HIV TESTING AND COUNSELING

About 1 in 7 people in the United State who have HIV do not know they are infected and are not aware of their risk. HIV infection goes undiagnosed in over 50% of HIV-positive 13- to 24-year-olds.

The only way people can know they are infected with HIV is if they get tested. People who are aware of their positive status can then receive treatment that can help them to remain healthy for many years, and the sooner they begin treatment following diagnosis, the more they can benefit. People who test negative for HIV can also be prepared to make more informed decisions about matters of sex, drug use, and healthcare. Those who are HIV-negative and are at very high risk, may begin HIV pre-exposure prophylaxis (PrEP), which is highly effective for prevention of HIV (HIV.gov, 2018; NIH, 2020a).

CDC Testing Recommendations

The CDC recommends that everyone between the ages of 13 and 64 get tested for HIV at least once as part of routine healthcare and that people with certain risk factors be tested quarterly or at least annually.

Repeat testing may be done many times. If an individual has tested negative for HIV in the past and answers any of the following questions affirmatively since that previous test, repeat HIV testing should be done:

• Are you a man who has had sex with another man?
• Have you had sex (anal or vaginal) with an HIV-positive partner?
• Have you had more than one sex partner?
• Have you injected drugs and shared needles or works with others?
• Have you exchanged sex for drugs or money?
• Have you been diagnosed with, or sought treatment for, another sexually transmitted disease?
• Have you been diagnosed with or treated for hepatitis or tuberculosis?
• Have you had sex with someone who could answer “yes” to any of the above questions or someone whose sexual history you do not know?
  (HIV.Gov, 2018; WA DOH, 2020a)

TESTING MEN WHO HAVE SEX WITH MEN

CDC recommends that clinicians screen asymptomatic gay, bisexual, or men who have sex with men (MSM) at least annually. Furthermore, clinicians should consider the benefits of more frequent screening (e.g. once every 3 or 6 months) for individual MSM at increased risk for HIV infection (CDC, 2019o).

TESTING PREGNANT WOMEN

The chance that HIV infection will be transmitted from an HIV-infected pregnant woman to her child can be reduced to 1% or less if the mother’s HIV status is known and she receives treatment. Since 1975 the CDC has recommended that all pregnant women be tested for HIV. Despite this recommendation, however, many women still do not get tested for HIV during pregnancy for a variety of personal reasons.

There are two ways to approach pregnant women about HIV testing:

• Opt-in: Pregnant women are given pre-HIV test counseling, and they must agree to receive an HIV test, usually in writing.
• Opt-out: Pregnant women are told that HIV testing will be included in the standard group of prenatal tests and that they may decline the test. Unless they decline it, they will receive the test.

Evaluations of both approaches have led the CDC to recommend universal opt-out HIV testing for all pregnant women early in every pregnancy. A second test in the third trimester is recommended in certain geographic areas or for women who are known to be at high risk for becoming infected. The CDC also recommends HIV testing at labor and delivery for women without a prenatal test result (CDC, 2020g).

TESTING SEXUAL ASSAULT VICTIMS

Anyone who has been sexually assaulted should have an HIV antigen test, which can detect infection sooner than standard antibody testing. They should also be started on postexposure prophylaxis (PEP) within 3 days of exposure (HIV.gov, 2018).

Types of HIV Tests

There is no HIV test that can detect HIV immediately after infection. The time between acquiring HIV and when a test can accurately detect it is called the window period. This period varies from person to person and also depends on the type of HIV test (HIV.gov, 2018).

ANTIBODY TESTS

Most HIV tests, including most rapid tests and home tests, look for antibodies produced by the immune system. Most people will develop detectable antibodies within 3 to 12 weeks of infection, and so the soonest an antibody test can detect infection is 3 weeks. These tests are usually done with blood from a fingerstick or with oral fluid, and results are ready in 30 minutes or less.

Oral testing uses a specially treated pad placed into the mouth and gently rubbed between the lower cheek and gum. The pad collects oral mucosal transudate (OMt), which contains HIV antibodies in an HIV-infected person. (It does not test for HIV in saliva.) OMt testing is an alternative to blood testing and is able to detect infection one month or more later than blood-based tests due to the lower concentration of antibodies in oral fluid than in blood.

Urine HIV antibody tests use the urine ELISA and urine Western Blot technique to detect HIV antibodies and are FDA-licensed as an alternative to blood testing (CDC, 2019k).

ANTIBODY-ANTIGEN COMBINATION (FOURTH-GENERATION) TESTS

This type of testing (ELISA test or EIA/enzyme immunoassay) is the most accurate and reliable and looks for both HIV antibodies and part of the virus itself, the p24 antigen. The antigen can be detected before antibodies appear, and combination tests are recommended as the first test to be done in a laboratory setting.

Most laboratories use an immunoassay for detecting the HIV p24 antigen and antibodies to HIV-1, followed by a confirmatory immunoassay to distinguish between HIV-1 and HIV-2. Results take several days to be available.

Most people will make enough antigens and antibodies for fourth-generation or combination tests to accurately detect infection in blood drawn from a vein 2 to 6 weeks after infection. Antigen/antibody tests done with blood from a fingerstick can take longer to detect (up to 90 days) after an exposure (CDC, 2019k).

There are no antigen/antibody tests available for use with oral fluid.

HIV-1/HIV-2 DIFFERENTIATION IMMUNOASSAY (FIFTH GENERATION) TEST

The HIV-1/HIV-2 differentiation immunoassay detects the same biomarkers as the combination tests but can also distinguish between HIV-1 and HIV-2. This is a rapid laboratory-based test typically used to confirm a positive fourth-generation combination assay. Test results can be obtained generally in under 20 minutes.

NUCLEIC ACID TEST (NAT)

This test looks for HIV RNA or DNA in the blood, not the antibodies to the virus. This test is very expensive and is not routinely used for screening people unless they have recently had a high-risk exposure or a possible exposure with early symptoms of HIV infection.

Nucleic acid testing is also used for infants and children younger than 18 months. The HIV antibody-only and antigen/antibody combination tests used for adults and older children are not reliable in infants and young children, as they will detect the transplancentally acquired antibody maternal HIV antibodies that persist for many months following birth. It is essential to establish the diagnosis of HIV infection in this population because infected infants have a high morbidity and mortality if treatment is delayed.

There are no nucleic acid tests available for use with oral fluid. Most people will have enough HIV in their blood for a nucleic acid test to detect infection 1 to 4 weeks after infection. The results of NAT may take several days to be available (CDC, 2019k; Gillespie, 2019a).

HIV SCREENING TESTS

Test Category	Test
(CDC, 2020g)
Antibody tests	Vironostoke HIV-1 Microelisa Genetic System HIV-1/2
Rapid antibody tests	OraQuick Advance for blood and saliva Uni-gold Recombigen INSTI HIV-1/HIV-2
Antibody/antigen combination tests (4th generation)	Determine HIV 1/2 Ag/Ab Combo ARCHITECT HIV Ag/Ab Combo
HIV-1/HIV-2 differentiation immunoassay (5th generation)	Bio-Rad Geenius HIV1/2 confirmation assay Bio-Rad Multispot HIV-1/HIV-2
Nucleic acid test	Aptima HIV-1 RNA Qualitative Assay

Testing Sites

HIV tests are generally available in many places, including:

• Healthcare providers’ offices
• Health clinics or community health centers
• STD/STI or sexual health clinics
• Local health departments
• Family planning clinics
• VA medical centers
• Substance abuse prevention or treatment programs
• Many pharmacies
• Some community-based organizations that extend the reach of state and local health departments
• Home testing kits available in pharmacies or online
  (HIV.gov, 2018)

These sites can connect people to HIV care and treatment if they test positive or can discuss the best HIV prevention options if they test negative.

HIV Test Funding

HIV screening is covered by health insurance without a co-pay, as required by the Affordable Care Act. If an individual does not have health insurance, some testing sites may offer free tests (HIV.gov, 2018).

Medicare Part B covers an HIV screening once per year if the person meets one of these conditions:

• The person is age 15 to 64.
• The person is younger than 15 or older than 65 and at increased risk for HIV.

Medicare also pays for HIV screening up to three times during a woman’s pregnancy (Medicare.gov, 2020).

Testing Approaches and Reporting Results

There are three approaches by which HIV testing is implemented and carried out. They include:

• Point-of-care testing is done onsite where the patient is receiving services. Most rapid HIV testing is done in nonclinical settings. The results of these rapid tests are often provided in less than one hour or even within minutes.
• Home testing is an effective method for reaching people who are not otherwise getting tested.
• Laboratory-based testing involves testing done in an approved laboratory, with the person returning at a later date for the test result and counseling.

HIV test results are reported as negative, positive, or indeterminate.

A negative test result means the person is unlikely to be infected with HIV. However, if the HIV test is done following a recent potential HIV exposure and the result is negative, testing should be done again after the window period. If the result of an HIV test within 3 months following a potential HIV exposure is negative, repeat testing should be done again in 3 months for confirmation. Diagnosing a recently acquired HIV infection is important because this is the period when viral levels are high and the person is most likely to transmit HIV to someone else.

If the test results are positive, a follow-up test will be conducted for confirmation.

• If the test was a rapid screening test, the testing site will arrange a follow-up test.
• If the test was a self-test kit used at home, a positive HIV test result must always be confirmed by additional HIV testing performed in a healthcare setting.
• If the blood was tested in a laboratory, the laboratory will automatically conduct a follow-up test on the same sample to rule out a false positive.

If the follow-up test is also positive, the person is diagnosed with HIV infection.

An indeterminate result occurs when the test results are not clearly positive or negative. The final result usually depends on the person’s risk of having HIV. The most important HIV-related cause of an indeterminate test result is a recently acquired infection. Persons with high risk for HIV may be in the early stages of infection, and follow-up testing will be positive. Sometimes a person can have an indeterminate result for unknown reasons, and follow-up testing will be negative.

False-positive test results can occur due to technical issues associated with the test or biological causes. Technical issues include:

• Specimen mix-up
• Mislabeling
• Improper handling
• Misinterpretation of a visually read rapid test result

Biological causes include:

• Participation in an HIV vaccine study
• Autoimmune disorders
• Other medical conditions

False-negative screening results are more likely to occur with antibody-only tests than with the combination antigen/antibody test. Most false-negative results are due to the window period following acquisition of the HIV infection before antibodies are detectable. The use of combination antigen/antibody assays has reduced, but not eliminated, the possibility of a false-negative result (CDC, 2020h; Sax, 2019a).

HIV Counseling

HIV counseling refers to an interactive process of assessing risk, recognizing specific behaviors that increase the risk for acquiring or transmitting HIV, and developing a plan to take specific steps to reduce risks. It is a very important step in the testing process and begins with forming a relationship with a patient. Counseling and risk assessment should be client-focused but counselor-driven.

For individual testing, the CDC no longer supports extensive pretest and post-test counseling. Instead, CDC guidelines recommend:

• Persons who test positive for HIV should be counseled, either on-site or through referral, concerning the behavioral, psychosocial, and medical implications of HIV infection.
• Healthcare providers should assess the need for immediate medical care and psychosocial support.
• Providers should link persons with newly diagnosed HIV infection to services provided by healthcare personnel experienced in the management of HIV infection. Additional services that might be needed include:
  • Substance abuse counseling and treatment
  • Treatment for mental health disorders or emotional distress
  • Reproductive counseling
  • Risk-reduction counseling
  • Case management
• Providers should follow up to ensure that patients have received services for any identified needs
  (CDC, 2020h)

Additional recommendations for HIV counseling include the following:

Pretest Counseling

• Discuss HIV, risk factors, and prevention methods
• Explain the meaning of positive and negative test results and their implications
• Assess the patient’s personal and social supports
• Determine the patient’s readiness to cope with test results
• Discuss disclosure of test results to others
• Advise the patient if reporting positive test results to health authorities is required

Post-Test Counseling

• Inform the patient of the results and meaning of the test results
• Provide education about avoiding risks of sexual and injection drug exposures
• For those who test positive, assess the impact of test results for the patient
• Explain treatment options
• Discuss partner counseling and disclosure of test results to others
• Initiate a support and treatment plan
  (CDC, 2020h)

Risk Assessment and Harm Reduction Strategies

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

RISK ASSESSMENT QUESTIONS

Behavioral risks can be identified either through open-ended questions by the provider or through screening questions (i.e., a self-administered questionnaire). An example of an open-ended question is: “What are you doing now or what have you done in the past that you think may put you at risk of HIV infection?”

Common risk assessment questions include:

• How do you identify your gender (male, female, trans, other)?
• What is your preference for a sexual partner (male, female, trans, other)? Have you ever had an HIV or STD/STI test in the past, and if so, was it within the last year?
• Since your last HIV/STD test have you:
  • Had unprotected anal or vaginal sex?
  • Had vaginal or anal sex with a person who is HIV positive?
  • (If female) Had vaginal or anal sex with a person whom you know is a man who also has sex with men?
  • Exchanged sex for drugs, money, or something you needed?
  • Had vaginal or anal sex with a person who injects drugs?
  • Used injection drugs, and if so, did you share injection equipment?
(HIV Alliance, 2020)

RISK REDUCTION COUNSELING AND INTERVENTION STRATEGIES

Risk reduction counseling and harm reduction strategies can reduce behaviors that result in higher risk of HIV infection. Studies have shown that such counseling decreases the risk of sexually transmitted diseases, including HIV. Risk reduction counseling can range from brief prevention messages, to high-intensity behavioral discussions tailored to the person’s risk, to group-based strategies.

• Continue to advise consistent condom use as a crucial element of prevention. For women who are unable to convince their partners to use a condom, assess other barrier methods. (Female condoms are also impervious to viruses, including HIV; however, there is limited clinical data regarding their efficacy.)
• Recommend screening and treatment of STDs in those at risk for HIV due to the shared risk factors for both and the association of other STDs with HIV infection.
• For those who have high ongoing risk for HIV infection, recommend that they receive daily pre-exposure prophylaxis (PrEP).
• For patients who have had a mucosal or parenteral exposure to HIV within the prior 72 hours, recommend postexposure prophylaxis with an antiretroviral regimen.

For people who inject drugs, risk reduction interventions can include:

• Voluntary opioid substitution therapy and needle exchange programs. Opioid substitution has been found to decrease illicit opioid use, injection use, and sharing injection equipment.
• Needle exchange or supervised injection programs. Such programs are found to decrease needle reuse and sharing and to increase safe disposal of syringes and more hygienic injection practices.

For couples in which one is HIV infected and the other uninfected:

• Counsel about and recommend the initiation of antiretroviral treatment. Pre-exposure prophylaxis for the uninfected partner may be indicated until the partner with HIV has achieved a stable viral suppression on ART. This usually requires six months of treatment.
• When the infected partner has achieved viral suppression, the risk of HIV transmission is negligible, but the use of condoms should continue in order to reduce risk of STD transmission and in case there is a failure in viral suppression.

Strategies for preventing mother-to-child transmission:

• ART for pregnant women
• PEP (postexposure prophylaxis) for the infant

(Cohen, 2019)