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CDC HIV Testing Guidelines: Unresolved Ethical Concerns

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ClinicalTrials.gov Identifier: NCT00564369
Recruitment Status : Completed
First Posted : November 28, 2007
Last Update Posted : November 26, 2013
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV Infections Other: CDC HIV testing recommendations

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: CDC HIV Testing Guidelines: Unresolved Ethical Concerns
Study Start Date : July 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations [ Time Frame: Immediate ]

Secondary Outcome Measures :
  1. Comparison/contrast of patient and provider perspectives on concerns raised about the 2006 CDC HIV testing recommendations [ Time Frame: Immediate ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Roland C. Merchant, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00564369     History of Changes
Other Study ID Numbers: 106879-42-RGAT
First Posted: November 28, 2007    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: February 2009

Keywords provided by Rhode Island Hospital:
HIV testing
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases