CDC HIV Testing Guidelines: Unresolved Ethical Concerns
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Other: CDC HIV testing recommendations |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
| Official Title: | CDC HIV Testing Guidelines: Unresolved Ethical Concerns |
- Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations [ Time Frame: Immediate ] [ Designated as safety issue: No ]
- Comparison/contrast of patient and provider perspectives on concerns raised about the 2006 CDC HIV testing recommendations [ Time Frame: Immediate ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Rhode Island | |
| Memorial Hospital of Rhode Island | |
| Pawtucket, Rhode Island, United States | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Miriam Hospital | |
| Providence, Rhode Island, United States | |
| Principal Investigator: | Roland C Merchant, MD, MPH, ScD | Rhode Island Hospital |
More Information
No publications provided
| Responsible Party: | Roland C. Merchant, Rhode Island Hospital |
| ClinicalTrials.gov Identifier: | NCT00564369 History of Changes |
| Other Study ID Numbers: | 106879-42-RGAT, 106879-42-RGAT |
| Study First Received: | November 26, 2007 |
| Last Updated: | February 3, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rhode Island Hospital:
|
HIV testing HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases HIV Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013