CDC HIV Testing Guidelines: Unresolved Ethical Concerns

NCT00564369 | Completed

• 1 other identifier: 106879-42-RGAT
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infections

Keywords

HIV testing; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

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

  Immediate

Secondary Outcomes (1)

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

  Immediate

Study Arms (2)

1

EXPERIMENTAL

2006 CDC recommendations

Other: CDC HIV testing recommendations

2

ACTIVE COMPARATOR

Prior CDC recommendations

Other: CDC HIV testing recommendations

Interventions

CDC HIV testing recommendations OTHER

Current vs. prior CDC recommendations

1; 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• amfAR, The Foundation for AIDS Research: collaborator

Study Sites (3)

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Miriam Hospital

Providence, Rhode Island, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Roland C Merchant, MD, MPH, ScD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 28, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 26, 2013

Record last verified: 2009-02

Locations

US (3)