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HIV/AIDS in the United States

Nancy Evans, BS

Susan Walters Schmid, BA, MA, PhD (candidate)

Our courses fulfill continuing nursing education requirements in all 50 states. For more accreditation information, click here. Nurse practitioners may apply these contact hours to pharmacy continuing education and prescriptive authorization.

This course is based on material from the Centers for Disease Control and Prevention (CDC) and some state governments.

Also available:
Washington State: HIV/AIDS (7 Units) Incorporating the KNOW Curriculum (meets WA-mandated requirements)
Florida HIV/AIDS (4-,3-,2-,1-unit courses meeting FL-mandated requirements)

Today, and every day, we must all commit to making a future without AIDS, something we will all live to see. Julie Gerberding, MD CDC Director, 2005

Since the first case of acquired immunodeficiency syndrome (AIDS) was diagnosed in 1981, AIDS has killed more than half a million Americans (CDC, 2007). The daunting human and economic costs of this disease in the United States are eclipsed only by its international impact. Since 1981, nearly 28 million people worldwide have died from AIDS and more than 39 million are infected with the virus. Since 2004 the number of people living with HIV has increased in every region of the world (UNAIDS, 2006).

Almost all of the newly infected people live in the developing world, particularly southern Africa. The majority are young adults, many of whom do not know they are infected. This disease is the leading cause of death in southern Africa. (See Wild Iris course, HIV in Africa, for more on this global challenge.) Worldwide, AIDS is the leading cause of death and lost years of productive life for adults between the ages of 15 and 59 years (UN AIDS, 2006).

In the United States, HIV/AIDS has forever altered the landscape of healthcare. Patient activism early in the epidemic spurred a massive research effort that led to greater understanding of AIDS and accelerated development of innovative drugs.

More effective antiviral drugs have slowed the death rate from AIDS in wealthier countries since 1996 but, without a cure or a preventive vaccine, there is no end in sight to the epidemic (Tables 1, 2).

TABLE 1

HIV/AIDS, THE GLOBAL EPIDEMIC, 2006

39.5 million people living with HIV/AIDS	37.2 million adults (17.2 million women) 2.3 million children under 15 11,000 new infections daily
Nearly 28 million dead of AIDS	22.5 million adults 5.3 million children under 15 14 million children orphaned; by 2010, AIDS orphans expected to number 25 million
During the year 2006	4.3 million people newly infected with HIV, half between ages 15-24 2.9 million people died of AIDS-related illnesses 2.6 million were adults 380,000 were children under 15
Source: UNAIDS, 2006.

Since the Centers for Disease Control and Prevention (CDC) began tracking HIV/AIDS cases in the United States in 1985, nearly 1 million cases have been reported (CDC, 2005). The statistics in Table 2 fail to reflect the true magnitude of the epidemic because the CDC considers reporting of cases to be only about 85 percent complete.

TABLE 2

AIDS DIAGNOSES, UNITED STATES, END OF 2005*

Race or ethnicity	Number of people
Non-Hispanic white	385,537
Non-Hispanic black	397,548
Hispanic	155,179
Asian/Pacific Islander	7,659
Indian/ Alaska Native	3,238
Unknown	887
Cumulative total: 984,155
* Estimated cumulative cases by race or ethnicity Source: CDC, 2007.

Although the CDC estimates that more than a million people in the United States are currently infected with HIV, at least one-fourth of them do not know they are infected, putting them at high risk for transmitting the virus to others. The development of antiretroviral drugs has reduced deaths from AIDS; yet the number of new infections has not changed since the late 1990s.

Each year another 40,000 people are infected with HIV—approximately 1 new infection every 12 minutes. Almost half of the HIV-positive population in the United States is not being treated, either because they lack access to care or because they have not been tested (CDC, 2007).

In the United States AIDS has been largely an urban epidemic, although it is growing rapidly in rural areas, particularly in the rural South. New York City has the largest number of reported cases, followed by Los Angeles, San Francisco, Miami, and Washington, D.C.

RISK GROUPS

AIDS is a changing epidemic. Once a disease of gay white men, HIV/AIDS is now decimating young people of color, particularly among the African American population. According to the CDC, more than half of all new HIV infections occur among African Americans, even though blacks represent only 13 percent of the U.S. population.

Black men are diagnosed with HIV at more than seven times the rate of white men, and black women at more than 20 times the rate of white women and more than 4 times the rate for Hispanic women. In the African American population, heterosexual transmission accounts for 11 percent of male infections, but more than 50 percent of female infections.

Men who have sex with men (MSM) account for nearly half of all newly reported HIV/AIDS diagnoses, and young men are at highest risk. A 2005 survey of MSM in several large U.S. cities (CDC, 2005) found that 1 in 4 of those surveyed was HIV-positive and nearly half of them were unaware of their HIV status. Prevalence of HIV/AIDS is higher among MSM from racial and ethnic minorities than among white MSM.

More than 400,000 people in the United States are living with full-blown AIDS, about three-fourths of them males. Men who have sex with men still comprise a majority of male AIDS cases. Injection drug users account for nearly one-fourth of new male cases. Men infected by a female partner comprise 10 percent of all male cases.

Women now constitute the fastest growing HIV/AIDS population, accounting for more than one-fourth of the infected population and nearly three-fourths of new AIDS cases. Women are primarily infected through heterosexual intercourse with the exchange of semen and pre-ejaculate fluid, although injection drug use accounts for more than one-third of female cases (CDC, 2006).

Ninety percent of children with AIDS are infected by their mothers. However, routine screening of pregnant women, prenatal treatment of HIV-infected women with antiretroviral drugs, and avoidance of breastfeeding have greatly reduced the incidence of mother-infant transmission nationwide.

Mother-infant transmission remains a challenge in the African American community. Nationwide, two-thirds of infected children younger than 5 years old are black. Nearly two-thirds of HIV-positive women in the United States are African Americans.

AIDS is caused by the human immunodeficiency virus (HIV). By attacking the immune system, HIV makes the body vulnerable to a number of opportunistic infections caused by viruses, bacteria, and yeasts that would pose no threat to a person with a normal immune system. With a weakened immune system, however, these infections are life-threatening.

Varying levels and concentrations of HIV have been found in most body fluids of infected persons: blood, semen, saliva, tears, breast milk, and vaginal and cervical secretions. However, only blood, semen, breast milk, and vaginal and cervical secretions have been proven to transmit HIV infection.

Although the mechanisms of HIV and the way it affects the immune system are not fully understood, the primary event is the entrance of HIV into the body's CD4⁺ cells ("T-helper lymphocytes," also called T4 cells), white blood cells essential to the function of the immune system in fighting infection.

Once inside a T4 cell, the virus replicates and signals other cells that produce antibodies. Producing antibodies is an essential immune system function. HIV infects and destroys the T4 cells and damages their ability to signal for antibody production. Thus it steadily deactivates the immune system, leading to dysfunction of various organ systems, including the endocrine, gastrointestinal, and nervous systems.

MODES OF TRANSMISSION

Contrary to flourishing myths and misinformation, HIV is not transmitted by casual contact such as hugging, other nonsexual touching, and the shared handling of objects. Insects do not carry HIV, nor is the virus transmitted through air or water. HIV is a relatively fragile virus and, once outside the human body, HIV has a very short lifespan, which makes most medical procedures and caregiving activities safe if standard infection control procedures are followed.

Three conditions are necessary for HIV to be transmitted:

1. An HIV source
2. A sufficient dose (viral load) of virus
3. Access to the bloodstream of another person

Sexual Contact

Transmission of HIV occurs primarily through sexual contact with an infected person. This includes anal, oral, and vaginal contact. The risk of transmission depends on sexual practices.

Unprotected anal intercourse is considered the greatest sexual risk for transmitting HIV. Anal intercourse often results in tears of mucous membranes, making it easier for the virus to enter the bloodstream. The receptive partner is thought to be at greater risk of becoming infected (if the virus is present) than the insertive partner (partner who penetrates during sexual activity).

Scientists believe that women and receptive partners are more easily infected with HIV, as compared to the insertive partner, probably because of the larger surface area of mucous membranes involved. Actually, receptive partners are at greater risk for transmission of any sexually transmitted disease, including HIV.

According to the CDC, female-to-female transmission of HIV appears to be rare. However, some case reports of female-to-female transmission, and the well-documented risk of female-to-male transmission, signal that vaginal secretions and menstrual blood are potentially infectious, and that exposure of mucous membrane (oral, vaginal, anal) to these secretions may lead to HIV infection (CDC, 2003). Consequently, women who have sex with women (WSW) should consider female sexual contact a possible means of transmission of HIV.

Health professionals need to remember that sexual identity and gender preference do not always predict behavior, and that women who identify as lesbian may still be at risk for HIV through unprotected sex with men or with injection drug users.

Injection Drug Use

Sharing injection needles, syringes, and other paraphernalia with an HIV-infected person can send HIV directly into the user's bloodstream, along with hepatitis B and C viruses, and other bloodborne diseases. Paraphernalia with the potential for transmission include the syringe, needle, "cooker", cotton, and/or rinse water (sometimes called "works").

Transmission also occurs through "indirect sharing" of contaminated paraphernalia and/or dividing a shared or jointly purchased drug while preparing and injecting it. "Indirect sharing" includes squirting the drug back from a dirty syringe into the drug cooker and/or someone else's syringe, or sharing a common filter or rinse water.

Transfusions of Infected Blood or Blood Clotting Factors

Transmission of HIV through transfusion has been uncommon in the United States since 1985 and in other countries where blood is screened for HIV antibodies. In 1999, about 1 percent of national AIDS cases were caused by transfusions or use of contaminated blood products. The majority of those cases were in people who received blood or blood products before 1985.

Donor screening, blood testing, and other processing methods have reduced the risk of transfusion-caused HIV transmission to between 1 in 450,000 and 1 in 600,000 transfusions in the United States. Donating blood in the United States is safe because sterile needles and other equipment are used.

Tattooing and Other Blood-Sharing Activities

HIV can be transmitted during tattooing or during blood-sharing activities such as "blood brothers" rituals or ceremonies where blood is exchanged or unsterilized equipment contaminated with blood is shared.

Pregnancy and Breastfeeding

A pregnant woman who is infected can transmit HIV to her fetus; after delivery an infected mother can transmit HIV to her infant while breastfeeding. Women newly or recently infected with HIV or those in the later stages of AIDS tend to have higher viral loads and may be more infectious.

When a woman's health care is monitored closely and she receives a combination of antiretroviral therapies during the last two trimesters of pregnancy and during delivery, the risk of perinatal transmission to the newborn drops below 2 percent. In addition, the infant is treated for the first six weeks of life (PHS Task Force, 2005).

The incidence of perinatally acquired AIDS peaked in 1992 and has decreased in recent years. Other contributing factors include the use of prophylactic cesarean delivery before the onset of labor or the rupture of membranes and the avoidance of breastfeeding by HIV-infected mothers. Advice about medications and C-section should be given on a case-by-case basis by a healthcare provider experienced in treating HIV-infected women.

Biting

Biting poses little risk of HIV transmission unless the person who is biting and the person who is bitten have an exchange of blood (such as through bleeding gums or open sores in the mouth). However, bites can transmit other infections and should be treated immediately by thorough washing of bitten skin with soap and warm water and disinfection with antibiotic skin ointment.

Factors Affecting Risk of HIV Transmission

OTHER SEXUALLY TRANSMITTED DISEASES

People who are HIV-positive often have other sexually transmitted diseases (STDs) such as syphilis, gonorrhea, genital warts, human papilloma virus (HPV), trichomoniasis, scabies, herpes, and chlamydia. Sores, lesions or inflammation from STDs make the skin or mucous membrane more vulnerable to other infections. Skin-to-skin contact can transmit herpes, genital warts and HPV infection, syphilis, scabies and pubic lice.

Although syphilis rates declined steadily among African American women and newborns between 1999 and 2004, rates have escalated sharply among gay and bisexual men. Nearly two-thirds of all cases of syphilis reported in 2004 occurred in MSM (CDC, 2004). Research indicates that STDs increase the risk of HIV transmission, and the immune suppression caused by HIV facilitates infection with other STDs, creating a destructive synergy.

Human papilloma virus (HPV) is highly prevalent among HIV-infected women and men, increasing viral shedding and raising the risk of cervical and anal cancers. Multiple strains of this virus are often present in HIV-positive women. The new HPV vaccine (Gardasil) has not been tested in HIV-positive women so no data is available on its safety or efficacy in this population.

Genital herpes (HSV-2) also appears to be a major risk factor for acquiring HIV infection, increasing the risk more than three-fold. According to CDC, most people with HSV-2 have not been diagnosed. Many of them have mild or unrecognized infections but shed virus intermittently in the genital tract.

These are the individuals most likely to transmit the infection. Diagnosis of HSV-2 should be confirmed by type-specific laboratory testing. Treatment of HSV-2 with antiviral agents reduces but does not eliminate subclinical virus shedding.

Screening for STDs is critical, since many of those infected do not have symptoms. For example, 80 percent of those with chlamydia and 70 percent of those with herpes are asymptomatic but can still spread the infections. It is essential that sexually active women get pap tests and that both women and men disclose any history of STDs during medical workups.

Prompt treatment is essential for anyone who tests positive for any STDs. Treatments vary with each disease or syndrome. Because of developing resistance to medications for certain STDs, healthcare providers should check the latest STD treatment guidelines.

ACUTE HIV INFECTION AND HIGH VIRAL LOAD

The first week or two after infection with HIV constitute the acute or primary HIV infection stage. During this time, infected persons may be symptom-free and unaware of the infection but highly infectious because of the viral load (high levels of the virus) in the bloodstream. Once infected, the person remains infectious for life.

Some researchers use the term "acute HIV infection" to describe the 6- to 12-week interval between initial infection and production of antibodies that can be detected by an HIV test. This interval is also called the "window period."

Although a high viral load is present during the acute stage of HIV, a new study indicates that those people in the asymptomatic stage of HIV who have medium levels of the virus have the greatest risk of infecting others. The asymptomatic stage lasts for years, rather than weeks, during which time the infected but untested population may continue to spread the virus unknowingly (Fraser et al., 2007).

MULTIPLE PARTNERS

The individual with multiple sex or injection drug–sharing partners is at great risk for exposure to HIV/AIDS. Anyone having unprotected sex with multiple partners (defined by CDC as six or more partners in a year) is considered at high risk for HIV/AIDS infection. But unprotected sex with even one partner who is HIV-positive risks transmission.

USE OF NONINJECTING DRUGS

Use of any mood-altering substance, including alcohol or non-injectable street drugs such as methamphetamine, can increase risk of HIV transmission by impairing judgment, thereby leading to risky behaviors such as unprotected sex. Methamphetamine abuse is growing among men who have sex with men (MSM), especially younger MSM. Research shows that both meth and HIV infection cause significant changes in the brain, impairing cognitive function (Jernigan et al., 2005).

Many MSM who use methamphetamine also use marijuana and poppers, and some also use cocaine, heroin, hallucinogens, and ketamine (Patterson et al., 2005). Certain substances have both physiologic and biologic effects on the body, such as masking pain and/or creating sores on the mouth and genitals, which creates additional entry points for HIV and other STDs.

GENDER, CULTURE AND EQUALITY ISSUES

The balance of power in an intimate relationship can affect an individual's ability to insist on safer sex practices such as condom use. Women who are socially and economically dependent on men may be unable to negotiate condom use or to leave a relationship that puts them at risk.

Culturally imposed ignorance about their bodies, especially about sexuality and reproduction, can make women even more vulnerable to HIV-infection. Some cultures endorse the concept of multiple sexual partners for men but monogamous relationships for women.

PREVENTION AND RISK REDUCTION

The prime mover of the epidemic is not inadequate antiretroviral medications, poverty, or bad luck, but our inability to accept the gothic dimensions of a disease that is transmitted sexually. Only when we cease to dodge this fact will effective HIV-control programs be established. Kent A. Sepkowitz, MD, 2006

High-risk drug use and high-risk sexual behaviors are often linked, thus further increasing the risk of HIV transmission.

HIV/AIDS is preventable. For example, screening of blood and blood products for the HIV virus has reduced the risk of HIV transmission with transfusion to 1:1,000,000. Mother-to-baby transmission has dropped by two-thirds (CDC, 2006). Following Universal Precautions in healthcare has unquestionably prevented thousands, if not millions, of cases of HIV/AIDS in the United States.

That's the good news. Because the virus is transmitted through behaviors that many people find pleasurable—sexual activity and injection drug use—prevention is difficult but not impossible. The bad news is that the annual number of new infections has held steady at 40,000 since the early 1990s.

Prevention of HIV/AIDS saves money as well as lives. The CDC estimates that the average cost of lifetime treatment for one person with HIV infection is $210,000. In 2006, CDC announced new prevention initiatives with the overarching goal to "reduce the number of new HIV infections in the United States from an estimated 40,000 to 20,000 per year, focusing particularly on eliminating racial and ethnic disparities in new HIV infections."

Strategies to reach that goal include:

• Make voluntary testing a routine part of medical care for all U.S. residents between the ages of 13 and 64.
• Implement new models for diagnosing HIV infection, such as rapid testing in high-prevalence areas, for example, correctional facilities..
• Prevent new infections by working with persons diagnosed with HIV, screening for risk behaviors, communicating prevention messages, discussing sexual and drug-use behaviors and offering positive reinforcement for changes to safer behaviors.
• Further decreasing perinatal HIV transmission, by promoting voluntary prenatal testing, rapid testing during labor, delivery and postpartum for women with unknown HIV status, and ensuring appropriate antiretroviral treatment and follow-up for HIV-positive women and their infants.

Prevention of HIV begins with education and counseling about sexual practices and injection drug use. For many people, just saying no isn't enough. Patients need basic, practical, how-to information.

Safer sex practices include:

• Abstinence from sexual contact
• Non-penetrative sex; no sharing of sex toys
• Mutual monogamy
• Correct use of latex (or polyurethane, if allergic to latex) condoms for all sexual intercourse (anal, oral, vaginal)
• Using only water-soluble lubricants with latex condoms; oil-based lubricants can cause condoms to break or tear.
• Avoiding natural membrane condoms, which do NOT protect against HIV, HBV and some other STDs
• Limiting the number of sexual and/or drug-injecting partners

Both women and men may need instruction in the correct use of condoms:

• Use a new latex condom for each act of intercourse.
• Leave space at the tip of the condom as a receptacle for semen and to decrease the risk of condom breakage.
• Hold on to the base of the condom to prevent slippage when withdrawing the penis after ejaculation.
• Do not attempt intercourse with a condom if the penis is only partially erect.

Prevention of HIV/AIDS should be part of a general program of sexually transmitted disease (STD) prevention because other preventable STDs, most of which are curable, have also reached epidemic proportions, particularly among sexually active young people. For example, the number of syphilis cases in Chicago climbed 41 percent in just one year. Nearly three-fourths of the cases were MSM (Chicago Department of Public Health, 2006).

Oral sex and anal sex are increasing among teens, perhaps due to the erroneous assumption that oral sex is safer than intercourse in preventing transmission of HIV. However, both oral and anal sex can transmit gonorrhea and chlamydia as well as HIV (Erbelding, 2006). Gonorrhea, syphilis, chlamydia, genital herpes (HSV-2), and human papillomavirus (HPV-16) increase susceptibility to HIV infection and actually make HIV more infectious by increasing viral shedding.

A rare and virulent strain of chlamydia appears to be spreading in the United States, primarily among MSM. More common to Africa and Southeast Asia, the strain is called lymphogranuloma venereum chlamydia (LGV), and it can cause genital ulcers, swollen lymph glands in the groin, flu-like symptoms, and gastrointestinal distress. Rectal symptoms among MSM, including bleeding of the rectum and colon, likely result from unprotected anal intercourse. These lesions increase the risk of transmitting or contracting HIV or other bloodborne diseases (Kaiser Daily HIV/AIDS Report, 2006).

Screening and treatment for STDs helps reduce HIV transmission by decreasing viral shedding and reducing the concentration of the virus. Ultimately, STD treatment reduces the spread of HIV within communities. The CDC Division of Sexually Transmitted Diseases (http://www.cdc.gov/std) suggests a variety of initiatives for prevention.

New urine ligase chain reaction (LCR) tests are available for some STDs, as well as Western Blot (blood tests) for herpes and hybrid capture tests for genital warts. However, in most places, cultures, wet preps and blood draws for syphilis remain the standard testing method.

Injection drug users who refuse treatment or who have no treatment programs available to them need instructions about precautions:

• Do not exchange needles or other paraphernalia.
• If sterile needles are not available, use bleach to clean needles.
• If you have sexual intercourse, use a latex condom to prevent infecting others.
• Anyone who knowingly exposes others to HIV/AIDS endangers the public health and may be taken into custody, tested for HIV without consent, hospitalized, and isolated.

These risk reduction measures also apply to people who use needles to inject insulin, vitamins, steroids, and prescription or non-prescription drugs.

Syringe exchange or needle exchange programs are public health measures that help prevent spread of HIV/AIDS and other bloodborne pathogens. These programs also offer referral sources for drug treatment. Many local health departments operate syringe exchanges in their communities. For more information, contact your local health department/district's HIV/AIDS Program.

Women who have sex with women need to take precautions during oral sex, even though female-to-female transmission appears to be rare. According to CDC (2003), vaginal secretions and menstrual blood are potentially infectious and mucous-membrane exposure (eg, oral, vaginal) to these secretions could lead to HIV infection. Precautionary measures include:

• Using condoms consistently and correctly each and every time for sexual contact with men or when using sex toys. Sex toys should not be shared.
• Using natural-rubber latex sheets, dental dams, cut-open condoms, or plastic wrap during oral sex. However, no barrier methods for use during oral sex have been shown to be effective by the FDA.
• Knowing your own and your partner's HIV status. This can help uninfected women reduce their risk of becoming infected and assist those who are infected to get early treatment and avoid transmitting the virus to others.

The availability of more effective therapies for HIV/AIDS is no reason for complacency among healthcare providers or the public. Without aggressive widespread prevention efforts, the tragedy of AIDS will continue to spread. Every healthcare professional has a role in identifying people at high risk, offering education and counseling, encouraging testing, and linking HIV-positive patients with treatment and social services. This is the most cost-effective and humane way to halt the devastation of this disease.

INFECTION CONTROL

Employer Standards and Procedures

The following standards are mandated by the Occupational Safety and Health Administration (OSHA) and may be supplemented and/or enforced by legislation and agencies specific to your state. Be sure you know your state's current regulations as citations or penalties may be the result of a failure to comply.

Bloodborne pathogens training is mandated for all new employees or employees being transferred into jobs involving tasks or activities with potential exposure to blood and/or other potentially infectious material (OPIM). This training must take place at the time of initial assignment to tasks where occupational exposure may occur, and must include:

• Information on hazards associated with blood/OPIM.
• Protective measures to minimize risk of occupational exposure.
• Information on appropriate actions to take if exposure occurs.

Retraining is required annually, or when changes in procedures or tasks affecting occupational exposure occur.

All employees whose jobs involve participation in tasks or activities with exposure to blood/OPIM shall be offered the first of the hepatitis B vaccination series within 10 working days of employment and/or new assignment. The vaccination will be provided free of charge. Serologic testing after vaccination (to ensure that the vaccination was effective) is recommended for all persons with potential occupational exposures.

The brief summary that follows is not meant to replace or supplant required bloodborne pathogens training required by your employer, local jurisdiction, or state. Occupational groups widely recognized as having potential exposure to HBV/HCV/HIV include but are not limited to healthcare employees, law enforcement, fire, ambulance, and other emergency-response and public service employees.

Although HBV and HIV are specifically identified in the standard, "bloodborne pathogens" include any pathogen present in human blood/OPIM that can infect and cause disease in people exposed to the pathogen. Bloodborne pathogens may also include HCV, hepatitis C, malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeldt-Jakob disease, adult T-cell leukemia/lymphoma (caused by HTLV-I), HTLV-I–associated myelopathy, diseases associated with HTLV-II, and viral hemorrhagic fever.

BODY FLUIDS

Body fluids recognized as OPIM and linked to transmission of HIV, HBV and HCV, and to which Standard Precautions and Universal Precautions apply are:

• Blood and blood products
• Semen
• Vaginal secretions
• Cerebrospinal fluid
• Synovial (joint) fluid
• Pleural (lung) fluid
• Peritoneal (gut) fluid
• Pericardial (heart) fluid
• Amniotic fluid (fluid surrounding the fetus)
• Saliva in dental procedures
• Specimens with concentrated HIV, HBV and HCV viruses

Body fluids such as urine, feces, and vomitus are not considered OPIM unless visibly contaminated by blood.

WASTEWATER

Wastewater (sewage) has not been implicated in the transmission of HIV, HBV, and HCV and is not considered to be either OPIM or regulated waste. However, plumbers working in healthcare facilities or who are exposed to sewage originating directly from healthcare facilities carry a theoretical risk of occupational exposure to bloodborne pathogens. Employers should consider this risk when preparing their written "exposure determination." Plumbers or wastewater workers working elsewhere are probably not at risk for exposure to bloodborne pathogens. Wastewater contains many other health hazards and workers should use appropriate personal protective equipment (PPE) and maintain personal hygiene standards while working.

EXPOSURE CONTROL PLAN (ECP)

An Exposure Control Plan requires the employer to identify those tasks and procedures in which occupational exposure may occur. It also requires the employer to identify the individuals who will receive the training, protective equipment, vaccination, and other benefits of the standard.

An Exposure Control Plan should contain at least the following elements:

• Those job classifications and tasks in which employees have potential for, or documented, occupational exposures. The exposure determination shall have been made without taking into consideration the use of personal protective clothing or equipment. It is important to include those employees who are required or expected to administer first aid.
• The schedule and method of implementation in a manner appropriate to the circumstances of the particular workplace.
• Engineering and work practice controls shall be used in preference to personal protective equipment to minimize or eliminate employee exposure. Many safer needle devices are now available and should be used. Employers must include employees in ongoing evaluation of engineering controls and implement appropriate engineering controls whenever feasible, and must document evaluation and implementation of these controls in the Exposure Control Plan.

Bloodborne pathogens training is mandated for all new employees or employees being transferred into jobs involving tasks or activities with potential exposure to blood and/or other potentially infectious material (OPIM). This training must take place prior to assignment to tasks where occupational exposure may occur, and must include:

• Information on hazards associated with blood/OPIM.
• Protective measures to minimize risk of occupational exposure.
• Information on appropriate actions to take if exposure occurs.

Retraining is required annually, or when changes in procedures or tasks affecting occupational exposure occur. Employees must be provided access to a qualified trainer during the training session to ask and have answered questions as questions arise.

All employees whose jobs involve participation in tasks or activities with exposure to blood/OPIM must be offered the first of the hepatitis B vaccination series within 10 working days of employment and/or new assignment. The vaccination will be provided free of charge. Serologic testing after vaccination (to ensure that the vaccination was effective) is recommended for all persons with ongoing exposure to sharp medical devices.

Universal and Standard Precautions

Universal Precautions, as defined by CDC, is a system designed to prevent transmission of bloodborne pathogens in healthcare and other settings. Under Universal Precautions, healthcare personnel are to assume that the blood and other body fluids from all patients are potentially infectious, and therefore they should always follow infection-control precautions in all settings.

Standard Precautions is a newer system that hospitals and other agencies are moving toward. It includes all recommendations for Universal Precautions plus body substance isolation (BSI) when OPIM are present.

Meticulous adherence to Universal Precautions is recommended by CDC for the care of all patients and mandated by OSHA.

Universal and Standard Precautions involve the use of protective barriers, defined below in the "personal protective equipment" section, to reduce the risk of exposure of the employee's skin or mucous membranes to OPIM. It is also recommended that all healthcare workers take precautions to prevent injuries caused by needles, scalpels, and other sharp instruments or devices.

Gloves, masks, protective eyewear and chin-length plastic face shields are examples of personal protective equipment (PPE). PPE shall be provided and worn by employees in all instances where they will or may come into contact with blood or OPIM. This includes, but is not limited to, dentistry, phlebotomy, or processing of any bodily fluid specimen, and postmortem (after death) procedures.

Universal Precautions include wearing the following PPE.

GLOVES

• When working with blood, blood products, semen, vaginal secretions, and any other potentially contaminated body fluids, such as cerebrospinal fluid, amniotic fluid, and saliva, as well as any items or surfaces in contact with the aforementioned fluids
• When touching mucous membranes or breaks in the skin
• When performing or assisting with any invasive procedures, such as venipuncture, surgery, or repair of traumatic injury
• When working in situations where hand contamination may occur, such as with an uncooperative or aggressive patient
• When you have cuts, scratches or other breaks in the skin

Change gloves after each client.

Latex gloves are recommended when dealing with blood or OPIM. However, people with allergies to latex must be provided with nitrile, vinyl, or other glove alternatives that meet the definition of "appropriate" gloves.

MASKS, GOGGLES, FACE SHIELDS, AND GOWNS

• During all invasive procedures and any procedure in which blood or body fluids may spatter or become airborne.
• During procedures where heavy bleeding or other extensive fluid (such as peritoneal fluid) loss may occur, a disposable plastic apron or gown and boots are also recommended.

Reusable PPE must be cleaned and decontaminated, or laundered by the employer. Lab coats and scrubs are generally considered to be worn as uniforms or personal clothing. When contamination is reasonably likely, protective gowns should be worn. If lab coats or scrubs are worn as PPE, they must be removed as soon as practical and laundered by the employer.

Universal Precautions also include frequent handwashing with warm water and soap (or a waterless alcohol based hand rub):

• Between clients
• Immediately after gloves are removed, even if they appear to be intact
• Immediately, if contaminated with blood or other body fluids to which Universal Precautions apply
• Upon leaving the work area
• Before and after using restroom facilities

People who have been exposed to body fluids should wash their hands before as well as after using the toilet. A pump-type liquid soap is preferable to bar hand soap. A waterless handwashing product should be made available for immediate use if a suitable sink is not readily available in the home or work setting.

Soap-and-water hand washing must be performed whenever hands are visibly contaminated or there is a reasonable likelihood of contamination. Proper soap and water hand washing technique involves the following:

• Using soap, warm (almost hot) water, and good friction, scrub the top, back, and all sides of the fingers.
• Lather well and rinse for at least 10 seconds. When rinsing, begin at the fingertips, so that the dirty water runs down and off the hands from the wrists. It is preferable to use a pump-type of liquid soap rather than bar soap.
• Dry hands on paper towels. Use the dry paper towels to turn off the faucets. Don't touch the faucets with clean hands.

It is advisable to keep fingernails short and wear as little jewelry as possible. Additional information on hand hygiene can be found in the Wild Iris course, Wash Hands, Save Lives.

SHARPS DISPOSAL

Needles are not to be recapped, purposely bent or broken, removed or otherwise manipulated by hand. After they are used, disposable syringes, needles, and scalpel blades are to be immediately placed in puncture-resistant, labeled containers for disposal.

Phlebotomy needles must not be removed from holders unless required by a medical procedure. The intact phlebotomy needle/holder must be placed directly into an appropriate sharps container.

Bar caregivers with weeping dermatitis (such as poison ivy or poison oak) or exudative lesions from all patient care and/or handling of patient care equipment or supplies. Adhere to agency protocols for disposal of infectious waste.

HOUSEKEEPING

The work area of the facility is to be maintained in a clean and sanitary condition. The employer is required to determine and implement a written schedule for cleaning and disinfection, based on the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed. All equipment and all environmental and working surfaces must be properly cleaned and disinfected after contact with blood or OPIM.

Potentially contaminated broken glassware must be removed using mechanical means, like a brush and dustpan or vacuum cleaner. Specimens of blood or OPIM must be placed in a closeable, labeled or color-coded leak-proof container prior to being stored or transported.

DISINFECTANTS

Chemical germicides and disinfectants in recommended dilutions must be used to decontaminate spills of blood and other body fluids. Consult the Environmental Protection Agency (EPA) for lists of registered sterilants, tuberculocidal disinfectants, and antimicrobials with HIV/HBV efficacy claims to verify that the product used is appropriate. Lists are available from EPA at http://www.epa.gov/oppad001/list_a_sterilizer.pdf

LAUNDRY

Laundry that is or may be soiled with blood/OPIM and/or may contain contaminated sharps must be treated as contaminated. Contaminated laundry must be bagged at the location where it was used, and shall not be sorted or rinsed in patient-care areas. It must be placed and transported in bags that are labeled or color-coded (red-bagged) as required.

Laundry workers must wear protective gloves and other appropriate personal protective clothing when handling potentially contaminated laundry. All contaminated laundry must be cleaned or laundered so that any infectious agents are destroyed.

WASTE DISPOSAL

All infectious waste must be placed in closeable, leak-proof containers or bags that are color-coded (red-bagged) or labeled as required by agency protocols to prevent leakage during handling, storage, and transport.

TAGS AND LABELS

Tags or labels must be used as a means to prevent accidental injury or illness to employees who are exposed to hazardous or potentially hazardous conditions, equipment, or operations that are out of the ordinary, unexpected, or not readily apparent. Tags must be used until the identified hazard is eliminated or the hazardous operation is completed.

All required tags must meet the following specifications:

• Tags must contain a signal word or symbol and a major message.
• The signal word shall be "BIOHAZARD," or the biological hazard symbol (below).
  
• The signal word must be readable at a minimum of five feet or such greater distance as warranted by the hazard.
• The tag's major message must be presented in either pictographs, written text, or both.
• The signal word and the major message must be understandable to all employees who may be exposed to the identified hazard.
• All employees will be informed as to the meaning of the various tags used throughout the workplace and what special precautions are necessary.

PERSONAL ACTIVITIES

Chemical germicides and disinfectants in recommended dilutions must be used to decontaminate spills of blood and other body fluids. Consult the Environmental Protection Agency (EPA) for lists of registered sterilants, tuberculocidal disinfectants, and antimicrobials with HIV/HBV efficacy claims to verify that the product used is appropriate. Lists are available from EPA at http://www.epa.gov/oppad001/list_a_sterilizer.pdf.

POST EXPOSURE MANAGEMENT

Risks for Transmission to Healthcare Workers

In 2003, CDC reported that "57 healthcare personnel in the United States have been documented as having seroconverted to HIV following occupational exposures. Twenty-six have developed AIDS. In addition, 139 other cases of HIV infection or AIDS have occurred among healthcare personnel who have not reported other risk factors for HIV infection and who report a history of occupational exposure to blood, body fluids, or HIV-infected laboratory material, but for whom seroconversion after exposure was not documented" (CDC, 2003).

An occupational exposure is defined as a percutaneous injury (eg, a needlestick or cut with a sharp object) or contact of mucous membrane or non-intact skin (eg, exposed skin that is chapped, abraded, or afflicted with dermatitis) with blood, tissue, or other potentially infectious materials (OPIM).

According to CDC, the risk of infection varies case by case. Factors affecting the risk include: whether the exposure was from a hollow-bore needle or other sharp instrument; to non-intact skin or to mucous membranes (such as eyes, nose and/or mouth); amount of blood involved and the amount of virus present in the source's blood.

The risk of developing HIV infection from a needle stick with infected blood is about 1:300 without prompt antiretroviral treatment, and the risk increases with deep punctures, hollow-bore needles, visible blood on the needle, and high virus load in the source. The risk after a mucous membrane exposure is about 1:1000. The risk of HIV transmission after nonintact skin exposure is estimated to be less than the risk for mucous membrane exposure.

The CDC recommends that postexposure prophylaxis (PEP) begin as soon as possible, within 24 hours after the exposure, and no later than 7 days (CDC, 2005). Animal studies indicate that cellular HIV infection occurs within 2 days of exposure to HIV. Virus in blood is detectable within 5 days. Therefore, prompt initiation of PEP is essential and should be continued for 28 days. PEP for HIV does not prevent other bloodborne diseases such as HBV or HCV.

The risk of HBV infection from a needlestick is 22 to 31 percent if the source person tests positive for hepatitis B surface antigen (SBsAg) and hepatitis Be antigen (HBeAg). If the source person is HBsAg positive and HBeAg negative, there is a 1 to 6 percent risk of getting HBV unless the person exposed has been vaccinated.

The risk of HCV infection from a needlestick is 1.8 percent. The risk of getting HBV or HCV from a blood splash to the eyes, nose or mouth is possible but believed to be very small. As of 1999, about 800 healthcare workers a year are reported to be infected with HBV following occupational exposure. There are no exact estimates of how many healthcare workers contract HCV from occupational exposure, but the risk is considered to be low.

Source testing does not eliminate the need for baseline testing of the exposed individual for HIV, HBV, HCV and liver enzymes. Initiating PEP should also not be contingent upon the results of a source's test. Current recommendations are to provide immediate PEP in certain circumstances, with possible discontinuation of treatment based on the source's test results. For more about source testing, see "Testing Without Informed Consent" in Part 6, Legal and Ethical Issues.

PEP is not as simple as swallowing a single pill. The medications must be started as soon as possible and continued for 28 days. The antiviral drugs uses in PEP are potentially toxic and should not be used for exposures that pose a negligible risk. CDC recommends consultation with an infectious disease consultant or another physician experienced with antiretroviral drugs; however, consultation "should not delay timely initiation of PEP."

Hepatitis B vaccine is available for HBV exposure. There is no vaccine for hepatitis C and no treatment that will prevent infection. Immune globulin is not advised for HCV exposure. Medical counseling is recommended regarding personal risk of infection or risk of infecting others.

Care at Home or in Home-Like Settings

Healthcare professionals who care for patients at home or in home-like settings should practice good hygiene techniques in preparing food, handling body fluids, and using medical equipment. Cuts, accidents, or other circumstances can result in spills of blood/OPIM on carpeting, vinyl flooring, clothing, skin, or other surfaces. Everyone, even young children, needs to have a basic understanding that they should not put their bare hands in or on another person's blood.

GLOVES

Gloves (latex or vinyl—or nitrile, in the case of latex allergy) should be worn in the following situations:

• When you anticipate contact with any body substance (blood/OPIM
• When you anticipate contact with any nonintact skin

At the end of a procedure, gloves should be carefully pulled off, inside-out, one at a time, so the contaminated surfaces are inside, preventing any contact with any potentially infectious material.

Gloves are not necessary for general care, or during casual contact (serving food, bathing intact skin). Gloves should be changed and hands washed as soon as possible after care of each patient. Never rub the eyes, mouth, or face while wearing gloves. Latex and other disposable gloves should never be washed and reused.

HANDWASHING

Correct handwashing is critically important. Good handwashing technique includes these elements:

• Using soap, warm (almost hot) water, and good friction, scrubbing the top, back, and all sides of the fingers.
• Lathering well and rinsing for at least 10 seconds. When rinsing, begin at the fingertips so the dirty water runs down and off the hands from the wrists. A pump-type liquid soap is preferable to bar hand soap.
• Dry hands on paper towels. Use a dry paper towel to turn off the faucets (don't touch the faucets with clean hands).
• Waterless handwashing product should be made available for immediate use if a suitable sink is not readily available. This does not replace proper handwashing with soap and water.

People who have been exposed to body fluids should wash their hands before as well as after using the toilet. The paper towel used to dry the hands may also be used to open the bathroom door, if necessary, before disposing of the towel.

PERSONAL HYGIENE ITEMS

People should not share razors, toothbrushes, personal towels or washcloths, dental hygiene tools, vibrators, enema equipment, or other personal care items.

CLEANING BLOOD/OPIM FROM SKIN SURFACES

Wear appropriate gloves when cleaning blood from skin surfaces. Use sterile gauze or other bandages and follow normal first-aid techniques to stop the bleeding. After applying the bandage, remove the gloves slowly so fluid particles do not splatter or become aerosolized. Hands should be washed using proper technique as soon as possible.

CLEANING BODY FLUID SPILLS ON VINYL FLOORS

Broken glass should be swept up using a broom and dustpan (never bare hands!). Empty dustpans into a well-marked plastic bag or heavy-duty container. Pretreat the body fluid spill with full-strength liquid disinfectant or detergent and then wipe it up with either a mop and hot soapy water or appropriate gloves and paper towels. Dispose of paper towels in the plastic bag.

Use a disinfectant such as household bleach 5.25% freshly mixed with water (1 part bleach to 10 parts water) to disinfect the area where the spill occurred. If a mop was used for cleaning, soak it in a bucket of hot water and disinfectant it for the recommended time. Empty mop water in the toilet, not the sink. Sponges and mops used to clean up body fluid spills should not be rinsed in the kitchen sink or in a location where food is prepared.

CLEANING BODY FLUID SPILLS ON CARPETING

Pour dry kitty litter or other absorbent material on the spill to absorb the body fluid. Then pour full-strength liquid detergent on the carpet to help disinfect the area. Any broken glass should be swept up with the kitty litter, using a broom and dustpan.

Carefully pour carpet-safe liquid disinfectant on the contaminated carpeting and leave it there for the amount of time indicated in manufacturer's instructions. Using sturdy rubber gloves, blot the spill with paper towels until it is absorbed. Vacuum normally afterward.

Any debris, paper towels, or soiled kitty litter should be disposed of in a sealed plastic bag that has been placed inside another plastic garbage bag. Twist and seal the top of the second bag as well.

CLOTHING AND OTHER LAUNDRY

Clothes, washable uniforms, towels, or other laundry stained with blood/OPIM should be washed and disinfected before further use. If possible, have the patient remove the clothing, or use appropriate gloves to assist with removing the clothes.

If the washing machine is not close by, transport the soiled items in a sturdy plastic bag. Then place the items in the washing machine and soak or wash them in cold, soapy water to remove any blood from the fabric.

Hot water will permanently set blood stains. Use hot water for the next washing cycle and include detergent, which will act as a disinfectant. Dry the items in a clothes dryer. Wool clothing or uniforms may be rinsed with cold soapy water, then dry cleaned to remove and disinfect the stain.

DIAPER CHANGES

Use a new pair of gloves to change diapers. Discard disposable diapers in an appropriate plastic bag or receptacle, along with gloves. Wash hands immediately after changing the diaper. Disinfect the diapering surface. Wash cloth diapers in very hot water with detergent and a cup of bleach, and dry them in a hot clothes dryer.

TOILET AND BEDPAN SAFETY

It is safe to share toilets/toilet seats without special cleaning, unless the surface becomes contaminated with blood/OPIM. If this occurs, spray the surface with a solution of 1 part bleach and 10 parts water. Wearing gloves, wipe the seat dry with disposable paper towels.

Persons with open sores on their legs, thighs, or genitals should disinfect the toilet seat after each use. Urinals and bedpans should not be shared between family members unless these items are thoroughly disinfected after each person's use.

THERMOMETERS

Electronic thermometers with disposable covers do not need to be cleaned between users unless visibly soiled. Wipe the surface with a disinfectant if necessary. Glass thermometers should be washed with soap and warm water before and after each use. If the thermometer will be shared among family members, it should be soaked in 70% to 90% ethyl alcohol for 30 minutes, then rinsed under a stream of warm water after each use.

Glass thermometers pose an additional hazard because they contain mercury, which is a potent neurotoxin. Broken thermometers and their contents should be treated as hazardous waste and disposed of appropriately. Never touch mercury with bare hands.

FOOD PREPARATION

Kitchens can harbor bacteria that may prove life-threatening to a person with HIV/AIDS. Use the following precautions during food preparation and clean-up:

• Wash hands thoroughly before preparing food.
• Use a clean spoon to taste food and wash the spoon after each taste.
• Avoid unpasteurized milk, raw eggs or products that contain raw eggs, cracked or nonintact eggs, and raw fish. Cook all meat, eggs, and fish thoroughly to kill any organisms that may be present. Wash fruits and vegetables thoroughly.
• Disinfect countertops, stoves, sinks, refrigerators, door handles, and floors regularly. Use window screens to keep out insects.
• Discard food that has expired or is past a safe storage date, shows signs of mold, or smells bad.
• Use separate cutting boards for meat and for fruits and vegetables. Disinfect cutting boards.
• Keep kitchen garbage in a leak-proof washable receptacle that is lined with a plastic bag. Seal the garbage liner bags and change bags frequently.

SAFE AND LEGAL DISPOSAL OF SHARPS

Syringes, needles and lancets are called "sharps" and their disposal is regulated. Sharps can carry hepatitis, HIV and other bacteria and viruses that cause disease. Throwing them in the trash or flushing them down the toilet can pose health risks for others—such as sanitation (garbage) workers, other utility workers, and the public—from needle sticks and illness. Rules and disposal options vary according to circumstance so it is essential to check with your local health department to see which option applies to your situation.

Used syringes that are carelessly tossed aside in parks, on roadsides, in laundromats and other public places present a potential risk for accidental scratches or punctures. Risk for infection from these items depends on how long they were left out, the presence of blood or other body fluid, and the type of injury sustained (scratch vs. puncture). The risk of HIV infection to a healthcare worker from a needle stick containing HIV-positive blood is about 1 in 300 (CDC).

Parents and caregivers should make sure that children understand never to touch a found needle or syringe, but to immediately ask a responsible adult for help.

Anyone with an accidental needle stick requires a prompt assessment by a medical professional. The professional should make certain that the injured person has been vaccinated against hepatitis B and tetanus. Testing for HIV, HCV and HBV may also be recommended. If someone finds and handles a syringe, but no needlestick occurs, testing for HIV is not necessary.

Safe disposal of found syringes should follow these guidelines:

• Do not pick up a found syringe or needle with your bare hands. Use gloves and tongs, shovel or a broom and dustpan to pick it up. Hold the needle away from your body.
• Do not break the needle off from the syringe. Do not flush needles or syringes down the toilet!
• Place used sharps and syringes in a safe container: one with at least a one-inch opening and a lid that will seal tightly. An empty plastic laundry detergent container, shampoo, pickle, oil or similar bottle or jar will work. If a glass jar is used, place it in a larger plastic bucket or container that has a tight-fitting lid. Soda cans are not good containers to use because people often try to recycle discarded cans.
• Carefully place the needle or syringe into the bottle or jar and seal the lid tightly. Tape it shut for added safety, and label it with the warning: "SHARPS, DO NOT RECYCLE!" The container should be placed well out of reach of children.
• Call your local health department to determine what disposal sites are available to you.

PET CARE

Certain animals can pose hazards for people with compromised immune systems. These animals include turtles, reptiles, birds, puppies and kittens under the age of eight months, wild animals, and pets without current immunizations or with illnesses of unknown origin.

Pet cages and cat litter boxes can harbor infectious organisms that may become aerosolized. These items should be cared for by someone who is not immunocompromised. If this is not possible, a mask with a sealable nose clip and disposable latex gloves should be worn each time pet care is done. All pet care should be followed by thorough handwashing.

Pets can spread disease by licking their person's face or open wounds. Wash hands after stroking or other contact with pets. Cats' and dogs' nails should be kept trimmed. Wear latex or nitrile gloves to clean up any pet urine, feces, vomit, or OPIM. Clean the soiled area with a fresh solution of 1:10 bleach.

Pet food and water bowls should be washed regularly in warm soapy water and rinsed clean. Cat litter boxes should be emptied and washed regularly. Fish tanks should be kept clean. Heavy latex "calf-birthing" gloves can be purchased from a veterinarian for immunocompromised individuals to wear to clean the fish tank.

Do not let pets drink from the toilet, or eat other animal feces, any type of dead animal, or garbage. Restrict cats indoors. Dogs should be kept indoors or on a leash. Many communities have volunteer groups and veterinarians who will assist people with HIV/AIDS in taking care of their pets if needed. Questions can be directed to a local veterinarian.

THE PROCESS OF TESTING

Most HIV infections are transmitted by people who do not know they are infected. Too often this means simultaneous diagnosis of HIV and AIDS, plus a decade or more of exposure for uninfected partners. Therefore, HIV testing is the first step in halting spread of the virus.

People unaware of their HIV infection have a transmission rate of almost 11 percent compared with a rate of less than 2 percent in those who know they are HIV-positive. When counseling services are available and effective, that rate falls to near zero (Holtgrave & Anderson, 2004).

New CDC prevention initiatives to increase HIV testing have met with some resistance from the advocacy community. However, health professionals support increased testing as the only way to reduce the number of new infections. Research indicates that routine voluntary screening is cost effective (Paltiel et al., 2005).

The revised CDC recommendations for voluntary HIV screening of patients in all healthcare settings include the following:

• Notify the patient that testing will be performed unless he or she declines (opt-out screening).
• Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.
• Persons at high risk for HIV infection should be screened for HIV at least annually.
• Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in healthcare settings.

Confidential and Anonymous Testing

Confidential HIV testing means that the patient gives his or her real name to the healthcare provider and test results are revealed only to the patient and to the health provider or counselor who tests or provides services to that patient. Those who perform HIV counseling and testing in public health departments or health districts must sign strict confidentiality agreements. These agreements regulate the personal information that may be disclosed in counseling and testing sessions and in test results.

HIV test results are kept in locked files, with only a few appropriate staff members having access to them. Positive HIV tests must be reported to local public health officials, however. More information on confidentiality requirements can be found under Legal and Ethical Issues.

Anonymous HIV testing means that the health professional who orders or performs the test does not maintain a record of the name of the person being tested. Public health departments must make anonymous HIV testing reasonably available. Anonymous testing may also be available through Planned Parenthood or other healthcare clinics.

INFORMED CONSENT

HIV testing can only be done with a person's specific informed consent, with rare exceptions. These exceptions may include source testing relating to occupational exposures and legally mandated situations. (See Legal and Ethical Issues, below.)

Consent may be contained within a comprehensive consent for medical treatment. However, before HIV testing is performed, patients must be explicitly told that this test is recommended and agree to HIV testing. Receipt of consent must be documented, either in the patient's regular medical record, in another record of services provided, or by written consent. Verbal consent is often used in anonymous testing situations.

Unless the person has been previously tested for HIV and declines receipt of information, all individuals to be tested for HIV should be informed about:

• The benefits of learning HIV status and the potential dangers of the disease
• The ways in which HIV is transmitted and ways in which it can be prevented
• The meaning of HIV test results and the importance of obtaining test results
• As appropriate, the availability of anonymous HIV testing and the differences between anonymous and confidential testing.

Both HIV and AIDS are reportable. For additional information on reporting requirements and informed consent, see Legal and Ethical Issues below.

HOW AND WHERE TO GET TESTED

HIV/AIDS testing is available in a variety of settings:

• Home
• Public health departments
• Medical providers
• Family planning clinics
• STD clinics
• Some community clinics

WHO SHOULD BE TESTED

Pregnant Women

The 2006 CDC recommendations for pregnant women including the following changes:

• HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women.
• HIV screening is recommended after the patient is notified that testing will be performed unless the patient declines (opt-out screening).
• Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.
• Repeat screening in the third trimester is recommended in certain jurisdictions with elevated rates of HIV infection among pregnant women.

If a pregnant woman refuses a confidential test, her reasons for refusal, as well as the provision of education on the benefits of HIV testing, should be discussed and documented in the medical record.

If screening suggests a high risk of HIV, the provider should provide or refer for behavioral change counseling, women who

• Have or recently had a sexual partner(s) known to be HIV infected or to be a man who has sex with other men or who is an injection drug user
• Use or have recently used injection drugs
• Have signs or symptoms of HIV seroconversion
• Have recently exchanged sex for drugs or money or had an STD or multiple sex partners, or
• Express a need for further more intensive counseling

Behavioral change counseling should be based on the CDC recommendations in Revised Guidelines for HIV Counseling, Testing and Referral, and Revised Recommendations for HIV Screening of Pregnant Women, November 9, 2001.

The provider should also offer referrals and provide follow-up to other necessary medical, social, and HIV prevention services.

Patients Seeking Treatment of an STD

Principal healthcare providers must counsel or ensure AIDS counseling and offer and encourage HIV testing for each patient seeking treatment of a sexually transmitted disease (STD).

Survivors of Sexual Assault or Abuse

Survivors of rape (sexual assault) are at risk for infection with HIV and other sexually transmitted diseases. Each year more than 300,000 women and 93,000 men are sexually assaulted in the United States, nearly half of them under age 18 (Tjaaden & Thoennes, 2006). The CDC estimates that the risk of HIV infection from a sexual assault in the United States is 2 in 1,000. The risk of infection with other STDs is higher, and females have the added risk of pregnancy.

The probability of HIV transmission during a single act of intercourse with an HIV-infected person depends on many factors. In specific circumstances it could be high. These factors include: type of intercourse (oral, vaginal, anal); presence of oral, vaginal, or anal trauma (including bleeding); site of exposure to ejaculate; viral load in ejaculate; and presence of an STD or genital lesions in the assailant or survivor.

Sexual assault also puts adolescent girls and women at risk of becoming pregnant so emergency contraception is part of the medical protocol for female rape survivors. A sexual assault survivor should go directly to the nearest hospital emergency department (ED) without changing clothing and without bathing or showering, which might remove evidence that could incriminate the assailant. Trained ED staff will counsel the victim and also offer testing or referral for HIV, STDs, and pregnancy.

Testing the survivor of sexual assault for HIV immediately after the event can establish that the survivor was not infected at the time of the assault. However, it is important to consider the "window period" and retest later if the assailant proves to be HIV-positive. In the rare cases that an assault survivor is infected by the assault, the earlier test can serve as evidence in criminal court.

The standard protocol is for the ED physician to take DNA samples of blood or semen from the vagina, rectum, or elsewhere, as indicated, which can be used as evidence for legal and criminal action. Some emergency departments may refer sexual assault survivors to the local health jurisdiction for HIV testing.

Questioning sexual assault survivors in the ED about their sexual risks can be difficult and unpleasant. However, testing shortly after a sexual assault provides useful baseline information on the various infections—especially for follow-up care and treatment.

Children may be at higher risk for HIV transmission from sexual assault because child sexual abuse is often associated with multiple episodes of assault and may result in mucosal trauma. The CDC has identified certain situations involving high risk for STD transmission to children, including HIV, and these constitute a strong indication for testing:

• The child has or has had symptoms or signs of an STD or of an infection that can be sexually transmitted, even in the absence of suspicion of sexual abuse. Signs that may be associated with a confirmed STD diagnosis are vaginal discharge or pain, genital itching or odor, urinary symptoms, and genital ulcers or lesions.
• A suspected assailant is known to have an STD or to be at high risk for STDs (has multiple sex partners, a history of STDs).
• A sibling or another child or adult in the household or immediate environment has an STD
• The patient or parent requests testing
• The prevalence of STDs in the community is high
• Evidence of genital, oral, or anal penetration or ejaculation is present

THE DIAGNOSTIC TESTS

HIV testing is a two-step process that includes a screening test and, when the screening test is reactive (positive), a confirmatory test.

Rapid Tests

Until 2002, testing for HIV antibodies relied on an enzyme-linked immunosorbent assay (EIA) of blood, a test that must be performed in a clinical laboratory and results take up to three weeks. However, four rapid HIV tests have been approved by the FDA, all of which are interpreted visually. Two of the tests are approved for use at in care settings outside a clinical laboratory.

• OraQuick Advance HIV-1/2 Antibody Test, which detects HIV-antibodies in blood in only 20 minutes. A version approved in 2004, detects both HIV-1 and HIV-2 in oral fluid.
• Uni-Gold Recombigen HIV Test, which detects HIV-1 antibodies in whole blood, serum and plasma, and results take from 10 to 12 minutes.
• Reveal G2 Rapid HIV-1 Antibody Test, which detects HIV antibodies in serum or plasma. Although the test takes only 3 minutes to run, it is categorized as a moderately complex test and is usually done in a clinical laboratory.
• Multispot HIV-1/HIV2 Rapid Test, uses fresh or frozen serum and plasma to detect HIV-1 and HIV-2, and distinguish one from the other. Results are available in 20 minutes. Also a moderately complex test, it is usually done in a clinical laboratory. (Greenwald et al., 2006)

Until rapid tests became available, many people tested in public clinics did not return to get their test results. Making results available during the testing appointment means that people can take precautions immediately to prevent transmission to their sexual partners. In addition, the oral fluid test offers another option for those people who may fear a blood test.

All reactive rapid HIV test results require confirmatory testing. The CDC (2004) protocols for confirming reactive rapid HIV tests recommend: (1) confirmation of all reactive rapid HIV test results with either Western blot (WB) or immunofluorescent assay (IFA), even if an enzyme immunoassay (EIA) screening test is negative; and (2) follow-up testing for individuals who get negative or indeterminate confirmatory test results, with a blood specimen collected 4 weeks after the initial reactive rapid test result.

To ensure accuracy of test results, all laboratory testing is regulated under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), which classifies tests according to their complexity. Tests that use direct, unprocessed specimens such as whole blood or oral fluid, are easy to perform and have a negligible chance of error may receive a CLIA waiver. This waiver permits personnel without training in laboratory procedures to perform the tests outside a traditional laboratory setting.

The OraQuick and Uni-Gold tests have received a CLIA waiver, but the other two rapid tests mentioned above must be performed in laboratories that meet more stringent standards for personnel, supervision, quality assurance, and proficiency testing.

HIV antibody testing usually relies on an enzyme-linked immunosorbent assay (EIA), which over-predicts positives. Consequently, a negative HIV antibody test is considered definitive and no further testing is required. If the results are positive, however, some states prohibit telling a person he or she is HIV-positive based only on EIA test results. This law reflects CDC recommendations.

Confirmatory Tests

WESTERN BLOT

If a person has three reactive (positive) EIA tests on the same blood sample, a separate confirmatory test is required, commonly a Western Blot test, which is considered more definitive. The HIV Western Blot detects antibodies to individual proteins that make up HIV. This test is much more specific, and more expensive, than the EIA screening tests.

URINE HIV

A test to detect HIV antibodies in the urine is available for use only in doctors' offices or medical clinics. Even though HIV antibodies can be detected in urine, urine is not considered a viable medium for transmitting the virus. A positive urine HIV test must be confirmed with a Western Blot test, which can be done on the same specimen.

Reporting Test Results

CDC (2004) recommends that clients tested with rapid HIV tests be advised that their preliminary results will be available in the same visit, and that confirmatory testing will be needed if the rapid test result is positive. In addition, retesting within 3 months should be recommended even if the rapid test result is negative.

HIV test results can be one of three types: negative, positive, or indeterminate. A person may test negative for HIV antibodies even though recently infected. As stated earlier, newly infected persons may have high levels of the virus in their blood, making them extremely infectious even though test results are negative.

NEGATIVE TEST RESULTS

If the confirmatory test result is negative, it means either (1) the person is not infected with the virus (the rapid HIV test was probably false positive), or (2) the person became infected recently and antibodies have not yet appeared. Additional testing is recommended as follows:

• If the original confirmatory test specimen was a blood specimen, repeat the confirmatory test with a new blood specimen to rule out specimen mix-up.
• If the original confirmatory test specimen was an oral fluid specimen, repeat the confirmatory test using a blood specimen.

POSITIVE TEST RESULTS

A positive test result shows the presence of HIV antibodies, which means that:

• The person is infected with HIV
• The person can transmit the virus to others through unsafe sexual practices, sharing contaminated injection equipment, and/or breastfeeding
• The person is infected for life

INDETERMINATE TEST RESULTS

Occasionally a rapid test or an EIA test will show an "indeterminate" or "inconclusive" test result. This may mean that the person is recently infected and is developing antibodies, a process called "sero-conversion." Indeterminate test results can also be caused by other factors, including but not limited to pregnancy, autoimmune diseases, blood transfusions, recent influenza vaccinations, or organ transplants.

• If the confirmatory test is indeterminate, based on a blood specimen, advise the client to return for repeat testing in one month and at three months from the last possible exposure to verify that they are not infected.
• If the confirmatory test is indeterminate, based on an oral fluid specimen, repeat the confirmatory test using a blood specimen.
• If the repeat blood specimen confirmatory test is also indeterminate, advise the client to return for repeat testing in one month.

Research has shown that only about 20 percent of people with indeterminate test results go on to become truly HIV positive. Only rarely do people remain indeterminate throughout their lives.

Home Testing Kits

Tests are now available for self-testing of HIV serostatus. However, Home Access Express HIV-1 Test System is the only FDA-approved home test kit currently on the market, although a number of unapproved kits are marketed on the Internet. This product is really an in-home sample collection system rather than a test with readily visible results.

The person who wants to test at home pricks a finger, collects blood spots on special paper, and mails the paper to a certified clinical laboratory with a confidential and anonymous personal identification number (PIN), using a standard EIA process.

If the EIA test is positive, the results would be confirmed by a Western blot test. The person tested obtains the results by calling a toll-free telephone and using the PIN. Post-test counseling is available by telephone for everyone tested, whether the results are positive or negative.

Home testing is a controversial issue, primarily related to the question of counseling. FDA has expressed concern that persons who have not been appropriately counseled by experienced staff in a culturally competent way before they receive the news that they are HIV-positive may commit suicide.

Counseling needs to help reduce anxiety and risk-taking behavior as well as link individuals to services. One survey showed that nearly one-fourth of clients at public testing services would choose a home self-test (Skolnik et al., 2001).

Other Tests

p24 ANTIGEN

This blood test is used to measure a core protein of HIV that occurs during the acute infection period (the first few weeks, before antibodies appear). This protein may disappear as soon as HIV antibodies appear. The transitory nature of this protein and the expense of the test limit the usefulness of the p24 antigen test.

PLASMA HIV RNA or PROVIRAL DNA

These blood tests may be used in people with suspected new HIV infection. Their expense prohibits the use of these tests as screening tests for the general public. However, anyone who has had a potential exposure to HIV through unprotected sex or sharing needles, and who presents with symptoms of primary infection (usually seen within the first two weeks of infection), should consult their healthcare professional about this test.

HIV VIRAL LOAD

This test measures the amount of HIV in the blood of an infected person. It is seldom used to diagnose HIV infection; rather, it is used to measure the effectiveness of antiretroviral medications that treat HIV infection.

COUNSELING

All testing offers an opportunity for counseling patients. If test results are negative, counseling efforts focus on avoiding exposure to HIV through safer sex practices and no needle sharing. If results are positive, counseling focuses on preventing transmission of the virus to others and referring the patient to resources for treatment, education, and support.

Risk Assessment

A client's individual HIV risk can be determined through risk screening based on self-reported behavioral risk and clinical signs or symptoms. Behavioral risks include injection drug use or unprotected intercourse with a person at increased risk for HIV. Clinical signs and symptoms include those suggestive of HIV infection and other STDs.

Behavioral risks can be identified either through open-ended questions by the provider or through screening questions (ie, a self-administered questionnaire).

An example of an open-ended question is "What are you doing now or what have you done in the past that you think may put you at risk of HIV infection?"

Examples of screening questions are: "Since your last HIV test (if ever) have you:

• Injected drugs and shared equipment such as needles, syringes, cotton, water with others?"
• Had unprotected intercourse with someone who you think might be infected?"
• Had unprotected vaginal or anal intercourse with more than one sex partner?"

This is not a comprehensive list of risk screening questions.

Behavior Change Goals

The behavior change goals should be: (1) based on the individual's risk; (2) perceived as realistic by the patient; and (3) based on the person's readiness and capability to change behavior.

Depending on the person's readiness for change, counseling can be simple and brief or can be complex and lengthy. In many clinical practice settings, time restraints only permit brief and simple counseling.

As an example, for a patient who has yet to contemplate behavior change, a realistic goal might be helping patients recognize which behaviors place them at risk for HIV. Skill building could help the patient self-identify situations where the risk behavior is practiced.

Other patients may be further along the behavior change continuum and have identified specific behaviors they wish to change. Support for those identified changes is appropriate. A relevant goal might be to identify barriers to the behavior change and help the patient self-identify solutions. Demonstrating how to use a condom or how to discuss condom use with a new partner could be examples of building skills.

For those patients who have complex needs beyond the provider's counseling skills or time available, referral to other resources should be arranged.

Pretest Counseling

Any person who requests pre-test counseling and anyone defined as at increased risk for HIV should be offered or referred for pre-test counseling. Anyone declining pre-test counseling should not later be denied HIV testing. If the provider determines the individual is at high risk for HIV infection, counseling should be based on assessment of the individual client as outlined above.

Post Test Counseling

All individuals tested for HIV should be offered an opportunity to receive post-test counseling. The goals of post-test counseling are to increase the individual's understanding of HIV infection, change the individual's behavior, and, if necessary, encourage the individual to notify people with whom there has been contact capable of transmitting HIV.

Positive HIV test results must be reported confidentially to the state or local health officer, unless the individual has been tested anonymously. People who test positive should be reminded about this legal reporting requirement.

If a person who tests positive for HIV infection fails to return for test results, the healthcare provider should provide the local health officer with the name of the individual and any information that could help locate him or her. The health officer then follows up to assure that post-test counseling and partner notification assistance is provided.

Spouse/Partner Notification

Both federal and state laws require that a good-faith attempt be made to notify the spouse and partners of an HIV-infected individual. Spouse is defined as the person(s) in a marriage relationship with the infected person up to 10 years prior to the HIV test. Partner notification also includes sex and/or injection equipment–sharing partners.

Those who test positive for HIV should be given the choice to notify their partner(s), to allow the healthcare provider to notify the partner(s), or refer to the local health jurisdiction for assistance in notifying the partner(s). The principal healthcare provider may take responsibility for partner notification based on consultation with the local health officer.

Preconception Counseling

Both CDC and the American College of Obstetrics and Gynecology (ACOG) recommend offering all women of childbearing age the opportunity to receive preconception counseling and care as part of routine primary medical care. The goals are to improve the health of each woman before pregnancy by identifying risk factors that could lead to adverse maternal or fetal outcome, provide education and counseling appropriate to her individual needs, and treat or stabilize medical conditions to optimize maternal and fetal outcomes.

Health professionals who routinely care for HIV-positive women of childbearing age play an important role in promoting preconception health. Since many HIV-infected women are aware of their HIV status prior to becoming pregnant, there may be opportunities during routine medical care to address issues that affect pregnancy prior to conception.

All HIV-infected women of childbearing age should be screened for pregnancy at initial and subsequent visits and asked about interest in future pregnancy and use of contraceptives. Providers should be aware of potential interactions of antiretroviral drugs with hormonal contraceptives that could reduce the efficacy of oral contraceptives.

Counseling about safer sexual practices can help protect women from acquiring other STDs or more virulent or drug resistant HIV strains. Women should also be counseled to eliminate alcohol, illicit drug use, and cigarette smoking.

HIV-infected women who become pregnant should be counseled. Specific drug treatment information changes frequently and providers should consult the latest recommendations online at http://AIDSinfo.nih.gov (Public Health Service Task Force, 2007).

Injection Drug Users

Injection drug users (IDUs) should be referred for substance abuse treatment. Those who refuse treatment should be counseled to use once-only sterile syringes and not to share needles with others.

The trajectory between infection with HIV and the development of full-blown AIDS can be steep or gradual and may take as long as a decade or more. If the infection is untreated, the average time from HIV infection to death is 10 to 12 years. However, early detection and appropriate medical treatment may extend the lives of those infected and reduce the rates of HIV transmission.

STAGES OF HIV/AIDS

Some conditions, called co-factors, can affect the course of disease progression, including age, genetic factors, drug use, smoking, nutrition, and co-infection with HCV and/or TB. Although the slope of the disease trajectory varies with each individual, HIV/AIDS progresses through five stages:

1. Viral transmission, the initial infection with HIV, also called acute HIV infection. Persons may become infectious to others within days of transmission, before any symptoms appear. Once infected, a person is always infectious to others. During acute HIV infection, high levels of virus are circulating in the bloodstream. Symptoms are nonspecific and may include fever, swollen lymph glands, rash, fatigue, and sore throat. This is sometimes called "seroconversion syndrome" or "seroconversion sickness." Initial symptoms resolve in a few weeks but the person remains infectious for life.
2. Seroconversion, the time period from infection to the production of antibodies detectable on an HIV test, usually within 3 to 6 months of transmission.
3. Asymptomatic HIV infection, a variable time period, sometimes 10 years or longer, during which an HIV-infected person has no noticeable signs or symptoms and appears healthy, but can transmit the virus to others. Unless tested for HIV, the person is unaware of being infected.
4. Symptomatic HIV infection, the stage during which noticeable physical symptoms of HIV are present. The most common symptoms include:
• Persistent low-grade fever
• Pronounced weight loss not due to dieting (wasting syndrome)
• Persistent headaches
• Diarrhea lasting more than 1 month
• Difficulty recovering from colds and flu
• More acute illness than normal
• Recurrent vaginal yeast infections in women
• Oral thrush (candidiasis) coating the mouth or tongue
5. AIDS: Diagnosis of AIDS can be made only by a licensed healthcare provider. The diagnosis is based on the result of HIV-specific blood tests and the person's physical condition. In 1993 the CDC identified a list of "AIDS-defining illnesses," or "AIDS indicator conditions," white-blood-cell counts and other conditions that are specifically linked to making an AIDS diagnosis (see Box 5, below). Once diagnosed with AIDS, a person is always considered to have AIDS, even if general health status temporarily improves.

Over time, people with AIDS frequently have a reduced white-blood-cell count and deteriorating health. They also may have a significant amount of virus present in their blood (viral load).

As the HIV virus suppresses immune function, the infected person becomes more vulnerable to opportunistic infections caused by a wide variety of bacteria, viruses, fungi and other pathogens encountered in daily life. The physical results of these opportunistic infections are called clinical manifestations. For example, the opportunistic infection cytomegalovirus (CMV) often causes the clinical manifestation of blindness in people with AIDS.

MULTI-SYSTEM EFFECTS OF HIV/AIDS

HIV infection affects more than just the immune system. It also affects the cardiovascular, neurologic, and musculoskeletal systems as well as the body's basic metabolism. These effects can alter:

• The kind and number of blood cells
• The amount and distribution of fat and muscles in the body
• The structure and function of the brain
• The basic metabolism of the body

These multi-system effects can lead to many painful or disruptive conditions, including

• Confusion or dementia
• Vision or hearing loss
• Diarrhea, urinary or fecal incontinence
• Thrush (yeast infections in the mouth)
• Fatigue
• Fever
• Nausea or vomiting
• Painful joints, muscles, or nerve pain
• Difficult breathing
• Chronic pneumonias, sinusitis, or bronchitis
• Loss of muscle tissue and body weight.

HIV/AIDS imposes an additional burden on African Americans, according to a new study, which showed that the risk of end-stage renal disease (ERD) in HIV-infected black patients was 4 to 5 times greater than the risk of ERD in HIV-infected white patients (Choi et al., 2007).

Children infected with HIV/AIDS may have different reactions to the virus, its progression, and their virologic and immunologic response. Without drug treatment, children may be developmentally delayed, experience failure to thrive, pneumocystis jiroveci pneumonia, and recurrent bacterial infections. Antiretroviral treatments available for adults with HIV/AIDS may not be available in pediatric formulations, and may cause different side effects in children.

Fortunately, prenatal treatment of HIV-positive pregnant women has dramatically reduced the incidence of children infected with HIV. Early diagnosis of HIV in newborns allows treatment to begin soon after birth.

PROVIDING COMPREHENSIVE CARE

Optimal care of people with HIV/AIDS includes not only antiviral therapies, health maintenance, and referral to support services but also an emphasis on prevention of transmission to uninfected partners. According to CDC (2003), "Medical care providers can substantially affect HIV transmission by screening their HIV-infected patients for risk behaviors; communicating prevention messages; discussing sexual and drug-use behaviors; positively reinforcing changes to safer behavior; referring patients for services such as substance abuse treatment; facilitating partner notification, counseling, and testing; and identifying and treating other sexually transmitted diseases(STDs)."

CDC recommends that anyone with HIV/AIDS should use prevention strategies even if their partner is also HIV-infected. The partner may have a different strain of the virus that could behave differently in each individual or that could be resistant to different anti-HIV medications.

Implementing preventive strategies begins at the initial visit and continues throughout subsequent visits, or periodically, at least once a year. Care providers should use a straightforward, nonjudgmental approach and open-ended questions to screen and assess patient behaviors associated with HIV transmission. Other strategies include self-administered questionnaires, and computer-, audio-, or video-assisted questionnaires.

Initial and periodic screening for STDs should also be performed. At the initial visit, both men and women should have laboratory tests for syphilis. Women should also be screened for trichomoniasis, and women age 25 and younger should be screened for cervical chlamydia, the most common STD among women.

Screening for STDs should be repeated periodically if the patient is sexually active, particularly for chlamydia. Women younger than age 19 are often re-infected with chlamydia, probably by male partners who are not being diagnosed and treated because the disease is asymptomatic.

Medications

Antiretroviral treatment of people with HIV/AIDS continues to prove complex, controversial, dynamic, and expensive. Since 1996 a number of new drugs have helped improve survival and quality of life for people with HIV/AIDS. However, these drugs do not constitute a "cure" for HIV/AIDS. If therapy is discontinued, viral load will increase. Even during treatment, the virus is replicating and the person remains infectious to others.

Five major classes of drugs are used to treat HIV/AIDS:

• Nucleoside and nucleotide analogs
• Protease inhibitors
• Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
• Fusion inhibitors (FIs)
• Integrase strand transfer inhibitors*

*The first of these drugs, raltegravir (Isentress), was approved by FDA October 12, 2007. This class of drugs is designed to slow the progression of HIV by blocking the HIV integrase enzyme that the virus needs in order to multiply. Raltegravir has not been studied in pregnant women or children under the age of 16.

These antiretroviral drugs are administered in cocktails of three or more, a treatment referred to earlier as highly active antiretroviral therapy (HAART). Clearly, HAART has made a positive difference in people's lives, but long-term use of some of these drugs increase the risk of liver problems, high cholesterol, stroke, heart disease, osteoporosis, diabetes, pancreatitis, neuropathy, and skin rashes. Some of the skin rashes can be life-threatening, such as Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which are two different forms of the same kind of skin rash. TEN may involve as much as 30 percent of the total body skin area. Both these severe rashes must be treated by a physician.

Antiretroviral drugs may also interact with other drugs used to treat opportunistic infections. For example, researchers reported that using oral erythromycin while taking protease inhibitors increased the risk of sudden death from cardiac causes (Ray et al., 2004). Another antibiotic, amoxicillin, did not have the same effect. As patients live longer with HIV/AIDS, many develop drug-resistant strains of the virus, which further complicates treatment.

DRUG RESISTANCE TESTING

Use of multidrug HAART by many people over time has allowed drug-resistant strains of the virus to develop. An estimated one-half of patients receiving antiretroviral therapy are infected with viruses that are resistant to at least one of the available antiretroviral drugs (Clavel & Hance, 2004). These drug-resistant strains have also been found in patients who have never received antiretroviral therapy, which limits their treatment options at the outset.

The prevalence of drug-resistant strains of the virus has led to recommendations that pretreatment drug-resistance testing be done in persons with acute or chronic HIV infection, and when changing antiretroviral regimens after drugs cease to be effective (treatment failure).

Two types of resistance assays are used: genotypic and phenotypic assays. Genotypic assays detect drug resistance mutations in the viral genes, while phenotypic assays measure a virus's ability to grow in different concentrations of antiretroviral drugs. Genotypic assays take 1 to 2 weeks and phenotypic assays, 2 to 3 weeks. A genotypic assay is generally recommended for patients who have never had antiretroviral therapy.

INITIATING HAART

The optimal time to initiate therapy in asymptomatic individuals with >200 CD4⁺ cells (T cells) is not known. The following recommendation provides general guidance rather than absolute recommendations for an individual patient. All decisions to initiate therapy should be based on prognosis as determined by the CD4⁺ cell count and level of plasma HIV RNA, the potential benefits and risks of therapy, and the willingness of the patient to accept therapy.

In 1996 tests to measure an individual's viral load became available, providing objective criteria on which to base treatment decisions. Current treatment recommendations from the National Institutes of Health (2006) are:

• Antiretroviral therapy is recommended for all patients with history of an AIDS-defining illness or severe symptoms of HIV infection regardless of CD4⁺ T cell count.
• Antiretroviral therapy is also recommended for asymptomatic patients with <200 CD4⁺ T cells/mm³.
• Asymptomatic patients with CD4⁺ T cell counts of 201–350 cells/mm³ should be offered treatment.
• For asymptomatic patients with CD4⁺ T cell counts of >350 cells/mm³ and plasma HIV RNA >100,000 copies/ml most experienced clinicians defer therapy but some clinicians may consider initiating treatment.
• Therapy should be deferred for patients with CD4⁺ T cell counts of >350 cells mm³ and plasma HIV RNA <100,000 copies/mL.

HEALTH MAINTENANCE ON HAART

Once HAART therapy has begun, CDC recommends these goals of therapy:

• Maximal and durable suppression of viral load
• Restoration and/or preservation of immunologic function
• Improvement of quality of life
• Reduction of HIV-related morbidity and mortality.

Treatment guidelines are revised frequently, based on ongoing research findings. Complete information can be found at http://aidsinfo/nih.gov/ContentFiles/AdultandAdolescentGL.pdf.

Guidelines for health maintenance of HIV-infected patients are summarized in Table 2.

TABLE 2

HEALTHCARE MAINTENANCE OF HIV-INFECTED INDIVIDUALS

Condition	Healthcare maintenance
All HIV-infected individuals	CD4 counts every 3–6 months Viral load tests every 3–6 months and 1 month following a change in therapy PPD (to screen for tuberculosis) INH for those with positive PPD and normal chest x-ray RPR or VDRL (to screen for syphilis) Toxoplasma IgG serology Cytomegalovirus IgG serology Pneumococcal vaccine Influenza vaccine in season Hepatitis B vaccine for those who are HBsAb-negative Haemophilus influenzae B vaccination Papanicolaou smears every 6 months for women Consider anal swabs for cytologic evaluation yearly for patients with history of receptive anal intercourse
HIV-infected individuals with CD4 <200 cells/μL	P jiroveci prophylaxis
HIV-infected individuals with CD4 <75 cells/μL	M avium complex prophylaxis
HIV-infected individuals with CD4 <50 cells/μL	Consider CMV prophylaxis
PPD = purified protein derivative INH = isonicotinic acid hydrazide (isoniazid) RPR = rapid plasma regain VDRL = Venereal Disease Research Laboratories IgG = immunoglobulin G HBsAb = antibody to the hepatitis B surface antigen CMV = cytomegalovirus Source: Katz et al., 2006.

Discontinuing or interrupting HAART may become necessary due to factors such as serious drug toxicity, intervening illness, surgery, or unavailability of medications. Although unplanned short-term interruption of therapy may be unavoidable, planned interruption is no longer recommended except in a clinical trial setting.

Planned interruption of treatment for economic or toxicity reasons was once suggested as a strategy for patients whose viral load was minimized. However, two recent trials showed a higher incidence of HIV disease progression and death in patients who discontinued therapy when CD4⁺ cell counts rose above 350 cells/mm³ and who restarted therapy when CD4⁺ cells fell below 250 cells/mm³ (El-Sadr & Neaton, 2006; Danel et al., 2006).

The efficacy of HAART can be measured by plasma HIV RNA testing. Four to six months after treatment begins, there should be no detectable virus (>50 copies/mL). Treatment failure at this point may be due to nonadherence, inadequate potency of drugs, suboptimal levels of antiretroviral agents, viral resistance, or other factors not completely understood.

Patients whose treatment fails despite careful adherence to the regimen should have their regimen changed. A thorough drug treatment history plus drug resistance testing guides the design of the new regimen.

Patients who are cared for by clinicians with expertise in HIV/AIDS have better outcomes—in mortality, rate of hospitalizations, compliance with guidelines, cost of care, and adherence to medication regimens—than those cared for by less-experienced providers (Kitahata et al., 2003; Delgado et al., 2003). Expertise is defined in terms of the number of patients actually managed. The DHHS panel recommends HIV primary care by a clinician with