Is the glass half empty or half full?

In the spirit of transparency and full disclosure, let me state that I am employed by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Network, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), Division of Acquired Immunodeficiency Syndrome (DAIDS). INSIGHT is one of the 6 clinical trial networks to which I am referring in this essay. Also, I have been living with HIV/AIDS for almost 20 years and have volunteered and worked in the field for the last 18 of those years. The opinions expressed are solely mine and therefore my responsibility.

Politics underlie everything in life and HIV/AIDS research is no exception. It should therefore come as no surprise that how "science" is conducted in this country is strongly influenced by politics. The decision-making of what to explore, who should explore it, and what methods shall be utilized to conduct this exploration are all the result of political decisions and leadership preferences. When money (or lack thereof) is added to this equation, the outcome is sometimes unpredictable. One must never lose sight of the fact that the results of this process trickle down to the person living with HIV and have real-life consequences for that individual and his or her loved ones.

In light of this observation, the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), is in the midst of a reorganization of its HIV clinical trials network. This network consists of 6 newly funded clinical trial networks, each with its own population expertise and approach (see studysource.org/networks for a brief explanation of the different networks). Although newly funded (with the exception of one network), the others have existed in previous machinations, several having up to a 15-year history of conducting clinical trials across the globe, serving tens of thousands of patient participants. These networks have also employed hundreds of researchers, clinical staff, and midlevel staff as well. Additionally, there have been countless community volunteers who have participated both as research subjects and on community advisory boards, giving their energy and time for this important work. However, several of these networks have grown very large and bureaucratic, rendering decision-making an arduous process at best.

The picture that I am trying to paint is one of a huge animal that slowly creeps over the landscape choosing specific low-lying vegetation to consume along the way and only responding noticeably to cataclysmic change. This cataclysmic change, in terms of the DAIDS funding world, has come in the form of diminishing funding resources.

In theory, the recent reorganization of all of the DAIDS networks was necessary and a long time in coming. The old system was unnecessarily complicated, expensive, and lacking transparent and consistently clear decision-making processes. Gathering input from each level within each of the networks into the decision-making process, while extremely helpful to the study design, slowed the entire process down, often making the questions being asked irrelevant by the time the studies were up and running. This made patient enrollment difficult, at best. Some studies had to be stopped prematurely as they just could not enroll or because the burden placed on patients was too unrealistic by the time the study was finalized.

It was thought that this reorganization would foster more collaboration and strengthen the partnership between DAIDS, the researchers, and the community members. One of the important goals/aims of the reorganization was to streamline resources at all levels, allowing for excesses and duplications to be eliminated. It was thought that the reorganization would strengthen the similarities of each network, while highlighting and respecting their differences. Though these are helpful and efficient aims, the community voice seems to be diminishing during this process. The recompetition has been a procedural nightmare and it is unclear how and what research will be supported in the future.

The reality is that there is an ever-growing need for more research to cover the entire continuum from prevention issues to problems that individuals face while living with HIV. Continued research into basic science and HIV pathogenesis are also needed. The challenge for us, as community advocates for people living and dying with HIV/AIDS, is to try to design a flexible research agenda that addresses the unique management problems at each point in the HIV disease spectrum: those who are at most risk of acquiring HIV, the newly infected, those experiencing drug-related side effects, those ill with AIDS, those with few treatment options, and those at the end of their lives. These issues are also true across the age-life cycle of individuals: fetus, neonate, children, adolescents, adults, and elderly people.

Advocates need to articulate what kind of research will be most helpful and then advocate for the kind of research questions we want answered. We need to advocate for research methods that adjust and grow and change, incorporating new creative approaches. For example, in rural geographic areas that do not have access to surrogate marker tests (such as viral load and CD4 tests), studies comparing established, but low-tech tests against the higher technology-based methods as indicators of disease progression, may be needed. Or, what about developing diagnostic tests for infants to measure disease progression because the use of dried blood indicates exposure but not infection status? We must support the establishment of infrastructure in geographic areas that have been unable to do so by themselves, as well as mentor and support researchers who live and work within their own communities because they understand their cultures and resource constraints.

HIV advocates have fought long and hard to establish credibility within the research structure so that the diversity of their voices and unique perspectives would be heard, acknowledged, and taken into account at crucial decision-making points. What is happening, though, through this reorganization, is that fewer HIV-infected people and their advocates are participating in the overall network decision-making processes. We are told that we need to streamline the process. But this "streamlining" creates an increasing sense of alienation and decreasing contribution from those participants in the actual trials. The funding cuts across all of the networks and the establishment of a new cross-network community group has limited the amount of community input available within the networks. Each clinical trial network has been financially cut and is struggling to do what they can with limited funds. Instead of fostering cooperation, it appears to be increasing self-preservation, with the community getting hit the hardest. It is a situation of "robbing Peter to pay Paul."

Although gathering community input is not an easy process, it is worthwhile. It is an additive process, not a reductive one. There is no single community voice, but rather there are as many voices as there are people who experience this disease. Sociologists have assigned individuals with certain attributes, such as socioeconomic status, ethnic background, and/or HIV risk behavior(s), into a less than perfect system. All of the facets of living with HIV must be recognized when developing strategies and priorities so that research questions bear directly on clinical relevance. Therefore, asking for one community voice is just as unreasonable and unfair as asking for one voice within a specific field of research. One expects researchers to have substantial differences of opinion, so why not community members?

I try to remain optimistic that the outcome of this reorganization and the millions of dollars that the United States taxpayers are spending to support it, will continue to ask and answer important HIV/AIDS research questions. The research focus seems to be shifting from what is needed here in the United States to what is needed abroad. Of course, there are overlapping research questions applicable across the globe, and there is also a need to expand research outside of the United States to successfully enroll the vast numbers of patients needed to assure statistical power within the trials. However, there already have been concerns that too much money has been taken from the United States and sent overseas when there are still tax-paying citizens failing their treatment regimens. Issues such as managing people beyond their initial 2 or 3 treatment regimens seem to have fallen far down the research priority list. The truth is that there are limitations to HAART (highly active antiretroviral therapy) and everyone with HIV will eventually develop drug resistance and run out of treatment options--whether as the result of burning through drug classes used as partially suppressive regimens or by staying on failing drugs while waiting for more choices or resources to come their way.

In addition, a more comprehensive understanding of the interactions between long-term drug therapy and developmental problems in HIV-infected children and adolescents is needed so that they can develop into fully functioning adults. We need to continue to develop strategies for holding treatment-experienced patients in a healthful place until there are new agents for them to use, while simultaneously better understanding how to administer these agents to the newly HIV-infected.

I am hopeful that there will remain in place mechanisms for meaningful community participation and dialogue in research, and that community members will be incorporated into the entire research process and seen as valuable assets. Historically, mistakes in the delivery of research have been corrected and improved by listening to the community. I remain optimistic that clinicians and researchers can form an even stronger partnership and address questions that are of importance to them as well as to all people living with this disease. Community is strong because it is diverse--we represent all voices of people across the globe who are concerned and care about those who are infected with HIV/AIDS.

The challenge is not to fight amongst ourselves for ever-shrinking dollars and programs, but rather to think creatively about what can be accomplished within the diverse populations and clinical research sites, with these shrinking dollars. We need to support the reduction of top-heavy bureaucracy and reduce waste within the firmly entrenched research system that we have created. We need proactive leadership at the top of the funding process. This research agenda should be developed in true partnership with community, researchers, DAIDS, and many other stakeholders across the globe. Most importantly, we must hold all people accountable for this research work and immediately address shortcomings and problems.

In other words, we need to step outside of our collective comfort zones and do what is best for those of us living with HIV across the globe.

Claire Rappoport is Community Liaison for the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Network. She is based in the Department of Medicine, Positive Health Program, Community Consortium at the University of California in San Francisco.