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CDC HIV Testing Guidelines: Unresolved Ethical Concerns

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CDC HIV testing recommendations
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infections focused on measuring HIV testing, HIV Seronegativity

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Memorial Hospital of Rhode Island
  • Rhode Island Hospital
  • Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

2006 CDC recommendations

Prior CDC recommendations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 26, 2007
Last Updated
November 25, 2013
Sponsor
Rhode Island Hospital
Collaborators
amfAR, The Foundation for AIDS Research
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1. Study Identification

Unique Protocol Identification Number
NCT00564369
Brief Title
CDC HIV Testing Guidelines: Unresolved Ethical Concerns
Official Title
CDC HIV Testing Guidelines: Unresolved Ethical Concerns
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rhode Island Hospital
Collaborators
amfAR, The Foundation for AIDS Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV testing, HIV Seronegativity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
2006 CDC recommendations
Arm Title
2
Arm Type
Active Comparator
Arm Description
Prior CDC recommendations
Intervention Type
Other
Intervention Name(s)
CDC HIV testing recommendations
Intervention Description
Current vs. prior CDC recommendations
Primary Outcome Measure Information:
Title
Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations
Time Frame
Immediate
Secondary Outcome Measure Information:
Title
Comparison/contrast of patient and provider perspectives on concerns raised about the 2006 CDC HIV testing recommendations
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland C Merchant, MD, MPH, ScD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hospital of Rhode Island
City
Pawtucket
State/Province
Rhode Island
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CDC HIV Testing Guidelines: Unresolved Ethical Concerns

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