By: S. Wakefield- HVTN, Seattle, WA, USA
Community responses in times of intense need are often the most effective agents for change. We have had the opportunity to witness the brilliant effect of human beings in action recently during several hurricanes and mass shootings in the US. Advocacy and change have been fueled by historical movements as well, such as the Boipaton massacre in South Africa that prompted local, and eventually global, efforts to end apartheid. Injustice and inhumanity, hate and oppression, have also sounded the clarion bell that demanded and demands unity, and encourages collective gathering for strength and sustained hope in the face of inequalities. As we gather for World AIDS Day 2017, there are advances brought forward by medical science, as well as a continued need for communities to lead the charge for change. For World AIDS Day 2017, let us reflect for a moment on critical points in HIV’s history, while also considering how to increase our efforts, individually and collectively, to get us to an HIV vaccine.
On April 23rd, 1984 at a press conference in Washington, D.C., the identification of the virus we now call HIV occurred, and Margaret Heckler, the U.S. Secretary of Health and Human Services, proclaimed that a preventive vaccine would be ready for testing within two years. Since then, many physicians who had already begun identifying significant health disparities in communities would also start providing care and services to communities underserved by the scientific and medical establishment. These clinicians came from around the world, and needed more than regular public health services to fight this new virus, so they built special clinics. Physicians such as Drs. James McIntyre, Glenda Gray, and Kenneth Mayer worked to establish clinics to ensure communities who were underserved could seek care and services. These clinicians and countless others were also spending time in community settings where they gained valuable insight to fuel innovative scientific inquiry.
Early in this epidemic community members took to the streets. Communities also gathered to share information about any scientific development which seemed hopeful or useful. ACT UP, TAC and other groups fought governments because they were not doing enough, or not doing it fast enough, or not doing it the right way. Community responses brought a sense of passion and urgency to make a difference, processing grief and anger, or because many were afraid their own time might be short due to the mysterious virus. Scientists and providers frequently left their labs or the bedsides of their patients to join marches and demonstrations. Others worked hard from inside hallowed halls to quietly identify ways to accelerate change.
Someone took a failed cancer drug called AZT and discovered it could impact the virus. No one knew how much there was to learn to move beyond toxic doses of this drug. Today, due to working with those governments and dreaded pharmaceutical companies, we have over 40 drugs that are just as smart and different as smartphones are from the rotary dial phones of the 1950s and -60s. Advocates and local advisory boards noted that while we had tools for HIV treatment, HIV prevention was a critical gap that could be filled by distributing condoms and supporting research that might help future generations avoid infection. Some advocates joined with US government-funded research, while others partnered with investigators who came together when government priorities differed on how to resource HIV vaccine research.
In January of 2000, a new National Institutes of Health (NIH) Division of AIDS (DAIDS)-funded network was formed to focus on HIV vaccines, the HIV Vaccine Trials Network (HVTN). The new leadership sought to demonstrate a commitment to answer questions raised by every study through providing specimens, sharing data, developing lab tests and other scientific endeavors. The HVTN noted that study participants made it possible for the scientific community to determine next steps with each product tested. HVTN leadership had heard the cry for “studies with us, not on us,” and was the first DAIDS network to develop a Participants’ Bill of Rights and Responsibilities. Through the HVTN, education and training were provided not just for clinicians but for members of Institutional Review Boards, ethicists, community members and those responsible for public health in the geographic areas where vaccine research occurred. Community advocates and leaders like Butch McKay and Mark Hubbard, who had fought for the participation of volunteers in informing treatment trials, joined people like Hamilton Richardson who had participated in vaccine studies to help shape the HVTN. These committed advocates knew the same advocacy spirit which prevailed on the street needed to ring loudly in the hallowed halls of science as well.
On February 24, 2003, results were released from the first HIV vaccine efficacy study, VaxGen. The vaccine was ineffective, yet the results were released with a controversial sub-analysis that indicated “possible protection in non-whites.” The VaxGen trial did not enroll adequate numbers of minority participants to yield scientifically valid results broken down by race/ethnicity, which created significant problems when the initial analyses raised the question of differential efficacy among Blacks, Asians, and others. Advocates noted that we needed to learn from this experience and not repeat it. Shortly after this in June 2003, the Global HIV Vaccine Enterprise, a global endeavor that emphasized the need for integration and capacity building around the world, was announced. Some of the top scientists announced unprecedented collaboration and shared strategic planning. Focused on new ways of working, creative public and private partnerships emerged. Years later, Bill Snow, a founder of the AIDS Vaccine Advocacy Coalition (AVAC), led the Enterprise as it embraced the HIV prevention science that has resulted in the organization moving under the auspices of the International AIDS Society. Professor Dr. Linda Gail Bekker, another scientist/advocate and president of the IAS, provided oversight to the transition.
The ongoing debate regarding what is needed most in an HIV vaccine response, t-cells or antibodies, continues. HIV and research myths have continued to have validity despite an army of CAB members and other advocates who immerse themselves in the science and can interpret trial results and progress. Community emphasis on building and leveraging key partnerships to ensure stronger voices and policy support for HIV vaccine research has struggled side by side with an enhanced behavioral research agenda to support engagement in trials. Barriers to participation in HIV preventive vaccine studies have persisted, including historical mistrust of medical providers and research. It may be easier for persons already diagnosed with an incurable illness (HIV) to participate in research than it is for healthy, uninfected persons who do not think of themselves as being at risk to join a study. Vaccine study participants and communities of otherwise healthy individuals are asked to make personal sacrifices for the sake of research. They must commit time, respond to invasive and personal questions, and potentially face criticism from their family, friends, and communities. The vaccines they receive may not provide any level of protection nor offer any immediate or long-term benefits. Many still hold on to unfounded myths such as “you can get HIV from a vaccine,” or wonder how researchers can test a vaccine without intentionally infecting people, while others say they believe a vaccine exists but is being kept secret.
Fostering trust and increased understanding of HVTN’s research begins with updates during potential study concept stages, with a goal of moving persons from community awareness of the scientific agenda through engagement during study planning, and community ownership throughout the time a study is being conducted. With this in mind, HVTN community engagement partners are in regular contact with local community stakeholders, country level representatives from multiple disciplines, and global HIV prevention stakeholders.
Recent years have seen HIV vaccine trials with surprise outcomes, where communities were armed with enough of the science to offer nonscientific explanations for why those studies ended. On the research side, efforts to develop HIV vaccines capable of eliciting broadly neutralizing antibodies have begun or increased, as well as work on new vectors to provide durable protective immunity in the communities most impacted by the virus. Tremendous scientific progress has occurred since 2009, when results of RV144 were announced, the first vaccine regimen that reduced the number of HIV infections by about 32%. HVTN has led the way to incorporate new proven HIV prevention technologies into its protocols as they have emerged. Medical male circumcision (MMC) and facilitating PrEP access have occurred in real time with protocol modifications. These efforts reflect HVTN’s continued commitment and ability to ensure people recognize a vaccine as the best long-term hope for ending the epidemic while simultaneously building awareness, knowledge, and support for other prevention technologies. HVTN continues to meet its commitment to ensuring trial participants have the best prevention available by maintaining linkages with HIV treatment, cure, and prevention advocates, as well as connections with condom and reproductive health advocates. We regularly participate in social media and listservs like the IRMA (International Rectal Microbicide Advocates) blog by providing clarity about our trials and policies. We also participate in public and private online groups such as Facebook’s Trans MSM: Rethinking Sexuality and Health, designed to support discussions, debates, questions, and concerns that promote fact-based information, understanding, respect, and compassion among transmasculine people who have sex with men (TMSM), and their partners and allies. There is also a new marketing campaign on TASP (treatment as prevention) to ensure people understand the prevention message “Undetectable equals Untransmittable (U=U).”
This time in the history of the HIV epidemic is bittersweet. There are exciting new tools for treatment and prevention, and funded cure research is occurring with remarkable attention across biomedical disciplines. Extraordinary advances in the treatment and prevention of HIV infection bring many to the conclusion that it is possible to end the HIV epidemic through scaling up these interventions. At the same time, there is a lack of resources to provide for those at highest need, and a surge in stigma/discrimination. Politics are once again placing the lives of people in need on the back burner. One new challenge is to be vigilant and hopeful while working with warriors who have been leading the charge. We must do this while developing the next generation of people who can exude unity, gathering for strength and sustained hope.
* S. Wakefield is the Director of External Relations for the HVTN.