April 08 Reporgramming: PPartner: Tulane Unversity, CDC, Funding Mech: HQ

This PHE is continuing

Title of study: Enhanced TB screening to determine incidence and prevalence of TB in a cohort of ART

clinic patients

Time and money summary:

Timeframe: The study is anticipated to start in March 2008 with data collection to be complete by

December 2009. Data analysis and results dissemination will be completed by April, 2010.

Total projected budget: $394,097

Year 1 projected budget: $196,000

Local Investigators:

Stewart Reid, MD, FRCP(C), MPH

Medical Director, Centre for Infectious Disease Research in Zambia (CIDRZ)

Anticipated Role: Principal Investigator

Bushimbwa Tambatamba-Chapula, MBChB, MPH

District Director of Health, Lusaka Urban Health Management Team

Anticipated Role: Co-Investigator

Nzali Kancheya, MD, MPH, MMED

TB Service Coordiator, Centre for Infectious Disease Research in Zambia (CIDRZ)

Anticipated Role: Co-investigator

Jennifer Harris, MPH

TB Research Coordinator, Centre for Infectious Disease Research in Zambia (CIDRZ)

Anticipated Role: Co-investigator

Project description:

It is hypothesized that there may be a significant amount of un-diagnosed TB among HIV-infected persons

in Zambia due to atypical symptom presentation and limitations in diagnostic technology. ART clinic

enrollees are a high-risk group for active TB and are currently being screened for TB only when

symptomatic. This study will thoroughly screen a cohort of 700 new ART clinic enrollees for prevalence and

1-year incidence of TB using symptoms, light and fluorescence microscopy, chest radiography and culture.

In addition, the usefulness and cost-effectiveness of each diagnostic tool will be evaluated.

Evaluation questions and hypothesis:

Hypothesis: Studies from sub-Saharan African countries suggest there could be a significant amount of

undiagnosed TB disease in HIV-infected persons due to limitations in existing diagnostic technologies and

atypical presentation of symptoms in this population.

Objectives:

1. Determine the prevalence of undiagnosed TB among a cohort of 700 new enrollees at an HIV Care and

Treatment Clinics

2. Determine the 12-month incidence of PTB in a cohort of 700 HIV-infected patients

3. Evaluate the value of each available diagnostic tool for the diagnosis of TB in this setting

3.1Determine the association between culture-confirmed disease and symptoms, smear results, chest x-ray

results

3.2Compare the yield in cases detected with differing combinations of screening tools

4. Determine the cost effectiveness of each diagnostic tool in this setting

Programmatic importance/anticipated outcomes:

Prompt and accurate diagnosis of TB in co-infected patients is critical to reduce the need for treatment with

combined TB and antiretroviral drugs, to reduce the incidence of immune reconstitution inflammatory

syndrome (IRIS), improve patient outcomes and reduce nosocomial spread. However, the lack of routine

screening and limitations in the existing diagnostic technology likely result in many TB cases in HIV-positive

adults going undiagnosed. The results of this study will be used to evaluate current TB screening practices

within Zambian ART clinics and guide TB screening policy revision.

Methods:

Beginning in January 2008, all consecutive ART clinic enrollees at Kalingalinga Health Center will be

screened until a sample size of 700 is reached. For the primary analysis of prevalence and incidence, all

persons on TB treatment at time of enrollment and subjects who develop extra-pulmonary TB will be

excluded, but their diagnoses will be recorded for estimations of all types of TB in our sample. This study

will focus on pulmonary TB (PTB) due to limitations in the capacity definitively diagnose extra-pulmonary TB

in this setting and the importance of identifying and treating PTB for infection control purposes.

Patient screening and cohort development: In addition to standard enrollment procedures, all new patients

will be asked to provide a spot sputum sample during their enrollment visit regardless of whether or not they

have TB-related symptoms. They will be instructed on proper expectoration technique and requested to

provide an additional early morning sample the following day, followed by a third sample when they return to

the clinic the next day, per Zambian sputum collection guidelines. Previously-enrolled patients will continue

to receive symptom-based TB screening based on present standard of care. In addition, when patients

return with the second sputum specimen they will be requested to undergo radiographic chest examination

as part of the diagnostic assessment. This will be provided free of charge and will be interpreted by the

clinic physician.

At the health center lab, a portion of the sample will be prepared for CM and examined by the technician.

Evidence of AFB will be considered smear-positive. The remainder of each sample will be sent directly to

the CIDRZ Central Lab for re-examination by fluorescence microscopy and for TB culture (with biochemical

testing and PCR analysis to differentiate MTB from mycobacteria other than tuberculosis). Drug sensitivity

testing will be performed on all MTB cultures.

All patients who are smear-positive by at least one sample will be enrolled in Zambia's national TB program

as soon as they receive their positive smear result and will be provided with directly-observed-therapy per

national guidelines. Zambia has a well-established TB Program with a TB Clinic at Kalingalinga Health

Center. Patients who are smear-negative may be treated empirically for TB based on radiographic results

and clinical discretion of a doctor. Any patient who has a positive culture, regardless of smear status, will

be treated for TB per national guidelines. Patient locator information will be kept on all patients so they can

Activity Narrative: be found if they have a positive culture but were not initially diagnosed with TB. Any patient found to have

drug resistant TB will be discussed with the national TB program for further management decisions. The

same procedures will be followed at the 6- and 12-month visits or if a patient presents with interim TB-

related symptoms in order to evaluate incident TB. Study screening will be performed in addition to, not as

a replacement for, the standard symptom-based screening at the ART clinics. Thus, if patients present with

TB symptoms at visits other than the specified study visits, they will be assessed for TB.

Data Collection: All demographic and clinical data will be collected from the SmartCare electronic patient

tracking system in which all pertinent demographic and clinical data is routinely entered as part of standard

HIV care. Additional study data including FM results will be collected on study forms and entered into a

study database that will be linked to SmartCare. All patient records and consent forms will be monitored by

a study nurse and kept in confidential, locked files. Over a 2-3 week period during the course of the study,

we will perform a micro-costing exercise where we collect person-time and unit cost data from the clinic and

laboratory. Time sheets and commodity usage charts will be developed and our staff trained in their use.

The CIDRZ Central Lab will record fluorescence microscopy results for all samples sent to them for quality

control comparison with results from the clinic labs.

Data Analysis:

Objective 1: The prevalence of undiagnosed PTB in our sample of HIV-infected patients will be determined

using a positive TB culture as the case definition.

Objective 2: The incidence of PTB in our sample of HIV-infected patients during their first year of care will

be determined using a positive TB culture as the case definition.

Objective 3.1: The association between culture-confirmed disease and symptoms, Z-N and florescence

smear results, chest x-ray results will be examined using log-binomial regression.

Objective 3.2: The sensitivity, specificity, positive predictive value, negative predictive value and increase in

case detection yield for differing combinations of symptoms and diagnostic tools will be calculated.

Objective 4: The data from the micro-costing exercise will be combined with budget /expenditure information

from the Lusaka District and CIDRZ to make estimates of each strategy's cost-effectiveness ratio. Our

primary perspective will be that of the health care system, and our primary outcome measure will be cost

per correct diagnosis made.

Population of interest:

The population of interest is new ART clinic patients in Lusaka. Patients enrolling for HIV Care and

Treatment represent a unique opportunity to screen and treat TB in a high-risk population. Beginning in

January 2008, all consecutive ART clinic enrollees at Kalingalinga Health Center will be screened until a

sample size of 700 is reached. The A sample size of 700 patients will allow us to estimate the prevalence

and incidence of TB in our sample with a precision of 0.02 at a significance level of 0.05. The Kalingalinga

ART clinic was opened in May, 2004 and has had an average enrollment of 100 new patients per month in

2007. At this enrollment rate, it is expected that that cohort enrollment will take 8 months. If it is determined

that consent is required, then enrollment may take a few months longer since not all patients will agree to

screening.

Preliminary results will be shared with the Ministry of Health and interested stakeholders at a dissemination

meeting to be held when initial data analysis is complete. Data will also be shared at relevant conferences

and submitted to peer-reviewed journals.

Budget justification for Year 1 budget:

Salaries/fringe benefits: $157,434

Equipment: $3,000

Supplies: $1,000

Participant Incentives: $3,713

Laboratory testing: $28,853

Other: $2,000

Total: $196,000

The funding level for this activity in FY 2008 has increased since FY 2007. Narrative changes include

updates on progress made and expansion of activities.

HIV in sub-Saharan Africa is causing an increase in incidence of HIV-related tuberculosis (TB). Data from

FY 2005 - FY 2006 shows that 60-70% of TB patients in Lusaka District are HIV-infected, and 80% meet

eligibility criteria for immediate antiretroviral therapy (ART).

When the Ministry of Health (MOH) began opening ART clinics in 2004, the overwhelming demand for care

hampered the ability to integrate HIV care with other services. Adequate systems were not in place to

encourage TB patients to learn their HIV status and refer them from TB to ART clinics. As a result, two

vertical systems exist within most health facilities and many co-infected patients do not receive the

coordinated care they need or are lost to follow-up. Encouraging TB patients to learn their status and

integrating services is essential to improving clinical outcomes of co-infected patients and the primary focus

of CIDRZ TB/HIV activities.

CIDRZ role in TB/HIV integration began in FY 2005 when they partnered with the Lusaka District Health

Management team and piloted a number of TB/HIV integration activities at one district clinic. As part of a

new patient triage system, all TB patients were requested to undergo Diagnostic Counseling and Testing

(DCT) as part of their enrollment in TB treatment with follow-up to ensure that HIV-positive patients enrolled

in HIV care. This was successful in identifying and referring patients to HIV care and has been expanded to

11 Lusaka clinics with the target of reaching 22 District clinics by end of FY 2007. Current data shows that

74% of TB patients have accepted an HIV test and 69% were HIV-infected.

CIDRZ TB/HIV integration activities include: (1) training in the diagnosis and clinical management of TB in

HIV-infected persons; (2) establishment of referral and communication systems between TB and HIV

clinics; and (3) systematic monitoring and follow-up of activities.

Lusaka District notifies more than 90% of the TB cases in Lusaka Province and one-third of national cases.

In 2007, the USG funded CIDRZ to provide technical and financial support to implementation of TB/HIV

activities. Since Lusaka District will have 100% coverage by the end of FY 2007, the goal for FY 2008, is to

expand this support for TB/HIV integration to Eastern, Western, Southern and Lusaka Provinces as well as

strengthen systems in sites based upon lessons learned in FY 2007. Activities are done in partnership with

provincial, district health offices, and CDC in order to build-upon and strengthen current activities . The

priorities for FY 2008 are:

1.Scale-up technical support for implementation activities to 35 facilities for a total of 57 facilities (22 in

Lusaka district, 35 outside of Lusaka District)

2.Increase capacity and strengthen systems through training of lay/community workers and infrastructure

development

3.Continue monitoring and evaluation of integration activities to improve operations.

With the focus shifting to sites outside of Lusaka District in FY 2008, CIDRZ will provide technical support to

35 sites in Eastern, Western, Southern and Lusaka Provinces. CIDRZ will ask provincial and district health

officials to identify programs and clinics that need support and coordinate services with CIDRZ-supported

ART clinics in these areas. We anticipate providing training or refresher training to about 12 staff at each

facility including medical and clinical officers, nurses, and pharmacy technicians. They will be trained in

TB/HIV epidemiology, diagnosis, treatment, coordination of care and DCT. CIDRZ will work with the district

teams to develop a model for integration of services specific for their locality that will focus on improving

patient flows and development of job descriptions for nurses and clinicians involved in providing integrated

services. Training will be provided to the district staff to enhance their ability to monitor the program data

with oversight from CIDRZ, with a view to transition to direct district oversight within a year or two.

Currently, isoniazid preventive therapy (IPT) has not been adopted by MOH. Should MOH adopt or

advocate piloting of IPT programs, CIDRZ will incorporate this into integration models. All TB/HIV co-

infected patients are targeted in integration activities including men and women, children and adults.

One of the major challenges encountered in FY 2007 was the shortage of health care staff. At larger clinics,

there are not enough nurse-counselors to counsel and test all TB patients and follow them up into ART care

and treatment. As a result, CIDRZ plans to train 50 community workers (which may include TB treatment

supporters, lay counselors, and peer educators) during the remainder of FY 2007 and an additional 70

during FY 2008.. This task-shifting will relieve some of the current staff burden as well as provide skill

training and work experience for a cadre of community workers. Roles and responsibilities for such

community workers are still under development through discussion with MOH staff and partner

organizations. Once roles are specified, trainings will be developed using materials from CDC, WHO, MOH,

CIDRZ and partner organizations.

Infrastructure was a significant challenge during FY 2007. Infection control is a growing issue in Lusaka

ART clinics due to continued patient enrollment leading to crowding in hallways and waiting areas. In an

area with a high TB burden and limited diagnostic technology, it is likely that there are infectious patients in

these waiting areas. Measures to prevent transmission are needed. Renovations to increase counseling

space and reduce nosocomial transmission in waiting areas will be made in ten clinics in FY 2007, and it is

anticipated that renovations will be required in an additional ten clinics during FY 2008.

With $425,000 plus up funds for TB/HIV, and working with CIDRZ's ART team, an assessment will be done

of all Lusaka ART clinics to identify approximately 5 clinics among those needing infrastructure renovations

to improve ventilation and change traffic flow patterns.

Another pressing issue is the availability of TB diagnostic centers. Lusaka has over 16,000 TB cases per

year with more TB treatment centers than TB diagnostic centers. The Lusaka District Health Management

Team (LDHMT) has identified four TB treatment centres- Lilayi, Chazanga, State Lodge, and Mandevu -

that need a laboratory for sputum smear microscopy. TB suspects referred from these centers to TB

diagnostic centers are often lost in the process because they have to travel to further health centers.

CIDRZ would like to renovate clinic space at these 4 centers to accommodate a lab for smear microscopy,

provide these centers with microscopes, and support training of lay microscopists through a program

Activity Narrative: developed by our partner organization, ZAMBART.

In an effort to improve LDHMT capacity for program monitoring, CIDRZ will purchase 3 computers for the

LDHMT TB/HIV/STI/Leprosy program staff and work with them to coordinate monitoring systems between

LDHMT and CIDRZ.

One of the strengths of CIDRZ programs is intensive follow-up, monitoring and evaluation. This helps to

ensure that activities continue as intended and that quality is not compromised. With the expansion to

provincial sites in FY 2008, systems will be developed to collect data from non-local sites and decentralize

follow-up visits through collaboration with provincial and district health offices.

All TB/HIV integration activities are designed to be sustainable and operate within the current district clinic

structure. CIDRZ is working with MOH staff to integrate services within the confines of staff capacity and

will continue efforts to expand and strengthen collaboration. Rather than providing services directly, CIDRZ

is training district nurses, doctors, clinical officers, treatment supporters, and peer educators as well as

helping them evaluate and re-organize their systems for greater efficiency and to ensure sustainability.

Data monitoring and supportive supervision will be provided in conjunction with DHMT. CIDRZ is a member

of the National TB/HIV coordinating body.

CIDRZ also completed and is conducting several operations research studies during FY 2007 with USG

funding.. These include a survey of TB laboratory diagnostic capacity in 15 Lusaka district clinics. Many

clinic labs were found to be understaffed and/or not have enough microscopes to handle the number of

sputum smears. To explore potential solutions to this, CIDRZ will evaluate the use of fluorescence

microscopy in 5 district labs, beginning in FY 2007 and continuing through FY 2008. CIDRZ has recently

acquired a Bactec MGIT liquid culture instrument which is currently being validated. Based on these two

assessments, fluorescence microscopy and TB culture will be integrated into present diagnostic algorithms

in a manner appropriate for the Zambian setting.

In FY 2008 a study will be conducted to determine the prevalence of TB in HIV-infected persons. A cohort

of new ART-clinic enrollees will be screened for TB with symptom evaluation, physical exam, sputum

smear, chest radiography and culture. This cohort will then be followed for 12 months to determine the

incidence of TB among ART clinic patients during their first year of care.

Results from all operations research activities and program monitoring will be evaluated and published in a

timely manner for programs in similar environments to benefit from lessons learned.

Targets set for this activity cover a period ending September 30, 2009.

The funding level for this activity in FY 2008 will remain the same as in FY 2007. Only minor narrative

updates have been made to highlight progress and achievements.

Related activities: This activity is linked to CIDRZ HTXS

In 2006, an intensive, coordinated community outreach project started in the Lusaka community of

Mtendere. Nicknamed "Save Mtendere!, this community education project aimed to dramatically increase

the population tested for HIV through intensive community mobilization, including door-to-door counseling

and testing (CT) for families. This is a critical adjunct to rapidly expanding HIV care and treatment, as

attitudes and perceptions towards HIV begin to change. In the period December 2006 to May 2007, more

than 50,000 individuals were reached with VCT messages through door to door outreach, radio shows, and

focus group discussions with more than 4,500 people testing through both mobile VCT and clinic and VCT

centre-based testing. Numbers associated with the intensive VCT program are recorded as directly

attributable to the program only through the mobile VCT activities spearheaded by the Save Mtendere team;

the remaining testing numbers are shown as an increase over averages in physical locations. In 2008, we

plan to introduce a referral card system to determine the exact numbers of clients accessing testing at

physical locations that can be directly attributable to the activities of Save Mtendere. All staff undertaking

testing activities, whether through mobile VCT or at the physical locations are fully qualified nurses trained

in rapid testing procedures.

The clinics are currently able to access all test kits through government stores and we have no plan to

supplement test kits to clinics as this system has shown no stock outs of test kits to date.

All clients testing, whether through mobile VCT or at physical locations are pre- and post-test counseled by

qualified counselors and are referred to their nearest ART clinic for follow up treatment if positive. All

counseling includes issues of disclosure, referral to clinic-based support groups, and couples counseling if

appropriate.

In the year prior to "Save Mtendere," just over 1,000 people voluntarily tested for HIV in the Mtendere

Health Center. Through the Save Mtendere program, more than 8,000 community members tested within a

6 month period, showing a 16 times increase in VCT uptake...

In 2007, we are continuing activities within the Mtendere community, and expanding the program using

lessons learned from Mtendere to three additional communities; two in the Lusaka District - Kalingalinga

and George - and one in Livingstone, the capital of the Southern Province. Provincial settings pose very

different challenges for community outreach and require effective community mobilization messages and

methods.

From May to July 2007, we have again experienced overwhelming success in both Kalingalinga and

Mtendere communities. Outreach activities have reached more than 20,000 individuals and more than

3,500 people have tested. We expect the numbers to only increase. The expansion into the George

community begins 15 August 2007.

In light of the overwhelming success of this project, a further expansion is planned in 2008 into 1 more

Lusaka community and 1 provincial community.

Principle activities of the project will continue to be community mobilization and participation and

development of innovative, community-based modes of communication. Community leaders and support

group members will be provided bicycles and a vehicle equipped with loudspeakers in order to reach

greater numbers of people. We propose to produce "chitengi'" (art on fabric materials), locality-specific

billboards and signs, and develop other community messages promoting: (1) hope with the availability of

treatment; (2) importance of mutual care and support; (3) availability of testing in the community; and (4)

importance of lifelong adherence to treatment.

Plans include training all community mobilization volunteers and clinic-based coordinators, who will monitor

their activities and ensure consistency of messages. These coordinators will also provide a central link

between community volunteers and members of the community. These clinic-based messages and

activities will be coordinated with other United States Government funded organizations conducting

community outreach.

Local VCT centers within the district clinics and stand-alone sites will be consulted to measure the impact of

these activities. Monitoring the demand for VCT before and after implementation of community outreach will

provide a crude measure of effectiveness.

Targets set for this activity cover a period ending September 30, 2009.

Reprogramming 10.08: Activity was mistakenly changed to "TBD" and moved to "State" as the agency for

implementation. Our OGAC Core Team Lead, Julianna Kohler, has requested that we reprogram these

funds back to CDC and the original Prime Partner. No further changes are required. [SEE UPDATE WITHIN

TBD WORKSHEET]

April 08 reprogramming: Formerly: Prime Partner: Tulane University, Agency: CDC, Funding mech: HQ

The title of the PHE is "Cost-effectiveness of Models of Adult Treatment Delivery." FY 2008 will be year 2 of

the study, which began in FY 2007 and will end in FY2008. To date, a budget of $150,000 has been

received and expended, and expected additional monies needed for completion total $250,000, which is

being requested for FY 2008. The study is being carried out by a joint Center for International Health and

Development (CIDH) at Boston University School of Public Health and Zambian team.

The purpose of this public Health Evaluation (PHE) is to support Zambia's goals for treatment of HIV/AIDS,

antiretroviral therapy (ART), by examining the wide range of settings and multiple levels of the healthcare

system. The characteristics of the treatment facility (setting, type, sector, size, etc.) and of the patients

treated (socioeconomic level, condition at initial visit, etc.) are both likely to affect the patient outcomes

achieved and the costs incurred. In COP 08, funding will be used to expand the evaluation to a total of

eight sites and to estimate costs and outcomes during the first 24 months of care.

The progress of the study to date includes the following: in FY 2007, this PHE provided an estimate of the

average costs per patient treated and per patient who remains in care and responsive to treatment 12

months after ART initiation, at an initial set of three sites in Zambia.

Lessons learned include the following: this PHE will provide some of the first information available about the

cost of the second year of treatment, changes in costs over time, and the relationship between resource

inputs and patient outcomes.

Information dissemination plan includes the following: This information will be disseminated and used to

assist the study sites, the Zambian Ministry of Health, private and nongovernmental providers, PEPFAR,

and other funding agencies to understand the factors that influence treatment costs and outcomes, estimate

resource needs, and improve the efficiency of the national treatment programme, thereby contributing to the

U.S. Mission's ability to reach its treatment targets.

Planned FY 08 activities include the following. The focus of the COP 08 evaluation will be to add

approximately five new sites to the project and to extend the period of follow-up to 24 months. New sites

will be selected to include promising or common models of treatment delivery that are not already

represented in the study and/or to provide additional examples of the models already represented. Sites

will be selected in consultation with the Ministry of Health, the USG Mission, PEPFAR partners, and other

stakeholders. For all sites that have been providing ART on a large scale for at least two years prior to data

collection, two patient samples will be selected: a sample of patients who initiated ART 2-3 years before

data collection; and a sample of patients who initiated ART 1-2 years before. This will allow changes in

average costs and patient outcomes to be tracked over time, in addition to generating cost estimates for

both the first and second years of treatment. The expected results of this activity are accurate and detailed

estimates of the costs of delivering treatment in Zambia across a wide range of settings and types of

patients.

Budget justification for FY 2008 monies follows: The proposed budget for this activity is $250,000, of which

approximately 46% will be allocated to salaries (BU and Zambian staff), 16% to travel, 18% to other costs,

and 20% to indirect costs. Approximately one third of the budget will be passed on to a local Zambian

research organization to cover local salaries and expenses. Because many of the data required for the

study (e.g. patient records) will not be computerized, the local budget includes time for data entry as well as

interview administration and coordination.

Budget for FY 2008 follows: Salaries/fringe: $115,000; travel: $40,000; equipment: $5,000; other costs:

$40,000; indirect costs: $50,000.

Reprogramming 10.08: Activity was mistakenly changed to "TBD". Our OGAC Core Team Lead, Julianna

Kohler, has requested that we reprogram these funds back to the original Prime Partner. No further

changes are required. [SEE UPDATE WITHIN TBD WORKSHEET]

This is a continuing PHE.

The title of this PHE is "Cost-effectiveness of Models of Pediatric Treatment Delivery." FY 2008 will be year

2 of the study, which began in FY 2007 and will end in FY2008. To date, a budget of $150,000 has been

received and expended, and expected additional monies needed for completion total $250,000, which is

being requested for FY 2008. The study is being carried out by a joint Center for International Health and

Development (CIDH) at Boston University School of Public Health and Zambian team.

The purpose of this public Health Evaluation (PHE) is to support Zambia's delivery of pediatric treatment.

Delivery of pediatric treatment for HIV/AIDS has lagged behind the rollout of adult treatment in most African

countries. As national governments, PEPFAR, and international agencies place greater emphasis on

expanding pediatric care, it is critical for treatment planning that Zambia has a good sense of the relative

costs of different models of pediatric treatment delivery. It is equally important to identify the most cost

effective ways to reach the largest number of pediatric patients. In Zambia, pediatric treatment is currently

being delivered at three types of sites: public district hospitals, public clinics, and centers of excellence that

are partnerships between government and PEPFAR partners. In COP 08, funding is sought to include one

example of each of these models in an evaluation of the cost effectiveness of pediatric treatment delivery.

The progress of the study to date includes the following: during 2007, the study carried out initial planning

for the project, including development of design, methodology and background research on key issues and

service delivery context for pediatrics in Zambia.

Lessons learned include the following: The expected results of this activity will be the first available

estimates of the costs of delivering pediatric treatment in Zambia under different models of care.

Planned FY 08 activities include the following: The first step in this evaluation will be to adapt the existing

data collection and analysis tools, which were developed for adult treatment sites, to pediatric sites. Three

pediatric sites will then be selected for the evaluation, in consultation with the Ministry of Health, the USG

Mission, and other stakeholders. Each site will represent one of the major models of pediatric treatment

delivery listed above. At each site, a random sample of pediatric patients will be selected and a

retrospective medical record review conducted. Data from medical records will be used to identify and cost

all resources used to treat the sample of patients in the first year following initiation of ART, including drugs,

diagnostics, outpatient visits, inpatient admissions, infrastructure, etc. An estimate will then be made of the

average cost per patient treated and the average cost per patient who remains in care and responding to

therapy 12 months after initiation. In addition, at each site a small sample of children's caregivers will be

interviewed to estimate the costs to children's households of obtaining treatment, such as transport fares to

the clinic, missed days of schooling, and the opportunity costs of caregivers' time. Depending on mutual

interests, the evaluation may be carried out in collaboration with researchers from Columbia University.

Information dissemination plan includes the following. This information will be disseminated and used to

assist the study sites, the Zambian Ministry of Health, private and nongovernmental providers, PEPFAR,

and other funding agencies to understand the factors that influence pediatric treatment costs and outcomes,

estimate resource needs, and improve the efficiency of pediatric treatment delivery, thereby contributing to

the U.S. Mission's ability to reach its treatment targets.

Budget justification for FY 2008 monies follows: The proposed budget for this activity is $250,000, of which

approximately 46% will be allocated to salaries (BU and Zambian staff), 16% to travel, 18% to other costs,

and 20% to indirect costs. Approximately one third of the budget will be passed on to a local Zambian

research organization to cover local salaries and expenses. Because many of the data required for the

study (e.g. patient records) will not be computerized, the local budget includes time for data entry as well as

interview administration and coordination.

Budget for FY 2008 follows: Salaries/fringe: $115,000; travel: $40,000; equipment: $5,000; other costs:

$40,000; indirect costs: $50,000.