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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04149782




Registration number
NCT04149782
Ethics application status
Date submitted
31/10/2019
Date registered
4/11/2019
Date last updated
30/10/2024

Titles & IDs
Public title
Gathering Records to Evaluate Antiretroviral Treatment-South Africa
Scientific title
Analysis of Existing Medical Record Data to Evaluate Coverage, Uptake, Benefits, and Costs of Differentiated Models of Service Delivery for HIV Treatment in Africa (South Africa)
Secondary ID [1] 0 0
H-38815
Universal Trial Number (UTN)
Trial acronym
GREAT
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
Other interventions - Routine medical record data collection

Patients enrolled in differentiated service delivery models -

Patients not enrolled in DSD models -


Other interventions: Routine medical record data collection
The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient-months enrolled in any DSD model
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Patient-months enrolled in any DSD model
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
Patient-months enrolled in any DSD model
Timepoint [3] 0 0
6 months

Eligibility
Key inclusion criteria
* = 15 years old
* Patients accessing care for HIV within the data collection period
* In any HIV transmission risk group
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
7000000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
South Africa
State/province [1] 0 0
Johannesburg

Funding & Sponsors
Primary sponsor type
Other
Name
Boston University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Bill and Melinda Gates Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Witwatersrand, South Africa
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To achieve global goals for the treatment of HIV, most high-prevalence countries are experimenting with and scaling up differentiated service delivery models (DSD). A handful of efforts have been formally described and evaluated in the literature; many others are being implemented formally or informally under routine care, without a research or evaluation goal. For most countries, however, we have little evidence on the big picture-the proportion of clinics offering alternative models, eligibility criteria and the proportion of patients considered eligible, the number of patients actually participating, health outcomes such as viral suppression, empirical resource utilization compared to traditional care, variations among the models, duration of patient participation, fidelity to model guidelines, effects on clinic efficiency, and sustainability without external donor support.

AMBIT a set of data synthesis, data collection, and data analysis activities aimed at generating information for near- and long-term decision making and creating an approach and platform for ongoing evaluation of differentiated models of HIV treatment delivery in the future. The project will collect and analyze a wide range of existing data sets pertinent to DSD. This protocol is for an analysis of existing medical record data collected by the Department of Health, implementing partners, and other completed, ongoing, or new evaluations, trials, and observational studies. Outcomes to be reported include coverage/uptake of DSD, patients' outcomes, and distribution of each model. There will be no study interaction with individual patients, providers, caregivers, or others for this analysis.
Trial website
https://clinicaltrials.gov/study/NCT04149782
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Sydney B Rosen, MPA
Address 0 0
Boston University School of Public Health, Global Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Matthew A Fox, DSc
Address 0 0
Country 0 0
Phone 0 0
617 414 1270
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04149782