HIV TESTING

About 1 in 7 people in the United States who have HIV do not know they are infected and are not aware of their risk. HIV infection goes undiagnosed in 51.4% of HIV-positive 13- to 24-year-olds. HIV testing is an essential first step in halting the spread of the virus.

Who Should Be Tested?

The State of Florida and the CDC recommend 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 (HIV.gov, 2018; FL DOH, 2020).

Additionally, Florida mandates testing for specific populations, as described below:

PREGNANT WOMEN

Florida Statute 64D-3.042 requires all pregnant women to be tested for sexually transmitted diseases (STDs), including HIV, chlamydia, gonorrhea, hepatitis B, and syphilis at the initial prenatal care visit and again at 28 to 32 weeks gestation. Women who present in labor and delivery or within 30 days postpartum with no record of STD testing after 27 weeks gestation are considered at a high risk and should be tested for HIV, hepatitis B, and syphilis (FL DOH, 2018).

Prior to any testing required by this rule, practitioners shall:

• Notify the women which tests will be conducted
• Inform the woman of her right to refuse any or all tests
• Place a written statement of objection signed by the woman each time she refuses required testing in her medical record specifying which tests were refused
• If the woman refuses to sign the statement, document the refusal in the medical record; no testing shall occur for the infections specified in the refusal statement of objection
  (FL DoS, 2020)

CORRECTIONAL POPULATIONS

A person convicted under Florida Statute 796.07 of prostitution or procuring another to commit prostitution must undergo screening for a sexually transmissible disease, including, but not limited to, screening to detect exposure to HIV.

Florida Statute 381.004(2) mandates that the department shall perform an HIV test on an inmate within 60 days prior to the inmate’s presumptive release date from prison. Those who test positive are to be provided special transitional assistance, which must include:

• 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/AIDS-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
  (FL Legislature, 2020a)

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. The earliest 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, 2019d).

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. 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, 2019d).

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. 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, 2019d; Gillespie, 2019a).

Testing and Informed Consent in Florida

One of the key components of Florida’s plan to eliminate HIV transmission and reduce HIV-related deaths is the implementation of routine HIV screening in healthcare settings and priority testing in non-healthcare settings.

OBTAINING CONSENT

In Florida, in a healthcare setting, persons shall be notified orally or in writing that an HIV test is planned and that they have the right to decline the test. A person who has signed a general consent form for medical care is not required to sign or otherwise provide a separate consent for HIV testing.

In a non-healthcare setting where testing is being done, a provider shall obtain informed consent preceded by an explanation of the right to confidential treatment of information. The provider shall also inform the person that a positive HIV test result will be reported to the county health department.

Informed consent must be obtained from a legal guardian or other authorized person if the person being tested is not competent, is incapacitated, or is otherwise unable to make an informed judgment (FL Legislature, 2020a).

Minors

Minors in Florida (unemancipated children under the age of 18) are considered adults and do not require parental or guardian consent for the examination and treatment of sexually transmissible diseases, including HIV testing and treatment (FL Legislature, 2020a).

During Pregnancy

In Florida, every person attending a pregnant woman during the period of gestation and delivery shall test the woman for sexually transmissible diseases, including HIV. The woman shall be informed of the test and of her right to refuse testing. If a woman refuses, a signed written statement of objection shall be placed in the woman’s medical record and no testing shall occur (FL Legislature, 2020a).

TESTING WITHOUT INFORMED CONSENT

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

• Bona fide medical emergencies if results are necessary for medical diagnostic purposes to provide appropriate care
• Court-mandated testing
• Epidemiological research consistent with institutional review boards (identity of test subject is not known and may not be retrieved by the researcher)
• Lawfully collected organ and tissue donations (certain blood and tissue donations, sperm donations, corneal removals, and eye enucleations)
• Significant exposures of medical personnel during the course of employment, within the scope of practice, or during provision of emergency medical assistance
• Significant exposures of nonmedical personnel while providing emergency medical assistance during a medical emergency
• Convicted persons of prostitution or of procuring another to commit prostitution
• Prison inmates prior to release
• Criminal acts, when victims of criminal offenses involving transmission of body fluids obtain a court order to test a defendant
• Hospitalized infants for which testing is diagnostically indicated for the appropriate care and treatment of the infant if, after a reasonable attempt, a parent cannot be contacted to provide consent
• Repeat HIV testing, when performing HIV testing to monitor the clinical progress of a patient previously diagnosed as HIV-positive or repeat HIV testing conducted to monitor possible conversion from a significant exposure
  (FL Legislature, 2020a)

CONFIDENTIALITY

The identity of any person upon whom a test has been performed and the test results are both confidential. No person who has obtained or has knowledge of a test result may disclose or be compelled to disclose the identity of any person upon whom a test is performed, or the results of such a test in a manner that permits identification of the subject of the test, except to:

• The subject of the test or the subject’s legally authorized representative
• The public health department
• An authorized agent or employee of a health facility and healthcare provider authorized to obtain the test results
• Healthcare providers consulting between themselves or with healthcare facilities for diagnosis and treatment decisions
• Health facility or provider that procures, processes, distributes, or uses donor body parts or semen
• Healthcare facility staff committees for program monitoring, evaluation, or service reviews
• Authorized medical or epidemiological researchers
• A person allowed access by a court order
• A person allowed by order of a judge of compensation claims
• Employees of the department or of child-placing and child-caring agencies or of family foster homes
• Adoptive parents of the person, or any adult custodian, adult relative, or person responsible for a child’s welfare
• Employees of residential facilities or of community-based care programs caring for developmentally disabled persons
• A healthcare provider involved in the delivery of a child, who can note the mother’s HIV test results in the child’s medical record
• Medical or nonmedical personnel who have received significant exposure
• The medical examiner shall disclose results to the department
  (FL, 2020)

Breaches of Confidentiality

Any violation of confidentiality provisions shall be grounds for disciplinary action contained in the facility’s or professional’s respective licensing chapter. Any person who violates the confidentiality provisions commits a first-degree misdemeanor, punishable by a definite term of imprisonment not exceeding one year. Anyone who knew or should have known the nature of the information and maliciously, or for monetary gain, disseminates this information to any other person commits a third-degree felony, punishable by a term of imprisonment not to exceed five years (FL Legislature, 2020a).

Notification of Test Results

The healthcare professional ordering an HIV test must ensure that all reasonable efforts are made to notify the person tested of the results, relating information to the test subject for both negative and positive test results.

Positive test results should be accompanied by information on availability of appropriate medical and support services, importance of partner notification, and prevention of transmission of HIV.

Negative test results shall include, as appropriate, information on preventing the transmission of HIV.
(FL, 2020)

Counseling

Each county health department shall provide a program of counseling and testing for HIV infection on both an anonymous and confidential basis. Counseling provided shall include criteria for evaluating risk of infection, offering testing on a voluntary basis as a routine part of primary health care, and informing the patient of the availability of partner-notification services, the benefits of such services, and the confidentiality protections available as part of such services (FL Legislature, 2020a).