Clinical trial NCT02167100: Patient Retention in HIV Medical Care in a Primary Care Practice in Australia
Official title: Patient Retention in HIV Medical Care in a Primary Care Practice in Australia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
Highly Active Antiretroviral Therapy
Patient Care
Patient Care Management
Lost to Follow-Up
Lead sponsor: Holdsworth House Medical Practice
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2014-06-18
Enrollment: 1537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to 5 years
Secondary outcomes:
measure: 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
timeFrame: Up to 5 years
Other outcomes:
measure: Determining the reasons for LTFU - death, move to another practice, move interstate or overseas, other reason, unknown
timeFrame: Up to 5 years
measure: The proportion of patients on antiretroviral therapy vs. not on therapy
timeFrame: Up to 5 years
measure: The proportion of patients with undetectable viral load i.e. most recent plasma HIV RNA <50 copies/mL
timeFrame: Up to 5 years
measure: The proportion of patients with normal immunity i.e. most recent CD4 >500 cells/μL
timeFrame: Up to 5 years
measure: The proportion of treatment-naïve patients with CD4>500 cells/μL.
timeFrame: Up to 5 years
measure: Antiretroviral regimen (including single-tablet-regimen) association with retention in care and LTFU
timeFrame: Up to 5 years
Locations:
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
Study officials:
affiliation: Holdsworth House Medical Practice
name: Mark T Bloch, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Fang CT, Hsu HM, Twu SJ, Chen MY, Chang YY, Hwang JS, Wang JD, Chuang CY; Division of AIDS and STD, Center for Disease Control, Department of Health, Executive Yuan. Decreased HIV transmission after a policy of providing free access to highly active antiretroviral therapy in Taiwan. J Infect Dis. 2004 Sep 1;190(5):879-85. doi: 10.1086/422601. Epub 2004 Jul 22.
citation: Giordano TP, Visnegarwala F, White AC Jr, Troisi CL, Frankowski RF, Hartman CM, Grimes RM. Patients referred to an urban HIV clinic frequently fail to establish care: factors predicting failure. AIDS Care. 2005 Aug;17(6):773-83. doi: 10.1080/09540120412331336652.