Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient Retention in HIV Medical Care in a Primary Care Practice in Australia (RiC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02167100
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : September 21, 2015
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Dr. Mark Bloch, Holdsworth House Medical Practice

Brief Summary:

The purpose of this study is to determine linkage and retention in care in patients with HIV infection and reasons for loss to follow up Care in a High HIV-caseload Inner City Primary Care Practice in Sydney, Australia.

The investigators hypothesise that patients attending HHMP will have higher rates of linkage and retention in care than the US HIV-infected population, and equivalent to Australian modelling.


Condition or disease
HIV

Detailed Description:

Many deficits in the spectrum of engagement in HIV care are still present and pose barriers to optimal treatment outcomes. These deficits include late diagnosis of HIV , insufficient linkage to and retention in care (RiC), poor usage of antiretroviral therapy (ART), and suboptimal adherence to ART. Based on data from the United States Center for Disease Control, where a cascade of care has been developed examining total numbers with HIV, numbers diagnosed, numbers linked to care, numbers on treatment and numbers on effective treatment; only about a quarter of persons living with HIV (PLWH) in the US are effectively in care, with undetectable HIV viral load.

Current data available in an Australian population are based on a patient modelling analysis, highlighting the lack of real cohort data from clinical practices managing HIV patients in Australia.

Appropriate continuum in care is relevant both for the prognosis of the single patient and for reducing the HIV transmission in the community. Substance use, high CD4 cell counts and young age seem to be risk factors for failure to establish care.

Holdsworth House Medical Practice (HHMP) is a high HIV-caseload community medical practice in inner city Sydney that provides a Continuum of Care for HIV-infected patients, from counselling and testing to antiretroviral treatment.

In this audit, we will examine retrospectively the case notes of >2000 HIV-infected patients who attended HHMP in Darlinghurst, Sydney, New South Wales with documented HIV infection from 1st January 2009 to 31st March 2014.

The primary objective of this audit is to determine linkage and retention in care in patients with HIV-1 infection and reasons for loss to follow up. Audit findings will be systematically evaluated, and where indicated, changes will be made with the aim of monitoring linkage and retention in care.

The initial audit will include patients with documented HIV-1 infection, who have attended the practice over a 5-year period (2009 - 2014) for at least 2 visits that are separated by 3 - 12 months, with specific laboratory tests (i.e. CD4 T lymphocyte count, plasma HIV RNA etc.) performed either on-site or at a co-management site.

Retention in care will be assessed by the number of visits to either HHMP or co-management sites over a 5-year period (2009 - 2014) for each patient audited. Demographic data along with laboratory test results and antiretroviral therapy regime data will be collected to assess factors associated with retention in care.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1537 participants
Time Perspective: Retrospective
Official Title: Patient Retention in HIV Medical Care in a Primary Care Practice in Australia
Study Start Date : June 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
Retained in Care
Each patient who had at least 2 practice visits separated by ≥90 days in a year involving HIV laboratory monitoring until 31st of March 2014.
Lost to follow-up (LTFU)
Each patient who had at 2 practice visits separated by ≥90 days in a year involving HIV laboratory monitoring but did not maintain regular attendance at HHMP until 31st March, 2014.



Primary Outcome Measures :
  1. The primary outcome measures are the rates of current linkage and retention in care for HIV-infected adults at Holdsworth House Medical Practice (HHMP) over a 5-year period [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. A secondary outcome measure is to determine the factors associated with loss to follow up (LTFU) in the study population over a 5-year period [ Time Frame: Up to 5 years ]

Other Outcome Measures:
  1. Determining the reasons for LTFU - death, move to another practice, move interstate or overseas, other reason, unknown [ Time Frame: Up to 5 years ]
  2. The proportion of patients on antiretroviral therapy vs. not on therapy [ Time Frame: Up to 5 years ]
  3. The proportion of patients with undetectable viral load i.e. most recent plasma HIV RNA <50 copies/mL [ Time Frame: Up to 5 years ]
  4. The proportion of patients with normal immunity i.e. most recent CD4 >500 cells/μL [ Time Frame: Up to 5 years ]
  5. The proportion of treatment-naïve patients with CD4>500 cells/μL. [ Time Frame: Up to 5 years ]
  6. Antiretroviral regimen (including single-tablet-regimen) association with retention in care and LTFU [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected patients attending HHMP from 1st January 2009 to 31st March 2014 inclusive, who had at least 2 practice visits separated by ≥90 days in a year involving HIV laboratory monitoring whilst attending HHMP.
Criteria

Inclusion Criteria:

  • Documented HIV-1 infection
  • Attendance during the study period for at least 2 visits >3 months and <12 months apart with measured laboratory virological or immunological markers (either on-site or at a co-management site)

Exclusion Criteria:

  • Attendance by patient with HIV infection who does not have laboratory markers of HIV viral load or CD4 count measured
  • Incomplete/inaccessible patient records to enable patient to meet inclusion criteria
  • Initial visit after 1st January 2014

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167100


Locations
Layout table for location information
Australia, New South Wales
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
Sponsors and Collaborators
Holdsworth House Medical Practice
Gilead Sciences
Investigators
Layout table for investigator information
Principal Investigator: Mark T Bloch, MBBS Holdsworth House Medical Practice
Publications:

Layout table for additonal information
Responsible Party: Dr. Mark Bloch, Director, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier: NCT02167100    
Other Study ID Numbers: Retention in Care Audit
HIV Retention in Care ( Other Identifier: HHMP )
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: September 21, 2015
Last Verified: September 2015
Keywords provided by Dr. Mark Bloch, Holdsworth House Medical Practice:
HIV
Highly Active Antiretroviral Therapy
Patient Care
Patient Care Management
Lost to Follow-Up