CDC HIV Testing Guidelines: Unresolved Ethical Concerns

HIV Infections Clinical Trial

Official title:

CDC HIV Testing Guidelines: Unresolved Ethical Concerns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564369
• Other study ID #: 106879-42-RGAT
• Secondary ID: 106879-42-RGAT
• Status: Completed
• Phase: N/A
• First received: November 26, 2007
• Last updated: November 25, 2013
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• CDC HIV testing recommendations
Current vs. prior CDC recommendations

Locations

Country	Name	City	State
United States	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island
United States	Miriam Hospital	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	amfAR, The Foundation for AIDS Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations		Immediate	No
Secondary	Comparison/contrast of patient and provider perspectives on concerns raised about the 2006 CDC HIV testing recommendations		Immediate	No