Questions and Answers about TLC+

May 2010     View PDF

Testing & Linkage to Care Plus, or TLC+, is a framework for working both with newly diagnosed HIV-positive people and those who have been lost to systems of care to link them on a voluntary basis to primary medical care, support services, treatment and prevention-with-positives counseling. TLC+ has two primary goals. The first is to increase the percentage of HIV-positive people who are engaged in care and treatment in order to improve their health outcomes. The second is to help reduce HIV incidence in light of data indicating that HIV-positive people who know their HIV status, are effectively treated for HIV and receive risk reduction counseling are less likely to transmit HIV to others.
TLC+ can be implemented by private and public medical providers, alone or in conjunction with other AIDS service organizations, as well as by state and local health departments. Specifically, its elements include:

1. Expanding both routine, population-wide HIV screening and targeted testing of individuals in groups at high risk for HIV;
2. Effective and immediate linkage of newly diagnosed HIV-positive people to primary medical care and social services, including housing, mental health, substance abuse and other services that will support them to remain in care; as well as innovative efforts to re-engage individuals who have been lost to systems of care;
3. Evaluation of eligibility for HIV treatment, counseling about treatment options, and assessment of services that might help a patient prepare to be in treatment, when and if they so choose;
4. Ongoing support for retention in care and adherence to anti-HIV treatment for maintenance of viral suppression;
5. HIV prevention counseling and support; and
6. Regular screening and treatment for sexually transmitted infections (STIs), viral hepatitis and other health issues.

What are the potential risks and benefits to HIV-positive people and to community health of TLC+?

The benefits to HIV-positive individuals are threefold. First, TLC+ can increase the percentage of HIV-positive people receiving care, treatment and support services in order to 1) prolong their lives, 2) improve their quality of life, and 3) support them in their efforts to avoid transmitting HIV to others. Potential risks to individuals include possible side effects and long-term consequences of HIV treatment, poor adherence to medication leading to viral resistance, and the stigma and discrimination that can result from uncontrolled disclosure of HIV status outside of provider settings. Benefits for community health include increased lifespan for HIV-positive people and a potential reduction in HIV incidence. Risks to community health could include increases in HIV-associated risk behaviors caused by disinhibition that sometimes accompanies HIV treatment and an increase in transmission of resistant virus. These risks and benefits are discussed in greater detail throughout the questions and answers that follow.

How does TLC+ differ from Test and Treat?

Test and Treat refers to a mathematical model put forth in a paper in The Lancet in January 2009 by Granich and colleagues. This model was based on the South African HIV epidemic and proposed that testing all South Africans annually and treating those identified as HIV-positive within one year of diagnosis would bring HIV to an elimination phase within five years and bring new infections close to zero. TLC+ is a framework designed to move the mathematical model closer to actual implementation. Several key components have been added and other ideas amended from the original model. Key additions include: supportive services, such as mental health, substance abuse treatment and housing to increase entry and retention into care, treatment initiation and adherence; STI and viral hepatitis screening; and prevention counseling. Test & Treat has been perceived by some as proposing mandatory testing and treatment. TLC+ stresses the purely voluntary nature of participation in all aspects of HIV testing, care and treatment and prevention programs.
The name TLC+ was chosen for this approach out of a belief that many HIV-positive people will be more receptive to engagement with systems of care if they are first asked to consider primary medical care rather than treatment, which is viewed as more intimidating. Primary medical care would include regular monitoring of CD4 and viral load and addressing general markers of health, while treatment refers to taking HIV antiretrovirals.

What is the difference between the TLC+ concept and the TLC+ study (HPTN 065)?

The TLC+ concept derives from a Think Tank conversation among a diverse group of HIV/AIDS stakeholders in December 2009 seeking to determine whether expanded testing and treatment could improve individual health outcomes and reduce new cases of HIV infection and, if so, what programs should be built to do so.
The TLC+ study (previously known as “Test and Treat”) is HIV Prevention Trials Network (HPTN) 065. It was underway before the Think Tank. The primary goal of HPTN 065 is to determine whether it is possible to provide HIV testing to an entire community (in this case Bronx, NY and Washington DC), to link HIV-positive individuals to care, and to assist HIV-positive individuals with adherence to medications in order to suppress viral loads. This study does not include all of the key elements of TLC+ (most notably, supportive services are not a key element in the study). The study will not be able to determine whether treatment has led to decreased viral load or whether treatment has led to a decrease in HIV incidence in the study communities. Those are research questions that may be asked and answered in a future research trial.

Some providers and cities are already doing things that look like TLC+, so what is new or different about this idea?

Programs that embody the elements of TLC+ are in effect throughout the country. Additionally, the NIH is supporting studies in Washington, DC and the Bronx, NY to assess the feasibility of this strategy. What is new about TLC+ is that it seeks to replace the term Test & Treat, which has been met with serious concerns, as a strategic and comprehensive approach to further controlling HIV in the United States. Additionally, advocates are asking that TLC+ become a major federal initiative in which key federal agencies coordinate policies and programs, as well as funding streams, to make it possible for states and local jurisdictions to integrate their HIV testing, care, treatment, social services and prevention-with-positives activities for greater impact.

How does TLC+ propose to link HIV-positive people to care and treatment, especially those who have been lost to health care?

TLC+ is based on the idea that HIV testing providers should link a newly tested HIV-positive person to primary medical care immediately or as soon as possible after diagnosis. The provider should discuss the importance of regularly monitoring CD4 and viral load, and work with the patient to link them to any support services that will strengthen their ability to remain in primary care. Once that is done, a conversation can be started about the benefits and risks of initiating treatment, and securing any additional support services that will help a patient initiate and adhere to treatment. TLC+ proposes that providers develop innovative programs, including peer-based approaches and use of social networks and collaborative agency and institutional efforts, to identify previously diagnosed HIV-positive people who are not in care and engage them in a conversation about entering or returning to care. Using all due caution to assure confidentiality and voluntary participation, local jurisdictions might also consider the use of HIV case registries to engage previously diagnosed but out-of-care individuals in a discussion about voluntary engagement in care and treatment.

TLC+ seems to overemphasize medical care and treatment. What about the role of social services and support in addressing the needs of HIV-positive people?

The emphasis on care and treatment in TLC+ is important because these essential services can greatly extend life for HIV-positive people. A key notion behind TLC+ is that HIV-positive people should be linked to a qualified provider who can describe the benefits of engaging in primary medical care and monitoring key markers of health. Discussion about readiness and ability to engage in treatment can come soon after if a patient feels ready. Lack of critical support, including housing, mental health and substance use counseling and other services has been shown to limit one’s ability to engage in and maintain participation in care and treatment. TLC+ actively encourages linkage to supportive services, as well as peer support, for people who are HIV-positive.

HIV-positive individuals experience stigma and discrimination. Encouraging people to engage in testing, care and treatment could put some at risk. How does TLC+ address this concern?

Stigma and discrimination against people with HIV are very real, and present major barriers to the willingness of at-risk individuals to seek testing and care. A major national effort to combat HIV stigma and discrimination is essential to further progress in the epidemic. In the final analysis, the effects of having undiagnosed or untreated HIV may be as serious a threat to positive individuals as the possibility of experiencing stigma and discrimination. It is therefore important to encourage all people at risk for HIV to learn their status because doing so can greatly prolong quantity and quality of life. Everyone who tests positive for HIV should be counseled that they can be selective about who they tell about their HIV status, that various laws protect the privacy of their health status, that a body of law including the ADA protects them from discrimination, and that legal services are available to help them with any issues they might experience.

Does TLC+ propose that all HIV-positive people should be on treatment?

Whether initiating treatment to support their individual health, prevent transmission or both, TLC+ proposes that federal guidelines should constitute the basis for making all treatment decisions. The problem, of course, is that current guidelines contain some measure of ambiguity. 100 percent of the guidelines panel agreed that HIV-positive people should begin treatment if they have 500 or fewer CD4s. (55 percent voted for a strong recommendation and 45 percent for a moderate recommendation to start.) 50 percent of the panel also suggested that treatment should be considered if a person has 500 or more CD4s. In keeping with principles of patient empowerment and informed consent, it is best for providers to have a thorough conversation with HIV-positive patients about the risks and benefits of starting treatment above or below 500 CD4s, offer their own recommendation, and let the patient decide. No one should be asked or encouraged to take HIV medications in support of prevention any earlier than they would take them in support of their individual health.

What if an HIV-positive person isn’t readyor able to engage in care or treatment?

Readiness to engage in health care for HIV – particularly taking medications – is extremely important. If an HIV-positive person isn’t emotionally prepared to engage, is concerned that others may find out they are HIV-positive, or has life issues such as a lack of housing, mental health or substance abuse issues, they should be linked to social and other support services that can help to consider engaging in care and treatment, if and when they feel ready. For TLC+ to be successful, it is important that resources are increased to assure access to services that support readiness for and retention in care and treatment.

HIV medications have serious short-term side effects. Why is TLC+ encouraging treatment so heavily?

Current evidence suggests that the negative effects of having untreated HIV are greater than those caused by taking medications. HIV medications do still have side effects, but newer HIV drugs are generally better tolerated than the earlier generation of drugs. Fewer side effects tend to occur in people who start HIV treatment earlier and who have higher CD4 counts and lower viral loads. It is important to note that the drugs some people fear might cause a change in their appearance, particularly ddI and d4T, are not routinely prescribed for people new to treatment. Virtually all HIV-positive people will need to take medications at some point. The decision about when to start treatment is entirely up to the patient and should be made along with a qualified and trusted medical provider. Community groups are available to help HIV-positive people think through questions about when to start. The critical thing is that they not avoid this question altogether and instead seriously consider engaging in treatment.

What is known about the effects of treatment for those who have been taking HIV medications for many years?

Some people who have been taking HIV medications for many years and even decades experience heart, liver, bone density and other serious medical issues. Some of those issues can be treated using other medications. However, it is not clear that these issues are caused entirely by HIV medications. Mounting evidence suggests that the virus itself causes and exacerbates a set of long-term health issues more than HIV treatments do. It is also important to note that many HIV-positive people who have taken medications for many years and experience health issues did take generations of medications whose long-term effects are greater than those caused by newer drugs. Still, there is no denying that HIV medications may themselves cause health issues over time. HIV-positive people need to consult with a provider to support good decision-making about when to start taking them, what specific medications they should use and how to manage side-effects. HIV-positive people should have a thorough physical exam before starting treatment to rule out pre-existing conditions that may influence their choice of medications.

Does TLC+ prioritize prevention over the health outcomes of the individual HIV-positive person? Is it ethical to ask HIV-positive people to consider treatment to help prevent transmission?

As a public health strategy, TLC+ has two equally important goals: to increase the percentage of HIV-positive people who are engaged in care and treatment and improve their health outcomes, and to help reduce new cases of HIV infection. With communicable diseases other than HIV, such as tuberculosis and sexually transmitted infections, patients are encouraged to treat in order to cure their infection and avoid transmission to others. TLC+ proposes that the nation’s approach to HIV include treatment to benefit the individual and the community, and suggests that doing so could help to slow the epidemic.

Most HIV-positive people want to take every reasonable step to prevent transmitting the virus to others, and doing so can contribute to their full health and well-being. It therefore seems consistent with concepts of patient empowerment and informed consent for a provider to let an HIV-positive person know that among the reasons for deciding to initiate treatment is that doing so, along with continuing to practice safe sex, could support their efforts to avoid transmitting HIV to partners. Ultimately, it is entirely up to the HIV-positive person to decide whether the possible preventive effect of treatment is reason, in whole or in part, to initiate it.

Does TLC+ suggest that if HIV-positive people are on treatment, they don’t also have to practice safe sex? Might TLC+ lead to more infections because people taking medications may stop having safe sex in the belief that that alone can prevent transmission?

Being on effective HIV treatment can reduce the chances that an HIV-positive person can transmit the virus, but it is also necessary for people taking anti-HIV drugs to continue to engage in safer sex or to use sterile syringes if they inject drugs. Combining treatment with safe behavior is the most effective strategy for preventing transmission. Evidence does suggest that some HIV-positive people who enter treatment are less likely to engage in safer behaviors. But that is not reason to discourage them from taking HIV medications. It does reinforce two important components of TLC+: that all HIV-positive people should be counseled that taking pills alone is not enough to prevent transmission and should be offered services that can support them to engage in safe behaviors, if needed, such as behavioral, mental health or substance use counseling.

Does TLC+ shift the burden of responsibility for HIV prevention to HIV-positive individuals?

No. Traditional public health approaches do emphasize the importance of engaging a person with a communicable disease in prevention. But HIV prevention has always and should continue to encourage HIV-negative people to take their role in avoiding infection seriously.

How would TLC+ affect health disparities in HIV?

A key assumption behind TLC+ is that a high percentage of the HIV-positive people engaged by this strategy will be people of color, women and male- to-female transgenders (MTF) who are disproportionately affected by the epidemic. These groups will presumably benefit from TLC+’s focus on increased awareness of serostatus, linkage to care, treatment and social services. Indeed, advocates for TLC+ want to make sure that this approach is implemented in jurisdictions with high incidence among people of color, women and MTF transgender individuals.

What is available for HIV negative individuals through TLC+?

TLC+ is primarily a framework for working with HIV-positive people. However, it does stress the importance of working with people who test HIV-negative to identify and address any needs they may have to remain uninfected. These might include behavioral counseling, support groups, mental health and substance abuse counseling or housing. TLC+ may stimulate the development of a similar national standard and program for working with high-risk HIV-negative people.

Will TLC+ replace other forms of prevention?

It is not intended to. Most HIV prevention experts call for “combination prevention,” which includes using behavioral, biomedical and structural approaches. TLC+ proponents have been clear that this approach could constitute an important addition to the arsenal of evidence-based prevention approaches, but it should in no way constitute the only one. At the same time, it is possible as HIV prevention dollars become scarcer that some providers or jurisdictions will decide to focus scarce resources on programs they find to be making the greatest contributions to reducing incidence. Like behavioral approaches, TLC+ may or may not be proven to be the most cost-effective approach to prevention. It is important to note that, while TLC+ is being advanced because of its potential role in prevention, it is also an intervention intended to increase participation in testing, care and treatment. Testing and prevention funds are not the only ones to be looked to for support of TLC+ implementation.

Is it reasonable or responsible to promote TLC+ if there are not resources to pay for care and treatment for everyone who decides to engage in them? There are already waiting lists for ADAP. Won’t this make them worse?

It is important that everyone know their HIV status so that they can monitor their health and because this knowledge can result in behavior change that helps to reduce new cases of HIV infection. HIV-positive people without private insurance in the United States currently have good, although not universal, access to free or low-cost HIV care and treatment services. Variations in coverage definitely exist between states, and ADAP currently has growing waiting lists. TLC+ is not likely to achieve a large increase in participation in services by HIV-positive people in the short-term. Advocacy groups are pressing federal and state governments hard to make certain that ADAP is able to keep up with growing demand for HIV medications, and fighting for increased appropriations to support all aspects of testing, care, treatment and social support for HIV-positive people during the transition to national health care reform. Reform legislation will result in dramatic improvements in access to care and treatment for nearly all people living with HIV in the United States by 2014. The future of coverage for undocumented individuals, however, is uncertain, particularly if the Ryan White Program is not reauthorized by Congress in future years. In any case, we should not settle for substandard clinical care and treatment for people with HIV due to limited resources. Instead, we should advocate for adequate financing to assure access.

How can cities even hope to implement TLC+ when their budgets are being cut due to the recession?

Budget cuts are a very real and troubling phenomenon and cities and counties are severely constrained in their ability to implement new programs. However, local jurisdictions might wish to decide whether implementing TLC+ might be of greater help in addressing their local epidemic and more cost-effective than other programs. This may be true in some places and not in others. TLC+ advocates are pressing federal agencies to implement TLC+ and to build funding streams that will enable state and local governments to implement it, as well.

(A thorough description of TLC+ and supporting documents are available at www.projectinform.org/tlc+/ If you have other questions, please contact the National TLC+ Work Group through Dana Van Gorder)