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NCT05902572Recruiting

DSD Models at Zambia Sentinel Sites (SENTINEL 2)

Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in Zambia (Sentinel-Zambia)
Boston UniversityClinicalTrials.govother
Study focus
Disease/Condition
HIV
Drug/Device/Intervention
No intervention
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
Boston University
Location
Lusaka, Zambia
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2021
End date
Jun 01, 2026
Enrollment
8280 participants
Primary outcome

Proportion of patient survey participants with HIV viral suppression ≤400 copies/ml at most recent test

Summary

To achieve global goals for the treatment of HIV, many countries are piloting 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 progress and challenges at the facility level-the number
 of patients actually participating in DSD models, health outcomes and non-health outcomes,
 effects on service delivery capacity and clinic efficiency and operations, and costs to
 providers and patients.
 
 Alternative Models of ART Delivery: Optimizing Benefits (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. The first AMBIT protocol, Gathering Records
 to Evaluate Antiretroviral Treatment (GREAT, Zambia Ref. No. 2019-Sep-030), collects and
 analyzes comprehensive patient medical record data, allowing us to assess the effect of DSD
 models on patients' clinical outcomes and to evaluate uptake of DSD models at scale.
 
 The Sentinel-Zambia study, the second AMBIT protocol, is examining the effect of DSD models
 on patient and provider satisfaction, service delivery capacity and quality, costs to
 patients, and other outcomes for which data are not routinely collected in patient-level
 medical records. The first round of Sentinel-SA was conducted in 2021. The AMBIT 2.0 protocol
 will allow up to four additional annual rounds of data collection, in 2022-2025. We collected
 clinic aggregate data, conducted surveys of patients and providers, and observed operations
 at a selected set of 12 Zambian healthcare facilities and their affiliated DSD models in
 Round 1. Round 2 (2022) and later rounds will collect the same types of data at 12 facilities
 in Zambia and will expand the study's research questions to include differentiated models of
 HIV testing and linkage to care. Results are expected to inform Zambian policy makers and
 other local and international stakeholders on the actual implications of DSD models for
 patients, health system operations, and healthcare budgets.

ICD-10 classifications
Human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other conditionsHIV disease resulting in other viral infectionsUnspecified human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other specified diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05902572
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05902572 through Pure Global AI's free database. This phase not specified trial is sponsored by Boston University and is currently Recruiting. The study focuses on HIV. Target enrollment is 8280 participants.

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