Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02167100




Registration number
NCT02167100
Ethics application status
Date submitted
5/06/2014
Date registered
18/06/2014
Date last updated
21/09/2015

Titles & IDs
Public title
Patient Retention in HIV Medical Care in a Primary Care Practice in Australia
Scientific title
Patient Retention in HIV Medical Care in a Primary Care Practice in Australia
Secondary ID [1] 0 0
HIV Retention in Care
Secondary ID [2] 0 0
Retention in Care Audit
Universal Trial Number (UTN)
Trial acronym
RiC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 5 years

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
1537
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
Holdsworth House Medical Practice
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02167100
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Mark T Bloch, MBBS
Address 0 0
Holdsworth House Medical Practice
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02167100