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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 1537

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Up to 5 years

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Holdsworth House Medical Practice
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Mark T Bloch, MBBS, Holdsworth House Medical Practice

Publications and helpful links

General Publications

• Gardner EM, McLees MP, Steiner JF, Del Rio C, Burman WJ. The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection. Clin Infect Dis. 2011 Mar 15;52(6):793-800. doi: 10.1093/cid/ciq243.
• Mugavero MJ, Lin HY, Willig JH, Westfall AO, Ulett KB, Routman JS, Abroms S, Raper JL, Saag MS, Allison JJ. Missed visits and mortality among patients establishing initial outpatient HIV treatment. Clin Infect Dis. 2009 Jan 15;48(2):248-56. doi: 10.1086/595705.
• 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.
• Hall HI, Halverson J, Wilson DP, Suligoi B, Diez M, Le Vu S, Tang T, McDonald A, Camoni L, Semaille C, Archibald C. Late diagnosis and entry to care after diagnosis of human immunodeficiency virus infection: a country comparison. PLoS One. 2013 Nov 5;8(11):e77763. doi: 10.1371/journal.pone.0077763. eCollection 2013.
• Centers for Disease Control and Prevention (CDC). Vital signs: HIV prevention through care and treatment--United States. MMWR Morb Mortal Wkly Rep. 2011 Dec 2;60(47):1618-23.
• Das M, Chu PL, Santos GM, Scheer S, Vittinghoff E, McFarland W, Colfax GN. Decreases in community viral load are accompanied by reductions in new HIV infections in San Francisco. PLoS One. 2010 Jun 10;5(6):e11068. doi: 10.1371/journal.pone.0011068.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Estimate): September 21, 2015
• Last Update Submitted That Met QC Criteria: September 17, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: HIV; Patient Care; Patient Care Management; Highly Active Antiretroviral Therapy; Lost to Follow-Up
• Other Study ID Numbers: Retention in Care Audit; HIV Retention in Care (Other Identifier: HHMP)