900.001 Informed Consent for HIV in a Routine Testing Environment
|Effective Date||September 1, 2010|
|Revision Date||September 1, 2010|
|Subject Matter Expert||Special Projects and Expanded Testing Team|
|Approval Authority||Branch Manager|
|Signed by||Ann S. Robbins, Ph.D.|
To provide procedural guidance for ensuring informed consent when implementing routine, opt-out HIV testing in clinical settings.
In 2006, the Centers for Disease Control and Prevention (CDC) released the Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. This document recommends diagnostic, opt-out HIV screening as part of routine clinical care in health-care settings for all patients aged 13-64. Health care settings include STD clinics, hospital emergency departments, urgent-care clinics, inpatient services, substance abuse treatment clinics, tuberculosis (TB) clinics, community clinics, correctional health-care facilities and primary care settings.
HIV has traditionally been viewed differently than other diseases, and as a result, testing protocols evolved with additional provisions, including separate consent forms, pre-test risk assessments and behavioral counseling. Normalizing HIV testing in health care settings by offering it in much the same way as other diagnostic procedures can serve to reduce the stigma associated with testing, increase rates of testing, and identify persons with unrecognized HIV infection earlier in the disease process.
Texas Health and Safety Code: §81.105 Informed Consent, §81.106 General Consent, and §81.109 Counseling Required for Positive Test Results; CDC Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings (55 RR14, 1-17, 2006).
Clinical, medical or health-care settings – includes hospital emergency departments, urgent-care clinics, STD clinics or other venues offering clinical STD services, tuberculosis (TB) clinics, substance abuse treatment clinics, other public health clinics, community clinics, correctional health-care facilities, and primary care settings.
Diagnostic testing – any medical test performed to aid in the diagnosis or detection of disease.
Informed consent – the outcome of a process through which the patient understands the extent of testing or treatment provided, has an opportunity to ask questions, and in the case of HIV testing, has an opportunity to opt-out or decline. Informed consent includes communication between patient and provider, and may include other media such as patient brochures, waiting room signage and/or videos.
Opt-in – presenting HIV testing to patients in such a way that requires the patient to specifically request the test be performed.
Opt-out – presenting HIV testing to patients in such a way that normalizes HIV testing by placing it alongside other diagnostic procedures; patient may decline testing.
Risk-based testing – gathering sexual and drug history for each patient within a venue or population, then testing only those perceived to be at risk for HIV infection.
Routine testing or screening - performing an HIV test for all persons in a defined population or venue, the terms also imply an absence of risk assessment and pretest counseling.
Texas law and DSHS policy require informed consent for all HIV testing.
6.0 Persons Affected
It is recommended that all DSHS programs implement routine, opt-out HIV testing in clinical settings.
In order to maximize HIV testing and ensure informed consent, it is recommended programs follow these steps to implement the routine, opt-out model:
Informed consent is the outcome of a process by which the patient understands the testing or treatment provided, has an opportunity to ask questions about it, and in the case of HIV testing, can decline if he/she does not wish to test. Key to this process is the patient – provider interaction, with forms, signage and other media playing an important supporting role.
- When implementing routine, opt-out HIV testing, pre-test risk assessment or risk counseling are not necessary as all patients within the venue are offered a test.
- The HIV test is presented in the same way as other routine diagnostic tests. A typical scenario might sound like this: “during your visit today, we’ll be doing several tests including _______, HIV, and _________. What questions or concerns do you have about any of these tests?” (note: fill in the blanks in this statement with other tests the provider is performing for the patient at this visit.)
- To ensure informed consent, practitioners must explicitly name the HIV test in this interaction.
- Avoid the phrase, “do you want an HIV test?” as it leads the patient to decline.
- Answer any questions the patient has about the test, the virus, or its implications.
- If a patient wishes to decline, find out why. A good response to why the patient is being tested for HIV is, “we recommend HIV testing for all our patients.”
- If after this discussion, the patient still wishes to decline, practitioners must document this in the patient’s medical record, and have the patient initial the general consent form at “I decline HIV testing at this time.”
A separate consent form is not required as the general consent form is considered sufficient. For this purpose, the DSHS General Consent and Disclosure form has been revised (L-36, April 2010).
7.3 Other Media
- Some providers use signs or videos in waiting areas or exam rooms to let patients know HIV tests are done routinely.
- Providers can order brochures and pamphlets about HIV and HIV testing from the DSHS warehouse. Place these in waiting areas or exam rooms.
As with all medical tests, HIV test results are confidential. Non-reactive or HIV negative test results can be provided in the same way as other non-reactive test results are given.
Post-test counseling for HIV-positive test results must be provided to patients in a face-to-face visit. Providing positive results, along with connecting the infected person to HIV medical care and public health follow-up services, can be provided by DSHS regional or local health department STD staff. Practitioners should become familiar with the STD program staff in their area and build relationships for this vital service.
8.0 Revision History
|9/3/2014||Converted format (Word to HTML)||-|