Gathering Records to Evaluate Antiretroviral Treatment-Malawi ( GREAT )

Study Overview
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Brief Summary
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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 is 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.

Official Title
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Analysis of Existing Medical Record Data to Evaluate Coverage, Uptake, Benefits, and Costs of Differentiated Models of Service Delivery for HIV Treatment in Africa (Malawi)

Conditions
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HIV

Intervention / Treatment
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* Other: Routine medical record data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 15 years old Patients accessing care for HIV within the data collection period In any HIV transmission risk group Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients enrolled in differentiated service delivery models<br> | Other: Routine medical record data collection<br>* The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.<br>|
| Patients not enrolled in DSD models<br> | Other: Routine medical record data collection<br>* The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Malawi, Differentiated service delivery, Antiretroviral therapy