Clinical trial NCT00564369: CDC HIV Testing Guidelines: Unresolved Ethical Concerns
Official title: CDC HIV Testing Guidelines: Unresolved Ethical Concerns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV testing
HIV Seronegativity
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: amfAR, The Foundation for AIDS Research
First posted: 2007-11-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations
timeFrame: Immediate
Secondary outcomes:
measure: Comparison/contrast of patient and provider perspectives on concerns raised about the 2006 CDC HIV testing recommendations
timeFrame: Immediate
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Roland C Merchant, MD, MPH, ScD
role: PRINCIPAL_INVESTIGATOR
References: