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NCT Number: NCT04158882

Gathering Records to Evaluate Antiretroviral Treatment-Zambia (GREAT )

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.

Recruiting

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Key information

Conditions

HIV

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Routine medical record data collection

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Brooke Nichols

CONTACT

[email protected]

6173282440

Sydney B Rosen

CONTACT

[email protected]

6173582251

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Clinton Health Access Initiative Inc.
  • University of Witwatersrand, South Africa

Registry information

Official study 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)

Acronym: GREAT

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Nov 12, 2019
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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