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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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:

  1. To develop generalized qualitative methods and instruments which can be used to evaluate VA HIV rapid testing implementation efforts;
  2. 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);
  3. 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 groups in NCT00680862
Study groupRoleWhat they receive
Group 1VA employees

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted20 May 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

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)
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
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

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.

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Clinical Trial NCT00680862 | AzTrials