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Release Date: January 15, 2013.

Please find the 2012 data report, along with a comparison report from 2011 & 2012. The comparison shows 34% growth in numbers, but also significant improvement in immune status.

Previously Released:

Peak Vista Community Health Centers -
       Patient Data Report - 2011PDF file

Peak Vista Community Health Centers
Collaborative Clinic publishes 2011-2012 HIV Quality Management Plan

HIV Quality Statement, Aug. 29, 2011PDF file

HIV Mandatory testing: The Dilemma Continues

The HIV/AIDS pandemic has now reached all countries of the world and has claimed the lives of roughly 25 million people since 1986. An additional 40 million people are living with HIV (see Table 2). To date, there are approximately 56,000 new HIV infections annually in the U.S.(CDC). In the beginning of the AIDS epidemic, HIV was initially reported as being prevalent amongst gay men, ultimately resulting in more debates about homosexuality, prejudice, discrimination, violence, issues of medical care and human rights than any other disease in history.

Research teams across the world are currently working  diligently on vaccine development and improved antiviral therapies that fight and disengage the HIV viral particles. With that privileged knowledge, as a society, still struggle with the basics of how to best identify HIV infection in our populations.

The Center for Disease Control has chosen to approach HIV mandatory testing, utilizing an opt-out testing approach in medical clinics across the nation. Is this approach violating or respecting our individual human rights to make an autonomous decision for HIV testing?

And what are the consequences and implications of a positive or negative test result for the person tested? Are we prepared to provide medical care to every individual that we identify as being infected with the HIV virus? What ethical issues do these concepts imply? These questions have caused heated debates between leading healthcare agencies as Centers for Disease Control (CDC), World Health Organization, (WHO) and United Nations on AIDS, (UNAIDS).

This paper will review the historical development of HIV testing and how we continue to question the issues that arise out of the debated question of HIV mandatory testing to prevent perinatal transmission and reduce future HIV infections.

Background and Relevant Facts

To understand how we arrived at the concept of considering HIV mandatory testing, it is necessary to review the steps that have been taken over the years. The initiative of rolling out the first HIV antibody test in 1985 was solely to protect the national blood supply from being infected with the virus. In conjunction, alternate sites were instituted for the purpose of identifying HIV infection, but little education was offered to those infected and health professionals were still uncertain how to interpret test results (Branson et al, 2006).

By 1987, high risk behaviors were identified in the homosexual population and intravenous drug users as being the two vulnerable groups for acquiring HIV infection. Concurrently, “routine” HIV testing and counseling (see Table 1) was suggested by the United States Public Health Service, (USPHS), for patients who were practicing high risk behavior and acquiring sexually transmitted diseases. At this point in public health history, STD contact tracing and investigation were considered standard practice in order to have contacts receive treatment for STI’s. With routine HIV testing, they believed it would be possible to trace HIV positive persons and investigate their sexual contacts. This resulted in great concern amongst the gay population, they felt that their HIV status would make their sexual orientation public, a matter they considered private. This exposure, at that time, did result in the loss of medical insurance and jobs to some who were HIV positive. Because of this, a covertness persisted to protect the privacy of the individual and his/her contacts. As a consequence of this exceptionalism, world figures of HIV infection rose to10 million with 1 million dying of this disease by the year 1990 (see Table 2). In 1993, CDC adapted this “routine” HIV testing approach and extended it to hospitalized patients, acute clinics and emergency departments. Specifically, the CDC recommended if prevalence rates in geographic areas for HIV infection were over 1 percent, then routine HIV testing should be implemented in patients between the ages of 15 and 54. By 1990, it was known that HIV infection could also be transmitted heterosexually.

Shortly thereafter in 1994, in a well known study entitled Protocol 076, AZT, a retroantiviral, was administered to HIV pregnant women during the antepartum and intrapartum periods and found that HIV transmission was reduced by two-thirds (Conner et al, 1994).This breakthrough sparked the USPHS to suggest voluntary testing for all pregnant women with the provision of informed consent (see Table1). The House of Delegates of the American Medical Association passed a resolution urging a stronger approach by recommending not voluntary testing but mandatory testing of pregnant women (Bayer &Fairchild, 2006). This suggestion did not get approval.

In 1996, we began to see a newer class of medications called Protease Inhibitors. These medications became available to be utilized in combination therapies with nucleoside classes to treat HIV infection. For the first time in this epidemic, HIV became a manageable disease, and possibly no different from a chronic infection. However, the exceptionalism still continued with HIV. Nonetheless, the availability of these medications helped to encourage those who were of high risk to finally be tested. By 1999, world data indicated that there were 30 million infected with HIV and 10 million had died (see Table 2). Over the next 10 years the CDC struggled with how best to introduce HIV testing in medical practices, clinics and health departments. One of the main issues regarding the testing process was the counseling and prevention component. (see Table 1). The CDC recognized that counseling is beneficial to high risk patients but may not be appropriate for all patients. In addition providers were somewhat reluctant to include this component because they simply were not prepared to do so. The CDC continued pushing for this testing process .In 2006, the CDC, conducted a survey of the general population. Approximately 65 percent of the individuals surveyed agreed that HIV testing should be treated no different than screening for any other diseases. By the time these new recommendations were finalized in early 2006, data revealed that worldwide HIV infections were at an astronomical figure of 40 million and the death rate had reached 25 million (see Table 2). The CDC finally defined what they considered to be the best approach and decided for all patients in a medical setting an opt-out approach would be best suitable (see Table 1).With this approach the CDC hopes to identify an estimated 250,000 people in the US that are HIV positive and unaware of their status (Branson, et el). The 2006 CDC recommendation for adolescents, adults and pregnant women state:

Diagnostic HIV testing and Opt-Out HIV screening be part of routine clinical care in all health care settings while also preserving the patient’s option to decline HIV testing and ensuring a provider-patient relationship conducive to optimal clinical and preventive care.

Statement of Problem and Ethical Questions

Should the CDC recommendations for HIV testing of all adolescents, adult, and pregnant women be instituted by all health care settings in order to protect the entire population? Ideally the utilitarian approach to this issue is the best approach, but probably not the mostimplementable. Two barriers to this approach in health care settings is cost of the HIV test and the method in which health care institutions would be reimbursed for this service. Would private insurance companies reimburse for this test? In either case is it ethical to even offer the test if the offering institution ignores whether it will be reimbursed?

Secondly what is the consequence of a positive test result? Are health care settings prepared to deal with the counseling issues of a positive result? Since 1986 stigmatization, discrimination and severe psychological burden are often times suffered by the individual with a positive HIV result (Bayer). Logically, physicians are best equipped to handle these situations. However the medical management of HIV has taken on a specialty status and non-specialists are not so inclined to offer appropriate treatment. Is it fair to offer HIV testing and then have no referral system in place even though treatment is available? Are the physician and the clinic being responsible in diagnosing something which they cannot treat? The question remains, is it better for the individual to know than not? Instinctually I would say yes.

Argument Against Mandatory HIV Testing

From a human rights stand point, when we argue for the sake of beneficence, what is the good that will come of identifying these vulnerable groups? On an international level, Mark Heywood, who is the head of the AIDS Law Project in South Africa, says, “From a human rights perspective, routine testing also carries the risks of becoming a war on “vulnerable groups”, and later on people with HIV who then must be identified so that the state can help them”. (qtd in Bayer & Edington, 2009). Although this approach would be considered just standard public health practice, Heywood believes it is paternalistic and coercive and fails to see its public utility. On the American front a view similar to Mr. Heywood’s is held by the American Civil Liberties Union which has concerns regarding coercive testing due to the slack approach in obtaining informed consent (Holtgrave, 2007.) HIV is also a reportable disease and carries with it laws that govern automatic contact tracing issues. This vulnerability has always been the main concern regarding issues of privacy and discrimination.

Secondly, medical care regarding HIV disease normally does not get addressed when CDC, WHO, HRSA and other national agencies consider the consequences of an opt-out testing site, especially when a positive result occurs.

Briefly, HIV infection is defined by CD4+T cell counts and viral load measurements. In a person with an intact immune system CD4+T levels range from 800/mm-1200/mm. A patient infected with HIV whose CD4+T cells fall below 200/mm are generally classified with an AIDS diagnosis. This distinction is important. A patient with CD4 cells below 200/mm is at risk for opportunistic infections. When factoring this condition into cost analysis, cost of care increases significantly. Many physicians regard the treatment of HIV positive patients as specialty care and are not so willing to assume care for the patient. This decision is defended under the AMA Principles of Medical Ethics, which state that a physician has the right to choose his/her patients except in emergency cases (AMA Principles, 2001).

To look at these issues, the University of Alabama conducted a cost analysis of their outpatient HIV clinic. Costs were significantly higher in patients whose CD4+T cells were between 50/mm-200/mm with a definition of having an AIDS diagnosis. Mean expenditures forannual cost for one patient was $23,864. Much of the cost of care went to medications to treat the opportunistic infections that these patients incurred. In contrast, a patient whose CD4+T cells over 350/mm, costs were considerably lower at $13,885 with the bulk of care dollars covering antiretroviral medications. In this particular clinic over the last five years patient volume has increased by 75%. Sources of receivable funding for this clinic such as Ryan White, Medicare and Medicaid have not increased in the last seven years. With this increase of patient load and lack of additional streamlined funding, hiring additional physicians or maintaining quality professionals become extremely difficult (Saag, 2007).

This scenario is not unique to Alabama. The HIV Medicine Association and the American Academy of HIV Medicine conducted a collaborative survey of over 800 HIV clinics. The respondents were seasoned internists and infectious disease specialists, practicing HIV care for more than ten years and having more than 500 patients. Most have seen increases in their HIV patient load by 30-70%, but not have had any additional resources to accommodate the increased patient load (Saag, 2007). This situation is rather frustrating for we have the retroviral medications to treat the patients but we do not have enough physicians, nurse practioners or physician assistants to prescribe them.

Argument for Mandatory Testing

Let’s examine the most vulnerable group. Since 1994, Antiretroviral (ARV) medication development for HIV has expanded to five different classes, nonetheless this has resulted in fewer than 30 different medications that must be used as combination therapies. These classes of antiretroviral medications are given to known HIV pregnant women during their prenatal care and at delivery during a cesarean section. HIV transmission to the unborn will be reduced to less than 2 percent. HIV in an unborn baby is preventable. (Black & Hawks, 2005). Preventable medicine is the best measure for containing cost in care.

Recent indicators show that awareness of the possibility of HIV infection will not only reduce risky behaviors but will, in theory, reduce potential new infections by 30 percent. With this reduction a mathematical model indicates that with widespread testing and treatment we essentially could eliminate the AIDS pandemic to less than 1percent of its present size by the year 2050, even in the world’s worst affected regions (Bioethics, 2009). In the interest of science and mankind we all hope that a vaccine is developed much sooner than 2050. The idea of widespread HIV testing is to capture those that are unaware of their status at a fairly manageable stage. The issue of mortality is greatly affected in relation to the stage one is diagnosed at. According to the Alabama study, after eight years, the mortality rate of patients that had less than 200/mm CD4 T cells were at 30-50 percent. In comparison to the group whose CD4T cells that were greater than 200, mortality rates were less than 10 percent (Saag, 2007).

Lastly, a newly published study in September, 2009 indicates that consent procedures actually may discourage HIV testing. New York State introduced a streamlined informed consent to allow for HIV testing and other procedures. The modified form, which is simpler and easier to read and use, included an informational section that replaces face to face pretest counseling.

Within six months of using the new form, there were 328,000 more individuals between the ages of 18 and 64 that had been tested. A CDC analyst concluded that informed consent is a barrier to HIV testing (Hollander, 2009).

My Position

The staggering 2006 figures of HIV positivity and HIV deaths shown earlier are visual reminders that this disease is a global pandemic. The 65 million people who are the unfortunate ones to be infected with this virus is equivalent to 20 percent of the US population. Is this enough of a figure to justify a utilitarian approach to mandate the concept of mandatory HIV testing? Of course. I would assign this as our constitution of health. We need to get rid of the exceptionalism, along with the vulnerability, discrimination, violence and the coercive naturerelated to this disease. We need to incorporate the test for this infection into all medical practices and clinics and treat it like any other test so that it normalizes itself into all societies.

We also must demand beneficence from the financial institutions that can support the medical care of this disease. These are mainly governmental institutions and it is hoped that they will honor the basic human right of health care for all Americans .This very idea of equal distributive power of medicine, would cement the bridge from the HIV test site to provide continuity of care at the medical clinic.

Lastly, our leaders and policy makers need to stop over analyzing concepts that have easy answers. As earlier reviewed, over the last ten years, the CDC has continued to refine various approaches of HIV testing while millions of people were being infected and died. As a nation and world, we no longer have the time and resources to look at this issue from every ethical angle known. We simply must ask, “If everyone knew their HIV status and could receive the needed health care, would that be a total benefit to all?” The utilitarian answer is a resounding yes.

Definitions

Table 1

Pence, 2008  World Wide Data
Year HIV+ People HIV Deaths
1981 600 200
1990 10,000,000 1,000,000
1999 30,000,000 10,000,000
2006 40,000,000 25,000,000

References

Looking Ahead to a START Approach
Spring 2011

I have lived in Colorado Springs for 26 years and there is a saying here, if you don't like the weather, wait 10 minutes and it will change. True to this statement, I awoke to snow on the ground today and yet yesterday was walking around Prospect Lake enjoying the balmy 75 degree temperature. What was nice and comfortable yesterday is certainly not so today. This unpredictability that produces ongoing change has been the environment in the DHHS (Department of Health and Human Services) and WHO (World Health Organization) guidelines for the treatment of HIV/AIDS over the last twenty years. The premise to start antiviral treatment has always differed among treating physicians, depending on their experience and current clinical trial research. However, the main goals or health outcomes have always been to reduce mortality and destructive pathogenic processes resulting in morbidities. This article briefly describes care and treatment guidelines over the last twenty years, largely focusing on a newly proposed study called START (Strategic Timing of Antiretroviral Treatment).

When I first entered the study and practice of Immune Deficiency back in 1991, most of my patients had a diagnosis of AIDS. Physicians had only four antiretroviral medications in their arsenal to choose from. Without additional guidance of a genotype or viral load studies, selecting medications was just a matter of choosing what was left of the four medications. In late 1995, the treatment picture changed dramatically and the approach to treating HIV became robust. The era of Protease Inhibitors saturated the medical world and a new aggressive approach surfaced. Equally important to this development was the availability of viral load studies that helped monitor the efficacy which the medications had on the virus. The mantra at that time was to hit the virus as early as possible with these newest inhibitors. It didn't matter if your CD4 was 800 or 50, or if a viral load was 500 or 100,000…the aim was to disengage this virus and hopefully eradicate it entirely.

Both physicians and researchers learned a great deal from those classes of protease inhibitors. We learned that many metabolic transient side effects occurred and permanent effects persisted. Peripheral lipodystrophy, hyperlipidemia, nephropathy and insulin resistance were the resulting complications from those medications (Murata). In conjunction with these side effects the HIV virus itself produces ongoing systemic damage resulting in inflammation of organs, malignancies that are associated with other viruses, (HPV, HCV, and HSV), cardiovascular disease, cognitive disorders and neurological impairments (DHHS). The challenge that exists is the delicate balance between how much time should elapse before we start treatment on the virus, knowing that when we start the medications, we are preventing premature death and other potentially harmful infections. However, this initiative contributes towards increasing resistance and eventual abnormal physiological functions leading to morbidity. Over the years many controlled trials and studies have evolved to shape our current understanding and treatment of HIV. To recognize these challenges the DHHS panel has revised its guidelines to reflect these considerations. Listed below are current treatment guidelines for HIV-1-Infected Adults and Adolescents.

Department of Health and Human Services Recommendations:

  • Antiretroviral therapy (ART) should be initiated in all patients with a history of an AIDS-defining illness or with a CD4 count <350 cells/mm3 (AI).
  • ART is also recommended for patients with CD4 counts between 350 and 500 cells/mm3 (A/B*-II).
  • ART should be initiated, regardless of CD4 count, in patients with the following conditions: HIV-associated nephropathy (HIVAN) (AII) and hepatitis B virus (HBV) coinfection when treatment of HBV is indicated (AIII).
  • A combination antiretroviral (ARV) drug regimen is also recommended for pregnant women who do not meet criteria for treatment with the goal to prevent perinatal transmission (AI).
  • For patients with CD4 counts >500 cells/mm3, Panel members are evenly divided: 50% favor starting ART at this stage of HIV disease (B); 50% view initiating therapy at this stage as optional (C) (B/C-III).
  • Patients initiating ART should be willing and able to commit to lifelong treatment and should understand the benefits and risks of therapy and the importance of adherence (AIII). Patients may choose to postpone therapy, and providers, on a case-by-case basis, may elect to defer therapy based on clinical and/or psychosocial factors.
  • (DHHS, 2011)

About START

The newest study that is underway is called START, known as the Strategic Timing of Antiretroviral Treatment. This randomized clinical study, co-funded by NIH, (National Institute of Health) will attempt to address that delicate balance of starting medications when CD4 counts are greater than 500 and concluding if this approach is better than starting medications when D4 cells fall below 350. This study will enlist approximately 4,000 patients in 30 countries that are completely naïve to antiviral medications. Patients will be on a five year evaluation plan that will include quarterly medical visits to monitor CD4 counts and viral load studies. The pre-approved medications that are to be used are from the DHHS guideline recommendations. Additionally, this study will focus on issues of health care cost analysis, risk factors for transmission, adherence of medications and drug resistance.

This important study also allows for a much broader spectrum in terms of public health. If the outcomes conclude that starting medications earlier (rather than later) prevent the destructive nature of the virus on the body and prolong longevity, then I am sure the guidelines once again will be changed to reflect this scientific outcome. The implication of starting early treatment equates with identifying patients that are HIV infected in an early stage. I feel we must, as health care professionals, consider incorporating universal HIV testing in all health care facilities to capture this population (CDC). Otherwise we are not only failing our community, but also ignoring what evidence-based practice is designed to do, and that is encompassing and benefitting all of mankind.

References

Updated on January 28, 2013