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CDC HIV Testing Guidelines: Unresolved Ethical Concerns

NCT ID: NCT00564369

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Keywords

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HIV testing HIV Seronegativity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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1

2006 CDC recommendations

Group Type EXPERIMENTAL

CDC HIV testing recommendations

Intervention Type OTHER

Current vs. prior CDC recommendations

2

Prior CDC recommendations

Group Type ACTIVE_COMPARATOR

CDC HIV testing recommendations

Intervention Type OTHER

Current vs. prior CDC recommendations

Interventions

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CDC HIV testing recommendations

Current vs. prior CDC recommendations

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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amfAR, The Foundation for AIDS Research

OTHER

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rhode Island Hospital

Principal Investigators

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Roland C Merchant, MD, MPH, ScD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

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Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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106879-42-RGAT

Identifier Type: -

Identifier Source: secondary_id

106879-42-RGAT

Identifier Type: -

Identifier Source: org_study_id