HIV InfectionsNCT00680862
Qualitative Assessment of Implementing Routine Rapid HIV Testing
An observational study of HIV Infections, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Qualitative assessment of implementing routine HIV rapid testing in primary care clinics within VA Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: key informant VA employees
Who may be able to join
- VA employees of LA OPC who are involved in HIV care and/or policy
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Qualitative assessment of implementing routine HIV rapid testing in primary care clinics within VA
Read the 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
- Conditions
- HIV Infections
- Keywords
- HIV, screening
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | VA employees |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed the Survey
survey responses from participants on thoughts pertaining to implementation of HIV rapid testing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Henry Anaya, PhD MA, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680862
- Sponsor's protocol ID
- SHP 08-158
- Status last verified
- Sep 2014
- First submitted
- 15 May 2008
- Last updated
- 29 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Anaya HD, Bokhour B, Feld J, Golden JF, Asch SM, Knapp H. Implementation of routine rapid HIV testing within the U.S. Department of Veterans Affairs Healthcare System. J Healthc Qual. 2012 Sep-Oct;34(5):7-14. doi: 10.1111/j.1945-1474.2011.00151.x. Epub 2011 May 25.
PubMed 22060061
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Assessment of Implementing Routine Rapid HIV Testing
- ClinicalTrials.gov ID
- NCT00680862
- Acronym / sponsor ID
- SHP 08-158
- Conditions
- HIV Infections
- Keywords
- HIV, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 May 2008 (estimated)
- Results
- Posted 29 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Qualitative assessment of implementing routine HIV rapid testing in primary care clinics within VA
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –VA employees |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- key informant VA employees
Key inclusion criteria (1 listed)
- VA employees of LA OPC who are involved in HIV care and/or policy
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Who Completed the Survey
Time frame: 6 months
survey responses from participants on thoughts pertaining to implementation of HIV rapid testing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22060061Anaya HD, Bokhour B, Feld J, Golden JF, Asch SM, Knapp H. Implementation of routine rapid HIV testing within the U.S. Department of Veterans Affairs Healthcare System. J Healthc Qual. 2012 Sep-Oct;34(5):7-14. doi: 10.1111/j.1945-1474.2011.00151.x. Epub 2011 May 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Anaya, PhD MA principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Completed the Survey (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00680862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2014.