Introduction Continued
Prior to the first
HIV cohort study, two HIV activities were ongoing in the Kericho HIV
program: the Prevention of Mother to Child Transmission (PMTCT) of
HIV program and the first phase of a Boston University-KEMRI-WRP
Kericho collaboration evaluating the impact of HIV and malaria on
James Finlay Plantation tea pluckers’ labor productivity. The WRP’s
PMTCT program started in 2001
in three sites in Kericho District. Since then, it has grown to
include 55 sites and has screened over 42,000 women, with around
2,200 infected pregnant women infected being given single dose
nevirapine (NVP) and about 1,500 infants being given NVP syrup.
Beginning in 2001 with support from the U.S.
National Institutes of Health through the International Studies in
Health and Economic Development grant program (ISHED I), a team from
the
Boston
University –KEMRI-WRP Kericho studied the impact of
HIV/AIDS-related morbidity on labor productivity. The ISHED I study
was a retrospective cohort study that compared the amount of tea
plucked by 54 tea pluckers who had died of AIDS-related causes or
been discharged on medical grounds due to AIDS (index subjects)
between 1997 and 2002 during the three years prior to termination of
service with that of pluckers who were not known to have died of
HIV/AIDS. This study concluded in December
2004 and the second part of the study is now in progress.
The
HIV and malaria cohort study opened to recruitment in June
2003 and served as the foundation study for the program’s upcoming
HIV vaccine clinical studies. The HIV and malaria cohort study was a
3-year prospective, bi-annual follow-up study of approximately 2800
adults working on the James Finlay Plantation. The study was
concluded in December 2006.
Recognizing the
critical importance of assuring that comprehensive HIV/AIDS care and
treatment is available in the larger Kericho community and southern
Rift Valley Province where HIV vaccine research would be ongoing,
the USAMRU-K HIV Program took on the ambitious task of opening up
HIV/AIDS care and treatment clinics in March 2004 in the Kericho
District. As one of the United States Government implementing
partners at the US Embassy in Nairobi for the
President’s Emergency Plan For AIDS Relief,
the USAMRU-K oversees two primary HIV care and treatment programs in
Kenya: the
South Rift Valley HIV Program (which started in the Kericho
District but now covers 6 districts in the southern Rift Valley
Province); and,
the Kenya Department of Defense- KDOD (which covers 5
military bases throughout Kenya).
The “Optimal Combination Therapy after Nevirapine Exposure (OCTANE)”
study is a phase III study comprising two randomized clinical trials
(RCT) being conducted concurrently. Both trials compare the
virologic response to non-nucleoside reverse transcriptase inhibitor
(NNRTI)-based (Arm 1A) versus protease inhibitor (PI)-based (Arm 1B)
antiretroviral treatment (ART) in HIV-infected treatment-naïve
women. The study systematically evaluates the hypothesis that single
dose nevirapine induces a clinically significant resistance to
nevirapine-based triple therapy in women who progress to need full
antiretroviral therapy for AIDS.
The United States Military HIV Research Program’s (USMHRP) first
HIV vaccine study to be conducted in Kenya opened in
Kericho in April 2006 and is fully enrolled. This study is 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.