- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680862
Qualitative Assessment of Implementing Routine Rapid HIV Testing
Study Overview
Status
Conditions
Detailed Description
Background:
During the past three decades, human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS) have caused extensive illness and death in the United States. Since the advent of the HIV epidemic, the VA healthcare system has been significantly impacted. Veterans are at much higher HIV risk than the general population. In addition, a significant proportion of VA patients are members of minority groups, and are homeless, both patient categories which have also been linked to high HIV prevalence. Because the VA is the largest provider of HIV treatment in the US, it is imperative that researchers develop innovative methods to 1) identify HIV-positive individuals, 2) provide them with the knowledge of their HIV-positive status; 3) do so early enough in the disease so that patients can be placed into care, so that antiretroviral therapies can be effective, and the HIV epidemic can be slowed and reversed.
Current HIV testing methods have been highly ineffective in this regard, due in large measure to the method itself. Conventional HIV testing requires both a blood draw and laboratory analysis, requiring a patient to schedule a future visit to receive results. Consequently, a significant number of people simply do not return for their test results. Current HIV prevalence figures bear this out. The Centers for Disease Control and Prevention (CDC) estimates that of the 1.2 million HIV infected persons in the US, as many as 1/3 are unaware of their infection. Indeed, the CDC now recommends routine HIV testing for all Americans. This recommendation was predicated on the evidence that moving from a risk-based, to a routine testing model is one of the most effective ways to significantly increase testing rates. As better HIV identification systems begin to spread through the VHA, the VHA must determine the proper place for broader routine HIV rapid testing programs in their delivery systems. Demonstrating effectiveness is only the first step. To make policy recommendations, we must better understand the challenges of implementing a testing system that would apply to all, not just at-risk patients.
The move toward routine HIV testing, combined with a novel diagnostic tool (rapid testing) although highly effective, provides many implementation challenges. For example, what are the unintended adverse consequences in implementing NRT? What are the barriers and facilitators to implementation? How important are local nursing and physician champions and opinion leaders? These issues are of paramount importance in reaching an evidence-based consensus as to what a 'best practices' approach could look like within a large, decentralized healthcare organization like VA.
Objectives:
The specific aims of this project then, are:
- To develop generalized qualitative methods and instruments which can be used to evaluate VA HIV rapid testing implementation efforts;
- To employ these developed instruments to qualitatively document the implementation of our previously successful NRT strategy for spreading NRT to VA primary/urgent care practice at our downtown Los Angeles Outpatient Clinic (OPC);
- To explore and document barriers, facilitators, and unintended consequences of implementing our NRT model of HIV testing at LAOPC.
Methods:
We used qualitative methods to conduct formative and process evaluations which allowed us to fully assess our research objective, which were:
A thorough examination, exploration and description of the barriers and facilitators to implementing NRT at the Los Angeles Outpatient Clinic (OPC).
Status:
project objectives completed; manuscript being developed
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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West Los Angeles, California, United States, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- VA employees of LA OPC who are involved in HIV care and/or policy
Exclusion Criteria:
- n/a
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
VA employees
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Completed the Survey
Time Frame: 6 months
|
survey responses from participants on thoughts pertaining to implementation of HIV rapid testing
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6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Henry Anaya, PhD MA, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHP 08-158
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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