This activity links with other PMTCT programs in WPHO (#9744), EPHO (#9736), and CARE international (#8818)

The Center for Infectious Disease Research in Zambia (CIDRZ), under the prime partner Elizabeth Glaser Pediatric AIDS Foundation, will continue to expand the prevention of mother to child transmission of HIV (PMTCT) implementation program in collaboration with the Ministry of Health (MOH). In FY 2007 CIDRZ, in partnership with Government of the Republic Zambia will focus on: 1) ensuring coverage to all 20 districts in the Lusaka, Western, and Eastern Provinces with PMTCT services, 2) upgrading of select districts to more effective PMTCT interventions (e.g. Nevirapine (NVP)-boosted Zidovudine (ZDV), and 3) achieving a radical reduction in pediatric HIV incidence in the capital city of Lusaka through ensuring maximally-effective services are available universally in the capital city of Lusaka.

By working directly with MOH, Provincial Health Offices and districts, CIDRZ plans to considerably expand the number of health centers providing PMTCT, from 87 at the end of February 2006 to 201 by the end of February 2008. This will bring PMTCT coverage to 62% of health facilities and 100% of districts in these three provinces. New districts include Shang'ombo in the Western Province and Nyimba and Luangwa in the Eastern Province. In partnership with CARE International and the Eastern Province Health Office, CIDRZ will assist service roll-out to the remaining rural districts in Eastern Province. Lastly, CIDRZ will continue providing support for PMTCT services in existing sites in Lusaka and Kafue Districts in Lusaka Province with the complete coverage of sites in the remaining two districts of the province. Sustainability of the PMTCT program will be achieved through the integration of PMTCT services into routine maternal and child health activities.

The mother-infant rapid intervention at labor and delivery (MIRIAD) intervention implemented in FY 2005 at the University Teaching Hospital will be continued and expanded to other high-volume clinics in Lusaka. Building on the referral system developed in FY 2006, CIDRZ will support districts to develop networks and referral systems for pregnant women to access other services offered at health centers and in the communities. A key activity will be referrals to HIV care and treatment programs, including screening of women for a CD4 count to determine eligibility for highly active antiretroviral therapy (HAART). The goal will be to initiate HAART in those pregnant women who require it for their own health and capture the remaining pregnant women into long-term HIV care and follow-up.

CIDRZ will continue to work with CDC to implement the continuity of care smart card, which will facilitate improved longitudinal care for pregnant women and their infants. Health workers will be trained in counseling, the minimum package of care of PMTCT, logistics, data management, and quality assurance as new and ongoing activities in these districts. Due to staff shortages and the overwhelming workload that PMTCT introduces to already overstretched staff at the maternal and child health departments, CIDRZ will also assist the districts with immediate staff shortages by looking at alternative retention models. Other innovative approaches will include the development of a rural PMTCT model that employs community-based cadres in the implementation of the PMTCT program. This will include the adaptation of the traditional birth attendant and community health worker manual to encompass issues of HIV and counseling. CIDRZ will provide technical assistance to districts and sites that are not directly supported but who take up the initiative to provide services and provide assistance for capacity building. As part of this program, CIDRZ will raise community awareness for the PMTCT program through the development of materials and information, education and communication strategies. The communities, especially men, will be mobilized and encouraged to participate in the PMTCT community outreach programs that promote HIV testing in order for the program to be effective. Finally, CIDRZ will continue to bring two volunteers for one year on PMTCT expansion to provide technical assistance, knowledge transfer, and creative solutions to problems.

The plus-up funds will be used to extend PMTCT services through increasing counseling and testing coverage by scaling up the opt-out routine counseling and testing model, thereby reaching more pregnant women; use of lay counselors and TBAs for rural areas and scaling out the "reflex CD4" services through the development of an effective referral

system between the PMTCT and ART programs to ensure that women have a baseline CD4 count which determines which PMTCT ART regimen to use or to refer women for care depending on their CD4 count. Secondly, the plus-up funds will be used to strengthen essential antenatal and postnatal interventions, especially support for optimal infant and young child feeding; infant diagnosis linked to child follow up and ART; and cotrimoxazole prophylaxis. This activity will also extend ART linkages at facility level where PMTCT services and MCH care is provided. Lastly by promoting sustainability of the PMTCT program by exploring and scaling out the "fixed cost obligation awards" model. This performance based award system encourages districts to plan, integrate, expand, maintain high standards and report PMTCT services. This award system will be implemented in all 17 districts supported by CIDRZ.

Three recent studies in Africa have shown that male circumcision prevented men from acquiring HIV. No studies have been done on neonatal male infants, but we can infer from the recent trials that early circumcision would have many health benefits including decreased acquisition of HIV. Infant circumcision is an acceptable and safe procedure that is routinely performed in the United States within 24 hours of delivery of the infant and has been performed in Africa without negative sequelae. A 2003 survey performed in Zambia in four different areas suggests that men and women in Zambia would support circumcision if it was safe, had health benefits, and was not too expensive. With this funding, we plan to focus on two areas 1) Working with the Ministry of Health, UTH and JHPEIGO to develop guidelines on neonatal circumcision 2) Training providers in Lusaka and possibly the provincial hospitals on performing neonatal circumcision. We will work with consultants at UTH and within the Ministry of Health to develop guidelines on neonatal circumcision procedure. We plan to hold several meetings surrounding this issue. Using local expertise, we will train at least 40 providers in infant circumcision in a variety of techniques including the Gomco and Plastibell. Providers and support staff will also be trained in proper sterile procedures; postoperative complications; as well as counseling parents or guardians on the procedure. Parents will be sensitized in local communities as well as in antenatal clinics on the risks and benefits of this procedure and leaflets will be produced which describe the procedure and its risks and benefits. After the initial training, each provider will be supervised on 25 neonatal circumcisions in the different techniques or until it is felt that they have adequate skills to perform neonatal circumcision. We will provide them with the necessary supplies to continue providing neonatal circumsion as part of routine care and will work with the providers to develop potential scale-up plans. The Center for Infectious Disease Research in Zambia is in a unique position to offer this training and supervision with five US trained obstetrician-gynecologists who have cumulatively done hundreds of neonatal circumcisions using both Gomco and Plastibell techniques.

Targets

Target Target Value Not Applicable Number of targeted condom service outlets  Number of individuals reached through community outreach that  promotes HIV/AIDS prevention through other behavior change beyond abstinence and/or being faithful Number of individuals trained to promote HIV/AIDS prevention 40
through other behavior change beyond abstinence and/or being faithful

Table 3.3.05:

This activity is related to #9000.

This activity will support patients enrolled at the joint Zambian Ministry of Health (MOH) and CIDRZ sites with getting a buffer stock of drugs when needed. This activity will give EGPAF the capability to procure first-line and a minimal second-line backup for the 32 existing and 18 new treatment sites supported by CIDRZ in FY 2007. The drugs that will be procured in this activity are Truvada, Lamivudine, Abacavir, Nevirapine, Efavirenz, and Kaletra of which 10% will be pediatric dosages. This backup is intended to help avoid emergency stock-outs as the Government of the Republic of Zambia stock reporting and drug forecasting systems are being strengthened. As of July 2006, approximately 2,412 patients (adult and pediatric) were on second line and/or drug combinations containing second line antiretroviral (ARV) treatment. Training and pharmaceutical staff support on ARV services at each treatment site are provided by this activity as necessary to help ensure appropriate stock management, ordering, and cooperation with national and district stores systems in information monitoring and forecasting.

This activity links to: CRS (#8827, #8829), EGPAF (#9003), EPHO HTXS (#9951), SPHO HTXS (#9760), WPHO HTXS (#9769), Columbia HTXS (#8993).

EGPAF and CIDRZ propose expansion of the ART service support to the GRZ sites. EGPAF-CIDRZ-supported GRZ sites have enrolled 59,159 adults and children and started 36,675 on ART as of the end of July 2006. Presently, 44 ART sites in Lusaka, Eastern, Western and Southern Provinces are being supported. EGPAF-CIDRZ has trained 1,171 health care workers in adult & pediatric ART delivery. EGPAF-CIDRZ has presented 14 abstracts, published one paper with three additional papers currently in preparation.

Building on these successes, in fiscal year (FY) 2007, there are five proposed components to this activity: (1) expansion of services to 18 new sites in five new districts; (2) increased focus on pediatric care and treatment; (3) improve quality of care and through focus on continuing quality improvement (CQI); (4) developing a replicable model of HIV care and treatment for street children and OVCs residing in orphanages; and (5) development of a community-based adherence support program at select sites. There are also four public health evaluations (PHE) to this activity.

In FY 2007, CIDRZ will support 18 new sites in the Eastern, Western, Southern, and Lusaka Provinces selected in consultation with the Provincial Health Offices (PHO); enabling an additional 28,000 individuals to start on ART and an additional 44,000 individuals to enroll in the HIV care and treatment program in all 59 sites. The linkage with the PHOs and other ART activities will ensure sustainability of ART service delivery. EGPAF-CIDRZ's approach to improved and expanded pediatric care will include: (1) improving infant diagnosis; (2) training of all providers in EGPAF-CIDRZ supported sites in pediatric care; (3) training of at least two providers at each site in advanced pediatric HIV care; (4) establishing a pediatric clinic day at each facility where children are seen with their family members and support is available from rotating pediatricians; (5) improved linkages and communication between primary care sites and the Pediatric and Family Center of Excellence at the University Teaching Hospital (UTH); and (6) increasing management methods of exposed-uninfected children.

EGPAF-CIDRZ intends to further enhance and formalize systems for clinical care quality monitoring. This will comprise the following major components: (1) continuing the development of the Continuity of Care Patient Tracking System (CC:PTS) software to provide quality reporting (2) training of nurse managers at each site in clinical audit techniques, chart review, and interpreting CC:PTS reports. A major focus of this year's activities will be on shifting accountability for clinical quality to the clinic leadership; and (3) strengthening and expanding of rotating clinical quality teams, which periodically visit each facility to assist in CQI, perform chart audits, and advise on clinic staffing and patient flow issues.

This year EGPAF-CIDRZ seeks to expand nascent ART services to street children and orphans living in institutional settings. This will expand two additional centers serving street children and two private orphanages. The fifth component is to develop scaleable, community models to support adherence to medication and to clinical visit schedules among patients starting ART. This activity will be critical as services continue to expand and the patient load burden on existing clinic staff increases. Key components include: (1) strengthening of clinic support groups to include specific training in adherence issues; and (2) recruitment and training of local community-based organizations to provide home-based adherence support services.

PHE NNRTI Response Study ($672,000): In 2007, support will provide an additional year of a critically important assessment to observe response to NNRTI-containing ART among women with and without exposure to nevirapine (NVP) for PMTCT. This will allow enrollment to continue until the end of 2006 and thus a larger sample size to accrue and also allow identification of more women with "remote exposure," i.e. those who have been exposed to NVP for PMTCT with at least a 1 year interval between NVP prophylaxis and starting ART. By increasing the number of women in this category, the interaction between exposure interval and failure risk will be better understood.

PHE Community Impact of HIV/AIDS Services ($225,000): EGPAF-CIDRZ will continue to evaluate the impact of ART services on the community. The project is evaluating the

city-wide impact of the USG-supported, government ART program in Lusaka by measuring community reductions in mortality and morbidity due to ART as well as changes in levels of community knowledge toward HIV/AIDS services. This PHE is ongoing and previously funded in FY 05 and FY 06.

New Proposed PHE Drug Resistance Surveillance ($500,000): As access to ART continues to expand rapidly through the region, there are legitimate public health concerns regarding the development and transmission of resistant HIV strains among the general population. Many groups, including the World Health Organization (WHO), have advocated viral drug resistance surveillance in settings where the incorporation of resistance testing into clinical care is not feasible. Surveillance of this phenomenon is also a stated priority of the Zambian MOH. EGPAF-CIDRZ will support the MOH's effort to evaluate the prevalence of drug-resistant HIV strains at a population level, concentrating on three important groups: (1) individuals recently diagnosed with HIV in general voluntary counseling and testing, (2) women recently diagnosed with HIV in antenatal clinics (ANCs), and (3) enrollees into long-term HIV care who have initiated ART. Results from this PHE will help the GRZ and USG determine trends in HIV resistance patterns at a population level, which in turn, will update local policy regarding the most appropriate treatment regimens.

New Proposed PHE Assessment of Early Mortality ($250,000): In Zambia, high rates of early mortality among those starting ART followed by more acceptable rates thereafter (26 deaths per 100 patient-years and 5.0 per 100 pt-years, respectively) have been noted. Similar findings have been reported in surrounding countries. In Lusaka, anemia (defined as hemoglobin <8), lower body mass index, and advanced disease (defined by either WHO staging or CD4 count) are associated with early mortality. It is unclear, however, what underlies these markers, and understanding the various causes of early mortality is an essential first step in developing interventional strategies to combat it. EGPAF-CIDRZ, in collaboration with CDC, will conduct a pilot PHE among 200 ART-naïve adults starting ART at select sites within the Lusaka Urban District or UTH. This intensive investigation at baseline and follow-up is critical to inform policy making around ART provision in Zambia. This targeted PHE represents a critical first step in identifying the most important causes of early mortality that should then be investigated further in interventional studies to reduce mortality in the highest risk group of individuals initiating ART in developing nations. The ultimate goal would be to develop clinical algorithms for high-risk individuals during the high-risk period for death, which appears to be the first 90 days in developing settings.

In FY07, a plus up request ($250,000) and a reprogramming request ($52,000) are requested for this activity; the total amount requested for this activity is $6,502,000. We propose to expand existing clinic infrastructure in at least 5 ART sites in Lusaka. This urgently needed space will allow programs to grow while at the same time maintaining quality of patient care.

This activity relates to: JHPIEGO SI (#9034), AIDSRelief - Catholic Relief Services (CRS) (#8828), Ministry of Health (MOH) (#9008), Technical Assistance - Centers for Disease Control and Prevention (CDC) (#9023), and CCPTS COMFORCE (#9691).

The Continuity of Care Program tools consist of heath data standards, health services standards, equipment (a touch screen monitor, clinical computer, un-interruptible power supply, smart card reader and cards), documentation, and software. These tools are being developed and scaled-up, and combined with large numbers of trained users, to provide a national Electronic Medical Record (EMR) based system to better assure high quality HIV/AIDS care. The software is presently called the Continuity of Care and Patient Tracking System (CCPTS). This clinical application is designed to provide a complete view of a patient's health, at each point of service that may be accessed by an HIV positive person. The program targets the linking and integration of all potentially HIV/AIDS related out-patient services via an informational medium (a smart card) that is portable across service providers and points of care. This is intended and expected to improve the quality of care and reduce the cost of services.

Whereas in fiscal year (FY) 2005 and early FY 2006 the CCPTS software development effort reflected primarily an effort to merge, into the Continuity of Care framework, two earlier efforts (the Centers for Disease Control and Prevention (CDC) Continuity of Care EMR Program and the Center for Infectious Disease Research in Zambia (CIDRZ) Patient Tracking System (PTS) software), increasingly the Zambia Ministry of Health (MOH) is taking leadership in engaging collaborators, providing authority for deployment, and contributing field support from within the Ministry. In mid FY 2006, the MOH corralled the efforts of all major care and treatment implementers, asking each for commitments of infrastructure for deployment of the system nationwide.

The MOH has also developed, planned and promoted its own very aggressive deployment process for the CCPTS, using an almost ‘viral' dissemination plan: a) train provincial level trainers of trainers at central trainings, b) send provincial technical leadership back to province to replicate training with district leadership, who then c) take the skills back to their districts for local training and implementation. So even before the FY 2007 activity period begins, the efforts of the initial three CCPTS collaborators (CDC, CIDRZ and MOH) have been joined by efforts of all other HIV/AIDS care and treatment partners in Zambia, including AIDSRelief - Catholic Relief Services (CRS) and the Zambia Prevention, Care, and Treatment (ZPCT), Health Systems Strengthening Project (HSSP), JHPIEGO, in addition to the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF).

On April 5, 2006, the MOH established this system as the Zambian national standard for electronic clinical systems, thus displaying a remarkable achievement of consensus as well as technology assimilation, in a short period of time. The immediate targets of this effort remain the quality of health care in Zambia and ‘local ownership' by the MOH. However, when the software is internationalized, which is an extension of functionality that will occur during 2007, we expect it may fill a niche in some other President's Emergency Plan for AIDS Relief (PEPFAR) countries, thus, leveraging the investment made in Zambia. The application is open source, and other countries continue to express interest in using the application.

The services which have been integrated to date are HIV care, antiretroviral therapy (ART), tuberculosis (TB) care in the context of ART, antenatal clinic services (ANC), prevention of mother to child transmission (PMTCT) protocols with opt-out counseling and testing (CT), and voluntary counseling and testing (VCT). Pediatric ART services are to a large extent complete in design, as the forms have been approved, and the software requires only small modifications to capture these data. However establishing the policies associated with ‘shared' maternal-child records may take longer for the country to sort out than will the engineering of the technology, and we hope to provide careful technical assistance with this process. This developing country EMR provides now services more than 60,000 patients, and with the additional partners starting deployment before the end October 2006, the rate of growth of services may increase non-linearly as the number of electronic clinics increase, provided there are no drug supply limitations.

The EGPAF activity in FY 2007 is a continuation and extension of the work in FY 2006, which included 1) support for some of the equipment required for the national scale up

and 2) contributing software development resources, via subcontractors, to the collaborative software development guided by CDC and the MOH. In FY 2007 EGPAF will continue to provide software resources through contractors, but transitioning to contractors with a strong in-country presence. Additionally EGPAF will provide increasing logistics support for the scale-up, to complement their contribution in acquiring equipment for the system.

Zambia's Health Management Information System (HMIS), a specific key MOH facility based aggregate data collection tool, will experience improved data timeliness, quality, completeness as a consequence of the CCPTS replacing the manual tally system in the clinics. All facility based HMIS indicators will be produced as a side-effect report of routine recording of patient care data. This information will feed directly into the HMIS software before the end of 2006, saving yet another HMIS task.

By October 2006, updated national HIV/AIDS care standards will have been incorporated reflecting the latest advice of the MOH and the growing experiences of a broad user community. These standards are reflected in the CCPTS forms that all providers must now use. In FY 2007, the following ongoing interdependent activities will be supported: (1) completing the full outpatient service functionality of the CCPTS to more effectively and to fully support care and treatment for people who may have HIV/AIDS and related illnesses; (2) improving the human capacity of the MOH both centrally, and in clinics, to operationally own and manage this national EMR application; and (3) supporting continued deployment of the CCPTS application nationwide at MOH sites, and MOH sites supported by different United States Government-funded partners, including CIDRZ, CRS, and ZPCT partnership, and others. This system will be central to generating some of the data use activities mentioned in the MOH activity.