CDC HIV Testing Guidelines: Unresolved Ethical Concerns

Completed · Not applicable

Conditions studied: HIV Infections

In brief

Advocacy groups have voiced concerns about the ethics of some of tenets of the CDC's new HIV testing recommendations for the healthcare setting. Three concerns are paramount: (1) the opt-out approach to HIV testing can potentially be coercive and not truly voluntary; (2) by replacing informed consent with general consent for medical care, test participants might not know or be adequately informed of the benefits and consequences of testing; and (3) eliminating HIV prevention counseling from the HIV testing process presumes that test participants are aware of how to prevent an HIV infection, which might not be correct. This study involves conducting interviews of HIV advocates who are raising these concerns, surveying outpatient and emergency department clinical providers about their beliefs and opinions regarding the tenets of the new guidelines, and then conducting a multi-center, randomized, controlled trial in which the ethical concerns of opt-out vs. opt-in testing are directly compared. We will conduct a multi-center, randomized, controlled, trial whereby patients will be surveyed on their perspectives and perceptions regarding opt-out or opt-in rapid HIV testing. We will survey the participants regarding their perception of coercion, their understanding of the elements contained in the informed consent process, their HIV risk factors, and their knowledge of HIV prevention. We will evaluate whether or not the CDC-recommended approaches regarding opt-out testing, consent, and decoupling of prevention counseling are supported. If there are no differences regarding these ethical concerns between testing approaches, then the opt-out approach would be considered not to be inferior to the opt-in approach.

Key facts

Study ID

NCT00564369

Run by

Rhode Island Hospital

People needed

1000

Starts

2007-07-01

Expected to finish

2008-12-01

Last updated by the study team

2013-11-26

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18-64-year-old patients in the outpatient family practice and medical clinics and emergency departments of Memorial Hospital, Miriam Hospital, and Rhode Island Hospital who speak English or Spanish and are not HIV infected

You may not qualify if…

• HIV infection
• Inability to speak English or Spanish
• A physical, psychiatric, or mental disability that prevents participation in the study
• Involvement in an HIV vaccine study
• Prisoner

Where it is running

• Memorial Hospital of Rhode Island — Pawtucket, Rhode Island, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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