Counseling Protocol for Rapid HIV Testing Sessions

Counseling Protocol for Rapid HIV Testing Sessions

This protocol is for use when only one CLIA-waived1 HIV rapid screening test is available and further testing by a licensed clinical laboratory is required to confirm a reactive screening test result. The New York State Department of Health will issue a revised protocol upon approval by the Food and Drug Administration (FDA) of a second CLIA-waived HIV rapid test, which can be used at the point of care to confirm an initial reactive test result.

The New York State Department of Health supports the use of rapid HIV testing, provided that the facilities adhere to Centers for Disease Control and Prevention (CDC) guidelines and to state regulations pertaining to laboratory testing, informed consent for HIV testing, the confidentiality of HIV-related information, and HIV reporting and partner notification.

CDC guidelines [MMWR 2001; 50(No RR-19):7-13] recommend that HIV testing be routinely recommended for pregnant women and for clients in health settings located in high seroprevalence areas. In low seroprevalence areas, CDC guidelines call for HIV counseling with testing recommended for all clients at increased behavioral or clinical risk of HIV.

Clinical and non-clinical providers seeking to offer waived rapid HIV antibody testing should contact the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP) at (518) 485-5378 or online (click on "Permit Applications Materials") for information concerning New York State application procedures and requirements.

Structure of the Rapid Testing Session

  • Pre-test counseling and informed consent;
  • HIV prevention/risk reduction counseling (in the clinical setting, risk reduction may be provided as part of pre-test counseling or by referral to a dedicated counselor or health educator);
  • Disclosure of the test result.

Pre-Test Counseling and Informed Consent

  • Recommend testing and introduce the rapid testing process.
  • Provide streamlined counseling, including information about the HIV test and ways HIV is transmitted, assisted by educational materials, such as "Key Messages About the Importance of HIV Testing".
  • Assess the client's readiness to receive the results, e.g. inquire about support systems and history of depression, suicide, and domestic violence.
  • Assist the client in choosing the appropriate test method (rapid or traditional, anonymous or confidential).
  • Obtain the client's signature on the informed consent form.
  • Collect the test specimen and order the test.

HIV Prevention/Risk Reduction Counseling

  • Explain how risk assessment will assist in interpreting the meaning of the test result.
  • Help the client specify behavior that place him/her at risk.
  • Help the client develop a realistic and incremental place to reduce risk, regardless of the test result.
  • Develop a written prevention plan.

Note: Risk reduction counseling may be provided even if the client does not consent to testing.

Disclosure of a Negative Test Result

  • Explain the test result.
  • Discuss the window period and, based on client risk, the need for subsequent testing.
  • Make an appointment for a subsequent post-test counseling visit if the client is at high behavioral risk for HIV.
  • Reinforce the prevention plan.

Disclosure of a Positive Result

  • Explain the meaning of the test result, using language to convey the probability (based on risk) that the client is infected, e.g. infection is "possible", "likely", or "probable".
  • Reinforce the necessity for confirmatory testing.
  • Provide the client with support for dealing with the test result, including the development of a plan for coping with the stress of waiting for the confirmatory test result. Provide crisis intervention and referrals as indicated.
  • Advise the client to adopt the behaviors discussed in the prevention plan (i.e., to act as if he/she is HIV-infected) until the reactive rapid test has been confirmed.
  • Make an appointment for the client's return to receive the confirmatory test result.
  • Arrange for a confirmatory HIV test (blood or oral fluid specimen) through a clinical laboratory.

Contacts for Questions

Questions regarding the HIV Primary Care Medicaid Program should be referred to:

Bureau of HIV Ambulatory Care
Division of HIV Health Care
New York State Department of Health, AIDS Institute
Empire State Plaza, Corning Tower Bldg., Rm. 459
Albany, NY 12237

Questions regarding performance of CLIA-waived tests should be referred to:

Clinical Laboratory Evaluation Program
New York State Department of Health
Wadsworth Center, P.O. Box 509
Albany, NY 12201-0509

Questions regarding training for HIV counseling and testing should be referred to:

Bureau of Program Review and System Development
Division of HIV Health Care
New York State Department of Health, AIDS Institute
Empire State Plaza, Corning Tower Bldg., Rm. 372
Albany, NY 12237