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Kenya

Site Established: Research, 1999; PEPFAR, April 2004
HIV prevalence: 14%
HIV incidence: 1.8%

The Walter Reed Project–Kenya (WRP), the Department of Defense's HIV program in Kenya, supports the USMHRP mission through HIV research and vaccine development efforts, as well operational research and HIV care and treatment. The Program integrates HIV research and comprehensive care, which enables the team to achieve critical research goals while improving HIV treatment services for the region.

With a population of nearly 32 million, Kenya is faced with the tragedy of the growing HIV/AIDS epidemic, with more than one million people there infected with HIV. UNAIDS estimated in 2002 there were 890,000 AIDS orphans in the country. Kenya is simultaneously addressing the epidemic, the potential contraction of its population and the lowering of the average life expectancy, as these factors threaten the country's social and economic progress.

Cohort development and surveillance are being conducted by WRP–Kenya. Efforts also include blood bank HIV surveillance of general populations, genetic subtypes and recombinants, plasma and cell samples to support vaccine research, and the evaluation of potential cohorts for Phase III clinical studies.

Activities in Kenya are centered at the U.S. Army Medical Research Unit–Kenya (USAMRU-K) on the campus of the Kenyan Medical Research Institute (KEMRI) in Nairobi. The U.S. military has maintained a substantial program for infectious disease research in Kenya for nearly 40 years. Field site activities are based in Kericho, in the Southern Rift Valley, west of Nairobi.

Research Efforts:

A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Boosted by a Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine in HIV Uninfected Adult Volunteers in East Africa

• Initiated April 7, 2006
• First HIV vaccine study in Kenya outside of Nairobi
• Third HIV vaccine study in Kenya

HIV Vaccine Cohort Research

A three year-study following 2,800 tea plantation workers and dependents that is looking at HIV prevalence and incidence will end in December 2006. This is the only prospective HIV cohort study in Kenya. The follow-up rate has been 84% over 24 months.

Optimal Combination Therapy After Nevirapine Exposure (OCTANE)

This therapeutic study was initiated in May 2006. This critical study for the Kericho area and for Africa systematically tests the hypothesis that women with prior single dose nevirapine in the context of Prevention of Mother-To-Child Transmission (PMTCT) of HIV have poor clinical outcomes in nevirapine-based antiretroviral therapy due to nevirapine resistance. The NIH/Division of AIDS/Therapeutics Research Program (TRP), AIDS Clinical Trials Group (ACTG), sponsors this study. It will be conducted in 10 sites in Africa, two in Kenya.

Kericho Prevention of Mother-to-Child Transmission Program (PMTCT)

The Kericho PMTCT program, initiated in 2001, has been the foundation for HIV care and treatment activities in the region. Director Frederick Sawe, MBChB, MMED, has built the program to include 60 clinics. The team has counseled more than 60,000 women. This is the second largest PMTCT program in Kenya.

Employee Productivity Research

The Kenya team has been involved in a four-year prospective cohort study in collaboration with Boston University evaluating the impact of anti-retroviral therapy on labor productivity in 400 tea plantation workers. The study is in the second phase of the initial study evaluating the impact of HIV disease on labor productivity. The study opened February 22, 2006 and approximately 100 volunteers are enrolled.

download: Kenya Research Strategy (pdf)

Future

• Kericho HIV Program Youth and Adult "High Incidence" HIV Cohort Study
• Phase I trial using DNA/Modified Vaccinia Virus Ankara (MVA) prime-boost vaccine strategy focusing on HIV subtype A

Facilities:

Nairobi:

Activities in Kenya are centered at the U.S. Army Medical Research Unit-Kenya (USAMRU-K) on the campus of the Kenyan Medical Research Institute (KEMRI).

Kericho:

Comprehensive field site built around the Clinical Research Center (CRC). The Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP CRC) is located in Kericho, Kenya, and serves as the Kenyan laboratory for the U.S. Military HIV Research Program. The facilities house a research clinic including a pharmacy equipped for both vaccine and therapeutic studies, a DAIDS- approved research laboratory currently preparing for College of American Pathology (CAP) certification, an information technology (IT) department/data management office and administrative offices.

Prevention, Care and Treatment:

Efforts include working with local partners throughout the South Rift Valley and within the Kenyan Department of Defense. Since 2003, activities have focused on developing the capacity of health facilities at two tea plantations, Kericho District Hospital, several surrounding private hospitals and a large mission hospital 50km southwest of Kericho.

Services have expanded to 11 hospitals, with some services being initiated at nearby smaller health centers. Work in community outreach and expansion of care outside of health care facilities has been undertaken in collaboration with local community-based organizations providing home-based care and support to Orphans and Vulnerable Children (OVC).

Partners include:

• Kericho District Hospital
• Tenwek Mission Hospital, Unilever Tea Plantation
• James Finlay Flowers Plantation
• Kapsabet District Hospital (DH)
• Kilgoris Transmara
• Nandi Hills District Hospital
• Kapkatet District Hospital
• Longisa District Hospital
• AIC Litein Hospital
• Live With Hope Center
• Samoei Community Response to OVC
• Kenya Department of Defense, as well as several national NGOs based in Nairobi

Staff: 125
download: Walter Reed Project–Kenya Organizational Chart (pdf)

Accomplishments:

• Site certified by NIH/DAIDS Vaccine - the first Phase I/II vaccine trial opened April 7, 2006.
• Site certified by NIH/DAIDS Therapeutics - the first Phase III therapeutic trial opened May 8, 2006.
• The HIV Program Research Laboratory received National Institutes of Health/Division of AIDS laboratory certification for supporting DAIDS-sponsored studies in January 2006. The laboratory continues with College of American Pathologists (CAP) certification procedures.
• The HIV Program Research Laboratory supports the USAMRU-K malaria program by conducing laboratory analyses for an ongoing epidemiological study being conducted in Kericho by the malaria program.
• In addition to supporting the entire HIV Program, the Kericho Information Technology Department now supports three clinical trials, all with different data management system requirements.
• After receiving two independent certifications from the National Institutes of Health/Division of AIDS Pharmacy Affairs Branch to conduct both vaccine and therapeutics research, the Kericho Research Pharmacy supported the opening of both vaccine and therapeutics clinical trials within a month.
• In December 2005, the HIV cohort study following 2,800 tea plantation workers and dependents achieved a 24-month, 84% follow-up.
• In February 2006, the HIV Program collaboration with Boston University opened the second phase of research evaluating the impact of antiretroviral therapy on labor productivity in tea plantation workers.
• In the first half of 2006, two peer-reviewed manuscripts were published, and approximately 10 additional manuscripts are currently in preparation.
• In the last year, more than 25 abstracts including nine oral presentations, representing the HIV research and treatment program have been presented or accepted for presentation at international HIV/AIDS meetings.
• Three USMARU-K HIV Program Staff have been selected by the U.S. Embassy to lead Emergency Plan "Interagency Technical Teams," including HIV Treatment, Prevention of Mother-to-Child Transmission of HIV, and Orphans and Vulnerable Children.

USMHRP International Network:
Nigeria | Kenya | Tanzania | Uganda | Thailand