PARTNER: Johns Hopkins University Bloomberg School of Public Health

Title of Study:

Effectiveness of food by prescription programs for severely malnourished HIV+ patients

Time and Money Summary:

Expected timeframe: 1 year, Budget Year 1: $90,000

Local Co-Investigator:

Dr. Solomon Gashu, Medical Director, St. Peter's Specialized Tuberculosis Hospital

Project Description:

Nutritional support is considered an essential part of a comprehensive HIV/AIDS package. Data indicate

that nutrient intake can improve ART absorption and is associated with medication adherence among ART

patients. Studies have shown that moderate to severe malnutrition (Body Mass Index, or BMI<17) at the

time of starting ART and severe anemia are independent predictors of mortality and likewise screening and

managing malnutrition among PLWH starting ART has survival benefits. USG partner Johns Hopkins

University (JHU) Technical Support For The Ethiopia HIV/AIDS ART Initiative has developed a plan to

introduce a food by prescription program (FBP) at the ART clinic at St. Peters' Specialized Tuberculosis

(TB) Hospital in Addis Ababa. Food by Prescription provides therapeutic and supplemental food to patients

on ART, pregnant or lactating HIV+ women, and HIV exposed children. A baseline nutritional assessment

of ART clients and then follow-up assessment after 6 months of nutritional support will be undertaken.

Change in body mass index, CD4 count, functional status, opportunistic infections and mortality, will be

compared to a historical cohort of patients that did not receive nutritional interventions.

Evaluation Question:

This proposal will address the following questions:

1) What are the baseline nutritional indices for patients about to start ART?

2) How do these indices vary by TB/HIV co-infection?

3) Does an intensive six month FBP intervention for severely malnourished patients improve patient

outcomes as measured by decreased mortality and morbidity?

4) What is the cost-effectiveness and sustainability of the FBP program?

Programmatic Importance:

Achieving food security and appropriate nutritional support is difficult in environments such as Ethiopia that

have been long plagued by food insecurity. This problem is especially evident among patients who are co-

infected with HIV and tuberculosis. For example, registry data of ART patients at St. Peters Specialized TB

hospital indicate that 19% of patients weigh less than 40 kilograms (kg) at the start of ART and 3% of adults

weigh less than 30 kg. In an analysis of survival, underweight patients had an increased risk of dying in the

first year of follow-up after initiating ART.

The currently measured early mortality rate among the Ethiopia national program is close to 10%; however

rates are as high as 14% among TB/HIV infected patients. Follow-up data indicate that this mortality occurs

usually within the first three months; however, a second peak occurs between 8-12 months and is likely due

to immune reconstitution. We believe much of this early mortality may be associated with severe

malnutrition, anemia and co-infections with subclinical opportunistic infections. Once patients start ART,

many report poor adherence due to the lack of consistent food and subsequent gastro-intestinal distress

with the medications. Providing patients with food supplementation and therapeutic feeding during this

early phase of ART initiation is likely to reduce this early mortality rate and will hopefully lead to improved

medication adherence. This is important for the overall program to reduce the development of resistance

from poor adherence and to encourage more patients to accept ART even when severely debilitated. It will,

as well, lead to patients who more quickly return to a functional status and have improved quality of life.

Methods:

1) Baseline nutritional assessment among pre-ART patients ready to start ART at St. Peters: A standard

nutritional questionnaire and nutritional screening tool (including BMI, mid-upper arm circumference and

diet review) will be developed and administered to all patients found eligible for ART, pregnant and lactating

HIV+ women and HIV+ and exposed children. Patients will be coded according to level of malnutrition with

severe malnutrition defined as BMI < 17. For children, standard z-scores will be used to assess

malnutrition. Any person with severe malnutrition will be offered the FBP intervention at the time of initiating

ART. A sample size of 200 is expected over the 12 month period of intervention; however all consecutive

patients who qualify will be enrolled into the study.

2) Food By Prescription Intervention: JHU will partner with the Ethiopian national FBP program with other

PEPFAR partners, UNICEF and other partners. This program will provide intensive therapeutic and

supplemental nutritional support, including ready to use therapeutic foods (RUTF) such as fortified flours

(e.g. First foods, Advantage or Foundation plus), prepared feeding (e.g. F75, F100), and biscuits and

PlumpyNut for children. Additionally, safe water will be secured for all patients in the program to avoid

diarrheal diseases. Counseling and education regarding local foods and nutrition will be conducted.

3) Evaluation of outcomes: After the patients have received 6 months of the food intervention and ART, and

evaluation of outcomes will be made. Comparison of change in weight, BMI, z-scores, CD4, and number of

opportunistic infections, loss to follow-up and death will be made between the patients receiving the FBP

support and a historical cohort at St. Peters with similar low weight who did not receive nutritional

intervention. Likewise, comparisons can be made with other ART programs that have not yet initiated the

FBP program. Factors associated with the outcomes of interest will be compared between the intervention

and comparison groups and independent risks measured using the chi-square and t-test analyses.

Multivariate analyses will be performed to identify independent risk factors while controlling for confounders,

such as TB/HIV co-infection or immune reconstitution inflammatory syndrome (IRIS).

Activity Narrative: 4) Cost effectiveness: Costs for the FBP program will be compared to costs related to early mortality and

morbidity avoided with the intervention program.

Population of Interest:

The populations of interest are HIV+ clients, pregnant and lactating HIV+ women, HIV+ and exposed

children attending ART clinic who are severely malnourished and/or eligible for food by prescription

Information Dissemination Plan:

Stakeholders include the Ministry of Health (MOH), Addis Ababa Regional Health Bureau, local non-

governmental organizations and faith-based organizations working in these communities, health care

providers, PEPFAR and other entities involved in the support of health care delivery. In the planning phase

of the evaluation, stakeholders meetings will be organized to describe the goals of the evaluation.

Stakeholders will be involved in review of the assessment form and the indicators to measure malnutrition.

MOH personnel will be involved in the gathering of data and review of findings. Results will be

disseminated in a review meeting for the region and findings will be shared with PEPFAR and other

partners.

Budget Justification for Year One Budget:

Baseline & follow-up survey

Coordinator (responsible for developing assessment, training assistants, standardization)$10,000

Dietary and nutritional assessment survey assistants - $15,000

Materials - $1,500

Transportation (to and from evaluation site) - $1,500

Data collection, management and analysis - $15,000

Intervention

Materials (includes educational and training materials) - $10,000

FBP program covered by other PEPFAR partners

On-site Training (on FBP) - $5,000

Office supplies and forms - $2,500

Transportation (Coordinator to travel to site weekly) - $6,750

Miscellaneous costs, telecommunications - $1,000

Review and stakeholders meetings- $10,000

Subtotal - $75,290

Indirect Costs - 18.8%

Total - $90,000

New/Continuing Activity: Continuing Activity

Continuing Activity: 18834

Continued Associated Activity Information

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

System ID System ID

18834 18834.08 HHS/Centers for Johns Hopkins 7485 3787.08 Support for $90,000

Disease Control & University program

Prevention Bloomberg School implementation

of Public Health

through US-

based

universities in

the FDRE

Table 3.3.11:

Title of Study: Public Health Evaluation of Training of Health Providers in Health PEPFAR funded health

centers in Ethiopia

Time and Money Summary:

The evaluation will be conducted from April 2008 to March 2009, pending clearance of the revised protocol,

and is expected to cost $150,000 for Year 2.

Local Co-Investigator: Marion McNabb, Mesrak Nadew, Yassir Abduljewad, Anne Pfitzer, Dr Anteneh

Worku, Petros Faltamo

Project Description

The availability of trained and competent service providers in delivering quality HIV/AIDS services is of

utmost importance in the Ethiopian context. Ethiopia's single point HIV prevalence is 2.1%, which translates

into a target of 350,000 eligible for ART in order to obtain the universal access for ART by 2010. The

Ministry of Health's 2005-06 publication "Health and Health Related Indicators" reported that there is one

physician for every 35,493 people and one nurse for every 4,207 people in Ethiopia. The numbers are

significantly below the WHO international standards for physicians with the standards set at one physician

for 10,000 people and near to the nurse ratio of one nurse for every 5,000 people making access to regular

healthcare services by skilled

There have been multiple reports of high attrition of health care providers in Ethiopia. The resources and

efforts put into PEPFAR training have been enormous. It is important to provide measurable information and

assess training effectiveness periodically. In the context of the Ethiopian scale up of ART services, health

centers were recently added as service provision sites. COP08 will be an opportune time to review the

effectiveness of training programs at this health facility-level to refine strategies for the future.

Status of study/progress to date

In FY07, JHPIEGO was funded to conduct an evaluation that will provide feedback to PEPFAR Ethiopia

regarding the effectiveness and cost of investments to train health care workers at facilities. The evaluation

included descriptive review of training processes and methodologies utilized by PEPFAR implementing

partners employing a quasi-experimental data collection methods to assess the performance of trained and

untrained providers(either on the job or in a simulation) on specific knowledge and skills included in the in-

service training they received. Additionally, the evaluation measured the attrition rates and reasons for

attrition.

The main evaluation questions were:

1) What proportion of health care workers who have attended training funded under PEPFAR are still in the

post they were in at the time of training?

2)Where are the providers that left the facilities?

3)How effectively are health care workers performing on specific skills for which they were trained?

4)What was the average training cost per trainee, by category of knowledge and skills of the training event?

What is the anticipated cost for re-training providers?

5)How are the PEPFAR trainers being used within the program and how many training events have they

conducted?

6)What is the perceived risk of HIV infection in providers trained versus providers not trained in providing

HIV services?

JHPIEGO reviewed PEPFAR Ethiopia's Training Information Management Information System (TIMS) for

data on providers trained in HIV/AIDS services to identify the population of health care workers trained by

PEPFAR in all areas of prevention, care and treatment at hospitals. Accordingly, data were collected from

selected but representative cohort hospitals in Ethiopia. Due to funding limitations in COP 07 the sample

only included hospitals.

The skills of trained providers were evaluated by comparing skills that providers are expected to have post-

training versus skills that are displayed at the time of assessment using standardized case study

assessment tools which were developed using competencies agreed upon in Ethiopia and all PEPFAR

Ethiopia Training Partners reviewed and approved the tools.

Surveys were distributed to PEPFAR Ethiopia's university partners to determine the costs of training. The

protocol was finalized and submitted for the CDC Institutional Review Board approval.

Planned FY08 Activities:

In COP08, JHPIEGO proposes another Training Evaluation with a similar study design and the same

objectives, but with a protocol targeting staff at health centers. The evaluation will assess similar elements

as the hospital version collected: including trainers, cost, and competency of providers and attrition rates of

providers at the health center level. The selection of health centers will be confined to those networked to

hospitals. JHPIEGO will work closely and collaborate with implementing partners that have trained staff at

health center level in refining the protocol and evaluation tools, including US agencies and

international/local partners. The evaluation of training effectiveness will provide useful information across all

PEPFAR funded training programs; working closely with PEPFAR partners on the evaluation will bring

greater impact. The availability of trained and competent service providers in delivering quality HIV/AIDS

services is of utmost importance in the Ethiopian context. Ethiopia's single point HIV prevalence is 2.1%

which translates into a target of 350,000 eligible for ART in order to obtain the universal access for ART by

2010. In 2005/06 the Ministry of Health document "Health and Health Related Indicators" that there is one

physician for every 35,493 people and one nurse for every 4,207 people in Ethiopia. The numbers are

significantly below the WHO international standards for physicians with the standards set at one physician

for 10,000 people and near to the nurse ratio of one nurse for every 5,000 people making access to regular

healthcare services by skilled providers limited for a significant proportion of Ethiopians.

Information Dissemination Plan:

Activity Narrative: The findings can be used by HAPCO and the Human Resource Department of Ministry of Health, Regional

Health Bureaus, and PEPFAR partners that invest in in-service training for capacity building. The study will

also inform retention strategies with a specific focus on the needs of health centers

Budget Justification for FY08 monies:

Given experience to date and the breadth of the proposed FY08 scope of work, the study is budgeted at

$150,000 in COP08. The funding will be used for protocol development, recruitment of data collectors,

training of data collectors, data collection and supervision, data cleaning, entry and analysis, dissemination,

salaries of staff, other direct costs and Johns Hopkins University financial and administration costs.

This is a continuing activity in COP 08 originally planned with JHPIEGO-E as Prime Partner. It was

erroneously entered in the databasewith JHU -Bloomberg as prime partner. The activity is to conduct a

targeted evaluation on the effectiveness of Training for staff at Health Centers under PEPFAR -E. The

findings of the evaluation will provide useful information across all PEPFAR funded training programs ,

partners and stakeholders to identify the retention and attrition status of trained health care providers.

JHPIEGO-E is a prime partner which has a strong potential in conducting targeted evaluation. CDC-E will

provide guidance and follow up of the targeted evaluation.

New/Continuing Activity: Continuing Activity

Continuing Activity: 18789

Continued Associated Activity Information

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

System ID System ID

18789 18789.08 HHS/Centers for Johns Hopkins 7485 3787.08 Support for $0

Disease Control & University program

Prevention Bloomberg School implementation

of Public Health

through US-

based

universities in

the FDRE

Table 3.3.14: