HIV/AIDS for Kentucky Nurses

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By Nancy Evans, BS

LEARNING OBJECTIVES

Upon completion of this course, you will be able to:

• Name the factors affecting risk for transmission of HIV in general and among healthcare workers in particular.
• List the types of HIV tests and legal issues associated with HIV testing in Kentucky.
• Describe the clinical manifestations and treatment guidelines for HIV/AIDS.

EPIDEMIOLOGY

Since the first case of acquired immune deficiency syndrome (AIDS) was diagnosed in 1981, AIDS has killed nearly 600,000 Americans (CDC, 2010a). The daunting human and economic costs of this disease in the United States are eclipsed only by its international impact. Since 1981, 30 million people worldwide have died from AIDS and more than 33 million are infected with the virus. Although HIV infection rates are declining globally, another 2.7 million people were infected in 2008. At the end of 2008, an estimated 4 million people were receiving AIDS drugs and another 5 million needed treatment and were not receiving it (UNAIDS, 2009).

HIV/AIDS in the United States

The CDC estimates that 1.1 million people in the United States are currently infected with HIV. At least 1 in 5 of them does not know he or she is infected and is at high risk for transmitting the virus to others. While antiretroviral drugs have reduced deaths from AIDS, the number of new infections has not changed since the late 1990s. Each year another 56,000 people are infected with HIV, approximately 1 new infection every 9.5 minutes (Hall et al., 2008). And each year more than 18,000 people die of AIDS in the U.S. (CDC, 2010a).

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 the development of innovative drugs. These drugs have slowed the death rate from AIDS in the U.S. and other countries since 1996, but without a cure and/or increased emphasis on prevention, there is no end in sight to the epidemic.

Antiretroviral drugs have reduced not only morbidity and mortality from AIDS. They have also reduced the public’s level of concern about the deadly nature of this epidemic, creating widespread complacency about the disease. This complacency, coupled with our society’s belief in the power of pharmaceuticals, has undermined prevention efforts. By extending the lives of people with HIV infection, drug treatment has also increased the prevalence (or number of cases per 100,000 people) of the disease and increased the likelihood of transmission.

HIV/AIDS in Kentucky

Since 1982, more than 5,000 people have been diagnosed with AIDS in Kentucky; nearly half of them have died of AIDS. As of 2008, Kentucky ranked 26th among the states in the annual number of AIDS cases diagnosed.

In 2004, Kentucky passed legislation mandating confidential name-based reporting of HIV infection (including AIDS). Between 2005 and 2009, 1,740 new cases of HIV have been reported, approximately 25% of which included a diagnosis of AIDS (CHFS, 2010). The rate of HIV infection in Kentucky is 10.2 cases per 100,000 population, about half the national average of 19.4 cases (CDC, 2010c).

Although the HIV/AIDS epidemic has touched every part of Kentucky, the cities of Louisville and Lexington have been hardest hit. Between 2005 and 2009, nearly half of new HIV infections occurred in the nine-county region of southern Indiana and north central Kentucky that includes the city of Louisville. More than 20% of cases came from the Bluegrass ADD, which includes the city of Lexington (CHFS, 2010).

Cumulative AIDS Cases by Area Development District (ADD), through December 31, 2009.

Risk Groups

HIV/AIDS takes a heavy toll on people of all ethnicities, genders, ages, and income levels. However, some populations have been uniquely affected by the epidemic. These populations include men who have sex with men, injecting-drug users, women, and people of color.

Three primary risk groups account for 75% of new HIV infections in the United States:

1. Men who have sex with men (MSM)
2. Injecting-drug users (IDUs)
3. MSM who also use injection drugs

Heterosexual transmission accounts for the remainder of new cases. Although HIV infection among IDUs has declined since the early 1980s, continued efforts to prevent transmission of HIV and other STDs are needed (Hall et al., 2008). Poverty, unemployment, lack of education, limited access to healthcare, incarceration, and disrupted social networks further increase risk among each of these groups.

Other important groups at risk for HIV include women and children, seniors, commercial sex workers, incarcerated populations, and transgender (TG) people. Each of these groups has unique needs for outreach and education on prevention and treatment of HIV infection.

MEN WHO HAVE SEX WITH MEN (MSM)

Men who have sex with men account for more than half of all newly reported HIV infections, and young men are at highest risk. MSM account for just 4% of the U.S. male population aged 13 years and older; however, the rate of new HIV diagnoses among MSM is more than 44 times that of other men. Although new infections have declined among both heterosexuals and injection drug users, the annual number of new infections among MSM has increased steadily since the early 1990s (CDC, 2010b). They are the only risk group in the United States in which new HIV infections are increasing.

Nearly half of HIV-infected young MSM do not know they are infected. A survey of MSM in 21 U.S. cities found that 1 in 5 of those surveyed was HIV-positive and nearly half of them (44%) were unaware of their HIV status. The highest HIV prevalence and infection unawareness were among young and minority MSM (CDC, 2010b).

MSM account for 8 out of 10 cases of HIV infection in Kentucky, primarily men between the ages of 20 and 49 years. Among blacks, the highest percentage of cases was diagnosed in men ages 20–29. MSM, injection drug users (IDUs) and MSM who also use injection drugs accounted for more than half of all new HIV infections in Kentucky between 2005 and 2009.

INJECTING-DRUG USERS (IDUs)

Injecting-drug use is the third most frequently reported risk factor for HIV infection in the United States. During 2004–2007, approximately two thirds of newly infected IDUs were males, more than half were black/African Americans, and three fourths lived in urban areas. Many IDUs continue to engage in high-risk behaviors such as sharing syringes and/or having unprotected sex. The highest prevalence of having unprotected vaginal sex was among those 18–24 years (CDC, 2009a).

Mainstream America disapproves of illegal drug use and those who become addicted. The methamphetamine epidemic has increased the risk of HIV transmission because the drug is so cheap and accessible. Successful efforts to prevent the spread of HIV/AIDS, HBV, and HCV among injection-drug users (e.g., syringe exchange programs) remain controversial because some people equate these programs with “approval” of drug use.

Injection-drug use (IDU) often coexists with poverty, low self-esteem, anxiety, depression, and mental illness. While drugs offer temporary relief from the realities of harsh living conditions, they create a tangled web of problems, including risk-taking behaviors like unprotected sex. Drug users who would like to stop using often lack access to inpatient treatment facilities. Waiting lists for drug treatment programs are long, and by the time a place is available, users may be lost to follow-up.

Those drug users who do seek treatment for HIV may find the cost of the drugs prohibitive or the complex multidrug regimens beyond their ability to manage. In addition, street drugs and drugs unapproved by FDA but available through online pharmacies may have dangerous interactions with AIDS medications.

OTHER HIGH-RISK POPULATIONS

Blacks/African Americans are disproportionately affected by HIV/AIDS in Kentucky. In 2008, blacks represented 36% of new HIV infections in Kentucky but only 7.6% of the general population. In 2008, nearly half of female HIV infections were reported among blacks (CHFS, 2010). AIDS is the fourth leading cause of death among African American males ages 25–44 in Kentucky. More than 80% of Kentucky’s perinatal AIDS cases were reported among African-American babies (CHFS, 2006).

Incarcerated individuals in the United States have 2.5 times the rate of confirmed AIDS cases than among the general population (Bureau of Justice Statistics, 2009), as well as higher rates of other sexually transmitted diseases. Kentucky has experienced the highest increase in its incarcerated population of any state in the United States since 2006, a trend expected to continue (Pew, 2008).

There is little research on HIV and other STDs among commercial sex workers in the United States. Yet the mathematical reality that sex workers have hundreds of partners each year makes this population a critical element in the spread of HIV throughout the wider community. Both street workers and Internet-based escorts report inconsistent condom use, high rates of unprotected sex, and low rates of HIV status disclosure (Mimiaga et al., 2008).

Women now constitute more than 25% of the HIV/AIDS-infected population nationwide and nearly 75% of new AIDS cases. Three fourths of the women and girls living with AIDS in the United States are African American and Hispanic, even though these populations account for only a fourth of U.S. females. HIV/AIDS is the leading cause of death of black/African American women aged 25 to 34. Women are primarily infected through heterosexual intercourse, although injection drug use accounts for a fourth of female cases (CDC, 2008).

Seniors represent 27% of the HIV-infected population in the United States. Males account for three fourths of cases and females account for a fourth. Half of HIV-infected seniors are black, a third are white, and the remainder are Hispanic. The recent increase in HIV among people over 50 is partly due to antiretroviral therapy, which has extended the lives of HIV-infected people, and partly due to newly diagnosed infections in older people.

TRANSMISSION OF HIV

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.

Modes of Transmission

Contrary to 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. 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

Varying levels and concentrations of HIV have been found in most bodily fluids of infected persons, including 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.

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. Receptive anal contact without a latex condom carries the greatest risk, probably because of the larger surface area of mucous membranes involved. (Receptive partners are at greater risk for transmission of any sexually transmitted disease, including HIV.)

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—suggest that women who have sex with women (WSW) should consider female sexual contact a possible means of transmission of HIV (CDC, 2006).

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 blood-borne 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.

LESS COMMON MEANS OF TRANSMISSION

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% of U.S. AIDS cases were caused by transfusions or use of contaminated blood products, and the majority of those cases were in people who received blood or blood products before1985. Donor screening, blood testing, and other processing methods have reduced the risk of transfusion-caused HIV transmission to between 1 in 450,000 to 1 in 600,000 transfusions in the United States. Donating blood in the United States is always safe because sterile needles and other equipment are used.

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.

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. However, when a woman’s healthcare 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%.

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.

Additional Risk Factors

People who become HIV-positive often have other sexually transmitted diseases, 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 these infections, which increases the risk of HIV transmission. The immune suppression caused by HIV then facilitates infection with other STDs, creating a destructive synergy.

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. However, unprotected sex with even one infected partner risks transmission.

Use of any mood-altering substances, 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 MSM, especially younger MSM.) Certain substances can also mask pain and/or create oral and genital sores, which create additional entry points for HIV and other STDs.

Prevention and Risk Reduction

HIV/AIDS is preventable, but because the virus is transmitted through behaviors that many people find pleasurable—sexual activity and injection-drug use—prevention is difficult. Prevention of HIV begins with education and counseling about sexual practices and injection-drug use. People unable to “just say no” need basic, practical, how-to information.

Safer sex practices include:

• Abstinence from sexual contact
• Mutual monogamy
• Correct use of latex condoms for all sexual intercourse (anal, oral, and vaginal) (both women and men may need instruction in the correct use of condoms)

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

• Do not share 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, or prescription or nonprescription drugs.

In late 2010 researchers reported that daily use of the antiretroviral pill Truvada, already in use to treat HIV, can also used for preexposure prophylaxis (PrEP) to prevent new infections (Grant et al., 2010). Because the trial enrolled only men (and transgender women) who have sex with men, the drug’s efficacy in women or intravenous drug users is unknown. Truvada is a combination of two oral antiretroviral drugs and has been used to treat HIV infection since 2004. The FDA has not yet approved the drug for preventive use, although the CDC has released interim guidelines for healthcare providers electing to provide PrEP to high-risk MSM (CDC, 2011).

INFECTION CONTROL

Risks for Occupational Exposure

Healthcare workers may be infected with HIV through needlesticks or direct contact with HIV-infected blood—for example, through a break in the skin or through the eyes or the mucosal lining of the nose. Healthcare providers who work in correctional institutions and in home care are at higher risk for occupational exposure to HIV and other bloodborne pathogens than those who work in other settings. Other occupational groups with potential exposure to HIV (as well as HBV and HCV) include, but are not limited to, law enforcement; fire, ambulance, and other emergency responders; and public service employees.

The risk of developing HIV infection from a needlestick 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 viral load in the source. (Comparatively, the risk after a mucous membrane exposure is about 1:9,000, and the risk of HIV transmission after nonintact skin exposure is estimated to be less than the risk for mucous membrane exposure.)

The high prevalence of HIV infections in correctional institutions increases the risk of exposure, as does the environment itself. CDC (2009b) and the National Institute for Occupational Safety and Health (NIOSH) cite these challenges:

• Jails and prisons can be unpredictable work settings.
• Security issues are often a higher concern than infection control.
• Inmates may have a higher rate of bloodborne diseases.

Correctional healthcare workers can be bitten or stabbed during an inmate assault, punctured with a used needle, or splashed in the face with blood. Exposure to bloodborne pathogens can happen in any of these situations.

Workplace Standards

Standards have been developed to protect workers from bloodborne pathogens such as HIV. Bloodborne pathogens include any human pathogen present in human blood or other potentially infectious materials (OPIM). Other bloodborne pathogens include HBV, HCV, hepatitis D, 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.

Infection Control Systems

To prevent HIV transmission in healthcare settings, CDC instituted universal precautions (blood and body fluid precautions). Under universal precautions, healthcare personnel should assume that the blood and other body fluids from all patients are potentially infectious and therefore follow infection-control precautions at all times and in all settings.

Standard precautions is a newer term that hospitals and other agencies are moving toward. It includes all recommendations for universal precautions plus body substance isolation (BSI) when other potentially infectious materials (OPIM) are present.

These precautions include:

• Routine use of barriers (such as gloves and/or goggles) when anticipating contact with blood or body fluids
• Washing hands and other skin surfaces immediately after contact with blood or body fluids, and
• Careful handling and disposing of sharp instruments during and after use

Other precautions are recommended in the areas of housekeeping and waste disposal. The work area of the facility is to be maintained in a clean and sanitary condition. Laundry that is or may be soiled with blood/OPIM and/or may contain contaminated sharps must be treated as contaminated. All regulated waste must be placed in closeable, leak-proof containers or bags that are color-coded (red-bagged) or labeled and then disposed of in accordance with federal, state, and local regulations.

TAGS AND LABELS
Tags or labels must be used as a means to protect employees from exposure to potentially hazardous biological agents.

INFECTION CONTROL AT HOME

Healthcare providers and other caregivers who care for HIV patients at home or in home-like settings are also at risk of exposure to HIV and other bloodborne pathogens. Medical procedures contributing to PIs in home care include injecting medications, performing fingersticks and heelsticks, and drawing blood. Other contributing factors include sharps disposal, contact with waste, and patient handling. Cuts, accidents, or other circumstances can result in spills of blood/OPIM on carpeting, vinyl flooring, clothing, skin, or other surfaces.

Healthcare providers and other caregivers who care for HIV patients should practice good hygiene techniques in preparing food, handling body fluids, and using medical equipment. Proper use of gloves and correct handwashing is critically important. 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.

Postexposure Management

Any healthcare worker who receives a needlestick or other significant exposure to potential HIV, HSV, or HBV infection should follow the employer’s protocol, which is based on guidelines issued by the CDC (2005b).

IMMEDIATE RESPONSE

Immediately after exposure to blood of a patient:

• Wash the affected area(s) with soap and water. Application of antiseptics should not substitute for washing.
• Flush splashes to the nose, mouth, or skin with water.
• Irrigate eyes with clean water, saline, or sterile irrigants.
• Remove any potentially contaminated clothing should as soon as possible.
• In the event of a sharps injury, wash the exposed area with soap and water. Do not “milk” or squeeze the wound. There is no evidence that antiseptics such as hydrogen peroxide will reduce the risk of transmission; however, use of antiseptics is not contraindicated. Seek emergency treatment if the wound needs suturing.
• For bites or scratch wounds, wash with soap and water and cover with a sterile dressing. All bite wounds should be evaluated by a healthcare professional.

REPORTING THE INCIDENT

Immediately report the incident to the department (e.g., occupational health, infection control) within your agency responsible for managing exposures. Prompt reporting is essential because in some cases postexposure prophylaxis (PEP) may be recommended and started as soon as possible. Discuss with a healthcare professional the extent of the exposure, treatment, follow-up care, personal prevention measures, the need for a tetanus shot, and other care. You should have already received the hepatitis B vaccine, which is extremely safe and effective in preventing HBV infection.

In some states, employers must make a confidential postexposure medical evaluation available to employees who report an exposure incident. Workers may also have a right to file a worker’s compensation claim for exposure to bloodborne pathogens.

POSTEXPOSURE PROPHYLAXSIS (PEP)

The CDC recommends that postexposure prophylaxis (PEP) begin as soon as possible, ideally within 24 hours after the exposure and no later than 7 days (CDC, 2005b).

For exposure to HIV-positive blood, recommendation is for a four-week course combining either two antiretroviral drugs for most HIV exposures, or three antiretroviral drugs for exposures that may pose a greater risk for transmitting HIV (e.g., those involving a larger volume of blood with a larger amount of HIV or a concern about drug-resistant HIV). The antiviral drugs used 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” (CDC, 2005b).

Frequent advances in treatment make it impractical to list medications and dosages here. PEP can only be obtained from a licensed healthcare provider. The employing facility may have recommendations and procedures in place for staff members to obtain PEP. After evaluation, certain anti-HIV medications may be prescribed.

The National Clinicians’ Post-Exposure Prophylaxis Hotline (PEPline) offers treating clinicians up-to-the-minute advice on managing occupational exposures (i.e., needlesticks, splashes, etc.) to HIV, hepatitis, and other blood-borne pathogens. In rural areas, police, firefighters and other at-risk emergency responders should identify a 24-hour source for PEP.

HIV TESTING AND COUNSELING

Most HIV infections are transmitted by people who do not know they are infected. Therefore, HIV testing is the first step in halting spread of the virus. Research shows that people who are unaware of their HIV infection have a transmission rate of almost 11% compared with a rate of less than 2% in those who know they are HIV-positive. When counseling services are available and effective, that rate falls to near zero (Holtgrave & Anderson, 2004).

Who Should Be Tested?

Testing is essential for anyone who has had a potential exposure to HIV. This includes anyone who has had unprotected anal, vaginal, or oral sex; who has shared needles or other injection drug preparation equipment; or who has had an occupational exposure. People with partners who have such risk factors should also consider testing.

The CDC (2006c) recommends routine voluntary HIV screening of patients aged 13–64 in all healthcare settings. Recommendations also include the following:

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

The CDC recommendations for pregnant women include the following:

• HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women.
• Repeat screening in the third trimester is recommended in certain jurisdictions with elevated rates of HIV infection among pregnant women.

Testing and Legal Issues

Kentucky has created legislation governing HIV testing and addressing issues such as informed consent, confidentiality, and notification requirements. All healthcare professionals must familiarize themselves with laws in their jurisdiction.

INFORMED CONSENT

Kentucky Statute 214.625 states that testing for HIV should be informed, voluntary, and confidential. This legislation corresponds closely with federal guidelines and accepted medical practice. Violations are heavily penalized, and good-faith efforts at compliance do not insure anyone against legal difficulties.

Before anyone can be tested for HIV in Kentucky, they must explicitly consent to be tested. Testing without informed consent can result in disciplinary action by a healthcare provider’s licensing board, fines, suspension or revocation of license, and civil liability for negligence and invasion of privacy.

A person who signs a general consent form for the performance of medical procedures and tests is not required to sign a separate specific consent form for HIV testing during the time that the general consent form is in effect (KRS 214.181, 214.625). However, a general consent form shall instruct the patient that, as part of the medical procedures or tests, the patient may be tested for HIV, hepatitis, or any other blood-borne infectious disease if a doctor orders the test for diagnostic purposes. Except as otherwise provided in subsection (5)(c) of this section, the results of a test or procedure to determine HIV infection, antibodies to HIV, or infection with any probable causative agent of AIDS performed under the authorization of a general consent form shall be used only for diagnostic or other purposes directly related to medical treatment.

Informed consent must be preceded by an explanation of the test, including its purpose, potential uses, and limitations, and the meaning of its results. All registered testing programs, except for blood donor centers, shall provide pretest counseling on the meaning of a test for HIV, including medical indications for the test; the possibility of false positive or false negative results; the potential need for confirmatory testing; the potential social, medical, economic consequences of a positive test result; the need to eliminate high-risk behavior (KRS 214.625(7)(d-e)).

Minors

Kentucky statute 214.185 authorizes physicians to examine, diagnose, and treat children under 18 who seek care for disease, addictions, or other conditions, including sexually transmitted (venereal) diseases (STDs). Kentucky statute 214.410 includes HIV and AIDS in the definition of sexually transmitted diseases. Parental permission is not required for a child judged by the healthcare provider to be sufficiently mature to consent or refuse to have an HIV test.

During Pregnancy

Unlike many other states, Kentucky does not have an opt-out system for HIV testing of pregnant women. Under an opt-out system, all pregnant women are advised that their healthcare provider will conduct an HIV test but that they have the right to refuse testing. Instead, Kentucky has an opt-in system, which requires pregnant women to choose to be tested for HIV. Any physician or midwife attending a woman for any pregnancy related condition should offer HIV testing in conjunction with other required blood tests at the initial prenatal care visit and again at 28 to 32 weeks’ gestation, regardless of risk behaviors.

When Donating Blood or Human Tissue

All patients donating blood must sign a consent form to have their blood tested for HIV (KRS 214.452). When donating organs, skin, or other human tissue to specialty banks, a written informed consent for HIV testing is required from the potential donor or the donor’s legal representative. Every donation of organs, skin, or other human tissue for transplantation to another shall be tested prior to use for HIV and other communicable diseases specified by the United Network for Organ Sharing, American Association of Tissue Banks, and Eye Bank Association of America by the agency responsible for procuring the tissue (KRS 311.281). If consent is not given, the person is not to be accepted as a donor.

Any tissue found to be HIV-positive shall be rendered noncommunicable by the person holding the tissue or shall be destroyed, unless the tissue is specifically labeled as HIV-positive and (a) is used for research purposes; or (b) is used to save the life of another and is transferred with the recipient’s informed consent.

Any HIV-positive results must be communicated to the donor in person. Negative test results shall be communicated either in person, by registered mail, or by phone. Notification is the responsibility of the agency procuring the tissue.

Under KRS 311.990, any person infected with HIV, knowing that he or she is infected and having been informed of the possibility of communicating the infection by donating human organs, skin, or other human tissues, who donates organs, skin, or other human tissue is guilty of a class D felony.

Incarcerated Individuals

Kentucky Revised Statute (KRS) 197.055 requires an introductory and continuing education program on HIV/AIDS for all inmates. If there is evidence that an inmate is engaging in high-risk behavior such as sexual contact with any person in the institution, use of injection drugs, or tattooing, that inmate will be tested for HIV. The results of the tests shall become a part of that inmate’s medical file, accessible only to persons designated by agency administrative regulations. Legislation was introduced in 2007 to require testing of inmates before release into the larger community, similar to laws in Florida, Arkansas, and other states. However, the bill failed to pass, apparently because of costs (Henry J. Kaiser Family Foundation, 2007).

TESTING WITHOUT INFORMED CONSENT

HIV testing without informed consent is permissible in the following circumstances:

• Bona fide medical emergencies in which treatment is indicated by HIV status (KRS 214.625(3))
• When there has been significant exposure by medical personnel or a victim of a crime to the blood or body fluids of a criminal defendant, inmate, parolee, probationer, or patient or resident of any healthcare facility owned or operated by the Commonwealth, the source shall be ordered to submit to testing for HIV, hepatitis B and C viruses, and any other disease if testing for that disease is recommended by the most current guidelines of CDC. (KRS 438.250)
• When a person is charged with sexual offenses or offenses which have sexual contact as an element when the circumstances of the case demonstrate a possibility of transmission of HIV. (KRS 438.250)
• When a person is convicted of prostitution or procuring prostitution with knowledge of sexually transmitted disease or HIV. Any person who commits, offers, or agrees to commit prostitution by engaging in sexual activity likely to transmit HIV, knowing that he or she is HIV-positive and could possibly transmit this infection to another person, is guilty of a Class D felony. (KRS 529.090)

CONFIDENTIALITY

Anonymous and confidential HIV tests are available at Kentucky county health departments and other registered testing sites. County health departments and registered testing sites are required to provide private pre-test and post-test counseling for all persons tested. Confidential HIV tests are also increasingly available in private-sector doctors’ offices and hospitals.

Disclosure

Disclosure of HIV test results (KRS 214.625) is limited to the following:

• The test subject and his or her representative
• A physician, nurse, or other healthcare provider who has a legitimate need to know the test result to protect himself or herself and to provide for the patient’s health and welfare
• The Department of Health
• The Cabinet for Health and Family Services
• Healthcare providers consulting among themselves or with healthcare facilities to determine diagnosis and treatment
• Authorized medical or epidemiologic researchers who shall not further disclose any identifying characteristics or information
• Hospital staff, administrators, and healthcare workers who provide aid and care to the subject, on a need-to-know basis. (This is especially important in cases of significant exposure to body fluids by healthcare workers.)
• A health facility or healthcare provider which procures, processes, distributes, or uses (a) a human body part from a deceased person, with respect to medical information regarding that person; or (b) semen provided prior to July 13, 1990, for the purpose of artificial insemination
• Health facility staff committees for the purposes of conducting program monitoring, program evaluation, or service reviews
• A parent, foster parent, or legal guardian of a minor; a crime victim; or a person specified in KRS 438.250
• A person allowed access by a court order, which imposes safeguards against unauthorized disclosure of test results, specifying the persons who may have access to the information, the purposes for which information shall be used, and appropriate prohibitions on future disclosure. When disclosure is made pursuant to this subsection, it shall be accompanied by a written statement that includes the following or similar language: “This information has been disclosed to you from records whose confidentiality is protected by state law. State law prohibits you from making any further disclosure of such information without the specific written consent of the person to whom such information pertains, or as otherwise permitted by state law. A general authorization for the release of medical or other information is NOT sufficient for this purpose.” An oral disclosure shall be accompanied by oral notice and followed by a written notice within ten (10) days (KRS 214.625 (5)(10)(e).

The result of a serologic test conducted under the auspices of the Cabinet shall not be used to determine if a person may be insured for disability, health, or life insurance or to screen or determine suitability for, or to discharge a person from, employment. Any person who violates the provisions of this subsection shall be guilty of a Class A misdemeanor (KRS 214.625 (6)(d).

Breaches of Confidentiality

Under KRS 214.420 and 214.625, all information in the possession of local health departments or the Cabinet concerning persons tested for, having, or suspected of having sexually transmitted diseases or identified in an epidemiologic investigation for sexually transmitted diseases, is strictly confidential. A general authorization for the release of medical or other information is not sufficient to authorize release of this information. Breach of this confidentiality is considered a violation under KRS 214.990(6).

Breach of confidentiality can result in disciplinary action, up to and including dismissal, as well as civil and criminal liability. A person who discloses the identity of a person upon whom has been conducted a test to detect HIV infection shall be guilty of a Class A misdemeanor. Anyone who intentionally releases any name or other identifying information shall be guilty of a Class A misdemeanor (KRS 214.995).

NOTIFICATION REQUIREMENTS

The physician who ordered the test or the attending physician is responsible for informing the patient of HIV-positive test results. The physician is also responsible for post-test counseling or referral to another appropriate professional for counseling (KRS 214.181, 214.625).

Federal law requires 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.

In Kentucky (KAR 2:020, section 7, and KRS 214.010), every physician, advanced practice registered nurse, and medical laboratory must report to the appropriate health department:

• A positive test result for HIV infection that has been corroborated by a result from one of the following:
  • Elisa
  • Western Blot
  • PCR
  • HIV antigen or
  • HIV culture
• CD4+ assay, including absolute CD4+ cell counts and CD4+%
• HIV detectable Viral Load Assay; and
• A positive serologic test result for HIV infection or a diagnosis of AIDS that meets the definition of AIDS established within the Centers for Disease Control and Prevention (CDC) guidelines and reported in the
  • “Adult HIV/AIDS Confidential Case Report Form,” or
  • “Pediatric HIV/AIDS Confidential Case Report Form”

An HIV infection or AIDS diagnosis must be reported within 5 business days and, if possible, on the “Adult HIV/AIDS Confidential Case Report Form,” or on the “Pediatric HIV/AIDS Confidential Case Report Form.” (Detailed information including case report forms are available at http://chfs.ky.gov/dph/epi/HIVAIDS/surveillance.htm.)

Types of HIV Tests

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

Until 2002, testing for HIV antibodies relied on an enzyme-linked immunosorbent assay (ELISA) of blood. Since then, six rapid HIV tests have been approved by the FDA, all of which are interpreted visually. Four of the tests have been approved for use outside of a clinical laboratory. The FDA and the Centers for Medicare and Medicaid Services have also issued guidelines for a rapid HIV test quality-assurance program (Greenwald et al., 2006).

RAPID HIV TESTS

1. OraQuick ADVANCE Rapid HIV-1/HIV-2 Antibody Test detects HIV-antibodies in oral fluid as well as in blood.
2. Uni-Gold Recombigen HIV Test detects HIV-1 antibodies in whole blood, serum, and plasma; results take from 10 to 12 minutes.
3. Reveal G3 Rapid HIV-1 Antibody Test 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.
4. Multispot HIV-1/HIV-2 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 (FDA, 2008).
5. Clearview HIV-1/HIV-2 STAT-PAK uses whole blood or serum and plasma; results are available in 15 minutes; requires no training to use.
6. Clearview HIV-1/HIV-2 Complete is a single-use, self-contained closed system for the collection, processing, and analysis of a whole blood, serum, or plasma sample; results are available in 15 minutes.

Until these rapid tests became available, many people being tested in public clinics did not return to get their test results. Making results available during the testing appointment means that people can take immediate precautions 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 positive (reactive) rapid HIV tests require repeat testing for confirmation. The CDC described protocols for confirming reactive rapid HIV tests based on a consultation convened in January 2003 with expert laboratory scientists, the FDA, and the Centers for Medicare and Medicaid Services. These protocols 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 persons with negative or indeterminate confirmatory test results, with a blood specimen collected 4 weeks after the initial reactive rapid test result (CDC, 2004).

OTHER TESTS

Enzyme-Linked Immunosorbent Assay (ELISA)

Before HIV rapid tests became available, HIV antibody testing relied on an enzyme-linked immunosorbent assay (ELISA or EIA). This test over predicts positives; consequently, a negative HIV antibody test is considered definitive and no further testing is required. If the results are positive, however, CDC recommends against telling a person he or she is HIV-positive based only on ELISA test results.

Western Blot

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

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.

p24 Antigen

This blood test is used to measure a core protein of HIV that occurs during primary infection. 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.

HOME TESTING KITS

Tests are now available for self-testing of HIV serostatus. Home Access Express HIV-1 Test System is the only FDA-approved home test kit currently on the market, but several unapproved kits are marketed on the Internet. This Home Access Express 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 and collects blood spots on special paper. The paper is mailed to a certified clinical laboratory with a confidential and anonymous personal identification number (PIN) and then tested using a standard ELISA process.

If the initial test result is positive, the results are confirmed by a Western blot test. The person tested obtains the results by calling a toll-free telephone and using the assigned 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 because of the need for counseling. The FDA has expressed concern that people 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. However, at least one survey showed that nearly 1/4 of clients at public testing services would choose a home self-test.

HIV Antibody Test Results

HIV test results can be one of three types: negative, positive, or indeterminate. CDC recommendations state that test results should be conveyed to patients in the same manner as for other routine diagnostic tests, either by telephone or by mail, followed by later counseling, if needed.

If the test result is negative, it means either (1) the person is not infected with the virus, or (2) the person became infected recently and antibodies have not yet appeared. A person who tests negative for HIV but remains concerned about a possible recent infection should test again in 3 to 6 months and practice safer behaviors in the meantime. If risky behavior continues, infection may still occur.

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

Occasionally a rapid test or an enzyme immunoassay 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 seroconversion. 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. Research has shown that only about 20% of people with indeterminate test results go on to become truly HIV positive. Only rarely do people remain indeterminate throughout their lives.

Counseling

All individuals tested for HIV should also be offered an opportunity to receive counseling. If test results are HIV-negative, notification should include appropriate information on preventing transmission of HIV. (Information for high-risk test subjects may not be appropriate for low-risk test subjects and vice versa.) If test results are HIV-positive, counseling the test subject should include information on the following:

• Availability of appropriate medical and support services
• Importance of notifying partners who may have been exposed
• Prevention of the transmission of HIV

Counseling someone who has just learned of his or her HIV-positive status requires not only that the healthcare provider be familiar with local HIV health and social services but also that the provider have the ability to communicate with clarity, sensitivity, and compassion.

CLINICAL MANIFESTATIONS AND TREATMENT

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.

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.

Some conditions, called co-factors, can affect the course of disease progression, including age, genetic factors, drug use, smoking, nutrition, and coinfection with hepatitis C virus (HCV) and/or tuberculosis (TB).

Stages of HIV/AIDS

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 and before any symptoms appear. Once infected, a person is always infectious to others. During acute HIV infection, high levels of virus circulate 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 will not be aware 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
   • 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 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. Once diagnosed with AIDS, a person is always considered to have AIDS, even if their health seems to improve. 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, measured as viral load.

CDC AIDS CASE DEFINITION FOR SURVEILLANCE OF ADULTS AND ADOLESCENTS

Source: Zolopa & Katz, 2010.
Definitive AIDS diagnoses with or without laboratory evidence of HIV infection	Candidiasis of esophagus, bronchi, trachea, or lungs Cryptococcosis, extrapulmonary Cryptosporidiosis, chronic intestinal (>1 month duration) Cytomegalovirus disease of an organ other than liver, spleen, or lymph nodes Herpes simplex virus infection causing a mucocutaneous ulcer(s) (>1 month duration) or bronchitis, pneumonitis, or esophagitis of any duration Kaposi’s sarcoma in a patient <60 years of age Lymphoma of the brain (primary) in a patient <60 years old Mycobacterium avium complex or disease caused by M. kansasii, disseminated (at a site other than or in addition to lungs, skin, or cervical or hilar lymph nodes) Pneumocystis jiroveci pneumonia Progressive multifocal leukoencephalopathy Toxoplasmosis of the brain
Definitive AIDS diagnoses with laboratory evidence of HIV infection	Coccidioidomycosis, disseminated (at a site other than or in addition to lungs or cervical or hilar lymph nodes) HIV encephalopathy Histoplasmosis, disseminated (at a site other than or in addition to lungs or cervical or hilar lymph nodes) Isosporiasis with diarrhea (>1 month duration) Kaposi’s sarcoma at any age Lymphoma of the brain (primary) at any age Other non-Hodgkin lymphoma of B cell or unknown immunologic phenotype Any mycobacterial disease caused by mycobacteria other than M. tuberculosis, disseminated (at a site other than or in addition to lungs, skin, or cervical or hilar lymph nodes) Disease caused by extrapulmonary M. tuberculosis Salmonella (non-typhoid) septicemia, recurrent HIV wasting syndrome CD4+ lymphocyte count below 200 cells per microliter or CD4 lymphocyte percentage below 14 percent Pulmonary tuberculosis Recurrent pneumonia Invasive cervical cancer
Presumptive AIDS diagnoses with laboratory evidence of HIV infection	Candidiasis of esophagus: (a) recent onset of retrosternal pain on swallowing; and (b) oral candidiasis Cytomegalovirus retinitis. A characteristic appearance on serial ophthalmoscopic examination Mycobacteriosis: Specimen from stool, normally sterile body fluids or tissue from a site other than lungs, skin, or cervical or hilar lymph nodes, showing acid-fast bacilli of a species not identified by culture Kaposi’s sarcoma: Erythematous or violaceous plaque-like lesion on skin or mucous membrane Pneumocystis jiroveci pneumonia: (a) a history of dyspnea on exertion or nonproductive cough of recent onset (within past 3 months); and (b) chest x-ray evidence of diffuse bilateral interstitial infiltrates or gallium-scan evidence of diffuse bilateral pulmonary disease; and (c) arterial blood gas analysis showing an arterial oxygen partial pressure of <70 mm Hg, or a low respiratory diffusing capacity of <80% of predicted values, or an increase in the alveolar-arterial oxygen tension gradient; and (d) no evidence of a bacterial pneumonia Toxoplasmosis of the brain: (a) recent onset of a focal neurologic abnormality consistent with intracranial disease or a reduced level of consciousness; and (b) brain imaging evidence of a lesion having a mass effect or the radiographic appearance of which is enhanced by injection of contrast medium; and (c) serum antibody to toxoplasmosis or successful response to therapy for toxoplasmosis Recurrent pneumonia: (a) more than one episode in a 1-year period; and (b) acute pneumonia (new symptoms, signs, or radiologic evidence not present earlier) diagnosed on clinical or radiologic grounds by the patient’s physician Pulmonary tuberculosis: (a) apical or miliary infiltrates; and (b) radiographic and clinical response to antituberculous therapy

Antiretroviral Therapy

Antiretroviral therapy (ART) has become the gold standard for treatment of HIV/AIDS. Antiretroviral drugs are administered in “cocktails” of three or more. (ART is also sometimes referred to as highly active antiretroviral therapy, or HAART.) The primary goal of ART is to reduce HIV-associated morbidity and mortality by suppressing the individual’s viral load to below detectable levels.

Antiretroviral treatment of people with HIV continues to prove complex, controversial, dynamic, and expensive. 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.

INITIATING ART

In 1996, tests to measure an individual’s viral load became available, providing objective criteria for treatment decisions. Following are treatment recommendations by the Panel on Antiretroviral Guidelines for Adults and Adolescents (2009):

• Antiretroviral therapy should be initiated in all patients with history of an AIDS-defining illness or with a CD4+ T cell count <350 cells/mm.
• Antiretroviral therapy should also be initiated in the following groups of patients regardless of CD4 T-cell count:
  • Pregnant women
  • Patients with HIV-associated nephropathy
  • Patients coinfected with HBV when treatment is indicated
• Antiretroviral therapy may be considered in all patients with CD4 T-cell counts between >350 and 500 cells/mm. (See detailed guidelines on the AIDSinfo website listed under “Resources” at the end of the course.)
• Patients initiating ART should be willing and able to commit to lifelong treatment and should understand the benefits and risks of therapy and the importance of adherence. Patients may choose to postpone therapy, and providers, on a case-by-case basis, may elect to defer therapy based on clinical and/or psychosocial factors.

TREATMENT GOALS AND GUIDELINES

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

• Maximal and durable suppression of viral load
• Reduction of HIV-related morbidity and prolonging survival
• Improvement in quality of life
• Restoration and/or preservation of immunologic function
• Prevention of HIV transmission

Treatment guidelines are revised frequently based on ongoing research findings. The most up-to-date information can be found online at http://aidsinfo/nih.gov/ContentFiles/AdultandAdolescentGL.pdf.

TREATMENT EFFICACY

The efficacy of ART 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 should guide 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. Expertise is defined in terms of the number of patients actually managed. The DHHS panel recommends HIV primary care by a clinician with at least 20 HIV-infected patients and preferably at least 50 HIV-infected patients.

Many new medications for HIV/AIDS are in clinical trials. Patients experiencing drug resistance may be appropriate candidates for drugs still in trials. Physicians without extensive experience in treating HIV/AIDS are strongly urged to consult with specialists in this area when considering clinical trials for their patients.

ART COMPLICATIONS

Discontinuing or interrupting ART 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. Interrupting therapy increases the risk of AIDS-related complications, declining CD4 counts, and other non-AIDS-related complications such as heart attack and liver failure.

While extending and improving lives of people with HIV, long-term use of some of these drugs increases 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% 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). As patients live longer with HIV/AIDS, many develop drug-resistant strains of the virus, which further complicates treatment.

Other Medications and Therapies

In addition to ART, people with HIV/AIDS may also receive medications to treat or prevent opportunistic infections, boost the immune system, and prevent anemia. Some of these medications may have serious interactions with ART, so prescribing physicians need to be familiar with all ART medications, as well as with their potential toxicities, when administered with other drugs.

Some people with HIV supplement their prescription drugs with vitamins, acupuncture, massage, yoga, meditation, herbs, naturopathic remedies, and other complementary therapies. People who turn away from prescription HIV medications and choose only herbs, vitamins, and other supplements are said to be using alternative therapies. Many of these remedies have not been studied to see if they offer any real benefit.

Therapies such as yoga, meditation and massage can help reduce stress and enhance quality of life. However, herbs and other “natural” remedies may also interact with prescription medication. For example, St. John’s wort has major interactions with HIV medications. Therefore, people on HIV medications need to tell their physician, pharmacist, and social worker about all other supplements and nonprescription drugs they take.

Coexisting Infections

Infections that are commonly found in HIV-positive patients include a number of other sexually transmitted diseases, TB, and hepatitis. Coexisting infections may increase the risk of transmission of HIV and make its treatment more complex.

TUBERCULOSIS

Mycobacterium tuberculosis (M. tuberculosis, or TB) is the most common and most deadly coexisting infection for HIV-positive individuals. Likewise, the spread of HIV/AIDS has helped fuel the TB epidemic. The CDC estimates that TB is the cause of death for one third of people with HIV worldwide. Any HIV-infected person with a diagnosis of TB should be reported as having TB and AIDS.

All people infected with HIV should be tested for TB and, if infected, begin complete therapy as soon as possible to prevent active TB disease. HIV-infected persons with either latent TB infection or active TB disease can be effectively treated. The first step is to ensure that HIV-infected persons are tested for TB. The second step is to help those infected with TB to get proper treatment and prevent rapid progression from latent TB infection to active TB disease.

HEPATITIS

Hepatitis is inflammation of the liver that may be caused by drugs and toxic agents or by one of several viruses, including hepatitis A, B, C, D, and others. People who are HIV-positive are at risk for hepatitis A, B, and C infection. HIV-infected people should be tested for both A and B viruses, and if they test negative, should receive vaccines against both. However, there is no vaccine for HCV.

An estimated one third of HIV-positive people in the United States are also infected with Hepatitis C (HCV), and liver disease from chronic HCV is now one of the leading causes of death among people living with HIV. The U.S. Public Health Service/Infectious Disease Society of America guidelines recommend that all HIV-infected persons be screened for HCV infection.

Coinfected patients also need to consult their health professional before taking any new medications, including over-the-counter (OTC), alternative/complementary, or herbal medicines, because of their possible effects on the liver. Those receiving ART may also be at risk for drug-induced liver injury (DILI) and should be carefully monitored.

HIV/AIDS in Women

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.

TREATMENT RECOMMENDATIONS

Current recommendations for pregnant women are to start antiviral therapy during the second trimester. Those women who seek perinatal care after the second trimester should start treatment as soon as possible thereafter.

Therapy should be individualized for each woman based on her history of HIV antiretroviral therapy (past or current use or never used) as well as possible coinfection with HBV and/or HCV. Choice of therapy regimen also should consider not only the effectiveness of drug treatment for maternal disease but also possible teratogenic effects of the drugs on the infant.

Public Health Service guidelines emphasize that combination drug regimens are considered the standard of care both for treatment of maternal HIV infection and for prevention of perinatal HIV transmission. Clinical trial results indicate that antiretroviral prophylaxis to prevent perinatal transmission of HIV should be offered to all HIV-infected women, regardless of CD4 cell count (Panel on Treatment of HIV-Infected Pregnant Women, 2010).

Specific detailed guidelines for the antepartum, intrapartum, and postpartum treatment of HIV-infected women of childbearing age and treatment of their infants evolve rapidly. Practitioners are advised to consult the most recent information on the CDC’s AIDSinfo website (Panel on Treatment of HIV-Infected Pregnant Women, 2010).

Smoking cessation is important for all women receiving ART because it interferes with the therapy’s effectiveness. A large, 8-year study of women showed that those who smoked were more likely than nonsmokers to die during the study period. Smokers also had higher viral loads and lower CD4 counts. They also were more likely to be diagnosed with an AIDS-related illness such as wasting syndrome or non-Hodgkin’s lymphoma (Feldman, 2006).

Women with HIV may suffer discrimination by prescribing physicians. A study of HIV-infected patients in 10 U.S. cities showed that women were less likely than men to receive prescriptions for the most effective treatments for HIV infection (McNaghten et al., 2004).

ART COMPLICATIONS

According to the Office of Women’s Health (2009), women taking antiviral drugs may have different side effects than men on the same drugs. This may be because women are generally smaller than men and have a higher body-fat content and different hormones. For example, ritonavir (Norvir, RTV) causes more nausea and vomiting in women but less diarrhea than in men.

Some women with HIV, especially those with a low CD4 count, experience irregular or long menstrual periods. Others may also experience early menopause and are more likely to have rashes, fat buildup, and problems with their pancreas and liver. However, more research is needed before treatment doses can change, and more clinical trials need to be done that include higher numbers of women.

GYNECOLOGICAL PROBLEMS

Women infected with HIV/AIDS face an increased risk of gynecologic problems, including pelvic inflammatory disease (PID), abscesses of the fallopian tubes and ovaries, and recurrent yeast infection (candidiasis). HIV-infected women also have a higher prevalence of infection with the human papillomavirus (HPV), certain strains of which cause cervical cancer, which is an AIDS-indicator condition.

Women with HIV need to have Pap tests twice a year and more frequently if the results are abnormal.

CONCLUSION

The AIDS epidemic has claimed the lives of more than 30 million people across the globe, more than 600,000 of them in the United States. More than a million people are living with HIV/AIDS in the United States, and every year another 56,000 Americans are infected with HIV.

Despite this ongoing tragedy, the public no longer has a sense of urgency or importance about AIDS. An editorial in the New England Journal of Medicine best describes the situation—“AIDS in America: Forgotten but Not Gone” (El-Sadr et al., 2009). Research has produced drugs that slow but do not stop the carnage, and the cost of these drugs has tripled during the past 10 years. No vaccine has proved effective in preventing HIV. So the epidemic continues to spread, primarily among disadvantaged and marginalized populations: the poor, people of color, people in prison, injection drug users, and men who have sex with men. Many do not realize they are infected and unknowingly transmit the virus to others.

Ignorance, prejudice, and lack of access to healthcare are fueling the epidemic. Therefore, health professionals have a critical role in screening and in educating patients, families and communities about prevention. Only by making prevention a priority will we achieve the goals of the National AIDS Strategy:

• Reducing infection rates
• Increasing access to care for those infected
• Eliminating disparities in prevalence, diagnosis, and treatment

Health professionals can also teach by example, through offering nonjudgmental, compassionate care to those affected by this deadly virus.