Patient Retention in HIV Medical Care in a Primary Care Practice in Australia (RiC)
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|ClinicalTrials.gov Identifier: NCT02167100|
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : September 21, 2015
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|
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.
|Study Type :||Observational|
|Actual Enrollment :||1537 participants|
|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|
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.
- 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 ]
- 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 ]
- Determining the reasons for LTFU - death, move to another practice, move interstate or overseas, other reason, unknown [ Time Frame: Up to 5 years ]
- The proportion of patients on antiretroviral therapy vs. not on therapy [ Time Frame: Up to 5 years ]
- The proportion of patients with undetectable viral load i.e. most recent plasma HIV RNA <50 copies/mL [ Time Frame: Up to 5 years ]
- The proportion of patients with normal immunity i.e. most recent CD4 >500 cells/μL [ Time Frame: Up to 5 years ]
- The proportion of treatment-naïve patients with CD4>500 cells/μL. [ Time Frame: Up to 5 years ]
- Antiretroviral regimen (including single-tablet-regimen) association with retention in care and LTFU [ Time Frame: Up to 5 years ]
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
|Australia, New South Wales|
|Holdsworth House Medical Practice|
|Darlinghurst, New South Wales, Australia, 2010|
|Principal Investigator:||Mark T Bloch, MBBS||Holdsworth House Medical Practice|