Building Technical Capacity | Supporting Trials |  Reaching Out Sustaining Political Support | Advocacy

In 2001, the Government of the Republic of Uganda and IAVI began a partnership to accelerate the development and clinical evaluation of preventive AIDS vaccines. This partnership is based in Entebbe, at the Uganda Virus Research Institute, the research unit of the Ministry of Health

IAVI has worked closely with UVRI to develop an AIDS vaccine research center dedicated to conducting clinical trials at the highest of standards. In the process, we have significantly built the country’s technical and professional capacity for conducting biomedical research.

IAVI's partnerships in Uganda include:

• UVRI-IAVI HIV Vaccine Program: This program for vaccine development was launched in partnership with the Government of Uganda. A subsidiary of the Uganda Ministry of Health, UVRI has been conducting biomedical research since 1936. The UVRI-IAVI HIV Vaccine program has been selected as a central laboratory in the Bill and Melinda Gates Foundation-NIH T-cell consortium, which is dedicated to innovative AIDS vaccine research. The program launched its first Phase I AIDS vaccine trial with 51 volunteers, in February, 2003, and conducted a Phase II clinical trial with 120 local volunteers in 2006 
   
• Medical Research Council (MRC): Since 2004, IAVI has been working in collaboration with the MRC’s Unit on AIDS, which is also based at UVRI and has conducted HIV-related research in the country since 1989. IAVI sponsored research activities are conducted in two of the MRC’s field sites (Entebbe Hospital and Masaka, a rural district in southwest Uganda). These activities focus on preparing communities for future large scale trials of AIDS vaccines
  
  

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BUILDING TECHNICAL CAPACITY

To ensure the long-term viability of the clinical trial programs in which we participate, we stress the cultivation of technical capacity to conduct biomedical research. Activities to date have included:

• Building and/or equipping research centers at UVRI and MRC that are devoted to clinical trials
   
• Providing a high level of technical training, including the training of scientists in Good Clinical Practice and Good Clinical Laboratory Practice (GCLP). In fact, the UVRI-IAVI HIV Vaccine Program was the first research center in sub-Saharan Africa to be accredited under the stringent GCLP scheme
   
• We have developed a curriculum to train site staff to take gender-related issues into account in conducting AIDS vaccine research. This training inculcates sensitivity to the needs and concerns of women—and other especially vulnerable groups—and so bolsters the recruitment and retention of volunteers, and ensures the ethical conduct of clinical trials
  
• To ensure an appropriately high standard of service at research centers, IAVI has helped UVRI-IAVI develop and implement a participatory quality improvement program that relies heavily on volunteer feedback and recommendations

Any effective program to conduct HIV research and run vaccine trials also relies on the availability of high-quality voluntary counseling and HIV testing (VCT) services, strong health care referral networks and effective mechanisms for community feedback in the planning and execution of clinical trials. Because volunteers are often referred to research centers from surrounding clinics and hospitals, IAVI has taken steps to improve HIV and AIDS services at those facilities by:

• Working with the MRC and the Research Unit on AIDS to expand and improve reproductive health services at a busy city hospital, Entebbe General Hospital/Wakiso District. These measures included the formalization of VCT services for the general public
   
• Partnering with a rural health center, Kisubi Hospital, to support health workers to provide VCT and HIV services at people’s homes

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SUPPORTING TRIALS

We work with the staff at our research centers in Uganda to help strengthen health services.

IAVI has supported the training of clinical staff in VCT, couples VCT, family planning counseling, vaccine literacy, and gender issues related to clinical trials.

To prepare for large scale clinical trials, IAVI supports epidemiological and social science research to estimate the incidence of new HIV infections and, among other things, collect information about risk behaviors.

IAVI is also supporting UVRI’s research in Ugandan fishing communities, whose members are known to be at a relatively high risk of contracting HIV infection. These communities may have an important role to play in future AIDS vaccine trials.

Community Advisory Boards at UVRI-IAVI and MRC research centers advise researchers about the needs and concerns of local citizens and volunteers, and play an active role in the design and conduct of vaccine trials. IAVI and the research teams in Uganda, meanwhile, keep CAB members updated on issues related to AIDS vaccine research. IAVI has also established a nationwide network of CABs to support the exchange of information and experience, and so improve the overall performance and coordination of CABs. 
 

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REACHING OUT

The AIDS vaccine effort would not be sustainable without the widespread civic and community support.

With that in mind, the UVRI-IAVI HIV Vaccine Program has developed a cadre of peer leaders—all volunteers—who promote informed awareness about AIDS vaccine research. Peer leaders provide basic information on HIV prevention and AIDS vaccine research to people in their communities. They play a key role in recruiting volunteers for clinical trials.

As part of our continuing efforts to prepare for the swift distribution of a future AIDS vaccine, we are partnering with PATH on a global project to introduce the cervical cancer vaccine (against human papillomavirus, or HPV). IAVI provides support to country programming and advocacy efforts in Uganda while learning lessons to inform the future introduction of AIDS vaccines in the developing world.

UVRI-IAVI HIV Vaccine Program produces a widely circulated quarterly newsletter with information on all issues relating to the AIDS vaccine effort. It also works closely with all other organizations conducting vaccine trials and other clinical research in the country to improve the community outreach of both researchers and CABs. We also arrange regional CAB meetings to allow CAB members to exchange ideas and discuss challenges.
 

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SUSTAINING POLITICAL SUPPORT

High-level political support and sound policy are also essential to the sustainability of the AIDS vaccine effort.

IAVI partners with government agencies, policymakers, and researchers to foster a supportive political environment for the swift development and future distribution of AIDS vaccines.

In 2005, IAVI played a coordinating role to help the government formulate its National Guidelines for AIDS Vaccine Research. The document provides guidance on ethical, regulatory and scientific issues related to AIDS vaccine R&D in the country

IAVI has helped to establish a Gender Advisory Committee (GAC) that advises IAVI-affiliated research teams and their civil society partners on matters related to gender in AIDS vaccine research. The GAC has organized influential public policy and advocacy events, such as a session on AIDS vaccines during the June 2007, Commonwealth Women Affairs Ministers’ Meeting

Working with the Uganda AIDS Commission and researchers from the Institute of Public Health at Makerere University, IAVI modeled the potential impact of AIDS vaccines in Uganda.  Results will be used to inform policy decisions. [add link to impact model in policy section] 

ADVOCACY

IAVI has garnered high-level support for the AIDS vaccine program through the Global Political Advocacy Initiative.

In 2005, for example, the UVRI-IAVI HIV Vaccine Program assisted the President Yoweri Museveni draft a letter that called on G-8 nations to boost their support for AIDS vaccine development

At the 2007 Commonwealth Head of Governments Meeting in Kampala, IAVI worked with the hosts, President and Mrs. Museveni, to highlight the importance of developing AIDS vaccines and other prevention technologies, and to strengthen alliances with government and civil society leaders and the Commonwealth institution. Through these efforts, IAVI secured supportive language for vaccines and other prevention technologies for HIV in the official meeting communiqué.