To purchase laboratory supplies and equipment to support activities related to prevention of mother to child

transmision.

New/Continuing Activity: New Activity

Continuing Activity:

Table 3.3.01:

N/A

New/Continuing Activity: Continuing Activity

Continuing Activity: 17608

Continued Associated Activity Information

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

System ID System ID

17608 11325.08 HHS/Centers for Save the Children 7822 5634.08 CA $201,908

Disease Control & US

Prevention

11325 11325.07 HHS/Centers for Save the Children 5634 5634.07 $140,241

Disease Control & US

Prevention

Program Budget Code: 15 - HTXD ARV Drugs

Total Planned Funding for Program Budget Code: $0

Program Area Narrative:

N/A

Program Budget Code: 16 - HLAB Laboratory Infrastructure

Total Planned Funding for Program Budget Code: $271,180

Total Planned Funding for Program Budget Code: $0

Program Area Narrative:

OVERVIEW

Following the signing of the Comprehensive Peace Agreement (CPA) which ended over 2 decades of conflict in Sudan, the newly-

formed Government of Southern Sudan (GOSS) has been struggling to address formidable health needs across the country.

Southern Sudan is faced with a critical lack of basic infrastructure and profound human resource challenges. Donor support for

health services during the war focused on curative clinical services and there was no functioning public health system. To date,

two and a half years after the CPA, no functional public health or clinical reference laboratory exists in Southern Sudan. Clinical

laboratories are basic in nature and struggle with inadequate staff, equipment and infrastructure, as well as relatively frequent

supply problems. The Central Reference Laboratory in Juba has been under renovation for years and is expected to be functional

in the next few months. A few Primary Health Care Centers (PHCC) are associated with delivery of basic laboratory services.

The policy of the Ministry of Health (MOH), Government of Southern Sudan (GOSS) is to offer a decentralized quality health care

package with laboratory services from referral hospitals down to the level of Primary Health Care Centers. These laboratories are

expected to be functional with trained personnel, functioning equipment and an adequate supply chain that ensures for no stock-

outs of supplies. After the CPA the MOH restructured the laboratory services and began with the recruitment of a cadre of

laboratory personnel and renovation of the Central Reference Laboratory. The renovation began almost two years ago in 2006

and is expected to be completed early in 2009. In the absence of appropriate infrastructure, trained technologists are difficult to

retain and they often leave government service for the private or non-governmental sector.

Neither a comprehensive national laboratory assessment nor a National Strategic Plan for Laboratories has been developed for

Southern Sudan. In September 2008, the MOH requested technical assistance from the US Centers for Disease Control and

Prevention to assist in conducting a comprehensive laboratory assessment, and in the development of a national strategic plan.

The USG team is conducting preliminary work to be able to respond to this request.

Other significant constraints include the complete lack of ELISA testing capacity in Southern Sudan. The only functioning CD4

machine in all of Southern Sudan is at the Sudan Peoples' Liberation Army (SPLA) headquarters laboratory near the SPLA ART

center in Juba. The rest of the four ART sites in Southern Sudan rely on syndromic management of HIV. These has a significant

negative impact, as the majority of HIV positive clients, already weakened with the disease, have to either travel to Uganda for

CD4 testing or not have valuable laboratory monitoring.

HIV testing in Southern Sudan is done within counseling and testing centers by lay counselors using Determine and Unigold test

kits. Hospitals and PHCC laboratories perform HIV testing, mostly for transfusion purposes, using the same algorithm.

Support for the establishment of GOSS laboratory capability to perform ELISA testing is critical for a range of surveillance

activities and quality assurance. In FY 08, the USG plans to hire an FSN laboratory technologist to provide leadership in HIV-

related laboratory activities. Renovation of the Central Reference Laboratory will hopefully be completed by early 2009.

Current PEPFAR Sudan support

In FY07 PEPFAR Sudan CDC provided training in laboratory sample management, biosafety, quality assurance, record keeping,

stock management and good laboratory practices to the laboratory staff at nine sentinel surveillance sites. This training enabled

the staff to successfully complete the first ANC sentinel surveillance in December 08 in Southern Sudan. From the nine sentinel

sites, a total of 6,227 samples were tested at CDC Kenya laboratory and the overall prevalence rate was 3.2% with prevalence

ranging from 1 to15%.

Other key accomplishments included the establishment of an External Quality Assessment (EQA) program for HIV rapid testing at

the 12 PEPFAR counseling and testing (CT) sites; training 27 Voluntary Counseling and Testing (VCT) counselors; and training

one senior laboratory technologist from the SPLA hospital on ART laboratory monitoring.

Direct assistance continues to be provided in the area of quality assurance of laboratory samples and the supervision of

laboratory operations at the SPLA laboratory and Juba teaching hospital laboratory.

Planned Support for FY 09

The PEPFAR Sudan program will continue to provide technical assistance and training for laboratory activities related to

surveillance, quality assurance, PMTCT, VCT, treatment monitoring and other areas as needed. With expansion of sentinel

surveillance to cover eight out of ten states within Southern Sudan, the need for this support will greatly increase. PEPFAR

Sudan, with technical assistance from CDC Headquarters, will provide technical assistance to the MOH to conduct a

comprehensive laboratory assessment that includes looking at the flow of laboratory services and capacity issues (i.e.,

infrastructure, equipment, trained personnel, etc) from all levels of service, i.e., Central, State, County and Primary Health Care

Centers. Technical assistance will also be provided for the development of the national laboratory strategic plan. Discussions are

on course with the Directorate of Laboratory services related to this activity, both of which are paramount for developing and

implementing smooth delivery of laboratory services.

With Global Fund support, WHO in collaboration with MOH, has reported having procured 12 CD4 machines to be installed in five

existing and other proposed ART treatment sites in Yei, Nzara, Juba, Kajokeji, and Nimule. Additional machines are planned to be

installed in more sites in the coming months. PEPFAR Sudan plans to collaborate with Global Fund to offer trainings on ART

laboratory monitoring, good laboratory practice and basic training to laboratory personnel working in these facilities. As a PEPFAR

team, we are also considering mentoring up to 3 laboratory personnel as trainers of trainers (TOT) in rapid HIV testing and

support supervisors to maintain rapid HIV testing quality as counseling and testing scales up.

Once the renovation of the Central Reference Laboratory in Juba is completed, technical assistance will be provided to assist the

MOH with setting laboratory standards. We plan to train and mentor laboratory technicians and technologists on how to conduct

laboratory sentinel surveillance using DBS samples, perform rapid HIV kit evaluation and other procedures as identified through

the laboratory assessment. Currently the rapid HIV test kits being used have not been evaluated within the country and ELISA

dried blood spot (DBS) technology is limited; the training provided will increase the local capacity to perform these evaluations and

procedures. A critical piece of equipment needed in order to perform the needed tests is the ELISA system (composed of the

incubator, washer, and reader). PEPFAR Sudan will work with partners and MoH in acquiring this capability.

PEPFAR Sudan, with technical assistance from CDC Headquarters, plans to conduct a surveillance of the genetic make up of HIV

in Sudan. This will help understand the nature of the epidemic by tracking the movement of the virus in the country and to

determine if there is any significant difference in the genetic make up of the virus between the north and the south of the country.

Sudan National AIDS Program (SNAP) in Khartoum has shown great interest in this project.

Linkages and Collaboration

The USG PEPFAR team will continue to work closely with its partners in Sudan, including the MOH, WHO, Global Fund, SSAC

and SPLA. This will include linking the MOH with other financial resources, providing technical assistance and training to the

extent possible when either requested by the MOH or as outlined in agreed upon planning or strategic documents. The linkages

and collaborations are to develop, improve, and increase laboratory capacity in Sudan including the standardization of guidelines

and policies, development of quality assurance practices, improving forecasting for supplies and supply chain management.

Expected Targets:

12.1 Number of laboratories with capacity to perform 1) HIV tests and 2) CD4 tests and/or lymphocyte tests =0

12.2 Number of individuals to be trained in the provision of laboratory-related activities=18

12.3 Number of tests to be performed at USG-supported laboratories during the reporting period: 1) HIV testing, 2) TB

diagnostics, 3) syphilis testing, and 4) HIV disease monitoring= 5400

Table 3.3.16:

For the purchase of laboratory supplies, rapid test kits, and other materials or equipment to support quality

assurance and laboratory activites by partner organizations with technical support from CDC.

New/Continuing Activity: New Activity

Continuing Activity:

Program Budget Code: 17 - HVSI Strategic Information

Total Planned Funding for Program Budget Code: $766,900

Total Planned Funding for Program Budget Code: $0

Program Area Narrative:

Program Area Context:

There is extremely limited information on HIV/AIDS strategic information in Sudan. HIV epidemiological information is still scanty

though the estimated seroprevalence is now estimated at 2.6% (UNAIDS). The recent completion of drafting of the "Southern

Sudan HIV/AIDS Framework" (2008-2012) provides a basis for the implementation of a national monitoring and evaluation (M&E)

framework which reportedly will be launched in FY 2009. During this planning period, the USG Team will continue to support

efforts to better understand the epidemiological situation, strengthen sentinel surveillance in both the South and North, build

related laboratory capacity, and obtain better HIV data from surveys. In addition, PEPFAR will support the national M&E

framework implementation and training of M&E staff in the Southern Sudan HIV/AIDS Commission (SSAC) and the Ministry of

Health (MOH) to implement a unified and efficient monitoring system that provides information for decision making on HIV/AIDS in

Sudan. The program will continue to strengthen M&E processes, with a special focus on improving data quality.

The USG Country team has no full-time Strategic Information (SI) staff or a defined SI Team. Due to high staff turnover over the

past year, various CDC and USAID staff, with the support of the USAID/East Africa regional staff have been functioning

intermittently as the SI Team. This has hampered surveillance and survey activities in Sudan, which are critical as the program

strives to gather epidemiological data to inform the program.

In spite of all the problems mentioned above, the PEPFAR Sudan team has been gradually strengthening M&E capacity in Sudan

over the last two years, relying upon technical assistance (TA) from CDC and OGAC, as well as assistance from USAID/East

Africa. In collaboration with USG partners and the host government authorities, the USG team began discussions on the

development of standardized data collection procedures, tools and a database. USG was active in the development of the M&E

component of the Southern Sudan HIV/AIDS Strategic Framework, HIV indicator lists, and M&E frameworks which now form the

basis for the development of a unified monitoring and reporting system for Southern Sudan.

The new M&E Officers appointed by SSAC in 10 States continue to receive capacity building support from the USG team though

staff attrition is high. In FY 2008 USG provided training in monitoring and evaluation for M&E coordinators from GOSS and partner

staff. The challenge during the coming year is to support SSAC and MOH to implement a unified and efficient monitoring and

reporting system from the states to the national level.

PEPFAR Sudan, with support from CDC headquarters, has supported antenatal clinic sentinel surveillance activities both in the

North and the South. In Southern Sudan, CDC established the basis of an ANC surveillance system, but due to various reasons,

including lack of manpower and resources, surveillance activities are not taking place at this time. This has been a great

disappointment. However, CDC actively participated in assessing additional sites throughout Southern Sudan for ANC

surveillance. In addition, the proposed Sudan AIDS Indicator Survey (AIS) has distracted authorities from other surveillance

activities; though ANC surveillance is now slowly taking off.

Laboratory capacity remains an important constraint for HIV surveillance in Sudan. For example, there is no ELISA testing

capacity in Southern Sudan. The USG PEPFAR team plans to support the development of laboratory capacity at the Juba

Reference Laboratory for surveillance purposes has also not been successful due to slow pace of progress on renovation.

SURVEILLANCE AND SURVEYS

CDC has been responsible for all aspects of ANC surveillance in Sudan to date. The relative lack of engagement of the MOH and

the SSAC in planning and management has been a major weakness. However, the MOH is actively engaged with CDC and

UNDP in planning for the expansion of ANC surveillance. USG anticipates collaborating with GFATM to support GOSS capacity.

ANC surveillance data showed a mixed epidemic, with an overall HIV prevalence rate of 3.2%, ranging from 1% to15% depending

on the site. In 2007, the program began dried blood spot (DBS) specimen collection. More sites have been assessed and it is

anticipated that at least three additional sites will become active this year.

In the North, CDC will continue to provide TA to the Federal MOH with sentinel surveillance. USG procured supplies and provided

TA and training to support the transition for the ongoing surveillance round. Some of the USG assistance has been undertaken in

collaboration with the UN High Commissioner for Refugees (UNHCR), which funded CDC headquarters technical assistance with

ANC Sentinel Surveillance.

FY 2009 SUPPORT

The key activities initiated in 2008 are expected to continue in 2009. However, basic challenges such as lack of trained and

experienced strategic information personnel and poorly coordinated efforts will continue to hinder progress for the foreseeable

future. USG will continue to collaborate with UNDP as the principal recipient of the Global Funds for AIDS, TB, and Malaria

(GFATM) grants that are currently the major source of HIV/AIDS funding in Sudan.

The likely role for the USG in supporting laboratory development is still being worked out with the MOH. The plan to hire an FSN

laboratory technologist, based at the Juba Reference Lab to provide leadership in HIV-related laboratory matters, is still pending.

Once the renovation of the reference lab is completed, PEPFAR Sudan will provide assistance in the foundation of HIV reference

section so as to set standard in evaluation of test kits and support Dried Blood Spot (DBS) Enzyme Linked Immunosorbent Assay

(ELISA) HIV testing mainly for surveillance and quality assurance purposes. These services are currently non existent in Southern

Sudan.

The USG team will continue to rely upon short-term TA from PEPFAR to work on strengthening Sudan's monitoring and reporting

systems and to work with partners on implementing these processes.

LEVERAGING AND COORDINATION

The Sudan PEPFAR team's efforts in the area of SI will link to the efforts of the GFATM and other donors and stakeholders.

Currently, CDC and UNDP are working closely with the MOH to make plans for the expansion of ANC surveillance and the

development of some GoSS capacity. In northern Sudan, the request from the Sudan National AIDS Program (SNAP) for USG

technical assistance in the North is directly linked to implementing a program supported by Round 5 GFATM grant

The development of USG M&E structures will be coordinated with concurrent national efforts supported by UNAIDS and the

GFATM. The USG Sudan team will seek to strengthen these efforts and will ensure that the M&E system is consistent with the

national framework that is developed.

Expected outcomes

- Strengthened antenatal surveillance in Sudan.

- Increased number and improved distribution of ANC surveillance sites in Southern Sudan.

- Established laboratory testing (ELISA assays) for surveillance in Southern Sudan.

- Improved laboratory standards, surveillance data management system and quality assurance procedures.

- Completed Data Quality Assessment.

Program Area Downstream Targets:

13.1 Number of local organizations provided with technical assistance for strategic information activities: 30

13.2 Number of individuals trained in strategic information (includes M&E, surveillance, and/or HMIS): 200

Table 3.3.17:

For laboratory supplies and related materials to conduct the ANC sentinal surveillance activity.

New/Continuing Activity: New Activity

Continuing Activity:

Table 3.3.17: