Detailed Mechanism Funding and Narrative

Details for Mechanism ID: 11938
Country/Region: Ethiopia
Year: 2009
Main Partner: Johns Hopkins University
Main Partner Program: Bloomberg School of Public Health
Organizational Type: University
Funding Agency: HHS/CDC
Total Funding: $0

Funding for Treatment: Pediatric Treatment (PDTX): $0

Added 10/21/08

This is approved country specific PHE activity. Reprogramming is taking place to reflect change of Prime

Partner and Agency. Prime Partner is changed from To Be Determined to the Ethiopian Public Health

Association (EPHA) and agecy is changed fro State Department/OGAC to HHS/CDC.There will be no

change in emphasis, coverage area or target population.

The narrative of this activity remains the same. The only change will be that it was initially proposed as a

potential multi country protocol, but now, it is approved and will be undertaken as a country specific Public

Health Evaluation (PHE).

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PARTNER: Johns Hopkins University Bloomberg School of Public Health

Title

Identifying Groups with Poor Access to ART - potential Multi Country Protocol

Time and Money Summary:

Expected timeframe: 1 year, Total projected budget: $ 100,000

Local Co-Investigators: In Ethiopia, this study would be carried out by Johns Hopkins University (JHU)

Technical Support For The Ethiopia HIV/AIDS ART Initiative (TSEHAI) as a supplement to the JHU/TSEHAI

Advanced Clinical Monitoring (ACM) of ART in Ethiopia project, which is governed by a Memorandum of

Understanding with 10 Ethiopian institutions.

Primary evaluation question:

What patient factors affect whether patients initially enroll in the national ART program at an early or late

clinical stage of disease?

Project Description:

This case-control study is designed to identify target groups with comparatively poor access to enrollment in

a country's national ART program. It takes advantage of the insight that hospitalizations for conditions

amenable to primary care can be used as indicators of poor access to primary care. The relationship of

access to demographic characteristics, risk behaviors, attitudes to HIV and pathways to care will be

assessed.

Programmatic importance:

Both WHO and the Institute of Medicine report evaluating PEPFAR have expressed great concern about

possible inequities in access to care for women, rural populations, the poor, and other vulnerable groups.

WHO said in April 2007 that in monitoring progress toward universal access to HIV/AIDS prevention,

treatment and care, "Higher priority must be given to promoting, monitoring and evaluating equity in access

to services. …special studies will be needed in order to help to understand uptake patterns, factors which

inhibit or facilitate access to services for men and women, and potential differences in clinical outcomes."

After these factors are identified, interventions targeting them can be developed.

Population of interest:

This study uses case-control methodology to compare the characteristics of three groups: (1) Cases:

Patients with "late" access to care, who are admitted to hospital wards with HIV disease without ever having

received outpatient HIV care. (2) Control group A: patients who enroll in ART "timely," become eligible due

to a CD4<200 without ever having developed WHO stage III or IV clinical disease, and (3) Control group B:

patients with "intermediate" access, who enroll in ART after developing WHO stage III or IV conditions but

without ever having been hospitalized for HIV disease. Cases will be sampled from hospital ward logs.

Controls will be identified from ART clinic registers. They will be matched by facility and month of case

admission matched to month of control ART enrollment. 900 participants per country will be selected: 180

cases, 360 from control group A and 360 from control group B.

Methods:

The exposures shown in the table below will be abstracted from hospital and clinic records. Not all

exposures may be available for analysis in all countries or sites; they are available in Ethiopian nationally

standard ART clinic forms, and staff at ACM sites ensures that these data elements are captured. A subset

may be available in hospital charts. Conditional and ordinal logistic regression techniques will be used to

assess the association between each exposure and different levels of access to ART. To assess the direct

effect of demographic factors on access, it is necessary to control for the fact that different demographic

groups (e.g. men and women) may have been infected with HIV at different periods of the HIV epidemic in a

given country. Therefore multivariate regressions will be conducted including and excluding proxy variables

for length of infection: CD4 count and time since first positive HIV test.

Exposures:

Demographic: Gender, age, urban/rural residence, income/poverty status, level of education, religion,

employment, marital status, household composition

Behavior: Sex risk behavior, drug use behavior

Attitudes: Disclosure of HIV status, perceived stigma, depression, attitudes toward ART

Pathways to care: referral source, HIV support group member

Sample size calculation:

Activity Narrative: The sample size was based on the number of cases required to detect a 15% point difference between

cases and controls with rural residence (Power= 0.9, alpha=0.05, 1 case: 2 controls). Based on these

calculations, the total number of cases required was rounded up to 180. They would be matched at a ratio

of 1 case: 2 timely access controls: 2 intermediate access controls; therefore the number in each control

group was set at 360 and the total number of participants in Ethiopia at 900. The cases would be divided

evenly among participating facilities that serve both rural and urban patients. If the ACM sites are used for

this study in Ethiopia, there are 5 such sites; 36 cases, 72 timely access controls and 72 intermediate

access controls would be enrolled per site.

Dissemination plan:

The study will be cleared by CDC and the ACM steering committee for publication in professional journals.

Budget justification:

Ethiopian personnel - $ 24,400

Statistical support - $ 12,000

International travel - $ 7,000

Domestic travel - $ 2,250

Computers - $4,000

Supplies/Communications - $5,000

Total - $54,650

Total including indirect costs - $67,470

New/Continuing Activity: Continuing Activity

Continuing Activity: 18792

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

18792 18792.08 HHS/Centers for Johns Hopkins 7485 3787.08 Support for $100,000

Disease Control & University program

Prevention Bloomberg School implementation

of Public Health

through US-

based

universities in

the FDRE

Table 3.3.11: