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CDC HIV Testing Guidelines: Unresolved Ethical Concerns

This study has been completed.
Sponsor:
Collaborator:
American Foundation for AIDS Research (amFAR)
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00564369
First received: November 26, 2007
Last updated: November 25, 2013
Last verified: February 2009

November 26, 2007
November 25, 2013
July 2007
December 2008   (final data collection date for primary outcome measure)
Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations [ Time Frame: Immediate ] [ Designated as safety issue: No ]
Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations [ Time Frame: Immediate ]
Complete list of historical versions of study NCT00564369 on ClinicalTrials.gov Archive Site
Comparison/contrast of patient and provider perspectives on concerns raised about the 2006 CDC HIV testing recommendations [ Time Frame: Immediate ] [ Designated as safety issue: No ]
Comparison/contrast of patient and provider perspectives on concerns raised about the 2006 CDC HIV testing recommendations [ Time Frame: Immediate ]
Not Provided
Not Provided
 
CDC HIV Testing Guidelines: Unresolved Ethical Concerns
CDC HIV Testing Guidelines: Unresolved Ethical Concerns

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
HIV Infections
Other: CDC HIV testing recommendations
Current vs. prior CDC recommendations
  • Experimental: 1
    2006 CDC recommendations
    Intervention: Other: CDC HIV testing recommendations
  • Active Comparator: 2
    Prior CDC recommendations
    Intervention: Other: CDC HIV testing recommendations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00564369
106879-42-RGAT, 106879-42-RGAT
No
Roland C. Merchant, Rhode Island Hospital
Rhode Island Hospital
American Foundation for AIDS Research (amFAR)
Principal Investigator: Roland C Merchant, MD, MPH, ScD Rhode Island Hospital
Rhode Island Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP