Patient Retention in HIV Medical Care in a Primary Care Practice in Australia

HIV Clinical Trial

— RiC  

Official title:

Patient Retention in HIV Medical Care in a Primary Care Practice in Australia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167100
• Other study ID #: Retention in Care Audit
• Secondary ID: HIV Retention in
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: September 17, 2015
• Start date: June 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Holdsworth House Medical Practice
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1537
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
Australia	Holdsworth House Medical Practice	Darlinghurst	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Holdsworth House Medical Practice	Gilead Sciences

Country where clinical trial is conducted

Australia, 

References & Publications (7)

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. — View Citation

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. — View 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. Epub 2004 Jul 22. — View Citation

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. Review. — View 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determining the reasons for LTFU - death, move to another practice, move interstate or overseas, other reason, unknown		Up to 5 years	No
Other	The proportion of patients on antiretroviral therapy vs. not on therapy		Up to 5 years	No
Other	The proportion of patients with undetectable viral load i.e. most recent plasma HIV RNA <50 copies/mL		Up to 5 years	No
Other	The proportion of patients with normal immunity i.e. most recent CD4 >500 cells/µL		Up to 5 years	No
Other	The proportion of treatment-naïve patients with CD4>500 cells/µL.		Up to 5 years	No
Other	Antiretroviral regimen (including single-tablet-regimen) association with retention in care and LTFU		Up to 5 years	No
Primary	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	No
Secondary	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	No