Activity Description Through these activities, we will provide ART drugs to 33,370 adult and pediatric patients at 16 APIN Plus ART sites. At 29 PMTCT sites (some of which are also ARV Services sites), we will provide the ART prophylaxis options and triple drug regimens for eligible women consistent with the national guidelines. Thus, a total of 31 APIN Plus sites will be providing ART drugs through ART or PMTCT services. We will purchase ART drugs directly from drug manufacturers and through different ART purchasing agents, including IDA and Crown Agents, in accordance with USG regulations and NAFDC Registration and follow 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. Drugs 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. John Snow International (JSI) has assisted with drug projections. 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 5 months of all of the requisite first and second line drugs. We have also moved to fixed dose combinations and other newly FDA-approved generic drugs.

Capacity building and training for our APIN Plus central pharmacy at NIMR and individual site pharmacies is ongoing to support pharmacy management and implementation of the National ART Program. We are 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. A central warehouse at NIMR (Lagos) provides storage for drugs once they enter the country. A subcontract with Fed-Ex provides monthly distribution to all site pharmacies. Assessments of all facilities to determine infrastructure needs have been conducted twice in COP06 and a supply chain management system has been established. 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 establish a sustainable supply chain management system for ART that incorporates existing and bolstered Nigerian institutional structures and is harmonized with GON activities.

Site expansion for ART and PMTCT will be ongoing. 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 31,000 adult and 2370 pediatric patients on appropriate ART drugs.

Contribution to Overall Program Area Through these activities we will have provided ART drugs to 34,300 patients at 16 ART service outlets. We have doubled the number of ART service provider sites to 16 and increased the number of states from 4 to 7. This represents a 28% contribution to the PEPFAR goal of providing ART to approximately 120,000 people in 2007. In addition, we

have scaled up our PMTCT activities with 29 points of service providing access to PMTCT services for 40,000 women. Through these activities, we will continue to strengthen the structure of our ART drug procurement system, as described above in section 1, 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, as discussed in section one, are consistent with PEPFAR 5-year goals to enhance the capacity of supply chain management systems to respond to rapid treatment scale-up.

Links to Other Activities This activity also relates to activities in TB/HIV (3.3.07), ART Services (3.3.11), and Strategic Information (SI) (3.3.13). Through this activity, we will maintain significant linkages with PMTCT (3.3.01) and ART Services through the procurement of ART drugs for individuals served by these programs. Additionally, we will maintain linkages to TB/HIV activities, since the supply chain management system will serve to provide drugs to ART sites that are providing these 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.

Key Legislative Issues Addressed None

Emphasis Areas As described in section one, these activities place major emphasis on commodity procurement as related to the purchase of ART drugs for all of our sites. As a corollary to that, we place minor emphasis on logistics, in order to further strengthen the ART procurement and distribution system for APIN Plus sites. We have also incorporated training initiatives into these activities in order to build the local human resource capacity to manage a sustainable drug procurement and distribution system. We also place minor emphasis on the development of SI management, through M&E activities, to provide feedback of the cost effectiveness of our drug-procurement activities. SI management is also ensures accurate drug projections in order to prevent stock-outs.

Track 1 and 2 funds are combined for this activity.

ACTIVITY DESCRIPTION We propose to provide high quality ART treatment to eligible patients at 16 PEPFAR sites and to provide ARV services to a total of 33,370 individuals, including 31,000 adults (9,000 new) and 2,370 children (1,200 new) at the end of the reporting period. 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). For patients at the Federal ART sites, we anticipate Government of Nigeria (GON) provision of first line ARV drugs and PEPFAR support for ART care and services. As patients require alternative or 2nd line drugs, they will receive PEPFAR provided drugs. GON provision of 1st line drugs, when actualized, will allow for additional adult and pediatric targets. We estimate that 2000 additional adults will be placed on therapy through the leveraging of GON drugs. Our 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. We have provided technical assistance and training expertise to the National ART program's training program for adults and pediatric patients, which will continue in 2007. 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.

A standardized protocol for adult and pediatric ART services is followed at all PEPFAR centers. TB diagnosis and treatment is provided to all patients. Patients initiating ART are provided ART education and adherence counseling (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. Patients are also encouraged to refer family members for VCT. ART EAC is reinforced with PLWHA support groups at each site, which serve both PEPFAR and Federal ART patients. Scheduled physician visits are at 3, 6, and 12months and every 6 months thereafter; patients pickup 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 staffs meet monthly for updates and training. Each site has a clinic coordinator and a central committee determines and approves drug regimen switching. An external quality improvement program is ongoing and will allow sites to further monitor the level of patient care.

This funding will support the personnel, clinic and lab services for monitoring of 31,000 adults and 2,370 pediatric patients at the end of COP07, which includes 9,000 new adult and 1,200 new pediatric patients. A total of 33,370 patients will be provided with ART services. Treatment is provided as a part of the National ART Program in 8 tertiary care teaching hospitals and federal medical centers, located in Plateau, Lagos, Oyo, Borno, Kaduna and Benue states. We plan to add an additional tertiary site from a new expansion state. Services are also currently provided in 2 secondary level hospitals/clinics in Oyo and Plateau States. We will add 2 new secondary level hospitals or clinics. We will also work with 3 primary health clinics (Lagos, Plateau and Kaduna) that provide VCT, clinical exams, phlebotomy, ART EAC, basic management of OIs, and referrals for specialty care.

CONTRIBUTION TO PROGRAM These ART activities are consistent with the PEPFAR aims of building and scaling up capacity to provide ARV drugs and services and lab support for increasing numbers of people with HIV. Our 16 ARV treatment sites represent a doubling in the number of our ART sites. Additionally, we will expand to two new states, with the majority of new expansion sites being secondary/primary level sites. We 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. Through these networks we will seek to ensure that facilities are able to develop linkages, which permit patient referral and the provision of specialty care supports. A tiered structure for ARV provision and monitoring will provide a

model for future expansion efforts in order to meet PEPFAR treatment goals.

LINKS TO OTHER ACTIVITIES Drug procurement, supply chain management and logistics are provided in the ART Drugs activity (#6714). Pediatric palliative care is provided through our OVC activity (#6720). SI M&E activity (#6717) will provide the GON with crucial information for use in the evaluation of the National ARV program and recommended drug regimens. APIN Plus PMTCT efforts (#6718) have established 29 sites for the screening of over 40000 women per year. This program is linked to ART services to optimize the PMTCT by providing ART to eligible pregnant women. This linkage provides an important entry point for new patients, by identifying HIV-infected women and their families. Linkages will also be made with the Nigerian Tuberculosis Reference Laboratory as a part of HIV/TB activity (#6713), to provide patients with TB treatment that are clinically coordinated with ARV services.

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. In order to increase access to ART to poor communities, we will provide care at primary health care clinics, including the existing Kuramo APIN Plus Clinic, the Mashiah Foundation, a faith-based organization and Mother's Welfare Group.

KEY LEGISTLATIVE ISSUES These activities will increase gender equity in programming by providing equitable access to ART services for both sexes. Furthermore, data collected from these activities will show the breakdown of sexes accessing ART, which may be used for future program and policy development. Additionally, 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 also seek to provide referrals to other wrap-around services, such as food & nutrition programs and educational services for patients. ART EAC provided to patients will also seek to address stigma and discrimination faced by PLWHA.

EMPHASIS AREAS Major emphasis is on training, community mobilization and participation. APIN+ will train 400 health care personnel involved in provision of ART services at the service outlets. Investigators from new and existing PEPFAR sites will participate in the biannual training courses that allow networking to build capacity at the newer sites. Community mobilization and participation is aimed at outreach to PLWHA and ART EAC. APIN+ places minor emphasis on commodity procurement, network linkages, QA and supportive supervision. APIN+ will facilitating networks and linkages between ART centers for system strengthening provide QA and supportive supervision to ensure high quality of care is provided for the increasing number of PLWHA utilizing care.

ACTIVITY DESCRIPTION This activity also relates to activities in PMTCT (6718), Counseling & Testing (6721), Palliative Care TB/HIV (6713), ART Services (6715), OVC (6720) and SI (6717) This activity provides maintenance of HIV labs at tertiary (7), secondary (9) and primary health care settings (1). In addition, APIN+ propose adding additional expansion sites in 2007 and have planned to build the infrastructure and capacities of 11 HIV support labs. These expansion sites will be at tertiary hospitals (2), secondary hospitals (7) and primary health care settings (2). All 28 labs will provide HIV serodiagnosis through rapid test technologies. By the end of FY06, our 9 major tertiary level labs will have capabilities for hematology, automated chemistry analyzers, and laser-based lymphocyte subset enumeration and PCR technology. We plan to have HIV serology, hematology, chemistries, and CD4 enumeration at all secondary hospitals with referral to the tertiary labs for PCR diagnostics. Our 3 primary health care facilities are closely partnered with 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 pulmonary X ray and sputum. We will begin the training for PCR diagnosis of TB at our tertiary sites in the proposed year. Our laboratories with infant PCR diagnostic capabilities will assist other PEPFAR IPs requiring these assays for PMTCT and pediatric treatment. We will use dried blood spots (DBS) to transport specimens from distant satellite sites

Standardized lab protocols have been developed to accompany the PEPFAR clinical protocol, and computerized records of lab results that link with patient records. Detailed annual quality control/assurance (QA/QC) assessments of all lab activities have been conducted with development of QA/QC policies. Quarterly lab site visits are conducted by the HSPH project management team. External quality control for all lab tests are being established, they are operational for CD4 and viral loads. Regular lab training has allowed 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. We also organize biannual trainings on specific techniques/topics integrating QA/QC, good lab practices and biosafety. Competency monitoring and evaluations and refresher trainings will be provided within individual labs. We will continue to participate in the USG-Nigeria coordinated Laboratory Working Group to ensure harmonization with other IP and the Nigerian government.

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 and managed through our central warehouse in Lagos.

The lab infrastructure developed through this activity allows the provision of quality services in all aspects of our activities. Funding will support procurement of lab equipment, generators and water purifiers necessary for lab work. Equipment for tertiary labs can be high in the first year but represent significant infrastructure development. Secondary and primary labs including VCT facilities have lower 1st yr equipment costs. Maintenance costs will 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 numbers of patients provided with testing and treatment continues to rise. We estimate we will be performing over 440,876 tests in FY07. We will perform 154,826 tests for HIV on 55,894 clients, and 286,050 tests for disease monitoring including CD4 enumeration, PCR diagnosis of infants and viral loads. In addition, we seek to train 220 laboratory staff members in FY07. Training laboratory staff will assist in building the human resource capacity of our sites to provide sustainable laboratory support to sites providing high quality VCT and ART treatment. Our 9 labs at tertiary care hospitals will have the capacity to perform early infant diagnosis by HIV DNA PCR. These labs are also linked to our 29 PMTCT sites, to provide a mechanism for early infant HIV diagnosis as a part of our PMTCT activities, which is consistent with 2007 PEPFAR objectives for Nigeria.

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 of the labs and increase capacity to respond to increasing demands resulting from increasing utilization of ART services through other activities. We have provided training to laboratory workers through the MOH ART training program at the National Institutes of Medical Research. 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 laboratory training for the MOH training program resulting in 14,000 indirect targets without budget allocation.

Links to Other Activities The laboratory activity relates to activities in PMTCT (6718), Counseling & Testing (6721), Palliative Care TB/HIV (6713), ART Services (6715) and OVC (6720). The laboratory is crucial in providing adequate HIV diagnostics in PMTCT, C&T, OVC, Palliative care and ART services. Furthermore the laboratory provides other diagnostics such as opportunistic infections crucial in Palliative care and ART services. In ART services, hematology, chemistries, viral load provide toxicities and treatment monitoring in addition to help in patient management. Furthermore, as a part of this activity, we seek to build linkages between laboratories and our patient care sites in order to ensure that laboratory information is fed back into patient records for use in clinical care. These activities are also linked to SI (6717) activities, which provide support in monitoring and evaluation, including data management of testing results.

Populations Being Targeted This program targets public and private health care workers who conduct laboratory testing at the participating sites. Training of these personnel seeks to maintain high quality laboratory standards.

Key Legislative Issues Addressed This program seeks to address gender equity by building the capacity of laboratories at affiliated sites to conduct testing related to PMTCT. Furthermore, the increased laboratory capacity will permit the sites to provide equitable treatment for both women and men.

Emphasis Areas The major emphasis area for this activity is on infrastructure building. The creation of a network of quality laboratories supported by strong tertiary laboratory is important in the provision of quality preventative and care HIV services. Furthermore, we place strong minor emphasis on quality assurance, training and the development of networks and linkages. Quality assurance and training are reinforced by the collaborative nature of the network of laboratories in a tiered system. We also place minor emphasis on commodity procurement and logistics as a part of infrastructure and capacity building to procure equipment and testing supplies necessary for the labs for continuous operation.