Testing and Linkage to Care plus
The Rationale for TLC+, and Project Inform’s
Position on When to Start HIV Treatment
May 12, 2010
By the Staff of Project Inform
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
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.
Conditions in the epidemic today are unacceptable
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.
TLC+ will help to address gaps in the nation’s
response to the epidemic
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+ builds upon previous concepts of testing and linkage
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.
TLC+ leaves decisions about when to start HIV treatment
in the hands of people with HIV
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
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.
Individual health versus public health
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
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.
Answers to other key concerns about TLC+
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
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
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.
The choice of words in the debate over TLC+ matters
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.
Project Inform supports earlier treatment of HIV
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
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
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.