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 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 Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Other: CDC HIV testing recommendations

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Pawtucket, Rhode Island, United States
      • Memorial Hospital of Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
    • Providence, Rhode Island, United States
      • Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; 2006 CDC recommendations	Other: CDC HIV testing recommendations; Current vs. prior CDC recommendations
ACTIVE_COMPARATOR: 2; Prior CDC recommendations	Other: CDC HIV testing recommendations; Current vs. prior CDC recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations	Immediate

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison/contrast of patient and provider perspectives on concerns raised about the 2006 CDC HIV testing recommendations	Immediate

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: amfAR, The Foundation for AIDS Research
• Investigators: Principal Investigator: Roland C Merchant, MD, MPH, ScD, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: November 26, 2007
• First Submitted That Met QC Criteria: November 27, 2007
• First Posted (ESTIMATE): November 28, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): November 26, 2013
• Last Update Submitted That Met QC Criteria: November 25, 2013
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: HIV Seronegativity; HIV testing
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 106879-42-RGAT