Clinical Trials


CDC HIV Testing Guidelines: Unresolved Ethical Concerns

This study has been completed
Rhode Island Hospital

amfAR, The Foundation for AIDS Research

Information provided by (Responsible Party)
Rhode Island Hospital Identifier

First received: November 26, 2007
Last updated: November 25, 2013
Last Verified: February 2009
History of Changes


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.

Condition Intervention
HIV Infections

Other : CDC HIV testing recommendations

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: CDC HIV Testing Guidelines: Unresolved Ethical Concerns

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures

  • Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations [ Time Frame: Immediate ]
Secondary Outcome Measures:
  • Comparison/contrast of patient and provider perspectives on concerns raised about the 2006 CDC HIV testing recommendations [ Time Frame: Immediate ]

Enrollment: 1000
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 1
2006 CDC recommendations
Other: CDC HIV testing recommendations

Current vs. prior CDC recommendations

Active Comparator: 2
Prior CDC recommendations
Other: CDC HIV testing recommendations

Current vs. prior CDC recommendations



Ages Eligible for Study: 18 Years to 64 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  


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

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT00564369


United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Miriam Hospital
Providence, Rhode Island, United States

Sponsors and Collaborators

Rhode Island Hospital
amfAR, The Foundation for AIDS Research


Principal Investigator: Roland C Merchant, MD, MPH, ScD Rhode Island Hospital
More Information

More Information

Responsible Party: Roland C. Merchant, Rhode Island Hospital Identifier: NCT00564369   History of Changes  
Other Study ID Numbers: 106879-42-RGAT  
Study First Received: November 26, 2007  
Last Updated: November 25, 2013  

Keywords provided by Rhode Island Hospital:

HIV testing
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections processed this data on July 23, 2018
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