Gathering Records to Evaluate Antiretroviral Treatment-Zambia (GREAT )

ConditionHIV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15+
SponsorBoston University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 15 years old

Patients accessing care for HIV within the data collection period

In any HIV transmission risk group

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Routine medical record data collection

    Other intervention

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

Treatment groups

1,200,000 Participants
are divided into 2 treatment groups
Group A: Patients enrolled in differentiated service delivery models1 intervention
Group B: Patients not enrolled in DSD models1 intervention

Trial outcomes

Primary outcomes

1

Patient-months enrolled in any DSD model

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

Time frame
12 months
2

Patient-months enrolled in any DSD model

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

Time frame
24 months
3

Patient-months enrolled in any DSD model

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston University

Lead sponsor

Bill and Melinda Gates Foundation

Collaborator

University of Witwatersrand, South Africa

Collaborator

Clinton Health Access Initiative Inc.

Collaborator