HIV PositiveNCT00012701
Measuring HIV Quality of Care
An observational study of HIV Positive and Facility Level Care, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
The VA is the largest single provider of HIV care in the United States. The late 1990's have seen a revolution in the quality standards for this disease with the onset of Highly Active Antiretroviral Therapy (HAART) and other developments. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Positive, Facility Level Care, Clinical Reminder
- How many people
- 1,600 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Jun 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Facilities with HIV clinics
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
The VA is the largest single provider of HIV care in the United States. The late 1990's have seen a revolution in the quality standards for this disease with the onset of Highly Active Antiretroviral Therapy (HAART) and other developments.
Read the detailed description
Background:
The VA is the largest single provider of HIV care in the United States. The late 1990's have seen a revolution in the quality standards for this disease with the onset of Highly Active Antiretroviral Therapy (HAART) and other developments.
Objectives:
Our purpose in this project is to develop a method for assessing quality in two important areas of HIV care - antiretroviral medications and opportunistic infection screening and prophylaxis - and explore the determinants of high quality care in order to suggest quality improvement strategies.
Methods:
The analysis has four parts. First, it will describe the level of adherence to the indicators in VA HIV patients nationwide and compare VA HIV patients to national benchmarks. Second, it will analyze facility and patient level predictors of adherence to indicators of quality of care and compare them with the predictors in the non VA population using staged logistic regressions. Third, it will seek to validate certain indicators (e.g. HAART therapy) against clinical outcomes like hospitalization and immune status. We will also model the clinical "price" that the VA pays in suboptimal clinical outcomes as a result of current performance levels. Fourth, we will compare the performance of the facilities after one year of an intensive targeted indicator-specific feedback group versus those receiving aggregate data only.
Status:
Data analysis.
- Conditions
- HIV Positive, Facility Level Care, Clinical Reminder
- Medical subject headings
- HIV Seropositivity
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 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV PositiveStudies 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
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven M. Asch, MD MPH, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CASamuel A. Bozzette, MD PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012701
- Sponsor's protocol ID
- HIS 99-042
- Status last verified
- Jul 2005
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Patterson ES, Nguyen AD, Halloran JP, Asch SM. Human factors barriers to the effective use of ten HIV clinical reminders. J Am Med Inform Assoc. 2004 Jan-Feb;11(1):50-9. doi: 10.1197/jamia.M1364. Epub 2003 Oct 5.
PubMed 14527974Bozzette SA, Phillips B, Asch S, Gifford AL, Lenert L, Menke T, Ortiz E, Owens D, Deyton L. Quality Enhancement Research Initiative for human immunodeficiency virus/acquired immunodeficiency syndrome: framework and plan. HIV-QUERI Executive Committee. Med Care. 2000 Jun;38(6 Suppl 1):I60-9. doi: 10.1097/00005650-200006001-00007.
PubMed 10843271Asch SM, Fremont AM, Turner BJ, Gifford A, McCutchan JA, Mathews WM, Bozzette SA, Shapiro MF. Symptom-based framework for assessing quality of HIV care. Int J Qual Health Care. 2004 Feb;16(1):41-50. doi: 10.1093/intqhc/mzh004.
PubMed 15020559Bozzette SA, Gifford AL. The economic viability of antiretroviral adherence interventions. Am J Med. 2003 Dec 1;115(8):672-3. doi: 10.1016/j.amjmed.2003.09.023. No abstract available.
PubMed 14656623
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring HIV Quality of Care
- ClinicalTrials.gov ID
- NCT00012701
- Acronym / sponsor ID
- HIS 99-042
- Conditions
- HIV Positive, Facility Level Care, Clinical Reminder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Jun 2003 (actual)
- First posted
- 16 Mar 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The VA is the largest single provider of HIV care in the United States. The late 1990's have seen a revolution in the quality standards for this disease with the onset of Highly Active Antiretroviral Therapy (HAART) and other developments.
Detailed description
Background:
The VA is the largest single provider of HIV care in the United States. The late 1990's have seen a revolution in the quality standards for this disease with the onset of Highly Active Antiretroviral Therapy (HAART) and other developments.
Objectives:
Our purpose in this project is to develop a method for assessing quality in two important areas of HIV care - antiretroviral medications and opportunistic infection screening and prophylaxis - and explore the determinants of high quality care in order to suggest quality improvement strategies.
Methods:
The analysis has four parts. First, it will describe the level of adherence to the indicators in VA HIV patients nationwide and compare VA HIV patients to national benchmarks. Second, it will analyze facility and patient level predictors of adherence to indicators of quality of care and compare them with the predictors in the non VA population using staged logistic regressions. Third, it will seek to validate certain indicators (e.g. HAART therapy) against clinical outcomes like hospitalization and immune status. We will also model the clinical "price" that the VA pays in suboptimal clinical outcomes as a result of current performance levels. Fourth, we will compare the performance of the facilities after one year of an intensive targeted indicator-specific feedback group versus those receiving aggregate data only.
Status:
Data analysis.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Facilities with HIV clinics
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 14527974Patterson ES, Nguyen AD, Halloran JP, Asch SM. Human factors barriers to the effective use of ten HIV clinical reminders. J Am Med Inform Assoc. 2004 Jan-Feb;11(1):50-9. doi: 10.1197/jamia.M1364. Epub 2003 Oct 5.
- Results publication: PubMed 10843271Bozzette SA, Phillips B, Asch S, Gifford AL, Lenert L, Menke T, Ortiz E, Owens D, Deyton L. Quality Enhancement Research Initiative for human immunodeficiency virus/acquired immunodeficiency syndrome: framework and plan. HIV-QUERI Executive Committee. Med Care. 2000 Jun;38(6 Suppl 1):I60-9. doi: 10.1097/00005650-200006001-00007.
- Results publication: PubMed 15020559Asch SM, Fremont AM, Turner BJ, Gifford A, McCutchan JA, Mathews WM, Bozzette SA, Shapiro MF. Symptom-based framework for assessing quality of HIV care. Int J Qual Health Care. 2004 Feb;16(1):41-50. doi: 10.1093/intqhc/mzh004.
- Results publication: PubMed 14656623Bozzette SA, Gifford AL. The economic viability of antiretroviral adherence interventions. Am J Med. 2003 Dec 1;115(8):672-3. doi: 10.1016/j.amjmed.2003.09.023. No abstract available.
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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.
Steven M. Asch, MD MPH principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Samuel A. Bozzette, MD PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Positive and Facility Level Care, run by US Department of Veterans Affairs at 2 sites 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 0 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00012701, which also lists 4 linked publications.
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 7 Apr 2015.