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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02167100