- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04158882
Gathering Records to Evaluate Antiretroviral Treatment-Zambia (GREAT ) (GREAT)
Analysis of Existing Medical Record Data to Evaluate Coverage, Uptake, Benefits, and Costs of Differentiated Models of Service Delivery for HIV Treatment in Africa (Zambia)
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, there is 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 Ministry 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sydney B Rosen
- Phone Number: 6173582251
- Email: sbrosen@bu.edu
Study Contact Backup
- Name: Brooke Nichols
- Phone Number: 6173282440
- Email: brooken@bu.edu
Study Locations
-
-
-
Lusaka, Zambia
- Recruiting
- All clinics
-
Contact:
- Sophie Pascoe
- Phone Number: +27 (10)001-7930
- Email: spascoe@heroza.org
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 15 years old
- Patients accessing care for HIV within the data collection period
- In any HIV transmission risk group
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients enrolled in differentiated service delivery models
|
The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
|
Patients not enrolled in DSD models
|
The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-months enrolled in any DSD model
Time Frame: 12 months
|
% of all patient-months of ART provided for the cohort that are provided within DSD models
|
12 months
|
Patient-months enrolled in any DSD model
Time Frame: 24 months
|
% of all patient-months of ART provided for the cohort that are provided within DSD models
|
24 months
|
Patient-months enrolled in any DSD model
Time Frame: 6 months
|
% of all patient-months of ART provided for the cohort that are provided within DSD models
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Sydney B Rosen, Boston University School of Pubic Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-38823
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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