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Gathering Records to Evaluate Antiretroviral Treatment-South Africa

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)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04149782
Acronym
GREAT
Enrollment
7000000
Registered
2019-11-04
Start date
2019-12-01
Completion date
2027-12-31
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, South Africa, Differentiated service delivery, Antiretroviral therapy

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.

Interventions

The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.

Sponsors

Bill and Melinda Gates Foundation
CollaboratorOTHER
University of Witwatersrand, South Africa
CollaboratorOTHER
Boston University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥ 15 years old * Patients accessing care for HIV within the data collection period * In any HIV transmission risk group

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Patient-months enrolled in any DSD model12 months% of all patient-months of ART provided for the cohort that are provided within DSD models

Countries

South Africa

Contacts

Primary ContactMatthew A Fox, DSc
mfox@bu.edu617 414 1270
Backup ContactSydney B Rosen, MPA
sbrosen@bu.edu617 358 2251

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026