December 14, 2009
Project Inform and the Community HIV/AIDS Mobilization Project (CHAMP) co-sponsored a Think Tank on December 7 and 8 in Washington D.C., bringing together fifty-four leading, multi-disciplinary HIV/AIDS experts to decide whether the United States should implement a "Test & Treat" strategy to further control HIV/AIDS. The Think Tank was held in part to inform the development of the National HIV/AIDS Strategy, a process being led by President Obama's Office of National AIDS Policy. Project Inform and CHAMP serve as members of the Steering Committee for the National HIV/AIDS Strategy (NHAS), which has three goals: to increase the percentage of HIV-positive people who are engaged in care and treatment, reduce the number of new cases of HIV infections, and reduce disparities in health outcomes among populations at risk for HIV disease.
The Think Tank resulted in a recommendation that a new approach called Testing & Linkage to Care Plus (TLC+) become a part of the NHAS to help the nation meet three important goals: 1) to increase the percentage of HIV-positive Americans who know their HIV status, 2) to improve the health outcomes of individuals who are HIV-positive, and 3) reduce HIV incidence (new cases of HIV infection). Implementation of TLC+ has the potential to further a long-held and partially realized goal of integrating HIV care and treatment with prevention in order to further control the domestic epidemic.
The Think Tank took place only days after new Federal Guidelines for HIV treatment were announced and that recommend earlier initiation of antiretroviral treatment for people infected with HIV. For Project Inform, these two developments create much-needed and long overdue momentum toward a more aggressive approach to addressing a set of persistent problems in the domestic epidemic: 1) the fact that 21 percent of 1.1 million HIV-positive Americans do not know their HIV status 2) the fact that up to 25 percent of HIV-positive Americans are not engaged in care and treatment that could protect their lives and help them to avoid transmitting HIV to others and 3) the fact that , every year for over a decade, 56,300 Americans have become newly infected with HIV.
It has generally been true that control of the spread of communicable diseases like tuberculosis, hepatitis and sexually transmitted infections has been achieved, in part, by assuring that an infected individual was treated to cure their illness and prevent transmission to others. With regard to HIV, it has long been known that a benefit of testing is that people who know they are HIV-positive are 33 percent less likely to engage in behaviors that might transmit the virus to others. Until recently, however, treatment of HIV has been focused on the benefits of antiretroviral treatment for the individual and has not had the goal of reducing transmission.
Within the past three years, various studies have suggested that expanded treatment of HIV-positive individuals could reduce transmission events given significant evidence that viral suppression resulting from antiretroviral use makes it less likely that an HIV-positive person can transmit HIV to a partner. (For a data review, go to Project Inform. Statistical models have come to different conclusions about how great the impact of a "test and treat" model might be on HIV incidence, but most have concluded that it would have an impact. Concerns were expressed, however, that as a public health strategy, test and treat might be coercive; that it was too medical an approach and devalued the role of social services and support in addressing the needs of HIV-positive people; and that some HIV-positive people might engage in riskier behaviors if they believed that antiretroviral treatment might reduce their chances of infecting others. Additionally, many community-based HIV agencies seemed to fear that this approach might somehow be intended to make traditional educational and behavioral approaches to prevention obsolete.
After a long and unfocused debate about these issues, Project Inform convened the December Think Tank in an effort to see if concerns about such an approach could be settled in the interest of developing a potentially powerful tool to further control the domestic HIV/AIDS epidemic.
Think Tank participants came to general agreement about some important points. First, they agreed that, based on currently available data, an approach called TLC+ (the plus referring to treatment) has potential to achieve greater control of the epidemic by 1) increasing the percentage of HIV-positive Americans who know their serostatus 2) increasing the percentage of HIV-positive Americans who are engaged in care and treatment and improve their health outcomes and 3) reducing overall HIV incidence. On this last point, participants agreed that a reduction in incidence as a result of TLC+ might be hard to measure, as are the impacts of other prevention interventions on actual incidence. However, it was also agreed that the combined effects of increased serostatus awareness, reduction in viral burden resulting from increased HIV treatment and behavioral counseling of HIV-positive individuals could help to reduce transmission events.
Participants were clear about the need to differentiate TLC+ from "test and treat." Fairly or unfairly, test and treat has come to be thought of as a strategy in which universal, even compulsory, testing was achieved and all HIV-positive people were placed on treatment. Consistent with the belief that HIV testing, care and treatment can and perhaps should be promoted and even encouraged, Think Tank participants agreed that informed consent, voluntariness and choice must underlie our approach to the domestic epidemic, and be at the core of the TLC+ strategy. The group agreed that the primary focus of TLC+ is on improving the clinical outcomes of the HIV-positive person with the public health, or prevention goal, being secondary but still important.
Additionally, participants agreed that, while it should certainly not be the only element of the National HIV/AIDS Strategy, TLC+ should be an important element; that TLC+ should not comprise the nation's only approach to HIV prevention, but that it has the potential to support prevention; and that TLC+ should also be considered as an element of the Strategic Plan for HIV Prevention to be developed by the U.S. Centers for Disease Control & Prevention.
Participants also acknowledged that entities across the United States are already taking important steps to implement programs that embody the principles of TLC+, which is not a wholly new concept but, rather, one whose goals have been clarified and focused. Additionally, the Centers for Disease Control & Prevention are greatly expanding HIV testing nationally, and the NIH is funding promising demonstration projects in Washington, DC and the Bronx to test key concepts of TLC+.
Think Tank participants defined what is meant by TLC+, or what the component parts of this strategy to integrate testing, care and treatment and prevention efforts should be.
A significant expansion of HIV testing both through efforts to make testing a routine part of medical care and targeted testing to reach high-risk individuals.
Effective bridging to HIV care early and through re-engagement efforts -- It was agreed that efforts to deliver a newly diagnosed patient to a provider who can discuss care and treatment as soon as possible following the test are critical to engagement with health and social support services. Additionally, health departments, clinics and community based organizations need to conduct innovative outreach efforts, including peer-based approaches, to encourage people diagnosed in the past but who are not engaged with health care to engage. Use of surveillance data, if sensitively handled, could support efforts to engage HIV-positive people in care, treatment and social support.
Positive prevention counseling -- Regardless of whether an HIV-positive person receives care and treatment, it was agreed that counseling about their role in HIV prevention is critical. Indeed, to address concerns about the behavioral disinhibition that can result when an HIV-positive person takes antiretroviral medications, it is important to remind them that treatment may not provide 100 percent assurance that they cannot still transmit HIV.
Prompt evaluation for ART eligibility and optimized ART initiation -- Patients should receive standard diagnostics to establish viral load and CD4 counts as quickly as possible after diagnosis and be encouraged to discuss options for when to initiate therapy, consistent with federal guidelines. Patients might also be counseled that in addition to improving their HIV health outcomes, treatment combined with safe behaviors can support them in their efforts to avoid transmitting HIV to others.
Adherence support for maintenance of viral suppression -- Providers should talk with their patients about the importance of adherence and determine whether any psychosocial or other issues need to be addressed in order for them to be adherent to antiretrovirals. These could include concerns about stigma and discrimination, homelessness or being marginally housed, mental health or substance abuse issues.
Supportive services, including housing, substance abuse and mental health services -- Linkage to housing, mental health, substance use, transportation, childcare and many other social services are essential of many patients to enter and maintain participation in HIV care and treatment. Providers therefore need to work with patients to assess their needs in these areas and link them to appropriate services.
STI screening and treatment -- A thorough medical evaluation, including evaluation for STIs and tuberculosis, should be conducted on all newly diagnosed and returning patients.
The Think Tank highlighted a set of issues that must be addressed at the national level to further the opportunities for TLC+ to succeed:
Stigma and discrimination continue to act as powerful barriers to people's willingness to be tested for HIV and engage in care and treatment if they are HIV-positive. Major national efforts are needed to address these issues, and also to persuade individuals at risk for HIV that addressing their health needs is vital despite stigma and discrimination.
Strengthened medical provider education -- It is clear that many primary medical providers are failing to encourage patients to be tested for HIV and to follow up in sensitive and helpful ways because they are uneasy about sex, gayness, race and other social factors associated with HIV and AIDS. A significant national effort needs to be launched to establish standards of care regarding HIV testing and care, and to encourage providers to follow them. Presidential leadership may be necessary on this point.
Strengthened patient education -- Similarly, there is evidence that many people at risk for HIV are failing to be tested or enter care and treatment based on a misunderstanding of several things. First, some patients do not understand that if they test HIV-positive, there are steps they can take to do something effective about it. Others have outdated impressions about HIV pharmaceuticals which, far from being perfect, are without many of the side-effects that until recently accompanied HIV treatment and concerned patients. Some patients are unaware that they can obtain HIV care and treatment and other services at no or low-cost. A significant national campaign is needed to help people at risk for HIV infection to better understand the benefits of knowing and addressing HIV disease, and even to promote treatment while also valuing the importance of individual choice.
HIV testing must always be reimbursed -- Some states have passed laws requiring that all insurers and payer sources reimburse for HIV testing whenever ordered by a medical provider. Federal legislation to this effect may be needed to ensure universal access to testing.
A guaranteed source of financing must be made available to finance TLC+ -- It goes without saying that the resources do not currently exist to implement TLC+ on the scale that is needed to gain further control of the domestic HIV/AIDS epidemic. Advocacy for national healthcare reform and other guaranteed sources of financing for these programs will be essential to the success of this strategy. Governments at all agencies may also wish to redirect existing funding or use existing resources to greater effect in order to implement aspects of TLC+. It is also critical that Congress and the President act swiftly to prevent the current growth of waiting lists for the AIDS Drug Assistance Program, the joint federal/state program that provides HIV medications to low-income Americans, which is in severe jeopardy due to state budget cuts.
A Working Group has formed to further the conversation started at the Think Tank and to prepare a final report of the group's findings to be transmitted to President Obama for consideration as a key element of the National HIV/AIDS Strategy. The Working group will also develop a tool kit of current best practices from across the country that can be replicated to begin to implement TLC. Project Inform will continue to keep its constituents up to date on developments on this important issue, as well as about the development of the National HIV/AIDS Strategy, of which we continue to play a leadership role.