Lesson 1 of 0

In Progress

Course Content

Introduction

The annual number of new HIV diagnoses has remained stable in recent years in the United States (US) and dependent areas. However, annual new diagnoses have increased among some groups. In 2017, 38,739 people received an HIV diagnosis in the US. The annual number of new HIV diagnoses remained stable between 2012 and 2016. Around 1.1 million people are living with HIV in the United States of America (USA). Nearly one in seven of these people are unaware they have HIV.

The size of the epidemic is relatively small compared to the country’s population, but is heavily concentrated among several key affected populations. Around 70% of annual new HIV infections occur among gay and other men who have sex with men (sometimes referred to as MSM), among whom African American/black men are most affected, followed by Latino/Hispanic men. Heterosexual African American/black women and transgender women of all ethnicities are also disproportionately affected.

The USA is the greatest funder of the global response to HIV, but also has an ongoing HIV epidemic itself, with around 37,600 new infections a year. Stigma and discrimination continue to hamper people’s access to HIV prevention as well as testing and treatment services, which fuels a cycle of new infections.

HIV rates are higher in southern states, which are home to around 45% of all people living with HIV, and account for around half of the new diagnoses annually in the USA, despite making up roughly one-third (37%) of the population. Since the beginning of the HIV epidemic, 692,790 people have died of AIDS-related illnesses in the USA.

For Florida statistics – view the attached PowerPoint slides.

Transmission of HIV

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 care giving activities safe if standard infection control procedures are followed.

Three conditions are necessary for HIV to be transmitted:

An HIV source
A sufficient dose (viral load) of virus
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.)

Injection Drug Use: Sharing injection needles, syringes, and other paraphernalia with an HIV-infected person can send HIV directly into the user’s bloodstream. 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.

Needlesticks: 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. 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 non-intact skin exposure is estimated to be less than the risk for mucous membrane exposure.)

Uncommon Modes 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. The majority of those cases were in people who received blood or blood products before1985.

An infected pregnant woman can transmit HIV to her fetus, and an infected mother can infect her breastfeeding infant. However, the incidence of perinatally acquired HIV peaked in 1992 and has decreased to 2% nationally in recent years. Implementation of Public Health Service guidelines for universal counseling and voluntary HIV testing of pregnant women, scheduled cesarean delivery, avoidance of breastfeeding, and the use of antiretroviral therapy by pregnant women and administered to newborn infants primarily account for the decline.

HIV Testing

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 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.

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.

In addition to the primary high-risk groups, Florida law provides for testing special populations

Pregnant Women: In Florida, the Targeted Outreach for Pregnant Women Act (TOPWA), established in 1999 by Florida statute 381.0045, requires that healthcare providers counsel and offer HIV testing to all pregnant women on their initial prenatal visit and again at 28 to 32 weeks’ gestation. TOPWA outreach workers go into the community and seek out pregnant women in housing projects, Laundromats, bars, or other public places. The TOPWA program has increased poor women’s access to prenatal care, including HIV testing and antiviral therapy, reducing the number of babies born with HIV infection. Through July 2009, more than 32,000 pregnant high-risk or HIV-infected women have been enrolled in TOPWA.

Correctional Populations

Florida Statute 495.355 mandates that prisons test inmates for HIV within 60 days before they are released back into the community. (Unlike prisons, jails are not required to test inmates unless they have been convicted of a sex-related crime.) Those who test positive must be provided with transitional assistance, which includes:

Education on preventing transmission of the virus to others and on the importance of follow-up care and treatment.
A written, individualized discharge plan that includes referrals to and contacts with the county health department and local HIV primary care services in the area where the inmate plans to reside.
A 30-day supply of all HIV-related medications that the inmate is taking prior to release under the protocols of the Department of Corrections and the treatment guidelines of the United States Department of Health and Human Services.

Types of HIV Tests

HIV Tests for Screening and Diagnosis:

HIV tests are very accurate, but no test can detect the virus immediately after infection. How soon a test can detect infection depends upon different factors, including the type of test being used. There are three types of HIV diagnostic tests: nucleic acid tests (NAT), antigen/antibody tests, and antibody tests.

NATs look for the actual virus in the blood. This test is very expensive and is not routinely used for HIV screening unless the person recently had a high-risk exposure or a possible exposure with early symptoms of HIV infection.

Antigen/antibody tests look for both HIV antibodies and antigens. Antigens are foreign substances that cause your immune system to activate. If you’re infected with HIV, an antigen called p24 is produced even before antibodies develop. Tests that detect both antigen and antibodies are recommended for testing done in labs and are now common in the United States. There is also a rapid antigen/antibody test available.

Antibody tests detect the presence of antibodies, proteins that a person’s body makes against HIV, not HIV itself. Most rapid tests and home tests are antibody tests.

An initial HIV test usually will either be an antigen/antibody test or an antibody test. If the initial HIV test is a rapid test and it is positive, the individual will be sent to a health care provider to get follow-up testing. If the initial HIV test is a laboratory test and it is positive, the laboratory will usually conduct follow-up testing on the same blood sample as the initial test. Although HIV tests are generally very accurate, follow-up testing allows the health care provider to be sure the diagnosis is right.

A negative test for HIV antigen and/or HIV antibody usually indicates that a person does not have an HIV infection. A negative screening test means only that there is no evidence of disease at the time of the test, however. It is important for those who are at increased risk of HIV infection to have screening tests performed on a yearly basis to check for possible exposure to the virus.

HIV tests that detect only HIV antibody will not detect an HIV infection soon after exposure, during the window period before the development of antibodies. Most people produce detectable levels of antibody 3 to 12 weeks after exposure. If someone is screened with an HIV antibody test too soon, the result may be negative despite the fact that the person is infected (false negative). If an HIV antibody test is negative but suspicion of exposure remains high, then repeat testing using the HIV antigen/antibody blood test may be required.

If someone tests positive on both the initial screen and supplemental testing, then that person is considered to be infected with HIV.

HIV Screening Algorithm

The CDC recommends use of a new testing protocol to screen for and diagnose HIV infection. The following lists the steps and meaning of test results:

Screen for HIV infection using a combination HIV antigen/antibody test, then
Verify a positive with a second HIV antibody test that differentiates between HIV-1 and HIV-2.
If results of the first and second test do not agree, then the next test to perform is an HIV-1 RNA test (nucleic acid amplification test, NAAT). If the HIV-1 RNA is positive, then the test is considered positive.

Home Testing Kits

Currently there is only one home HIV test available in the United States, the OraQuick In-home HIV test. The OraQuick In-Home HIV Test provides rapid results in the home. The testing procedure involves swabbing your mouth for an oral fluid sample and using a kit to test it. Results are available in 20 minutes. If you test positive, you will need a follow-up test. The manufacturer provides confidential counseling and referral to follow-up testing sites. Because the level of antibody in oral fluid is lower than it is in blood, oral fluid tests find infection later after exposure than do blood tests. Up to 1 in 12 infected people may test false-negative with this test.

The Home Access HIV-1 Test System was a home collection kit, available for purchase through December 2018. Effective January 1, 2019, Home Access will no longer be selling the HIV-1 Test Service, however they will continue to test finger stick blood specimens associated with the HIV-1 Test Service through March 31, 2019.

Testing and Informed Consent in FL

Florida’s Omnibus AIDS Act of 1988 and its 1998 update are essential for doctors, nurses, and other healthcare providers to understand. This legislation corresponds closely with federal guidelines and accepted medical practice. Violations are heavily penalized, and good-faith efforts at compliance do not ensure anyone against legal difficulties.

The principal methods for dealing with the HIV/AIDS epidemic as stipulated in the Florida Omnibus Aids Act are education and testing that is informed, voluntary, and confidential. Florida legislation stipulates four reasons for deviation from traditional educational and testing methods:

It is assumed that involuntary and non-confidential testing may drive HIV-infected individuals underground.
The government cannot constitutionally investigate or regulate much of the private behavior that permits the transmission of HIV.
Because there is no effective cure for AIDS, there is less incentive to enforce mandatory testing and notification of individuals who have been exposed.
The excessively anxious and sometimes intensely hostile public reaction” to people with this illness requires the protection afforded by anonymity.

Obtaining Consent

Before anyone can be tested for HIV in Florida, 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 general consent to draw a patient’s blood and run unspecified tests does not meet the Florida criteria of informed consent for HIV testing. The healthcare provider must explain the HIV test in a manner appropriate to the age, mental capacity, and language skill of the subject. The explanation should include the following information (Department of Health Rule 64D-2.004, F.A.C):

That an HIV test is a test to determine if an individual is infected with the virus that causes AIDS
The potential uses and limitations of the test
The procedures to be followed
That HIV testing is voluntary and consent to be tested can be withdrawn at any time prior to testing
That if the test results are positive, that is, if the results show that the person is infected with HIV, the provider is required to report the test subject’s name to the local county health department

Minors: Children under 18 are considered adults for the purpose of consenting to, or refusing, an HIV test. Parental permission is not required for a child judged by the healthcare provider to be sufficiently mature to consent or refuse an HIV test. Florida law forbids informing parents of a minor’s HIV test results either directly or indirectly (such as sending a bill for testing or treatment without the minor’s consent). It is up to the healthcare provider to decide whether the minor is capable of understanding the risks and benefits of the test or treatment.

During Pregnancy

A 1998 amendment to the Florida Omnibus AIDS Act requires the physician or midwife attending a woman for a condition related to pregnancy to offer HIV testing in conjunction with her required blood tests at the initial prenatal care visit and again at 28 to 32 weeks’ gestation, regardless of risk behaviors.

In 2005, the statute was amended to establish the current system of opt-out testing for all pregnant women. Under this system, all pregnant women are advised that their healthcare provider will conduct an HIV test but that they have the right to refuse testing. Any pregnant woman who refuses testing must do so in writing, and her refusal must be placed in her medical record (§384.31, F.S.).

Any pregnant woman who has positive test results should be referred to medical and support services related to HIV/AIDS as well as the Healthy Start Care Coordination System. Any pregnant woman who presents at delivery without a record of a blood test for HIV during pregnancy must be counseled and offered an HIV test.

HIV testing without informed consent may occur in the following circumstances:

Bona fide medical emergencies in which treatment is indicated by HIV status
When there has been significant exposure by medical personnel to a person’s blood, the source will not voluntarily submit to HIV testing, and a blood sample is not available (court order required)
In the event of a significant exposure to medical or nonmedical personnel providing help in an emergency and the victim has expired during treatment for the emergency
When a person is charged with sexual offenses (court order required)
When donating blood, sperm, or tissue to specialty banks
For infants whose parents cannot be located after reasonable attempts (court order required, and attempts to locate the parents documented)
Of prison inmates before they are released into the community
When performing HIV testing to monitor the clinical progress of a patient previously diagnosed as HIV-positive or repeated HIV testing conducted to monitor possible conversion from a significant exposure
Certain medical examiner cases, including court-ordered autopsies
When a child is deemed too young to make an informed decision (however, parental consent is required; the law does not specify what age is too young to make an informed decision)
Established epidemiologic research methods that ensure test subject anonymity
Of convicted prostitutes

Confidentiality

Anonymous and confidential HIV tests are available at Florida 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.

The legal requirements for counseling and testing are different for public- and private-sector facilities. County health departments must obtain written informed consent from the test subject. Registered testing sites and private-sector facilities are not required to obtain written consent, provided that the medical record includes documentation that the test was explained and consent was obtained. Written consent is preferable, nonetheless, because it provides practical advantages to the testing agency or facility and the healthcare worker in the event of litigation.

Superconfidentiality

Medical records are, by law, confidential. The Florida Omnibus Aids Act designates information about HIV testing as superconfidential if the tests can be traced to an identifiable individual. All test results, positive or negative, are superconfidential, which means that the information is only made available to healthcare personnel on a need-to-know basis. Providers, in turn, must sign a legal document not to divulge this information except on a need-to-know basis.

However, the law uses a narrow definition of “HIV test result.” The superconfidentiality standard applies only to the part of a person’s medical record that documents an HIV test and the results, negative or positive, of that test. If the documented HIV status was based on a health department anonymous test or a home testing kit, that does not constitute “HIV test results” and is not covered by the superconfidentiality standard.

Providers’ clinical assessments of any medical conditions associated with AIDS are also exempt from the superconfidentiality standard because they do not constitute “HIV test results” unless they include laboratory reports or medical-record notes of an HIV test. For example, a patient’s chart documenting symptoms of AIDS and including the word AIDS throughout the chart, but without an HIV test result or report, is not considered superconfidential.

Disclosure

Disclosure of HIV test results is limited to the following:

The test subject and his or her representative
Healthcare providers consulting among themselves regarding diagnosis and treatment of AIDS
The Department of Health
Healthcare providers exposed to the subject’s body fluids
Authorized medical or epidemiologic researchers; repeated tests may be given to monitor clinical progress without seeking renewed consent
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
Appropriate authorities in the course of reporting child abuse
Adults responsible for a child who is placed in foster care or for adoption
An exposed healthcare worker who exercised the right to subpoena the medical records of the patient and demand that HIV status be determined

Breaches of Confidentiality

The 1998 amendment to Florida’s Omnibus AIDS Act increased the penalty for breaches of confidentiality. Anyone who maliciously, or for monetary gain, breaches the confidentiality of sexually transmitted disease information commits a third-degree felony.

Notification

The healthcare provider ordering an HIV test must make all reasonable efforts to notify the person tested of the results. If the HIV-negative person fails to obtain the results, either by missing a scheduled visit or not calling in, the provider has met the “all reasonable efforts” standard.

However, if the test results show the person to be HIV-positive, the provider must exhaust all available means to contact the patient. If all efforts fail, the responsibility for notification can be transferred to the county health department through HIV infection–reporting requirements.

Post Test 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 must 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.

The Florida Department of Health has developed “Model Protocols on Counseling and Testing” that may be obtained through the website at http://www.floridaaids.org

Infection Control Procedures

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 Potentially Infectious Materials (OPIM): OPIM linked to transmission of HIV, HBV, and HCV are listed below. Standard precautions and universal precautions apply Blood and blood products, Semen, Vaginal secretions, Cerebrospinal fluid, Synovial fluid, Pleural fluid, Peritoneal fluid, Pericardial fluid, Amniotic fluid, Saliva in dental procedures, Any body fluid visibly contaminated with blood, All body fluids in situations where it is difficult or impossible to differentiate between body fluids, Any unfixed tissue or organ (other than intact skin) from a human (living or dead), and HIV-containing cell or tissue cultures, organ cultures, and HIV-or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV

Protocols for Healthcare Workers Exposed to Blood

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 (2005c):

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 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.
Exposure to urine, feces, vomitus, or sputum is not considered a blood-borne pathogens exposure unless the fluid is visibly contaminated with blood. Follow your employer’s procedures for cleaning these fluids.

Reporting 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 post-exposure 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.

Post-Exposure Prophylaxis (PEP)

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

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” .

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.

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. Medical counseling is recommended regarding personal risk of infection or risk of infecting others.

Follow Up

If the source individual cannot be identified or tested, decisions regarding follow-up should be based on the exposure risk and whether the source is likely to be infected with a blood-borne pathogen. Follow-up testing should be available to all personnel who are concerned about possible infection through occupational exposure.

CDC recommends that “healthcare personnel with occupational exposure to HIV receive follow-up counseling, post-exposure testing, and medical evaluation regardless of whether they receive PEP. HIV-antibody testing by enzyme immunoassay should be used to monitor healthcare personnel for sero-conversion for >6 months after occupational exposure”.

Healthcare personnel undergoing PEP should be monitored for drug toxicity by testing at baseline and again 2 weeks after starting PEP.
It is important to complete the full 4 weeks of PEP, despite side effects, which can include nausea, malaise, and fatigue. Many healthcare personnel, perhaps as many as 47 percent, do not complete the full course of therapy because of an inability to tolerate the drugs.

Safety devices have been developed to help prevent needle-stick injuries. If used properly, these types of devices may reduce the risk of exposure to HIV. Many percutaneous injuries are related to sharps disposal. Strategies for safer disposal, including safer design of disposal containers and placement of containers, are being developed.

Clinical Management

Antiretroviral therapy (ART) has reduced HIV-related morbidity and mortality at all stages of HIV infection and has reduced HIV transmission. Maximal and durable suppression of plasma viremia delays or prevents the selection of drug-resistance mutations, preserves or improves CD4 T lymphocyte (CD4) cell numbers, and confers substantial clinical benefits, all of which are important treatment goals. HIV suppression with ART may also decrease inflammation and immune activation thought to contribute to higher rates of cardiovascular and other end-organ damage reported in cohorts with HIV. Despite these benefits, eradication of HIV infection cannot be achieved with available antiretrovirals (ARVs). Treatment interruption has been associated with rebound viremia, worsening of immune function, and increased morbidity and mortality. Thus, once initiated, ART should be continued, with the following key treatment goals:

Maximally and durably suppress plasma HIV RNA;
Restore and preserve immunologic function;
Reduce HIV-associated morbidity and prolong the duration and quality of survival; and
Prevent HIV transmission.

Achieving viral suppression currently requires the use of combination ARV regimens that generally include three active drugs from two or more drug classes. Baseline patient characteristics and results from drug resistance testing should guide design of the specific regimen. When initial HIV suppression is not achieved or not maintained, changing to a new regimen with at least two active drugs is often required. The increasing number of ARV drugs and drug classes makes viral suppression below detection limits an achievable goal in most patients.

After initiation of effective ART, viral load reduction to below limits of assay detection usually occurs within the first 12 to 24 weeks of therapy. Predictors of virologic success include the following:

Low baseline viremia;
High potency of the ARV regimen;
Tolerability of the regimen;
Convenience of the regimen; and
Excellent adherence to the regimen.

Strategies to Achieve Treatment Goals

Selection of Initial Combination Regimen

Several ARV regimens are recommended for use in ART-naive patients. Most of the recommended regimens have comparable efficacy but vary in pill burden, potential for drug interactions and/or side effects, and propensity to select for resistance mutations if ART adherence is suboptimal. Regimens should be tailored for the individual patient to enhance adherence and support long-term treatment success. Considerations when selecting an ARV regimen for an individual patient include potential side effects, patient comorbidities, possible interactions with conconcomitant medications, results of pretreatment genotypic drug-resistance testing, and regimen convenience.

Improving Adherence

Suboptimal adherence may result in reduced treatment response. Incomplete adherence can result from complex medication regimens; patient-related factors, such as active substance abuse, depression, or the experience of adverse effects; and health system issues, including interruptions in patient access to medication and inadequate treatment education and support. Conditions that promote adherence should be maximized before and after initiation of ART.

Initiation of Antiretroviral Therapy

ART is recommended for all individuals with HIV, regardless of CD4 cell count, to reduce the morbidity and mortality associated with HIV infection (AI). ART is also recommended for individuals with HIV to prevent HIV transmission (AI). When initiating ART, it is important to educate patients about the benefits of ART, and to address barriers to adherence and recommend strategies to optimize adherence. On a case-by-case basis, ART may be deferred because of clinical and/or psychosocial factors; however, therapy should be initiated as soon as possible. Patients should also understand that currently available ART does not cure HIV. To improve and maintain immunologic function and maintain viral suppression, ART should be continued indefinitely.

While ART is recommended for all patients, the following conditions increase the urgency to initiate therapy:

Pregnancy
AIDS-defining conditions, including HIV-associated dementia (HAD) and AIDS-associated malignancies
Acute opportunistic infections (OIs) (see discussion below)
Lower CD4 counts (e.g., <200 cells/mm3)
HIV-associated nephropathy (HIVAN)
Acute/early infection
HIV/hepatitis B virus coinfection
HIV/hepatitis C virus coinfection

Anti-Retrovial Therapy

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

Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
Non-nucleoside reverse transcriptase inhibitors (NNRTI)
Protease inhibitors (PI)
Entry inhibitors, including fusion inhibitors and CCR5 antagonists
Integrase inhibitors

Nucleoside reverse transcriptase inhibitors (NRTIs) – block reverse transcriptase (an HIV enzyme). HIV uses reverse transcriptase to convert its RNA into DNA (reverse transcription). Blocking reverse transcriptase and reverse transcription prevents HIV from replicating.

Examples of NRTIs include:

abacavir (Ziagen)
abacavir/lamivudine (Epzicom)
abacavir/lamivudine/zidovudine (Trizivir)
lamivudine/zidovudine (Combivir)
lamivudine (Epivir)
zidovudine (Retrovir)
emtricitabine/tenofovir disoproxil fumarate (Truvada)
emtricitabine (Emtriva)
tenofovir disoproxil fumarate (Viread)
emtricitabine/tenofovir alafenamide (Descovy)

Some NRTIs are rarely used and will be discontinued by the manufacturer by 2020.

These drugs include:

didanosine (Videx)
didanosine extended-release (Videx EC)
stavudine (Zerit)

Non-nucleoside reverse transcriptase inhibitors (NNRTIs) – These drugs work in a similar way to NRTIs. They stop the virus from replicating itself in your body.

Examples of these drugs include:

efavirenz (Sustiva)
etravirine (Intelence)
nevirapine (Viramune)
nevirapine extended-release (Viramune XR)
rilpivirine (Edurant)
delavirdine mesylate (Rescriptor): rarely used

Protease inhibitors – Protease inhibitors work by binding to protease. This is a protein that HIV needs to replicate in the body. When protease can’t do its job, the virus can’t complete the process that makes new copies. This reduces the number of viruses that can infect more cells. Some protease inhibitors are only approved by the FDA to treat hepatitis C, but these are not the same as those used to treat HIV infection.

Examples of protease inhibitors used to treat HIV include:

atazanavir/cobicistat (Evotaz)
darunavir/cobicistat (Prezcobix)
lopinavir/ritonavir (Kaletra)
ritonavir (Norvir): always used to boost other medications, such as atazanavir, lopinavir, darunavir, or elvitegravir
atazanavir (Reyataz): often given together with ritonavir
darunavir (Prezista): must be given together with ritonavir
fosamprenavir (Lexiva): often given together with ritonavir
tipranavir (Aptivus): must be given together with ritonavir

HIV protease inhibitors that are rarely used because they have more side effects include:

nelfinavir (Viracept)
indinavir (Crixivan): often given together with ritonavir
saquinavir (Invirase): must be given together with ritonavir

Entry inhibitors (including fusion inhibitors) – Entry inhibitors are another class of HIV medication. HIV needs a host T-cell in order to make copies of itself. These drugs block the virus from entering a host T-cell. This prevents the virus from replicating itself. Entry inhibitors are rarely used in the United States because other available drugs are more effective and better tolerated. An example of an entry inhibitor is: enfuvirtide (Fuzeon)

Chemokine co-receptor antagonists (CCR5 antagonists) – CCR5 antagonists block HIV from entering cells. CCR5 antagonists are rarely used in the United States because other available drugs are more effective. An example of this type of drug includes: maraviroc (Selzentry)

Cytochrome P4503A (CYP3A) inhibitors – CYP3A are enzymes that protect liver and gastrointestinal health. CYP3A inhibitors increase the levels of certain HIV drugs in the body. These HIV drugs include protease inhibitors and certain integrase inhibitors.

Examples of CYP3A inhibitors include:

cobicistat (Tybost)
ritonavir (Norvir)

Immune-based therapies – Because HIV affects the immune system, researchers are studying ways that biological drugs can prevent viral replication. Certain immune-based treatments have been successful in some people in clinical trials and are currently being researched. They would be used along with other HIV medications. An example of an immune-based therapy is ibalizumab. This drug is an entry inhibitor. It prevents HIV from entering certain immune cells.

Integrase inhibitors – Integrase inhibitors are a class of medication that stops the action of integrase enzyme. This is a viral enzyme that HIV uses to infect T-cells. Integrase inhibitors are usually among the first HIV drugs used in people who have recently contracted HIV because they work well and have minimal side effects.

Examples of these drugs include:

dolutegravir (Tivicay)
elvitegravir (Vitekta)
raltegravir (Isentress)
raltegravir extended-release (Isentress HD)

Multiclass combination drugs – Combination drugs combine medications from different classes into one drug form. The drugs are combined to make a complete HIV regimen. This type of regimen is usually used to treat people who have never taken HIV medications before.

Examples of these drugs include:

abacavir/dolutegravir/lamivudine (Triumeq)
dolutegravir/rilpivirine (Juluca)
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild)
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya)
efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera)
emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey)
bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy)

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.

Prevention & Risk Reduction

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, 2006a). Following universal precautions in healthcare has unquestionably prevented thousands, if not millions, of cases of HIV/AIDS in the United States.

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

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:
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 partly erect

Women who have sex with women (WSW) also need to take precautions during oral sex, even though female-to-female transmission appears to be rare. According to the CDC, “vaginal secretions and menstrual blood are potentially infectious and mucous-membrane (e.g., oral, vaginal) exposure to these secretions have the potential to lead to HIV infection” (CDC, 2006b).

Precautionary measures include:

Using condoms consistently and correctly each and every time for sexual contact with men or when using sex toys; not sharing sex toys
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 one’s own and one’s 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

Injection Precautions: 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.

Prevention among MSM

The CDC (2010) has identified challenges to prevention of HIV transmission among men who have sex with men (MSM), particularly those aged 15–49 years old.

They include:

Unprotected sex
Use of alcohol and other drugs
Lack of awareness of HIV infection
Stigma and internalized homophobia
Social isolation
Racism, poverty, and lack of access to healthcare
Complacency about HIV based on ignorance

Complacency about HIV among young MSM stems from two key factors. The first is their lack of experience with the severity of the early HIV epidemic. The second is their mistaken belief that advances in treatment and decreased mortality mean that HIV is no longer a serious threat. They also fail to recognize that antiretroviral drugs are very expensive and may have serious, even life-threatening side effects.

Prevention among Seniors

Many seniors are sexually active well into their seventies and eighties, a fact sometimes overlooked by health professionals. Thus, physicians and other healthcare workers may fail to ask patients about unprotected sex or to offer voluntary HIV testing.

Perceived barriers to condom use among seniors include the following factors:

Drug and/or alcohol use before or during sexual activity
Belief that unprotected sexual activity is more exciting and that condoms reduce sexual pleasure
Lack of knowledge about effective use of condoms
HIV conspiracy beliefs
Belief that known and/or trusted partners are “safe”

Preventing Transmission to Uninfected Partners

Optimal care of people with HIV/AIDS includes an emphasis on prevention of transmission to uninfected partners. The CDC recommends that anyone with HIV/AIDS use prevention strategies even if his or her 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.

Summary

Thousands of people are living with HIV/AIDS in Florida, which has the third highest prevalence of HIV/AIDS in the country. Despite this ongoing tragedy, the public no longer has a sense of urgency or importance about AIDS. 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, testing, and educating patients, families, and communities. Health professionals can also teach by example, through offering nonjudgmental, compassionate care to those affected by this deadly virus.

Active Learning: Florida’s Plan to Eliminate HIV Transmission and Reduce HIV-related Deaths

Please review:

http://www.floridahealth.gov/diseases-and-conditions/aids/index.html
http://www.floridahealth.gov/diseases-and-conditions/aids/surveillance/fact-sheet1.html

Resources

Florida Department of Health, Bureau of HIV/AIDS
http://www.floridaaids.org/

Florida HIV/AIDS Hotlines
English: 800-FLA-AIDS (800-352-2437)
Spanish: 800-545-SIDA (800-545-7432)
Creole: 800-AUDS, 101 (800-243-7101)
TDD/TTY: 888-503-7118AIDS.gov http://www.aids.gov

AIDSinfo (Comprehensive site of the USDHHS) http://www.aidsinfo.nih.gov

Black AIDS Institute http://www.blackaids.org

The Body (HIV/AIDS Resource) http://www.thebody.com

Centers for Disease Control and Prevention (CDC) http://www.cdc.gov/hiv/

CDC National STD and AIDS Hotlines
English: 800-342-2437 or 800-227-8922
Spanish: 800-344-7432

References

CDC National Prevention Information Network (CDCNPIN). (2012). HIV/AIDS Today. Retrieved September 12, 2013 from: http://www.cdcnpin.org/scripts/hiv/hiv.asp.
Centers for Disease Control and Prevention (CDC). (2013). Surveillance Brief: Terms, Definitions, and Calculations Used in CDC HIV Surveillance Publications. Retrieved September 4, 2013 from http://www.cdc.gov/hiv/statistics/recommendations/terms.html.
Centers for Disease Control and Prevention (CDC). (2013a). HIV in the United States: At A Glance. Retrieved September 9, 2013 from http://www.cdc.gov/hiv/statistics/basics/ataglance.html.
Centers for Disease Control and Prevention (CDC). (2013b). HIV/AIDS, HIV Basics: Testing. Retrieved September 12, 2013 from http://www.cdc.gov/hiv/basics/testing.html.
Centers for Disease Control and Prevention (CDC). (2013c). HIV and Viral Hepatitis Fact Sheet. Retrieved September 13, 2013 from http://www.cdc.gov/hiv/resources/factsheets/hepatitis.htm.
Centers for Disease Control and Prevention (CDC). (2013d). HIV and Viral Hepatitis. Fast Facts. Retrieved September 13, 2013 from http://www.cdc.gov/hiv/pdf/library_factsheets_HIV_and_viral_Hepatitis.pdf.
Centers for Disease Control and Prevention (CDC). (2013e). High-Impact HIV Prevention: CDC’s Approach to Reducing HIV Infections in the United States. Retrieved September 13, 2013 from http://www.cdc.gov/hiv/policies/hip.html.
Centers for Disease Control and Prevention (CDC). (2011). Hand Hygiene in Healthcare Settings. Retrieved September 3, 2013 from http://www.cdc.gov/handhygiene/.
Centers for Disease Control and Prevention (CDC). (2011a). Occupational HIV Transmission and Prevention Among Health Care Workers. Retrieved September 13, 2013 from http://www.cdc.gov/hiv/resources/factsheets/hcwprev.htm.
Centers for Disease Control and Prevention (CDC). (2002) Guideline for Hand Hygiene in Health-Care Settings. MMWR Recommendations and Reports October 25, 2002 51(RR-16). Retrieved September 13, 2013 from http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf
Falagas ME, Karydis I, Kostogiannou I. (2007). Percutaneous Exposure Incidents of the Health Care Personnel in a Newly Founded Tertiary Hospital: A Prospective Study. PLoS ONE. 2007; 2(2): e194. Retrieved September 13, 2013 from http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1805815.
Florida Department of Health, Bureau of Communicable Disease (FDOH). (2013). Florida’s Omnibus AIDS Act: A Brief Legal Guide for Health Care Professionals. Originated by Jack P. Hartog, Esq. Retrieved September 3, 2013 from http://www.doh.state.fl.us/disease_ctrl/aids/legal/Omnibus-booklet-update-2013.pdf
Florida Department of Health, Bureau of Communicable Disease (FDOH). (2012). Florida HIV/AIDS Annual Report 2012. Retrieved September 12, 2013 from http://www.doh.state.fl.us/disease_ctrl/aids/trends/epiprof/HIVAIDS-annual-morbidity-2012.pdf.
Florida Department of Health, Bureau of Communicable Disease (FDOH). (2010). Model Protocol for HIV Counseling and Testing for County Health Departments and Registered Testing Programs. Retrieved September 13, 2013 from http://www.doh.state.fl.us/Disease_ctrl/aids/legal/ctforchd.htm.
Florida Department of Health, Bureau of Communicable Disease (FDOH). (2010a). HIV Disease: United States vs. Florida. Retrieved September 12, 2013 from http://www.doh.state.fl.us/disease_ctrl/aids/updates/facts/10Facts/
2010_US_VS_FL_Fact_Sheet.pdf
Florida Department of Health, Bureau of Communicable Disease (FDOH). (2010b). Model Protocol for HIV Counseling and Testing Conducted Outside County Health Departments and Registered Testing Programs. Retrieved September 13, 2013 from http://www.doh.state.fl.us/Disease_ctrl/aids/legal/ctfornonchd.htm
Florida Senate. (2013). The 2013 Florida Statutes: HIV Testing. Retrieved September 13, 2013 from http://archive.flsenate.gov/statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0300-0399/0381/Sections/0381.004.html.
Global HIV Prevention Working Group. (2008). Behavior Change and HIV Prevention: (Re)Considerations for the 21st Century. Available from http://www.globalhivprevention.org/pdfs/PWG_behavior%20report_FINAL.pdf.
Nunn AS, Fonseca EM, Bastos FI, et al. (2007). Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment. PLoS Med 4(11): e305. doi:10.1371/journal.pmed.0040305. Retrieved September 13, 2013 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2071936/pdf/pmed.0040305.pdf?tool=pmcentrez.
Pittet D. (2001). Improving Adherence to Hand Hygiene Practice: A Multidisciplinary Approach. Emerging Infectious Diseases 7(2). Retrieved September 13, 2013 from http://www.cdc.gov/ncidod/EID/vol7no2/pittet.htm.
Sendi P, Gafni A. (2003). The HAART side of resource allocation. CMAJ 169(2): 120–21. Retrieved September 13, 2013 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC164977/pdf/20030722s00022p120.pdf?tool=pmcentrez.
Sougrat R, Bartesaghi A, Lifson JD, et al. (2007, May). Electron tomography of the contact between T cells and SIV/HIV-1: Implications for viral entry. PLoS Creative Commons Attribution 2.5 license.
UNAIDS. (2012). Global Fact Sheet. Retrieved September 12, 2013 from http://www.unaids.org/en/media/unaids/contentassets/documents/epidemiology/2012/
gr2012/20121120_FactSheet_Global_en.pdf
UNAIDS. (2009). 2009 AIDS epidemic update. Retrieved September 12, 2013 from http://www.unaids.org/en/media/unaids/contentassets/dataimport/pub/report/2009/
jc1700_epi_update_2009_en.pdf.
U.S. Department of Health and Human Services (DHHS). (2013). Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Retrieved September 13, 2013 from http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
Washington State Department of Health (WSDOH). (2007). KNOW HIV Prevention Education, 2007 Revised Edition: An HIV and AIDS Curriculum Manual for Healthcare Facility Employees. Retrieved September 6, 2013 from http://www.doh.wa.gov/Portals/1/Documents/Pubs/410-007-KNOWCurriculum.pdf.
World Health Organization (WHO). (2009.) WHO Guidelines on Hand Hygiene in Health Care. 2009. Retrieved September 13, 2013 from http://www.cdc.gov/handhygiene/Guidelines.html and http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf.