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Clinical Trials/NCT00564369
NCT00564369CompletedNot Applicable

CDC HIV Testing Guidelines: Unresolved Ethical Concerns

Rhode Island Hospital3 sites in 1 country1,000 target enrollmentStarted: July 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,000
Locations
3
Primary Endpoint
Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
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

Arms & Interventions

1

Experimental

2006 CDC recommendations

Intervention: CDC HIV testing recommendations (Other)

2

Active Comparator

Prior CDC recommendations

Intervention: CDC HIV testing recommendations (Other)

Outcomes

Primary Outcomes

Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations

Time Frame: Immediate

Secondary Outcomes

  • Comparison/contrast of patient and provider perspectives on concerns raised about the 2006 CDC HIV testing recommendations(Immediate)

Investigators

Sponsor Class
Other

Study Sites (3)

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