Testing & Counseling

Testing for HIV

Why be tested?

As 45,000 people are being diagnosed with HIV in the United States each year and nearly 30% of new HIV infections are due to undiagnosed people who unknowingly transmit HIV, it stands to reason why HIV testing is the first step in maintaining a healthy life and reducing the spread of HIV.

By means of a routine preventive healthcare measure, the CDC (The Centers for Disease Control and Prevention) is attempting to lower the risks on HIV by recommending that all people aged 13 to 64 be tested for HIV at least once. Anyone with a higher risk of acquiring infection may need more frequent testing.

People with a higher risk should be tested once a year. The most prominent need for yearly testing (and possibly even as frequently as every 3 to 6 months) would include a male who is a sexually active gay or bisexual man. Others include those who have had an HIV-positive partner, or who have had more than one partner since the last HIV test, or have shared needles or works to inject drugs, or have exchanged sex for drugs or money, or have another sexually transmitted disease, hepatitis, or tuberculosis.

Any woman pregnant or planning to get pregnant is also advised to be tested as early as possible to protect herself and her baby.

Data retrieved from a clinical trial (sponsored by the National Institutes of Health) indicate there is a clear personal health advantage to being diagnosed and for starting therapy in the early course of HIV infection as it can extend the life of HIV-infected person by many years. Studies are showing the importance of routine HIV testing and its potential impact toward creating better health outcomes.

There is a window period between the time a person contracts HIV and when a test can accurately detect it. The period varies from person to person and is dependent on the individual’s immune response and the type of test used with the blood, oral fluid or urine specimen. When deciding to test, it’s important to determine the last possible exposure.

The Different Types of Testing

Antibody Tests

Because antibodies help the body fight off infection by identifying and neutralizing pathogens such as bacteria and viruses–marking them for the immune system to destroy these intruders or render them harmless–testing for antibodies within our system can determine if these HIV foreign pathogens are invading our body.

For the body to produce antibodies against HIV, it takes the immune system approximately 2 to 8 weeks to produce enough of them to be detected by testing. As these tests are improved with time, current antibody tests can identify infection as early as 21 days. Not all testing providers have the most current testing technology, however. Antibody tests may be used as an initial screening for HIV or as supplemental tests to assist in making a diagnosis.

As the most commonly used testing for HIV, antibody-screening tests (immunoassays) conducted at the point of care are capable of providing preliminary rapid results in 20 minutes or less. Some more advanced tests can identify infection as early as 3 weeks after infection. These preliminary screening immunoassays are designed to detect HIV-1 and/or HIV-2 antibodies in blood, oral fluid and urine specimens. Supplemental testing is required to confirm the infection.

Specific Types of Antibody Testing:

1. Blood-based screening tests – used in public health clinics, medical offices and community outreach settings, this type of test detects antibodies in whole blood, plasma and/or serum. Most point of care rapid tests can detect antibodies in whole blood collected via finger stick or venipuncture. When a point of care test is unavailable, plasma or serum specimens may be collected at the test site and submitted to a lab for processing.
2. Oral fluid screening – this test detects HIV antibodies within fluid inside the mouth called oral mucosal transudate. By using a special swab, a specimen can be collected by swabbing the fluid around the gums of the mouth. If the oral specimen rapid test kit is unavailable at point of care, an oral fluid collection device may be sent to a licensed lab for processing. HIV testing using oral fluid specimens are sometimes offered by public health clinics and community outreach agencies.
3. Urine screening – this test is limited within physician’s offices in Washington state. Only one FDA approved enzyme immunoassay (EIA) is actually available on the market to detect HIV antibodies in urine (Maxim HIV-1 Urine EIA, manufactured by Maxim Biomedical, Inc.).

Supplemental antibody tests

Newer technology is capable of confirming early infection. Historically, positive/reactive screening tests were used by laboratory-based antibody tests such as the Western blot (WB) or immunofluorescence assays (IFA). These are no longer part of the recommended for serum and plasma testing of HIV.

More recent to date, a combination antigen/antibody immunoassay (see below) is capable of identifying infection earlier and is preferred as the initial screening test for HIV.

The recommended supplemental antibody tests are those like the Multispot HIV-1/HIV-2 (Bio-Rad Laboratories), which is capable of differentiating HIV-1 antibodies from HIV-2 antibodies. This is recommended to confirm an HIV diagnosis. Negative or indeterminate results on the differentiation test may require supplemental viral RNA testing (discussed below).

At-Home HIV test kits:

Two home HIV test kits are currently approved by the United States Food and Drug Administration (FDA) to detect antibodies against HIV.

1. Home Access HIV-1 Test System – this collection kit manufactured by Home Access Health Corporation is intended for the purpose of anonymous HIV-1 testing and requires a few drops of blood, which is mailed to a licensed lab in a safe mailer. For reactive screening tests, supplemental testing is performed by the lab to confirm the result. Results are obtained via phone to the company using an anonymous code number. Confidential counseling and referral services is provided by the manufacturer. An estimated 99.9% of infected individuals who test will receive a reactive result when the kit is used according to the manufacturer’s guidelines.
2. The OraQuick In-Home HIV Test – this over-the-counter (OTC) diagnostic home-use test uses an oral swab for detection of HIV-1 and HIV-2. Manufactured by OraSure Technologies, the special collection device looks like a toothbrush and tests for antibodies against HIV-1 and HIV-2. Results are obtained in 20 minutes; shipping the sample is not required. Positive results are preliminary and supplemental testing will be required. The company offers a confidential 24/7 support center. The FDA states that an estimated 1 out of 12 people tested with the OraQuick in-Home HIV test will test negative when they are actually positive (i.e. receive a “false negative” result). A false positive result is also possible, but in rare cases.

Combination Antigen (Ag) / Antibody (Ab) Tests:

Combination tests are recently developed “4th generation” immunoassays that are capable of detecting antibodies against the Human Immunodeficiency Virus (HIV) and parts of the virus itself (antigen). These type tests are capable of identifying HIV infections earlier than tests that detect only antibodies. Detectible in this testing are viral antigens such as the viral capsid (core) protein p24 may appear as early as two weeks after infection. Since p24 protein may be undetectable after the body begins to produce antibodies to the virus, combination tests provide detection of both virus antigens and antibodies to HIV. For combination antigen and antibody tests, serum, plasma or whole blood samples need to be collected.

Nucleic Acid Tests:

A much faster test to detect HIV is the Nucleic acid test. It detects the genetic material of the virus and can identify HIV in the bloodstream around 10 days after infection. Ribonucleic acid (RNA) is FDA approved and RNA tests must be performed by licensed laboratories. To perform this type of test, a blood (plasma) specimen is required.

HIV Testing - How and W here?

How is a person tested for HIV?

Initial HIV tests are either an antibody test or a combination test. For a rapid test, it involves obtaining blood or oral fluid and sending it to a laboratory. If the initial test is a rapid test and it is positive, follow-up testing will be required. If the initial HIV test is a laboratory test and is positive, the laboratory will usually conduct follow-up testing on the same blood specimen as the initial test. HIV tests are generally very accurate; however, follow-up testing allows the health care provider to be sure the diagnosis is right.

Where to Test for HIV?

Public health departments, medical providers, family planning or sexually transmitted disease clinics, and some community sites provide HIV testing, particularly those provide syringe exchanges or ones designated as nonprofit HIV prevention agencies. Healthcare providers in Washington State are in charge of diagnosing and reporting two thirds of new HIV infections. Home HIV testing kits are available for those who prefer in-home testing. (See Different Types of Testing previously mentioned in this section for more information about in-home testing.)

Confidential Testing

When seeking medical care for HIV testing, a client can be assured that their medical information is kept confidential. A legal name is needed and all the information about their testing is maintained in medical records. Advantages to confidential HIV testing allows people diagnosed with HIV to be efficiently linked to HIV medical care. This then leads to better health for them and reduces the chance that they will transmit HIV to others. Records are not released to others except when medically necessary or under special circumstances, such as when they sign a release for the results to be given to another person or agency that will offer them medical or social support services.

Anonymous Testing

Although anonymous HIV testing is not recommended for most people who need an HIV test, it is available. This is not recommended because this type of testing may delay or prevent efficient linkage to medical care for people diagnosed with HIV. While confidential HIV results are reported to local public health officials, an anonymous HIV antibody test gives the client the option to not give a name and the person who orders or performs the test does not maintain a record of the name of the person they are testing.

By Washington law, assigned rights and responsibility is given to local Health Officers for determining how much confidential testing should be available within their jurisdictions. HIV is a reportable condition, as it is important to protect the public from harmful infections.

Informed Consent

In order to perform an HIV test, consent must be obtained from the person attaining it so they will know they are receiving a test for HIV and have the chance to ask questions about the test prior to getting the test This can be a consent for medical treatment, or if conducted in a non-medical setting, be separate from medical treatment. Whether verbal or written, the consent must be specific to HIV and documented by the organization providing the test. Rare exceptions where a person can be tested without their consent would relate to occupational exposures and legally mandated situations specified in Washington State law. (See Legal Issues in Section 5 of this course for more information about mandatory testing.)

Testing Information and Risk Assessment

All people tested for HIV (other than those private exceptions listed above) should be assessed for their risk of infection and given appropriate information about their test and the disease process. The information to provide, though not limited to, includes:

1. The person’s HIV status and the potential dangers of the disease and the benefits of learning more about it
2. The meaning of the HIV results and their importance in being obtained.
3. How HIV is transmitted and how it can be prevented and/or how to lessen its risk concerning self and others
4. The availability of anonymous testing (when appropriate) and the differences between anonymous and confidential testing.

The Antibod y Test for HIV

Window Period

The time between an exposure to HIV infection, and when the HIV-infected person begins to develop enough antibodies to be detected by an HIV test, is referred to as the “window period.” An antibody test will reveal a negative result until the infected person’s immune system is able to make enough antibodies so it can show up on testing. This means that a person can be infected with HIV while having a negative test result until their immune system produces a sufficient amount of HIV antibodies.

The window period for nucleic acid tests is much shorter than for an antibody test. This is a more expensive test that can detect genetic material of the body to determine HIV. Test results will indicate RNA of HIV virus present in the body.

The production of antibodies varies among people and take anywhere from two weeks to twelve weeks for antibodies to develop and reveal themselves on tests. Most people develop enough antibodies for detection by three months after exposure. This is why it is necessary for people to test three months after the last potential HIV exposure.

HIV virus tends to multiply rapidly in newly infected people, the reason why it is essential for early treatment. Before an HIV-infected person begins antiviral drug treatment, the virus contained in the body is large and their blood is highly contagious.

This makes the "window period" a contagious period for HIV-infected people, even though an antibody test is negative. Engaging in behaviors that place a person at risk for HIV should be discouraged even if their HIV test was negative. Adopting risk reduction practices will be beneficial while awaiting another HIV test. Anyone who practices risky behaviors should test at least twice annually.

Negative Results

Two things can result in a negative HIV test:

1. The person does not have an HIV infection
2. The infection was obtained recently and the immune system has not produced enough antibodies to be detected by a test

For those who have had recent incidents pertaining to HIV infection, it is advised to test three weeks to three months from the date of the last possible exposure. Cases that involve direct bloodstream incidences (those with higher risks to HIV), such as sharing of needles or unprotected sex, may obtain an HIV test sooner than three weeks. The most appropriate test will be determined by the HIV test provider consulted by the person seeking the test. Referrals for testing (when indicated for testing) can be provided as necessary if a particular testing modality is not available from the provider sought. Negative test results do not mean the person has an immunity to HIV, for if risky behaviors continue, infection may occur.

Positive Results

When a test is confirmed positive and the presence of HIV antibodies or HIV RNA is present, this indicates:

1. The person is infected with HIV
2. The virus can be spread too thers through unsafe sexual practices, sharing contaminated injection equipment and/or breastfeeding
3. Infection is lifelong
4. HIV medical care treatment is needed immediately and the person should be assisted toward starting treatment.

Indeterminate Results

For persons who have recently engaged in risky behaviors that place them high at risk for contracting HIV and test results come back as “indeterminate” or “inconclusive,” it’s possible that they are newly-infected and may not have enough antibodies produced in their body to show up on testing. These test results occasionally happen and is referred to as “seroconverting.”

RNA testing is an option if seroconversion is suspected, and when this test isn’t available for determining the presence of HIV, then a second specimen should be drawn and tested with a different antibody test. If a person is seroconverting, this second test might give a positive result.

Results that are labeled “indeterminate” are not always indicative of seroconversion. Such results can also be caused by cross-reaction with other proteins from several sources including pregnancy, other autoimmune diseases, and recent influenza vaccinations. If seroconversion is not suspected (when person is low risk for HIV), re-testing should be conducted at one month and again at three months from the last possible exposure to ensure that they are not infected. If subsequent tests continue to be indeterminate (without additional HIV antibody protein bands) or reveal negative results, then non-infection is determined.

Although it’s possible for some uninfected people to always test indeterminate, low risk clients with indeterminate results are rare. Other uninfected people who first test indeterminate cab clear their bodies of other proteins that are causing the cross-reaction and test negative in subsequent tests. For those who go back and forth between indeterminate and negative, the client needs to be counseled encouragingly, explaining that only HIV positive tests indicate infection with HIV and that some people test indeterminate because of other non-HIV proteins in their bodies that register on the test. No further testing is indicated for other diseases.

Early Testing Advantage

Treatment for HIV through drug therapies can greatly improve a person’s health and extend their life. By testing early, the necessary treatment can be started immediately and sustain an infected person’s health by many years, thus allowing people with HIV to live as long as non-infected persons. Not only is early detection important to begin treatment as soon as possible, the risk of transmitting HIV is also lowered once the administration of antiretroviral drugs begins.

Testing & Counseling

Counseling the HIV-infected person is mandated by Washington State law (WAC 246-100-207 and -209). It requires that anyone testing for HIV be offered counseling and the necessary information he/she needs for learning more about the disease and how to prevent it from spreading to others. Anyone at high risk for HIV, or who requests counseling should receive it.

In retrospect, the law states that persons who refuse counseling should not be denied an HIV test. Everyone has a right to refuse counseling and referrals can be made to another person or agency for counseling if the client requests it. Pre-test counseling and post-test counseling is available. The person testing the client does not have to provide the counseling themselves, however.

Any request for HIV counseling, it should be provided and directed towards (1) increasing the client’s understanding of their own risk of acquiring or transmitting HIV; (2) motivating the client to reduce their risk; and (3) assisting the client to build skills to reduce their risk.

Pre-Test Counseling

Though not required, pre-test counseling is available to a person seeking an HIV test after being informed of the option.

Functions of Pre-test counseling:

1. Assists the individual in setting realistic behavior-change goals and establishes strategies for reducing his/her risk of acquiring or transmitting HIV
2. Provides appropriate risk reduction skills to support their behavior-change goals
3. Provides references for other appropriate prevention, support and information about medical services.

Post-test Counseling

Post-test counseling accomplishes the same goals as pre-test counseling (see the list above.) It is offered to those who test either negative or positive. For those who test negative, it should be offered at the time a person receives his/her test results. Counseling may be provided by the person providing the results, or by a referral for the client to receive such counseling at another agency.

For positive tests, counseling can’t just be offered; it must be provided or referred.

Functions of post-test counseling (in addition to pre-test):

1. If confidentially tested, allows HIV information to be reported under Washington State law
2. Supports in notifying partner or provides referral to a public health provider for partner notification
3. Provides appropriate referrals for alcohol and drug and mental health counseling, medical evaluation, TB screening, and HIV prevention and other support services.
4. Assists persons who are newly diagnosed with HIV to obtain appropriate medical care.

Testing Confidentiality

HIV information requires strict confidentiality agreements. Anything concerning a person’s HIV test and/or results is confidential information and must not be shared with others. Testing and counseling held in public health departments or health districts provide agreements for clients to sign to ensure confidentiality of their medical records. These agreements regulate the personal information that may be revealed in counseling and testing sessions, and test results.

HIV records have more restrictive rules than other records that govern personal medical records. Severe penalties for anyone disclosing confidential HIV information is punishable under Washington State law. Even accidental information breaches must be immediately reported to and investigated by the Washington State Department of Health.

Only authorized staff members have access to HIV test results. They are kept in locked files and/or secure databases. For more information on confidentiality requirements, see Section 5 – Legal & Ethical Issues.

HIV Testing and Pregnancy

Every pregnant woman seeking medical care must be offered HIV testing and should be tested unless they refuse the HIV test. Health care providers are required by Washington State law to provide HIV counseling and testing to all pregnant clients (RCW 70.24.095 and WAC 246-100-208).

A refusal of HIV testing requires a signature on a waiver form saying that the client is opting out of the HIV test. If a woman is HIV positive during pregnancy, by taking antiretroviral therapy, the chances of transmitting the virus to their unborn child during pregnancy and delivery is lessened considerably. See Section 2 for more information about HIV and pregnancy.)

Sexual Assault & HIV Testing

According to the National Violence Against Women Survey (NVAWS), more than 300,000 women and almost 93,000 men are raped annually. Reported data estimates 40% of female rape survivors are under age 18. It has been found that most sexual assault survivors know their assailant.

Men are survivors of sexual assault too, though they are much less likely to report, thus data and reporting are not as accurate. HIV is a big concern for sexual assault survivors and HIV testing is recommended.

Risks of HIV with Sexual Assault

Odds for transmission of HIV from a sexual assault incident in the United States is two in 1,000, according to the CDC. Although the risk is low, the fear of HIV adds to the emotional burden to many who are survivors of sexual assault.

HIV Testing

Having an HIV test after a sexual assault incident can help in the healing process. Having a negative HIV test is a relief to the survivor and can lessen the stress and emotional trauma that accompanies sexual assault. Few tests are ever positive, but when they are, the information will be needed for the individual and for any legal proceedings resulting from the assault.

Assault Window Period

For the sexually assaulted, the window period for testing is an important significate for the victim, for if tested shortly after the assault, the result provides the baseline status of the survivor. If negative, it can signify that the survivor did not have HIV at the time of assault. If results should come in positive three months later (and this is only in rare cases), then the test is helpful in providing evidence in criminal cases.

Because of the window period in antibody testing, survivors will need to be re-tested three months after the assault. Negative tests at the time will indicate that the individual is uninfected. If positive, this test will indicate that the survivor was infected by the assault (providing there were no risky behaviors engaged in by the survivor during those prior to testing).

Sexual Assault and PEP

PEP (Post-Exposure Prophylaxis) is offered as an option for the sexually assaulted to take in order to prevent HIV. Taking PEP is not effective 100% and can’t guarantee that someone exposed to HIV will not become infected with HIV. Used as a precautionary measure, PEP consists of 2-3 antiretroviral medications to be taken over a strict 28-day period. Although safe, it may cause nausea in some people, but side effects are treatable and not life threatening. Another important element to consider is that it must be started within 72 hours of exposure to be effective, before the virus has time to make too many copies of itself in the body.

Other Testing

Several factors must be considered when a person is sexually assaulted. Though HIV risks are low, risks of contracting other STIs are much higher and the potential for pregnancy also exists for women survivors.

It’s important for victims of sexual assault to get testing for STIs. If female, she should take emergency contraception. It is recommended that a sexual assault survivor go directly to the nearest hospital emergency room without changing their clothing, bathing or showering first. Counseling is provided by trained staff in the emergency room and they may offer testing or referral for HIV, STIs, and pregnancy.

Common practice for sexually assault victims include a physician’s order in the emergency room to take DNA samples of blood or semen from the survivor’s body. This can later be used as evidence against the attacker. HIV testing may come as referrals from emergency departments, sending assault survivors to local health jurisdiction for such testing. As with any HIV testing, no matter where done, all testing should be done in confidentiality.

Assailant Testing

Washington State allows only the victims of convicted sexual offenders to learn the attacker’s HIV status. The victim will have to consider whether or not to start post-exposure prophylaxis (PEP) independently of the source’s test result. This has to be decided on as soon as possible as the effectiveness in taking the medication is dependent on starting it within 72-hours after the attack.

Notifying the Partner

Notifying partners of an HIV status is an important step in preventing more risks for self and others. As it is sometimes a difficult feat for those newly diagnosed with HIV, a volunteer service is available for partner notification. This service is provided to HIV-positive people and their sex and/or injection equipment-sharing partner. A variety of strategies is used to maintain the confidentiality of both the HIV-infected client and the partners.

Notification can be done by the clients or public health staff can notify partners for them. When public health staff notify partners, they inform them of their exposure, provide counseling and information, and offer HIV testing but they do not identify the original client who tested positive.

By notifying partners, the necessary steps to avoid further risks of infection and the spreading of infection can be handled as quickly as possible. All parties involved will have the information needed to act on and prevent any added infection to others. Assisting in appropriate medical care for partners is also a function of partner notification services.