ACTIVITY DESCRIPTION

AIDSRelief will procure ARV drugs in COP07 to treat 14,304 patients including 12,874 adults and 1,430 children.

Our supply chain management system (SCM) ensures that the necessary infrastructure, systems and skills are in place for efficient forecasting, procurement, storage, distribution and use of quality and efficacious ARVs to our Local Partner Treatment Facilities (LPTFs) with effective monitoring and evaluation. Assessment of new sites follows the AIDSRelief Information Gathering Tool and the Pharmacy Support and Assessment Standards Checklist. Pharmacies will be refitted to improve commodity security. Technical support to LPTFs to institutionalize standard operating procedures (SOPs) for drug management is ongoing. We will train 52 pharmacists and 52 doctors in SOPs. The SOPs in line with national SOPs are for drug requests, receipts, recording, dispensing, discrepancy reporting; temperature control and disposal of expired drugs. We use the same SCM for ARVs and for laboratory reagents (CD4-test kits) but use ARV service funds to buy lab reagents. CHANPharm is the first source for palliative care drugs for our LPTFs for quality reasons but LPTFs can buy them elsewhere.

Procurement follows USG and NAFDAC regulations and is consistent with National Treatment Guidelines. NAFDAC importation waivers are secured for unregistered drugs. We contract with IDA and Phillips pharmaceutical for procurement, CHANPharm for warehousing and distribution. We will substitute innovator proprietary ARVs with FDA approved generic equivalents taking into consideration issues of safety, quality and cost.

The Pharmaceutical Management team manages country operations with a Therapeutic Drug Committee (TDC) of clinicians, pharmacists, strategic information advisors and program managers. The TDC reviews drug utilization patterns across all LPTFs, assesses scale-up progress and develops required technical support plans. The TDC is replicated at LPTFs to ensure ARV SCM is clinically informed and logistically supported.

Quality assurance covers the entire spectrum from procurement to dispensing. All our ARVs are from Good Manufacturing Practice certified sources, FDA registered and for generics all batches are tested by an independent laboratory (VIMTA) in India or CENQAM, North West University, South Africa for compliance with all requirements before shipping. They are warehoused and transported under air conditioned environment in country and have goods in transit insurance cover.

The LMIS used includes a web-based enterprise inventory and financial management system that allows drug tracking from procurement to dispensing and interfaces with the ART Dispensing Software developed by MSH RPMPlus Program installed at LPTFs. The LMIS will be harmonized with the national system.

In COP06, we provided ARV drug services at 12 LPTFs in 6 states. In COP07, we will extend services to 26 LPTFs in 11 states of Anambra, Benue, Edo, FCT, Kaduna, Kano Lagos, Kogi, Nasarrawa, Oyo and Plateau.

CONTRIBUTION TO OVERALL PROGRAM AREA The ART drug activity will ensure that quality ARVs are supplied to all patients in a timely manner. Appropriate product selection and forecasting will ensure the effective use of scarce resources. By scaling out our ARV drug services to 14 new LPTFs in COP07 (Mostly rural based primary and secondary faith based facilities), we will contribute towards the national and PEPFAR plan of availing ARV drugs to previously underserved communities. By providing ARV drug services to 14,340 clients, the activity will help to meet the PEPFAR target of providing ARV drugs to 2 million PLWAs by 2009 and to the Government of Nigeria's (GoN) plan for universal access to ARV drugs by 2010.

The capacity of the AIDSRelief country program and LPTFs to take on this responsibility will be strengthened in COP07 to enable them take on this role in future thus contributing to the overall program sustainability. This includes our contracting with local distribution agents (CHANPharm), helping LPTFs integrate ARVs and other hospital drug management systems and ongoing technical assistance to LPTFs. In this way local capacity is built to

ensure that the ARVs SCM system from forecasting, warehousing, distribution and utilization monitoring is sustained and done at the national and local levels. By proactively switching to generic ARVs we will contribute to ARV price reduction making them more affordable and thus contribute to the sustainability of their supply to PLWHA.

LINKS TO OTHER ACTIVITIES This activity is linked to HTXS (3.3.11), MTCT (3.3.01), HBHC (3.3.06), and HTXS (3.3.11) thus ensuring continuity of services to all of our clients. It is also linked to HLAB (3.3.12) and HTXS (3.3.11) by providing the supply chain for lab reagents and HVSI (3.3.13) for LMIS services and to adherence support through the HTXS (3.3.11) activity.

We will continue collaboration with other IPs including HARVARD, GHAIN and IHV-ACTION for information sharing on procurement mechanisms and for sharing of supplies when unanticipated delivery delays occur. We will continue collaboration with the GoN in the harmonization of procurement and forecasting for ARVs. Opportunities for leveraging on expertise in training will be actively pursued. The program will, as part of the global AIDSRelief effort, proactively identify areas of collaboration with USAID's SCMS project for long term harmonization and local sustainability.

POPULATIONS BEING TARGETED The activity targets all PLWHAs qualifying for ART according to WHO and GoN guidelines including women from PMTCT clinics and children from OVC programs. In COP07, ARV drugs will be provided to maintain 5,604 existing patients and treat 8,700 new patients to reach a total of 14,304 patients of whom 1,430 will be children using only USG funds. If AIDSRelief were to get a further 30% of ARV drug need from the GoN, we would extend ART drug services to an additional 3,800 patients including 380 pediatric patients.

KEY LEGISLATIVE ISSUES ADDRESSED AIDSRelief will continue to work with the GoN and NAFDAC to ensure that policies and legislation enacted prioritize increasing ART access by prioritizing registration of ARV drugs and post marketing surveillance to ensure quality of ARVs on the market.

EMPHASIS AREAS This activity has major emphasis on commodity procurement and minor emphasis on logistics, training, quality assurance, quality improvement and supportive supervision plus linkages with other sectors and initiatives.

Track 1 and 2 funds are combined for this activity.

ACTIVITY DESCRIPTION This activity relates to activities in Counseling and Testing (#6681), MTCT (#6683), HBHC (#6675), HVOP (#6735 ) HVTB (#6677), and HKID (#6679).

AIDSRelief (AR) through the primary and secondary faith based networks will extend ART services to more underserved rural communities with no existing ART services. In COP07, ART services will be increased from 12 COP06 Local Partner Treatment Facilities (LPTFs) to 26 LPTFs across 11 states. Comprehensive ART services will be expanded to recruit 8,700 new patients including 870 children, maintain 5,604 to reach a total of active 14,304 patients including 1,430 children. All LPTFs will have capacity to deliver quality ART services including prevention for positives through counseling and provision of full and accurate information for PLWA including discordant couples. Each LPTF will recruit a coordinator to promote prevention for positives activities that will be monitored by the AR program managers in each state. AIDSRelief will continue to participate in Government of Nigeria (GON) harmonization activities and to participate in the USG coordinated Clinical Working Group to address ongoing topics in ARV service delivery.

In COP06, we trained 74 doctors, 148 nurses, 100 counselors and 140 community volunteers. Bringing on the 14 new LPTFs in COP07 will involve a 2 week pre-site activation intensive didactic and practical training followed by ongoing capacity building. In COP07 we will train an additional 650 health workers including 60 physicians, 120 nurses, 200 adult ART counselors, 30 pediatric counselors, 240 adherence counselors and 300 community volunteers including PLWHA. 315 health workers of the 650 will be trained in pediatric ART services. Training includes ART clinical care, treatment adherence and laboratory monitoring. There will be intensive patient treatment preparation before ART initiation, ongoing treatment support through the use of treatment support specialists, community volunteers and PLWHA. We will have specific pediatric ART and counseling training using one of our established sites in Jos for practical trainings.

Sustainability lies at the heart of our program, and is based on durable therapeutic outcomes to first line regimens and health systems strengthening. In COP07, we will continue to strengthen LPTFs health systems with the support of AR global Health Systems Management within AR global structure through joint seminars and twining hospitals in Nigeria and other countries and experience sharing with other AR countries. This will include human resource support and management, financial management, infrastructure development, improvements in health management information systems, improvement of operational efficiency with establishment of cost centers and activity budgeting, streamlining of patient flow systems and integration of financial and clinical patient outcome information with other hospital services. We will include 44 personnel from 22 additional sites (2 per each of the 11 states) in our training programs for the provision of quality ART services at those sites and for health systems strengthening.

In COP06 we supported 12 LPTFs in 6 states. We will add 14 new LPTFs in COP07 to support a total of 26 LPTFs in 11 states of Anambra, FCT, Benue, Edo, Lagos, Kaduna, Kano, Kogi, Nasarrawa, Oyo and Plateau.

CONTRIBUTION TO THE OVERALL PROGRAM AREA: By adhering to the Nigerian National ART service delivery guidelines, and building strong community components to the program, AIDSRelief will ensure that the PEPFAR and GON goals of expanding ARV care to more PLWHA is accomplished in a durable and sustainable manner, and local capacity to deliver high quality care and support for PLWHA is strengthened. This activity is in response to the need to achieve the overall target of PEPFAR to place 350,000 clients on ART by 2009 and also support the Nigerian government's universal access to ART by 2010 initiative. By putting in place structures to strengthen LPTFs health systems we will contribute to the long term sustainability of the ART programs. Our working with 22 additional state and FB institutions and training 44 additional personnel in ART care and health systems strengthening will further contribute towards GoN/USG goal of scaling up quality ART services and their sustainability.

LINKS TO OTHER ACTIVITIES This activity is linked to HVCT (#6681), MTCT (#6683) to ensure that people tested for

HIV are linked to ART services; HVOP (#6735) for prevention for HIV positives, HBHC (#6675) for basic care and support services including home based care; HKID (#6679) for OVCs needing ART services and HVTB (#6677) for routine screening and treatment of TB among PLWHA.

We will collaborate with FBOs including the 7-D program of Catholic Relief Services (#6686) to establish networks of community volunteers including PLWHA to assist with adherence counseling and provide treatment support for clients on ART. The FBOs will be sub-granted to provide these support services for our ART clients.

Networks will be created to ensure cross-referrals and sharing of best practices among our and other implementing partner sites including sharing our training curriculum. We will work with the GoN and other stakeholders to develop networks and cooperating mechanisms for local partners to address sustainability issues that are bigger than any one of them but with sustainability implications for all.

POPULATIONS BEING TARGETED This activity targets PLWHA from rural communities who qualify for ART services as per the WHO staging criteria and GoN guidelines. 14,304 PLWAs will be targeted to receive ART by Feb 28, 2008 including 1,430 pediatric clients. In addition 15% of our ART clients will come through the MTCT activities to ensure these women have access to PMTCTplus services.

We will work with 2 additional sites per state, a total of 22 sites and train 44 health care workers in ART care, and health systems strengthening for sustainability of ART services in Nigeria. By training these personnel we hope to indirectly benefit at least 3, 220 PLWHA (3,000 adult and 220 pediatric patients) who will be enrolled into the ART services at the 22 sites. These will be both state and faith based facilities that are not directly funded by the PEPFAR program.

KEY LEGISLATIVE ISSUES ADDRESSED The ART services will ensure gender and age equity in access to ART services through linkages with OVC and PMTCT services in our sites and neighboring sites.

The extension of ARV services into rural and previously underserved communities will contribute to the equitable availability of ART services in Nigeria and towards the goal of universal access to ARV services in the country. The provision of ART services will improve the quality of life of PLWHA and thus reduce the stigma and discrimination against them.

EMPHASIS AREAS This activity will include major emphasis on human resources and minor emphasis on commodity procurement, infrastructure development, training, quality assurance/improvement and development of networks/linkages/referral system, community mobilization and participation.

ACTIVITY DESCRIPTION This activity relates to MTCT (6683), HMBL (6684), HVTB (6677), HKID (6679), HVCT (6681), HTXS (6678) and HTXD (6682) by ensuring that appropriate Lab support is provided for lab diagnosis, clinical monitoring and HIV testing. Linkages with HVSI (6674) will ensure tracking of lab infrastructure indicators. AIDSRelief (AR) works in primary and secondary health care facilities to provide quality HIV and AIDS services to people living with HIV and AIDS (PLWHAs). We support Laboratory (Lab) infrastructure to all of our local partner treatment facilities (LPTFs). We provide on-site capacity to test for HIV, laboratory monitoring of disease progression and response to treatment, opportunistic infections (OIs) diagnosis and monitoring of antiretroviral drug (ARVs) toxicity. We don't routinely do Viral load (VL) testing since our LPTFs are mostly primary and secondary level facilities, but ensure that VL testing is done on a sample of our clients from each LPTF at Institute of Human Virology (IHV-ACTION) supported laboratories when appropriate. AR will expand infant diagnosis for PMTCT in its primary care facilities by ensuring that dried blood spots (DBS) samples are collected and sent to UMD ACTION labs for diagnosis. Standard operating procedures (SOPs) for sample transport for testing and receipt of results will be developed. The SOPs include procedures for blood collection in vacutainers, for viral load, correct labeling and then transporting by LPTF lab personnel to ACTION labs for processing. We will train LPTF lab personnel on procedures for preparing, storing and transporting DBS samples to be taken to ACTION labs for PCR. We will work with ACTION to procure storage and transport equipment like vacutainer boxes and liquid nitrogen containers. Based on developed SOPs between AR and ACTION, our vehicles will move stored patient samples from LPTF to ACTION labs and collect the results. AR will continue to participate in the USG-Nigeria coordinated Laboratory Working Group to ensure harmonization with other IP and the Nigerian government. We provided lab equipment and reagents to 12 LPTFs in COP06 and will do the same for the 14 new LPTFs in COP07 and continue to supply Lab reagents to all the 26 LPTFs. We will provide automated CD4 testing equipment, cytospheres for manual CD4 testing as backup, hematology analyzers, chemistry machine and binocular microscope that are easy to use and appropriate for primary care centers. All equipment will be centrally procured and shipped to Nigeria. AR will hire 2 new full-time in country lab specialists who will be responsible for equipment installation, initial and follow up trainings and monitoring of quality assurance and quality control (QA/QC) activities. These will be supported by a Baltimore based lab specialist. AR will centrally procure lab reagents from manufacturers locally and abroad and distribute to LPTFs. HIV Test kits will be provided directly by USAID through the SCMS mechanism.

Thirty-six (36) lab personnel were trained in COP06 and 78 will be trained in COP07. Most of our LPTFs have less than 3 lab personnel per site and we train all of them. We emphasize a hands-on training during laboratory start up in lab techniques and lab management. Refresher trainings are done at six months and periodically as per identified needs at each LPTF. We provide simplified lab manuals to reinforce each training episode. The onsite trainings are done by AR technicians in collaboration with IHV-ACTION tertiary lab specialists. We use Nigerian Institute of Medical Research Training Manuals to supplement simplified manual from IHV-University of Maryland. Ongoing QA/QC is done onsite, at IHV ACTION tertiary labs, and a small percentage at IHV Baltimore as a 2nd line of QA/QC. AR sub-contract to IHV ACTION for this service. AR lab personnel and selected partner personnel (3 in total) will participate in the training of trainers (TOT) lab management program to be provided by Association of Public Health Labs, with support from USG-Nigeria. They will then transfer the knowledge gained to the 78 LPTF personnel using the provided training materials.

We will work with 2 other sites per state (State and Faith based) in the 11 states of our operation a total of 22. At these 22 sites we will include a total of 44 lab personnel (2 per site) in our training activities. The lab personnel will be trained to effectively provide quality lab services (2,399 each a total of 62,374 tests for COP07) for a total of 3,220 patients (124 per site).

In COP06 we supported Lab infrastructure in 12 sites in 6 states of FCT, Benue, Edo, Kaduna, Kano and Plateau and will do the same for an additional 14 new sites in COP07 in 11 states of Anambra, FCT, Benue, Edo, Lagos, Kaduna, Kano, Kogi, Nasarrawa, Oyo and Plateau.

CONTRIBUTIONS TO OVERALL PROGRAM AREA By supporting Lab infrastructure at all of our LPTFs, AIDSRelief will help them carry out 262,074 tests including 153,677 rapid HIV tests for 55,479 clients (5,548 children and 49,931 adults), 85,824 HIV monitoring tests and 22,573TB/OIs tests This will contribute to the PEPFAR target of preventing 1,145,545 new infections in Nigeria by 2010. The activity will also contribute to AIDSRelief's target of providing quality ART services to 14,304 clients including 12,874 adults and 1,430 pediatric patients by Feb 28, 2008. This activity will also contribute to the reduction in Mother to child transmission of HIV and early detection of any infant HIV infection by ensuring that DBS are provided for. The activity will further contribute to the reduction and early detection of any treatment failures among our clients by providing for VL tests for a subset of the 14,304 ART clients in COP07. This will support the possible need for ARV regimen switch for patients failing on first line regimens. The activity will also provide infrastructure and training for TB diagnosis for the 22,573 clients in care at the 26 LPTFs. The activity will contribute to the overall program sustainability by improving Lab infrastructure and by building capacity among primary and secondary level facilities.

LINKS TO OTHER ACTIVITIES This activity relates to MTCT (6683), HMBL (6684), HVTB (6677), HKID (6679), HVCT (6681), HTXS (6678) and HTXD (6682) by ensuring that appropriate Lab support is provided for lab diagnosis, clinical monitoring and HIV testing. Linkages with HVSI (6674) will ensure tracking of lab infrastructure indicators.

We will collaborate with IHV- ACTION, other implementing partners and state hospitals to optimize resources and strengthen the comprehensive networks of care across the 11 states including centralized lab training, establishment of high level laboratory services for VL testing and DBS. We will collaborate with the state and other faith based facility labs by including 44 lab personnel from 22 facilities in our training activities and by sharing our training manuals.

AR will link LPTFs with local procurement and distribution agents such as CHANPharm to ensure a sustainable supply chain for lab reagents. Our regional program managers will act as network coordinators.

POPULATIONS BEING TARGETED This activity targets the general population, PLWHAs, orphans and Vulnerable Children, HIV positive pregnant women and their infants plus health care providers.

KEY LEGISLATIVE ISSUES ADDRESSED Support to laboratory infrastructure will ensure that there is gender equity in access to HIV testing and monitoring for those on ART services. Provisions for infant diagnosis will ensure that children have access to early diagnosis and timely access to ART services.

EMPHASIS AREAS This activity includes major emphasis on infrastructure development and minor emphasis on training, commodity procurement, Quality Assurance, Quality Improvement, targeted evaluation and the development of Network/Linkages/Referral Systems.