May 12, 2010
Project Inform appreciates the opportunity to respond to recent blogs and other conversations that expressed concerns about Testing & Linkage to Care Plus (TLC+) and a related Project Inform position paper on when we believe HIV-positive people should start HIV treatment. These postings exposed the need for a thorough explanation of the logic supporting TLC+ and contributed to important ongoing national discussion that could help increase agreement about how to save lives.
In this statement, Project Inform explains key concepts behind TLC+, asks for caution in the national debate about it, and describes our position on when to start HIV treatment.
Project Inform is deeply troubled by life-threatening gaps in the response to the epidemic after nearly 30 years of intense national focus on HIV and AIDS. Today, a staggering 448,000 out of 1.1 million people living with HIV are not receiving primary medical care for their infection, with an estimated 231,000 people completely unaware of their HIV status, and 217,000 people who know they are positive unengaged in care and treatment.
38 percent of people who test positive for HIV today test so late that they receive an AIDS diagnosis within only one year. Over half of current HIV cases have occurred within the last ten years, and 56,300 people become infected with HIV year after year after year. Women and people of color are experiencing much poorer health outcomes than others living with HIV. On a more hopeful note, median CD4 count at diagnosis increased from 216 in 2004 to 340 in 2008, suggesting that concerted efforts to increase HIV testing in recent years may be having a good effect.
We believe these gaps are inhumane, unjust and unnecessary. We are concerned that initiatives to close them are far too slow to develop, and that effective processes are not in place to settle longstanding disagreements about how to protect health and life for hundreds of thousands of people now and in the future.
In December 2009, Project Inform and Community HIV/AIDS Mobilization Project (CHAMP) assembled a Think Tank of 54 multi-disciplinary HIV/AIDS experts, including many people with HIV, to answer three questions: Would efforts to increase HIV testing and treatment strengthen the health outcomes of people with HIV? Would they support a reduction in new cases of HIV infection? And because Project Inform and CHAMP have been helping to lead the coalition for a National HIV/AIDS Strategy, we wanted to determine what, if anything, should be contained in that developing document as a result of answers to the two prior questions.
Think Tank participants began their discussion by agreeing that certain values had to inform any product of the meeting -- among them the right of HIV-positive people to be healthy; their right to choose whether and when to engage in testing, care and treatment; and the need for social justice in all efforts to address HIV. The group looked carefully at data concerning the potential risks and benefits of increasing diagnosis, care and treatment for the individual, and also for preventing transmission.
At the conclusion of its discussion, the group issued a letter to President Obama recommending inclusion of TLC+ as a major element of the National HIV/AIDS Strategy because it can make a significant contribution to the goals of that document: to improve individual health outcomes, reduce incidence and reduce health disparities. The letter said that "While it is predicated on the need for strengthened efforts to assure that nearly all HIV-positive Americans know their serostatus, TLC+ would establish a national standard of care in which all public and private testing providers work intensively with HIV-positive people as soon after diagnosis as possible to link them voluntarily to a spectrum of care and support services including primary medical care, social services that support engagement in and maintenance of participation in HIV treatment, if appropriate, and prevention with positives counseling." The letter also indicated that TLC+ could benefit people just diagnosed with HIV, those previously diagnosed but not yet engaged either in care or treatment, and those who have fallen out of care and treatment completely. The letter to President Obama, and the full report of the Think Tank, are available at www.projectinform.org/tlc+.
Think Tank participants chose the name TLC+ to differentiate this approach from the "Test & Treat" model developed by Granich, which proposed that achieving nearly universal HIV testing and treatment for HIV-positive people would improve the health outcomes of South Africans and nearly eliminate new infections. Test & Treat is perceived by many as being coercive, and as placing public health before individual health.
TLC+ is firmly rooted in principles of informed choice by HIV-positive people regarding all aspects of their care, particularly decisions about whether to be tested and when to start HIV treatment. And it also proposes that, given the urgency of conditions in the epidemic, advances in HIV treatment and insufficient awareness among HIV-positive people about them, it is time to more visibly and actively promote the benefits of serostatus awareness, care and treatment.
TLC+ strongly asserts the need for HIV-positive people to have access to essential social services such as housing, mental health and substance abuse counseling treatment, if needed, in order to be prepared to engage in and maintain their participation in care and treatment. It recognizes that, unless they need immediate treatment, most people are more likely to address HIV if they are first linked to primary medical care, then linked to any needed social services, and only then asked to consider options for when to start treatment.
TLC+ is not a new idea. Providers and jurisdictions in different parts of the country have been implementing similar programs for some time. The National Institutes of Health has been studying the feasibility and potential effect of a similar approach. The Health Resources Services Administration has been encouraging jurisdictions receiving Ryan White Program dollars to demonstrate that they are increasing their outreach efforts to those at risk and effectively linking diagnosed individuals to care and treatment services.
What is different about TLC+ is that the overwhelming majority of a group of HIV experts of differing perspectives, including people living with HIV, agreed that this concept had merit as an approach to improving the health outcomes of individuals and preventing new infections, and that it should become a national initiative in which key federal agencies intensively coordinate policies, planning and funding streams to support all states and localities to implement it.
Few people seem to disagree with the basic approach proposed by TLC+ to improve health outcomes of individuals with HIV. Some, however, inaccurately conclude that TLC+ is intended to assure that every HIV-positive person takes antiretrovirals even before it might be in their interest to do so. Some believe TLC+ will result in coercion, which proponents agreed would be unethical and unacceptable.
The Think Tank agreed that HIV-positive people should consult with a qualified provider who advises them about the pros and cons of the options for when to start and then decide for themselves what to do, if anything. Participants also agreed that treatment should occur consistent with federal treatment guidelines. The difficulty, of course, is that those guidelines contain some ambiguity. 55 percent of the panel strongly recommends and 45 percent moderately recommends starting below 500. Additionally, one-half of the panel favors starting treatment above 500. Nevertheless, TLC+ places the decision about when to start firmly in the hands of the person with HIV.
The primary disagreement over TLC+, then, concerns whether data support the idea that expanded treatment of HIV would reduce new cases of HIV and whether it is ethical to ask HIV-positive people to consider engaging in treatment in support of prevention.
Think Tank participants reviewed available literature and decided that, while it is inconclusive and additional data are needed, there is a basis for suggesting that effective treatment of HIV-positive people reduces infectiousness and that expanded efforts to diagnose and treat HIV mightsupport a reduction in incidence. (A review of the data can be found at www.projectinform.org/tlc+.) The group agreed that the primary goal of TLC+ should be to benefit the individual, and a secondary but still essential goal should be to prevent cases of HIV transmission.
In this regard, TLC+ proposes taking a more traditional public health approach to HIV prevention. Historically, people with communicable diseases such as sexually transmitted infections and tuberculosis have been treated with two goals in mind: to cure their infection and prevent transmission to others. Health officials and HIV prevention agencies have tread lightly since the beginning of the epidemic on strategies that speak directly to HIV-positive people about their role in prevention for fear of further stigmatizing them. It has only been in recent years that a change in these approaches has been considered in light of growing evidence that effective treatment may help to reduce infectiousness and thus prevent new infections.
Project Inform views it as ethical and empowering of people with HIV to describe treatment as a possible support for prevention in the context of the provider/patient treatment initiation discussion; in fact, we think it would be unethical not to. For us, taking carefully considered steps to prevent transmission, up to and including treatment, can contribute to an HIV-positive person's overall sense of health and well-being. We believe that most HIV-positive people are altruistic and willing to factor the possible benefits for prevention into their treatment decisions. Doing so helps, in part, to reduce HIV-related stigma.
We propose that it is in keeping with principles of informed consent and patient empowerment for a provider to advise a person with HIV that, in addition to the fact that treatment may improve their own health outcomes, it is also possible that it will support them in their goal of preventing transmission of HIV to others. Providers should make clear that the data are not conclusive, that HIV-positive people are not being asked to take medications just to prevent transmitting HIV, and that they are not being asked to initiate treatment any earlier for prevention purposes than they would start to protect their own health. Ultimately, it is entirely up to the person with HIV to decide whether, why and when to engage in treatment.
Justifiable concern has been expressed that providing treatment in support of prevention will result in a sense among some HIV-positive people that, if they take pills, they no longer have to engage in safe behaviors. In response to this concern, we believe it is critical to advise and periodically remind HIV-positive patients that it is essential to continuously engage in safe behaviors even though they are taking medications to treat HIV. As TLC+ moves forward, providers will need to be adequately trained to appropriately address the prevention issue with their HIV-positive patients.
A lengthy document of questions and answers about TLC+ is currently being completed and will also be available on May 24 at www.projectinform.org/tlc+. We would like to respond to some of the most frequently expressed concerns here.
One concern is that TLC+ is intended to replace other forms of HIV prevention, particularly behavioral prevention. Think Tank participants agreed that TLC+ should not replace other forms of prevention, but that it has the potential to be an important new addition to the prevention arsenal. Indeed, TLC+ depends upon prevention for positives counseling and other behavioral approaches for its success.
People have also expressed concern that it is unfair to diagnose more people with HIV if the nation does not guarantee them access to costly care and treatment, and that providers and health departments cannot even hope to implement costly new initiatives like TLC+ in the current recession.
While care and treatment resources for people with HIV are strained, we think it would be wrong to lower standards of care due to resource limitations. Project Inform and other advocates are working hard to ensure that national health care reform substantively addresses gaps in coverage for as many HIV-positive people as possible, including through access to the national high-risk insurance pool scheduled for implementation in July 2010. Project Inform is also working to address growing AIDS Drug Assistance Program waiting lists. We welcome all advocates to join in aggressive efforts to secure universal access to diagnosis, care and treatment of HIV, as well as the resources needed to implement promising new programs like TLC+.
Finally, Think Tank participants agreed that Presidential leadership is needed to address stigma and discrimination that continue to act as a monumental barrier to the health of people with HIV, and that state laws that criminalize transmission of HIV must be amended or eliminated because they, too, are acting as barriers to HIV testing and willingness to engage in care and treatment.
In recent blogs, TLC+ and early treatment for HIV have been criticized as radical, dangerous, an injustice and an assault on the rights of people with HIV. They have been attacked as a plot to "make every HIV-positive person in America take pills that would disfigure them and shorten their lives," and treating HIV-positive people as mere vectors of HIV infection. They suggest that people with HIV should not and will not engage in treatment in part because it could support community health.
These charges are unfounded and they can be harmful. They take a very dim view of people living with HIV. Project Inform wants to express concern that perhaps the worst thing anyone working in the epidemic can do today is to incite fear in people living with and at risk for HIV, who already face countless barriers to knowing their serostatus, let alone to considering voluntary engagement in care and treatment that might save their lives.
In the course of our advocacy, we have seen community members predict horrible outcomes for people with HIV from virtually every evidence-based policy change, particularly names-based reporting and simplifying consent for HIV testing. Those outcomes have not come to pass. In fact, these and other policy changes are providing important benefits and helping to improve outcomes in the epidemic. Moving forward, we hope for greater willingness to consider change in the nation's approaches to ending the epidemic.
In support of our work on TLC+, Project Inform issued a position paper on April 13, 2010 on the closely related question of when we believe HIV-positive people should, voluntarily and in consultation with a qualified clinician, start HIV treatment. The paper also made a set of suggestions about how to prepare to initiate and maintain participation in care and treatment.
We issued the position out of great concern that many people untested for HIV or not in care do not fully know the benefits and current state of HIV treatment, and hoping that this information might reduce some of the fear and denial that are clear barriers to increased participation in testing, care and treatment. We are currently developing a series of publications that more fully discuss the issues and options that individuals should consider when starting therapy.
Project Inform views current evidence on the benefit of starting treatment when CD4s are below 500 as compelling. Our April 13 paper made a recommendation to start treatment "before CD4 counts fall below 500," which is supported by updated federal Guidelines. Based upon feedback that our word choice was ambiguous or misleading, and because it did not accurately reflect our true intent, we revised that language on May 4 to recommend starting treatment "if CD4 counts fall below 500." We also recommended consultation with a clinician before making a decision about whether to start treatment at that point.
Our April 13 paper noted that there is increasing but not conclusive evidence that preventing immune system damage and inflammation may improve HIV health outcomes, as well as evidence that the harm done by HIV is likely greater than that caused by current antiretrovirals. Based upon this and other evidence, Project Inform recommended that a person with more than 500 CD4s begin treatment if they experience deterioration in key clinical markers and after consulting their doctor. 50 percent of the federal Guidelines panel favors starting treatment above 500. Project Inform's May 3 revision changed the word begin to consider.
This language change has been characterized as a complete reversal of our position. We do not view the change as a reversal. Given that data are less conclusive on this point, we feel it is better to encourage people with HIV to consider starting treatment above 500 than to begin treatment if their clinician does not support doing so. But once again, we support HIV-positive people's right to decide when to start treatment.
On April 13, San Francisco's public HIV clinics announced their policy to offer treatment to all HIV-positive individuals, regardless of CD4 counts and unless there was a reason not to. Project Inform supports this decision by the City of San Francisco as a rational interpretation of current evidence to address the unique aspects of the local epidemic. We have not abandoned San Francisco with our revised language. In fact, we support San Francisco for its leadership, which will benefit individual health and which data suggest will further reduce new cases of infection in the city.
Finally, Project Inform reiterates its support for START, which is currently enrolling, as a vital effort to more conclusively determine by means of a randomized controlled study the optimal start time is for initiating HIV treatment. We did not sign a community letter supporting the study because we felt the letter criticized current federal treatment guidelines, which we support. Nevertheless, we look forward to supporting START enrollment.
As always, Project Inform welcome feedback on our positions and on the work we are doing to end the HIV/AIDS epidemic.