Detailed Mechanism Funding and Narrative

Years of mechanism: 2008 2009

Details for Mechanism ID: 3481
Country/Region: Uganda
Year: 2008
Main Partner: U.S. Centers for Disease Control and Prevention
Main Partner Program: NA
Organizational Type: Own Agency
Funding Agency: HHS/CDC
Total Funding: $7,828,149

Funding for Care: Adult Care and Support (HBHC): $170,000

FY 2008 activities will continue to build on and follow the FY07 HBAC 1000 ART clients and approximately

400 HIV-infected household members who were not yet ART eligible. All HIV infected clients receive a

basic care package, daily cotrimoxazole and can access acute medical services at home or through the

HBAC clinic. The first 3 years of this evaluation was completed and investigators found small, but

significant increases in the risk of death or new opportunistic infections among participants who were

randomized to receive clinical monitoring without any routine laboratory tests. No significant differences in

mortality or new opportunistic infections were found between participants who were randomized to receive

clinical monitoring plus quarterly CD4 cell counts and participants who were randomized to receive clinical

monitoring plus quarterly CD4 cell counts and viral load testing. Dissemination of the 3 year HBAC results

occurred through small workshops or seminars conducted with stakeholders in Tororo, Entebbe, and

Atlanta and at the HIV implementers meeting in Kigali, Rwanda.

Based on the 3 year results, an amendment to the current protocol has been submitted to continue this PHE

for an additional 3 years starting in FY 2008 as a 2-arm trial in order to fully answer the question of the

added value of viral load testing, in addition to CD4 cell count monitoring. In addition a new proposal is

being developed to evaluate the utility for additional prophylactic treatment against TB and cryptococcal

disease which will enroll another 1000 ART patients through the Tororo Field station. Through care for

existing HBAC clients and the addition of another 1000 clients for the new study, more than 2500 individuals

[including TB patients] will receive HIV-related palliative care.

Funding for Care: TB/HIV (HVTB): $150,000

FY 2008 activities will continue to build on and follow the FY07 HBAC 1000 ART clients approximately and

400 HIV-infected household members who were not yet ART eligible. All HIV infected clients and

uninfected household members can access acute medical services at home or through the HBAC clinic,

including diagnostic and treatment services for TB. In FY07, 11 HIV infected individuals were diagnosed

and treated for TB. The first 3 years of the HBAC evaluation was completed and investigators found small,

but significant increases in the risk of death or new opportunistic infections among participants who were

randomized to receive clinical monitoring without any routine laboratory tests. No significant differences in

mortality or new opportunistic infections were found between participants who were randomized to receive

clinical monitoring plus quarterly CD4 cell counts and participants who were randomized to receive clinical

monitoring plus quarterly CD4 cell counts and viral load testing. Dissemination of the 3 year HBAC results

occurred through small workshops or seminars conducted with stakeholders in Tororo, Entebbe, and

Atlanta and at the HIV implementers meeting in Kigali, Rwanda.

Based on the 3 year results, an amendment to the current protocol has been submitted to continue this PHE

for an additional 3 years starting in FY 2008 as a 2-arm trial in order to fully answer the question of the

added value of viral load testing, in addition to CD4 cell count monitoring. In addition a new proposal is

being developed to evaluate the utility for additional prophylactic treatment against TB and cryptococcal

disease which will enroll another 1000 ART patients through the Tororo Field station. We expect that

approximately 10 of the existing 1000 ART patients will develop active TB and will be treated through HBAC

and 50% of newly enrolled clients will receive isoniazid preventive therapy (IPT) as part of the new

evaluation (HBAC2). We expect approximately 30 new cases of active TB to be diagnosed in these 1000

new clients.

Funding for Treatment: Adult Treatment (HTXS): $835,412

FY 2008 activities will continue to build on and follow the FY07 HBAC 1000 ART clients and 30 additional

individuals initiated on ART. In addition in FY07, 59 HIV infected children of index clients were receiving

ART and an additional 7 started ART during this period. The first 3 years of this evaluation was completed

and investigators found small, but significant increases in the risk of death or new opportunistic infections

among participants who were randomized to receive clinical monitoring without any routine laboratory tests.

No significant differences in mortality or new opportunistic infections were found between participants who

were randomized to receive clinical monitoring plus quarterly CD4 cell counts and participants who were

randomized to receive clinical monitoring plus quarterly CD4 cell counts and viral load testing.

Dissemination of the 3 year HBAC results occurred through small workshops or seminars conducted with

stakeholders in Tororo, Entebbe, and Atlanta and at the HIV implementers meeting in Kigali, Rwanda.

Based on the 3 year results, an amendment to the current protocol has been submitted to continue this PHE

for an additional 3 years to start in FY 2008. This 2-arm trial will fully answer the question of the added

value of viral load testing, in addition to CD4 cell count monitoring. In addition a new proposal is being

developed to evaluate the utility for additional prophylactic treatment against TB and cryptococcal disease

which will enroll another 1000 ART patients through the Tororo Field station. We expect that approximately

30 HIV infected house-hold members of the existing 1000 ART patients will become ART eligible and start

therapy in FY08. An additional 1000 clients will be recruited into the new evaluation isoniazid preventive

therapy (IPT and fluconazole prophylaxis (HBAC II). An additional 30 HIV infected house-hold members of

the newly recruited 1000 clients will also be expected to become ART eligible and start therapy in FY08.

We expect to continue to provide ART for 66 children, with another 8 becoming ART eligible in the next

year. New households enrolled into HBAC II are likely to have 50 ART eligible children who will also be

provided with ART as part of the program.

Funding for Treatment: Adult Treatment (HTXS): $0

FY07 COP activity number - 10163

Title Developing a Collaborative Cohort of USG-Supported ART programs in Uganda to assess Costs and

Clinical Outcomes Associated with Different Programmatic Approaches

Time and money summary: Year 2 of activity; 2007 - 2009; Expended $0 to date, Expected $440,000

needed for completion (including FY08 request)

Local Co-investigators: Jordan Tappero, CDC Uganda, co-PI; Krysia Lindan, CDC Uganda, co-PI

Project description: PEPFAR currently provides funding for ART for more than 66,600 HIV-infected

individuals through more than 10 implementing partners in Uganda, most with several clinic sites. IPs adopt

a variety of programmatic approaches and work in diverse settings throughout the country. These include

home, facility and community based sites in urban and rural settings through government, NGO, faith based

and private sector facilities. Some partners currently provide program-level summaries of clinical data on a

quarterly basis. This project will expand the extent of centralized data collection within PEPFAR-funded

ART programs to develop a collaborative cohort of ART clients using program descriptive data, cost data

and individual-level clinical data. Such a collaborative cohort could be used to answer numerous clinical and

programmatic questions that cannot be examined within individual program analyses. This project should

provide data for the proposed FY08 multi -country PHE entitled "The cost and cost-effectiveness of HIV

treatment and care in resource-limited settings".

Status of study: The study concept was presented to a meeting of implementing partners in April 2007 to

solicit participation and input into protocol development. The protocol is still under development and has not

yet been submitted for research ethics board approval.

Lessons Learned: Awaiting project implementation.

Information Dissemination Plan: Dissemination of results will occurr through workshops and seminars

conducted with participating implementing partners, Ugandan MOH officials and other local stakeholders. In

addition, it is expect that this project will facilitate the ability of implementing partners to present their own

clinical and cost-effectiveness data at international conferences and through the publication of research

papers in the scientific press.

Planned FY08 activities: The study protocol will be finalized and submitted for local and CDC research

ethics board approval and a local steering committee will be formed to advise on project implementation

and approve any proposed data analyses. While the goal is to complete this for all USG ART sites, it will be

difficult to do so for all sites in the first year of this activity. To optimize data that has been previously

collected as part of an OGAC centrally funded costing study, this collaborative cohort will prioritize 9 pilot

sites - those same facilities where cost data was collected in summer 2006 to evaluate the following

questions for a cohort of 10,000 Ugandan clients in FY 2007. Some additional sites of participating

implementing partners may be included in the first year of the project, since work with satellite sites of some

partners (eg. TASO, MJAP) will likely require involvement of central informatics management.

Standardized informatics tools to collate program descriptive data, supplemental cost data and clinical and

sociodemographic data from individual participants from implementing partner programs will be developed.

Participation in this collaboration will be voluntary for all implementing partners and all analyses will be

approved by a steering committee made up of participating programs, representatives of CDC, USAID and

the Ugandan Ministry of Health.

The first round of data merging will occur by end of June 2008 and if successful, further rounds for merging

will be proposed on an annual basis. These rounds of data collection will seek to gather data on PEPFAR

funded ART clients from program initiation to the end of December 2007. With assistance from members of

the informatics team at CDC, implementing partners will compile standardized data in Epi-Info or Access

data files which will be transferred through a secure, password protected system to the CDC Uganda offices

in Entebbe.

Data collection will rely on existing data sources. However, some assistance will be available to support

programs without active follow-up of clients in order to determine the status of patients who are lost to follow

-up. Names will be removed from these files prior to transmission and new patient IDs will be assigned

based on birthdates, gender, program site and year of enrollment. These files will then be translated into

SAS data files for further merging, recoding and analysis.

Budget Justification for FY08 monies:

Salaries/fringe benefits: $133,000

Equipment: $25,000

Supplies: $0

Travel: $42,000

Participant Incentives: $0

Laboratory testing: $0

Other: $0

Total: $200,000

Funding for Laboratory Infrastructure (HLAB): $1,041,237

During FY 2008 the CDC-Uganda laboratory will continue to offer the high quality HIV related services

provided in FY07; these include serological testing for HIV, HHV-8, HSV-2, and Hepatitis B; CD4+ and

CD8+ cell counting, hematology, serum chemistry and viral load testing. The laboratory also introduced

PCR techniques in FY07 to diagnose HIV from dried blood spots collected from infants. Testing services

were provided for CDC evaluation activities and for partners who had no established laboratory capacity of

their own. The CDC laboratory also provided technical assistance and training for lab staff of several

PEPFAR implementing partners and to Ministry of Health (MOH) public facilities in order to enhance

national laboratory services capacity. In FY 2008, the CDC laboratory will also continue to assist in health

service policy development and the restructuring of MOH Central Public Health Laboratory (CPHL) to take

on a central role in improving the standards of testing in health service laboratories, including HIV testing

services.

In addition to expanding this initiative in FY08, the need for laboratory management training will also be

addressed as well as the continuation of the roll-out training program for rapid testing.

In FY08 CDC laboratories will continue to support partners by providing services where they are not

available and will also continue to assist in building capacity in both partner laboratories as well as MOH

laboratories. Skills, such as PCR for the national HIV infant testing programs will be disseminated to other

laboratories with capacity so the program can be extended to cover a greater proportion of the population.

This will entail provision of technical training sessions at the CDC laboratories, follow-up and support

supervision to ensure quality of testing and enrollment in external quality assurance programs. In order to

integrate services and technical assistance the CDC laboratory will work closely with the MOH Lab

Technical Committee (LTC) and with the health labortory service sector. This includes the Ministry of

Health, in developing a national laboratory health service policy, the Ministry of Education and Sport to

support laboratory technician training schools, the Central Public Health Lab to develop its role in

coordination of reference laboratory and lab support programs, the National TB/Leprosy Laboratory (NTLP)

to provide quality assurance programs and re-establishing an HIV Reference Lab (HRL). The CDC

laboratory will also continue to work closely with the National Medical Stores for commodity procurement;

and will continue to provide high-end diagnostic services required for eligibility screening and monitoring of

patients on ART, as well as developing, validating and monitoring new, appropriate approaches to

diagnostic testing. The laboratory will upgrade its procedures to obtain College of American Pathologists

(ACP) accreditation, thus ensuring that testing procedures and results meet internationally acceptable

standards.

Funding for Laboratory Infrastructure (HLAB): $129,599

In FY07, the HBAC laboratory continued to provide support to HIV-infected clients enrolled in care and

treatment programs and their families. In addition to providing emergency field workers to conduct home

visits and phlebotomists at the HBAC clinic, technicians conducted a large number of lab tests as follows;

CRAG (438), malaria (8865), TB (5099), syphilis (2069, urinalysis (3220), pregnancy (1002) and stool

analysis (878). High-end diagnostics including viral load (VL), complete blood counts (CBC), and CD4+

counting were performed on all routine blood samples collected on a quarterly basis. An additional 500

subjects were screened at the CDC laboratory in Entebbe for inclusion in HBAC with VL, CBC, CD4

counting, and liver and renal function tests.

In FY08, HBAC will screen several thousand persons in order to enroll an additional 1000 clients on ART.

Clients currently enrolled in HBAC will continue to be monitored, but less frequently, and their other health

needs will continue to be catered for. The HBAC lab staff in Tororo have been provided with technical

assistance and on-the-job training by CDC-Uganda lab staff. This will be expanded in FY 2008 in order to

devolve much of the responsibility for testing from the CDC lab in Entebbe to the HBAC laboratory in

Tororo. Quality assurance will continue to be provided by the CDC lab in Entebbe. Activities at both labs is

expected to increase in FY08 due to the addition of up to 1000 new clients to be initiated on ART.

Funding for Strategic Information (HVSI): $2,400,000

This FY 2008 PHE relates to the FY07 COP activity number:8380

Title: The Home-Based AIDS Care project

Time and money summary: Year 5 of activity; 2003 - 2010; Expended $3,451,142 to date, Expected $6.0 M

needed for completion (including FY08 request).

Local Co-investigators: Jordan Tappero, CDC-Uganda, co-PI; David Moore, CDC Uganda, co-PI; Alex

Coutinho, The AIDS Support Organisation, co -PI; Jonathan Mermin, CDC-Kenya, co-PI; Rebecca Bunnell,

CDC-Kenya, co-PI

Project description: The Home-Base AIDS Care project is a public health evaluation designed to answer key

operational questions to inform the scale-up of ART in rural Uganda. The Ugandan Ministry of Health

(MOH), The AIDS Support Organisation (TASO) and USG are partners in this important activity. The first

phase of this project involved the provision of ART and three-years of follow-up for 1000 people, using a

home-based approach to service delivery. Protocols were developed for lay workers to do weekly drug

delivery and monitoring using motorcycles to cover a 100km radius. All family members in HBAC were

offered VCT and care and treatment as needed. HBAC has developed counseling protocols and behavioral

interventions for ART literacy, adherence, and prevention of HIV transmission. It was designed as a

randomized clinical trial to compare the effectiveness of three different ART monitoring strategies: a

clinical/syndromic approach using lay workers; the syndromic approach with quarterly CD4 laboratory

monitoring; and, the syndromic approach with both quarterly CD4 and viral load monitoring. After wide

consultation both within USG, and with partners in Uganda and internationally, a proposal was accepted to

continue this project as a 2-arm evaluation for another 3 years, comparing clinical outcomes between those

participants receiving only clinical and CD4 cell count monitoring and those receiving clinical, CD4 cell count

and viral load monitoring. Other evaluations will also be conducted to observe the evolution of ART drug

resistance, the frequency of ART failure and the effects of discontinuing cotrimoxazole prophylaxis among

participants with immune recovery during years 3 to 6 of ART.

Continuing the study for the next 3 years of follow-up should better define the relative value of the addition

of viral load testing, above that of CD4 monitoring and directly influence Ugandan and PEPFAR policy in

this area. Other evaluations will provide additional valuable information to allow the Ugandan MOH to

develop appropriate policies regarding which drug regimens to use for second-line ART, the need for

continued use of cotrimoxazole in ART patients and to examine the risks and benefits associated with early

versus late ART drug switching. All of which will contribute to the expansion of cost-effective ART programs

throughout sub-Saharan Africa.

Status of study: The first 3 years of this evaluation was completed in February 07 and Investigators found

small, but significant increases in the risk of death or new opportunistic infections among participants who

were randomized to receive clinical monitoring without any routine laboratory tests. No significant

differences in mortality or new opportunistic infections were found between participants who were

randomized to receive clinical monitoring plus quarterly CD4 cell counts and participants who were

randomized to receive clinical monitoring plus quarterly CD4 cell counts and viral load testing. The

amendment to the protocol to allow for this continued follow-up and to reduce the frequency of home-visits

is pending IRB approval.

Lessons Learned: The 3 year results of HBAC provide general support for current Ugandan MOH policies

regarding the provision of ART, in that laboratory monitoring, primarily through the use of CD4 cell count

testing is preferable to clinical monitoring alone. However, where laboratory monitoring is not available or

feasible, good clinical outcomes can still be achieved through clinical monitoring alone. The results of the 3

year analysis were presented at the HIV Implementers Meeting in June 07 (Mermin et. al., 1st HIV

Implementers Meeting, Kigali, Rwanda). Publications regarding HBAC results include: Forna F, et. al.

JAIDS 2007: 44(4):456-62; 30;21(6):713-9; Moore D, et. al. AIDS Res Therp 2007: 4:1; Apondi, R et. al.

JAIDS 2007: 44(1):71-76; Weidle, P et. al. Lancet 2006: 368(9547):1587-94; Were WA et. al. JAIDS 2006:

43(1):91-5; Kaharuza F et. al. AIDS Behav 2006: 10(4 Suppl):S105-11; Mermin J et. al. Lancet 2006:

367:1256-61; Bunnell R et. al. AIDS 2006; 120: 85-92; Leitchy et. al. AIDS 2005; 19(9):993-4. In particular,

HBAC analyses regarding the continued morbidity and mortality associated with TB (Moore D, et. al. AIDS

2007) and cryptococcal disease (Liechty C, et. al. TMIH 2007: (8):929-35) among patients receiving ART in

this setting has influence the design of subsequent proposed studies to examine interventions for these

diseases.

USG also uses HBAC as a venue for training Ugandans in ART service delivery as well as in key

components of SI, including data analysis and data dissemination. CDC-Uganda staff level of effort provides

training for all HBAC clinical care providers and patients in basic care services. In addition, to this HBAC

technical assistance, key staff are currently working with Ministry of Health and the PEPFAR ART working

group to promote the use of basic care services and provide technical knowledge for ART delivery. In

particular, HIV transmission risk reduction counseling protocols developed in HBAC for sero-discordant

couples have been adapted for use in other programs in Uganda.

Information Dissemination Plan: Dissemination of the 3 year HBAC results occurred through small

workshops or seminars conducted with stakeholders in Tororo, Entebbe, and Atlanta. Such presentation will

continue to be important fora for sharing our results, in addition to international conferences and research

publications.

Planned FY08 activities: The current 1000 participants will continue to receive ART, with the frequency of

monitoring visits spaced out from weekly to monthly, to eventually quarterly. Evaluations of the clinical,

behavioral, social and economic impact of ART will continue and results will be shared with MOH and ART

stakeholders, both within Uganda and internationally. The project also provides HIV basic care and HIV

prevention counseling to ART-ineligible HIV-infected household members of ART clients. We expect an

additional 30 adults and 8 children from these households will require ART in FY08. Additionally, the project

offers annual home-based HCT and HIV prevention counseling for an estimated 4000 HIV uninfected

household members. Analysis of data collected within the first 3 years will continue and results

disseminated through local workshops and seminars, presentations at conferences and publication of

research papers.

Activity Narrative: Budget Justification for FY08 monies:

Salaries/fringe benefits: $1,188,152

Equipment: $66,150

Supplies: $92,709

Travel: $36,588

Participant Incentives: $1000

Laboratory testing: $100,000

Other: $915,431

Total: $2,400,000

Funding for Strategic Information (HVSI): $550,000

This activity is not new in FY08 and is a continuation of FY07 Activity 13342.

The CDC Informatics Unit provides technical assistance for the development and implementation of

strategic information systems to the PEPFAR/Uganda country partners. The informatics initiatives include

support to the Ministry of Health Uganda Government, routine health service data collection at the district

and National levels and support to USG partners offering ART care to patients, through the development

and deployment of system.

Appropriate technologies for Health:

This activity will involve the pilot of power backup resources in resource limited setting using the solar

panels and PDA for data collection to enhance the use and quality of data received at the District level. The

results of this activity will be incorporated in the feasibility study of implementing Phones for Health in

Uganda. This activity will provide insight in the following:

1.Suitability of technology (PDAS) for capturing large amounts of HMIS (including HIV indicators) data at

local health centers

2.GPRS connections reliability in the field for transferring data between health centers and district head

quarters

3.The use of Reporting Services in conjunction with GIS data

4.Increase field staff's appreciation of new technologies

Electronic Medical records :

This activity includes the development of an electronic medical record. The need to share information

across partners on treatment of HIV/AIDS patients was identified. This will allow free movement of patients

across organization and improve duplication errors and improve care provided to ART patients. The activity

involves looking at possibilities of having one common set of indicators with appropriate technology for easy

transfer and sharing of data. This activity will be in conjunction with the ART group and implementing

partners.

Funding for Strategic Information (HVSI): $175,000

In FY07 the country team reviewed the need to establish a full-time strategic liaison position, supervised by

the PEPFAR Coordinator and co-located in the Embassy, to assist the Coordinator and the Country Team

to support all SI activities. A final decision to approve this position was made by the country team in June

and approved by the PEPFAR executive committee in August. Recruitment for this position will begin in

October with the goal of filling the position by March '08.

In FY08 the PEPFAR Strategic Information Liaison will be hired through a personnel services contract

mechanism to work in the PEPFAR coordination office at the US Embassy with direct supervison and

oversight by the Deputy Chief of Mission and the PEPFAR Coordinator. The final position description is

attached.

PEPFAR Uganda - Strategi Informaton Liaison:

Under the supervision of the PEPFAR Coordinator, the Strategic Information Liaison will provide high-

quality technical assistance to the U.S.G. PEPFAR country team and technical workgroups, Implementing

Partners and GoU counterparts to ensure that the portfolio of program activities contribute to the national

HIV/AIDS strategic goals and targets, generate accurate data to inform national policy, and respond to the

OGAC reporting requirements. Specific duties and responsibilities include:

•Coordinate all in-country program area and project assessments and evaluations as well as the Public

Health Evaluation activities across U.S.G. agencies and partners; provide technical oversight for

evaluation/study design and implementation; facilitate dissemination of findings; ensure national and OGAC

reporting requirements are met; and, identify areas for further study to inform PEPFAR and national

programming. Lead country team contributions and participation in OGAC multi-country Public Health

Evaluations and Assessments and provide technical assistance to participating implementing partners as

needed.

•Lead the U.S.G. response to support UAC in the implementation of the ‘Three Ones" and provide technical

advise as needed; represent U.S.G. on national M&E technical workgroup, and, liaise with international

partners to ensure effective exchange of strategic information.

•Oversee U.S.G. technical support to the national HMIS, MOH Patient Tracking System, HIV surveillance

activities, facility surveys, and databases development and lead PEPFAR assistance in the development

and implementation of the HIV/AIDS National Monitoring and Evaluation Plan and SI components of the

National Strategic Framework.

•Review the need for and lead the development of a PEPFAR strategic information plan to ensure all

evaluations, assessment and studies are directly linked to and inform national priorities and planning; and,

monitor U.S.G. PEPFAR contributions to the Health Sector Strategic Plan, HIV/AIDS National Strategic

Framework; and, other key GoU and Development Partner strategies .

•Facilitate the work of the strategic information technical workgroup with the in-country monitoring and

evaluation contractor (MEEPP) to ensure SI/M&E requirements of the Emergency Plan are met on a timely

basis: including the review and decipher SI sections of guidance documents; lead activity and national

review of PEPFAR targets for annual country operational plan; coordinate semi-annual and annual progress

reports planning; and, plan technical work group sessions to analyze progress/achievement against targets,

and coordinate responses to ad hoc SI requests from O/GAC Technical Workgroups.

•Coordinate technical assistance to U.S.G. agencies' and implementing partners monitoring and evaluation

staff to meet SI reporting and activity requirements, and provide technical training, as needed. Ensure close

technical links with MEEPP and implementing partners to address SI issues and activities.

•Serve as the principal field counterpart to the HQ SI Advisor and lead development of country responses

on SI queries from HQ SI Advisor, Core Team and OGAC.

•Determine and when necessary, solicit appropriate human and financial resources to provide SI technical

assistance to the U.S.G. PEPFAR team, implementing partners, or national workgroups.

•Assist U.S.G. agencies and technical work groups, and partners with data analysis and preparation of

abstracts and presentations for PEPFAR annual conference, in-country meetings and international

conferences as appropriate.

•Assist the PEPFAR Coordinator to identify and communicate SI issues, challenges, and policy questions to

GoU, Department of State and Country Team for response and plan of action; and advise Country Team

and Executive Committee as needed.

•Provide orientation for new U.S.G .agency PEPFAR staff on all SI requirements, reports and procedures,

including one-to-one assistance and formal trainings.

•Perform all other related duties as assigned.

QUALIFICATIONS AND SCORING CRITERIA

Education:

•Masters-level (or higher) training as a public health specialist in epidemiology, monitoring and evaluation or

related field is preferred;

•Excellent written and oral communication skills and computer applications knowledge is highly desired.

•Demonstrated evidence of excellent interpersonal, facilitation and teambuilding skills/experience is favored.

.

Experience:

Activity Narrative: •Five years work experience managing public health or other social sector programs; three years managing

an HIV/AIDS program, ideally in sub-Saharan Africa, is preferred.

•Experience working in close collaboration with high level government and other counterparts is desired.

•Public speaking and public presentations experience is favored.

.

Skills and Abilities:

Extensive knowledge of the principles, concepts, methods, and techniques of public health to analyze,

evaluate, and provide expert advice and consultation.

Knowledge of the methods, applications, and state-of-the-art technology to provide direction and guidance

on critical and complex issues.

Ability to: communicate, both orally and in writing, to make clear, convincing presentations and explain and

justify recommendations; represent the PEPFAR Country Coordinator and team and provide guidance and

advise on how to respond to data inquiries; and independently interact with high level officials and

representatives from public and private health organizations.

Ability to use advanced software programs for internal management and presentations.

Evidence of excellent interpersonal, facilitation and team building skills/experience.

SUPERVISION

The PEPFAR/Uganda Strategic Information Liaison will report to the PEPFAR Country Coordinator and will

work closely with PEPFAR Country Team.

Funding for Strategic Information (HVSI): $120,000

FY COP Activity Number-10084

This activity is a continuation from FY2007 and has not been updated

Title: Evaluating Anti-Tuberculosis Drug Resistance Among Smear-Positive TB Patients

Time and money summary: Year 2 of activity; 2007 - 2009; Expended $0 to date, Expected $240,000 total

needed for completion (including FY08 request).

Local Co-investigators: Jordan Tappero, Frank Kaharuza, Rosemary Odeke, CDC-Uganda; Francis Adatu,

Moses Joloba, Ministry of Health-National TB & Leprosy Programme

Project description: CDC Uganda and Ministry of Health Uganda National TB & Leprosy Program will

support a survey of anti-tuberculosis drug resistance among smear-positive TB patients. This survey will

provide national data regarding primary and acquired anti-tuberculosis drug resistance as well as MDR TB

in Uganda. In addition this survey will also serve as HIV surveillance among smear positive TB patients and

give an estimate of MTB drug resistance (mono drug resistance, MDR TB and XDR TB) in HIV-infected TB

patients included in the survey.

World Health Organization (WHO) estimates that approximately 19% adults with active TB disease in

Uganda are HIV-infected. Recent survey in Uganda estimates that the prevalence of HIV to be as high as

50% among TB patients. HIV co-infection is a significant challenge for the prevention, diagnosis and

treatment of drug-resistant TB. Mortality rates in MDR TB have been reported to be as high as 37% in HIV-

negative patients and 89% in HIV positive individuals. Recently a very high fatality rate was seen among

HIV-infected patients with XDR TB receiving anti-retroviral therapy in South Africa.

WHO and International Union Against TB and Lung Diseases (IUATLD) recommend countries to monitor

anti-tuberculosis drug resistance either through ongoing surveillance or periodic surveys. There is no

nationally representative data available on TB drug resistance in Uganda. In a drug resistance survey

conducted in three regions in 1996-97, the resistance to rifampicin was found to be 0.8% and prevalence of

MDR TB was 0.5% among all isolates collected. In 2005, a drug resistance survey was conducted among

hospitalized patients at the national reference hospital, Mulago and the MDR TB prevalence was 4.5%

among new TB patients, a 10 fold increase compared to the 1996-97 survey.

This survey will provide a national estimate of primary and acquired anti-tuberculosis drug resistance

including MDR TB in Uganda. As per the National TB HIV policy all the TB patients included in the survey

will be provided HIV counseling and testing. Given the importance of HIV infection in TB epidemic along

with the importance of diagnosing HIV in TB patients, this survey will also serve as an important tool for HIV

surveillance among TB patients. The survey will provide information to compare the prevalence of drug

resistance (including presence of MDR TB and XDR TB) among TB patients with HIV and those without

HIV. It will also help to assess the need for capacity building of the National Tuberculosis Reference

Laboratory (NTRL) and National TB program to manage MDR TB cases especially among TB HIV co-

infected patients.

Two sputum samples from new sputum smear positive patients identified during routine clinical care in

nationally representative sample of health facilities will be transported to the NTRL for culture examination.

Population-proportional cluster sampling method will be used to select the health facilities. In all the

selected health facilities, all the consecutive new sputum smear positive patients diagnosed will be included

until the number of patients required per cluster is reached. All the re treatment cases identified during the

intake period will be included in the survey. Specimen designated for culture will be decontaminated and

digested using Petroff's method. The sediments will be inoculated on L-J medium. Specific identification of

M. tuberculosis in culture showing growth of organisms will be done using growth inhibition test.

Susceptibility to Isoniazide. Rifampicin, Streptomycin and Ethambutol will be evaluated using the MGIT

liquid susceptibility method following a subculture of M. tuberculosis recovered using L-J media into the

MGIT system. HIV testing will be provided according to the national TB HIV policy which recommends

routine counseling and testing of all TB patients. All HIV-infected patients will be referred for HIV care &

treatment. A sample of isolates found to be MDR TB will be tested for second line drug susceptibility to

assess XDR TB.

Population of interest:

Sputum samples from sputum smear positive patients from nationally representative sample selected from

420 health facilities (80 district, 240 sub district and 100 sub county level facilities with smear microscopy

capacity) using population proportionate cluster sampling will be sent for culture and drug susceptibility

testing. Based on the prevalence of MDR TB from 2005 survey (4.5%)2 and 20,559 new sputum smear

positive patients reported in 20051, the sample size required for cluster sampling with 1% precision and

95% confidence interval will be around 4000 (after increasing the sample size by 15% as per WHO

guidance to account for patients with contaminated specimens, lost specimen or for whom DST can't be

performed).

Status of study: The protocol is yet to be developed. A merging of this activity with a multi-country PHE

covering the same area is being considered. We anticipate that this activity will commence its "field

activities" during FY08.

Lessons Learned: Awaiting project implementation.

Information Dissemination Plan: Dissemination of results will occur through and at workshops, meetings,

conferences, and publications. Dissemination will be conducted with participating implementing partners,

Ugandan MOH officials and other local stakeholders.

Planned FY08 activities: During FY08, the study protocol will be developed, human subjects review will

commence, followed by data collection, laboratory testing, data analysis and dissemination of findings.

Budget Justification for FY08 monies:

Salaries/fringe benefits: $60,000

Equipment: $10,000

Supplies: $5,000

Travel: $5,000

Participant Incentives: $1,000

Laboratory testing: $30,000

Activity Narrative: Other: $9,000

Total: $120,000

Funding for Strategic Information (HVSI): $26,650

FY07 COP activity number 10084

This activity is a continuation from FY2007 and has not been updated

Title: Sero-Behavioral Surveys among Most-at-Risk Populations (MARP) in Kampala, Uganda

Time and money summary: Year 2 of activity; 2007 - 2009; Expended $0 to date, Expected $251,600 total

needed for completion (including FY08 request).

Local Co-investigators: Wolfgang Hladik, Jordan Tappero, Frank Kaharuza, CDC-Uganda; Alex Opio,

Michael Muyunga, Edith Nakku, Ministry of Health; David Serwada, School of Public Health, Makerere

University; Lillian Tibatemwa, Uganda AIDS Commission

Project description: In Uganda, HIV surveillance and prevention activities focus almost entirely on the

general population. Little is known about the risk of HIV infection among most-at-risk populations (MARPs),

as well as their prevention, care and treatment needs. Similarly, little bio-behavioral surveillance is

conducted among MARPs. This activity aims at conducting surveillance activities among men having sex

with men, male and female sex workers, university students, and transport workers in Kampala, Uganda.

The project goal is to inform Uganda's public health system about groups at high risk for HIV infection and

to eventually facilitate and evaluate prevention activities and related services. The project objectives

include identification and recognition of selected high risk groups, monitoring trends in prevalence of HIV

and other selected sexually transmitted infections (STIs), and identifying and describing risk factors

associated with HIV infection. This survey will be conducted in collaboration with the Ugandan MOH and

the School of Public Health, Makerere University. The target sample size is 600 per MARP group; the

estimated sampling period is 3 months per group, 6-8 months total. MARP groups will be sampled nearly

concurrently using the same infrastructure. Respondent-driven sampling will be employed; quantitative data

will be collected through computer-assisted self interviews; qualitative data will be collected through

individual semi-structured interviews. Specimen collection includes blood and urine, as well as rectal and

vaginal swabs. HIV voluntary counseling and testing will be provided, as well as testing and treatment for

selected STIs. Findings will be disseminated to develop or improve control activities and services.

Status of study: The protocol was is currently under review locally, at CDC, and at OGAC. We anticipate

that this activity will commence its "field activities" by January 2008.

Lessons Learned: Awaiting project implementation.

Information Dissemination Plan: Dissemination of results will occur through and at workshops, meetings,

conferences, and publications. Dissemination will be conducted with participating implementing partners,

Ugandan MOH officials and other local stakeholders.

Planned FY08 activities: During FY08, the study protocol will undergo further review until human subjects

review is complete. Data collection will then begin as described above, as well as laboratory testing,

followed by data analysis and dissemination of findings.

Budget Justification for FY08 monies:

Salaries/fringe benefits: $40,800

Equipment: $35,000

Supplies: $15,000

Travel: $10,000

Participant Incentives: $15,000

Laboratory testing: $50,000

Other: $10,000

Total: $175,800

Funding for Strategic Information (HVSI): $75,000

Year 1 of activity; 2007 - 2009; Expended $0 to date, Expected $75,000 total needed for completion

(including FY08 request, which is $75,000).

Local Co-investigators: Wolfgang Hladik, Fulgentius Baryarama, Dennis Olara-CDC Uganda; Raymond

Byaruhanga, AIDS Information Center

Project description:

Conventional HIV surveillance focuses on monitoring HIV prevalence. Prevention programs however need

information on the determinants of acquiring and transmitting HIV. The surveillance system described here

is tailored after the slogan "Know your epidemic - the last 1000 HIV infections". It primarily aims at tracking

recently HIV-infected persons to better inform about the current determinants that put people at risk. At

selected sites VCT clients' demographic and behavioral characteristics will be evaluated by their HIV status:

HIV-negative, recently HIV-infected, long-term HIV infected. The clients' left-over HIV-positive blood will

undergo additional off-site testing to identify those likely to have been recently infected. Same-site HIV-

negative "controls" serve as a comparison group. At the sites where this PHE will be implemented, a more

risk profile will be available to counselors for the purpose of counseling. Further, the introduction of

computer-assisted self interviews (CASI) may decrease workload for site staff.

Evaluation Question:

This PHE intends not to monitor HIV prevalence but to determine and monitor HIV acquisition/transmission

risk behaviors and characteristics.

Its main objectives are to describe:

1) HIV acquisition determinants (among recently infected individuals)

2) HIV transmission risk behaviors (among both recently and long-term infected individuals)

These data will facilitate the tailoring of prevention activities targeting HIV-uninfected and ‘Prevention With

Positives' (PWP) programs.

Methodology:

Design: Cross-sectional annual surveys.

Sampling population: VCT clients attending selected AIDS Information Centers (AIC) in Uganda

Data collection: At the selected sites, an expanded questionnaire will be administered for all clients. The

risk profile obtained through this questionnaire will be used both for counseling as well as for the data

evaluation described here. Computer-assisted self-interviews (CASI) will be administered to increase

privacy and lessen the workload for staff. The interview will focus on recent (last 6 months) behavioral

characteristics. Clients unable to conduct a CASI will be offered assistance (computer-assisted personal

interview).

Sampling frame: Up to three AICs will be selected for this PHE. At the selected AICs, clients' data will be

evaluated identified HIV-positive persons will be consecutively offered participation. For every 5th HIV-

positive client enrolled, we will enroll the next available (consenting) client. Individuals testing as couples will

both be offered participation, as long as at least one couple member tests HIV-positive. For each HIV-

positive couple enrolled, the next available concordant negative couple will be offered enrolment.

Target sample size for analysis: ~5,000

At the three largest AIC branches, approximately 25,000 persons undergo. The HIV prevalence in this

group is approximately 10%. We assume that 5%-7% of HIV-infected clients will be identified by additional

laboratory testing as having been "recently" infected. The target sample size comprises three groups:

Recent: ~100 recently HIV-infected clients.

Long-term: ~2400 "long-term infected" clients.

Negative: ~2500 negative clients. For risk factor analysis, matched with HIV-positive clients by AIC site,

age, sex, and reason for testing.

Total: 5,000 (~100 recent, 2,400 long-term infected, 2500 uninfected).

Sampling period: Sampling will be continuous.

Laboratory procedures: Routine tests for VCT will identify all HIV-positive and negative clients). The

laboratory procedures for this surveillance system apply to HIV-positive specimens only: A venous blood

sample will be drawn. CD4 testing will be performed at the CDC laboratory in Entebbe. Specimens with a

CD4 count <350/µl will be assumed to be long-term infected. Specimens with a CD4 count =350/µl will

undergo testing with the BED serological HIV incidence assay. Specimens test "positive" by the BED assay

if the infection had occurred within on average of 155 days. CD4 test results will be provided back to the

testing facility to facilitate assessment of HIV treatment eligibility, incidence assay results will not be

communicated back to the client.

Classification of HIV infection status:

"HIV-recent": 1) clients testing BED-positive, or 2) repeat testers testing HIV-positive within six months of a

documented HIV-negative result at the same facility (irrespective of laboratory-based classification)

"HIV-long term": 1) clients testing BED-negative, or 2) clients with a CD4 count <350/µl

Data analysis: We will exclude clients aged <15 years as well as clients who undergo diagnostic testing

(illness). Data will be analyzed on an annual basis. Three groups will be described, and compared:

Recently infected clients (=6 months)

Long-term infected clients (> 6 months)

Uninfected clients (serve as "controls" in the analysis of risk behaviors)

Risk factors for HIV acquisition will be evaluated by analyzing and comparing recently infected and

uninfected individuals.

Risk factors for HIV transmission will be described by analyzing recently and long-term infected individuals.

As an ongoing surveillance system, these risk behaviors will be monitored over time and determinants

leading to the "last 1000" HIV infections described.

Limitations:

Serological incidence assays have imperfect sensitivity and specificity. However, the assays' accuracy is

sufficient for the purpose of this surveillance system, and work to improve the accuracy of HIV incidence

testing is ongoing. VCT clients are not fully representative for the general adult Kampala population. Still,

assuming that sampling bias is stable over time should ensure adequate monitoring of acquisition and

transmission risk behaviors.

Population of Interest: The target population is the general population in Kampala, Uganda. Sampled VCT

clients serve as a proxy.

Activity Narrative: Budget Justification:

Costs are related to computer hard- and software to collect interview data, site staff time, as well as

laboratory testing costs. Other costs (laboratory staff time, data analyst time) are covered by routine CDC

Uganda operational costs.

Status of study: This is a new activity. The protocol has yet to be developed.

Lessons Learned: Awaiting project implementation.

Information Dissemination Plan: Dissemination of results will occur through and at workshops, meetings,

conferences, and publications. Dissemination will be conducted with participating implementing partners,

Ugandan MOH officials and other local stakeholders.

Planned FY08 activities: Protocol development, human subjects review, project implementation.

Budget Justification for FY08 monies:

Salaries/fringe benefits: $25,000

Equipment: $20,000

Supplies: $3,000

Travel: $0

Participant Incentives: $0

Laboratory testing: $25,000

Other: $2,000

Total: $75,000

Funding for Strategic Information (HVSI): $50,000

FY07 COP activity number: 10084

This activity is a continuation from FY07 and has not been updated.

Title: Evaluating the Utility of: (1) Using Routine Program HIV testing Data for Surveillance and (2) the HIV-1

Incidence Assay for Incidence-Based Surveillance

Time and money summary: Year 2 of activity; 2007 - 2009; Expended $0 to date, Expected $100,000

needed for completion (including FY08 request).

Local Co-investigators: Wolfgang Hladik, Frank Kaharuza, CDC-Uganda; Alex Opio, Wilford Kirungi,

Ministry of Health

Project description: The traditional ante-natal clinic (ANC) based surveillance system relies on unlinked

anonymous HIV testing (UAT), is relatively small (~10,000 clients/year) and slow in detecting changes in

trend. In Uganda, PEPFAR is the largest donor for HIV testing for PMTCT and VCT clients. Such routine

testing programs generate large amounts of HIV testing data (PMTCT: 250,000, VCT: >75,000 in 2005),

therefore having the potential of facilitating more precise prevalence estimates for surveillance. Importantly,

HIV-positive left-over blood from these programs can be tested with HIV incidence assays, with the

prospect of establishing an incidence-based surveillance system for a more timely detection of trends in

Uganda's HIV epidemic.

This activity evaluates the utility of routine PMTCT, VCT, and STD program data and specimens for an

expanded prevalence and a new incidence-based surveillance system. Potential biases and limitations to

be examined include self-selection bias for testing and the accuracy of laboratory-based incidence testing

for surveillance.

The new methodologies will be piloted at no more than a total of 10 PMTCT/VCT/STD clinics. Routinely

collected program data will be transcribed and left-over HIV-positive blood will be collected on filter paper

for incidence testing. As PMTCT and STD clinic clients are not consented for further testing and data

analysis, testing of these left-over specimens will be performed unlinked, akin to the traditional UAT-based

ANC surveillance system. VCT clients are routinely consented for further testing and analysis allowing a

more in-depth analysis using the standard VCT client questionnaire data. Same site PMTCT and UAT-

based prevalence data will be compared, as well as PMTCT/VCT/STD-based incidence estimates

generated.

The sampling populations constitute PMTCT/VCT/STD clinic clients. Akin to traditional ANC-based

surveillance, PMTCT/VCT based prevalence (and incidence) estimates and trends would be extrapolated to

the general adult populations with or without adjustments; STD clinic clients serve as a high-risk group

sentinel.

Status of study: The protocol was developed and is currently under review locally. We anticipate that this

activity will commence its "field activities" by January 2008.

Lessons Learned: Awaiting project implementation.

Information Dissemination Plan: Dissemination of results will occur through and at workshops, meetings,

conferences, and publications. Dissemination will be conducted with participating implementing partners,

Ugandan MOH officials and other local stakeholders.

Planned FY08 activities: During FY08, the study protocol will undergo further review until human subjects

review is complete. Data collection will then begin as described above, as well as the serological incidence

testing, followed by data analysis and dissemination of findings.

Budget Justification for FY08 monies:

Salaries/fringe benefits: $6,000

Equipment: $8,000

Supplies: $4,000

Travel: $0

Participant Incentives: $0

Laboratory testing: $27,000

Other: $5,000

Total: $50,000

Funding for Management and Operations (HVMS): $110,091

The CDC Informatics Unit provides technical assistance for the development and implementation of

strategic information systems to the country office and national prevention, care and treatment

implementing partners. These service providers, who are key recipients of PEPFAR funds, are given direct,

hands-on support by the informatics team to design strategic information systems tailored to meet the

specific needs of the programs and to build institutional capacity across the organization. The team actively

engages partner management and clinic staff at all levels to build consensus and develop applicably

standards for effective information system development. Strategic information program interventions range

from the design of patient care records, clinic management and logistics system to the integration of

monitoring and evaluation of national indicators between the MOH HMIS and the PEPFAR program.

CDC Uganda informatics Unit will continue to provide guidance to our partners and develop software

following proven computer software design techniques such as structure programming, industrial data base

data management standards will be used and taught. System development planning will be based on the

practical needs of the partner, the expected long term resources available to the partner, and the skills and

capabilities of the partner.

Through coordination with our PEPFAR and CDC Uganda Program unit we have developed an in depth

understanding of Uganda's infrastructure and our partner's resources, capabilities and desires. CDC

Informatics has a number of highly skilled, well educated individuals who understand our mission is to assist

our partners in developing there capabilities and abilities. For the most part our partners have become

capable of maintaining the initial less complicated data base and data entry systems. They recognize the

need for better data quality control, and better reporting tools.

We have partners that are using and tracking thousands to a little over a hundred thousand patients.

The Uganda infrastructure is lacking in reliable power and computer connectivity systems. Some areas

have no access to internet, telephone or power. Developing systems that allow these areas to be included

in surveillance system will require multiple capability systems that are standardized. Multiple parties

working independently on the same problems often create incompatible systems which reduces efficiency

and causes

In following activities initiated in FY05, FY06 and FY07, the Informatics Unit will focus on the following key

areas in FY08: investigate and where applicable develop computer related capabilities such as biological

patient recognition, computer power sources, and hand held computers which support our public health

partners, support the MOH resource center development of computer capacity for national data collection

and reporting; connectivity and computer infrastructure from internet access to specific network topology

design and implementation; applications development for the creation of standard information systems and

tools for management and clinic facilities; development and design of SI collection instruments; data entry

and management; analysis and reporting of SI; and, information and infrastructure security and

maintenance. Training in each of these areas will also be developed and supported either directly by the

CDC Informatics team or through utilization of outside resources and partners. The goal of training and

technical support provided will be to build capacity in partners to implement and maintain their own HMIS

with limited on-going technical support from CDC. Technical assistance will also be provided in the

interconnectivity of MIS for all partners into the national HMIS and USG systems where required or relevant.

Finally, the CDC Informatics Unit will conduct on-going SI needs assessments of partners to ensure

informatics resource growth to match needs necessitated by increasing care and prevention activities. The

increases in demand reflect the success in implementing initial programs since the partners have used

these initial systems and by passed the systems capacity. This activity works closely with MEEPP to

maximize synergies and avoid duplication.

Funding for Management and Operations (HVMS): $1,093,100

During FY 2008 the CDC-Uganda laboratory will continue to offer the high quality HIV related services

provided in FY07; these include serological testing for HIV, HHV-8, HSV-2, and Hepatitis B; CD4+ and

CD8+ cell counting, hematology, serum chemistry and viral load testing. The laboratory also introduced

PCR techniques in FY07 to diagnose HIV from dried blood spots collected from infants. Testing services

were provided for CDC evaluation activities and for partners who had no established laboratory capacity of

their own. The CDC laboratory also provided technical assistance and training for lab staff of several

PEPFAR implementing partners and to Ministry of Health (MOH) public facilities in order to enhance

national laboratory services capacity. In FY 2008, the CDC laboratory will also continue to assist in health

service policy development and the restructuring of MOH Central Public Health Laboratory (CPHL) to take

on a central role in improving the standards of testing in health service laboratories, including HIV testing

services.

In addition to expanding this initiative in FY08, the need for laboratory management training will also be

addressed as well as the continuation of the roll-out training program for rapid testing.

In FY08 CDC laboratories will continue to support partners by providing services where they are not

available and will also continue to assist in building capacity in both partner laboratories as well as MOH

laboratories. Skills, such as PCR for the national HIV infant testing programs will be disseminated to other

laboratories with capacity so the program can be extended to cover a greater proportion of the population.

This will entail provision of technical training sessions at the CDC laboratories, follow-up and support

supervision to ensure quality of testing and enrollment in external quality assurance programs. In order to

integrate services and technical assistance the CDC laboratory will work closely with the MOH Lab

Technical Committee (LTC) and with the health labortory service sector. This includes the Ministry of

Health, in developing a national laboratory health service policy, the Ministry of Education and Sport to

support laboratory technician training schools, the Central Public Health Lab to develop its role in

coordination of reference laboratory and lab support programs, the National TB/Leprosy Laboratory (NTLP)

to provide quality assurance programs and re-establishing an HIV Reference Lab (HRL). The CDC

laboratory will also continue to work closely with the National Medical Stores for commodity procurement;

and will continue to provide high-end diagnostic services required for eligibility screening and monitoring of

patients on ART, as well as developing, validating and monitoring new, appropriate approaches to

diagnostic testing. The laboratory will upgrade its procedures to obtain College of American Pathologists

(ACP) accreditation, thus ensuring that testing procedures and results meet internationally acceptable

standards.

Funding for Management and Operations (HVMS): $349,852

In FY 2008 this funding will cover the CDC-Uganda management and operational expenditures of the

Tororo field station to ensure all activities are fully mplemented.

Funding for Management and Operations (HVMS): $552,208

In FY 2008 the HHS/CDC Information Technology Services Office (ITSO) has established a support cost of

$3280 per workstation and laptop in each country office to cover the cost of information technology

infrastructure services provided to the field by ITSO Atlanta. This cost includes support for the base-level

of connectivity for the primary CDC office in-country and connection to the HHS/CDC global network;

maintaining the IT equipment located in the field offices as refreshed and updated on a regular cycle; and,

strengthening the ITSO global activities team in Atlanta to better support the field. In addition, this funding

will support the full implementation of the ITSO regional technology services executives to be deployed for

in-country technical assistance as needed. This is a structured cost model which represents the 'cost of

doing business' and has been mandated for each country to ensure full service delivery.