Track 1 and 2 funds are combined for this activity.

ACTIVITY DESCRIPTION:

Through these activities, Harvard/APIN+ will provide ART drugs to 48,500 adult and pediatric patients at 36

APIN+ sites in nine states (Benue, Borno, Ebonyi, Enugu, Kaduna, Lagos, Oyo, Plateau, Yobe). These sites

include 28 comprehensive ART sites serving pregnant women, adults and children, and eight PMTCT sites

that also provide HIV+ children identified through the PMTCT program with ART. At all sites APIN+ will

provide the ART prophylaxis options and triple drug regimens for eligible pregnant women consistent with

the national guidelines. Thus, a total of 36 APIN Plus sites will be providing ART drugs through ART or

PMTCT services.

In COP08, APIN+ will begin to collaborate with Clinton Foundation for the procurement of second line drugs

for adult patients and all pediatric drugs for pediatric patients. Drugs procured through SCMS will be

shipped to APIN's Central Medical Stores (CMS) in Lagos, from which they will be distributed to sites in

accordance with an internal supply chain management system. We will purchase first-line ART drugs

directly from drug manufacturers and through different ART purchasing agents, including IDA and SCMS,

as applicable, in accordance with USG regulations and NAFDC Registration and following Nigerian National

ARV drug regimens. We have developed SOPs for supply chain management, drug usage, drug regimen

tracking, drug distribution, warehouse storage and individual pharmacy site management. These SOPs are

also used for procurement and distribution of OI drugs and certain lab supplies and test kits.

All drug orders are based on projections of patient numbers as determined by several factors including: rate

of patient enrollment, weight class of patients affecting drug dosage, gender, rates of toxicity, and rates of

failure. Our rates of drug ordering and estimation of buffer stock needs have been informed by our

experience with lengthy and variable order to delivery times, global shortages (e.g. BMS and Merck),

splitting of most orders, delays in NAFDAC registration and lengthy clearance of drugs in country. As a

result, our drug orders had been adjusted to accommodate with an increase in buffer stocks. This year, we

have buffer stocks for approximately 3-5 months for all of the requisite first and second line drugs, most of

which are fixed dose combinations and other FDA-approved generic drugs.

Capacity building and training for our APIN+ CMS at NIMR and individual site pharmacies is ongoing to

support pharmacy management and implementation of the National ART Program. Harvard/APIN+ is

participating in the ART harmonization process with the GON. The goal of these activities is to facilitate the

pharmacies' ability to scale up capacity as patient utilization of ART increases. The CMS is located at NIMR

(Lagos), where the project operates and manages a warehouse that provides storage for drugs once they

enter the country. An electronic bin card system is utilized to track and monitor drug stores and distribution.

A subcontract with Fed-Ex provides monthly distribution to all site pharmacies. Assessments of all facilities

to determine infrastructure needs have been conducted in COP07 and will continue to be conducted in

COP08 for new sites. These site capacity assessments have been the basis for efforts to strengthen the

supply chain management system for new sites. Ongoing assessments ensure sustainability of pharmacies

and supply chain management at the sites. All site pharmacists have participated in regular training

sessions and work with site data managers in providing regular supply chain information electronically to

our central pharmacy. The computerized supply chain information system linked to patient clinical records

also provides reporting data for M&E at each site. Our logistician consultant conducts regular drug inventory

audits to our central warehouse and individual site pharmacies.

Our long-term goal is to support a sustainable supply chain management system for ART that incorporates

existing and bolstered Nigerian institutional structures and is harmonized with GON activities. Continued

collaboration with SCMS and GON procurement efforts contribute to this goal. Implementation of the

PEPFAR-Nigeria LGA coverage strategy in the program areas of PMTCT and TB/HIV, designed to ensure

the provision of PMTCT and TB/HIV services in at least one health facility in every local government area

(LGA) of 6 identified states, will help to guide the ongoing site expansion for ART and PMTCT. As a part of

that plan, secondary health care facilities covering all 17 LGAs in Plateau state will be targeted for

pharmacy support and drug distribution. As expansion of ARV drug services is prioritized to rural areas,

APIN+ will strengthen existing referral channels and support network coordinating mechanisms. Each new

site will be visited by a team of technical staff from Nigeria and Boston as well as other sub-partners.

Pharmacy and logistics management procedures will be assessed and be part of the site development plan.

Recommendations for drug storage, equipping of pharmacies and minor renovations are considered. All

APIN+ pharmacists have completed the IDA ARV training program. Pharmacists hold meetings on a

quarterly basis and training updates are provided. On a monthly basis, drug updates are provided to all

APIN + investigators by email. Pharmacists and their data entry staff also participate in the electronic data

tracking system; regular training in computer entry and database management are also provided.

This funding will specifically support the procurement of ART drugs, their distribution and storage in a

central pharmacy established at NIMR (Lagos). Funding supports the central pharmacy, security, equipment

and two full time pharmacists. Subcontracts to JSI and Crown agents for supply chain management are also

included. All drug regimens are consistent with the National ART guidelines for adult and pediatric patients.

Funding in this activity provides drugs for 44,000 adult and 4,500 pediatric patients on appropriate ART

drugs.

CONTRIBUTION TO OVERALL PROGRAM AREA

Through these activities we will have provided ART drugs to 48,500 patients at 36 ART service outlets. We

have almost doubled the number of ART service provider sites from 17 and increased the number of states

from seven to eight. In addition, we have scaled up our PMTCT activities with 36 points of service providing

access to PMTCT services for 56,250 women. Through these activities, we will continue to strengthen the

structure of our ART drug procurement system, as described above, in accordance with PEPFAR goals in

order to ensure cost effective and accountable mechanisms for drug procurement and distribution.

Furthermore, efforts to build local capacity through infrastructure building and training mechanisms are

consistent with PEPFAR 5-year goals to enhance the capacity of supply chain management systems to

respond to rapid treatment scale-up. Additionally, through procurement via SCMS, we seek to provide

support to efforts to build national capacity related to drug procurement and distribution.

LINKS TO OTHER ACTIVITIES

This activity also relates to activities in TB/HIV (3222.08), ART Services (6715.08), and Strategic

Information (3226.08). Through this activity, we will maintain significant linkages with PMTCT (3227.08) and

Activity Narrative: ART Services through the procurement of ART drugs for individuals served by these programs. Additionally,

we will develop and maintain linkages to TB/HIV activities, with expansion focusing on co-locating ARV sites

with existing DOTS sites. The supply chain management system will serve to provide drugs to ART sites

that are providing TB services in conjunction with ART services. SI activities will provide crucial information

for M&E as well as efficacy of the drug regimens, which may impact drug procurement decision-making.

POPULATIONS BEING TARGETED

The primary target of these activities are health care workers, including program managers doctors, nurses,

and pharmacists who are involved in the drug procurement and distribution process. Furthermore, by

building mechanisms for drug procurement, these activities seek to target PLWHA, both adults and children,

who are in need of or already receiving ART care.

EMPHASIS AREAS

Emphasis areas include strategic information and local organization capacity building.

Training initiatives have also been incorporated into these activities in order to build the local human

resource capacity to manage a sustainable drug procurement and distribution system.

Track 1 and 2 are combined for this activity.

ACTIVITY DESCRIPTION:

In COP07 Harvard/APIN+ provided comprehensive ART services in 17 sites In COP08 will provide high

quality ART services to eligible patients at a total of 36 sites; 28 comprehensive ART sites (11 tertiary and

17 secondary facilities) and eight PMTCT sites that also provide ART for HIV+ children identified through

PMTCT services. The 28 sites are located in the nine states of Benue, Borno, Ebonyi, Enugu, Kaduna,

Lagos, Oyo, Plateau, and Yobe. This will provide ART services to a total of 48,500 individuals, including

44,000 adults (14,000 new) and 4,500 children (1,500 new) at the end of the reporting period. At the

additional eight PMTCT sites there will also be ART services provided for eligible pregnant women and

eligible infected infants. Implementation of the PEPFAR-Nigeria LGA coverage strategy in the program

areas of PMTCT and TB/HIV, designed to ensure the provision of PMTCT and TB/HIV services in at least

one health facility in every local government area (LGA) of 6 identified states, will increase the reach of

adult and pediatric ART services as well.

For patients at the Federal ART sites, the program anticipates GON provision of first line ARV drugs and

PEPFAR support for ART care and services. As patients require alternative or second line drugs, they will

receive PEPFAR provided drugs. GON provision of first line drugs, when actualized, will allow for additional

adult and pediatric targets. APIN+ estimates that 2,500 additional adults will be placed on therapy through

the leveraging of GON drugs. APIN+ will also partner with Clinton Foundation and Global Fund (GF) as

appropriate to leverage resources for providing antiretroviral drugs to patients. The site investigators and

project managers will actively participate in the GON National ART program. Harmonization of data

collection for M&E will be coordinated with USG and GON efforts. APIN+ has provided technical assistance

and training expertise to the National ART program's training program for adults and pediatric patients,

which will continue in 2008. APIN will continue to participate in the USG coordinated Clinical Working Group

to address emerging topics in ARV service provision and to ensure harmonization with other IPs and the

GON.

ART provision and monitoring follows the 2005 revised National ART guidelines for adult and pediatric care.

All sites focus on the integration of ART services for all patients regardless of the source of funding for

different components of treatment (e.g. external funding sources for services or lab commodities). A

standardized protocol for adult and pediatric ART services is followed at all APIN PEPFAR sites. At each

site support is provided for the management of electronic data and patient medical records for use in the

provision of clinical care. Continued support to ART sites in the area of pediatrics, including the training of

pediatric clinicians, will build capacity at sites to provide pediatric ART. TB diagnosis and treatment is

provided to all patients via facility co-location of DOTS centers and/or referral of patients into ART from

DOTS sites. ART eligible patients identified through HCT conducted at a DOTS site will be provided with

ART. By the end of COP07 all APIN+ ART sites will be co-located with DOT centers to facilitate TB/HIV

service linkages. All HIV infected clients will be symptomatically screened and confirmed with laboratory

and radiological diagnostics as indicated while all TB patients will be offered HIV testing.

Patients are identified through HCT services including facility based, mobile, and family centered strategies.

Those initiating ART are provided ART EAC prior to and during ART provision. ART EAC will follow the

National Curriculum for Adherence Counseling and includes partner notification, drug adherence strategies

and other prevention measures. Care services including prevention for positives will be provided for all ART

patients as outlined in the BC&S narrative.

Non-ART eligible individual that are enrolled in care will have periodic follow-up to identify changes in

eligibility status. Patients are also encouraged to refer family members for HCT. ART EAC is reinforced with

PLWHA support groups at each site, which serve both PEPFAR and Federal ART patients. PLWHA on

treatment are encouraged to have a treatment support partner to whom he/she had disclosed status to

improve adherence and to optimize care.

Scheduled physician visits are at three, six, and 12 months and every six months thereafter; patients pick

up ART drugs monthly. At each visit, clinical exams, hematology, chemistry, and CD4 enumeration are

performed. All tertiary site labs perform the necessary lab assays. Secondary and primary sites with limited

lab capability send samples to an affiliated tertiary site lab for analysis. Electronic clinic and lab records

provide data for high quality patient care and centrally coordinated program monitoring.

Clinical staff meets monthly for updates and training. Each site has a clinic coordinator and a central

committee determines and approves drug regimen switching. As clinical training needs are identified for

new sites or new staff at existing sites, APIN+ provides training on regimen switching and other relevant

topics. APIN+ will continue to implement internal and external QA/QC programs through SI activities and will

allow sites to further monitor the level of patient care. In COP07, APIN+ developed standardized indicators

and piloted QA assessments at ART sites; results were utilized to strengthen services at sites. In COP08,

APIN+ will continue to implement these assessments at additional sites. At each site, indicators specific to

site needs and activities will be developed.

In addition to providing training to improve care at supported sites, APIN+ will also fully support the training

of 100 lab scientists working at GON and GF supported sites. APIN+ will utilize its training lab to train them

in ARV lab monitoring including good laboratory practices, HIV rapid testing, automated CD4, hemogram

and chemistries. This will serve to increase the quality and sustainability of ARV services outside of

PEPFAR-supported sites.

This funding will support the personnel, clinic and lab services for training of 900 people, monitoring of

44,000 adults and 4,500 pediatric patients at the end of COP08, which includes 14,000 new adult and 1,500

new pediatric patients. Funding is also used to support renovations of physical infrastructure at expansion

sites to build physical capacity for the provision of ART services. A total of 48,500 patients will be provided

with ART services. Treatment is provided as a part of the National ART Program in 11 tertiary care teaching

hospitals and federal medical centers, located in Plateau, Lagos, Oyo, Borno, Kaduna, Enugu and Benue

states. Services will also be provided in 17 secondary level hospitals/clinics in Oyo, Yobe, Borno and

Plateau States. Mobile services are also provided to patients served by a CBO in Ebonyi State.

CONTRIBUTION TO PROGRAM:

ART activities are consistent with the PEPFAR goal of scaling up capacity to provide ARV drugs, services

Activity Narrative: and lab support to serve more HIV+ people. The 28 comprehensive ART sites represent a significant

increase in the number of ART sites. Additionally, APIN+ will expand to two new states, with the majority of

new expansion sites being secondary level sites. APIN+ will seek to support the expansion of ARV services

into more local areas by developing a network of secondary or primary health care clinics providing ART

services that are linked to tertiary health care facilities. Plateau State will be targeted for additional

expansion through PMTCT services as a component of the PEPFAR Nigeria LGA coverage plan. As

expansion of ARV drug services is prioritized to rural areas, existing referral channels and support network

coordinating mechanisms will be strengthened. These networks will ensure that facilities are able to develop

linkages, which permit patient referral and the provision of specialty care support. A tiered structure for ARV

provision and monitoring established in COP07 provides a model for additional expansion efforts in COP08

in order to meet PEPFAR treatment goals.

LINKS TO OTHER ACTIVITIES:

This activity is linked to ART drugs (9888.08), OVC (5415.08) for pediatric palliative care, adult BC&S

(5369.08), PMTCT (3227.08) as the program will support 36 PMTCT sites, TB/HIV (3222.08) to provide

ART to patients with TB, Lab (6716.08) to provide ART diagnostics, HCT (5424.08) as an entry point to

ART, and SI (3226.08) will provide the GON with crucial information for use in the evaluation of the National

ARV program and recommended drug regimens. This program is linked to PMTCT services to optimize the

PMTCT by providing ART to eligible pregnant women.

POPULATIONS BEING TARGETED:

The care and treatment components of these activities target HIV-infected adults and children for clinical

monitoring and ART treatment. The operational elements of these activities (M&E, health personnel training,

infrastructural supports, technical assistance and quality assurance) target public and private program

managers, doctors, nurses, pharmacists and lab workers at PEPFAR sites. The expansion of ART services

to secondary health facilities will increase access to necessary services in poor communities.

EMPHASIS AREAS:

Emphasis areas include in-service training. This increases gender equity by providing equitable access to

ART services for both sexes. Counseling services will seek to identify and provide appropriate referrals for

women who are or are at risk of becoming victims of violence. ART EAC will seek to provide referrals to

wraparound services, such as food & nutrition programs and educational services. ART EAC will also seek

to address stigma and discrimination.

Track 1 and Track 2 funds will be combined for this activity.

ACTIVITY DESCRIPTION:

This activity provides maintenance of activities at the National Central Public Health Reference Lab

(NCPHRL) and HIV labs at tertiary (11) and secondary (22) health facilities in Plateau, Oyo, Borno, Yobe,

Lagos, Enugu, Kaduna, and Benue States. These 34 labs represent an overachievement of our COP07

target (30 labs in the same 8 states). In COP08, APIN+ proposes adding additional expansion sites by

building the infrastructure and capacities of 3 labs in secondary health facilities in Plateau state to for a total

of 37 labs. In addition, we will expand the capacity of labs at primary health facilities throughout Plateau and

Oyo states (HIV testing). By the end of COP07, our 11 major tertiary level labs and the NCPHRL will have

capabilities for hematology, automated chemistry analyzers, and laser-based lymphocyte subset

enumeration. Ten of these facilities will also have PCR technology.

APIN will work with GON in developing the NCPHRL into a national reference lab, a project identified by the

MOH as a priority. This lab will serve national HIV QC/QA needs and with 2-3 additional APIN+ supported

labs, will serve as a national laboratory training center. This lab's capacity will include standard HIV assays,

clinical chemistries, hematology, and TB culture. In addition, we will continue to strengthen existing labs by

providing backup equipments to major tertiary sites in geographically isolated areas to avoid interruption in

service. Equipment maintenance is coordinated through assistance from a consultant trained in the

maintenance of freezers and through the manufacturers for other items.

All 37 labs will provide HIV diagnosis through rapid test technologies. All 36 ART sites will have western blot

capacity to confirm HIV status prior to initiation of ART. HIV serology, hematology, chemistries, and CD4

enumeration will be supported at all secondary hospitals with referral to the tertiary labs for PCR diagnostics

and viral loads. Primary health care facilities are closely partnered with secondary and tertiary care facilities,

allowing for baseline and periodic evaluation with full lab monitoring. The primary facilities provide limited

lab monitoring with basic clinical, hematologic and CD4 assays. We are currently screening for TB by

sputum and/or pulmonary X-ray at all ART sites. We will be evaluating the use of PCR diagnosis of TB at

selected tertiary sites in COP07; this will help to guide programmatic decisions regarding its use in COP08.

Our labs with infant PCR diagnostic capabilities will continue to assist other PEPFAR IPs, using dried blood

spots (DBS) to transport specimens from distant satellite sites. APIN+ will support the PEPFAR-Nigeria LGA

coverage strategy (PMTCT and TB/HIV). Secondary sites will have lab capacity for HIV serology,

hematology, chemistries, and CD4 enumeration. Primary feeder sites will be limited to HIV serology with

referral to the secondary sites for additional lab monitoring.

Standardized lab protocols have been developed to accompany the PEPFAR clinical protocol and

computerized lab results link with patient records. These protocols include provisions for the disposal of

biomedical waste in accordance with good laboratory practices. Quality control / quality assurance (QA/QC)

policies have been developed and detailed annual assessments of all lab activities are conducted. Quarterly

QA/QC lab site visits are conducted by the HSPH project management team and will use a standardized

assessment tool developed in Nigeria by the Lab Technical Working Group (LTWG). Results from the

proficiency testing and site visits will be sent into a centralized system within Nigeria, developed and

supported by the PEPFAR LTWG. EQA for lab tests was established in COP07 and is operational for CD4,

HIV, HCV and HBV serology, chemistries, VL and HIV PCR diagnostics; through individual lab registration

with UK-NEQAS and CAP. All PCR labs will participate in the CDC's DBS DNA PCR proficiency program

(EID QA). We provide support for 264 lab staff persons (based at sites), responsible for implementation of

lab protocols, data entry and performance of lab tests. In addition, we provide support for 7 APIN+ staff who

provide technical assistance to sites. Regular lab training allows the development of high quality lab

standards in our PEPFAR labs and this has been networked to our secondary and primary labs with specific

tailoring to the needs and skills at each level. Biannual trainings are provided on specific techniques/topics

integrating QA/QC, good lab practices and biosafety. Competency monitoring/evaluations and refresher

trainings will be provided within individual labs. PEP protocols have been implemented at each of our labs,

supported under our ART drugs activities. APIN has supported international laboratory accreditation for

NIMR and in COP08 will seek international accreditation for 2 additional labs and local accreditation for 10

other labs.

A laboratory information system (LIS) will be implemented at sites, with appropriate capabilities, to

streamline the capture of lab data, minimize transcription errors and facilitate data entry and results output.

We will continue to participate in LTWG monthly meetings to ensure harmonization with other IPs and the

GON, including the development of a common lab equipment platform (appropriate for each lab level).

Procurement of lab reagents is structured in two ways. Reagents available in Nigeria are procured directly

by the sites from specific distributors. Labs are advised to maintain a 3 month reagent buffer. Most reagents

needing importation are ordered at HSPH and shipped to our central warehouse in Lagos. PEPFAR funding

supports procurement of lab equipment, generators and water purifiers necessary for lab work. Equipment

costs for tertiary labs can be high in the first year, but represents significant infrastructure development.

Secondary and primary labs, including VCT facilities, have lower start up costs. Maintenance costs include

minimal renovation costs for some labs, replacement of small lab equipment and training costs for additional

personnel. As further regional networks are developed around these centers of excellence, training, lab and

clinical support will be provided to secondary and primary points of service.

CONTRIBUTION TO OVERALL PROGRAM AREA:

These activities contribute to the goal of maintaining high quality services as the PEPFAR program

expands. APIN will perform 1,137,248 tests in COP08, including HIV diagnosis and tests for disease

monitoring including CD4 enumeration, PCR diagnosis of infants and VL. In addition, we seek to train 720

lab staff members in FY08. APIN will provide training at their supported training facilities to a large number

of non-APIN and non-PEPFAR supported laboratorians. Training lab staff will assist in building the human

resource capacity of our sites to provide sustainable lab support to sites providing high quality HCT and

ART treatment. Nine labs at tertiary care hospitals will have the capacity to perform early infant diagnosis

(EID) by HIV DNA PCR. These labs are also linked to PMTCT sites, to provide a mechanism for EID as a

part of the PEPFAR supported national scale-up plan (consistent with 2008 PEPFAR objectives for Nigeria).

APIN will partner with the GON and Clinton Foundation for procurement of EID test kits and specimen

collection supplies. The NIMR PCR lab will provide QA support for the EID program in the Southern half of

Activity Narrative: Nigeria (through retesting). Through a tiered system of labs at tertiary, secondary and primary sites we are

able to ensure that patients at community based primary facilities are provided with a full complement of lab

monitoring as a part of ART treatment and care. Our training activities include management and

competency training, which seeks to build sustainability. We have provided training to lab workers through

the MOH ART training program at the NIMR. Lab workers from all 36 states and the FCT are invited to

participate on a biannual basis at the NIMR and JUTH sites. Three of our sub-partner sites are actively

involved in lab training for the MOH training program resulting in 14,000 indirect targets without budget

allocation.

LINKS TO OTHER ACTIVITIES:

These activities relate to activities in PMTCT (3227.08), Counseling & Testing (5424.08), Palliative Care

TB/HIV (3222.08), ART Services (6715.08) and OVC (5415.08). Our labs are crucial in providing adequate

HIV diagnostics in PMTCT, C&T, OVC, Palliative care and ART services. Furthermore the lab provides

other diagnostics such as OIs. As a part of this activity, we seek to build linkages between labs and our

patient care sites in order to ensure that lab information is fed back into patient records for use in clinical

care. Our SI (3226.08) activities provide support in M&E, including data management of testing results.

POPULATIONS BEING TARGETED:

This program targets public and private health care workers with training to maintain high quality lab

standards.

EMPHASIS AREAS:

This activity focuses on infrastructure building, creating a network of quality labs supported by strong tertiary

labs, as well as commodity procurement and logistics. This activity also focuses on QA, training and the

development of networks / linkages. QA and training are reinforced by the collaborative nature of the tiered

network of labs. This program seeks to address gender equity by building the capacity of labs at affiliated

sites to conduct testing related to PMTCT. Increased lab capacity will permit the sites to provide equitable

treatment for both women and men.