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
  Purpose

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 Blind (Subject)
Primary Purpose: Health Services Research
Official Title: CDC HIV Testing Guidelines: Unresolved Ethical Concerns

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564369

Locations
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States
Miriam Hospital
Providence, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
American Foundation for AIDS Research (amFAR)
Investigators
Principal Investigator: Roland C Merchant, MD, MPH, ScD Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Roland C. Merchant, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00564369     History of Changes
Other Study ID Numbers: 106879-42-RGAT, 106879-42-RGAT
Study First Received: November 26, 2007
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV testing
HIV Seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
HIV Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014