Gathering Records to Evaluate Antiretroviral Treatment-Zambia (GREAT )

HIV Clinical Trial

— GREAT  

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 (Zambia)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04158882
• Other study ID #: H-38823
• Status: Recruiting
• Start date: December 1, 2019
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Boston University
• Contact: Sydney B Rosen
• Phone: 6173582251
• Email: sbrosen[@]bu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200000
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• = 15 years old

• Patients accessing care for HIV within the data collection period

• In any HIV transmission risk group

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Zambia	All clinics	Lusaka

Sponsors (4)

Lead Sponsor	Collaborator
Boston University	Bill and Melinda Gates Foundation, Clinton Health Access Initiative Inc., University of Witwatersrand, South Africa

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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