-performance of India ink staining, latex antigen testing, or fungal cultures for

Cryptococcus. Serologic testing for hepatitis B and C is inconsistent, as is laboratory testing for common STIs.

India has considerable microbiologic and general laboratory expertise though it is fragmented. There is a huge need in India to

develop a holistic, quality system of laboratories that are networked, have SOPs and viable and useful information management

systems. While this cross-cutting need appears to be beyond the scope of NACO and NACP-III alone, NACO has recognized the

need to improve laboratory services and address quality and has initiated steps to assess, strengthen and accredit public sector

laboratories with USG assistance. A remaining challenge for USG is to have NACO work with other Ministry of Health programs

and external partners to build broader laboratory capacity and quality systems in a meaningful and sustainable way.

Coordination and Other Donor Support: The Clinton Foundation has, as noted above, supported NACO in the purchase of FACS

Caliber and FACS Count CD4 machines. The USG is, however the only major donor to provide ongoing technical assistance in

this area through the new TA program started in 2008 by CDC. As also noted, it will be important to foster collaboration between

NACO and other partners in the Ministry of Health and the private sector.

Current USG Support: At NACO's request, USG, in collaboration with the World Health Organization (WHO), led an independent

assessment in July 2008 of the 13 National Reference Laboratories (NRLs) across India to provide an unbiased report of the

current quality of HIV testing and to provide recommendations linked to observed deficits for further strengthening these

laboratories. NRLs were assessed in eight broad "Quality Systems Elements": documentation/records, personnel, training,

internal/external quality assessments, occurrence management for lab errors, equipment, procurement/inventory, safety and

laboratory infrastructure, and customer services. Only two NRLs were practicing the recommended HIV testing procedures. The

complete report was shared with NACO and the Secretary of Health, who, following the recommendations, called a meeting of all

NRLs in September. The meeting produced a plan of action to bring all NRLs to acceptable international quality standards. USG

will provide technical assistance (laboratory experts, trainings, inspections) according to this plan.

In addition, USG has provided valuable technical advice and assistance to NACO and the Clinton Foundation on CD4 testing

scale up and quality assurance systems. An HIV Rapid Test Toolkit developed by WHO and CDC has been incorporated into

various in-country training programs and curricula for laboratory technicians.

The USG supported state-of-the-art laboratory at the Government Hospital for Thoracic Medicine at Tambaram (GHTM), Chennai

was opened in late 2004 and has been directed by a USG-hired microbiologist since early 2005. GHTM has been recognized as

one of the leading laboratories in India providing HIV services. In 2008, it is expected to perform approximately 1.2 million tests

including 26,000 CD4 tests and 150,000 Acid Fast Bacilli (AFB) smears. Bacterial and fungal cultures are now performed routinely

as are basic chemistries and hematology tests for the approximately 26,000 PLHAs cared for annually at GHTM. Since 2006, a

substantial portion of the recurring costs for reagents has been transferred to the Tamil Nadu state budget, increasing the

likelihood for sustainability of the project.

USG has recently begun developing laboratory accreditation processes in the private/NGO sector in two states. One pilot,

developed in collaboration with the Tamil Nadu State AIDS Control Society (TNSACS), involves training local for-profit labs

performing high volume HIV testing in proper testing, counseling, and quality control techniques with subsequent bi-annual

inspections and reviews. In return, laboratories are certified by TNSACS and are eligible to receive a free supply of HIV test kits if

they agree to perform HIV testing for $1.25, approximately 50-70% less than most private laboratories currently charge.

USG also provides technical and financial support to a network of 15 private medical colleges in Andhra Pradesh to scale up their

HIV care and educational services. An important piece of this intervention is providing a mechanism for all colleges to have

access to HIV-related laboratory tests at a reasonable price. For example, a CD4 machine has been established in one central

medical college hospital with a model specimen distribution system so that PLHAs seeking care in any of the 15 institutions can

get a low-cost CD4 test performed routinely and conveniently.

The USG has also supported upgrading the laboratory capacity of the Armed Forces Medical Services (AFMS). Provision of CD4

equipment, laboratory reagents and HIV test kits by USG to the AFMS has strengthened their HIV services, including the services

of five newly-established "immunodeficiency centers" for Indian military personnel and their families.

USG FY09 Support: The HIV-related laboratory needs in India are great. Significant resource constraints dictate a limited but

focused role of the USG to provide technical staff support in laboratory sciences and policies to NACO. USG will continue to

collaborate with, and leverage other laboratory partners' resources to efficiently support critical areas under NACP-III to improve

laboratory quality assurance/control practices, engage the private and military sectors, expand quality access to essential HIV-

related laboratory tests such as HIV serology and CD4 testing and advocate for standardized testing procedures.

USG will continue to provide technical support to states and NACO with a focus on quality assurance systems, CD4 testing scale

up, and public-private collaborations. In Andhra Pradesh, USG consultants and staff are working with APSACS on strengthening

quality assurance systems in the over 700 government HIV testing centers and on laboratory training to diagnose commonly

occurring OIs. Similar laboratory support will be provided in Tamil Nadu and Maharashtra where USG will establish state-wide

technical support units. As part of a broader USG initiative to support India's ART roll out, USG will provide more intensive

technical assistance for expanding CD4 testing nationally and piloting strategies to increase CD4 testing efficiencies, including

outsourcing of some testing to reputable private laboratories.

In FY09, USG will also provide more direct technical assistance to NACO. One such project involves building the capacity of the

National AIDS Research Institute (NARI) to conduct batch testing of all NACO-procured HIV test kits. Currently, only the first batch

is tested which is problematic since millions of HIV test kits are procured and distributed in many subsequent batches each year.

Another proposal will help strengthen hazardous waste disposal at the National Institute of Biologics, Delhi.

As described under current support, USG will continue to develop strategies and materials for building a quality laboratory system

starting with laboratory accreditation. Lessons from current assessments will be used to expand these accreditation strategies,

define training needs to fill the gap areas and develop and strengthen an electronic laboratory information management system.

The evidence thus generated will be used to refine the National Laboratory Guidelines by NACO in FY09.

Table 3.3.16:

Funding for Laboratory Infrastructure (HLAB): $173,698

$173,698 in CDC GAP funding is necessary to support a percentage of expenses and activities for one TBD

technical staff member. The amount requested includes salaries, fringe, travel proportionate office

overhead, desk, operational charges, head tax charges, and ICASS charges.

New/Continuing Activity: New Activity

Continuing Activity:

Table 3.3.16:

Funding for Strategic Information (HVSI): $134,526

$134,526 in CDC GAP funding is necessary to support a percentage of expenses and activities for one

technical staff member in the Chennai Consulate. The amount requested includes salaries, fringe, travel

proportionate office overhead, desk, operational charges, head tax charges, and ICASS charges.

New/Continuing Activity: New Activity

Continuing Activity:

Table 3.3.17:

Funding for Health Systems Strengthening (OHSS): $603,264

$603,264 in CDC GAP funding is necessary to support a percentage of expenses and activities for seven

technical staff in the three GAP India offices. This covers three staff members in Delhi, three in Chennai,

and one in Hyderabad. The amount requested includes salaries, fringe, travel proportionate office overhead,

desk, operational charges, head tax charges, and ICASS charges for technical staff.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14469

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14469 10952.08 HHS/Centers for US Centers for 6846 5786.08 $210,908

Disease Control & Disease Control

Prevention and Prevention

Table 3.3.18:

Funding for Management and Operations (HVMS): $903,678

The HHS/CDC Global AIDS Program (GAP) is led by a USDH CDC Country Director and a Deputy Director

for Operations based in New Delhi. This office has one FSN medical officer; one locally contracted technical

consultant, the PEPFAR SI officer, two FSN support staff and one driver. In Chennai, Tamil Nadu, two

USDH positions (one epidemiologist- and one behavioral scientist) based at the US Consulate provide

technical support to CDC programs in south India, supported by two FSN technical officers (medical and

scientific), one laboratory scientist (to be filled), one FSN support staff and one driver. In Hyderabad,

Andhra Pradesh (AP), there are two FSN technical officers (medical and scientific), who are co-located with

the AP State AIDS Control Society.

CDC's core strength is in providing technical assistance and capacity development activities. CDC requires

staff with administrative and technical experience, often with a medical background and strong expertise in

training. Core strengths include a focus on surveillance, M&E, lab strengthening and evidence based

strategic planning for HIV/AIDS activities. CDC provides technical consultants and support to NACO, the

SACS, and input in several technical areas, including ART rollout, CT, PMTCT, laboratory, care, M&E

protocols, national guidelines and training curricula. In the field, CDC is directly involved in providing

technical assistance to partners to improve laboratory and surveillance systems and implement integrated

prevention, care and treatment programs at the state and district level.

CDC estimates the FY09 ICASS costs for sixteen employees will be approximately $51,840 for a full range

of ICASS services, including basic package, management, health services, security, residential,

procurement, shipping, property, travel, mail, financial and HR. The Capital Security Cost Sharing (Head

Tax) is projected to be $119,909. The annual ITSO IT support tax is projected to be $59,757 for FY09.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14471

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14471 6243.08 HHS/Centers for US Centers for 6847 3969.08 $1,171,096

Disease Control & Disease Control

Prevention and Prevention

10866 6243.07 HHS/Centers for HHS/CDC 5612 3969.07 $1,052,038

Disease Control &

Prevention

6243 6243.06 HHS/Centers for US Centers for 3969 3969.06 $1,085,700

Disease Control & Disease Control

Prevention and Prevention

Table 3.3.19: