Gathering Records to Evaluate Antiretroviral Treatment-South Africa (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 (South Africa)

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.

Study Overview

• Status: Recruiting
• Conditions: HIV
• Intervention / Treatment: Other: Routine medical record data collection

• Study Type: Observational
• Enrollment (Estimated): 7000000

Contacts and Locations

• Study Contact: Name: Matthew A Fox, DSc; Phone Number: 617 414 1270; Email: mfox@bu.edu
• Study Contact Backup: Name: Sydney B Rosen, MPA; Phone Number: 617 358 2251; Email: sbrosen@bu.edu

Study Locations

• South Africa
  • Johannesburg, South Africa, 2193
    • Recruiting
    • All clinics
    • Contact: Sophie Pascoe; Phone Number: +27 (10)001-7930; Email: spascoe@heroza.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adults who are accessing care for HIV anywhere in the country.

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients enrolled in differentiated service delivery models	Other: 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.
Patients not enrolled in DSD models	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-months enrolled in any DSD model	% 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	% 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	% of all patient-months of ART provided for the cohort that are provided within DSD models	6 months

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Bill and Melinda Gates Foundation; University of Witwatersrand, South Africa
• Investigators: Principal Investigator: Sydney B Rosen, MPA, Boston University School of Public Health, Global Health; Principal Investigator: Matthew A Fox, DSc, Boston University School of Public Health, Global Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: HIV; South Africa; Antiretroviral therapy; Differentiated service delivery
• Other Study ID Numbers: H-38815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No