Wednesday, August 15, 2007

Millennial Challenges: Universal Manadatory HIV testing and its implications

Global Strategic Enterprises, Inc for Peace and Prosperity-;

Re: The Challenges of UNiversal Manadatory HIV Testing- Stimga &Discrimination

Almost after a quarter of a century, HIV remains to be a hihgly potent disease with serious biological and social consequences.

Due to its first advent among the Politically active Homosexual Communities in North America and Europe, it continues to be treated differently than other sexually transmitted infectious diseases. Making is a political and social issue rather than a biological and personal issue it is.

The victim are the majority populations with the disease in the Developing world who have inherited the fatal disease and its backward social response to it and find themselves in a serious social and biological crisis due to the ignornance that prevails about the disease regardless of the fastest development and improvements in the life cycle and demographics of any disease.

The worst story is that the damaging ignorance is rampant among the so called experts who do not articulate just the science directly to the public and policy makers. The disease can be stopped in its tracks if we have universal mandatory HIV testing globally among all sexually active people. Treat early and ensure that it is not spread among the unsuspecting public.

Make it mandatory for prior to all forms of legal or illegal sexual contacts among humans any where in the world and you can literraly stop its spreat in atleast five years.

Here is the latest controversy of what is referred to as 'opt out" or exceptionalism of the HIV tests. It is just not acceptable. It should be treated as any sexually transmitted disease such as hepatitis virus which is more dangerous and rather fatal too.

Yet the experts drawn us with all the lingo of scientific, legal and social embargo, against making the HIV test, universal and manadatory for any sexually active individual any where in the world.

The HIV test should be the only thing that should be discussed preneptually along with the fiscal and social comprence of the potential mate.

Here are the experts in their own words and see if you can make it out, why not universal and mandatory testing for every sexually active person.

Here you go and read it yourself what the experts say....

Expert Reviews and Commentary
Literature Commentary by Dr. John G. Bartlett: HIV Testing, August 2007
Posted 08/07/2007

John G. Bartlett, MD

Author Information

Information from Industry
HIV Management InfoSite from LEXIVA® (fosamprenavir calcium)
Depending on a patient's HIV treatment history, LEXIVA may be taken once or twice daily. Either way, it's always 4 pills a day. Read:
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Wynia MK . Routine Screening: Informed Consent, Stigma and the Waning of HIV Exceptionalism. Am J Bioethics. 2006;6:5-8.

Issues associated with new Center for Disease Control and Prevention (CDC) guidelines for 'opt-out' human immunodeficiency virus (HIV) testing were addressed. Although Matthew K. Wynia, MD, MPH, FACP, Director, The Institute of Medical Ethics, American Medical Association (AMA); Clinical Assistant Professor, Infectious Disease, University of Chicago, Chicago, Illinois, represents the AMA, he notes that the views expressed in the article are his own.

'HIV Exceptionalism' is defined as 'the notion that being diagnosed with HIV is so different from any other diagnosis that it must be handled very differently.' He goes on to define criteria for screening tests advocated for routine medical care as follows:

Important: HIV infection is considered very important both in terms of disease severity and frequency;

Actionable: HIV screening clearly qualifies here since detection is important for both access to treatment and for prevention;

Accurate: The current HIV test provides specificity and sensitivity exceeding 99%. Even in low risk populations, the probability of a false positive test is now only about 1/250,000;

Cost-effective: Multiple experts have defined cost-effectiveness with universal testing (although this may not be accurate when rates are less than 0.1%); and

Acceptable: Routine HIV screening in pregnancy, for example, has become more acceptable, with up to 90% or more of women agreeing to prenatal HIV screening.[1]

Paradoxically, reduced time in discussions with physicians regarding HIV screening resulted in higher testing acceptance rates by pregnant patients.[2]

The main concern on this topic is the continuing stigma associated with HIV infection, including:

Concerns about confidentiality of HIV test results despite new legal protections such as Health Insurance Portability and Accountability Act (HIPAA); , and

Fears of personal and employment discrimination.

A recent report indicated that 26% of persons with HIV infection in the United States experienced discrimination within the health care system.[3] Possible stigma and discrimination remain the most powerful rationale for continuing HIV exceptionalism.

The AMA policies that support removing the requirement for written, informed consent in the effort to 'normalize and destigmatize testing' appear inconsistent with the AMA Code of Medical Ethics which states that "the physician should secure the patient's informed consent specific for HIV testing before the testing is performed. Because of the need for pretest counseling and the potential consequences of an HIV test on the individual's job, housing, insurability and social relationships, the consent should be specific for HIV testing."[4]

Campbell S, Klein R. Home testing to detect human immunodeficiency virus: boon or bane? J Clin Microbiol. 2006;44:3473-3476.

Pros and cons for home testing for HIV are reviewed. This has become an issue because of the CLIA waiver of the OraSure OraQuick rapid HIV test in January, 2003. The implication is that the test is so simple to perform that there is minimal risk of erroneous results. All home use tests are waived, but not all waived tests are approved for home use. There are 2 CLIA-waived HIV tests:

OraQuick HIV 1/2; and

The Trinity Uni-Gold test.

The OraQuick test is approved for blood and oral fluid; the Uni-Gold test is approved for blood. The technical aspects of the tests are really quite simple, although the consequences of the test results could be substantial.

The arguments favoring the home test are the same that prompted the Centers for Disease control to recommend opt-out testing for all persons aged 13 to 64.[5] The concern is that approximately 25% of persons with HIV infection in the United States are not aware of their infection,[6] and consequently are not aware of the potential risk they pose to others. The lack of information about their HIV serostatus has also become a major concern for late presentation for care.

Comment: The US Food and Drug Administration (FDA) had public hearings on home use of HIV tests in November, 2005 and March, 2006. At the November hearings,[7] arguments against the test included the possibilities of:

Adverse psychological outcomes;

Erroneous impression of noninfection if testing after acute transmission;

Testing by minors;

Assumption that a positive test is correct without adequate confirmation -- a particular problem in low-risk populations;

Concerns that untrained persons are performing a test that has important individual health and public health implications;

Lack of follow-up or partner notification; and

Extensive use overloading treatment programs.

Despite these negative concerns, the CDC described a positive field experience with the OraQuick test and presented a proposal for quality assurance. A plan was described for the FDA to require the manufacturer to show that the test is accurate and reliable for lay users and label the device to provide all information about proper use and interpretation.

At the March, 2006 hearings, the American Society of Microbiology stated concerns about the potential harm of unsupervised testing. The FDA stated its intention to perform phase III trials. The anticipation is that the FDA will provide a specific guidance to the industry regarding the required studies.

The review finishes with the observation that there is a general lack of good scientific data on the impact of other home tests so that an important concern is the inability to accurately assess probabilities with this test.

Fiscus SA, Pilcher CD, Miller WC, et al. Rapid, real-time detection of acute HIV infection in patients in Africa. J Infect Dis. 2007;195:416-424. Epub 2006 Dec 22.

This prospective study evaluated methods to detect acute HIV infection in Malawi.

Methods: Patients being evaluated for acute sexually transmitted diseases (STD) were offered voluntary HIV serology using 2 rapid antibody tests. HIV RNA testing was performed on samples that had negative or discordant results with the rapid tests, and a subset of specimens was tested for p24 antigen (Ag) using standard and ultrasensitive tests. The latter was a heat-associated, signal-amplified method designed to disrupt antigen-antibody complexes.[8] Acute HIV infection was established by negative serologic tests combined with positive viral load with subsequent seroconversion.

Results: 1450 patients agreed to testing, including 588 (40.5%) with established HIV infection and 21 (1.45%) with acute infection. The sensitivity and specificity of the 3 alternative tests for detection of acute HIV are shown in Table 1 .

Standard pooled testing for HIV viral load is feasible for detection of acute HIV infection in resource-limited settings, but rapid antibody testing and parallel p24 antigen testing are technically easier and together may detect up to 90% of acute cases.

Comment: This is the North Carolina study[9] applied to Africa with 1 major difference -- the prevalence of acute HIV infection in North Carolina was 0.02%, but prevalence in the STD population sample from Malawi was 1.4%, or nearly 100-fold greater. This would substantially change the sensitivity, specificity, and positive predictive values of various assay methods. In North Carolina, for example, the authors estimate that the p24 antigen or the ultrasensitive p24 antigen assay would increase case detection by only 3.5% . Nevertheless, the standard p24 antigen had a positive predictive value of 81% in the Malawi population and 83.4% for the ultrasensitive test. A positive predictive value of 46% to 50% was estimated for these assays when the prevalence of acute HIV infection is 0.5%. These issues are obviously important in consideration of resources for these tests.

Chadborn TR, Delpech VC, Sabin CA, Sinka K, Evans BG. The late diagnosis and consequent short-term mortality of hiv-infected heterosexuals (England and Wales, 2000-2004). AIDS. 2006;20:2371-2379.

The purpose of the study was to estimate the mortality consequences of late diagnosis of HIV infection.

Methods: The analysis is based on data for the United Kingdom for reports of positive HIV serology from January 2000 through December 2004. The data were restricted to heterosexual, non-injection drug user patients. The CD4 cell count at diagnosis was reviewed and late diagnosis was defined as a count less than 200/microliter. Short-term mortality was defined as death from any cause within 1 year of HIV diagnosis.

Results: Data were available for 10,503 patients. Of these, 4425 (42%) were considered late diagnoses and 32% of this group had an AIDS-defining diagnosis within 3 months. The 1-year mortality in this group was 271/4425 (6.1%). For patients with an earlier diagnosis, the mortality was 41/6078 (0.7%) as summarized in Table 2 .

Based on the mortality in those with an earlier diagnosis, the authors calculated that an earlier diagnosis would have reduced the short-term mortality by 56%, or 249 deaths.

Conclusions: The authors conclude that earlier diagnosis of HIV in primary care is important, particularly among recent arrivals from countries with high rates of HIV infection.

Comment: This observation in the United Kingdom is similar to the experience in the United States in which early diagnosis to foster early enrollment in care is a prime motivating factor for the new CDC recommendation for 'opt-out HIV testing.'

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