ACTIVITY DESCRIPTION This activity also relates to activities in Counseling and Testing (#6721), OVC (#6679), ARV Services (#6715) Injection safety (#6726) and SI (#6717). This funding will support a comprehensive PMTCT program, in line with the revised National PMTCT Guidelines (2005), at 32 service outlets. "Opt out" counseling and testing (C&T), with same day test results, will be provided to all pregnant women presenting for ANC including labor and delivery. All women are provided post-test counseling services on prevention of HIV infection including the risks of MTCT. They are encouraged to bring partners and family members for C&T. The program has a target of providing C&T, with 52,250 receiving results. A full course of ARV PMTCT prophylaxis will be provided to approximately 3,312 women. ART-eligible HIV-infected women will be provided with ART treatment for their own disease following the National PMTCT Guidelines (2005). ART sites will provide downward referrals to secondary and primary sites for continuity of care. Counseling on infant feeding options begins in the antenatal period following the National PMTCT guidelines. A follow up team consisting of counselor, support group of PLWHAs will assist in tracking positive mothers to provide nutritional support and ascertain infant diagnosis. Infants at all sites are diagnosed and monitored for ART eligibility by HIV DNA PCR and CD4 testing respectively, which are performed at tertiary care sites. Through implementation of the National PMTCT Guidelines, we aim to reduce MTCT substantially from the current 10-12% rate. This funding will support the ANC, labs, ARV prophylaxis intervention to mothers and babies (not HAART), and personnel involved in PMTCT. A regular training program will be established at all sites to train and retrain all health personnel (600) involved in the PMTCT program in the National PMTCT curriculum. Indirect targets include training Traditional Birth Attendants (TBAs) (using an adapted curriculum) in local areas near our sites in PMTCT counseling, training PMTCT counselors for the Federal PMTCT program, and technical assistance for the Federal PMTCT counseling manual. This training supports PMTCT efforts at all Federal PMTCT centers; we would propose all pregnant women tested and receiving results at Federal PMTCT sites as indirect targets (approximately 50,000). Per patient costs reflect the expansion to 10 new sites and replacement of 4 other sites in COP06. Cost of PMTCT ART prophylaxis drugs were previously not included in this activity. In COP 07 HARVARD will increase her sites from the present 19 to 32. Ten teaching hospitals/specialist hospitals, 18 secondary level hospitals and 4 primary health care clinics in Lagos, Oyo, Borno, Plateau, Kaduna and Benue states will provide care under this funding. Harvard will leverage UNICEF support in capacity building/training in identifying new PMTCT sites in its scale up plans.

CONTRIBUTIONS TO OVERALL PROGRAM AREA Through our PMTCT program, we seek to provide C&T with test results to 52,250 pregnant women. Additionally, we seek to provide treatment and prophylaxis to 3,990 pregnant women. Implementation of the National PMTCT Guidelines in 32 sites (old and new) contributes to the PEPFAR goal of expanding ART and PMTCT services. We have increased our sites by adding additional secondary and primary level sites in the radius of our tertiary care institutions which will continue to build the network capacity and coverage in our target states. Counseling aims to encourage mothers to bring their partners and family members for testing, to reach discordant couples and expand the reach of VCT, based on the PEPFAR 5-year strategy. This program is implemented in geographically networked sites to optimize training efforts and provide collaborative clinic/lab services as needed. We will train and retrain 605 health care personnel from our PMTCT sites, including doctors, nurses, and counselors. Training aims to build capacity at local sites to implement PMTCT programs and provide essential treatment supports to pregnant women with HIV/AIDS. Capacity building efforts are aimed at future expansions of PMTCT programs. Quality assurance and control will be carried out through personnel training, data collection from sites for monitoring and evaluation and supervisory visits from key program management staff, which may include representatives from the USG and GON.

LINKS TO OTHER ACTIVITIES This activity is also linked to counseling and testing (#6721), OVC (#6679), ARV Services (# 6715) Injection safety (#6726) and SI (#6717). Pregnant women who present for C&T services will be provided with information about the PMTCT program and referred to the PMTCT program if they are eligible for these services. ART treatment services for infants and mothers will be provided through ART Services. Basic pediatric care supports, including TB care, are provided for infants and children through our OVC activities. Personnel involved in patient care will be trained in universal precautions as a part of our injection safety activities. Additionally, these activities are linked to SI, which provides support for monitoring and evaluation of the PMTCT activities.

POPULATIONS BEING TARGETED In addition to providing PMTCT services for HIV infected pregnant women and girls on HAART for testing and prophylaxis, this program also targets women who may not know their HIV status and may be at greater risk for MTCT. Furthermore, it seeks to target infants, who are most at risk of becoming infected from an HIV positive mother during antepartum, intrapartum and postpartum periods. Through the counseling and testing components, we seek to target a broader group of adults by encouraging women to bring their partners and family members in for counseling and testing. Furthermore, our training activities will seek to train public and private health care workers on the implementation of PMTCT protocols and HIV related laboratory testing.

KEY LEGISLATIVE ISSUES We aim to increase gender equity by specifically targeting pregnant women, girls and their male partners for C&T and PMTCT prophylaxis. Data collection on PMTCT regimens provides a basis for developing strategies to ensure that all pregnant women have access to needed and optimally effective PMTCT services. This program addresses stigma and male norms and behaviors through the encouragement of partner notification and bringing other family members in for C&T. Infant feeding counseling, including on the appropriate use of BMS where AFASS is available, will be in line with the National PMTCT Guidelines. We will also provide referrals to Income Generating Activities (IGAs) for women as a part of our palliative care and counseling activities

EMPHASIS AREAS This activity will place major emphasis on the development of networks through expansion into more local areas through a network of secondary or primary PMTCT clinics with rural outreach to community healthcare workers involved in home delivery, which are linked to tertiary health care facilities. In addition, major emphasis will be placed on building organizational capacity in order to work towards sustainability of PMTCT centers and further expand the Nigerian PMTCT program. These system strengthening activities are led by local investigators at our current PMTCT sites who participate in new site assessments, overseeing QA/QC, capacity development and training for new PMTCT centers. We place minor emphasis on performing targeted evaluations of PMTCT interventions, to estimate the rate of transmission with each of the ART treatment and prophylaxis courses.

This activity was suspended at the direction of the OGAC Prevention TWG.

ACTIVITY DESCRIPTION This activity also relates to activities in Counselling and Testing (6721), Medical Transmission Injection Safety (3.3.04), and, and Laboratory Infrastructure (6716).

This activity will support capacity development for blood safety (training and equipment), blood bank screening for HIV, universal precautions and good lab practices, waste management, and QA/QC for HIV serologic testing. The funding will support the building of infrastructure and capacity for high quality blood bank practices, the support of counseling and laboratory personnel and their training. We will increase capacity for high quality HIV testing associated with blood bank services at 7 Harvard APIN Plus Supported ARV centers.

Each of these centers are tertiary teaching hospitals that have blood banks that require blood screening. Actual HIV testing is conducted at the individual blood banks and this activity will support the infrastructure development, laboratory training, HIV counseling training and replacement laboratory equipment to affiliated blood banks. Personnel capacity development will cover the basic needs for the collection of blood and HIV testing to ensure that all blood used for transfusion is HIV free. Personnel at each site will be trained in line with the GON National Training Guidelines, and curriculum for HIV testing for blood transfusion safety. We will train a total of 350 doctors, nurses, and lab workers at our sites in counseling, universal precautions, good laboratory practices, lab safety and the use of rapid HIV tests kits as related to blood safety.

This activity will promote the principles of Universal Safety Precautions, like the reduction of unnecessary transfusions, exposure to blood, accidental injury/contamination as well as the essential consumables and services that protect health care workers form contacting infections, especially HIV. These universal precaution materials will include personal protective equipment such as hand gloves, laboratory coats, masks, and other essential consumables for each site. Additionally, each site will make provisions for the referral of staff for access to post exposure prophylaxis (PEP) when needed. PEP will be provided through our ART drugs and services activities (3.3.10 and 3.3.11). Proper waste management will be encouraged at each site through the use of biohazard bags, suitable sharps containers, and the use of incinerators.

The UCH Virology laboratory (University of Ibadan, Oyo State) will establish and coordinate a regular QA/QC program to insure that HIV testing at VCT centers meets national and international standards. This laboratory will also insure coordination of HIV testing SOPs and provide regular training for existing and new laboratory personnel. QA/QC activities will include site M&E and personnel trainings on proficiency in HIV testing, universal precautions, and good laboratory practices.

This activity will provide support for 7 service outlets, train 350 individuals in counseling and testing, blood bank safety protocols, and provide blood bank screening for an estimated 15,000 individuals. All screening activities will be linked to pre- and post-test counseling services at each site.

CONTRIBUTION TO OVERALL PROGRAM AREA This activity will provide support for 7 service outlets at tertiary health care facilities. We will train a minimum of 350 individuals in counseling and testing, blood bank safety protocols. We aim to provide blood bank screening for an estimated 15,000 individuals. The emphasis on training and infrastructure building within this program is consistent with the PEPFAR 5-year goal of providing technical assistance for the development of site specific blood safety policies, protocols and guidelines. Furthermore, it is consistent with the goal of ensuring that all US funded clinical settings are able to screen transfused blood for HIV.

LINKS TO OTHER ACTIVITIES This activity relates to activities in counseling and testing (3.3.09). The universal processes put in place at the blood bank screening centers will also enhance blood bank worker knowledge on best practices for high quality HIV testing and the proper procedures for handling of blood specimens throughout the blood banking protocol. These activities

are also linked to our injection safety activities (3.3.04) and laboratory infrastructure (3.3.12) through the promotion of universal safety precautions, good laboratory practices, and proper waste management for biohazardous materials.

POPULATIONS BEING TARGETED This activity targets adults and, even more specifically blood donors, in that it seeks to build the infrastructure and capacity of blood banks to provide HIV screening of banked blood. Additionally, it targets public health care workers and laboratory workers for training in HIV testing techniques and proper universal precautions in the handling of blood specimens.

KEY LEGISLATIVE ISSUES ADDRESSED None

EMPHASIS AREAS This activity includes major emphasis on building the infrastructure of participating hospitals and their laboratories and blood banks to perform HIV screening on donated blood. As part of the infrastructure building, there will be minor emphasis on the training of laboratory workers and public health personnel in the implementation of an HIV screening program. Additionally, there will be minor emphasis on quality assurance and supportive supervision through the establishment of a quality assurance and control program by the UCH Virology laboratory. Lastly, this program will have a minor emphasis on the development of networks and referral systems in order to build capacity collectively among blood banks and hospitals to monitor blood safety.

ACTIVITY DESCRIPTION This activity is linked to Laboratory Infrastructure (#6716), Care and support (#6719), TB/HIV (#6713), ART Services (#6715) and OVC (#6720).

This activity provides the initiation of intensive training program in injection safety practices for health care workers at 13 of our high volume APIN +/PEPFAR sites. As HIV/AIDS care and treatment programs are scaled up under the PEPFAR goals, it is critical that we build the capacity of our partners to provide such care in a medically safe environment. This includes the education on appropriate practices to diminish the risks of medical transmission. In HIV endemic settings, health care facilities need to discuss and adopt policies that address the risks of HIV medical transmission and methods that can be used to mitigate these risks. In this vein, at all APIN+/PEPFAR sites, we provide a basic package of safe injection activities, which includes needle disposal containers and vacutainers and basic educational materials for staff. We also provide ongoing training efforts in "universal precautions" that has been ongoing as part of the continuing education of health care workers. Through ongoing training in universal precautions, staff are encouraged to use personal protective equipment such as hand gloves, laboratory coats, vacutainers, masks, and other essential consumables in order to protect themselves and other patients from exposure to blood.

In order to build the human resource capacity of each site for these activities, we plan to conduct at least one workshop on injection safety procedures with at least 20 workers from each site in attendance (260 people trained in total). To encourage sustainability of safe infection techniques at each site, these trained workers will be tasked with returning to their sites and providing training and support to other personnel in this area. Workers attending the workshop will include proportional representation of physicians, nurses, laboratory workers, community health workers involved in Home Based Care (HBC) and administrative personnel. Site based waste handlers will also be provided with training on safe waste management techniques. At this workshop, we will review the protocol for safe needle handling, and disposal. At the proposed workshop, we will review the policy for provision of Post Exposure Prophylaxis (PEP) for personnel at our sites as a component of the injection safety policy. However PEP will be provided to employees through our ART drugs and services activities (3.3.10 and 3.3.11).

The funding for this activity will also support the procurement of needle disposal boxes and autoclave containers at these 13 high volume APIN+/PEPFAR sites. The procurement of this equipment will be shipped and managed through our central warehouse in Lagos.

The funding will also support the development of educational brochure materials and posters on injections safety for relevant locations at all 13 sites. These educational brochures will be used as a part of the workshops for health care workers and distributed to other health care workers at each site. Training activities at each of the 13 sites will be accompanied by the development of safe injection standard operating procedures at each site, which will be shared with all of our other APIN+ sites in the following year. These 13 sites will become the training sites for additional APIN+/PEPFAR sites when more resources are available. In this manner, we hope to network our sites to allow the roll-out of training, services and best practices in a sustainable manner.

CONTRIBUTION TO OVERALL PROGRAM AREA These activities will contribute to capacity building efforts for our APIN +/PEPFAR sites. As the program continues to scale-up, the number of patients will continue to increase at each of our sites and the need to have well-trained staff in injection safety will be a necessity. The adoption of practices and policies to address the risks of HIV medical transmission will be important for the overall practice of a high quality and comprehensive HIV/AIDS care and treatment program.

LINKS TO OTHER ACTIVITIES This activity also relates to activities in Laboratory Infrastructure (3.3.12), Palliative Care (3.3.06), TB/HIV (3.3.07), ART Services (3.3.11) and OVC (3.3.08). Health care workers involved in these programs will benefit from the training program in injection safety and the adoption of a safe needle, needle stick policy and PEP protocol, all which will improve the safety for workers involved in these activities.

POPULATIONS BEING TARGETED All levels of health care providers that handle needles and/or blood from patients should be involved in the training efforts. In addition, heads of service and administrators need to be aware of the policies put in place to limit medical transmission of HIV. Furthermore, these activities will indirectly benefit to the general population, who will be provided with safer injection practices, which are designed to prevent transmission of HIV.

KEY LEGISLATIVE ISSUES ADDRESSED Stigma and discrimination also occurs in healthcare settings and this has also been reported in Nigeria. As HIV/AIDS treatment and care programs have been initiated, the training of all levels of healthcare providers in "universal precautions" and the risks of medical transmission have helped reduce the stigma and discrimination that can occur in these settings. A training program in safe needle handling and development of safe needle practices and needle stick policies will further educate workers on the actual risks of medical transmission and how these risks can be reduced.

EMPHASIS AREAS Through these activities, we place major emphasis on training of staff at our partner APIN +/PEPFAR supported sites and minor emphasis on their capacity development. Training program will improve the medical practices that are ongoing at our sites and provide important policies that will further diminish the risks of medical transmission of HIV in the healthcare settings We also believe that this program will provide the basis for a workplace program through professional medical associations that will ensure that the care and treatment of HIV/AIDS infected patients and specimens are handled safely, with minimal risk to our healthcare providers. We also place minor emphasis on commodity procurement, to procure needle disposal boxes and autoclave containers.

ACTIVITY DESCRIPTION This activity relates to activities in counseling & testing (#6721), care & support (#6719), TB HIV (#6713), ARV services (#6715), OVC (#6720) This activity supports prevention efforts at 18 APIN + sites as part of comprehensive VCT services for 63,300 individuals. For HIV negative individuals, trained counselors will provide education on HIV/AIDS transmission, risks and the disease, and provide risk reduction strategies including HIV testing. Counseling and education for HIV infected individuals will be specifically targeted towards their unique risks, including recommendations for partner notification and condom use. Condoms will be provided to all individuals at all our sites. Condoms will be provided to APIN+ by the Society for Family Health (SFH). The provision of condoms will be accompanied by, individual and group counseling and demonstrations from experienced counselors on their proper use. Brochures and other publications will be distributed to all individuals as a part of the counseling process. These materials will be specifically tailored to address the unique risks that individuals from various risk groups face. Community outreach efforts and PLWHA support groups will be supported and prevention interventions and information will be included in their activities. These support groups provide key community linkages for our PMTCT, palliative care and ART services. This funding will be used to support the procurement distribution of written prevention messages. The materials will provide patients and clients with HIV prevention information using the "ABC" model, including information about healthy behaviors, safer sexual practices, PMTCT, and condom usage. Several of our sites target Most At Risk Populations (MARP) including outpatient STD patients, border traders, military personnel, fashion designers, young male market agents, and motor mechanics. A regular mobile VCT service in Ibadan and Saki that serves these MARP also promotes condom usage and distributes prevention materials. A prevention program for young male market agents has been established in the Ibadan marketplace and implemented through the Association for Reproductive Family Health (ARFH) NGO. HaltAIDS, a community based-NGO in the poor community of Tudun Wada in Jos, has an established community VCT center, which currently provides prevention messages, condoms and VCT to 150 community members per month. Our VCT clinic in Kuramo Village clinic serves a community (n=20,000) where most residents are sex workers and bar workers, resulting in a greater than 60% HIV prevalence in this high risk population. Prevention activities at this clinic will provide educational materials based on the risks that this population faces and distribute condoms. In addition to comprehensive counseling on HIV prevention and risk reduction, HIV-infected individuals identified through this activity are referred for ART services or Palliative HIV/TB care depending on eligibility. An emphasis on high risk men through these community based efforts should enhance prevention efforts and facilitate access to their partners. This funding will go specifically to support the implementation of behavioral interventions for MARP at stand-alone VCT centers, the development of educational prevention materials developed by ARFH and HALTAIDS and referral for STD diagnosis and treatment. Where appropriate, Harvard will build site capacity for STD syndromic management. Additional staffing and training of counselors will also be provided by this funding, including a dedicated fulltime staff person. This activity will provide support for 18 service outlets, train 340 individuals in condom promotion, STD prevention and risk reduction to an estimated 63,300 individuals.

CONTRIBUTION TO OVERALL PROGRAM AREA As described in section 1, these prevention activities are consistent with PEPFAR's 2006 goals for Nigeria, which aims to support a number of prevention strategies in addition to abstinence. In order to be maximally effective, the prevention messages developed at different sites will be tightly targeted to various high risk groups that they serve. Furthermore, these activities are consistent with the PEPFAR 5-year strategy, which seeks to scale up prevention services, build capacity for long term prevention programs, and encourage testing and targeted outreach to high-risk populations. The establishment of networks and referral systems from prevention efforts at the community level to PMTCT and HIV care and treatment will help facilitate the scale-up of the overall program. By continuing to support and build the overall capacity of VCT centers and provide linkages to treatment and care centers, these activities will be able to meet the increasing utilization of these services, expected to result from other prevention and outreach initiatives.

LINKS TO OTHER ACTIVITIES This activity relates to activities in counseling & testing (#6721), care & support (#6719), TB HIV (#6713), ARV services (#6715), OVC (#6720) Strong prevention programs that accommodate the array of societal and cultural norms can also help reduce stigma and discrimination. The provision of such services at the

community level will serve as an important platform from which general HIV/AIDS information can be provided and risk reduction strategies discussed.

EMPHASIS AREAS Through these activities, we place major emphasis on community mobilization and participation, as an element of outreach for prevention efforts. Additionally, we place major emphasis on training and additional emphasis on infrastructure and human resources in order to build the capacity of VCT centers to provide a full range of prevention strategies to the various community members that attend these centers. We also place emphasis on information, education and communication as an essential element of outreach to high-risk populations, to encourage utilization of VCT services. We also place minor emphasis on developing networks and linking these activities with our VCT, PMTCT, and other ART activities to serve as a source of prevention information.

ACTIVITY DESCRIPTION This activity also relates to activities in Palliative Care (#6719) TB/HIV (#6713), PMTCT (#6718), ART Services (#6715), and OVC (#6720). All 22 APIN+ sites will identify HIV-infected persons through the PMTCT, VCT, TB, and ART centers. These include 10 tertiary teaching hospitals, 10 secondary hospitals and 2 primary health care clinics and supplemented by 3 stand-alone VCT centers in Plateau and Oyo states. All HIV-infected individuals are clinically pre-assessed for eligibility for ART services. Palliative care services, which are consistent with the Nigerian Palliative Care Guidelines, are provided through all 22 APIN+ sites. Facility-based palliative care services will be provided to approximately 52,900 PLWHA. We will also provide community outreach to an additional 75,000 individuals through PLWHA support group activities. A network model of care will be used to deliver services. The program will identify, collaborate with and strengthen the capacities of support groups and community based organizations (CBO) to deliver palliative care services, including the provision of services such as domestic support, management of minor ailments (ex diarrhea ORS preparation and use), pain management, referral services, and counseling services. HIV-infected individuals with CD4+ <200 will be provided with co-trimoxazole prophylaxis, according to national guidelines. Diagnostics for common opportunistic infections (OIs) are performed at pre-assessment and may include: Candida albicans, protozoal infections, and gastrointestinal parasites. A basic care package including clean water kits and bed nets will be provided for all HIV infected patients. Pain management assessments will also be conducted by clinicians in the ART sites and analgesics will also be provided. When ART patients miss scheduled clinic visits, or bed ridden clients are reported by the home based care (HBC) team from the communities, the HBC team from ART sites will follow them up. An SOP will be developed to guide HBC visits. During these visits, the team will provide basic medical assessments of signs and symptoms, basic nursing care, nutritional assessments and psychosocial supports and make appropriate referrals. A basic care kit (consisting of ORS, ITN, water guard, bleach, cotton wool, gloves, soap, calamine lotion, Vaseline, and GV) will be provided and when needed, visiting teams will provide, cotrimoxazole, paracetamol, clean water kits and bed nets to patients and their families. We will partner with PLWHA support groups and CBOs to mobilize the community, provide psychosocial support to PLWHAs and their families, provide ART treatment adherence counseling, and assist with patient follow-up and HBC activities. We will build the capacity of these groups to develop more innovative means of interacting and supporting HIV infected and affected populations. HBC activities will be supervised by a hospital team in each of the sites. Two hundred-twenty health care and non-health care workers will be trained in palliative care including HBC using national training manuals. This will be in line with the National Palliative Care Guidance and the USG Palliative Care policy. These activities will strengthen the overall health systems at our individual sites, provide an integrated and comprehensive health care package to our patients thereby enhancing the overall program of treatment and care.

CONTRIBUTION TO OVERALL PROGRAM AREA Harvard PEPFAR will contribute to the PEPFAR PC 2007 goal by providing basic palliative care services in 22 such facilities. At these facilities, we will provide palliative care services to 52,900 PLWHA. We will also provide community outreach to an additional 75,000 individuals through PLWHA support group activities. The program will also contribute to strengthening human capacity through training of health worker, community workers and PLWHAs and their families. These activities are consistent with the PEPFAR 5-year strategy because they seek to scale up palliative care services and build capacity to provide care and support for PLWHA. LINKS TO OTHER ACTIVITIES This activity relates to activities in Palliative Care (#6719) TB/HIV (#6713), PMTCT (#6718), ART Services (#6715), and OVC (#6720). Linkages between sites will be developed for the development of referral networks and capacity building in this area. Furthermore, linkages between tertiary, secondary and primary health care sites will improve outreach to the community and will allow for different levels of medical intervention as needed. As part of this program, we will provide nutritional counseling and multivitamin support for patients. The program will also link up with other USG IPs, private sector and the GON. POPULATIONS BEING TARGETED This activity targets all HIV infected patients who seek treatment and care at the 22 Harvard APIN Plus sites participating in this program. 720 individuals will also be trained in palliative care.

KEY LEGISLATIVE ISSUES ADDRESSED This program seeks to increase gender sensitivity in programming through counseling and educational messages targeted at vulnerable women and girls. Furthermore, through gender sensitive programming, and improved

quality services the program will contribute to reduction in stigma and discrimination as well as encourage men to contribute to care and support in the families. We will accomplish this through PLWHA outreach and patient counseling. Community outreach groups will assist our PLWHAs and their families in the many psychosocial issues involved in HIV infection and ART treatment.

EMPHASIS AREAS There is no emphasis that is 50%, hence, this activity places minor emphasis on community mobilization and the development of networks through palliative care and outreach initiatives as detailed in section 1 above. Additionally, this program places minor emphasis on logistics, commodity procurement for treatment and care modalities, training, and information, education and communication. These emphases are further detailed above in section 1.

ACTIVITY DESCRIPTION This activity also relates to activities in Palliative - Care & Support (6719), ART Services (6715), Prevention of Mother to Child Transmission PMTCT (6718) and Orphans and Vulnerable Children OVC (6720) APIN Plus/Harvard sites will identify HIV infected patients through PMTCT, VCT centers and ART centers and hospitals. These sites constitute a network of delivery points including tertiary teaching hospitals (10), secondary hospitals (11) and primary health care clinics (3). At 25 APIN+ sites, all HIV-infected individuals are clinically pre-assessed for eligibility for ART treatment and funding through this activity will provide palliative care for TB/HIV coinfected patients (n=9,500). TB screening by sputum examination according to national guidelines is conducted in all HIV-infected patients pre-assessed (~52,900) for ART and monitoring for TB coinfection in the 33,370 maintenance patients already on ART. All HIV infected women (~3,312) from our 32 PMTCT sites will be assessed for ART eligibility and diagnosed for TB. The TB clinics at 9 of our sites are National TB centers offering the government DOTS program. NIMR is the National Tuberculosis Reference Laboratory and will provide an important resource to our other sites in strengthening their capacity for TB diagnosis and cross-training of health care workers in TB and HIV. TB services provided at these clinics will be integrated with ART services and VCT in order to promote the development of a comprehensive system of care for individuals with HIV/TB coinfection. Training of 238 health care workers in both HIV and TB clinical and laboratory settings will be provided. The TB diagnosis, treatment and prophylaxis will follow the National TB Leprosy Control Program (NTBLCP) guidelines and will integrate our referral and scale-up plans accordingly. To date, more than 40% of our clinic attendees present with pulmonary tuberculosis. Depending on clinical status, many patients will be treated for TB prior to receiving ART, following the NTBLCP Guidelines. TB drugs are not often adequate at our associated TB DOTS centers, a small number of TB drugs will be provided on an emergency basis. Concurrent ART and TB treatment follows the National guidelines of d4T+3TC+EFV (800mg). All coinfected patients with CD4 values <200 cells/mm will receive cotrimoxazole. INH prophylaxis therapy will only be provided on a case by case basis following the NTBLCP guidelines. 1,200 HIV+ patients are estimated to be given IPT. Nosocomial transmission of TB to HIV+ patients will be prevented through such measures and principles such as basic hygiene, proper sputum disposal, and good cross ventilation at clinics. Facility co-location of TB/HIV services is preferred to clinic co-location. The national guidelines on infection control on co-located sites will be implemented in all our sites. Treatment is provided in connection with the Federal ART Program in 9 tertiary care teaching hospitals and specialist hospitals (Plateau, Lagos, Oyo, Borno, Benue & Kaduna). We plan to add additional tertiary care sites of which 1 will be in Benue and 1 in Enugu. We will work with 11 secondary level hospitals/clinics in the 7 states and 3 primary health clinics (Lagos & Plateau) that provide TB diagnosis in addition to VCT, clinical exams, phlebotomy, ART care, basic management of OIs, and referrals for specialty care. APIN will also work with GON in developing the Federal Public Health Laboratory into a national reference lab, a project which has been identified by the Minister of Health as a priority. TB diagnostic capacity will include culture, PCR, and sequencing for resistance testing. A dedicated TB program officer has been hired and will provide TB expertise to all APIN+ sites. He will be responsible for training efforts and reporting of TB patients to the NTPLCP. CONTRIBUTION TO OVERALL PROGRAM The provision of TB diagnostics and treatment within participating ART facilities is consistent with the PEPFAR goal of ensuring that all facilities offering ART develop the ability to diagnose TB and provide nationally accepted directly observed therapy, short course strategy (DOTS) sites within their facility. There will deliberate attempt to locate CT in DOTS centers so as to increase detection of co-infected TBHIV patients. At these facilities, we estimate that we will provide clinical treatment for TB to 9,500 patients with HIV/TB coinfection either prior to or during their ART therapy, thus contributing significantly to the 2007 PEPFAR goals. At all of our APIN + sites we will provide referral to TB DOTS sites that are either co-located or within short proximity. The provision of TB diagnosis and treatment, infrastructure building and health care personnel training under this program will work towards building and maintaining Nigerian National tuberculosis treatment capacity, which is consistent with the PEPFAR 5-year strategy. LINKS TO OTHER ACTIVITIES This activity also relates to activities in Palliative - Care & Support (6719), ART Services (6715), Prevention of Mother to Child Transmission PMTCT (6718) and Orphans and Vulnerable Children OVC (6720). Through this activity we will provide linkages between participating treatment sites and the National Tuberculosis Reference Laboratory, as described above in the above section. Additionally, linkages to potential patient populations through outreach initiatives, VCT activities, and ART services will improve utilization of care opportunities created through PEPFAR

funding. This activity is most immediately linked to care and support and ART services because TB diagnosis and treatment are provided as a part of patient palliative care and support at sites which also provide ART and the TB co-infection rate is high in our populations and has a major impact on ART management. POPULATIONS BEING TARGETED This activity targets adults and children with HIV and TB coinfection by providing a mechanism for critically important TB diagnosis and treatment both prior to the initiation of ART and also during the course of ART therapy. We will pre-screen newly enrolling ART patients for TB in the coming year and will also diagnose and treat TB in patients that are currently on ART therapy. All HIV infected pregnant women participating in our PMTCT testing and prophylaxis programs will also be eligible for TB diagnosis and treatment under this program. KEY LEGISTLATIVE ISSUES ADDRESSED This activity will increase gender equity by focusing on strategies which seek to reach an equitable number of men and women who have HIV and TB coinfection. Furthermore, it seeks to provide additional focus on supports for pregnant women who have HIV and TB coinfection. Through data collection and patient surveillance from this activity, we will be able to show the breakdown of men and women who are accessing TB diagnostics and treatment services. Outreach activities and patient counseling also seek to address stigma and discrimination and increase access to information, education and TB diagnosis and treatment for women and girls with HIV. EMPHASIS AREA We place major emphasis on the training of health care workers at participating sites to provide TB treatment in accordance with program protocols. This activity places substantial emphasis on the development of networks and referral systems by linking the National Tuberculosis Reference Laboratory to participating treatment centers. This activity places minor emphasis on commodity procurement, infrastructure building, and logistics through funding for TB diagnosis and treatment for eligible patients, as described above in section 1. Minor emphasis is also placed on community mobilization and participation through outreach initiatives described above in section 1.

ACTIVITY DESCRIPTION This activity is also linked to PMTCT (6714), C&S activities for adults (6719), TB/HIV activities (6713), pediatric ART services (6715), C&T activities (6721) and SI activities (6717).

Twenty-five APIN Plus/Harvard sites will identify HIV-infected OVC through PMTCT, VCT centers and ART centers and hospitals. These sites constitute a network of delivery points including tertiary teaching hospitals (10), secondary hospitals (13) and primary health care clinics (4) in Plateau, Oyo, Borno, Lagos, Kaduna, Benue, and Enugu states. While many of the original PMTCT sites are classified as secondary or community-based in nature, the expansion sites represent a continuation of the overall movement from primary to secondary sites as these new sites are virtually all secondary or community-based. We will strengthen the coordination of PMTCT, ART and OVC services for seamless movement of HIV+ children across the various services. The experience gained from the initial rounds of this activity will assist us in more efficient implementation of OVC activities in the new centers. Active PMTCT programs at 32 sites will identify HIV-exposed infants who will require PCR diagnosis and clinical assessment to determine ART eligibility. OVC who are ART eligible will be provided ART services under our ART Activities. We aim to provide care and monitoring to 5000 HIV-infected OVC who are not ART eligible under these care and support (C&S) activities. HIV-infected OVC will be provided with co-trimoxazole prophylaxis according to national guidelines. Diagnostic testing for common opportunistic infections (OIs) will be performed at pre-assessment and may test for: malaria, protozoal infections, and gastrointestinal parasites. Multivitamins, clean water kits, ORS (preparation and use), and bed nets will be provided for all babies and infants covered under this activity.

Monitoring and evaluation of all aspects of our OVC activities (6720) will be conducted as a part of our SI activities (6717). We collect electronic data on patient care, which is used for site and program specific evaluation of services provided in each of our OVC program areas, including evaluations of CD4 counts, loss to follow-up and viral suppression. This data is used to conduct program evaluation and provide feedback to site investigators on a quarterly basis. On site data managers will conduct monthly evaluations.

We will partner with persons living with HIV/AIDS (PLWHA) support groups to provide outreach to OVC and their families and caregivers through VCT advocacy, ART education and counseling, stigma reduction, risk reduction and ART adherence. These PLWHA community outreach groups will provide supports to our ART patients and their families in the many psychosocial issues involved in HIV infection and ART treatment and assist with patient follow-up and home-based care. Supports will include referrals for special educational services for OVC, food and nutritional support, and income generating activities for caregivers and older OVCs. Outreach through the PLWHA support groups will also encourage utilization of VCT services by other family members. We will build the capacity of these groups to develop more innovative means of interacting and supporting HIV-infected and affected populations.

This funding will also support training for 400 caregivers of HIV-infected OVC. These activities will strengthen the capacity of our sites to provide comprehensive care to OVC.

CONTRIBUTION TO OVERALL PROGRAM AREA Outreach activities through PLWHA support groups will seek to provide comprehensive psychosocial supports for OVC and their families, in line with the National Strategic Framework for HIV/AIDs. Additionally, we seek to strengthen the capacity of the PLWHA support groups to continue to provide psychosocial support and outreach to PLWHA and OVC, in line with National objectives. Additionally, by working with pediatric ART and PMTCT sites to provide pediatric C&S services for HIV-infected OVC, we aim to scale-up the ability of participating sites to provide comprehensive and sustainable services for this population, which is consistent with national objectives and the PEPFAR 5-year strategy. LINKS TO OTHER ACTIVITIES This activity also relates to activities in PMTCT (6714) through a system of referrals to provide pediatric care and support services to HIV-infected pregnant women and their infants. Linkages will be made to our C&S activities for adults (6719) and TB/HIV activities (6713) in order to ensure a comprehensive system of care for OVC and their families. The integration of pediatric ART services (6715) and care linked to active PMTCT (6714) and adult ART centers will facilitate the development of the overall network of care for

HIV-infected families and communities. Linkages to outreach initiatives and C&T (6721) activities seek to improve the utilization of care opportunities created through PEPFAR funding. Additionally, through our SI activities (6717) information about efficacy of care, derived from data collected on the patients treated under this activity may be used to develop new treatment protocols to increase the quality of pediatric C&S services. POPULATIONS BEING TARGETED These activities seek to target OVC who have been exposed to HIV through pregnancy and breastfeeding from an HIV-infected mother through the identification of exposed infants from our PMTCT program. We will also identify OVC from other areas as targets for supportive pediatric care and family outreach. Outreach initiatives also seek to target mothers and family members of HIV-infected OVC, including PHWHA, to ensure comprehensive family psychosocial supports. Caregivers of OVC are also targeted to encourage VCT for potentially exposed children and as the individuals responsible for ensuring care utilization for pediatric patients in these programs. We also seek to target street youth and out of school youth through community outreach initiatives based in VCT clinics. The targets listed above are within reach if the requested funding is approved. In COP06, our target of 600 OVC was reached in mid-year, of this funding cycle, with over 600 HIV-exposed OVC receiving intervention supported by our programs. With the 32 PMTCT sites proposed coupled with continued development and support of the existing sites, the target of 5000 will be reached without difficulty. KEY LEGISLATIVE ISSUES ADDRESSED These activities will address gender equity through the collection of data to show the breakdown of girls and boys that are accessing pediatric HIV care, which may lead to the development of strategies to improve equity in the utilization of care and outreach to OVC. Through counseling of families, we will seek to provide referrals for educational services for OVC as well as to directly educate OVC and their families about HIV/AIDS, ART, and adherence. Counseling will also provide families with referrals to nutrition supports and IGAs as necessary. Furthermore, outreach activities and PLWHA support groups will seek to address issues of stigma and discrimination, provide psychosocial supports for women and girls and increase access to information about ART. EMPHASIS AREAS These activities will place major emphasis on the development of networks and referral systems in order to support the development of a comprehensive system of care through links to community PLWHA support groups and PMTCT, VCT and ART sites. Minor emphasis is placed on community mobilization and participation and on information, education and communication through outreach to OVC in the community and their families as described above. Minor emphasis is also placed on training through activities focused on training caregivers in the care of HIV infected OVC.

ACTIVITY DESCRIPTION This activity also relates to activities in Basic Care & Support (#6719), TB/HIV (#6713), ART Services (#6715) and OVC (#6720). This activity provides the comprehensive counseling and testing services (VCT) to most at risk individuals, delivered through 20 service outlets. 63,300 individuals will receive HIV counseling & testing and receive their results. At the 17 APIN Plus ARV sites, and 3 stand alone VCT centers, provider initiated HIV testing will be provided. VCT will be provided to patients that do not know their HIV status, including partners and family members of patients currently accessing ART services at the ARV sites. We have used family counseling sessions and "love letter" strategies to encourage partners of HIV-infected patients to access VCT so that couples receive HIV counseling and testing together. Counselor training will include couple counseling to strengthen this program. Pediatric patients will be identified at these sites and they will benefit from our OVC activities. VCT will also be offered to patients receiving TB services at each of our APIN Plus sites. We will use the National "Heart to Heart" logo at our VCT sites so as to reflect our integration within the national program. In Lagos, we will also partner with GHAIN, who will provide VCT services to 18,106 persons. HIV infected individuals will be referred to our ART and PMTCT sites in the same catchment area for additional services. GHAIN has established an excellent outreach and expanded VCT program through mobile VCT centers. This partnership will ensure broader community based VCT services, with emphasis on CT in TB patient populations, throughout Lagos state and referrals for needed ART care. GHAIN will report on the direct counts for these services. Three stand-alone VCT service outlets provide HIV testing as well as pre- and post-test counseling and condom distribution. Patients are provided with Information, Education & Communication (IEC) materials on HIV prevention and referrals for ART services and palliative care as appropriate. The materials will address HIV prevention using the "ABC" model, information about healthy behaviors, safer sexual practices, PMTCT, and condom usage. We are also providing VCT services in conjunction with projects in Lagos, Plateau and Oyo states that serve MARP, including: outpatient STD patients, bar workers, sex workers, border traders, military personnel, fashion designers, and motor mechanics. Mobile VCT services will be used to reach these populations. Activities targeting these populations are linked with APIN Plus sites to provide referral linkages to Palliative HIV/TB and ART services depending on eligibility for ART. Condoms will be made available at VCT sites. The Society for Family Health (SFH) will supply condoms. This activity will provide support for 20 service outlets, train 200 individuals in counseling and testing (using the National training curriculum), and provide counseling and testing services to an estimated 63,300 individuals. Refresher training will be provided during the year, particularly after final revision of the National training curriculum. HIV testing at satellite sites will be performed with rapid test assays, immunoblot confirmation will be provided by HIV laboratories at the APIN Plus ARV centers during assessment for ART. The UCH Virology lab will establish and coordinate a regular QA/QC program to insure that HIV serologic testing at VCT centers meets national and international standards. This lab will also ensure coordination of HIV testing SOPs and provide regular training for new lab personnel. The USG team will be providing us with rapid test kits that will be managed by our pharmacy logistics team in Lagos and stored and distributed from our central warehouse. We will continue to harmonize this process with GON LMIS and ICS activities. This year we have 11 additional sites providing C & T and startup costs are reflected in the per-patient cost.

CONTRIBUTION TO OVERALL PROGRAM AREA As described in section 1, these VCT activities are consistent with PEPFAR's 2007 goals for Nigeria, which aim to increase uptake of VCT by supporting VCT centers, which are linked to treatment and care services, and to expand their reach through mobile testing services. By continuing to support and build the capacity of VCT centers and provide linkages to treatment and care centers, these activities will be able to meet the increasing utilization of these services, expected to result from other prevention and outreach initiatives. The network of VCT centers linked to HIV services and care will provide a sustainable network for infected and affected individuals in our catchment area.

LINKS TO OTHER ACTIVITIES This activity also relates to activities in Palliative Care & Support (#6719), TB/HIV (#6713), ART Services (#6715) and OVC (#6720). Through these activities, we have incorporated a number of currently funded VCT prevention programs (Gates Foundation) to provide access to a broad range of palliative care, support and ART services. This network of community, research-based and tertiary care institutions should provide sustainable and high quality HIV and related services to the

communities served. Furthermore, both primary and satellite APIN Plus sites are linked in order to provide laboratory and specialty care supports, as related to the VCT activities.

POPULATIONS BEING TARGETED These activities target adults for HIV counseling and testing, particularly those from most at risk populations, as described above. Targeting these populations is important to encourage utilization of VCT services and provide ART treatment for eligible HIV infected individuals. Counseling provided through these activities also seeks to target PLWHA who are newly diagnosed by encouraging them to bring their partners and other family members in for VCT.

KEY LEGISTLATIVE ISSUES ADDRESSED These activities address gender equity issues by providing equitable access to VCT services for men and women. In some cases, our activities seek to target men who may be at high risk for HIV in order to provide a mechanism for VCT as a means of prevention and access to services for their sexual partners. Male targeted counseling seeks to address male norms and behaviors in order to encourage safer sexual practices. Counseling also seeks to address sexual norms and issues of HIV related stigma and discrimination.

EMPHASIS AREAS Major emphasis is on community mobilization and participation. Minor emphasis is on training; infrastructure; information, education and communication as well as quality assurance and supportive supervision.

ACTIVITY DESCRIPTION Through these activities, we will provide ART drugs to 33,370 adult and pediatric patients at 17 APIN Plus ART sites. At 32 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 32 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. As expansion of ARV drug services is prioritized to rural areas, we 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 30,033 adult and 3,337 pediatric patients on appropriate ART drugs. Contribution to Overall Program Area through these activities we will have provided ART drugs to 38,100 patients at 17 ART service outlets. We have more than doubled the number of ART service provider sites to 17 and increased the number of states from 4 to 7. This represents a 32% 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 32 points of service providing access to PMTCT services for 52,250 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 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. 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 17 PEPFAR sites and to provide ARV services to a total of 33,370 individuals, including 30,033 adults (10,170 new) and 3,337 children (1,130 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 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 2500 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 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 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 staff 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 30,033 adults and 3,337 pediatric patients at the end of COP07, which includes 10,170 new adult and 1,130 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. Services are also currently provided in 2 secondary level hospitals/clinics in Oyo and Plateau States. We will provide ART services at Federal Medical Center, Nguru in Borno state and 2 new secondary level hospitals or clinics. By the completion of COP07, we propose to expand to the University of Nigeria Teaching Hospital in Enugu state. 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 17 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. As expansion of ARV drug services is prioritized to rural areas, we will strengthen existing referral channels and support network coordinating mechanisms. 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+ 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 existing DOTS sites as expansion focuses on co-locating ARV sites with existing DOTS sites, and 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+ Clinic and the Mother's Welfare Group. KEY LEGISTLATIVE ISSUES Increase gender equity by providing equitable access to ART services for both sexes. Data collected from these activities breakdowns sexes accessing ART. 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 wrap-around services, such as food & nutrition programs and educational services. ART EAC 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 800 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. Minor emphasis on commodity procurement, network linkages, QA and supportive supervision. APIN+ facilitates 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 provides maintenance of HIV labs at tertiary (7), secondary (9) and primary health care (PHC) settings (1). In addition, APIN+ propose adding additional expansion sites in 2007 and have planned to build the infrastructure and capacities of 22 HIV support labs. These expansion sites will be at tertiary hospitals (2), secondary hospitals (12) and PHC settings (6). During COP06, our 10 major tertiary level labs will have capabilities for hematology, automated chemistry, laser-based lymphocyte subset enumeration and PCR technology. APIN will work with GON in developing the Federal Public Health Laboratory into a national reference lab, a project which has been identified by the Minister of Health as a priority. It will serve national HIV quality control and assurance needs and as a laboratory training center. This lab's capacity will include standard HIV assays, HIV genotyping, HIV resistance testing, TB culture and PCR based TB diagnostics, clinical chemistries, and hematology. All 30 labs will provide HIV serodiagnosis through rapid test technologies. We will have HIV serology, hematology, chemistries, and CD4 enumeration at all secondary hospitals with referral to the tertiary labs for PCR diagnostics. Our 7 PHC facilities are closely partnered with tertiary care facilities, allowing for baseline and periodic evaluation with full lab monitoring. The PHC 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 training for PCR diagnosis of TB at our tertiary sites in COP07. 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 satellite sites. Standardized lab protocols have been developed to accompany the PEPFAR clinical protocol. Computerized records of lab results 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 QA/QC for all lab tests is being established and is 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 IPs and the GON. 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 costs for tertiary labs can be high initially but represent significant infrastructure development. Secondary and primary labs including VCT facilities have lower first year 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 481,792 tests in COP07. This will include HIV tests and tests for disease monitoring including CD4 count, PCR diagnosis of infants and viral load. In addition, we seek to train 720 laboratory staff members in COP07. This will assist in building the human resource capacity of our sites to provide sustainable laboratory support along with high quality VCT and ART treatment. Our 10 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 32 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 PHCs 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 to build sustainability of the labs and to 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 (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 The laboratory activity relates to activities in PMTCT (6718), Counseling & Testing (6721), Palliative Care TB/HIV (6713), ART Services (6715), OVC (6720) and SI (6717). The laboratory is crucial in providing adequate HIV diagnostics in PMTCT, C&T, OVC, palliative care and ART services. Furthermore the lab provides other diagnostics such as opportunistic infections crucial in palliative care and ART services. Hematology, chemistries, and viral load provide toxicity and treatment monitoring, and help with patient management in ART services. Furthermore, as a part of this activity, we seek to build linkages between laboratories and our patient care sites in order to ensure that lab 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 a strong tertiary laboratory is important in the provision of quality prevention and care HIV services. Furthermore, we place 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.

ACTIVITY DESCRIPTION This activity is linked to PMTCT (#6718), OVC (#6720), TB/HIV (#6713), HCT (#6721) and ART Services (#6715). These activities include broad Monitoring and Evaluation (M&E), Health Management Information Systems (HMIS), special operational research studies, improved data management and maintenance of data quality in all APIN+ sites (38) and the central pharmacy. Funds will also be utilized to build the capacity of site staff and Harvard School of Public Health (HSPH) personnel in the above areas and promote efficient use of data to improve services and influence policy. In collaboration with the HSPH team, a data manager assists our sites with on-site clinical, pharmacy and project reporting data collection. We will collaborate with the GON at both Federal and State levels. A relational database system, which is interlinked by ID number, has been developed and contains different data required in the course of care and treatment, ART drug pharmacy logs, toxicity records, discontinuation forms, PMTCT and pediatrics. All paper files are stored in locked file cabinets as hospital patient records. Data are electronically entered at sites by trained data entry clerks. The data are then uploaded to a password protected web server, accessible to authorized personnel and data managers in Nigeria and Boston. Electronic data is used to prepare timely reports for GON and USG. Data managers conduct M&E of the data collection and reporting process and provide feedback to each site. The APIN+ electronic record system is functional and responsive to the GON Patient Management Monitoring (PMM) forms and provides access to pharmacy pickup data, lab results and other clinical patient information. Information in these databases is used for site and program-specific evaluation of services provided in each of our program areas, including evaluations of CD4 counts, loss to follow-up and viral suppression. SOPs govern data entry, security, management and report generation related to the ART treatment and care protocol. Refinement of instruments and databases are ongoing to accommodate program reporting requirements from HQ, central, and the GON. We will provide computer hardware and software support for our sites as services expand. There are presently 8 ARV, 17 PMTCT APIN+ sites and we plan to increase to 17 ARV, 32 PMTCT and 3 stand alone VCT sites in COP07. Site evaluation teams will implement an annual M&E plan for APIN+ globally and for each site, with M&E results fed back to the sites to promote systems improvement. HSPH will continue to participate in the National M&E workgroup (WG) and our SI team will continue to be active participants on the SI WG established and coordinated by USG-Nigeria. In 2006, JSI conducted a Quality Improvement (QI) visit to our ART sites, focusing on ART services. Through HIVQUAL, additional QI indicators will be added in a coordinated fashion with USG-Nigeria. These QI efforts are linked with similar long term efforts in other Harvard PEPFAR countries (Tanzania, Botswana). In 2007, we aim at adopting most of the QI activities to a cross-site model with significant input from Boston, our Nigerian program offices and our partners in Botswana and Tanzania. Each of our sites will be visited and assessed in 2007. All related activities will be carried out in all our sites to develop management experience for sustainability. APIN+ sites' personnel working with medical records and patient data will participate in regular central data management training. Regular inter-site interactions will be encouraged, facilitated by HSPH personnel in Nigeria and from the US. Targeted Evaluations (TEs) assess the efficacy of ART at all sites to provide feedback on program implementation, and PMTCT activities and related ART interventions. Sites are involved in studies supported by National Institute of Allergic and Infectious Diseases (NIAID)/National Institute of Health (NIH) funding which investigate drug resistance relative to subtype and the interaction of HBV and HCV on HIV infection. Study results will provide information to the Nigerian National ART (NNART) committee about co-infections and the levels of drug resistant virus for use in the evaluation of national drug regimens.

CONTRIBUTION TO OVERALL PROGRAM AREA With these activities, we aim at providing Technical Assistance (TA) and SI to 38 local organizations, which are APIN+ sites, which is consistent with 2007 PEPFAR goals to strengthen site capacity in the areas of data management and analysis. We will also provide SI support to our local administrative office, central pharmacy and warehouse. We will train 800 individuals, in the areas described in the above sections, which is consistent with 2007 PEPFAR goals to conduct human capacity assessments and training to build SI human resource capacity at sites providing ART. In 2007, PEPFAR aims at strengthening surveillance efforts and PMM systems in Nigeria. Our SI activities are consistent with these goals in that we will use our funding to refine and implement a global M&E plan for all of our sites and for each site individually. Furthermore, we will collect data on the efficacy and utilization of ART and build data management capacity at each APIN+ site. Our data collection activities will facilitate the ability of PEPFAR to report on Emergency Plan indicators, which may be used

for programmatic decision-making.

LINKS TO OTHER ACTIVITIES These activities are linked to PMTCT (#6718), OVC (#6720), TB/HIV (#6713), HCT (#6721) and ART Services (#6715), where we will use SI for QA/QC and M&E. In our M&E activities, we will link to the National M&E WG and Nigeria MEMS. Additionally, through the provision of Information Technology (IT) supports and our data management personnel, we will provide linkages between all APIN+ sites as related to data sharing and HIV surveillance in the above mentioned areas. Through our operational research studies, we will collaborate with the FMOH, GON, NNART committee and the NIAID/NIH.

POPULATIONS BEING TARGETED Our SI M&E activities target program managers and evaluation officers, site coordinators and principal investigators to provide them with a mechanism for programmatic evaluation. The data collection and management components of these activities target medical record clerks, data managers, and other health care workers who are involved in the implementation of these processes. Furthermore, IT support will target all health care workers involved in the process of recording patient information or data collection. Lastly, our M&E and capacity building efforts target implementing organizations, including community based and faith based organizations involved in the provision of ART, VCT, BC&S, TB/HIV and PMTCT services.

KEY LEGISLATIVE ISSUES ADDRESSED This activity will address gender equity issues through the collection of data on the breakdown of sex accessing ART care. Through this data collection, we will be able to contribute to national surveillance on the impact of HIV on both sex. This data will be essential to the development of outreach, treatment programs and education to reach an equitable number of men and women. EMPHASIS AREAS These activities place major emphasis on monitoring, evaluation, and reporting through data collection and implementation of our M&E plan. We also place minor emphasis on IT and communications infrastructure through the procurement of new technology to build the infrastructure at participating sites and TA in these areas. We will also place minor emphasis on developing and supporting HIV surveillance systems through our data collection and management activities, particularly in our larger sites. We will also place minor emphasis on TEs to answer research questions about drug resistance.