CDC HIV Testing Guidelines: Unresolved Ethical Concerns

Study Overview
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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.

Official Title
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CDC HIV Testing Guidelines: Unresolved Ethical Concerns

Conditions
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HIV Infections

Intervention / Treatment
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* Other: CDC HIV testing recommendations


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2006 CDC recommendations | Other: CDC HIV testing recommendations<br>* Current vs. prior CDC recommendations<br>|
| Active Comparator: 2<br>Prior CDC recommendations | Other: CDC HIV testing recommendations<br>* Current vs. prior CDC recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV testing, HIV Seronegativity