Informed Consent: Streamlined Pretest Information

Streamlined pretest information disconnects risk assessment from the pretest process. In a streamlined pretest information session, patients would receive oral or written information on the meaning and ramifications of HIV testing, the risks and benefits of testing, the implications of preliminary test results, and how and when test results will be communicated to them.  Patients would also have the opportunity to raise and discuss any questions they may have. Intensive counseling and referral for further care would be employed when patients are diagnosed with HIV or when HIV testing and counseling are otherwise consistent with the medical visit, such as when the visit is related to a behavioral or clinical risk factor (e.g., substance abuse or symptoms of an STD) or when other health promotion services are usually offered (e.g., as part of comprehensive health assessments, reproductive health care, or family planning).

When undergoing rapid HIV testing, patients must be additionally advised that:

• Results of their rapid HIV test will be available quickly, within as little as 20 minutes of administering the test
• Positive rapid tests are preliminary results and a second test will need to be performed to confirm the test result

The FDA also requires that an information pamphlet on the specific rapid HIV test used be given to the patient. These are available from the test manufacturers and distributors. 

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