HIV/AIDS Program

 

Introduction

By 2010, there will be 45 million new HIV infections for a total of 105 million worldwide. By 2020, more that 70 million deaths will be attributed to HIV which is more than all the soldiers killed during World War II. HIV/AIDS is one of the biggest threats to global health and stability. While the epidemic has reached a plateau in the developed countries, it is still on the increase in developing countries. Out of 42 million infected with HIV, 29 million are from sub-Saharan Africa accounting for 70% of all infections. The Demographic Health Survey (DHS) conducted by the Kenya Ministry of Health in 2003 revealed an overall HIV prevalence of around 6.7% with variation according to gender and location. Young women between the ages of 20-24 are almost four times as likely to be infected as men in the same age cohort (8.7 versus 2.4 %). Prevalence in urban areas is almost twice that in rural areas.

 

Despite the ravages imposed by HIV/AIDS on the Kenyan people, there are some encouraging trends. Sustained prevention efforts focusing on information, education and communication that reach down to the village level are in place in many Kenyan districts to hopefully subdue this epidemic.  Progress is also being made on the treatment and care of HIV-infected patients.  Kenyan and international researchers have already conducted a few HIV vaccine trials and have developed National HIV/AIDS Vaccine Research Guidelines for future proposed Phase I-III HIV vaccine trials in Kenya. 

Background           

The United States Army Medical Research Unit – Kenya (USAMRU-K) HIV/AIDS Program is the primary field station for the U.S. Military HIV Program, also known as The Walter Reed Project (WRP). The USAMRU-K HIV/AIDS Program is located in Kericho, Kenya approximately 300km northwest of Nairobi. It has 85 core staff and 67 temporary staff drawn from the HIV program and other collaborating projects working in various departments: Administration, Clinical, Laboratory, Field Operations, Information Systems & Data Management, Transportation and Security.  The primary mission of the Project is to develop strategies to prevent HIV infection globally through 1) education and prevention, 2) research and development, 3) care and treatment and 4) health policy development.  The primary objective of this effort is establishing a vaccine for HIV.  

Core Research Activities

A key element in developing a vaccine is to appropriately identify cohorts in which to conduct vaccine trials.  In June 2003, we commenced our HIV Vaccine Development Cohort at James Finlay Kenya (Ltd) Tea Plantation with the following objectives among others: (1) estimate the incidence and prevalence of HIV, (2) characterize the risk factors associated with HIV infection, (3) determine the viral clade and recombinations of HIV-1 in this part of Kenya, (4) characterize the kinetics of HIV-specific immune responses, CD4 counts and viral loads in early HIV infection and in the face of malaria co-infection, and (5) characterize the drug resistance patterns of Plasmodium species. 

The current available information from our HIV Vaccine Cohort Development Study reveals an HIV prevalence of 14.5% with variation according to gender and tribal affiliation. Normal and abnormal laboratory values for this population have been determined and shared with regional hospitals and dispensaries. Recently, eight abstracts were presented at the XV International AIDS Conference in Bangkok, Thailand describing the HIV epidemic in this rural cohort and noted that over 90% of the study volunteers would be willing to participate in future HIV vaccine trials. WRP plans to commence Phase I/II HIV-1 vaccine and therapeutics trials in collaboration with the National Institutes of Health, Division of AIDS, at the James Finlay Kenya plantation site and other sites in 2005. A 7,000 square-foot state-of-the-art Clinical Research Center (CRC) was inaugurated in March 2004 to serve as the USAMRU-K HIV/AIDS Program headquarters, regional clinical research training site and referral laboratory.  


WRP Clinical Research Center and Inauguration Plaque

 
Mobile Operational Field Research by Tent in the Tea Plantations

 
CRC’s 4-color Flow Cytometer to Determine CD4 Counts


CRC Lab Technician Performing HIV Viral Load Testing

Prevention of Mother to Child Transmission of HIV Infection Program

The WRP Prevention of Mother to Child Transmission of HIV Infection (PMTCT) Program commenced in August 2001 in three hospitals and has now expanded to a total of 29 health facilities. Antenatal clients are offered PMTCT services with routine reproductive health care. Seventy three nurses have been trained in PMTCT counseling with some receiving further training in rapid HIV antibody testing and “training of trainers”. There were 26,178 new antenatal cases. 15,531 (59%) pregnant women were offered PMTCT counseling, out of which, 14,774 (95%) accepted to be tested. 12,774 (86%) of those tested received their results. Mothers 1288 (8.7%) of the pregnant women were HIV infected and 903 (70%) of them and 495 (39%) of their infants were given Nevirapine. The percentage of pregnant women offered counseling has increased from an initial 4% in the first 4 months of the program to approximately 100% in the last 11 months.


PMTCT Program Implementing Group Counseling

Boston University Collaboration

WRP began collaborating in January 2002 with Boston University to evaluate to the impact of HIV/AIDS upon labor productivity at James Finlay Kenya.  The objectives of the study were to 1) estimate the decline in on-the-job labor productivity associated with HIV/AIDS, 2) estimate the additional paid and unpaid leave taken by workers with HIV/AIDS, 3) estimate shifts of workers to light duty and 4) calculate the earnings loss caused by HIV/AIDS and malaria.  The study ended in December 2003.   

In comparing workers without HIV/AIDS to workers with HIV/AIDS, the study found that workers with HIV/AIDS on average were absent 31 more days (increase of 87%), spent 22 more days on light duty (increase of 66%), produced an average of 7.1kg less tea leaf plucked per day (decrease of 17%), and had overall earnings decreased by 18%.  One caution noted in the study regarding the results was that since workers often bring unrecorded “helpers” to the field, the actual differences may be even greater. 

The WRP-Boston University team published their results recently in a manuscript entitled “The impact of HIV/AIDS on labour productivity in Kenya” in the Tropical Medicine and International Health Journal (March 2004).  The study is continuing to now evaluate the impact of malaria on labor productivity.  In the future, it is anticipated that the WRP-Boston University will work with James Finlay Kenya to evaluate the impact of HIV/AIDS drug treatment on labor productivity. 

President Bush’s Emergency Plan for AIDS Relief

In April this year, several Kericho hospitals began offering comprehensive HIV/AIDS care and treatment through the Walter Reed Project and the United States’ “President’s Emergency Plan for AIDS Relief.”  The President’s Emergency Plan is a 5-year, 15 billion dollar program offering comprehensive HIV/AIDS care and treatment worldwide including 15 focus countries, 12 in Africa.  In excess of 70 million dollars will be introduced in to Kenya this fiscal year for HIV/AIDS care and treatment.  As one of the United States Government Agencies involved in the President’s Emergency Plan in Kenya, the United States Army Military Research Unit/Walter Reed Project has implemented comprehensive HIV/AIDS care in western Kenya. 

A focus of the President’s Emergency Plan is the provision of anti-retroviral therapy to individuals with HIV/AIDS who need therapy.  In April, WRP partners at the Kericho District, bordering tea plantation and faith-based hospitals/dispensaries began treating HIV-infected patients and their affected family members with medicines provided by the Walter Reed Project under the President’s Emergency Plan.  By the end of July 2004, over 450 patients had been started on anti-retroviral therapy, and approximately 600 others not yet warranting anti-retroviral therapy, have been incorporated into the program to receive other HIV/AIDS care and support.  In addition, funds under the President’s Emergency Plan have been used to improve regional hospital laboratories and train clinical teams to administer and monitor antiretroviral and opportunistic infection treatment.  Several counselors have also been trained to promote HIV educational and prevention messages as well. WRP, through its implementing partners, plans to offer comprehensive HIV/AIDS care to over 8,000 patients in western Kenya by March 31, 2005.    

Other Accomplishments

  1. Instituted community programs for voluntary counseling and testing in 2000-present.

  2. Completed Good Clinical Practice training for over 200 African researchers and staff in September 2001 at Nairobi, Kenya.

  3. Completed seminar on antiretroviral therapy for the Kericho branch of the Kenya Medical Association in 2001.

  4. Completed Good Laboratory Practice training for over 200 African researchers and staff in May 2002 at Nairobi, Kenya.

  5. Donate essential medications to local Kericho hospitals in 2002-present. 

  6. Developed HIV Post exposure Programs (PEP) for Kericho Hospitals and sponsored training of their Medical Officers supervising PEP in September 2002.  Our PEP has been transferred successfully to other laboratories in Kenya, Uganda and Tanzania.

  7. Granted AIDS Vaccine Advocacy Coalition (AVAC) funding to purchase essential medical equipment for the Kericho District Hospital Maternity and Delivery Wards in January 2003 and January 2004 to help prevent the transmission of HIV from mother to child.

  8. Commenced Proficiency Testing in 2003 of all ELISA/WB and rapid HIV tests to maintain quality assurance and control at all laboratory sites involved in the WRP HIV Vaccine Cohort Development and Elizabeth Glaser Pediatric AIDS Fund for Prevention of Mother to Child HIV Transmission.

  9. Completed Rapid HIV test study in August 2003 to determine accuracy and most useful algorithm of current and future HIV Rapid Tests in Kenya. Results have been published in the August 2004 issue of the Journal of Clinical Microbiology.

  10. Granted Phizer Free Donation of Diflucan in December 2003 to treat HIV-infected patients with cryptococcal meningitis and esophageal candidiasis.

  11. Installed and trained IT and Laboratory Staff on new state-of-the-art data management and information systems infrastructure from July 2003 – present.  Data is managed by the clinworX 4.1 system. This client-server based system consists of Oracle-based databases and Oracle Forms interface. clinworX consists of four interdependent systems which assist research in managing clinical, laboratory, and specimen data, as well as, tracking participant registration and enrollment, and study personnel management.

  12. Appointed by the Kenyan Ministry of Health in 2003 to serve on the National AIDS Contol Program to advise the Minister of Health on HIV Care and Treatment issues.

  13. Appointed by the Kenyan Ministry of Health in 2004 to serve on the National HIV Vaccine Expert Sub-committee to develop national HIV/AIDS vaccine strategies, guidelines and monitoring for Kenya.

  14. Completed 4,000 square foot Maternal Child Health Clinic and Counseling Center at the Kericho District Hospital in March 2004.

  15. Assisting the Kenya Medical Research Institute in developing an Institutional Biosafety Committee to implement all NIH-funded trials of vaccines containing recombinant DNA or RNA derived from recombinant DNA in 2004.

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