NCT02167100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,537

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

June 5, 2014

Last Update Submit

September 17, 2015

Conditions

Keywords

HIVHighly Active Antiretroviral TherapyPatient CarePatient Care ManagementLost to Follow-Up

Outcome Measures

Primary Outcomes (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

    Up to 5 years

Secondary Outcomes (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

    Up to 5 years

Other Outcomes (6)

  • 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

  • +3 more other outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • Attendance by patient with HIV infection who does not have laboratory markers of HIV viral load or CD4 count measured
  • Initial visit after 1st January 2014

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holdsworth House Medical Practice

Darlinghurst, New South Wales, 2010, Australia

Location

Related Publications (7)

  • 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.

    PMID: 24223724BACKGROUND
  • 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.

    PMID: 21367734BACKGROUND
  • 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.

    PMID: 22129997BACKGROUND
  • 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.

    PMID: 19072715BACKGROUND
  • 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.

    PMID: 20548786BACKGROUND
  • 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.

    PMID: 15295691BACKGROUND
  • 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.

    PMID: 16036264BACKGROUND

Study Officials

  • Mark T Bloch, MBBS

    Holdsworth House Medical Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 18, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 21, 2015

Record last verified: 2015-09

Locations