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CompletedNCT00680862Updated Sep 29, 2014Results posted

Qualitative Assessment of Implementing Routine Rapid HIV Testing

An observational study in HIV Infections, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-29.

Sponsored by US Department of Veterans Affairs · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV
  • screening
03

In context

HIV Infections

4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 25 is below the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

key informant VA employees

Inclusion criteria

  • VA employees of LA OPC who are involved in HIV care and/or policy

Exclusion criteria

Exclusion Criteria:

  • n/a
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
25 participants (actual)

Groups and cohorts

  • Group 1

    VA employees

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Completed the Survey

    survey responses from participants on thoughts pertaining to implementation of HIV rapid testing

    Time frame: 6 months

07

Results

Posted Sep 29, 2014

Participant flow

Participant flow — Overall Study
MilestoneGroup 1
Started25
Completed25
Not completed0

Outcome measures

PrimaryNumber of Participants Who Completed the Survey

survey responses from participants on thoughts pertaining to implementation of HIV rapid testing

Time frame:
6 months
Reported as:
Number · participants
Number of Participants Who Completed the Survey
participantsGroup 1
Number of Participants Who Completed the Survey25

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1———

Baseline characteristics

VA employees

Age, Continuous
Age, Continuous(years)Group 1
Mean36 ± 2
Age, Categorical
Age, Categorical(Participants)Group 1
<=18 years0
Between 18 and 65 years25
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Group 1
Female0
Male25
Region of Enrollment
Region of Enrollment(participants)Group 1
United States25
08

Study locations

1 site
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
    West Los Angeles, California 90073, United States
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00680862
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
May 20, 2008
Start date
Jun 2008
Primary completion
Sep 2008
Completion
Sep 2008
Results posted
Sep 29, 2014
Last update
Sep 29, 2014

Study contacts

Henry Anaya, PhD MA
principal investigator · VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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