GREAT: Gathering Records to Evaluate Antiretroviral Treatment-South Africa

Sponsor
Boston University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04149782
Collaborator
Bill and Melinda Gates Foundation (Other), University of Witwatersrand, South Africa (Other)
7,000,000
1
39
179648

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Routine medical record data collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
7000000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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)
Actual Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Patient-months enrolled in any DSD model [12 months]

    % of all patient-months of ART provided for the cohort that are provided within DSD models

  2. Patient-months enrolled in any DSD model [24 months]

    % of all patient-months of ART provided for the cohort that are provided within DSD models

  3. Patient-months enrolled in any DSD model [6 months]

    % of all patient-months of ART provided for the cohort that are provided within DSD models

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 All clinics Johannesburg South Africa 2193

Sponsors and Collaborators

  • Boston University
  • Bill and Melinda Gates Foundation
  • University of Witwatersrand, South Africa

Investigators

  • Principal Investigator: Sydney Rosen, Boston University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston University
ClinicalTrials.gov Identifier:
NCT04149782
Other Study ID Numbers:
  • H-38815
First Posted:
Nov 4, 2019
Last Update Posted:
Dec 28, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Boston University

Study Results

No Results Posted as of Dec 28, 2021