ANZCTR - Registration

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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

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]

H-38815

Universal Trial Number (UTN)

Trial acronym

GREAT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

HIV

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]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Patient-months enrolled in any DSD model

Timepoint [1]

12 months

Primary outcome [2]

Patient-months enrolled in any DSD model

Timepoint [2]

24 months

Primary outcome [3]

Patient-months enrolled in any DSD model

Timepoint [3]

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?

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]

South Africa

State/province [1]

Johannesburg

Funding & Sponsors

Primary sponsor type

Other

Name

Boston University

Address

Country

Other collaborator category [1]

Other

Name [1]

Bill and Melinda Gates Foundation

Address [1]

Country [1]

Other collaborator category [2]

Other

Name [2]

University of Witwatersrand, South Africa

Address [2]

Country [2]

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

Sydney B Rosen, MPA

Address

Boston University School of Public Health, Global Health

Country

Phone

Fax

Contact person for public queries

Name

Matthew A Fox, DSc

Address

Country

Phone

617 414 1270

Fax

mfox@bu.edu

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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/NCT04149782

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