This funding will be utilized by CDC-Ethiopia to provide technical assistance to standardize IEC/BCC

activities with in the CDC-Ethiopia program areas including TB/HIV, Blood Safety, STIs, ART, Palliative

care, prevention with positives, VCT, etc. Local and international TA will work as a team. Part of the funding

under this activity will also be used to strengthen the technical assistance to MARCH program partners in

terms of reproducing the Print Serial Drams, strengthening reinforcement activities by producing new and

using existing IEC/BCC materials and resources to support the MARCH program.

New: 10/7/08

Evaluation of Interventions to Reduce Early Mortality among Adults Initiating ART in Emergency Plan

Countries

Background:

Several reports of HIV-infected adults initiated on ART in resource-limited settings suggest that 10-15% of

patients die within 12-18 months of starting therapy, and a high proportion of these deaths occur within the

first 90 days of initiating therapy (let's use 12 month data - need source). Little information is available

about what causes early deaths of patients on ART in resource-limited settings, however TB and

cryptococcal infections are the probable etiology in a substantial proportion these deaths (source).

This is a multiyear protocol designed to allow interested countries to join on an ongoing basis. Similarly, the

protocol infrastructure will allow for additional interventions to be added over time.

Primary Objectives:

1) Establish an infrastructure to monitor the extent and causes of early mortality among patients eligible for

and initiating ART. This will be a platform that provides the opportunity for multiple countries and sites to

participate,

2) Evaluate interventions to reduce early mortality among patients initiating ART, with a focus on the first 3

months following ART initiation.

Secondary Objectives:

1) Evaluate the impact of enhanced TB case finding and treatment on early mortality

2) Evaluate the impact of enhanced screening and treatment for cryptococcal disease on early mortality

3) Compare cost-effectiveness of interventions

A subset of the participating sites will be eligible for participation in addressing these secondary objectives,

based on minimum criteria, including laboratory services, retention in care, as specified in each of the

substudies.

Countries will provide estimates of 6 and 12 month mortality.

Clinical Sites and Study Population:

Patients eligible for ART or on ART in programs are eligible for this PHE; sites should be selected to reflect

the range of HIV care sites within a country, considering regional, urban/rural settings, and level of clinical

and laboratory services. Participating sites should have been treating ART patients for at least 1 year and

should be actively enrolling at least 10-20 new ART patients per month. Patients should be followed up

monthly for the first 3 months, and then at least quarterly thereafter.

Sites will be randomized to be intervention or control sites. Intervention and control sites should be

matched by country, region, urban/rural location, level of laboratory services, and patient volume.

Inclusion Criteria:

Participating countries will consent, enroll, and follow for at least 1 year adult patients as defined by the

country but expected to be >15 years of age, who are ART-naïve with a CD4 count <350 and/or stage III

disease, and who are ART eligible or initiating ART.

Patients need to be followed at the same medical facilities, or mechanisms need to be in place to follow

patients at facilities to which they are referred, for the 12 month period of follow-up.

The sites will record information on patient visits and follow-up, record routine testing performed (e.g., Hg,

CD4, VL, and chest x-ray), specific ART drugs provided, and other site-specific interventions (e.g., provision

of nutritional supplementation for patients with low BMI).

The sites will follow a standard procedure for ascertaining and recording key outcomes (mortality, loss to

follow-up, transfer out, default).

Exclusion Criteria:

Patients who have received ART previously will be excluded except in the case of women who have

received short-course therapy only for PMTCT. Additional exclusion criteria may apply to the specific

substudies.

Endpoints:

The primary endpoint will be mortality during the first year of ART. A secondary endpoint will be treatment

failure, using AIDS-defining illness and WHO criteria.

Staffing needs and responsibilities:

1) Site coordination

2) Country-level data management

3) Laboratory coordination

4) Country coordination

Steering Committee:

Each participating country will organize a country steering committee, including representatives from the

MOH, clinical partners, and USG staff.

Each country will designate a representative to the overall steering committee. The overall steering

committee will also include technical experts from the USG agencies.

The overall steering committee will develop principles for collaboration, including procedures for decision

making, data storage and access, and authorship.

Data Safety and Monitoring Board (DSMB):

Activity Narrative: A plan for review by a PEPFAR-organized DSMB of baseline data and at 3, 6 and 12 months of follow-up.

Budget:

$ 500,000 will be allocated for this multi country PHE which will be centrally coordinated and managed.

The number of sites and the sample size Ethiopia will have for this PHE will be determined based on the

number and extent of other countries' participation as well as guidance from the OGAC team involved in

coordinating and managing this multi country PHE.

Management and staffing (HVMS) CSCS Charges CDC Ethiopia

Background: The CSCS Program is designed to (1) generate $17.5 billion over 14 years to accelerate the

construction of approximately 150 new secure, safe, and functional diplomatic and consular office facilities

for all U.S. Government personnel overseas, and (2) provide an incentive for all Departments and agencies

to right size their overseas staff by taking into account the capital costs of providing facilities for their staff.

To achieve these objectives, the CSCS Program imposes a per capita charge for (a) each authorized or

existing overseas position in U.S. diplomatic facilities, and (b) each projected position above current

authorized positions in those New Embassy Compounds (NECs) that have already been included in the

President's Budget or for which a contract has already been awarded.

FY08 CSCS charges are included for 73 unclassified desk positions, 18 non-desk positions, and CDC

Ethiopia share of CSCS for ICASS, and rent credits are as follows:

desk 1,196,543.00

non-desk 51,066.00

office rent (66,000.00)

warehouse rent (29,028.00)

share of CSCS for ICASS 79,740.00

total 1,232,321.00

rounded 1,233,000