The Community and the Scientists: 
A synergistic relationship

A Backgrounder on Community Involvement prepared in conjunction with the press launch of Phambili

8 February 2007

The Community and the Scientists:  A synergistic relationship
A successful HIV vaccine is probably our best hope for controlling the HIV epidemic. Other viral epidemics such as smallpox and polio, which caused death and suffering, have been largely controlled and even eradicated by the use of vaccines and there is no doubt that the same is required for HIV/AIDS. 

The discussion of HIV vaccines stimulates interest, discussions (often heated), misconceptions and misperception in almost all settings. Healthy individuals must possess both trust and altruism before they will agree to participate in clinical trials of experimental vaccines. Community assent is an essential ingredient for individuals to be able to decide to participate or not to participate in research. This is particularly challenging when no vaccine has yet been proven to work.  Furthermore, there is an ongoing misconception in many communities that participation in a vaccine study is limited to people who are already infected with HIV.  In fact, each participant in a study investigating a preventive vaccine must be HIV negative when enrolling.

Community Preparedness and Education
An operating principle for the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN) is that clinical trials of HIV vaccines and other prevention interventions are most likely to succeed when all parties concerned—study participants, researchers, government, vaccine developers, and the community—regard the trials as a collaborative process. Successful conduct of trials requires an aware, knowledgeable, and involved community throughout the research process and beyond. Since 1999 when the organisations were formed, the HVTN and SAAVI have worked to build partnerships that result in a broad community support of vaccine clinical trials from a wide array of non-governmental organisations (NGOs) and faith groups. This education strives to create a community level of informed consent that ensures support for appropriate individual informed consent. While community level informed consent is important, individual and free consent must be given by every participant. Providing communities with the tools for engagement and a true partnership between researchers and the community requires that communities have access to up-to-date, culturally and linguistically appropriate educational information; opportunities for ongoing learning and participation; and, ongoing interaction with clinic staff.

The HVTN is committed to conducting ethical research of the highest scientific quality; fostering community education and seeking community input; maximizing the involvement of women and men living with HIV/AIDS; preventing discrimination regarding HIV status, gender, religion, race, sexual orientation, sex work, drug use, and cultural or social status and providing resources to support the activities and infrastructure to build and sustain the community-research partnership. These commitments are made on several levels:

1. assisting each HIV Vaccine Trials Unit (HVTU-research site) in developing a Community Education Plan and a Recruitment and Retention Plan;
2. joining community representatives from the HVTUs into a Global Community Advisory Board that advises the HVTN governing body, the Scientific Support Committee;
3. ensuring that each HVTU Community Advisory Group (CAG) determines its own priorities, methods of organization, and programs.

This model ensures that particular attention is paid by all stakeholders to the intervening factors and research dynamics that influence and impact the ethical decisions that must be made. This is particularly critical when undertaking research involving participants in vulnerable communities.

Community Involvement in the Phambili Study
The SAAVI/HVTN’s five South African clinical trial sites each has a well-established community programme that has been engaging and involving their communities in preparation for the Phambili study (HVTN 503).  Community Advisory Groups (CAGs) include a diverse representation of interested people in the community, including traditional healers, governmental leaders, religious leaders and community nurses. These CABs actively engaged in review, comment and advise on the informed consent, community education activities and recruitment and retention plans.  Each site has a dedicated team of educators focusing their work on fostering the understanding of clinical research and HIV vaccine trials in the community-at-large.  Ultimately, this builds community knowledge and support not only for the HIV vaccine effort but, more importantly, for the participants who join the trials. Many of these educators have been working in the field of research for several years and have become trusted leaders in their communities.  Their work has built a strong sense of collaboration and trust between the clinical trial sites and the communities in which they work.

The vaccine being tested in the Phambili study has already been tested in the US and nearly two thousand people have already received this product.

South Africa’s commitment to community involvement in HIV vaccine trials
Since the start of SAAVI in 1999, one of its key elements has been the existence of a national community involvement programme (now called Masikhulisane). The Masikhulisane vision is a South African society working in a mutually beneficial and meaningful partnership with researchers within a vibrant human and legal rights environment. Masikhulisane aims to educate communities about the process involved in vaccine research and development, and specifically about clinical trials and clinical research to enable them to make informed decisions at community and individual level.

These educational initiatives acknowledge that the process of evaluating candidate vaccines involves some risk and that there needs to be full disclosure of these risks to both communities and individuals.

Masikhulisane is independent of any recruitment activities.  

Recruitment
The South African Constitution makes it clear that no person may be subjected to medical experimentation/research without their informed consent. This means that individuals need to have full access to all information and must be able to ask any questions about the clinical trial in order to make a free and informed decision.

The process of recruitment into HIV vaccine trials is therefore long term and complex. Community educators and recruiters from the trial sites go out into the communities to do initial awareness raising. Interested individuals are then invited to vaccine discussion groups where more detailed information is made available.  After a number of these sessions interested individuals undergo pre-screening to assess their eligibility for the trial. They are given additional information to take away and discuss with families and partners. Ongoing one-on-one counselling is done at which all the risks and benefits of participation are clearly explained. Volunteers can only give informed consent after their understanding has been assessed and tested.  Ongoing counselling throughout the period of the trial is also done to ensure that full understanding and consent is maintained. Volunteers are also able to leave the trial at any point.

One of the operating principles of the HVTN and SAAVI is the commitment to true partnerships with communities where research is conducted. These partnerships require an investment of resources, and community education has been key to securing and building trust in a collaborative vaccine programme. There are no guarantees all these efforts will be successful in reaching all potential partners, but it is guaranteed that no success will be achieved without such commitments.

The Phambili study was designed by South African researchers. The HVTN as an organisation provides support but the scientific leadership of the study is South African, and study procedures have been reviewed and discussed with community representatives from the participating trial sites.

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