PEPFAR's annual planning process is done either at the country (COP) or regional level (ROP).
PEPFAR's programs are implemented through implementing partners who apply for funding based on PEPFAR's published Requests for Applications.
Since 2010, PEPFAR COPs have grouped implementing partners according to an organizational type. We have retroactively applied these classifications to earlier years in the database as well.
Also called "Strategic Areas", these are general areas of HIV programming. Each program area has several corresponding budget codes.
Specific areas of HIV programming. Budget Codes are the lowest level of spending data available.
Expenditure Program Areas track general areas of PEPFAR expenditure.
Expenditure Sub-Program Areas track more specific PEPFAR expenditures.
Object classes provide highly specific ways that implementing partners are spending PEPFAR funds on programming.
Cross-cutting attributions are areas of PEPFAR programming that contribute across several program areas. They contain limited indicative information related to aspects such as human resources, health infrastructure, or key populations programming. However, they represent only a small proportion of the total funds that PEPFAR allocates through the COP process. Additionally, they have changed significantly over the years. As such, analysis and interpretation of these data should be approached carefully. Learn more
Beneficiary Expenditure data identify how PEPFAR programming is targeted at reaching different populations.
Sub-Beneficiary Expenditure data highlight more specific populations targeted for HIV prevention and treatment interventions.
PEPFAR sets targets using the Monitoring, Evaluation, and Reporting (MER) System - documentation for which can be found on PEPFAR's website at https://www.pepfar.gov/reports/guidance/. As with most data on this website, the targets here have been extracted from the COP documents. Targets are for the fiscal year following each COP year, such that selecting 2016 will access targets for FY2017. This feature is currently experimental and should be used for exploratory purposes only at present.
Years of mechanism: 2008 2009
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 rationalization in geographic coverage:
CDC KEMRI is scaling down on the supported sites within Nyanza (from 5 districts to 2) in order to improve
efficiency by not spreading the partner too thin in geographic coverage and while allowing for in-depth
coverage in the selected areas.
1. LIST OF RELATED ACTIVITIES
ARV Services (#6945), and Palliative Care: TB/HIV (#6944)
2. ACTIVITY DESCRIPTION
The Kenya Medical Research Institute (KEMRI) has been supporting the delivery of PMTCT services in the
five districts of Kisumu, Nyando, Kisii, Gucha and Nyamira in Nyanza Province with Emergency plan
funding since 2004. To date, the program has supported integration of PMTCT services in 201 ANC and
maternity units. In FY 2008, KEMRI will redirect efforts to concentrate and take leadership in the core
function of supporting research oriented activities instead of direct service implementation in some of the
districts. KEMRI will continue to support implementation of PMTCT activities in two districts of Nyamira and
Masaba, both within the Nyanza region. Program activities include counseling and testing of pregnant
women in antenatal clinics (ANC) and in maternity wards, and provision of the more efficacious PMTCT
ARV regimens to HIV+ women and exposed infants. In 2008, KEMRI will counsel and test 23,844 pregnant
women and provide antiretroviral prophylaxis for 1,860 HIV-positive women; 50% (930) of these women will
receive both SD Nevirapine and AZT while 558 will get SD Nevirapine. In addition the program will support
the WHO clinical staging of all HIV positive pregnant women to identify those eligible for HAART in line with
the National guidelines, and will facilitate linkage or access to HAART for 372 of these women. CD4 testing
will also be used as additional criteria for identification of women eligible for HAART. All HIV positive women
identified through the PMTCT program will be given Cotrimoxazole for OI prophylaxis therapy. TB is one of
the common opportunistic infection seen in HIV positive individuals. The program will continue to work with
the TB/HIV program to strengthen TB screening among HIV-positive pregnant women and make referrals
for treatment. The program will continue to support the follow up of HIV-positive women and their infants in
the postnatal period through strengthening postnatal care services at facility level. The current package of
care for the mother includes regular follow up, linkage to family planning services, OI prophylaxis and
counseling on correct infant feeding practices; infant additional care activities include OI prophylaxis using
Cotrimoxazole starting at six weeks of age, and DBS for HIV- PCR (Early Infant HIV Diagnosis-EID). The
program will target 1,860 HIV exposed infants for DBS, and will work with the HIV/AIDS treatment program
to ensure linkage to pediatric HIV care services for all eligible infants. The program will also strengthen
psychosocial care and support for the HIV-positive mother and her family at both the facility and community
levels through the establishment of structured support groups. At the facility level, interventions will include
psychosocial counseling with a focus on giving information and skills to the HIV-positive women to
encourage adherence to interventions such as correct use of ARVs and optimal infant feeding practices. At
the community level, the interventions will include establishment of support groups, dealing with disclosure
and encouraging partner and family support. The program will also initiate and support couple counseling
and testing to strengthen HIV prevention incase of discordant couples. KEMRI will work with the Ministry of
Health to support implementation of PMTCT services in 70 health facilities with the goal of achieving
universal geographic coverage of services. The program will train 100 service providers on PMTCT and
comprehensive HIV management for HIV-positive mothers and their families. This program will also support
DBS for DNA PCR activities through the purchase of the required supplies, and will conduct Quality
Assurance activities in HIV testing at MCH and maternity settings at selected PMTCT sites.
3. CONTRIBUTIONS TO OVERALL PROGRAM AREA
This activity will contribute 2 % of the pregnant women who receive counseling and testing and 2% of the
ARV prophylaxis to the 2008 PEPFAR PMTCT target totals. This program will also contribute to the number
of HIV positive women accessing TB screening and treatment services thereby contributing to the PEPFAR
care and treatment goals. Finally, the program will also contribute to pediatric HIV care and treatment goal
through identification of HIV-exposed and infected infants who require care and treatment.
4. LINKS TO OTHER ACTIVIES
This activity relates to the KEMRI ARV Services program (#6945), and the KEMRI TB program in Nyanza
Province (#6944). This activity is linked to Palliative Care and HIV/AIDS treatment/ARV services through the
provision of ongoing care to the HIV-positive women in the antenatal and post natal settings, care of the HIV
exposed infant in the post natal period, referral for pediatric HIV diagnosis and referral to the ART sites for
women and infants based on the national guidelines. It also linked to Palliative Care: TB/HIV through the
integration of TB screening services among the HIV positive pregnant women in PMTCT settings and
referral to the TB clinics.
5. POPULATIONS BEING TARGETED
The target population is children under 5 years, pregnant adolescent girls and their partners (15-24 years),
adults, Discordant couples, people living with HIV/AIDS, and pregnant women.
6. EMPHASIS AREAS/KEY LEGISLATIVE ISSUES
Program emphasis areas are increasing gender equity in HIV/AIDS by improving access to HIV testing for
women accessing PMTCT services as well as strengthening couple counseling and testing. Other program
emphasis areas include in-service training, Family Planning , Malaria and safe motherhood which all
contribute to improved reproductive health and malaria prevention and treatment.
PHE CONTINUING STUDY:
Project Title: PMTCT coverage and impact assessment in the comprehensive package study in the
demographic surveillance study area
Name of Local Co- Investigators: Kenya Medical Research Institute and CDC-Kenya staff
Project Description:
This project evaluates three main questions 1) current coverage and effectiveness of PMTCT programs in
the study area 2) the impact of expanding PMTCT coverage and linkages into care on declines in morbidity
and mortality in children < 5 and 3) cost-effectiveness of providing PMTCT to both HIV-infected and HIV-
uninfected women in a population with near universal knowledge of HIV status. These questions will be
investigated in a matched cluster-randomized trial with a two by two factorial design within the
comprehensive package study in the demographic surveillance site in Western Kenya.
Timeline:
FY 2008 = Year 2 of activity
Year started: '07 SI Plus Up funding; so beginning late in '07.
Expected year of completion: 2010
Funding:
Funds received to date: $0
Funds expended to date: $0
Funds requested to complete the study:
FY 08: $200,000
Beyond FY08: $180,000 for FY09
Describe funds leveraged/contributed from other sources:
This PHE is nested in the larger Comprehensive Package Study which is also supported by other PEPFAR-
Kenya program areas. In addition, the CPS leverages the DSS which is jointly supported by several CDC
Divisions through KEMRI. Through this platform, we are able to use rigorous methods to address our
PMTCT program and policy questions and obtain population-level impact data at very low cost. In addition,
85,000 people will benefit from comprehensive HIV prevention, care and treatment services as part of this
study.
Status of Study:
A protocol has been drafted and is being reviewed by MOH, KEMRI, CDC and other collaborators. Staffing
plans and SOPs are currently being drafted. As soon as '07 Plus-Up Funding becomes available and IRB
approval is finalized, baseline study implementation as well as service delivery, including home-based VCT
for the whole study population, will begin.
Lessons Learned:
N/A at this time
Information Dissemination Plan:
Results will be disseminated through the PMTCT Technical Working Group at the national level as well as
through regional meetings for MCH and Reproductive Health providers. In addition, we will share results
with PEPFAR implementing partners as well as the PEPFAR USG Kenya team.
Planned FY08 Activities:
During FY08, service delivery and evaluation will continue until the entire study population of Gem has been
covered. During FY08, analysis of baseline data will allow for completion of question 1 above, e.g. a
comprehensive assessment of current coverage and effectiveness of PMTCT service delivery in this rural
Nyanza population. Results will be disseminated and used to inform national policy and scale-up plans as
well as PEPFAR '09 planning.
Budget Justification for FY2008 Budget (USD):
Salaries/ fringe benefits: $70,000
Equipment: $30,000
Supplies: $30,000
Travel: $20,000
Participant Incentives: $ -
Laboratory Testing: $50,000
Other: $ -
Total: $200,000
The only changes to the program since approval in the 2007 COP are:
• In 2008, KEMRI will be rolling out door-to-door HIV counseling and testing and a comprehensive package
of prevention, care and treatment services. This will provide an excellent opportunity to include AB
prevention messages in a family setting. In particular, we plan to target couples reached with faithfulness
messages, and abstinence messages to young people in families reached. We expect to train 1,500
individuals to promote these prevention messages and we will reach 250,000 individuals with AB
messages.
This activity relates to activities in Counseling and Testing (#6941), Condoms and Other Prevention
(#6948), and Abstinence and Be Faithful Programs (#6903).
The Kenya Medical Research Institute (KEMRI), through its collaboration with CDC, will participate in a
study of youth interventions conducted by the Institute of Tropical Medicine (ITM) in the Asembo and Gem
areas of Nyanza Province, which has the highest HIV prevalence rates in the country. KEMRI and CDC
have had a long collaboration in Nyanza Province, and KEMRI implements activities through a cooperative
agreement with CDC Atlanta. Although some of the activities for this youth intervention are implemented by
ITM, and are described in that entry, KEMRI is also actively involved in the study, primarily through the
hiring of local staff and by supporting local implementation of the project. One of the major activities being
conducted by KEMRI in partnership with ITM is the implementation of a "Families Matter" curriculum which
involves both the youth and their parents. This is an adaptation of the US-based "Parents Matter" curriculum
which CDC has evaluated in the US. To date, parents and community and religious leaders in Asembo and
Gem are very supportive of this approach of enabling parents to take a more active role in HIV prevention
for their adolescent children. Staff hired by KEMRI will be involved in the continued "roll-out" of this
intervention. Efforts to change the social norms which contribute to the high risk for young girls in this part of
Kenya are part of this intervention. The project has also found that the lack of skills and employment
opportunities contributes to high-risk behavior among girls, so one aspect of the project is the provision of
vocational skills and opportunities for income-generating activities for these youth. In the past, CDC-
prevention programs have been met with unexpected shortfalls in funding or supplies which require a rapid
response such as supporting partner organizations to attend particularly important forums or providing
essential prevention supplies. To provide a back up for this, up to $50,000 is included in this narrative to
enable KEMRI, in collaboration with CDC respond favorably to such needs.
This project will contribute to the Kenya Five-Year Strategy which focuses on HIV prevention in youth, as
the primary target group is young people, including children aged 10 to 14. It will primarily provide staffing
and other administrative support in the implementation of the ITM project; therefore the specific targets
related to this activity are listed in the CDC-AB-ITM entry and are therefore not duplicated in this entry.
Through the door-to-door counseling and testing activity, we expect to train 1,500 individuals to promote
these prevention messages and we will reach 250,000 individuals with AB messages.
4. LINKS TO OTHER ACTIVITIES
This activity will be very closed linked to AB activity (#6903) implemented by the Institute of Tropical
Medicine and to the KEMRI OP activity (#6948) and CT KEMRI activity (#6941) for Nyanza province. These
activities serve as referral points for each other, and ITM staff provide technical assistance in the scientific
adaptation of curricula that is largely implemented by KEMRI staff. Young people needing counseling and
testing are served under the KEMRI CT activity.
The primary population being targeted is rural youth, including both in-school primary and secondary
students and out-of-school youth. Ages of youth targeted range from 10 to the early twenties. Different, age
appropriate curricula are used with these groups. In addition, their parents and community and religious
leaders are targeted by the project including religious leaders and volunteers. All of the targets relating to
this study of model youth interventions are described in the ITM entry and are not duplicated here.
6. KEY LEGISLATIVE ISSUES ADDRESSED
This project will have a strong gender component, including increasing young women's access to income
and productive resources and addressing male norms and behaviors.
7. EMPHASIS AREAS
The primary emphasis area is human resources, as the project has a large staff needed to implement and
assess the impact of these interventions. Community mobilization to change social norms which encourage
early sexual debut is also an important component of this project, along with IEC activities to educate the
youth and their parents about abstinence and faithfulness.
The only change to the program since approval in the 2007 COP is:
+ KEMRI will work closely with NASCOP, the Nyanza Circumcision Consortium, IRDO, and other partners
to deliver a package of MC services in Nyanza Province. KEMRI's service delivery work will involve both
Facility and Mobile approaches to MC service delivery, particularly within the existing Demographic
Surveillance Study (DSS) area in Nyanza Province. Services will target consenting HIV-uninfected men at
high risk of HIV acquisition, including HIV-negative members of discordant couples, with OP messages.
This service delivery of MC complements the PEPFAR PHE evaluating MC uptake and coverage and the
added value of mobile approaches to MC service delivery. Through this activity, KEMRI will add 10 more
condom outlets, reach 15,000 people with OP messages and train 40 providers in OP message delivery.
This activity relates to Abstinence and Be Faithful Program (#6903) and to the Condoms and Other
Prevention Activity (#6904).
The Kenya Medical Research Institute, through its collaboration with CDC, will participate in a study of
youth interventions conducted by the Institute of Tropical Medicine (ITM) in the Asembo and Gem areas of
Nyanza Province, which has the highest HIV prevalence rates in the country. KEMRI and CDC have had a
long collaboration in Nyanza Province and KEMRI implements activities through a cooperative agreement
from CDC Atlanta. Although most of the activities for this youth intervention are implemented by ITM, and
are described in that entry, KEMRI is also actively involved in the study, primarily through the hiring of local
staff and to support some of the local implementation of the project. In 2008, 21,000 individuals will be
reached with targeted HIV prevention messages. 40 individuals will be trained in OP message delivery. 20
condom outlets will be established. This comprehensive youth intervention study includes the following OP
activities. One activity being conducted by ITM is the adaptation and implementation of a safer sex
curriculum targeting youth aged 13 to17 years old. "Healthy choices for a better future" is an adaptation of
"Making Proud Choices", a curriculum that was selected by CDC as an effective intervention. The
curriculum is currently going through the final stages of adaptation and will be pilot tested in the coming
weeks. ITM is also developing a proposal to evaluate this curriculum. Staff hired by KEMRI will be involved
in the assessment and implementation of this curriculum. In addition, prevention activities are organized
throughout the year at schools and in the community in close participation with local youth committees and
volunteers. Efforts to change the social norms which contribute to the high risk for young girls in this part of
opportunities contributes to high risk behavior among girls, so one aspect of the project is the provision of
vocational skills and opportunities for income generating activities for these youth.
This project will contribute to the Kenya's Five-Year Strategy which focuses on HIV prevention in youth, as
the primary target group is young people, including adolescents aged 13 to 17 years. 21,000 young people
will be reached with this intervention and 20 condom outlets will be established. 40 individuals will be
trained in OP message delivery.
This activity will be very closely linked to AB activities implemented by the Institute of Tropical Medicine
(#6903) and to the OP activities being implemented by ITM (#6904) in Nyanza province.
The primary population being targeted is rural youth, including both in-school and out-of-school youth. Ages
of youth targeted range from 10 to the early 20's. Different, age appropriate curricula are used with these
groups. In addition, their parents and community and religious leaders and volunteers are targeted by the
project. Teachers and rural communities are also targeted as well as adults through adult involvement. It
also targets People Living with HIV/AIDS.
This project will have a strong gender component, including addressing male norms and behaviors,
focusing on reducing violence and coercion and increasing gender equity in HIV/AIDS programs. Through
its' livelihoods project, it will increase women's access to income and productive resources.
The primary emphasis area is community mobilization to change social norms which encourage early
sexual debut. Another emphasis is Human resources, as the project has a large staff needed to implement
and assess the impact of these interventions. IEC activities to educate the youth and their parents about
abstinence and faithfulness as well as conducting needs assessment are also important areas in this
project.
Project Title: Male circumcision service delivery and cost-effectiveness evaluation in the comprehensive
package study in the demographic surveillance study area
This project evaluates four main questions 1) factors that affect uptake of male circumcision at community
and fixed-site service points 2) the population level impact of a male circumcision comprehensive package
on HIV incidence, including assessment of disinhibition 3) associations between the provision of community
-based circumcision to HIV-uninfected men and a decline in HIV incidence compared to provision of male
circumcision at fixed health care facilities and 4) cost of each intervention per person served and cost of
each intervention per HIV infection and disability-adjusted life year (DALY) averted. These questions will be
Year started: '07 Plus Up funding; so beginning late in '07.
FY 08: $600,000
Beyond FY08: $300,000 for FY'09
Divisions through KEMRI. Through this platform, we are able to use rigorous methods to address our CT
program and policy questions and obtain population-level impact data at very low cost. In addition, 85,000
people will benefit from comprehensive HIV prevention, care and treatment services as part of this study.
Results will be disseminated through the Male Circumcision Task Force at the national level as well as
through regional MOH meetings. In addition, we will share results with PEPFAR implementing partners as
well as the PEPFAR USG Kenya team.
covered. During FY08, analysis of baseline data will allow for completion of question 1 above, e.g. an
evaluation of uptake, coverage, adverse events associated with provision of male circumcision services in
this rural Nyanza population. Results will be disseminated and used to inform national policy and scale-up
plans as well as PEPFAR '09 planning.
Salaries/ fringe benefits: $175,000
Equipment: $85,000
Supplies: $95,000
Travel: $60,000
Laboratory Testing: $125,000
Other: Consultants to assist with adverse events monitoring $60,000
Total: $600,000
Project Title: Comprehensive care and treatment coverage and impact assessment in the comprehensive
package study in the demographic surveillance site
This project evaluates four main questions 1) the current coverage and effectiveness of HIV care and
treatment programs 2) the decline in morbidity and mortality associated with the additional provision of a
community-based care package compared to the current comprehensive care provision at area health care
facilities 3) the effectiveness of using a TB screening questionnaire by home-based VCT staff to identify and
refer persons for TB diagnostic services; and 4) the cost-effectiveness of different care and treatment
service delivery models. These questions will be investigated in a matched cluster-randomized trial with a
two by two factorial design within the comprehensive package study in the demographic surveillance site in
Western Kenya.
FY 08: $300,000
Beyond FY08: $250,000 For FY'09
This PHE is nested in the larger CPS which is also supported by other PEPFAR-Kenya program areas. In
addition, the CPS leverages the DSS which is jointly supported by several CDC Divisions through KEMRI.
Through this platform, we are able to use rigorous methods to address our care and treatment program and
policy questions and obtain population-level impact data at very low cost. In addition, 85,000 people will
benefit from comprehensive HIV prevention, care and treatment services as part of this study, including an
estimated 5000 people living with HIV.
N/A at this time.
Results will be disseminated through the care and treatment Technical Working Group at the national level
as well as through regional meetings for comprehensive care providers. In addition, we will share results
comprehensive assessment of current coverage and effectiveness of comprehensive care and treatment
delivery in this rural Nyanza population. Results will be disseminated and used to inform national policy and
scale-up plans as well as PEPFAR '09 planning.
Salaries/ fringe benefits: $105,000
Equipment: $50,000
Supplies: $25,000
Travel: $30,000 -
Laboratory Testing: $90,000
Total: $300,000
Project Title: A Retrospective Cohort Study Among HIV-infected Pregnant Women to Measure the
Effectiveness of Daily Cotrimoxazole on Prevention of Placental Malaria
Name of Local Co- Investigator: KEMRI and CDC:
This project is a retrospective cohort study to determine the effectiveness of daily cotrimoxazole prophylaxis
(CPT) in preventing placental malaria parasitaemia in pregnant HIV-infected women. WHO currently
recommends that HIV-infected pregnant women receiving CPT for opportunistic infection prevention
shouldn't also be provided with intermittent preventive treatment (IPTp) with sulfadoxine-pyrimethamine
(SP) but the effect of CPT on placental malaria hasn't been demonstrated. The study plans to enroll 800
women (200 HIV-infected women who received IPTp with SP, 200 HIV-infected women who took CPT, 200
HIV-infected women who took neither SP nor CPT and 200 HIV-uninfected women who took IPTp with SP).
FY2008= Year 2 of activity
Year started: Year 1 funding cycle to begin September 2007
Expected year of completion: 2008
Funds received to date: $178,000 awarded, not yet received
Funds expended to date: 0
FY 08: $62,000
Beyond FY08: TBD
USD 60,000 will be contributed from CDC Atlanta by the emerging infections disease working group.
Protocol currently being developed, submitted to local IRB. Consensus building with partners occurring in
August 2007. Staff recruitment and training commencing in September 2007.
None—project not yet started.
The findings will have strong programmatic implications in Kenya and throughout Africa by guiding policy on
how to effectively prevent malaria in pregnancy for HIV-infected pregnant women receiving CPT. The
results of the study will be disseminated to Kenya's Ministry of Health at the national, provincial, and district
levels and regionally.
To continue enrollment of participants and perform data analysis.
Salaries/ fringe benefits: $30,000
Equipment: $ -
Supplies: $3,000
Travel: $3,000
Participant Incentives: $500
Laboratory Testing: $23,000
Other: Communication $2,500
Total: $62,000
THIS IS AN ONGOING ACTIVITY. THE REFERENCES TO TARGETS AND BUDGETS HAVE BEEN
UPDATED.
• The only change to the program since approval in the 2007 COP is that geographic coverage has been
revised to include more health facilities in Siaya, Bondo and Nyando districts while transitioning support to
all the other districts to partners highlighted in the activity description below.
This activity relates to activities in ARV Services (#6945), Counseling and Testing (#6941), TB/HIV (#6944),
and PMTCT (#6949).
This will be an expansion of the existing COP 07 activities. Kenya Medical Research Institute (KEMRI) will
expand ongoing treatment activities to cover 1 provincial general hospital in Kisumu, 27 health facilities in
Siaya, 22 in Bondo and 21 in Nyando districts in Nyanza province. Support for the Provincial General
Hospital (PGH) in Nyanza will also be expanded as the regional referral hospital including support for
training and QA within the region. These expanded activities include support for provision of facility based
palliative care services for 30,000 people with HIV and support for training for 500 health care workers.
Laboratory and clinical network centers will be supported at the Provincial Hospital in Kisumu and District
Hospitals in Siaya, Bondo and Nyando. Points of service will include all District and Sub-District Hospitals in
the regions served by these referral hospitals, as well as many health centers and dispensaries. The
support in COP 07 for North Eastern and Eastern South will transition to APHIA II and TBD partner
respectively while Kilifi will be transitioned to APHIA Coast. In Nyanza support for treatment will be
transitioned as follows: Kisumu East district (except PGH) to UCSF, Kisumu West district to DOD, Gucha,
Nyamira and Kuria to APHIA II Nyanza.
At each site KEMRI provides technical assistance, equipment and supplies, infrastructure improvement,
improvement of laboratory capacity, laboratory reagents, adherence counseling, assistance with monitoring
and reporting, cotrimoxazole prophylaxis to prevent opportunistic infections, treatment of opportunistic
infections, improved access to safe drinking water, establishment of psychosocial support groups linked to
each clinic and additional community-based services. KEMRI conducts a number of activities that enhance
the development of care services at the national and regional level. These include regular coordination
meetings of HIV care providers in the province in collaboration with the Provincial ART Officer, regional
quality assurance programs, and specimen transfer networks to optimize the availability of high quality CD4
cell count determination and national infant diagnostic HIV testing. KEMRI supports facility-based practical
training during which health care workers are invited to join the functioning clinics and gain experience in all
aspects of HIV treatment and clinic management. This activity's scope includes: identification and treatment
of HIV-infected children and adults and provision of care in remote areas. The latter is facilitated by mobile
teams that move between rural health centers and dispensaries, particularly those providing PMTCT
services or TB treatment, an important step towards decentralization. KEMRI has implemented a data
collection system designed to assist health facilities report national and PEPFAR indicators. In FY 2008,
KEMRI will continue supporting initiation of HIV care provision to mentally ill patients at Mathari Mental
Hospital, the national referral hospital for mentally ill patients in Kenya. This activity will support
development of treatment guidelines for the mentally ill patients and training curriculum for the health
workers in Mathari Hospital. This facility will act as a referral center for all other mental health facilities in the
country.
The long-standing (>25 years) collaboration between KEMRI and CDC in Kenya was initially research-
based, then expanded in 1999 to include HIV prevention and treatment activities. By the end of March 2007,
this collaboration was supporting care at more than 56 facilities and was supporting palliative care services
for more than 30,000 patients, mainly in Nyanza but also in eastern South and Kilifi.
These activities will contribute to the results of expansion of palliative care services for people with HIV,
strengthened human resource capacity to deliver palliative care services, and a strengthened referral
network for these services. In addition, these activities will contribute to expansion of care for HIV-infected
children, in particular by supporting infant testing at sites supported both by this partner and other
Emergency Plan partners.
These services link to KEMRI-supported ARV treatment services (#6945) as well as other ART and non
ART services provided by other Emergency Plan Partners like University of California, San Francisco,
Catholic Relief Services and Cooperative Housing Foundation in Nyanza Province. They also tie into well-
established referral linkages with local VCT (#6941) and PMTCT (#6949) programs. Practical training
supported by KEMRI is linked directly to classroom training supported by Mildmay International (#6992).
The population level impact of the supported services is being evaluated through SI activities (#6946)
conducted by KEMRI. KEMRI activity support in Central and Eastern Provinces will gradually be replaced
by support from Columbia University (#6868) and TBD partner (#7043).
The target population for this activity is people with HIV. The main geographic region served by these
activities is Nyanza Province, a priority region because it has the highest prevalence of HIV in Kenya (15%
compared to 7% nationally). Most of the services are provided to the general population with HIV, but
special services are provided to women and children through pediatric and PMTCT-plus services, to
participants in US government funded research programs and their families, and the mentally ill. Discordant
couples are targeted by behavior change counseling and other prevention activities focused on HIV-infected
patients.
This activity addresses legislative issues related to stigma and discrimination through involvement of
PLWAs in service provision and community sensitization activities.
This activity includes minor emphasis on commodity procurement, development of network/linkages/referral
Activity Narrative: systems, human resources, logistics, local organization capacity building, and quality assurance and
supportive supervision, training, and strategic information.
THIS IS AN ONGOING ACTIVITY.
The narrative is essentially unchanged except for updated references to targets, budgets, new initiatives in
TB infection control in HIV care settings, specific support to TB laboratory services and new activities on TB
preventive treatment for PLWHA .
This activity relates to activities in CT (#6941), Palliative Care (#6942), ARV Treatment (#6945), and
PMTCT (#6949)
KEMRI will support TB/HIV services for approximately 30,000 patients at 71 sites in Nairobi and Nyanza
Provinces. TB screening for 15,000 HIV patients and HIV screening for 8,000 TB suspects/patients will be
offered as a standard of care in all the facilities; approximately 4,000 patients will be identified as being
infected with both TB and HIV. In FY 2008, Kenya Medical Research Institute (KEMRI) will expand
collaborative TB/HIV activities in Nyanza Province, an area that is projected to register 25,000 new TB
patients. All 12 districts in Nyanza Province will be supported to continue expansion of TB/HIV collaborative
activities, including HIV testing of TB suspects (reaching >95% of all TB cases) and monitoring and
treatment of HIV in TB clinics (reaching 100% of TB patients with cotrimoxazole and 50% of those eligible
with ART). PEPFAR funds will support provincial and district TB/HIV stakeholders meetings, train workers in
and implement enhanced TB screening, diagnosis, treatment, and referral, coordinated delivery of
integrated HIV and TB services through the expansion and strengthening of technical supportive
supervisions, and develop and print IEC materials. Mechanisms of referral to TB clinics and back-referral to
HIV care settings, and referral tracking, will be emphasized, and treatment and recording and reporting,
including the implementation and evaluation of an electronic TB monitoring and evaluation system will be
implemented. Funds will be used to pilot program level IPT in selected districts in Nyanza Province. IPT will
be considered for HIV+ persons (both children and adults) for whom active TB disease has been ruled out.
Funds will also be used to assist the MOH to implement infection control practices to prevent TB
transmission of TB to PLWHA and health care providers in selected health facilities. Funds will also be used
to supplement the capacity of a KEMRI/CDC TB laboratory in Kisumu with potential for becoming a western
Kenya regional reference laboratory. In order to improve and expand manpower base for TB laboratory
services, Emergency Funds will also be used to hire laboratory technologists to supplement similar support
from the Global Fund. The Kenya HIV Prevention Summit 2007 underscored the importance of "Turning off
the Tap" and prevention with positives (PWPs) activities in TB settings will be a priority for KEMRI in FY
08. The EP will support prevention within discordant couples through support services, training, and
condom provision. In addition, communication and education efforts will increase knowledge about HIV
discordance within TB settings and strategies to decrease HIV transmission.
KEMRI will collaborate closely with other programs to ensure that HIV-infected children are considered in all
TB/HIV policies and programs, including IPT for HIV-infected children whose parents have active TB.
KEMRI is also supporting TB/HIV services in Kodiaga and Kibos prisons, and will expand services to
prisons in Siaya, Homa Bay and Kisii, including intensified TB case detection. In collaboration with the
Kenya Association for Prevention of TB and Lung Disease (KAPTLD), KEMRI will support good clinical and
laboratory practice in 10 private clinics. Activities will focus on capacity building, provision of equipment,
minor renovation, and procurement of supplies including cotrimoxazole (CTX), HIV test kits and laboratory
reagents. In addition 5 laboratory technicians will be recruited to improve access to AFB microscopy and
investigations for HIV care. In FY 08, TB/HIV activities will be coordinated by KEMRI through partnership
with the National Leprosy and Tuberculosis Program (NLTP), Nairobi City Council (NCC) and the USG
agencies. In both Nyanza and Nairobi, the funds requested for will be used for testing TB suspects and
patients for HIV, screening for TB among HIV+ persons, providing HIV+ TB patients with referral and
CTX/ART, risk reduction counseling and psycho-social support, training of health workers to deliver TB/HIV
services, supporting infrastructural development, supporting supply of HIV test kits and medicines for TB
prevention and other opportunistic infections and improving referral linkages. To improve community
participation in DOTs delivery, 700 community health workers (CHWs) from Migori and Rachuonyo Districts
will be trained. In addition, supervision of the already trained 1,460 CHWs will be strengthened through
recruitment of a coordinator. Motivation of the trained community health volunteers will be maintained
through regular meetings, refresher trainings, exchange visits and non-monetary incentives. In order to
improve supervision of TB/HIV work, 3 motor bikes will be provided. All sites delivering collaborative TB/HIV
services will use a standard TB/HIV data collection tool developed by the NLTP.
These activities will result in strengthened delivery of integrated TB/HIV services, including strengthened
referral systems, improved diagnostics and treatment of TB among HIV-positive patients and of HIV in TB
patients, strengthened capacity of health workers to provide integrated TB/HIV services and strengthened
systems capacity for program monitoring and evaluation and management of commodities. There will be a
special focus on screening for TB in at least 50% of the HIV-infected patients from the PSC/CCC and
medical in-patient wards. The proportion of HIV-positive TB patients on ARVs will be increased from 30% to
50% with 100% CTX coverage. Quality of laboratory services will be improved through a laboratory
renovation in Kisumu to create a regional reference culture/DST laboratory, recruitment of laboratory
technologists and other staff, AFBs microscopy training and improved supervision.
These activities will be linked to ongoing CT (#6941), Palliative Care (#6942), ARV Treatment (#6945), and
PMTCT (#6949) activities in Nyanza and Nairobi Provinces including linkages with the private sector and
prisons.
TB suspects (adults and children), TB patients, HIV+ persons identified from PSC/CCC/medical inpatient
wards, and PLWHA organizations - deliberate action will be taken to intensify TB screening and TB case
finding among PLWHA.
Provider-initiated HIV testing for all TB patients will be given on an "opt out" principle. Guidelines on HIV
testing based on consent, confidentiality and counseling will be observed as part of standard practice.
Activity Narrative: Increased availability of CT in clinical settings and increased access to HIV-related care for TB patients will
help reduce stigma and discrimination.
7. EMPHASIS AREAS TB screening, DTC, commodity procurement, quality assurance, community
mobilization, infrastructure, targeted evaluation, network/linkages/ referral systems, treatment for latent TB
infection, infection control, laboratory strengthening, and training.
Project Title: Operational evaluation of a TB screening tool and implementation of the 2006 WHO
guidelines for the diagnosis of smear-negative TB in HIV-infected persons in HIV care settings
Name of Local Co- Investigator: KEMRI and CDC
In high TB burden countries, a large proportion of HIV-infected persons may have undetected TB. A missed
TB diagnosis increases mortality and the chances of the development of the immune reconstitution
syndrome. A TB diagnosis is more complicated in HIV-infected persons. TB in HIV-infected individuals
may be under-diagnosed due to lack of systematic searching and awareness by health providers, and also
due to limitation/delays in available diagnostic methods. We propose to evaluate the systematic application
of a simple TB case-finding screening tool and the implementation of the 2006 WHO-revised TB diagnostic
algorithm to detect smear-negative TB among HIV-infected persons.
Year started: 2007
Funds received to date: $150,000 [2007]
FY 08: $75,000
Beyond FY08: None
Will partner with all programmatic TB/HIV activities in the facilities; Many activities and staff costs will be
covered with ongoing TB and HIV program funds.
Protocol under development; anticipated submission date: September 2007
N/A
Will provide feedback to the facilities and design interventions based on the results
Implement protocol
Salaries/ fringe benefits: $20,000
Equipment: $5,000
Supplies: $10,000
Travel: $10,000
Laboratory Testing: $20,000
Other: $10,000
Total: $75,000
Project Title: Prevalence of pulmonary tuberculosis and access to tuberculosis care in HIV infected and
uninfected tuberculosis patients in Asembo and Gem, western Kenya.
Name of Local Co- Investigator: KEMRI, CDC, University of Amsterdam
Tuberculosis (TB) is an important cause of illness and death among HIV-infected individuals in Africa. In
high HIV-prevalence areas like western Kenya, a majority of TB-cases are HIV co-infected and require
additional treatment and care. Based on low tuberculosis case detection rates access to care for this group
is regarded inadequate, but the magnitude of the problem requires further study, to guide efforts to increase
access to care for co-infected persons. This study estimates the prevalence of pulmonary tuberculosis in a
population with high HIV-prevalence and evaluates barriers to accessing treatment in TB-patients,
especially those co-infected with HIV.
FY 2008 = Year 4 of activity
Year started: 2005
Expected year of completion: 2008 / early 2009
Funds received to date: $ 1,600,000
Funds expended to date: $1,060,000
FY 08: None, requested; carry over funds from FY 07 will be used to cover the costs of completing the study
during FY 08
The Academic Medical Centre of the University of Amsterdam contributes the salary and travel costs of the
Kenya based PI. The KEMRI Centre for Respiratory Diseases Research contributes towards the salary of 9
KEMRI employed staff who work the microbiology and radiology aspects of the project.
Enrollment of study participants started on 31 July 2006. By 18 July 2007 enrollment was at 12,845
participants. The target of 20,000 is expected to be completed by the end of 2007. Of the enrolled
participants, 95% provided the required sputum samples and 93% came for chest radiography at a mobile
unit.. Fifty-two persons with active pulmonary TB were identified, most of whom were not on anti-TB
treatment at the time of enrollment. Five study nurses continue to support MoH TB and HIV work in
Bondo/Siaya districts and offer study participants diagnostic HIV testing and counseling (100% acceptance),
TB treatment, and ART if applicable. For comparison purposes, self reported TB cases will be enrolled in a
study on care-seeking behaviors and HIV status from August 2007 through 2008. Follow-up of treatment
outcomes (including HIV treatment) will continue till end 2008 / early 2009.
In total 50 KEMRI staff were trained on study procedures, general knowledge on TB and disease control
and ethical aspects of community based evaluation studies; 6 laboratory staff were trained on sputum
smear diagnosis using fluorescent microscopy and sputum concentration methods. 25 field workers were
trained on the use of PDA's (personal digital assistants) for data collection. 3 clinicians were trained on
chest X-ray reading, including an ongoing chest radiography reading quality assurance program.
Many lessons were learned on field operations, including best practices for community involvement and the
use of mobile X-ray equipment in rural Kenya. Through interviews of identified TB cases and follow-up
attempts on defaulters, we learnt important lessons about access to care of persons with pulmonary TB who
were not on treatment at the time of study enrollment.
Two abstracts on study preparations were accepted/presented at the 37th International TB Conference
2006, and 3 abstracts were accepted for the 38th International TB Conference 2007. Final study results will
be presented during oral presentations to the ministry of health (district and provincial level), national
tuberculosis control program, the participating community, the local research community and at international
forums, including written publications.
Wind up of study activities and further dissemination of results.
Budget Justification for FY2008 Budget (USD): N/A - funds are not being requested for FY08.
Project Title: Evaluation of the Uptake of Antiretrovirals among TB Patients Referred to HIV Care and
Treatment Sites in Nyanza Province, Kenya
In Kenya, >100,000 TB cases occur annually; 60% of TB patients are HIV-infected. HIV testing among TB
patients and cotrimoxazole provision has improved; however, only 30% of HIV/TB patients receive ART.
To improve service delivery to co-infected patients, we will examine facilities providing ART and TB
treatment and assess HIV testing rates and ART provision at TB clinics. We will explore/pilot models of
HIV/TB integrated services that a) promote HIV testing among TB patients and TB screening among HIV
patients, and b) investigate the feasibility of providing ART within TB clinics and TB treatment in HIV clinics.
Funds received to date: $26,500 [2007]
FY 08: $27,000
Will partner with all programmatic TB/HIV activities in the facilities; Most activities and staff costs will be
Salaries/ fringe benefits: $14,000
Equipment: $4,000
Supplies: $4,000
Travel: $5,000
Laboratory Testing: $ -
Total: $ 27,000
+ the target population has been expanded) to include a special emphasis on couples and family members
+ in FY 2007 KEMRI received supplementary funds for the expansion of HIV counseling and testing
services in Nyanza province. With these additional resources KEMRI was able to establish a home based
HIV counseling and testing program in the underserved and very high-prevalence areas of Asembo, Gem
and Karemo. These enabled KEMRI to reach an additional 70,000 people with HIV counseling and testing
services. Funds were used to employ additional personnel, especially VCT counselors, as well as data
personnel. It was also used to improve logistics such as transport for outreach personnel, and for the
procurement of essential commodities. A small component was used for community mobilization at various
levels, including mass media and employment of community mobilizers.
In FY 2008, these activities will be consolidated and expanded. KEMRI will also support couple counseling
and testing services country-wide. For this to succeed, KEMRI will work closely with Partners in Prevention,
which has four satellite centers in Kisumu, Eldoret, Nairobi and Thika. These four sites will be used as the
nuclei for the rapid expansion of couple counseling and testing in the country. These centers will support
training, mentorship, supervision and development of materials for couple counseling and testing.
This activity is related to activities in AB (#6943), OP (#6948), ART (#6945), PMTCT (#6949), TB/HIV
(#6944), and Lab (#6940).
In FY Kenya Medical Research Institute (KEMRI) will strengthen and expand HIV counseling and testing
(CT) services in Nyanza province, the region with the highest prevalence in the country. CT services in
Nyanza include both client and provider initiated CT approaches, and is provided both in health facilities and
in the community. In FY 2008, KEMRI will put more resources into provider-initiated, couple and home-
based CT. In provider-initiated CT, KEMRI will support dissemination of policies and guidelines, training and
supervision. In the same FY 2008 KEMRI will expand the implementation of home based CT in Asembo,
Gem and Karemo, as part a comprehensive community HIV/AIDS program. Other components of the home
care program will be PMTCT, ART, Lab and TB-HIV. Proper implementation of the home-based CT
program in Nyanza will lead to many previously undiagnosed people knowing their status and being referred
to care and treatment. It will also support community and client education about HIV/AIDS. Special efforts
will be made to promote couples VCT and to provide prevention services for discordant couples. In FY
2008, KEMRI will provide CT services to at least 250,000 people in the region. In order to achieve this, they
will train 300 counselors and health workers. Most of these will be deployed to the home-based CT
program. Currently there are 12 health facilities that provide DTC in both out-patient and in-patient services
in the whole of Nyanza. In FY 2008, this service will be expanded to cover 120 sites in the province. In FY
2007, KEMRI will also facilitate quality assurance for both counseling and testing.
CT in this high prevalence area will result in identification of many previously undiagnosed HIV positive
individuals and discordant couples who will benefit from prevention, care and treatment that have been
made available through the President's Emergency Fund. This partner is expected to contribute 7% the total
USG target for CT during FY 2008. These planned activities will contribute to the result of increased access
to CT services, particularly among underserved and high risk populations. In health care settings, increased
availability of diagnostic CT services will lead to identification of many HIV infected patients who are eligible
for ART. The activity also contributes substantively to Kenya's 5-Year Strategy that focuses on encouraging
Kenyans to learn their status and emphasizes HIV testing as standard package of care in medical settings.
The strategy also emphasizes the development of strong links between CT services and care outlets and
also between the community and the heath care system.
KEMRI CT activities in Nyanza province and neighboring areas will refer increased number of HIV positive
patients requiring care to the Emergency fund supported Comprehensive care centers in the three districts
of Kisumu, Bondo and Siaya. Strengthened linkages between CT centers and care outlets will improve
utilization of care opportunities created through the President's Emergency Fund and other partners. This
activity is linked to KEMRI AB activity (#6943), KEMRI-ART activity (#6945), KEMRI PMTCT activity
(#6949), KEMRI TB/HIV activity (#6944) and KEMRI OP activity (#6948). This activity is also linked to
KEMRI Lab activity (#6940).
This activity will mainly target rural communities in the project site, working together with community and
religious leaders in each community. In this area, the whole population will be targeted, including adults,
youth and children (including infants). The activity will also target symptomatic individuals seeking care at
health facilities especially in medical wards, STI clinics, TB clinics and other service outlets targeting
conditions that are commonly associated with HIV. In addition, health care providers in both public and
private medical settings will be trained to provide CT services to patients as part of routine medical care.
This activity will increase gender equity through family approach to CT, during the home based CT program.
The low CT service uptake by couples and low disclosure rate by partners will be addressed through
vigorous campaigns to educate people of Nyanza on the benefits of couple VCT and mutual disclosure of
HIV status. The much increased availability of CT services in clinical and community settings will help to
reduce stigma and discrimination besides addressing people's right to access the highest standards of CT
and care services.
In FY 2007 KEMRI will implement home based CT. Major emphasis areas for this activity are in the area of
training. In addition, part of the implementation of this activity will involve a minor emphasis on targeted
Activity Narrative: evaluation activities. But for this to succeed there will be need for other emphasis to be in the areas of
human resource development, community mobilization and development of network/linkages. In some
instances, there may be need for infrastructural support to facilitate referral. Apart from the home based CT
program KEMRI will continue to provide oversight technical support to CT activities in the entire Nyanza
region, for quality assurance and quality improvement.
Project Title:
CT Service Delivery Evaluation and Social Outcomes Assessment in Comprehensive Package Study in the
DSS
This project evaluates two main questions 1) the uptake and cost-effectiveness of provision of door-to-door
HIV VCT and 2) the social outcomes of home-based testing (including gender-based violence and
relationship-strengthening, stigma and stigma reduction) in a population with near universal access to HIV
VCT. These questions will be investigated within the comprehensive package study (CPS) in the
demographic surveillance study area in Western Kenya. The CPS is a population-based randomized trial
designed to test the effectiveness of HIV prevention, care, and treatment service delivery models in
reducing all-cause and HIV-related mortality and HIV incidence in a high-HIV prevalence area of rural
Kenya.
Year started: '07 SI Plus up funding; so beginning late in '07.
Beyond FY08: $150,000 for FY'09
Results will be disseminated through the CT Technical Working Group at the national level as well as
comprehensive assessment of effectiveness of the home-based VCT service delivery in this rural Nyanza
population. Results will be disseminated and used to inform national policy and scale-up plans as well as
PEPFAR '09 planning.
Equipment: $20,000
Supplies: $70,000
Travel: $30,000
Laboratory Testing: $75,000
This activity relates to activities in ARV Drugs (#6997, #6989, #6969) and ARV Services (#6945, #7004).
The Kenya Medical Research Institute (KEMRI) will assist with forecasting and procurement of additional
drugs needed to treat 160,000 Kenyans with ARVs. Two other major partners - Mission for Essential Drugs
and Supplies, Management Systems for Health/Rational Pharmaceutical Management Plus (MSH/RPM
Plus) will maintain primary responsibility for procurement and distribution of pharmaceuticals nationally and
under the Emergency Plan. Together with USG staff in country, these major partners are primarily
responsible for quantification and tracking for ARVs procured with Emergency Plan funds. This alternate
procurement mechanism through KEMRI will allows some flexibility that will help to continue to avoid stock
outs and treatment interruptions.
These activities are essential to maintaining a full and uninterrupted supply of HIV/AIDS related
pharmaceuticals and commodities.
These activities will coordinate with other partners involved in ARV drugs, KEMSA, MEDS, MSH/RPM Plus,
and complement and link with all activities listed in the ARV services program area.
This activity targets men, women, and children with HIV.
6. EMPHASIS AREAS
This activity includes a major emphasis in commodity procurement.
Updated August 2008 reprogramming: additional $150K for PwP monitoring and evaluation and $50K for
discordant couple activities. $75K for surge recruitment of health care workers, $625K correction from April
08 reprogramming.
ARV Resistance Surveillance ($200,000)
WHO and CDC have developed a method to monitor the emergence of HIV drug resistance (HIVDR) during
the first year of antiretroviral treatment (ART) and evaluate potentially associated program factors which
could be altered to optimize ART program functioning for HIVDR prevention. A sample size of
approximately 100 patients initiating ART is evaluated at baseline and 12 months at 3-5 sentinel sites. At
baseline, a genotype and brief ARV history are taken. At 12 months, or at time of switch to a second-line
regimen, a viral load (VL), a genotype, and an adherence assessment are performed. Monitoring is defined
as the measurement and interpretation of viral suppression in populations taking first-line ART 12 months
after commencement of ART and the measurement and interpretation of HIVDR in populations commencing
ART and in populations not achieving viral suppression after 12 months of first-line ART. Data will assist the
Kenya Ministry of Health National AIDS and STI Control Program (NASCOP) and other national and
international partners to design strategies to improve ART outcomes and support recommendations for
optimal first- and second-line regimens and indications for time of regimen switch. This strategy will be
implemented along with early warning indicators available from routine ART clinical data. The sentinel
methodology will be incorporated as a routine evaluation.
(HTXS narrative exempt in COP 2008)
Project Title: Feasibility and operational implications of HIV, CD4 and viral load testing in the
comprehensive package study in the demographic surveillance study area
This project evaluates the feasibility and operational implications of HIV, CD4 and viral load testing in a
population with near universal knowledge of HIV status and one of the highest HIV prevalence rates in
Kenya. Specific questions will address the amount of testing required, transport and timing issues,
laboratory capacity, quality assurance, and costs. The evaluation will also assess whether community
health workers who provide ART prescription refills can also draw blood for CD4 and viral load testing,
arrange transport to the laboratory, and receive and report back testing results. These questions will be
Year started: '07 Plus Up SI funding; so beginning late in '07.
FY 08: 300,000
Beyond FY08: $150,000 for FY09
laboratory questions and obtain population-level impact data at very low cost. In addition, 85,000 people will
benefit from comprehensive HIV prevention, care and treatment services as part of this study.
Results will be disseminated through the laboratory Technical Working Group at the national level as well as
through regional meetings for laboratory providers. In addition, we will share results with PEPFAR
implementing partners as well as the PEPFAR USG Kenya team.
covered. During FY08, analysis of baseline laboratory data will allow for completion of part of the questions
above, e.g. the amount of testing needed and preliminary results on operational implications. Results will be
disseminated and used to inform national policy and scale-up plans as well as PEPFAR '09 planning.
Salaries/ fringe benefits: $90,000
Equipment: $80,000
REFERENCE TO:
+Infrastructure improvement at the HIV and TB lab sites in Kisumu
+Recruitment of additional technical staff for the CDC/KEMRI labs in Kisumu and Nairobi
+Local organizations' capacity building through enhanced TA to NPHLS
+Enhanced support for targeted evaluations in Kilifi, Kisumu and Nairobi
+The WHO international surveillance and monitoring for HIV drug resistance.
+Procurement of commodities(test kits) to buffer centrally funded and procured stocks
This activity relates to all activities in MTCT, HVCT (#7009) and HVTB (#7001) and Surveillance (#............).
2. ACTIVITY DESCRIPTION:
The Kenya Medical Research Institute (KEMRI) is a premier Government of Kenya (GOK) biomedical
research institute and home of CDC offices and laboratories. KEMRI has highly trained laboratory staff who
conduct research and assess laboratory technologies. Key KEMRI objectives include: i) Provide highly
technical laboratory services to support HIV testing, and treatment programs. ii) Provide laboratory services
to support surveillance activities iii) Provide supportive supervision iv) Assist with development and
implementation of training curricula and materials required to expand capacity in clinical laboratories; v)
Collaborate with the National Public Health Laboratory Services (NPHLS) to strengthen NHPLS capacities
including the conduct of supportive supervision, reference laboratory services, and local evaluations of
laboratory tests; vi) Support the NPHLS to improve and sustain the national quality assurance (QA) and
Quality Improvement [QI] programs for HIV testing, laboratory monitoring of HIV treatment, and TB testing
in district and provincial/regional hospitals. The most important example of technical lab services provided
through the KEMRI labs is DNA PCR assays for early infant diagnosis (EID). The KEMRI laboratories are
now networked over 40 clinical sites through a courier supported transport system for filter paper samples
and results. Although the capacity for infant diagnostic testing is being established/expanded at other sites,
including NPHL and the MOH Coast Provincial Hospital clinical lab, KEMRI still remains a key provider of
this service. KEMRI already has a working relationship with Kilifi District Hospital in areas of DNA PCR
assays for early infant diagnosis. In FY 2008, KEMRI will build on this relation to strengthen Coast region's
lab capacity to meet emergency targets. During FY 2004-2007, KEMRI conducted serologic testing for
sentinel surveillance and demographic health surveillance surveys. In 2007, KEMRI was a major player in
the Kenya Aids Indicator survey [KAIS 2007], in terms of training, testing and procurement of lab
commodities. These functions are gradually being transferred to the NPHLS with support from KEMRI and
KEMRI will continue to train the NPHLS staff on sample collection, processing, calibration and validation of
instruments. Although various training functions are also being transferred to the NPHLS, KEMRI in
collaboration with other Lab ICC members, will assist with development of training curricula and standard
operating procedures [SOP] and will remain an essential provider of in-service training to clinical lab staff,
particularly in the areas of rapid HIV testing and collection of samples for EID. In addition, KEMRI will also
assist in the procurement of test kit stocks as a back up to those centrally funded and procured through the
SCMS. KEMRI laboratories have conducted most local validations of new laboratory assays. During FY
2007, much of this function was shifted to NPHLS with KEMRI support; KEMRI will continue to assist with
evaluations of highly complex assays such as alternate assays for infant diagnosis (for example ultra-
sensitive p24 antigen assays), Incidence assays [BED Assays] and DBS for Viral Load assays. KEMRI will
collaborate with NPHLS staff in the expansion of a proficiency testing [PT] program for HIV rapid and
confirmatory tests and CD4 cell count determination. KEMRI roles in this expansion will include assistance
in developing national CD4 cell count standards, development of proficiency panels, and assistance with
supportive supervision and oversight of QA/QI procedures.
3. CONTRIBUTION TO OVERALL PROGRAM AREA:
KEMRI laboratory activities play a key role in enhancing capacity of the NPHLS and point-of-service labs to
support surveillance, prevention, and care and treatment of HIV/AIDS and TB. Training/capacity building
focuses on the NPHL will held to build long term sustainable laboratory capacity in Kenya. These activities
will continue to support the training of 300 individuals in the provision of lab-related services and will
continue to contribute to improvement of the capacity of 60 laboratories to perform HIV and CD4 and or
lymphocyte tests.
4. LINKS TO OTHER ACTIVITIES:
This activity relates intimately to NPHLS, APHL and SCMS activities as well as to virtually all counseling
and testing and care and treatment activities.
5. POPULATION BEING TARGETED:
This activity targets the laboratory technologists of the NPHLS throughout the country at sub-district, district
and provincial levels where ARV services are being rolled out. Technologists from institutions outside the
NPHLS will also be trained.
6. EMPHASIS AREAS:
This activity will place major emphasis on technical training on QA/C, new and appropriate technologies.
Minor emphasis areas will include procurement of specialized laboratory commodities and
operationalization of laboratory QA schemes for HIV care and treatment.
The only changes to the program since the approval in 2007 COP are:
(i) The KAIS analysis and dissemination workshops. The KAIS is expected to provide a rich behavioral and
serological data set. It is therefore expected that there will be ongoing analysis and writing up workshop on
subsets of the data set in response to specific programmatic questions.
(ii) National scaling up of the PDA based TB case finding data management system will be completed. In
addition, this system will be hooked into the Phones for Health infrastructure in areas where the two
systems will have been implemented. This therefore extends the geographical coverage from two provinces
to national.
(iii) Evaluation of the male circumcision trial in Nyanza province, which is linked to prevention activities
(#####).
(iv) The use of smart cards will be piloted at health facilities in the DSS area to assess the acceptance and
feasibility of the card for identification and the embedded memory chip as storage of basic health data that
can be transferred with the patient if they move to another health facility within the DSS area.
Recommendations will be made to the Ministry of Health on the scale up to cover a wider area, taking into
account the lessons learn from the pilot and from other countries like Zambia that have implemented similar
systems.
Going alongside the smart cards will be another pilot on the use of fingerprint recognition to uniquely identify
patients who seek HIV related services, especially care and treatment. Various products exist in the market
that can support will be evaluated and the best performing one integrated with the data management
systems installed at the health facilities.
This activity relates to activities in HVTB (#7001 and #6944), HVAB (#6903), HBHC (#7005), HVCT (#7009
and #6941), HVSI (#7002 and #6988) and HLAB (#6940).
This activity will result in improved HIV surveillance and in the increased capacity for analysis,
dissemination and utilization of strategic information to strengthen HIV/AIDS policies and programs. This
activity has several components: (i) Intervention Evaluation: KEMRI/CDC maintains a jointly funded
Demographic Surveillance System (DSS) that monitors a population of 240,000 in Nyanza Province with
HIV prevalence in adults of approximately 25%. The DSS is being used to capture individual and aggregate-
level data on HIV infection, care and treatment services uptake, and HIV/AIDS-associated mortality. The
DSS is also being used to evaluate both the indirect and direct impact of ARV use on a population level,
including economic impact, impact on land use and impact on mortality. In addition, KEMRI is evaluating the
impact of HIV on orphanhood (approximately 1/3 of children under the age of 15 are orphans). The DSS
has been expanded within Siaya district and will include the Siaya District Hospital. The expanded DSS will
better be able to monitor the impact of the HIV interventions on all-cause mortality, HIV-specific mortality,
and the rates of opportunistic infections through population-based surveys utilizing thrice-yearly census data
and once yearly individual-level data. Mortality data will be collected using verbal autopsy in collaboration
with the Ministry of Health and the Central Bureau of Statistics and improve HIV/AIDS mortality surveillance.
A related sub-activity will entail setting up and maintaining a microwave/radio connection of Siaya District
Hospital and two selected health facilities with KEMRI/CDC Kisian. This will allow real-time connections
between DSS and clinical sites, greatly increasing the utility of DSS data in demonstrating ARV penetration.
This project will also evaluate the feasibility of the use of fingerprint-based ID system vs. a photo ID/barcode
based system for the unique identification of patients. (ii) Training: KEMRI will continue to offer training for
MOH and PEPFAR partners' staff in strategic information and assist in collection, data entry, management,
analysis, and utilization of program information. This continually improves the local human resource
capacity to carry out SI activities. KEMRI data staff will also offer technical support to the national TB
program on Portable Digital Assistant (PDA) data capture. The data management team will support the
rollout of the new NASCOP registers and forms at facilities in Nyanza, Eastern and Central provinces. In
addition to strengthening the national M&E system, PEPFAR reports will also be generated from these data
and facility feedback provided on the scale-up of various services (HTXD, MTCT, HVCT, etc). As part of this
activity, 140 individuals will be trained on data management and analysis. (iii) TB Reporting: To enhance the
HMIS at the National Leprosy and TB Program (NLTP) integrated TB/HIV case reporting system in PDAs
has been piloted in Nyanza and Nairobi. Following the successful pilot, PDA use will be extended to Coast
and Eastern provinces. District and Provincial TB coordinators from these provinces will be trained on the
use of PDA and each supplied with the handheld device. A GPRS module will be added to enable direct
submission of data from the field to a central database at the provincial level resulting in fast and secure
data submission. It is expected that the level of reporting for electronic TB data will increase to about 90%.
A total of 80 individuals will be trained. (iv) Integrated AIDS Care Services Evaluation: An evaluation of an
Integrated AIDS Care Services will be undertaken, with the aim of improving clinic-based HIV diagnostic
testing and counseling (DTC), home-based HIV counseling and testing (HBT), and decentralized care and
treatment in the KEMRI/CDC DSS. In order to carry out this evaluation, 50 counselors and health care
workers at health facilities will be cross-trained so that they can offer HIV testing and counseling under a
variety of circumstances (e.g., Home-based VCT, Diagnostic DTC, PMTCT, VCT). DTC will be implemented
in health facilities following national guidelines. PLWHAs will be incorporated into the evaluation staff.
Following HBT, all HIV-positive persons will be linked to a nearby health facility offering HIV services and
receive an HIV "package of care". All HIV patients will be screened for TB and care provided for those who
are dually infected. All persons from the DSS area that test HIV-positive (whether through HBVCT or DTC)
will be treated and managed by MOH clinical staff and/or through community-based lay health workers.
Pregnant women found to be HIV+ will be referred to the closest PMTCT site, and prevention interventions
for discordant couples, as well as HIV+ and HIV- individuals will be delivered. (v) AIS Quality Assurance:
Working in collaboration with the Central Bureau of Statistics and NASCOP on the AIDS Indicator Survey
(AIS), KEMRI will, through its laboratory infrastructure, provide technical oversight and quality assurance for
all laboratory testing using Dried Blood Spots (DBS) samples. Laboratory data will be managed by the
KEMRI data management staff, who will also assist in analysis and report writing. 25 individuals will be
trained (vi) KEMRI Kilifi has developed a DSS covering a 240,000 population that represents an 80%
Activity Narrative: catchments area for District Hospital admissions. Support for data management at the hospital level will link
routine counseling and testing information with the DSS follow-up system to evaluate outcomes and impact
of CT in the referral for care and treatment. 10 individuals including data managers and health workers will
be trained.
This activity will contribute in numerous ways to overall program area goals, including assessing the
penetration of HIV care and treatment activities, better understanding of orphanhood, TB, AIDS mortality,
and home-based counseling and testing of HIV. It will strengthen the national M&E systems and reporting
though the training of 160 individuals in SI and 20 organizations, including 12 MoH district programs.
The Demographic Surveillance Site targets the general population, sentinel surveillance targets pregnant
women and STI patients, the training and capacity building activities targets health workers and data
managers, and the reports generated by this activity target policy makers. Comprehensive evaluation of MC
service delivery models and population level impact of MC: Leveraging the existing Demographic
Surveillance System (DSS) in Nyanza Province, we will be able to evaluate the impact of MC circumcision
on HIV incidence at the population level. We will also be able to document uptake, coverage and cost-
effectiveness of facility-based MC service delivery and the added value of mobile approaches to MC service
delivery. In addition, we will monitor adverse events as well as risk compensation and disinhibition. The
existing DSS infrastructure provides a unique and excellent platform to assess operational research
questions and identify the most efficient and effective models of MC service delivery. This evaluation will be
conducted in partnership with NASCOP and KEMRI and the results will be used to inform GOK policy and
strategy development. The evaluation will be incorporated in the comprehensive prevention, care, and
treatment activity already planned for the DSS area to ensure that the population has full access to all
services.
Project Title: Population level Incidence Impacts of Interventions and Comparison with HIV incidence and
prevalence data with other data sources in the comprehensive package study in the demographic
surveillance study area
This project evaluates differences between HIV incidence, prevalence and behavioral risks from the
comprehensive package study and other data sources, including routine sentinel surveillance and the
Kenya AIDS Indicator Survey 2007. This will allow for better calibration of surveillance estimates based on
sentinel surveillance sites and will assist the Government of Kenya to develop an effective surveillance
system. The evaluation will be part of a matched cluster-randomized trial with a two by two factorial design
within the comprehensive package study in the demographic surveillance site in Western Kenya.
Year started: '07, largely with Plus Up funding; so major activities beginning late in '07.
Funds received to date: $800,000 total for '07 expected with Plus Up
Funds expended to date: $20,000 for protocol development work
Beyond FY08: $400,000 for FY'09
Divisions through KEMRI. Through this platform, we are able to use rigorous methods to address our SI
questions and obtain population-level impact data at very low cost. In addition, 85,000 people will benefit
from comprehensive HIV prevention, care and treatment services as part of this study.
Results will be disseminated through the Monitoring and Evaluation Committee of the MCGIV at the national
level as well as through regional meetings for policy development. In addition, we will share results with
PEPFAR implementing partners as well as the PEPFAR USG Kenya team.
covered. This will allow to answer the PHE questions. Results will be disseminated and used to inform
national policy and scale-up plans as well as PEPFAR '09 planning.
Salaries/ fringe benefits: $185,000
Equipment: $105,000
Travel: $75,000
Laboratory Testing: $140,000
THIS IS AN ONGOING ACTIVITY. THE NARRATIVE IS EXPANDED INCLUDING UPDATED
1. ACTIVITY DESCRIPTION
KEMRI has a mandate to provide an evidence base for new GOK MOH policy formulation. In this activity,
KEMRI will work closely with NASCOP, the Nyanza Circumcision Consortium and other partners to
strengthen MC delivery systems in Nyanza Province. KEMRI's work will involve both Facility and Mobile
approaches to MC service delivery and will also incorporate a comprehensive evaluation of MC service
delivery models and population level impact of MC. Leveraging the existing Demographic Surveillance
System (DSS) in Nyanza Province, KEMRI will be able to evaluate the impact of MC circumcision on HIV
incidence at the population level. KEMRI will also be able to document uptake, coverage and cost-
delivery. In addition, KEMRI will monitor adverse events as well as risk compensation and sexual
disinhibition. The existing DSS infrastructure provides a unique and excellent platform to assess operational
research questions and identify the most efficient and effective models of MC service delivery. This
evaluation will be conducted in partnership with NASCOP and IMPACT and the results will be used to
inform GOK policy, implementation guidelines and strategy development.
2. CONTRIBUTIONS TO OVERALL PROGRAM
The KEMRI Systems Strengthening activity will guide and strengthen the capacity of all program personnel
and service systems in providing high quality medical male circumcision services through an efficient
system. It will identify key staff requiring training and establish effective health service delivery systems.
The program will help train MOH and other program personnel in identifying efficient ways of service
delivery thus optimizing resource utilization.
3. LINKS TO OTHER ACTIVITIES
This activity links to support given to NASCOP for policy development and UCSF for cost-effectiveness
work. In addition, this activity links to prevention activities implemented by KEMRI, ITM, IMPACT and other
groups that target youth and most-at-risk groups in Nyanza Province. Other linkages include facility-based
and mobile VCT and Provider-initiated counseling and testing services provided by KEMRI, LVCT, and
other partners.
4. POPULATIONS BEING TARGETED
MOH personnel at National, Provincial and district levels will be involved in the development of service
delivery systems, training, implementation and quality assurance processes and will work in coordination
with all PEPFAR-funded MC implementers. For the MC systems strengthening component, personnel
including health care workers and lay counselors serving in service delivery sites will be targeted. Staff of
other affiliate agencies in the consortium providing community education and other services will be targeted.
5. EMPHASIS AREAS / KEY LEGISLATIVE ISSUES ADDRESSED
KEMRI's Policy and systems strengthening will focus mainly on developing and strengthening systems to
support the Medical Male Circumcision program. Behavioral interventions will include addressing male
norms and behaviors, particularly relating to behavior disinhibition following circumcision. Training will be
conducted for health service providers, particularly in-service training.
