Gathering Records to Evaluate Antiretroviral Treatment-South Africa

Официальное название

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

Обзор

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 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 Department 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.

Вмешательства

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

Первичные конечные точки

• Patient-months enrolled in any DSD model [Срок оценки: 12 months]
• Patient-months enrolled in any DSD model [Срок оценки: 24 months]
• Patient-months enrolled in any DSD model [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

• None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

ЮАР · 1 центр

• All clinics — Johannesburg

Публикации

• Huber AN, Jamieson L, Fox MP, Manganye M, Malala L, Chidarikire T, Khoza N, Nichols BE, Rosen S, Pascoe S. Evaluating the impact of differentiated service delivery (DSD) on retention in care and HIV viral suppression in South Africa: A target trial emulation using routine healthcare data. PLoS Med. 2025 Aug 26;22(8):e1004489. doi: 10.1371/journal.pmed.1004489. eCollection 2025 Aug. PMID 40857347

Идентификаторы

NCT: NCT04149782 · H-38815

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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