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Clinical Trials/NCT04158895
NCT04158895
Recruiting
Not Applicable

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)

Boston University1 site in 1 country1,000,000 target enrollmentDecember 1, 2019
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Boston University
Enrollment
1000000
Locations
1
Primary Endpoint
Patient-months enrolled in any DSD model
Status
Recruiting
Last Updated
5 months ago

Overview

Brief 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, 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.

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
December 31, 2027
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Sites (1)

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