Qualitative Assessment of Implementing Routine Rapid HIV Testing
| Tracking Information | |||||
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| First Received Date ICMJE | May 15, 2008 | ||||
| Last Updated Date | April 23, 2012 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
survey responses [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00680862 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Qualitative Assessment of Implementing Routine Rapid HIV Testing | ||||
| Official Title ICMJE | Qualitative Assessment of Implementing Routine Rapid HIV Testing | ||||
| Brief Summary | Qualitative assessment of implementing routine HIV rapid testing in primary care clinics within VA |
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| 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:
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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | key informant VA employees |
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| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Group 1
VA employees |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 25 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - VA employees of LA OPC who are involved in HIV care and/or policy Exclusion Criteria: - n/a |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00680862 | ||||
| Other Study ID Numbers ICMJE | SHP 08-158 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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