Detailed Mechanism Funding and Narrative

Years of mechanism: 2008 2009

Details for Mechanism ID: 303
Country/Region: Kenya
Year: 2008
Main Partner: University of Nairobi
Main Partner Program: NA
Organizational Type: University
Funding Agency: HHS/CDC
Total Funding: $1,768,700

Funding for Biomedical Prevention: Prevention of Mother to Child Transmission (MTCT): $1,100,000

THIS IS AN ONGOING ACTIVITY. THE NARRATIVE IS UNCHANGED EXCEPT FOR UPDATED

REFERENCES TO TARGETS AND BUDGETS.

The only change to the program since approval in the 2007 COP is an expansion in geographic coverage to

include Kisumu East and Nyando Districts.

1. LIST OF RELATED ACTIVITIES

ARV services (#7095)

2. ACTIVITY DESCRIPTION

UON, Department of Obstetrics and Gynecology has been supporting implementation of comprehensive

PMTCT services in Kenyatta National Hospital (KNH) and Pumwani Maternity Hospital (PMH), the two

largest maternity units in the country and has successfully integrated these services as part of routine care

for all women accessing services here. Following the country's rationalization of geographical coverage to

ensure efficient resource utilization, there has been an expansion in the program's geographical coverage

to include support to implementation of PMTCT services in Kisumu East and Nyando districts in Nyanza

Province. In FY 2008, the program will continue to support these activities and will provide HIV counseling

and testing to 43,070 pregnant women provide ARV prophylaxis to 7,262 HIV positive pregnant women. Of

these HIV positive women 1,452 will be provided with Highly Active Antiretroviral Treatment (HAART) and

3,631 will receive more efficacious ARV regimens, while 2,179 will receive the minimum intervention of sd

Nevirapine . The program will strengthen comprehensive PMTCT including couple counseling. In

strengthening the linkage between PMTCT and HIV care services, the program shall support early infant

HIV infection diagnosis by use of Polymerase Chain Reaction (PCR) for 3,631 infants and link all eligible

infants to the pediatric ART program. The program shall strengthen the post natal HIV care clinic and shall

support identified facilities to initiate this strategy. Intra-partum and immediate post partum counseling and

testing shall also be strengthened with a target of reaching 80% of all women attending delivery services at

the maternity units within the program area. Currently over 50% pregnant women admitted in the labor and

delivery units do not know their HIV status. The program will also promote couple counseling and testing to

identify discordant and concordant couples to improve primary prevention and facilitate linkage to HIV care

and treatment program for the eligible. The program will support the training of 300 service providers on

PMTCT, Rationale use of ARVs, and Data collection and reporting in 70 facilities. In line with the capacity

building mandate of the UoN, the program in collaboration with NASCOP and DRH will facilitate a structured

platform for regular review of PMTCT research to inform and guide national PMTCT policy and practice.

3. CONTRIBUTIONS TO OVERALL PROGRAM AREA

PMTCT activities in these two high volume national referral facilities and Nyando and Kisumu East districts

will contribute to approximately 4% of 2008 overall Emergency plan PMTCT targets for Kenya.

Strengthening HIV counseling and testing of women during labor and around delivery will increase the

number of HIV-positive women accessing HIV care services. Couple counseling and testing will contribute

to more men knowing their HIV status and those who are positive will be able to access other HIV care

services. This activity also contributes to expansion of pediatric HIV care services.

4. LINKS TO OTHER ACTIVITES

This activity relates to ART program (#7095). All HIV-positive mothers, their infants and partners who are

eligible for treatment will be referred to the HIV/AIDS treatment and care services

5. POPULATIONS BEINGTARGETED

This activity targets Children under 5 years, adolescents aged 15-24 years, adults, discordant couples,

people living with HIV/AIDS and pregnant women.

6. EMPHASIS AREAS/ KEY LEGISLATIVE ISSUES ADDRESSED

This activity will increase gender equity in HIV/AIDS programs through providing PMTCT services to

pregnant women and their partners. Other emphasis areas include capacity building through supporting in-

service training for providers on comprehensive PMTCT programming that addresses all the four prongs,

wrap around programs for family planning, malaria and safe motherhood through the provision of

comprehensive PMTCT package that addresses all these elements. The comprehensive PMTCT package

includes focused antenatal care that addresses safe mother hood issues, malaria prevention through the

provision of insecticide treated bed nets for the pregnant woman and intermittent presumptive treatment for

malaria, and increased access to family planning with a focus on dual method for the HIV + mothers .

Funding for Biomedical Prevention: Prevention of Mother to Child Transmission (MTCT): $150,000

PHE CONTINUING STUDY:

Project Title (This is part of a multi-country study with other sites in Zambia and Thailand): Effectiveness of

non-nucleoside reverse transcriptase inhibitors-containing HAART in women with prior exposure to

nevirapine for PMTCT (NRS PROJECT)

Name of Local Co- Investigator: CDC Kenya and University of Nairobi

Project Description:

This project evaluates the response to non-nucleoside reverse transcriptase inhibitors (NNRTI)-containing

HAART (i.e. Nevirapine or Efavirenz) among women over 18 years who have been exposed to single-dose

nevirapine for PMTCT versus non-exposed women. The project is part of a multi-site prospective

observational cohort study being carried out in the comprehensive care center at Kenyatta National Hospital

in Kenya. The project is expected to inform program implementation to guide decisions on management of

women who after receiving single-dose nevirapine for PMTCT require treatment with HAART.

Timeline:

FY 2008 = Year 3 of activity

Year started: 2006

Expected year of completion: 2010

Funding:

Funds received to date: USD 400,000.00

Funds expended to date: USD 243,000.00

Funds requested to complete the study:

FY 08: USD 150,000

Beyond FY 08: USD 300,000

Describe funds leveraged/contributed from other sources:

There were no funds which were received from any other source. However, Kenyatta National Hospital

provided the facilities and support staff for the study.

Status of Study:

Recruitment of the participants was completed by January 2007. A total of 229 women have been seen in

the study clinic, 187 (82%) consented for screening, 157 (84%) of the screened were eligible and 152 (97%)

of the eligible were enrolled. Currently 22 participants have completed the study, 111 are continuing with

follow up, 3 have been lost to follow up and 17 have died. Under the current protocol the last participant is

expected to be seen in March 2008. Of 113 patients evaluated at 6 months 12 (11%) have had treatment

failure.

Lessons Learned:

1. Preliminary results do not indicate a higher than expected rate of treatment failure in this population

2. Treatment failure is captured earlier with use of viral load

3. Mortality rate is high in patients initiating treatment late in the disease stage particularly in the first month

after initiating treatment

4. Women identified in PMTCT programs maybe accessing ART at an earlier disease stage

5. Poor adherence is a common reason for treatment failure

Information Dissemination Plan:

The results of the study will be published in a peer reviewed journal. Furthermore, the findings will be

presented in national, regional and international conferences and seminars by the investigators.

Planned FY 08 Activities:

Continue follow up to of this well described cohort for 3 more years to determine

1. Clinical and virologic failure rates of first and second line HAART regimens

2. Frequency and patterns of drug toxicity and their impact on adherence and regimen durability

3. Reproductive health decisions and outcomes of the women on HAART including contraception,

pregnancy, and abnormal cervical cytology

Budget:

Salaries: $74,623.60

Fringe benefits 25% of Salary: $18,655.90

Supplies: $19,560.00

Study tests: $27,500.00

Participant fare reimbursement:$4,800.00

Post test support clubs:$2,160.00

Others: $7,500.00

Total costs: $150,000.00

Budget Justification for FY2008

The budget is prepared according to local costs of materials and equipment. Salaries have been calculated

in accordance with annual salaries for personnel involved in the programme.

Salaries and fringe benefits:

In project leadership the principal investigator will oversee protocol review and implementation and

supervise all data collection, entry and analysis procedures in the site. The co-investigators, will assist in

protocol review and personnel administration.

In administration the administrator will liaise with the University of Nairobi on personnel and financial

matters, while the accountant will keep records of financial transactions, prepare financial reports and

ensure procurement procedures.

Activity Narrative: The research clinic will be ran by the research doctor, research nurse, clinical officer, and a research

receptionist who will be responsible for clinical care of study participants, conduct of research procedures

and retention of participants.

The laboratory manager and laboratory technician will be responsible for day-to-day running of the

laboratory, overall maintenance of laboratory equipment, ordering laboratory supplies, archiving and

shipping of specimens.

Data management will be led by the data manager and the M&E/IT manager who will be responsible for

creating data bases, data entry and cleaning.

Supplies:

Stationery, office utilities, clinic supplies and laboratory consumables will be used to carry out daily activities

of the study

Study tests:

Tests including viral load, full haemogram, liver function tests, renal function tests and CD4 counts will be

carried out for study purposes

Participant fare reimbursement:

Participants will be reimbursed fare as approved by the Kenyatta National Hospital ethics and research

committee whenever they make scheduled study visits

Post test support clubs:

These will be held monthly for enrolled participants to promote retention

Others:

Communication costs will include telephone and internet to communicate between the administrative office,

clinic and laboratory. Office rent will be paid for the program office from where all activities will be

coordinated. Office utilities will include electricity and water charges for the program office The UON will

operate specific accounts for the program funds, conduct internal audits annually and provide quarterly

financial reports. Department of obstetrics and gynecology will Provide teaching aids, training equipment,

materials and training venues. KNH will waive consultation fees for participants who are not able to afford.

Funding for Biomedical Prevention: Prevention of Mother to Child Transmission (MTCT): $228,700

PHE CONTINUING STUDY:

Project Title: Evaluation of the Impact of the National PMTCT program in Kenya

Name of Local Co- Investigator: CDC Kenya and University of Nairobi

Project Description:

This project evaluates PMTCT services in a random sample of 2000 mother-infant pairs attending MCH

clinics in Kenya. The evaluation addresses 3 main questions: 1) HIV prevalence among mothers and infants

(prevention impact) and 2) availability and uptake of services (PMTCT, family planning, HIV care and

treatment) and 3) impact of service delivery on HIV knowledge and risk behavior. HIV prevalence will be

determined by testing maternal and infant dry-blood-spots with HIV ELISA and HIV DNA PCR, respectively.

Timeline:

FY 2008 = Year 2 of activity

Year started: 2007

Expected year of completion: 2008

Funding:

Funds received to date: USD 400,000.00

Funds expended to date: USD 12,500.00

Funds requested to complete the study:

FY 08: USD 228,700

Beyond FY 08: USD 0

Describe funds leveraged/contributed from other sources:

No funds have been received from any other source.

Status of Study:

Protocol development for the study is currently ongoing.

Lessons Learned:

Pilot studies indicate that infant HIV infection rates at 9 months may grossly overestimate effectiveness of

PMTCT programs due to higher mortality of HIV infected infants.

Information Dissemination Plan:

The results of the study will be published in peer reviewed journals. The findings will be presented in

National, Regional and International conferences by the investigators. A stakeholders meeting is planned

at the end of data collection to disseminate the study findings.

Planned FY 08 Activities:

To collect similar data from 3 communities in a high, medium and low HIV prevalence areas so as to

determine the extent of bias created by using a clinic based sample:

1.Over estimation of program impact by failing to reach mothers whose infants died or are too sick to attend

MCH

2.Under estimation of program impact by selecting for mother-infant pairs who likely to be seeking care due

to illness

Budget (USD):

Total salaries:$93,360.00

Fringe Benefits:$23340.00

Travel: $12,000.00

Supplies: $25,000.00

Laboratory costs:$15,000.00

Other costs: $60,000.00

Total: $228,700.00

Budget Justification for FY2008:

The budget is prepared according to local costs of materials and equipment. Salaries have been calculated

in accordance with annual salaries for personnel involved in the programme.

Salaries and fringe benefits:

In project leadership the principal investigator will oversee protocol review and implementation; and

supervise all data collection, entry and analysis procedures in the site. The co-investigators will assist in

protocol review and personnel administration.

In administration the administrator will liaise with the University of Nairobi on personnel and financial

matters, while the accountant will keep records of financial transactions, prepare financial reports and

ensure procurement procedures.

In the field data collection will be done by research assistants supervised by nurse counselors. And

coordinated by a field coordinator in each of the selected sites

The laboratory manager and laboratory technician, will be responsible for day-to-day running of the

laboratory, overall maintenance of laboratory equipment, ordering laboratory supplies, archiving and

shipping of specimens.

Data management will be led by the data manager and the M&E/IT manager who will be responsible for

creating data bases, data entry and cleaning.

Travel:

Activity Narrative: This will cover the cost of travel to and from the field sites.

Supplies:

Stationery, office utilities and field supplies will be used to carry out daily activities of the study

Study tests:

Tests on maternal and infant dry-blood spots including HIV DNA PCR for exposed infants and HIV ELISA

on maternal samples will be carried out for study purposes

Others:

Communication costs will include telephone and internet to communicate between Nairobi and the field

sites. Office rent will be paid for the program office from where all activities will be coordinated. Office

utilities will include electricity and water charges for the program office. Per diem will be paid to officers

outside their duty station and funds will also used to sensitize the community on the study.

Funding for Biomedical Prevention: Injection Safety (HMIN): $60,000

PHE CONTINUING STUDY:

Project Title: An Assessment of Injection Practices in Kenya

Name of Local Co- Investigators: Dr. Mark D. Joshi and Dr. James Kiarie

Project Description:

The Clinical Epidemiology Unit; University of Nairobi will perform this evaluation consisting of a national

survey based on collection of retrospective data on injection practices in formal and informal health care

delivery points and facilities. Health care facility records will be reviewed, key informants interviewed and

community focus group discussions conducted to assess attitudes, practices and adverse events related to

injections. Direct and indirect costs of therapeutic management via various routes of administration will be

determined. Reports generated through qualitative and quantitative data analysis will be disseminated to all

stakeholders through workshops, seminars and publications.

Timeline:

FY 2008 = Year 2 of activity

Year started: 2007

Expected year of completion: 2008

Funding:

Funds received to date:$125,000

Funds expended to date: $46,000

Funds requested to complete the study:

FY 08:$60,000

Beyond FY08: $0

Describe funds leveraged/contributed from other sources:

Principle investigators, accountant and project administrator work on project part time. Complement of their

salaries is met by the University of Nairobi. ($40,000)

Status of Study:

Investigators have obtained ethical clearance from Kenyan authorities (University of Nairobi / Kenyatta

National Hospital and Ministry of Science and Technology ethical committees) and are now seeking ethical

approval from CDC Atlanta.

Lessons Learned:

Pending.

Information Dissemination Plan:

The findings of this evaluation will be communicated to the Ministry of Health and other Kenyan

stakeholders through seminars and publication of a summary report.

Findings will also be published in appropriate peer review journals.

Planned FY08 Activities:

Field work and analysis will be completed in FY07. In FY08 the final report will be printed and disseminated

to the Ministry of Health and other stakeholders. These findings will serve to guide policy on injection use in

health care settings, training requirements, procurement of injectables and work place safety for health care

workers. Specific activities in FY08 include: printing of final report and dissemination seminars for Ministry of

Health, organizations implementing Injection Safety Programs and Medical professional associations

including nurses, doctors, clinical officers and pharmacists.

Budget Justification for FY2008 Budget (USD):

Salaries/ fringe benefits: $ 10,000

Equipment: $ 0

Supplies: $ 10,000

Travel: $ 15,000

Participant Incentives: $ 0

Laboratory Testing: $ 0

Other: (Printing) $ 25,000

Total: $ 60,000.00

Funding for Biomedical Prevention: Injection Safety (HMIN): $30,000

PHE CONTINUING STUDY:

Project Title: Assessment of Attitudes to use of Rectal Suppositories in Kenya

Name of Local Co- Investigators: Dr. Mark D. Joshi and Dr. James Kiarie

Project Description:

The Clinical Epidemiology Unit; University of Nairobi will perform this evaluation consisting of a national

survey to examine factors that may hinder acceptance of rectal suppositories in preference to injections for

the treatment of malaria and other medical conditions. This information will guide the development of IEC

messages and training material to enhance acceptability of effective suppository treatments that will

contribute to rational injection use. This would contribute to the prevention of HIV transmission through

medical injections.

Reports generated will be disseminated to all stakeholders through workshops, seminars and publications.

Timeline:

FY 2008 = Year 2 of activity

Year started: 2007

Expected year of completion: 2008

Funding:

Funds received to date:$75,000

Funds expended to date: $26,000

Funds requested to complete the study:

FY 08:$30,000

Beyond FY08: $0

Describe funds leveraged/contributed from other sources:

Principle investigators, accountant and project administrator work on project part time. Complement of their

salaries is met by the University of Nairobi. ($3,000)

Status of Study:

Investigators have obtained ethical clearance from Kenyan authorities (University of Nairobi / Kenyatta

National Hospital and Ministry of Science and Technology ethical committees) and are now seeking ethical

approval from CDC Atlanta.

Lessons Learned:

Pending.

Information Dissemination Plan:

The findings of this evaluation will be communicated to the Ministry of Health and other Kenyan

stakeholders through seminars and publication of a summary report.

Findings will also be published in appropriate peer review journals.

Planned FY08 Activities:

Field work and analysis will be completed in FY07. In FY08 the final report will be printed and disseminated

to the Ministry of Health and other stakeholders. These findings will serve to guide the development of IEC

messages targeting health workers and the community for rational injection use. Specific activities in FY08

include: printing of final report and dissemination seminars for Ministry of Health, organizations

implementing Injection Safety Programs and Medical professional associations including nurses, doctors,

clinical officers and pharmacists.

Budget Justification for FY2008 Budget (USD):

Salaries/ fringe benefits: $ 5,000

Equipment: $ 0

Supplies: $ 3,000

Travel: $ 7,000

Participant Incentives: $ 0

Laboratory Testing: $ 0

Other: (Printing) $ 15,000

Total: $ 30,000.00

Funding for Sexual Prevention: Other Sexual Prevention (HVOP): $50,000

Funding for Testing: HIV Testing and Counseling (HVCT): $50,000

Funding for Treatment: Adult Treatment (HTXS): $100,000

THIS IS A NEW ACTIVITY: LSTIK PEDIATRICS

1. LIST OF RELATED ACTIVITIES

This activity relates to activities in ARV Services.

2. ACTIVITY DESCRIPTION

It is estimated that there are 100,000-150,000 HIV-infected children in Kenya of which ~40,000 will require

ART. As scale-up of ART services has increased substantially among adults, pediatric ART services have

lagged behind. As of March 2006, only 190 (60%) of 314 ART sites were providing pediatric services to

10,000 children. Strategies to improve pediatric ART enrollment include pediatric counseling, pediatric ART

training and mentorship, caregiver programs, expansion of the early infant diagnosis, and pediatric testing

campaigns. Surveillance of pediatric care in Kenya will measure process and outcomes of enrollment into

care by pediatric patients. It will look at both community and facility referral systems, and include measures

of clinical/laboratory staging, retention, ART initiation and maintenance, morbidity and mortality. Protocol

development will be performed by CDC in collaboration with implementing partners, other USG agencies,

and NASCOP.

3. EMPHASIS AREAS/TARGET POPULATIONS

This activity will collect strategic information about pediatric patients.

Cross Cutting Budget Categories and Known Amounts Total: $51,000
Food and Nutrition: Commodities $51,000