Track 1 and 2 funds are combined for this activity.

ACTIVITY DESCRIPTION:

In COP07 AIDSRelief (AR) is providing ARV drugs to 18,304 PLWHAs at 28 Local Partner Treatment

Facilities (LPTFs) and 10 satellite clinics in 14 states of Adamawa, Anambra, Benue, Ebonyi, Edo, Enugu,

FCT, Kaduna, Kano, Kogi, Nasarrawa, Ondo, Plateau and Taraba. In COP08, AR will procure first and

second line ARV drugs to treat 28,200 patients including 27,914 adults and 2,270 children at 30 LPTFs and

20 satellite clinics in 16 states of Abia, Adamawa, Anambra, Benue, Ebonyi, Edo, Enugu, FCT, Imo,

Kaduna, Kano, Kogi, Nasarrawa, Ondo, Plateau and Taraba. An estimated 30% of PLWHA already enrolled

in care will start treatment during the year. An estimated 8% of ART clients will require 2nd line treatment in

COP08. In setting and achieving COP08 targets, consideration has been given to modulating AR's rapid

COP07 scale up plans in order to concomitantly work towards continuous quality improvement.

AR's supply chain management system will ensure that the necessary infrastructure, systems and skills are

in place for efficient forecasting, procurement, storage, and distribution of quality and efficacious ARVs to

AR-supported LPTFs with effective monitoring and evaluation. Assessment of new sites follows the AR

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 will continue in COP08. AR will train 30 pharmacists

and 30 other health workers including pharmacy technicians or assistants in the use of developed SOPs

which are in line with national guidelines. These SOPs include drug requests, receipts, recording,

dispensing, discrepancy reporting, temperature control and disposal of expired drugs. In-depth training of

the LPTF staff in the utilization of SOPs, forecasting and quantification for ARVs and general drug

management issues will be conducted.

All ARVs are from Good Manufacturing Practice certified sources and are FDA approved/preapproved.

Generic 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 environments in-country and have in transit insurance coverage. AR uses

the same supply chain management system for ARVs purchased under this program and for laboratory

reagents purchased under other program areas.

Procurement procedures follow USG and NAFDAC regulations and are consistent with National Treatment

Guidelines. NAFDAC importation waivers are secured through the USG for unregistered drugs. IDA and

Phillips Pharmaceuticals are contracted for procurement and CHAN Medi-Pharm for warehousing and

distribution. AR will substitute innovator proprietary ARVs with FDA approved generic equivalents taking

into consideration issues of safety, quality and cost. SCMS will be used for some of the drug procurement in

line with USG Nigeria's guidance on this, and potentially through an Indefinite Quantity Central Contract that

CRS-Baltimore has with SCMS. CHAN Medi-Pharm is the first source for palliative care drugs for AR

LPTFs. As a backup, AR will ensure that LPTFs can source for palliative care drugs from GON certified

distributors with evidence of regulatory clearance for quality reasons.

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 the LPTF level to ensure that the ARV supply chain management is

clinically informed and logistically supported. Quality assurance covers the entire spectrum from

procurement to dispensing. All sites will be provided with ongoing TA by AR's Health Supply chain technical

team. Pharmacy and logistics management procedures will be assessed and will be part of site

development planning. 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.

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 ARV drug services to 2 new LPTFs and 10 satellite clinics in COP08 (mostly rural based primary and

secondary faith based facilities), AR will contribute towards the National and PEPFAR plans of increasing

access to ARV drugs in previously underserved communities. As expansion of ARV drug services is

prioritized to rural areas, AR will strengthen existing referral channels and will support network coordinating

mechanisms. By providing ARV drug services to 28,200 clients, the activity will contribute to the PEPFAR

target of providing ARV drugs to 350,000 PLWHAs in Nigeria by 2009 as well as to the Government of

Nigeria's (GON) plan for universal access to ARV drugs by 2010.

In contributing to overall sustainability, the capacity of LPTFs to take on supply chain responsibilities will be

strengthened. AR will continue strengthening local distribution agents (CHAN Medi-Pharm) and helping

LPTFs integrate ARVs with other hospital drug management systems.

LINKS TO OTHER ACTIVITIES:

This activity is linked to ARV services (6678.08), basic care and support (5368.08), OVC (5416.08), and

PMTCT (6485.08), thus ensuring continuity of services to all AR supported clients. It is also linked to

laboratory (6680.08), by providing the supply chain for lab reagents and SI (5359.08) for LMIS services. AR

will continue collaboration with other IPs including Harvard/APIN+, GHAIN, ICAP-CU, and IHVN-ACTION

for information sharing on procurement mechanisms and for sharing of supplies when unanticipated delivery

delays occur. AR 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. AR will

collaborate with the Clinton Foundation in order to leverage their resources for OI drugs, pediatric lab

reagents and ARVs, and adult second line ARVs. In addition, AR will partner with Global Fund as

appropriate to leverage resources for providing antiretroviral drugs to patients. Currently 10% of ART

patients at AR-supported LPTFs are receiving GON procured ARV drugs; in COP08, AR will continue this

collaboration. The program will, as part of the global AR effort, proactively identify areas of collaboration

with USAID's SCMS project for long term harmonization and local sustainability.

Activity Narrative: TARGET POPULATIONS:

The activity targets all PLWHAs, particularly those qualifying for ART according to WHO and GON

guidelines, including women from PMTCT clinics and children in OVC programs.

EMPHASIS AREAS:

This activity has an emphasis on local organization capacity building, logistics, training (including in-service

supportive supervision), renovations of pharmacy/stock rooms, quality assurance/quality improvement and

linkages with other sectors and initiatives.

Track 1 and 2 funds are combined for this activity.

ACTIVITY DESCRIPTION:

In COP07 AIDSRelief (AR) is providing ART services to 28 Local Partner Treatment Facilities (LPTFs) and

10 satellite sites. In COP08 these services will be increased to cover 30 LPTFs and 20 satellites across the

16 states of Abia, Adamawa, Anambra, Benue, Ebonyi, Edo, Enugu, FCT, Imo, Kaduna, Kano, Kogi,

Nasarawa, Ondo, Plateau, and Taraba. Through primary and secondary faith-based facilities AR will extend

ART services to underserved rural communities to reach 10,200 new patients (including 1000 children) for a

total of 28,200 active patients (including 2270 children) reached in COP08. In setting and achieving COP08

targets, consideration has been given to modulating AR's rapid COP07 scale-up plans in order to

concomitantly work towards continuous quality improvement.

All LPTFs will have the capacity to provide comprehensive quality ART services through a variety of models

of care delivery. This includes quality management of OIs and ART, a safe, reliable and secure

pharmaceutical supply chain, technologically appropriate lab diagnostics, treatment preparation for patients,

their families and supporters and community based support for adherence. This technical and programmatic

assistance utilizes on-site mentoring and preceptorship. It also supports the development of site specific

work plans and ensures that systems are in place for financial accountability. AR will adhere to the Nigerian

National ART service delivery guidelines including recommended first and second line ART regimens. In

addition, AR will partner with Clinton Foundation and Global Fund as appropriate to leverage resources for

providing antiretroviral drugs to patients.

In COP07 AR trained 690 health service providers. In COP08 AR will train and retrain an additional 400

health service providers. Training topics include ART clinical care, treatment adherence and laboratory

monitoring consistent with the National ARV guidelines/training curriculum. AR will make special efforts to

increase LPTF capacities in the delivery of pediatric ART services, including counseling, using one of its

established partners in Jos for practical training. In COP08 AR will continue conducting 2-week intensive

didactic and practical trainings preceding site activation followed by continuous onsite mentoring. Training

will maximize use of all available human resources including a focus on community nursing and community

adherence. AR will work closely with the USG team to monitor quality improvement at all sites and across

the program.

AR will work with supported sites to identify HIV-infected patients, to enroll them in care and treatment, to

perform appropriate clinical and laboratory staging of adults and children, and to provide comprehensive

care and support, including the prompt initiation of ART for eligible patients. Non ART eligible individuals will

be enrolled into care for periodic follow-up, including laboratory analysis at least every 6 months, to identify

changes in ART eligibility status. All enrolled PLWHA will have access to the preventive care package

(water sanitation/treatment education, ITN), and be linked to community social services. Other care

components, discussed under the basic care and support narrative, include TB screening, OI

prophylaxis/treatment, routine laboratory analysis, and nutritional counseling. ART sites at LPTFs are co-

located in facilities with TB DOTS centers to facilitate TB/HIV service linkages. As a part of comprehensive

service delivery, activities addressing prevention for positives shall be enhanced through counseling and

provision of full and accurate information for PLWHA including discordant couples.

A key component for successful ART is adherence to therapy at the household and community levels.

PLWHA on treatment are encouraged to have a treatment support person such as a family member to

whom he/she had disclosed HIV status to improve support in the home and increase adherence. AR will

continue to build and strengthen the community components by using nurses and counselors to link health

institutions to communities. Each LPTF will appoint a specific staff member to coordinate the linkages of

patients to all services. This will also build the capacity of LPTFs for better patient tracking, referral

coordination, and linkages to appropriate services. These activities will be monitored by the AR technical

and program management regional teams.

In COP08, AR will strengthen its program for Continuous Quality Improvement (CQI) in order to improve

and institutionalize quality interventions. AR will hire an additional three CQI staff that will be supervised by

the CQI specialist. These 4 CQI specialists will be responsible for spearheading CQI activities in their

respective regions. This will include standardizing patient medical records to ensure proper record keeping

and continuity of care at all LPTFs. Monitoring and evaluation of the AIDSRelief ART program will be

consistent with the national plan for patient monitoring. The CQI specialists will conduct team site visits at

least quarterly during which there will be evaluations of infection control, the utilization of National PMM

tools and guidelines, proper medical record keeping, efficiency of clinic services, referral coordination, and

use of standard operating procedures across all disciplines. On-site TA with more frequent follow-up

monitoring visits will be provided to address weaknesses when identified during routine monitoring visits.

Some of the data will be used to generate biannual life table analyses that identify factors associated with

early discontinuation of treatment. In addition, at each LPTF an annual evaluation of program quality shall

consist of a 10% random sample of linked medical records, adherence questionnaires and viral loads to

examine treatment compliance and viral load suppression for adult patients who have been on treatment for

at least 9 months. A similar process will be undertaken for all children who have been on ART for at least 9

months. Each of these activities will highlight opportunities for improvement of clinical practices.

Sustainability lies at the heart of the AR program, and is based on durable therapeutic programs and health

systems strengthening. AIDSRelief has developed a Sustainability Plan in Year 4 focusing on technical,

organizational, funding, policy and advocacy dimensions. Through its comprehensive approach to

programming, AR will increase access to quality care and treatment while simultaneously strengthening

health facility systems. All activities will continue to be implemented in close collaboration with the

Government of Nigeria (GON) to ensure coordination and information sharing, thus promoting long term

sustainability. AR will continue to strengthen the health systems of LPTFs. This will include human resource

support and management, financial management, infrastructure improvement, and strengthening of health

management information systems. In collaboration with the CRS SUN project, AR will focus on institutional

capacity building for indigenous umbrella organizations such as the Catholic Secretariat of Nigeria (CSN).

These strategies will enable AR to transfer knowledge, skills and responsibilities to in-country service

providers.

AR will continue to participate in Government of Nigeria (GON) harmonization activities and to participate in

Activity Narrative: the USG coordinated clinical working group to address ongoing topics in ARV service delivery.

CONTRIBUTION TO THE OVERALL PROGRAM AREA:

By adhering to the Nigerian National ART service delivery guidelines and building strong community

components into the program, this activity will contribute to achieving the overall PEPFAR Nigeria target of

placing 350,000 clients on ART by 2009 and will also support the Nigerian government's universal access to

ART by 2010 initiative. By putting in place structures to strengthen LPTF health systems, AR will contribute

to the long term sustainability of the ART programs.

LINKS TO OTHER ACTIVITIES:

This activity is linked to HCT services (5425.08) to ensure that people tested for HIV are linked to ART

services; it also relates to activities in ARV drugs (9889.08), laboratory services (6680.08), care & support

activities including prevention for positives (5368.08), PMTCT (6485.08), OVC (5416.08), AB (15655.08),

TB/HIV (5399.08), and SI (5359.08).

AR will collaborate with the 7-D program of Catholic Relief Services to establish networks of community

volunteers. Networks will be created to ensure cross-referrals and sharing of best practices among AR and

other implementing partner sites. Effective synergies will be established with the Global Fund to Fight AIDS,

Tuberculosis and Malaria through harmonization of activities with GON and other stakeholders.

POPULATIONS BEING TARGETED:

This activity targets PLWHA, particularly those who qualify for the provision of ART, from rural and

underserved communities. Special focus will be placed on identification and treatment of HIV infected

children.

EMPHASIS AREAS:

This activity will include emphasis on human capacity development specifically through in-service training.

These ART services will also ensure gender and age equity in access to ART through linkages with OVC

and PMTCT services in AR 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.

Track 1 and 2 funds are combined for this activity.

ACTIVITY DESCRIPTION:

This activity ensures that appropriate Lab support is provided for lab diagnosis, clinical monitoring and HIV

testing. Linkages with HVSI will ensure tracking of lab infrastructure indicators. AIDSRelief (AR) works in

tertiary and secondary health care facilities to provide quality HIV and AIDS services to people living with

HIV and AIDS (PLWHAs). AR supports Laboratory (Lab) infrastructure to all of our local partner treatment

facilities (LPTFs).

AR provides 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. AR

will support the improved diagnosis of TB, cryptococcal infection, syphilis, hepatitis B (HBV) and other

bacterial infections. AR does not routinely do Viral load (VL) testing since our LPTFs are mostly primary and

secondary level facilities, but ensure that VL testing is done to make difficult therapy switch decisions as

well as for program evaluation on a random 10% subset of our clients from each LPTF who have been on

therapy for longer than 9 months annually at Institute of Human Virology (IHV-ACTION) supported

laboratories and at 2 of our LPTFs with VL capacity. In addition, 2-3% of AR clients on ART would require

VL testing based on clinical indications. AR will also support expansion of early infant diagnosis (EID) at

PMTCT supported facilities in accordance with the national EID scale up plan. AR will provide standardized

training and supplies for collection and transport of dried blood spots (DBS) and clinical samples.

AR will continue to participate in the USG-Nigeria coordinated Laboratory Technical Working Group (LTWG)

to ensure harmonization with other IP and the Nigerian government. AIDSRelief will continue to work with

the PEPFAR LTWG for the development of a common Lab equipment platform appropriate for each lab

level.

In COP07 AIDSRelief is providing support to 30 sites in a total of 14 states (Adamawa, Anambra, Benue,

Ebonyi, Edo, Enugu, FCT, Kaduna, Kano, Kogi, Nasarawa, Ondo, Plateau and Taraba). Of these 30 sites,

28 are secondary level and 2 are tertiary level. Two of these facilities have PCR capacity: 1) St Vincent's

DOC (DREAM model) has bDNA VL testing supported by CRS private funding and 2) Annunciation

Specialist Hospital in Enugu has NucliSens VL machine (initiated prior to PEPFAR). AR will continue

providing automated CD4 testing equipment with capacity for processing large patient loads, cytosphere

reagents using binocular microscopes that are easy to use and appropriate for secondary care centers for

manual CD4 testing as backup in place of automated CD4, hematology analyzers and chemistry machines.

All labs will be supported to test for syphilis, TB, HBV, hematology, chemistry, cryptococcosis and CD4. In

COP 07, AR provided 5 LPTFs with fluorescent microscopes. In COP08, fluorescent microscopes will be

provided to 5 additional LPTFs. In addition to 10 primary level satellites activated in COP07, 10 new satellite

sites will have a laboratory capacity for hematology and HIV rapid testing and positive patients will be

referred to the parent site for ART. Satellite sites do not have full laboratory capacity and are therefore not

counted as lab targets. In setting COP08 targets and expansion, consideration has been given to

modulating AR's rapid COP07 scale up plans in order to concomitantly work towards continuous quality

improvement.

All equipment will be centrally procured and shipped to Nigeria. AR in-country lab specialists will be

responsible for equipment installation. All AR lab specialists have received training by CD4 manufacturers

as maintenance engineers to service CD4 machines. 10% of the cost of all equipment is kept in reserve for

maintenance purposes.

In COP08 AR will develop a comprehensive lab program with 9 locally based FTE lab specialists focused in

the following areas: 1 centrally based lab program director, 1 equipment installation/trouble shooting, 3

QA/QC, 1 blood / injection safety, 1 TB lab and 2 training. These will be supported by a Baltimore-based lab

specialist.

AR will use its reagent forecasting tools at all levels to determine consumption and predict need, to forestall

stock outs. Working with SCMS and CHANPharm, AR will centrally procure lab reagents from

manufacturers locally and abroad and distribute to LPTFs. HIV Test kits will be provided directly by the USG

through the SCMS mechanism.

AR works with UMD-ACTION for external QC, back-up CD4 testing support, training support for EID/DBS

and provision of specialized Lab tests such as VL and DNA-PCR. To support pediatric diagnostic and

treatment, Clinton Foundation will provide DBS collection material, transportation of specimens/results and

CD4 test reagents. AR will work with MMIS to provide blood safety training and AD needles to all sites.

To ensure safe lab conditions, AR will increase its provision of appropriate sharps and bio-medical waste

disposal containers at all sites. AR will ensure the availability of functional incinerators and/or collection of

biomedical waste by approved, private companies. AR will also support post HIV exposure programs (PEP)

at all sites.

In COP 08, AR will work with MLSCN to gain accreditation for 10 labs. This will include 2 tertiary and 8

secondary sites across 5 states.

In COP08 AR will contract with IHV-ACTION tertiary lab specialists to train 90 lab personnel from all LPTFs

in the following areas: HIV diagnostics, CD4, chemistry, hematology and OI diagnosis. AR emphasizes

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. AR provides simplified lab

manuals to reinforce each training episode. AR use Nigerian Institute of Medical Research Training

Manuals to supplement simplified manual from IHV-University of Maryland.

AR will conduct QA activities consisting of quarterly site monitoring visits (using a standardized tool

developed by the LTWG), quarterly proficiency testing (PT) for all tests and reporting of these results into a

centralized system. AR will sub-contract to IHV ACTION for support of the AR PT program.

AR lab personnel and selected partner personnel 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.

Activity Narrative: They will then transfer the knowledge gained to all LPTF lab personnel using the provided training

materials.

CONTRIBUTIONS TO OVERALL PROGRAM AREA:

By supporting Lab infrastructure AR will help all LPTFs carry out 282,738 tests (including testing for 7,000

children). This will contribute to the Nigeria 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

28,200 clients including 2,270 pediatric patients in COP08. This activity will also contribute to the reduction

in Mother to child transmission of HIV and early detection of any infant HIV infection. 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 28,200 ART clients in COP08. 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 42,070 clients in care at the 30 LPTFs and 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:

AR activities in adult basic care and support are linked to HCT (5425.08), ARV services (6678.08), PMTCT

(6485.08), ARV drugs (9889.08), OVC (5416.08), AB (15655.08), TB/HIV (5399.08), and SI (5359.08) to

ensure that appropriate Lab support is provided for lab diagnosis, clinical monitoring and HIV testing. AR

will collaborate with IHV-ACTION, other implementing partners and state hospitals to optimize resources

and strengthen the comprehensive networks of care across the 16 states including centralized lab training,

establishment of high level laboratory services for VL testing and EID. AR will link LPTFs with local and

PEPFAR procurement and distribution agents such as CHANPharm and SCMS to ensure a sustainable

supply chain for lab reagents. AR regional program managers will act as network coordinators.