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How Should HIV Vaccine Efficacy Trials Be Conducted? Diverse U.S. Communities Speak Out, Kegeles et. al. - a report from Project LinCS - Linking Communities and Scientists (2006)
WOMEN
ADOLESCENTS
GAY MEN
INJECTING DRUG USERS (IDUs)
SEX WORKERS
AFRICAN AMERICANS
WOMEN
Women, AIDS and the Search for a Vaccine - As women become one of the fastest-growing risk groups for HIV infection it has become increasing important to ensure their inclusion in HIV vaccine and prevention research. Read about how to include women in the research process and how to address the social issues they may face as a result. From the AIDS Vaccine Handbook (2005).
HIV trial needs women - opinion piece from the Philadelphia Inquirer on women in vaccine trials. (2005)
Women, HIV/AIDS and the search for an AIDS vaccine - a statement from AVAC underlining women's vulnerability to HIV/AIDS, the need for prevention now and in the future, and the obstacles and solutions to enrolling women in AIDS vaccine trials. (2004)
Women and HIV/AIDS: Confronting the Crisis - A joint report from UNAIDS/UNFPA/UNIFEM that makes the call to action to address the "triple threat" of gender inequality, poverty and HIV/AIDS. (2004)
Why women especially need an AIDS vaccine - Policy brief from the International AIDS Vaccine Initiative on the importance of including women in AIDS vaccine research. (2005).
ADOLESCENTS
Adolescents and AIDS Vaccine Research in the United States and Adolescents in HIV Vaccine Trials: Perspective from Botswana - People between the ages of 13 and 25 account for about half of all new HIV infections worldwide. Adolescents must be included in HIV vaccine trials so that they will have access to an effective vaccine as soon as one becomes available. Perspectives from the US and Botswana. From the AIDS Vaccine Handbook (2005).
Testing STD Vaccines in Young People: How it's Done - A discussion of the unique challenges that face researchers in conducting clinical trials with adolescents. Outlines the experience of two other STD vaccine trials, human papilloma virus (HPV) and herpes simplex virus (HSV) and the lessons for the AIDS vaccine field. From the AIDS Vaccine Handbook (2005).
Adolescents: The Missing Cohort - From AVAC's 2004 Report, a call for the inclusion of adolescents in HIV vaccine clinical trials to help ensure that they have access to an effective AIDS vaccine once one is developed and licensed. (2004)
GAY MEN
A Queer Eye on AIDS Vaccine Development - Gay men have always had a major role in the story of HIV and AIDS. This crucial role as advocates and community leaders must be maintained as we work to develop an effective AIDS vaccine. From the AIDS Vaccine Handbook (2005).
Project LinCS - Linking Communities and Scientists: The lessons learned - Lessons learned from a CDC study that studied three different communities (African Americans in Durham, North Carolina; injecting drug users in Philadelphia, Pennsylvania; and gay men in San Francisco, California) to find out how scientists and communities can better communicate with each other when research is being done within a community setting. (1998)
INJECTING DRUG USERS (IDUs)
Testing Vaccines in Injecting Drug Users: VaxGen's Efficacy Trial in Thailand - Discusses the need to conduct trials in high-risk IDU populations as well as the barriers involved when working with IDUs, using VaxGen's efficacy trial in Thailand as an example for discussion. From the AIDS Vaccine Handbook (2005).
Thai Drug Users Network, AIDS and Human Rights: A Conversation with Karyn Kaplan - Karyn Kaplan, International Advocacy Coordinator for the Thai AIDS Treatment Action Group (TTAC) talks about her work with the Thai Drug Users Network (TDN), the dire situation faced by Thailand's IDUs and clinical trial participation by this highly vulnerable group. From the AIDS Vaccine Handbook (2005).
Human Rights Watch (HRW) report on Thailand's war on drugs - a report from HRW that discusses Thailand's war on drugs, HIV/AIDS and the violations of human rights that have occurred. (2004)
Project LinCS - Linking Communities and Scientists: The lessons learned - Lessons learned from a CDC study that studied three different communities (African Americans in Durham, North Carolina; injecting drug users in Philadelphia, Pennsylvania; and gay men in San Francisco, California) to find out how scientists and communities can better communicate with each other when research is being done within a community setting. (1998)
SEX WORKERS
AIDS Research with Sex Workers: Lessons Learned - An introduction to the issues and challenges involved in AIDS research work with sex workers, one of the populations most highly affected by the AIDS epidemic. From the AIDS Vaccine Handbook (2005).
AFRICAN AMERICANS
Vaccine Trials and Black Americans - A discussion of why Black Americans should participate in AIDS vaccine trials and the challenges that may arise along the way. From the AIDS Vaccine Handbook (1999).
Myths About HIV Vaccines and Vaccine Research - From the Black AIDS Institute, a helpful vaccine fact sheet that debunks some of the myths surrounding AIDS vaccine research. (2005)
Project LinCS - Linking Communities and Scientists: The lessons learned - Lessons learned from a CDC study that studied three different communities (African Americans in Durham, North Carolina; injecting drug users in Philadelphia, Pennsylvania; and gay men in San Francisco, California) to find out how scientists and communities can better communicate with each other when research is being done within a community setting. (1998)
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In order to develop safe and effective vaccines for everyone who needs them, clinical trials must involve a diverse range of populations and communities from around the world. To determine if an experimental AIDS vaccine is safe and effective, it has to be tested in the populations that will use it - in this case, populations at high risk for HIV infection.
High-risk populations are typically groups of people that are socially and/or economically disadvantaged. Examples of such groups are gay men, women, injecting drug users, transgender individuals, youth and racial/ethnic minorities. However, conducting clinical research involving vulnerable participants - especially considering the stigma that comes with AIDS - raises a lot of sensitive issues. These issues must be addressed and special considerations made to protect vulnerable populations from exploitation and harm.
For large-scale clinical trials in particular, it's important that the study population, often called a cohort, reflect the diversity of people who will use a vaccine in the future. Researchers must determine if there will be any differences in how the vaccine works in different populations. If too few individuals of a particular group (like women or adolescents) are included in a trial, it is not possible to determine the nature of any differences, should any occur, among that group. The first large-scale AIDS vaccine trial taught us this lesson in terms of women and racial minorities. For more on the VaxGen trial see Anticipating the News on AIDSVAX, Understanding the Results of the AIDSVAX Trial, Facing Failure on the Way Towards Success and VaxGen: Pushing the Envelope.
Below is a brief description of some of the most important communities and cohorts that need to be involved in AIDS vaccine research.
WOMEN
Women represent one of the fastest growing populations in terms of new HIV infections around the world. Many of the reasons for the growing HIV burden on women are rooted in cultures that limit women's control over their own lives. Addressing gender bias and the cultural role of women is critical to including them in AIDS vaccine research.
ADOLESCENTS
Adolescents are another group of people who are at great risk for HIV infection around the world. When an AIDS vaccine becomes available, it will need to be given to people before they begin to have sex - probably in the early teens or even before. However, because adolescents are not legal adults, they cannot volunteer to participate in AIDS vaccine clinical trials without parental permission. Balancing protection of minors with the incredible need to study how AIDS vaccines work in adolescents is a difficult but critical challenge we must face.
GAY MEN
Gay men were one of the first communities to experience the impact of AIDS. Early on they accounted for the bulk of AIDS cases. Today gay men continue to represent a large portion of new HIV infections and AIDS cases in the United States and in many countries around the world. Homophobia, in some cases institutional and/or government sanctioned, must be addressed when working with this population.
INJECTION DRUG USERS (IDUs)
Along with gay men, IDUs were one of the first communities to be impacted by AIDS. IDUs continue to represent a substantial portion of new HIV infections and AIDS cases in areas of North America, Eastern Europe and Asia. Balancing the conflict between public health research and local criminal justice systems is a serious challenge to working with these populations.
SEX WORKERS
Much like injection drug users, sex workers around the world are highly impacted by HIV/AIDS. Working with sex workers also raises the issue of public health research versus criminal justice. And in the case of female sex workers, gender bias also contributes to the challenges of including sex workers in clinical trials.
AFRICAN AMERICANS
African Americans are disproportionately affected by HIV/AIDS, bearing more of the burden of HIV disease and death than other racial groups in the United States. Racism, poverty and distrust of the government are all key issues to address when working with African Americans in AIDS vaccine research - especially with the legacy of the Tuskegee Syphilis studies in which African American share croppers' human rights and health were not protected by researchers.
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