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NCT00564369 · ClinicalTrials.gov registry record · NA

CDC HIV Testing Guidelines: Unresolved Ethical Concerns

A NA study, sponsored by Rhode Island Hospital.

Completed
Registry status
NA
Development phase
1,000
Enrollment target

NCT00564369 is a NA study that has completed, run by Rhode Island Hospital. The registered enrollment target is 1,000 participants.

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The verdict

NCT00564369, a NA study, has completed, sponsored by Rhode Island Hospital.

COMPLETED
Registry status
NA
Development phase
1,000 participants
Enrollment target

Study 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.

Interventions

  • OTHER CDC HIV testing recommendations

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2007-07
Est. Completion 2008-12
Phase NA

Sponsor

Rhode Island Hospital

130 total trials

What the Registry Record Tells You About NCT00564369

The ClinicalTrials.gov registry entry for NCT00564369 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which CDC HIV testing recommendations is the first listed.

NCT00564369 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00564369 about?

NCT00564369 is a clinical study titled "CDC HIV Testing Guidelines: Unresolved Ethical Concerns". 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 consen...

What is the current status of trial NCT00564369?

This trial is currently completed. It is a NA study. The enrollment target is 1,000 participants. The study started on 2007-07. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00564369?

The interventions under investigation include: CDC HIV testing recommendations (OTHER).

Who is sponsoring clinical trial NCT00564369?

This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.