Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04158882

Gathering Records to Evaluate Antiretroviral Treatment-Zambia (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 (Zambia)

Status
Recruiting
Phase
Study type
Observational
Enrollment
1,200,000 (estimated)
Sponsor
Boston University · Academic / Other
Sex
All
Age
15 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2019-12-01
Primary completion
2026-12-31
Completion
2027-12-31
First posted
2019-11-12
Last updated
2025-11-17

Locations

1 site across 1 country: Zambia

Source: ClinicalTrials.gov record NCT04158882. Inclusion in this directory is not an endorsement.